Villa Sistemi Medicali S p A 76593030 Modular Wireless remote control for radiological unit User Manual Title
Villa Sistemi Medicali S.p.A. Modular Wireless remote control for radiological unit Title
User Manual
CDEF Release May 6, 2014 (Draft) 0051 SERVICE MANUAL Revision history DF Rev. Date Page/s 14.02.13 04.09.13 12, 13, 28, 31, 36, 42, 86, 88, 90 Modification description Document approval. FDA approved revision. Added note on spacer insertion during stand arm set assembling. Mains plug on mobile stand version no more supplied. Spare Parts update. (Ref. RDM 7723, RDM 7763, RDM 7773, RDM 7797, RDM 7836) (Rev. 1) ENDOGRAPH DC SERVICE MANUAL Revision history THIS PAGE IS INTENTIONALLY LEFT BLANK ENDOGRAPH DC (Rev. 1) SERVICE MANUAL Contents Contents 1. INTRODUCTION 1.1 1.2 2. Icons in the manual................................................................................ 1 How to contact VILLA SISTEMI MEDICALI technical service................... 2 SAFETY ASPECTS 2.1 2.2 2.3 2.4 Protection from X-rays............................................................................ 9 Environmental risks and disposal ........................................................ 10 Symbols in use ..................................................................................... 11 3.3 High Frequency (HF) Generator.......................................................... 15 Extension arm and scissors arm ........................................................ 15 Tube-head......................................................................................... 16 Timer ................................................................................................ 16 Configurations...................................................................................... 17 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 Standard configuration...................................................................... 17 Remote timer configuration ............................................................... 18 Mobile stand configuration ................................................................ 19 Remote X-ray button configuration .................................................... 20 Configuration with wireless X-ray button ........................................... 21 TECHNICAL DATA 4.1 4.2 4.3 4.4 22 Method for measuring technical factors................................................ 25 Curves tube features ............................................................................ 26 Reference standard............................................................................... 28 Dimensions .......................................................................................... 30 PRE-INSTALLATION 5.1 5.2 6. 12 Identification plates .............................................................................. 12 Functions, Models and Versions........................................................... 14 3.2.1 3.2.2 3.2.3 3.2.4 5. Electromagnetic emissions................................................................... 5 Electromagnetic immunity................................................................... 6 Recommended separation distances to portable and mobile radio equipment ....................................................................... 8 DESCRIPTION 3.1 3.2 4. Warnings ................................................................................................ 4 2.1.1 2.1.2 2.1.3 3. 31 Mounting methods ............................................................................... 31 Electric pre-setting ............................................................................... 32 INSTALLATION 6.1 Wall installation ................................................................................... 33 6.1.1 6.2 (Rev. 1) 33 Timer set up (standard configuration) ................................................ 34 Assembling the mobile stand and timer installation ............................. 35 ENDOGRAPH DC SERVICE MANUAL Contents 6.3 Assembling the arms ............................................................................ 37 6.3.1 6.3.2 6.3.3 6.4 Installation of the optional parts........................................................... 45 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.5 7. External signaling devices ................................................................. 45 Remote X-ray button ......................................................................... 46 Wireless X-ray button ....................................................................... 48 6.4.3.1 Wireless X-ray button –battery assembling ......................... 48 6.4.3.2 Wireless upgrade kit assembling ........................................ 49 6.4.3.3 Wireless X-ray button – Timer matching ............................. 51 Remote Timer configuration............................................................... 52 6.4.4.1 Wall support set-up ........................................................... 52 6.4.4.2 Remote Timer set up .......................................................... 53 Installation of chemical screws .......................................................... 54 Electrical connection ............................................................................ 55 6.5.1 6.5.2 6.6 Assembling the extension arm ........................................................... 37 Assembling the scissors arm (DP arm) ............................................... 39 Assembling the stand arms set .......................................................... 44 Electrical Electrical 6.5.2.1 6.5.2.2 connection for standard and mobile stand versions............. 55 connection for Remote Timer version .................................. 57 Wall support connection .................................................... 57 Remote Timer connection................................................... 58 Power-up sequence............................................................................... 59 CHECKS, CALIBRATIONS AND ADJUSTMENTS 7.1 60 Arm adjustment.................................................................................... 60 7.1.1 7.1.2 7.1.3 Adjusting the extension arm support frictioning mechanism .............. 61 Adjusting the extension arm frictioning mechanism ........................... 62 Adjusting the balance scissors arm.................................................... 63 8. SET-UP 65 9. TROUBLESHOOTING 71 9.1 Error messages on the display .............................................................. 72 9.1.1 9.1.2 9.1.3 Fatal errors upon power-up and in the ready, idle and cooling statuses73 Fatal errors during X-ray emission .................................................... 74 NON fatal errors................................................................................ 75 10. REPLACING PARTS 76 10.1 Replacing the tubehead and the Driver board....................................... 76 10.1.1 10.1.2 Replacing the tubehead ..................................................................... 77 Replacing the Driver board ................................................................ 77 10.2 Replacing the CPU board ...................................................................... 78 10.3 Replacing the keypad............................................................................ 79 10.4 Replacing the scissors arm ................................................................... 80 10.4.1 10.4.2 ENDOGRAPH DC Replacing the scissors arm with wall timer (standard configuration) ... 80 Replacing the scissor arm on mobile stand ........................................ 81 ii (Rev. 1) SERVICE MANUAL Contents 11. MAINTENANCE 82 12. SCHEMATICS AND DRAWINGS 83 13. SPARE PARTS 87 14. FIXING TEMPLATES 99 This publication can only be reproduced, transmitted, transcribed or translated into any human or computer language with the written consent of the Manufacturer. This Manual in English is the original version. (Rev. 1) iii ENDOGRAPH DC SERVICE MANUAL Contents THIS PAGE IS INTENTIONALLY LEFT BLANK ENDOGRAPH DC iv (Rev. 1) SERVICE MANUAL Introduction NOTE: This manual is updated for the product it is sold with, in order to guarantee an adequate reference to use the product properly and safely. The manual may not reflect changes to the product that do not affect operating modes or safety. The Endograph DC intra-oral X-ray unit takes high quality intra-oral Xrays thanks to reduced exposure times and the small dimensions of the focus spot. Endograph DC is intended exclusively for intra-oral X-rays. System operation is managed by a microprocessor, which permits high reproducibility of the exposure times. The system consists of the following parts: • timer: Endograph DC complete with the wall support • extension arm (30cm, 60 cm or 80cm for the wall version) • Scissors arm (DP) • Tube-head (60-65-70) kV ; 6 mA The aim of this manual is to instruct the user on the safe and effective use of the device. The device must be used in compliance with the procedures described, and never be used for purposes different from those herewith indicated. Indicates a “NOTE”; we recommend particular attention in reading the subjects identified with this icon. Indicates a “WARNING”; subjects identified with this icon concern safety aspects regarding the patient and/or the operator. (Rev. 1) ENDOGRAPH DC SERVICE MANUAL Introduction C C DEF For any technical queries please contact the following: • Telephone number +39 02 48859.1 • Fax number +39 02 48859222 • E-mail: dentalservice@villasm.com ENDOGRAPH DC (Rev. 1) SERVICE MANUAL Safety aspects B C WARNING: Please read this chapter thoroughly. VILLA SISTEMI MEDICALI designs and builds the devices in compliance with the safety requirements; furthermore it supplies all information necessary for correct use, and the warnings related to danger associated with X-ray generating units. The manufacturer cannot be held responsible for: • use of Endograph DC equipment different from the purpose for which it was originally designed, • • damage to the unit, the operator or the