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ENGLISH

Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H

A.4 LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES

The X-MIND unity: x-ray equipment for dental intraoral radiography, is in compliance with the following:

• MDD 93/42 EEC and subsequent amendments

In compliance with the classification indicated in the Medical Device Directive 93/42/EEC, Annex IX, article 10: “Active devices intended to

emit ionizing radiation and intended for diagnostic radiology”, the system is classified as:

Class IIb

•

DHHS Radiation performance standards 21 CFR Subchapter J

• IEC 60601-1:1988, 2nd edition

• IEC 60601-1/A1

• IEC 60601-1/A2

• CSA C22.2#601.1-M90 and S1+A2

• UL 60601-1: 2003