patient, caused both by incorrect installation and maintenance procedures different from those described in this user and service manuals supplied with the unit, and by wrong operations, mechanical and/or electrical modifications performed during and after the installation, different from those described in the service manual. Only personnel authorised by the manufacturer may carry out technical operations on the unit. Only authorised personnel can remove the tube-head from its support and/or access the components under tension. (Rev. 1) ENDOGRAPH DC SERVICE MANUAL Safety aspects The device must be used in compliance with the procedures described and never be used for purposes different from those herewith indicated. Before performing any maintenance operation, disconnect the unit from the power supply using the provided circuit breaker. Endograph DC is an electro-medical device and therefore it can be used only under the supervision of suitably qualified medical personnel, with the necessary knowledge on X-ray protection. The user is responsible for the fulfilment of the legal requirements regulating the ownership, installation and use of the equipment itself. Endograph DC has been built to support continuous operation at intermittent load; therefore please follow the described use cycles. Wherever necessary, use the appropriate accessories, such as the leaded aprons, to protect the patient from radiation. Endograph DC must be turned off when using electrosurgical devices or similar equipment near the unit. This device has not been designed to be used in environments where anaesthetic mixtures flammable with air, oxygen or nitrous oxide can be detected. In order to prevent risks of short-circuit and corrosion, avoid the entry of water or other liquids in the equipment. The parts of the unit that can come into contact with the patient must be cleaned regularly according to the instructions provided below in this document. WARNING: For safety reasons, it is prohibited to abnormally overload the extension arm or the scissors arm, for example by leaning on it. ENDOGRAPH DC (Rev. 1) SERVICE MANUAL Safety aspects In accordance with the IEC 60601-1-2 standard, Endograph DC is suitable for use in the electromagnetic environment specified below. The customer or user of the system must ensure that it is used in the said environment. Emissions test Conformity EMC environment of use RF emissions Class B Endograph DC is suitable for use in all domestic environments and in environments directly connected to the mains power supply at low voltage that supplies buildings for domestic use. Endograph DC uses RF power only for its internal functioning. As a result, its RF emissions are very low and most likely will not cause any interference in electronic devices located nearby. CISPR 11 Group I Harmonic emissions IEC 61000-3-2 Flicker/voltage fluctuation emissions IEC 61000-3-3 (Rev. 1) Class A In compliance ENDOGRAPH DC SERVICE MANUAL Safety aspects In accordance with the IEC 60601-1-2 standard, Endograph DC is suitable for use in the electromagnetic environment described below. The customer or user of the system must ensure that it is used in the said environment. Immunity test Test level IEC 60601-1-2 Compliance level Electrostatic discharges (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV in air ± 6 kV contact ± 8 kV in air Transients/sequence of rapid electric impulses IEC 61000-4-4 ± 2 kV for power supply lines ± 2 kV for power supply lines ± 1 kV for input/output lines ± 1 kV between phases ± 1 kV for input/output lines ± 1 kV between phases EMC environment of use The flooring must be must be wood, concrete or ceramic tile. If the flooring is covered with synthetic material, the relative humidity must be at least 30%. The quality of the mains voltage must be the same as a typical commercial or hospital environment. The quality of the mains voltage must be the same as a typical ± 2 kV between phase ± 2 kV between phase commercial or hospital environment. and earth and earth 0 % Ut for 0.5 cycles 0 % Ut for 0.5 cycles The quality of the mains Voltage dips, short voltage must be the breaks and voltage 40 % Ut for 5 cycles 40 % Ut for 5 cycles 70 % Ut for 25 cycles 70 % Ut for 25 cycles same as a typical variations of the commercial or hospital power supply feed 0 % Ut for 5 s 0 % Ut for 5 s line IEC 61000-4-11 environment. If the Endograph DC user requires continuous operation during interruptions in the mains voltage, it is recommended to power the Endograph DC with an uninterrupted power supply or batteries. 3 A/m The levels of the Magnetic field at the 3 A/m magnetic fields at mains main frequency frequency must be the (50/60 Hz) same as a typical IEC 61000-4-8 commercial or hospital environment. Note: Ut is the a.c. mains voltage prior to the application of the test level. Overvoltages IEC 61000-4-5 ENDOGRAPH DC (Rev. 1) SERVICE MANUAL Safety aspects Immunity test Test level IEC 60601-1-2 Compliance level EMC environment of use The RF portable and mobile communications units should not be used closer to any part of the Endograph DC, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: Radiated RF IEC 61000-4-3 Conducted RF IEC 61000-4-6 3 V/m from 80 MHz to 2.5 GHz 3V from 150 kHz to 80 MHz 3 V/m 3V d = 1.2 x √ P 800 MHz from 80 MHz to d = 2.3 x √ P 2.5 GHz from 800 MHz to d = 1.2 x √ P where "P" is the maximum rated output of the transmitter in watts (W) according to the transmitter manufacturer and "d" is the recommended separation distance in meters (m). The field strength of the fixed RF transmitters, determined by an on-site electromagnetic survey, should be lower than the compliance level in each frequency range. Interference may be verified near devices marked with the following symbol: (Rev. 1) ENDOGRAPH DC SERVICE MANUAL Safety aspects DE Endograph DC is designed to operate in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the system can help prevent electromagnetic interference by ensuring a minimum distance between mobile and portable RF communication devices (transmitters) and Endograph DC as recommended in the following table in relation to the maximum output power of the radio devices. Maximum rated output power of the transmitter (W) Separation distance according to the frequency of the transmitter (m) from 150kHz to 80MHz d = 1.2 x √ P from 80MHz to 800MHz d = 1.2 x √ P from 800MHz to 2.5GHz d = 2.3 x √ P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters maximum rated output not shown in the table, the recommended separation distance "d" in meters (m), can be calculated using the equation applicable to the frequency of the transmitter, where "P" is the highest rated output of the transmitter in watts (W) according to the manufacturer of the transmitter. Note 1: at 80 MHz and 800 MHz, apply the separation distance for the higher frequency interval. Note 2: these guidelines may not apply to all situations. Electromagnetic propagation depends on the absorption and reflection of structures, objects and people. ENDOGRAPH DC (Rev. 1) SERVICE MANUAL Safety aspects Although the dose supplied by modern X-ray units is quite low, the operator must adopt the precautions and/or suitable protection for the patient and himself according to current regulations, during the execution of radiography. WARNING: Protection against radiation is regulated according to law. The equipment may only be used by specialised personnel. a) The film (or the digital sensor) must be placed in the patient's mouth either manually or using the specific supports, and must be held in position by the patient if necessary. b) During exposure to the rays, the operator must not be in contact with the tube-head or the collimator cone. c) During exposure, the operator must maintain a certain distance from the source of the rays (at least 2 metres) in the opposite direction of the emission. d) During exposure, only the operator and the patient may be present in the room. e) Use the specific leaded aprons to reduce the undesired effect of secondary radiations for the patient. (Rev. 1) ENDOGRAPH DC SERVICE MANUAL Safety aspects FE Some of the device's components contain material and liquids that, at the end of the equipment life-cycle, must be disposed of at the recycling centres appointed by the local health units. In particular, the device contains the following materials and/or components: • • ENDOGRAPH DC Tube-head: non biodegradable plastic materials, glass, dielectric oil, lead, tungsten, aluminium, copper. Other parts of the device: non biodegradable plastic materials, metal materials, printed circuits, iron-plastic materials. 10 (Rev. 1) SERVICE MANUAL Safety aspects In this manual and on the Endograph DC itself, apart from the symbols indicated on the keypad, also the following icons are used (see chapter 6 of User's Manual): Symbol Description Device with type B applied parts In some of its parts, the device contains materials and liquids that, at the end of the lifespan of the unit, must be disposed of at the appropriate disposal centres ∼ Alternating Current Connection point to the neutral conductor Connection point to the line conductor Earth protection Operation earthing OFF; device not connected to the mains ON; device connected to the mains Exposure enabling key; the exposure enabled status is indicated by the switching on of the corresponding green symbol Ray Emission Focus spot according to IEC 336 Warning: see the accompanying documentation Product identification code Serial number Date of manufacture (year and month) Manufacturer's name and address Filtration Tube-head X-ray tube 0051 0051 (Rev. 1) Conformity to the EC 93/42 Directive and subsequent amendments and additions Guarantees wireless switch for Endograph DC compliance with Directive R&TTE 1995/5/EC 11 ENDOGRAPH DC SERVICE MANUAL Description CB ENDOGRAPH DC 12 (Rev. 1) SERVICE MANUAL Description 1b Endograph DC plate for configuration with Wireless X-ray button 1a Endograph DC plate Tube-head plate DP arm plate Extension arm plate WARNING plate Collimator 30 cm (optional) plate (Rev. 1) Wireless X-ray button (optional) plate 13 ENDOGRAPH DC SERVICE MANUAL Description DE The Endograph DC intra-oral X-ray unit makes it possible to obtain consistently high quality X-rays thanks to the reproducibility of the unit parameters with very short exposure times and a very small focus spot. The Endograph DC intra-oral X-ray unit is compatible for being combined with digital image acquisition systems, thereby obtaining the maximum benefits of today's digital intra-oral radiologic technology. If you do not currently have a digital system, the use of high-speed film or film in the EKTRASPEED (Kodak) category is recommended in order to limit the dose absorbed by the patient. A button on the control keypad is used to select the operating mode and it is possible to select films with different speeds (sensitivity), the phosphor sensor, the digital sensor or a customised user mode "Custom mode". The Endograph DC X-ray unit has an LCD display with dimensions of 84mm x 45mm (240x128 pixel) which makes it easier for the operator to perform all operations, guaranteeing the immediate and complete display of the exposure parameters. The Endograph DC system can use the optional 30 cm collimator cone (to be ordered separately with code 6159400000). The "long cone inserted" selection is signalled by the specific symbol on the display. In this configuration, the exposure times that were pre-set in the anatomic selection are automatically increased by a multiplicative factor of 2. The Endograph DC system includes the following: generator, tube-head complete with collimator, CPU (or logic) card that controls the system functions, keypad, extension arm and scissors arm. WARNING: The Endograph DC system does not automatically detect the presence of a cone or other item: the operator is responsible for checking the congruity between the indication on the display and the actual situation of use. ENDOGRAPH DC 14 (Rev. 1) SERVICE MANUAL Description ED D DE The remote controlled HF generator, together with the tube-head, uses state-of-the-art microelectronic technology to obtain optimal quality X-rays while reducing the patient dose of rays. Conventional systems generally use the intrinsic capacity of the RX generator tube to conduct the electric current in one direction only. This generates a "train" of RX impulses. The Endograph DC unit instead uses constant-voltage technology that generates continuous and stable emission of X-rays. This reduces the emission of soft rays, guaranteeing the constancy of the emission parameters, kVp and mA. The microprocessor-based control ensures constant and repeatable exposure times; by simply pressing a button it is possible to automatically select the exposure times based on the size of the patient and the selected tooth. This consists of an arm with a double joint, which permits horizontal and upward extension. The tube-head remains balanced in all positions. NOTE: The scissors arm was designed to work correctly with a maximum opening angle of 160°; therefore, an opening angle of less than 160° is required for its use. A horizontal extension arm can also be added, which is available in different sizes (30 / 60 / 80 cm) to satisfy all requirements. (Rev. 1) 15 ENDOGRAPH DC SERVICE MANUAL Description The tube-head makes it possible to select one of three different high voltage values: 60 / 65 / 70 kVp. The radiogenic unit is equipped with a collimator with a focus skin distance of 20 cm and a ray emission diameter of 6 cm at the cone exit. The tube-head is connected to the arm by a guide, which permits 390° horizontal rotation and 290° vertical rotation. DE The timer consists of an LCD display (240x128 pixel), two LEDs (yellow: X-rays in progress– green: ready for X-rays) and 5 buttons that are used to select from among 3 different patient sizes, 3 types of sensors (film, phosphor or digital) and 7 different pre-set anatomical structures (incisor, canine, premolar, lower molar, upper molar, front bite-wing and rear bite-wing). There are 36 fixed times available for manual selection which vary from a minimum of 0.01 seconds up to a maximum of 2 seconds. The timing is managed in order to guarantee exact precision of the exposure times. NOTE: The configuration can be set using the remote X-ray control outside the examination room. This consists of a wall support onto which the X-ray button is connected with an extendable cable. NOTE: The unit provides two separate contacts for the possible connection with external signalling devices. One contact signals the status of the unit as operative and ready to be used, the second emits the X-rays. The connection methods and the requirements necessary for the signalling devices are described in the "Service Manual". ENDOGRAPH DC 16 (Rev. 1) SERVICE MANUAL Description Figure 3-1 (Rev. 1) Tubehead Scissors arm Extension arm Timer X-ray button 17 ENDOGRAPH DC SERVICE MANUAL Description DE Figure 3-2 ENDOGRAPH DC Tubehead Scissors arm Extension arm Wall support Remote timer X-ray button 18 (Rev. 1) SERVICE MANUAL Description Figure 3-3 (Rev. 1) Tubehead Scissors arm Mobile stand Timer X-ray button 19 ENDOGRAPH DC SERVICE MANUAL Description Figure 3-1 ENDOGRAPH DC Remote X-ray button (optional) 20 (Rev. 1) SERVICE MANUAL Description ED D Figure 3-2 (Rev. 1) Wireless X-ray button (optional) 21 ENDOGRAPH DC SERVICE MANUAL Technical data BA Technical characteristics Equipment Endograph DC Manufacturer VILLA SISTEMI MEDICALI Buccinasco (MI) Italia Class Class I with type B applied parts (according to EN 60601-1 classification) Protection degree IPX0 standard device Line voltage 99-264 V∼ Rated voltage 110-240 V∼ Line frequency 50 / 60 Hz Maximum line current 5.2 A rms impulsive 2.5 A rms impulsive @ 115 V ∼ @ 230 V ∼ Technical factors for maximum line current 70kV, 6mA Absorbed power Maximum apparent line resistance 583W (584VA) 566W (570VA) 0.4 Ω (99-132 V∼) Mains fuse 0.8 Ω (198-264 V∼) 6.3 AT Selectable times from 0.01 to 2.00 s in 36 steps Automatic selection 882 pre-programmed times (7 anatomic 3 sizes - 3kV - 2 SID- 3 receptors) Time accuracy ± 5 % ± 2 ms High voltage values 60-65-70 kVp selectable Tubehead current 6 mA kV accuracy ± 8 % @ rated voltage Tubehead anodic current accuracy ± 10 % @ rated voltage Maximum exposure time 2.0 s Timer size 284×253×123.3 mm ENDOGRAPH DC 22 (Rev. 1) SERVICE MANUAL Technical data Tube-head characteristics Manufacturer CEI Bologna (Italy) Rated voltage 60-65-70 kVp (selectable) Tubehead power 420 W Total filtration ≥ 2.5 mm Al eq. @ 70 kV HVL (Half value Layers) > 2 mm Al eq. Transformer insulation Oil bath Interval between the exposures / duty cycle 60 times the X-ray time/ 1 : 60 Focus size 0.5 (IEC 336) Minimum focus to skin distance 20 cm (optional 30 cm cone) X-ray diameter (@ 20cm focus) ≤ 6 cm (35x45 mm + 25x35 mm + 20x30 mm optional) Cooling Convection Leakage radiation at 1 metre < 0.25 mGy/h Technical factors for leakage radiation 70 kV, 6 mA, 1 s duty cycle 1 exposure every 60 seconds X-ray tube characteristics Manufacturer CEI Bologna (Italy) Type OX/70-5 Inherent filtration 0.5 mm Al equivalent to 70 kV Anode tilt angle 19° Anode material Tungsten Rated voltage 60-65-70 kV (selectable) Filament max voltage 3.1 V Filament max current 2A Anode thermal capacity 7 kJ Anode cooling capacity (max) 110 W (Rev. 1) 23 ENDOGRAPH DC SERVICE MANUAL Technical data Environmental conditions Operating temperature range +10°C ÷ +40°C Relative working humidity (RH) range 30% ÷ 75% Temperature range for transport and storing -20°C ÷ +70°C Humidity range for transport and storing <95 % non-condensing Minimum atmospheric pressure for storing and transport 630hPa Weight of the unit and the removable parts Gross weight including packaging 30 kg Net weight of the unit in the standard configuration 23 kg Extension arm 60 cm (standard) 2.9 kg Extension arm 80 cm 3.5 kg Extension arm 30 cm 1.9 kg Scissors arm with tube-head support 10 kg Timer + wall support 5.05 kg Tube-head 5 kg ENDOGRAPH DC 24 (Rev. 1) SERVICE MANUAL Technical data The measuring method with non-invasive instruments, for example kVp/t meter, is accepted, even if it generally provides less accuracy. In fact, the measurement of the high voltage at the tube with non-invasive instruments is closely correlated to the method selected by the instrument manufacturer; in general, this method is more inaccurate than the direct method and may also require two subsequent exposures. In the same way, the method of measuring the anodic current with the indirect method is affected by systematic errors, as they are often based on the measurement of the current/time product, dividing the measurement by the time measured with the said method. • DF The kVp value is defined as the stationary value of the high voltage applied at the tube that is stabilised under load after the pre-heating time. Measure the value of the kVp with a non-invasive instrument (with 2% accuracy), setting the exposure time to 1 second. • DD ED The exposure time must be measured using a non-invasive instrument. In compliance with standard IEC 60601-2-7, the exposure time is measured as the interval of time between the moment in which the high voltage has reached for the first time a value equal to 75% of the peak value and the moment in which it goes down below this value. (Rev. 1) 25 ENDOGRAPH DC SERVICE MANUAL Technical data B EFD D D ED OX/70-5 Emission characteristics Filament characteristics Load ENDOGRAPH DC 26 (Rev. 1) SERVICE MANUAL Technical data Anode cooling curve Curv a Tube-head raffre ddame nto monoblocco cooling curve 90 80 70 E [kJ] 60 50 40 30 20 10 100 200 300 400 Time [min] (Rev. 1) 27 ENDOGRAPH DC SERVICE MANUAL Technical data D DED Endograph DC complies with the following standards: IEC 60601-1:1988 + A1:1991 + A2:1995 Medical Electrical Equipment – Part 1: General requirements for safety. IEC 60601-1-6:2004 Medical electrical equipment - Part 1: General requirements for safety collateral standard: Usability. IEC 60601-1-2:2001+ A1 Electromagnetic Compatibility Requirements and Tests. IEC 60601-1-3:1994 Gen. Requirements for 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. IEC 60601-2-28:1993 Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis. IEC 62304:2006 + Ac:2008 Medical device software - Software life-cycle processes. ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices. CAN/CSA C22.2 No. 601.1-M90 (2nd edition) +A1 + A2 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance UL 60601-1 (1st edition) Medical Electrical Equipment - Part 1: General Requirements for Safety 0051 Guarantees Endograph DC compliance with Directive 93/42 and as amended. (subsequent amendments and additions) CFR 21 Code Federal Regulation. Sub Chapter J Canadian Medical Device Regulations ENDOGRAPH DC 28 (Rev. 1) SERVICE MANUAL Technical data D DED ED ED D Endograph DC contains radio module with FCC ID: 2ABYS76593030 The wireless switch for Endograph DC complies with the following standards: ETSI EN 300 220-2 v.2.3.1 ETSI EN 301 489-3 v.1.4.1 Electromagnetic Compatibility and Radio Spectrum matters (ERM). 0051 Guarantees wireless switch for Endograph DC compliance with Directive R&TTE 1995/5/EC CFR title 47 part 15 Subpart C-Intentional Radiators 15.231 Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. (Rev. 1) 29 ENDOGRAPH DC SERVICE MANUAL Technical data ABC Figure 4-1: Dimensions of the wall version Figure 4-2: Dimensions of the mobile stand version ENDOGRAPH DC 30 (Rev. 1) SERVICE MANUAL Pre-installation Endograph DC does not ask for special pre-installation works, still it is necessary to grant an adequate grounding for EMC compatibility and safety. Section of grounding cable must be at least equal of greater than the section of line cables. It is advisable to use a grounding cable with section 2.5mm². If cables are going to be positioned inside the wall, it is better that ducts are already positioned, taking into account where the device will be installed, taking care that cables exit in correspondence of the hole on the lower side of the wall plate. The Manufacturer can assist technically in the pre-installation phase, but preparation works are a customer’s responsibility. NOTE: This chapter is valid for Wall version. The user does not need to assess the consistency of the wall for Stand version. The installer is responsible for assessing the consistency of the wall. The extraction load on each screw is 446 N (46 kg) for the wall version standard assembly (3 mounting screws), 634 N (65 kg) for the wall version "single stud" assembly (5 mounting screws). For each type of wall use the appropriate mounting method complying with the following specifications which guarantee a safety factor 4: • Wooden uprights: self-threading screws 8x70 A 4.8 (provided with the installation kit) • Full or concrete bricks: screw anchors (provided with the installation kit) in cast iron M8 or chemical screws WURTH (not provided) • Hollow bricks: chemical screws (not provided). A counter-plate must be used with walls with a lower resistance. WARNING: The Manufacturer is not responsible for any installations that do not comply with the specifications stated above. (Rev. 1) 31 ENDOGRAPH DC SERVICE MANUAL Pre-installation ED D • Single-phase supply + ground 110-240 V∼ ±10% • Frequency 50 – 60 Hz • Max absorbed current during emission 5.2 A rms impulsive @ 115 V∼ 2.5 A rms impulsive @ 230 V∼ • Apparent line resistance 0.4 Ω @ 99-132 V∼ 0.8 Ω @ 198-264 V∼. NOTE: The device is intended for permanent installation. It is forbidden to connect the system by a plug in a wall socket for safety reasons. Mobile version has to be requested on order and it is not possible to transform wall mounted version into a mobile version in field. NOTE: A circuit breaker with overcurrent protection must be connected to the intraoral X-ray equipment with the following features: – Nominal current: 10A – Differential sensitivity: 0.03A. Section of line cables must be not lower than 1.5 mm². Grounding of the system must meet requirement of the laws; a bad grounding can be dangerous for the operator and can generate malfunctioning of the device. NOTE: The mobile stand is supplied without the mains plug to permit the free connection at every socket. Is in charge to the installer supply a mains plug compatible with the local electrical network with follow features: connection 2P+Earth protection, minimum working voltage compliant with the power supply in use, minimum rated current 10A. Then install the mains plug on the cable by connecting the Y/G wire in the earth protection connector and the others conductors in the others free connectors. The mains plug must be in compliance with the laws and directive in force of the Country of use and report at least one quality/safety mark released by a recognized Notified Body. NOTE: Endograph DC can be connected to signaling devices outside the installation room; please make reference to chapter 6.4.1. It is also possible to mount the system with remote keyboard: in this case it is necessary to use a RJ45 cable provided by the Manufacturer. ENDOGRAPH DC 32 (Rev. 1) SERVICE MANUAL Installation Endograph DC intraoral X-ray equipment is shipped pre-assembled in sub-assys. Mechanical assembly work consists solely in assembling these units. All the mechanical components are therefore adjusted before delivery; not only is there no need to carry out any adjustment on these parts but it would also cause the equipment to malfunction; any adjustment must be carried out by authorised personnel only. (Rev. 2) 33 ENDOGRAPH DC SERVICE MANUAL Installation DE D 1. To be sure that the equipment is in the correct position we recommend you put the provided template code 39599100 (3 Figure 6-1) in the requested position, in this way identifying the requested wall-mounting position. Considering the overall dimensions of the equipment, put the top part of the template at 1450 mm from the floor. WARNING: The installer will assess the consistency of the wall taking into consideration the screw extraction load specified in paragraph 5.1. 2. Mark the mounting points and make the respective holes with a diameter corresponding to the chosen screws. Making reference to the template, use holes "A" for standard installation. Use holes "B" for single stud installation. 3. Remove the plastic timer cover (1 - Figure 6-1) loosening the two sealing screws (2 - Figure 6-1) placed on the top part. Do not remove completely the screws and the relevant plate (4 Figure 6-1); with the extention arm in place, will not be possible to reassemble the plate. To make the operation easier, disconnect all wires between wall plate and cover. 4. Fix the timer to the wall using the relevant screws verifying the perpendicularity of both axes with respect to the wall. Figure 6-1 ENDOGRAPH DC 34 (Rev. 2) SERVICE MANUAL Installation DE 1. Cross the two base tubes (1 - Figure 6-2) into the provided cut, fixing them together with the screw (2 - Figure 6-2) and relevant nut (3 Figure 6-2). Do not tighten the screw completely. 2. Position the base plate (4 - Figure 6-2) and fix it with the four screws (5 - Figure 6-2). If necessary, reposition the two base tubes (1 Figure 6-2) slightly in order to align the relevant holes on the plate. 3. Lock the nut (3 - Figure 6-2) in order to block the base tubes (1 Figure 6-2) permanently. 4. Assemble the stand column (6 - Figure 6-2) on the base plate (4 Figure 6-2) with the four screws (7 - Figure 6-2). Figure 6-2 5. Assemble the timer support plate (8 - Figure 6-3) to the stand column, fixing it with the two screws (9 - Figure 6-3) present on the stand column. (Rev. 2) 35 ENDOGRAPH DC SERVICE MANUAL Installation WARNING: The timer must be fixed to the support plate after assembling the scissors arm (see paragraph 6.3.3). 6. Remove the plastic timer cover (10 - Figure 6-3) by loosening the two sealing screws (12 - Figure 6-3) placed on the top. To make the operation easier, disconnect all cables connecting the timer and the plastic cover. 7. Fix the timer onto the support plate with the two screws (14 - Figure 6-3) taking care to thread the supply cable and the cables coming from the scissors arm inside the hollow one (15 - Figure 6-3). Check that the upper level is level using a bubble level. 12 14 14 15 10 Figure 6-3 ENDOGRAPH DC 36 (Rev. 2) SERVICE MANUAL Installation DD 1. Insert the extension arm into the arm support block which is an integral part of the wall support plate. NOTE: You must keep the arm orthogonal to the plate to be able to insert the shaft into the bush placed inside the support. 2. Assemble the extension arm frictioning mechanism block (1 – Figure 6-4); this frictioning mechanism (code 6159300100) is included in the mounting hardware packaging. 3. Assemble the arm rotation stop screw (2 - Figure 6-4) in the hole present on the shaft; this screw (code 2100014800) is included in the mounting hardware packaging. 4. Tighten the two lateral screws (3 - Figure 6-4 – one on each side) ensuring that they block the arm rotation without interfere with the extension arm pin. (Rev. 2) 37 ENDOGRAPH DC SERVICE MANUAL Installation NOTE: The purpose of the frictioning mechanism and the rotation stop pin is to prevent the extension arm from becoming detached. Spring washers sequence Figure 6-4 ENDOGRAPH DC 38 (Rev. 2) SERVICE MANUAL Installation NOTE: To help assembly Endograph DC is shipped with the tubehead already mounted on the scissors arm; it is recommended to let the tape wrapping the arm in place. In case it is removed, besides making more difficult the assembly it is possible that the installer is hurt or the arm damaged. 1. Remove the friction group fixing plate fixed to the extension arm with three screws (scissor arm side). Take note that the upper screw is shorter than the other two and has to be mounted in the same position. Friction group Fixing plate Figure 6-5 2. Remove also the friction taking care not to loose the spring washer. Here following is indicated the right sequence of the washers. Spring washer sequence Figure 6-6 (Rev. 2) 39 ENDOGRAPH DC SERVICE MANUAL Installation 3. Remove the fixing bushing. This operation will permit an easier insertion of the scissor arm group into the extension arm. Figure 6-7 4. Insert the extension arm pin in the bushing; during insertion take care to the O-Rings present in the bushing. The friction group fixing holes must be toward tube head support. Figure 6-8 ENDOGRAPH DC 40 (Rev. 2) SERVICE MANUAL Installation 5. Insert the scissor arm into the extension arm, aligning the bushing fixing holes to the extension arm screws. Power cable, signal cable and grounding cable must be let out freely from the extension arm. Figure 6-9 6. Mount the friction group and fix the plate using the shorter screw in the top hole (Figure 6-5). Tighten the grub screw until it is frictioned but don't force the friction. It has to be adjusted only if necessary. 7. Remove the safety clamp and completely open the scissors arm to locate the position where the cable is more recovered inside the arm itself. (Rev. 2) 41 ENDOGRAPH DC SERVICE MANUAL Installation NOTE: The following operations must be done with the scissors arm completely open. 8. Holding this position, gently pull the cables coming from the scissors arm down to avoid excess cable in the arms. Figure 6-10 9. Insert the cables inside the extension arm (power cable on one side and filament cable and the grounding cable on the other side) following the drawing in Figure 6-11 (fase 1); this will make sure that the cables are not tensioned during use. To make this easier, wrap together the grounding and filament cables with tape. 10. Run the cables inside the extension arm until they come completely out at the opposite end. 11. Insert the cables inside the rotation pin as shown in the following figure (fase 2 and 3). Figure 6-11 ENDOGRAPH DC 42 (Rev. 2) SERVICE MANUAL Installation 12. Push the cables inside the extension arm (scissors arm side), so that no excess is left at the extremity. When doing this, firmly pull the cables on the other end of the extension arm (timer side). Front view Lateral view Figure 6-12 13. Make sure that cables don't push the end cap when opening and closing the scissors arm. Repeat this operation several times in all the arm positions. If necessary, repeat step 12 and carefully adjust the excess cable. 14. Check that the DP arm is perfectly inserted; check that the rotation of the scissors arm inside the extension arm is the one ergonomically requested by the operator, otherwise work on the frictioning mechanism (1 - Figure 7-2) until you get the requested run. NOTE: This frictioning mechanism is also used to prevent the scissors arm from becoming detached and for this reason it must never be loosened completely. 15. Check the ergonomics of the arm opening movement, otherwise adjust the tension of the arm balance springs (see paragraph 7.1.3). 16. Assemble the front covers of the extension arm included in the mounting hardware packaging. (Rev. 2) 43 ENDOGRAPH DC SERVICE MANUAL Installation 1. Loose the two screws (1 - Figure 6-13) to allow the positioning of the scissors arm. 2. Assemble the scissors arm (there is no extension arm in this configuration), being careful to insert the spacer (2 - Figure 6-13) into the rotation pin. The spacer (code 6161305600) is included in the mounting hardware packaging. NOTE: Be sure that the two pins are inserted into the spacer as showed in the drawing. NOTE: Keep the arm perfectly orthogonal to the pole when inserting the extension arm rotation pin. Do not release the scissors arm from their sealing packing. 3. Secure the arm tighten the two screws (1). Figure 6-13 ENDOGRAPH DC 44 (Rev. 2) SERVICE MANUAL Installation DE DF Endograph DC allows connecting additional signaling devices outside the room, as specified here below: • A signaling device indicating "READY" and "RX ON" status can be connected to X11 connector of the "External signal" board A5 (Figure 6-14). • To use signaling devices it is necessary to prepare connections using 4 wires having a section of 0.5 mm2. Max 230 Vac CPU K2 Lamp READY X8 Lamp RX ON X11 K1 Figure 6-14 (Rev. 2) 45 ENDOGRAPH DC SERVICE MANUAL Installation NOTE: Whatever remote X-ray button installation is implemented, the front panel of the timer must be visible from the remote button location to allow the user to see technical factors before starting an exposure. There are two possible alternative for remote X-ray button: 1. A door bell X-ray button (not provided by Villa Sistemi Medicali) can be installed following the instruction here below. NOTE: The connecting cable between Timer and Remote X-ray button, passing into the wall or external, must always be put into a metal conduct to avoid any kind of disturbance to the signals passing through the cable. The cable can be a maximum of 15 meters long and consequently the distance between Timer and X-ray button must be shorter than this length. The connecting cable must have a 1mm2 minimum section and must be connected to the X6.1 and X6.2 connectors on the CPU board A2 (see chapter 12). The remote X-ray button can be connected in parallel to the standard X-ray button supplied with the timer, using the same connectors. Safety regulations stipulate that a button enabled by an appropriate safety key must be used. 2. The kit P/N 6659120000 provides a way to install remotely the X-ray button supplied with the timer. The kit includes a wall support plate with a terminal strip. NOTE: The connecting cable between Timer and remote X-ray button (not provided by Villa Sistemi Medicali) must have a 1mm2 minimum section. The connecting cable must always be put inside a metal conduct to avoid any disturbance to the signals passing through the cable. ENDOGRAPH DC 46 (Rev. 2) SERVICE MANUAL Installation Remove the X-ray button from the Timer disconnecting the cable from X6.1 and X6.2 connectors. Assemble the button on the wall support plate connecting the cable on the terminal strip. The connecting cable between Timer and remote X-ray button must be connected to X6.1 and X6.2 connectors (Timer side) and to the terminal strip of the support plate. The support plate has to be fixed on the wall using the fisher type screws provided. (Rev. 2) 47 ENDOGRAPH DC SERVICE MANUAL Installation ED D ED D DE To insert the battery inside the wireless X-ray button, proceed as follow: 1. unscrew the two screws located on the back of the button 2. open the two half-shells, keeping the green button facing upwards and paying attention to the electronics located inside 3. insert the batteries respecting the indicated polarities 4. reclose the two half-shells and tighten the screws. ENDOGRAPH DC 48 (Rev. 2) SERVICE MANUAL Installation ED D NOTE: This procedure has to be performed in case of field upgrade. System coming with wireless X-ray button are pre-assembled in factory. The wireless upgrade kit (code 7659303000) includes: • Wireless X-ray button • 2 x AAA batteries • A6 Radio board • X7 connecting cable. To assemble the parts proceed as follow: 1. Remove the plastic timer cover (see paragraph 6.1.1 – point 3) and disconnect the cables between timer and cover. 2. Remove the CPU board from the timer cover. 3. Assemble the hexagonal spacer on the CPU board A2 (component side) as shown in Figure 6-15 and Figure 6-16. Figure 6-15 Figure 6-16 (Rev. 2) 49 ENDOGRAPH DC SERVICE MANUAL Installation 4. Assemble the A6 Radio board on the CPU board using the provided screw (Figure 6-17). Figure 6-17 5. Reassemble the CPU board on the timer cover. 6. Connect the X7 cable between CPU board – connector X7 and Radio board – connector J7. 7. Reconnect the cables between timer and CPU board and reassemble the plastic timer cover. ENDOGRAPH DC 50 (Rev. 2) SERVICE MANUAL Installation ED D DE NOTE: This procedure has to be performed in case of wireless X-ray button replacement or in case of matching lost. To match wireless X-ray button and timer, proceed as follow: 1. Switch on the equipment and verify that it is into ready mode. 2. Press and hold pressed the wireless X-ray button until the green LED switches on (about 6 seconds). 3. Press and release the wireless X-ray button: the green LED blinks slowly for three times. If the LED blinks quickly, the matching failed; repeat the procedure. (Rev. 2) 51 ENDOGRAPH DC SERVICE MANUAL Installation DE NOTE: The mains power supply has to be provided only on wall support side. NOTE: The connection cable between wall support and remote timer supplied in the Remote Timer kit (code 6659300100) is 20 meters long, ending with RJ45 connector. The maximum distance between wall support and timer must not exceed the cable length. For the Remote Timer wall support set-up follow the instruction listed in paragraph 6.1.1 – Timer set-up (standard configuration). ENDOGRAPH DC 52 (Rev. 2) SERVICE MANUAL Installation DE D To be sure that the equipment is in the correct position we recommend you put the provided template code 39599101 (3 Figure 6-18) in the requested position, in this way identifying the requested wall-mounting position. Considering the overall dimensions of the equipment, put the top part of the template at 1450 mm from the floor. Mark the mounting points and make the relevant holes with the diameter corresponding to the chosen screws. Remove the plastic timer cover (1 - Figure 6-18) by loosening the two sealing screws (2 - Figure 6-18) placed on the top part. Fix the timer to the wall using the provided screws (4 - Figure 6-18) verifying its perpendicularity with the wall accordingly to both axis. Figure 6-18 (Rev. 2) 53 ENDOGRAPH DC SERVICE MANUAL Installation ED You are recommend to use chemical screws when installing the equipment on hollow bricks. ENDOGRAPH DC 54 (Rev. 2) SERVICE MANUAL Installation FDE NOTE: Cables coming from the tubehead are supplied for the 80 cm extension arm. For the 30 cm and 60 cm extension arm and for mobile stand version, the surplus part of the cables must be positioned to the top of the timer with a suitable loop, without passing over the Driver board area. Fix the cables with the provided strip. 1. Connect the power cables from the tubehead to the Driver board wiring the cables to the connector X4 (OUTPUT) and shield to screw W2, following the positions as in the table: Tubehead wires colour Green Brown White Yellow/Green Black Tubehead wires identification Ground Shield Driver board X4.1 X4.2 X4.3 X4.GND Screw W2 2. Connect the signal cable of the tubehead to the Driver board wiring the cables to the connector X2 (HEATER) following the position as in the table: Tubehead wires colour White/Yellow Green/Brown Tubehead wires identification Driver board X2 terminal 3. Make the connection between the general switch and the terminal strip of the timer using a bipolar cable plus ground, section 1.5 mm2 (16 AWG). Fix the cable to the terminal strip following the positions as shown (L = line, N = neutral, Ground = yellow/green cable). The conductors have to be secured to the timer base. 4. Assemble the two pins lock (1 - Figure 6-19) on the timer cover; these pins (code 2100511300) are included in the mounting hardware packaging. (Rev. 2) 55 ENDOGRAPH DC SERVICE MANUAL Installation 5. Connect the cables between timer and cover: flat cable between CPU board – connector X1 – and Driver board – connector X1 (CONTROLS); X-ray button cable to CPU board – connector X6. 6. Place the cover on the timer taking care that the cover is positioned under the upper plate (4 – Figure 6-1). Push the cover against the locking pins and tighten the two upper screws (2 – Figure 6-1). W2 X4 X1 X2 X5 Main power supply terminal strip Figure 6-19 ENDOGRAPH DC 56 (Rev. 2) SERVICE MANUAL Installation DE FDE 1. Remove the X-ray button complete of its support from the timer. 2. Connect the timer following the procedure listed in paragraph 6.5.1, steps from 1 to 3. 3. Assemble the Remote Interconnection Timer board (A8), included in the Remote Timer box, on the timer as shown in Figure 6-20. 4. Connect the flat cable, supplied with the Remote Timer box, between Driver board – connector X1 (Figure 6-19) – and A8 board – connector X1 (Figure 6-20). 5. Connect the RJ 45 cable to the A8 board – connector X9 (Figure 6-20). 6. Assemble the two pins lock (1 - Figure 6-20) on the Remote Timer cover (1 - Figure 6-18); these pins (code 2100511300) are included in the mounting hardware packaging. 7. Place the cover on the timer taking care that the cover is positioned under the upper plate (4 - Figure 6-1). Push the cover against the locking pins and tighten the two upper screws (2 - Figure 6-1). Remote Interconnection Timer board (A8) X9 X1 Figure 6-20 (Rev. 2) 57 ENDOGRAPH DC SERVICE MANUAL Installation DE 1. Assemble the X-ray button complete of its support (2 - Figure 6-21) on the Remote Timer plate. 2. Connect the RJ 45 cable to the Remote Interconnection Timer board (A9) – connector X9 (Figure 6-21). 3. Assemble the two pins lock (1 - Figure 6-21) on the Timer cover (1 Figure 6-1); these pins (code 2100511300) are included in the mounting hardware packaging. 4. Connect the flat cable between CPU board – connector X1 – and A9 board – connector X1. Connect the X-ray button cable to the connector X6 on the CPU board. 5. Place the cover on the remote support taking care that the cover is positioned under the upper plate (3 - Figure 6-21). Push the cover against the locking pins and tighten the two upper screws. X1 X6 Remote Interconnection Timer board (A9) X9 X1 Figure 6-21 ENDOGRAPH DC 58 (Rev. 2) SERVICE MANUAL Installation DE At start-up the timer automatically checks all the internal hardware and particularly: • Display lights ON • LEDs light for 2 seconds • CHECKSUM check of the storage program and display of the words "CH0" if the check result is negative or in the event of non-initialized memory • Buzzer check (rings) • Check of all buttons and X-ray buttons in particular, no button must be pressed. If any buttons are pressed an error code message will appear on the display • Showing of software and hardware versions (HW: X.XX – SW: X.XX). NOTE: During the first start-up, the volatile memory may not be programmed and therefore the "CH0" message will appear. In this case, press "F" key to restore the factory default setting. The "CH0" message must not be displayed any more. If this happens again, replace the EEPROM on the CPU board and proceed to the set-up sequence. WARNING: Replacing the EEPROM, all the custom tables will be lost. (Rev. 2) 59 ENDOGRAPH DC SERVICE MANUAL Checks, Calibration and Adjustment BA B C B The device is calibrated in the factory during final testing carried out at the manufacturer’s site. Some adjustments (for example the friction mechanisms of the scissors arm and extension arm) may need to be done once the installation has been completed and are described in the installation chapter 6. The arms may need adjusting in the following cases: • the movement of the extension arm combined with the scissors arm is not considered to be ergonomic by the end user; in this case it will be necessary to adjust the extension arm frictioning mechanism. • the scissors arm is not perfectly balanced; in this case you must adjust the springs. ENDOGRAPH DC 60 (Rev. 1) SERVICE MANUAL Checks, Calibration and Adjustment DD The device to adjust the arm support frictioning mechanism is placed on the front of the wall support. To make this adjustment you have to proceed as follows. 1. Remove the plastic timer cover by loosening the two sealing screws (1 - Figure 7-1) placed on the top part of the wall plate. Be careful to the cables connecting the timer and the plastic cover. 2. Using a 10 mm wrench, adjust the frictioning mechanism nuts (2 Figure 7-1) until the movement of the arm is ergonomic. 3. Reposition the plastic cover when you have finished. Figure 7-1 (Rev. 1) 61 ENDOGRAPH DC SERVICE MANUAL Checks, Calibration and Adjustment DD 1. Remove the small front extension arm cover, working carefully. 2. Adjust the frictioning mechanism (1 - Figure 7-2) using a 5 mm hexagon wrench checking the rotation of the scissors arm. NOTE: The purpose of this frictioning mechanism is to prevent the scissors from becoming detached, so it must not be loose. 3. Assemble the cover again. Figure 7-2 ENDOGRAPH DC 62 (Rev. 1) SERVICE MANUAL Checks, Calibration and Adjustment • D D Proceed as follows to adjust the scissors arm: – Adjusting the friction (for small corrections - picture A) 1. Put the arm in a horizontal position; remove the plastic coordinator covers. This must be done carefully to avoid breaking the covers themselves. 2. Using a 2.5mm hexagon wrench, loosen the dowel (1). 3. Using two 13 wrenches, adjust the frictioning mechanism by rotating one of the wrenches ¼ of a turn each time. 4. When you have finished the adjustment, tighten the previously loosened dowel and reassemble the plastic covers. – Adjusting the spring (picture B) If adjustment of the friction is not enough, you can adjust the spring to optimise the balance: 1 Put the arm in a horizontal position; remove the plastic coordinator covers. This must be done carefully to avoid breaking the covers themselves. 2 Insert a 6mm hexagon wrench (about 200mm long – contained in the kit P/N 6661209900). This wrench must rotate clockwise if the arm tends to go down compared to the release position; anticlockwise if it tends to go up. 3 When you have finished the adjustment, reposition the plastic covers. Ø13 Ø13 Figure 7-3 (Rev. 1) 63 ENDOGRAPH DC SERVICE MANUAL Checks, Calibration and Adjustment • If the first arm also needs to be adjusted: – Adjusting the friction (for small corrections - picture A) 1 Close the arm scissors arm; remove the plastic co-ordinator covers. This must be done carefully to avoid breaking the covers themselves. 2 Using a 2.5mm hexagon wrench, loosen the dowel (1). 3 Using two 13 wrenches, adjust the frictioning mechanism by rotating one of the wrenches ¼ of a turn each time. 4 When you have finished the adjustment, tighten the previously loosened dowel and reassemble the plastic covers – Adjusting the spring (picture B) If adjustment of the friction is not enough, you can adjust the spring to optimise the balance: 1. Put the arm in a horizontal position; remove the plastic coordinator covers. This must be done carefully to avoid breaking the covers themselves. 2. Insert a 6mm hexagon wrench (about 200mm long – contained in the kit P/N 6661209900). This wrench must rotate clockwise if the arm tends to go down compared to the release position; anticlockwise if it tends to go up. 3. When you have finished the adjustment, reposition the plastic covers Ø13 Figure 7-4 ENDOGRAPH DC 64 (Rev. 1) SERVICE MANUAL Set-up The Endograph DC system has a modifiable configuration that can be adapted to specific usage needs. To enter the "set-up" function press the "Increase" "Decrease" and keys simultaneously during the software / hardware version display phase; the display will show: DEEF Press "Function" A B A B AC CDE AF key to go to the following parameter; touch either the "Increase" or "Decrease" keys to change the displayed parameter value. Press "Function" key and then confirm (Increase key) or cancel (decrease key) the new setting. Press and hold pressed the "Function" key to exit the setup program, the system will restart. P00: This parameter indicates the time in minutes after that the system enter in "sleep" condition. With "Value = 0", the system is always in the "Ready for X-rays" conditions. The selectable value changes between 0 and 5 (default 2). (Rev. 1) NOTE: When Value = 0, the green "Ready for X-rays" LED is always ON. 65 ENDOGRAPH DC SERVICE MANUAL Set-up P01: This is the value of parameter K (value selectable between 0 and 80) which, multiplied by the current value of exposure time, calculates the value of the cool down time between consecutive exposures. COOL DOWN BETWEEN EXPOSURES = Exposure time x K Default value = 60 (sixty times the exposure time). WARNING: This parameter must not be changed from the factory configuration. Changing on this parameter may effect on the equipment life time. P02: ED B DE This parameter shows the number of the performed exposure. The counter can be reset to zero by pressing the "Size Selection" "Tooth automatic selection" keys together; the operation requires confirmation, by pressing the "Increase" P03: and key. This parameter adapts the exposure times associated to Anatomic and Size selections to the film speed used by the user. The available values are shown in the following table: Value (multiplies the pre-set exp. time) Film type 0.75 1.00 1.25 1.50 2.00 -F -D Default value = 1.00 (F) ENDOGRAPH DC 66 (Rev. 1) SERVICE MANUAL Set-up P04: When you use a 30 cm limiter cone, the exposure times in the preset tables must be multiplied by a 2 factor to get a correct dose. The default value is "OFF", which corresponds to the standard cone (Film Focus Distance = 20cm). The change from standard cone to long cone times is made by selecting "ON". This setting is available also in normal working or out of set-up program modes, and it is available to the user. P05: This parameter makes it possible to vary the display back light, in order to compensate any differences in environmental light. Values are changed by "Increase" P06: D B EED and "Decrease" keys. This parameter is used only during factory test. P07: NOTE: Do not modify factory configuration. Using "Increase" and "Decrease" keys, select the desired language between: English, Italian, French, Spanish, German, Portuguese, Russian, Dutch, Arabic, Turkish, Chinese (traditional), Chinese (simplified), Symbols only (visualize only the tooth symbol). (Rev. 1) 67 ENDOGRAPH DC SERVICE MANUAL Set-up P08: EDE This parameter allows to visualize / hide Villa logo at system start-up. Default value = Show Logo. P09: This parameter make it possible to enable / disable the X-Rays emission. Default value = X-Rays ENABLED (ON). P10: D EDFDE D This parameter allows to change the display between white text on blue background and blue text on white background. Default value = OFF (white text on blue background). P11: This parameter makes it possible to vary the contrast of the display, in order to compensate any differences in environmental light. Two adjustments are possible: − Press " Tooth automatic selection" key for a coarse regulation. Default value = 2 − Press "Increase" and "Decrease" keys for a fine regulation. Default value = 24. ENDOGRAPH DC 68 (Rev. 1) SERVICE MANUAL Set-up P12: DD ED This parameter makes it possible to enable / disable the acoustic sound on key press. Default value = ON P13: ED D This parameter is used only during factory test. P14: NOTE: Do not modify factory configuration. ED E CD Select value = ON to restore the system configuration and the custom time tables to factory default. After confirmation, the system will restart with factory settings. (Rev. 1) NOTE: All custom settings will be lost. 69 ENDOGRAPH DC SERVICE MANUAL Set-up DF D DE Display Parameters Set Value P00 Stand-by timeout 2 min P01 Duty cycle 60 P02 Exposure Counter //// P03 Film sensitivity 1.00 P04 Long cone OFF P05 Display back light //// P06 Dose Correction Factor //// P07 Language //// P08 Manufacturer's Logo Show logo P09 Disable X-Rays X-ray enabled (ON) P10 Display mode reverse OFF P11 LCD Contrast Adjustment //// P12 Beep on keypress ON P13 Exposure extra time P14 Restore Factory Settings //// New setting WARNING (1) (1) WARNING: Parameters shown with (1) in the previous table can not be changed; the perfect running of the system or its compliance with Directive CE 93/42 cannot be guaranteed if any change is made. ENDOGRAPH DC 70 (Rev. 1) SERVICE MANUAL Troubleshooting CA WARNING: The system must be switched off before performing integrity checks on fuses and components. System F1 F3 110 – 240 V wall version 6.3 AT 250 V 110 – 240 V stand version 6.3 AT 250 V 6.3 AT 250 V • Symptom: Display off when main switch is ON • Action: − check if the LED on the keyboard are ON and pressing the keyboard buttons you can hear any beep. If the keyboard doesn't work, switch OFF the equipment and verify: − the flat cable connecting the CPU and the Driver board − integrity of fuses F1 and F3 (if present) − measure the presence of the main power supply. If no anomalies are found, start replacing boards in the following order: CPU, Driver board (including tubehead). (Rev. 1) 71 ENDOGRAPH DC SERVICE MANUAL Troubleshooting EE E As described in chapter 3, the Endograph DC is totally controlled by a microprocessor which, not only checks the programming of exposure parameters but also signals the various machine statuses and any anomalies and errors, by messages in code on the display unit. The following tables contain the various messages which may appear on the display, their meanings, their cause and how to behave. NOTE: Error messages belong to three different groups, classified according to the seriousness of the anomalies found and their possible effect on the safety of the operators’ and/or the system. ENDOGRAPH DC 72 (Rev. 1) SERVICE MANUAL Troubleshooting DEE E DE D ED These signals DO NOT allow any examination to be performed. Displayed message ANOMALY type Corrective actions E01 X-ray button pressed at start-up Switch the system off and on again; if the message is still present, replace the X-ray button. E02 A key pressed at start-up The pressed button is identified by an (different from X-ray button) hexadecimal code according to Table 1 Verify that the relevant button is not really pressed. Switch the system off and on again; if the message is still present, replace the CPU board. E03 More keys pressed at startup The pressed button is identified by an hexadecimal code according to Verify that the relevant button is not really pressed. Switch the system off and on again; if the message is still present, replace the CPU board. E05 Unwanted X-ray emission Switch the system off and on again; if the message is still present, replace the tubehead and the Driver board. The main key codes used to identify the pressed button are listed in the following table: Code Description 0001 Function key (F) 0002 Increment key (+) 0004 Tooth key 0008 Decrement (-) key 0010 Size key Table 1 All other key codes identify a combination of two or more pressed buttons. (Rev. 1) 73 ENDOGRAPH DC SERVICE MANUAL Troubleshooting DEE E Possible anomalies during exposure always interrupt the exposure itself. Whether there is an acoustic signal or not depends on the time the fault occurred and on the success of the X-ray interruption procedure. Displayed message ANOMALY type Corrective actions E04 No emission (breakage in the filament circuit) Measure the impedance value between "+" and "-" of Driver board - connector X2 (HEATER); this value must be lower than 20 ohm. If the value is greater than 20 ohm, remove the tubehead plastic covers and measure the impedance value between J3.IN+ and J3.IN- of Filament Voltage Regulator board. If the value is still greater than 20 ohm, disconnect the cables J3.Fil+ and J3.Filfrom the Filament terminal strip and measure the impedance value between them. If the measured value is lower than 20 ohm, replace the DP arm, otherwise replace tubehead and Driver board. E06 Activation of the back-up timer Check integrity of the flat cable connecting the CPU to the Driver board. Switch the system off and on again; if the message is repeated after an exposure, replace the Driver board and the tubehead. E07 Protection intervention Switch the system off and on again; if the message is still present, replace the Driver board and the tubehead. WARNING: When an error signal appears and the buzzer sounds, always switch the system off. In any case when the back-up timer is triggered it always interrupts X-ray emission. ENDOGRAPH DC 74 (Rev. 1) SERVICE MANUAL Troubleshooting DEE E Situations which do not directly effect the safety of the operator, patient or the system are considered as re-settable anomalies. The error condition prevents additional exposures until it is reset by pressing the "Increase" Displayed message key. ANOMALY type Corrective actions CH0 Memory checksum error (EEPROM) If present at the first start-up of the equipment after replacing EEPROM, follow the displayed procedure. On the contrary, if present during normal working, replace the EEPROM, if not enough, replace CPU board. E11 X-ray button active after the cooling phase Release the X-ray button and follow the displayed procedure. If the X-ray button is not pressed, switch off the system and replace the button. E12 Release of X-ray button during emission Reset the error and repeat exposure. Make sure NOT to release the X-ray button before the buzzer stops. If the message is still present, replace the X-ray button. E13 Release of X-ray button during pre-heating phase Reset the error and repeat exposure. Make sure NOT to release the X-ray button before the buzzer stops. If the message is still present, replace the X-ray button. (Rev. 1) 75 ENDOGRAPH DC SERVICE MANUAL Replacing parts NOTE: The Service Engineer has to take special care for all what concerns electrical safety of the device and must make sure of restoring all provisions for electrical safety which may be affected during a service intervention and to solicit the customer to have the electrical safety tests repeated every time the intervention has caused the replacement of important parts or the intervention has significantly affected safety provisions of the device. D D E FDE WARNING: The tubehead and the Diver board are matched in the factory and therefore MUST be replaced as a couple. WARNING: Before proceeding with the replacement of the tubehead, close and tie the two sections of the scissors arm together. Failure to follow these instruction may harm both the technician and damage the arm itself. NOTE: Before carrying out the following operations, disconnect the equipment from the line. NOTE: No specific actions are required after replacing the tubehead and the Driver board. ENDOGRAPH DC 76 (Rev. 1) SERVICE MANUAL Replacing parts D D NOTE: The spare tubehead is always shipped with a new set of plastic covers and with a new identification plate, giving the new serial numbers of the tubehead itself and of RX tube. 1. Remove the tubehead covers removing the front fixing ring of the extension cone and loosing the two screws (one on each part) located under the lateral triangular labels; gently open the two plastic covers. 2. Disconnect the cables coming from the scissor arm. 3. Holding the tubehead, unscrew the extension cone and remove the four fixing screws fixing the tubehead itself to the support. Remove the tubehead. 4. Take the new tubehead and assemble it on the support. 5. Connect the cables coming from the arm with the corresponding connectors on the tubehead. 6. Assemble the new plastic covers set. (Rev. 1) E FDE 1. Remove the plastic timer cover loosening the two sealing screws placed on the top part. Pull the cover to release the locking pins. To make the operation easier, disconnect all wires between wall plate and cover. The flat cable connecting the CPU board and the Driver board has to be removed from the connector on the Driver board. 2. Disconnect cables from connectors X2, X4 (including shield W2) and main power supply cable from connector X5 (Figure 6-19). 3. Remove the board and assemble the new one, fixing it. 4. Connect the cables disconnected at step 2. 5. Connect all the connections cables between wall plate and cover; close the timer again. 77 ENDOGRAPH DC SERVICE MANUAL Replacing parts DB NOTE: Before carrying out the following operations, disconnect the equipment from the line. 1. Remove the plastic timer cover loosening the two sealing screws placed on the top part. Pull the cover to release the locking pins. To make the operation easier, disconnect all wires between wall plate and cover. The flat cable connecting the CPU board and the Driver board has to be removed from the connector on the CPU board. 2. Remove the failed CPU board and replace it with the new one. NOTE: If the system is equipped with the wireless X-ray button, remove from the failed CPU board the A6 Radio board (Figure 6-17) complete of cable X7 and exagonal spacer support and assemble it on the new CPU board as described in paragraph 6.4.3.2, steps 3 and following. 3. Connect all the connections cables between wall plate and cover; close the timer again. 4. Switch the system on and enter the setup procedure (chapter 8). Check all configuration parameters. NOTE: It is possible to save the stored customized table, removing the EEPROM from the old CPU to the new one. ENDOGRAPH DC 78 (Rev. 1) SERVICE MANUAL Replacing parts Replacing the keypad consists in replacing the adhesive membrane: remove the timer covering panel, remove the old membrane carefully and clean the surface where the membrane was attached. NOTE: Do not use solvent, but only alcohol. Attach the new membrane. (Rev. 1) 79 ENDOGRAPH DC SERVICE MANUAL Replacing parts DE WARNING: Before to remove the tubehead, close and tie the two sections of the scissors arm together. Failure to follow these instruction may harm both the technician and damage the arm itself. NOTE: Before carrying out the following operations, disconnect the equipment from the line. 1. Remove the tubehead as described in paragraph 10.1.1, steps from 1 to 3. 2. Remove the plastic timer cover loosening the two sealing screws placed on the top part. Pull the cover to release the locking pins. To make the operation easier, disconnect all wires between wall plate and cover. 3. Remove the front covers of the extension arm. 4. Disconnect cables from connectors X2 and X4 (including shield W2) (Figure 6-19). Remove the cables from the extension arm completely. 5. Remove the friction group on the extension arm as described in paragraph 6.3.2, steps 1 and 2; remove the arm. 6. Assemble the new arm as described in paragraph 6.3.2, steps 3 and following. 7. Connect the cables ad described in paragraph 6.5.1. 8. Reassemble the tubehead as described in paragraph 10.1.1, steps from 4 to 6. ENDOGRAPH DC 80 (Rev. 1) SERVICE MANUAL Replacing parts WARNING: Before to remove the tubehead, close and tie the two sections of the scissors arm together. Failure to follow these instruction may harm both the technician and damage the arm itself. (Rev. 1) NOTE: Before carrying out the following operations, disconnect the equipment from the line. 1. Remove the tubehead as described in paragraph 10.1.1, steps from 1 to 3. 2. Remove the plastic timer cover loosening the two sealing screws placed on the top part. Pull the cover to release the locking pins. To make the operation easier, disconnect all wires between wall plate and cover. 3. Disconnect cables from connectors X2 and X4 (including shield W2). Disconnect the main power supply cable from the main power supply terminal strip (Figure 6-19). 4. Remove the timer from the support plate. 5. Remove the scissor arm. 6. Assemble the new arm as described in paragraph 6.3.3. 7. Fix the support plate and the timer as described in paragraph 6.2, steps 5 and following. 8. Connect the cables as described in paragraph 6.5.1. 9. Reassemble the tubehead as described in paragraph 10.1.1, steps from 4 to 6. 81 ENDOGRAPH DC SERVICE MANUAL Maintenance Like all electrical equipment, this unit requires not only correct use, but also maintenance and checks at regular intervals. This precaution will guarantee that the equipment works safely and efficiently. Periodic maintenance consists in checks carried out directly by the operator and/or by the Technical Service. The operator can carry out the following checks himself: • check there are no oil marks on the tubehead • check the remote control cable is not broken or scratched • check there are no external damages to the equipment which could make it unsafe in terms of protection from radiation • check the scissors arm balance • • • check that the X-ray beam is centered check proper functioning of X-ray exposure LED and exposure buzzer check the plates are intact and well attached. The Service Engineer, during preventive maintenance, besides the checks listed above, will verify also: • correct adjustment of the rotation friction mechanism of the extension arm and of the scissors arm • correct balancing of scissors arm, making proper adjustment when necessary. NOTE: The Service Engineer has to take special care for all what concerns electrical safety of the device and must make sure of restoring all provisions for electrical safety which may be affected during a service intervention and to solicit the customer to have the electrical safety tests repeated every time the intervention has caused the replacement of important parts or the intervention has significantly affected safety provisions of the device. NOTE: Interventions carried out by the Service Engineer must be noted in the Maintenance Record page at the end of the User Manual, with a short description of the actions done ENDOGRAPH DC 82 (Rev. 1) SERVICE MANUAL Schematics and drawings CBA BC 1. ENDOGRAPH DC – General connection diagram (Rev. 1) 83 ENDOGRAPH DC SERVICE MANUAL Schematics and drawings THIS PAGE IS INTENTIONALLY LEFT BLANK ENDOGRAPH DC 84 (Rev. 1) SERVICE MANUAL Schematics and drawings D DE (Rev. 1) 85 DF ENDOGRAPH DC SERVICE MANUAL Schematics and drawings THIS PAGE IS INTENTIONALLY LEFT BLANK ENDOGRAPH DC 86 (Rev. 1) SERVICE MANUAL Spare Parts CB CC (Rev. 1) 87 ENDOGRAPH DC SERVICE MANUAL Spare parts WARNING: The Driver board and the tubehead are matched in the factory and therefore MUST be replaced as a couple. 6159300100 Frictioning mechanism assy 6659400000 A2 Driver board and Tubehead assembly 5859301000 A2 CPU board 4695463800 A6 Radio board -- 6259300300 Flat cable CPU-Driver board 4291420900 ON/OFF switch 6659300500 X-ray push button 6659300600 Wireless X-ray push button 5459301200 Timer keypad 6659300200 Timer front cover complete of keypad 5459301600 Remote timer keypad 6659300400 Remote timer front cover complete of keypad 10 5859301400 A8 / A9 Remote Interconnection control board Present only with Remote Timer version 11 5859301200 A5 External signal board Optional F1 2300997200 Fuse 6.3 A T 6.3x32 250V Mounted on Power PCB F3 2300997200 Fuse 6.3 A T 6.3x32 250V For mobile version 4560311800 Fuse holder 4560311900 Cap for fuse holder For mobile version ENDOGRAPH DC 88 Present only with wireless X-ray button (Rev. 1) SERVICE MANUAL Spare Parts 11 10 (Rev. 1) 89 ENDOGRAPH DC SERVICE MANUAL Spare parts CB CC 8159200000 Scissor arm complete of tubehead support 8161200302 Extension arm 30 cm 8161200502 Extension arm 60 cm 8161200402 Extension arm 80 cm 6661210013 Scissor arm joint covers kit (DX + SX) 6659210013 Extension arm end-covers kit 6659210100 Extension arm frictioning mechanism 5160249500 Busher ∅ 28 mm ENDOGRAPH DC 90 (Rev. 1) SERVICE MANUAL Spare Parts (Rev. 1) 91 ENDOGRAPH DC SERVICE MANUAL Spare parts 8160120000 Mobile stand complete 4890310400 Wheel with brake 80x24 4890307000 Wheel 80x24 6661305600 Mobile stand spacer 5259300105 Timer fixing plate ENDOGRAPH DC 92 (Rev. 1) SERVICE MANUAL Spare Parts (Rev. 1) 93 ENDOGRAPH DC SERVICE MANUAL Spare parts WARNING: The tubehead and the Diver board are matched in the factory and therefore MUST be replaced as a couple. 6659400105 Tubehead covers kit (without plate) 5460461813 Front fixing ring 5160423813 Angle indicator 5460420813 Tubehead lateral cover 6659400000 Tubehead complete assembly including Driver board ENDOGRAPH DC 94 (Rev. 1) SERVICE MANUAL Spare Parts (Rev. 1) 95 ENDOGRAPH DC SERVICE MANUAL Spare parts 6659300100 Remote Timer kit 6659120000 Remote X-ray button support 7659303000 Wireless upgrade kit for wired X-ray button. 7659303100 External lamp connection kit 6159400000 Extension cone for 30cm Source to Image Distance 6159410000 Rectangular beam limiting device 45x35mm 6159410100 Rectangular beam limiting device 25x35mm 6159410200 Rectangular beam limiting device 20x30mm 6659200100 Allen wrenches kit ENDOGRAPH DC 96 (Rev. 1) SERVICE MANUAL Spare Parts THIS PAGE IS INTENTIONALLY LEFT BLANK (Rev. 1) 97 ENDOGRAPH DC SERVICE MANUAL Spare parts THIS PAGE IS INTENTIONALLY LEFT BLANK ENDOGRAPH DC 98 (Rev. 1) SERVICE MANUAL Fixing templates The system is equipped with a set of templates, composed of the following elements: (Rev. 1) Code Description 39599100 Template for standard version 39599101 Template for remote version 99 ENDOGRAPH DC SERVICE MANUAL Fixing templates THIS PAGE IS INTENTIONALLY LEFT BLANK ENDOGRAPH DC 100 (Rev. 1) Cod. 6959900703_Rev.1 VILLA SISTEMI MEDICALI S.p.A. Via Delle Azalee, 3 20090 Buccinasco (MI) – ITALY Tel. (+39) 02 48859.1 Fax (+39) 02 4881844 0051
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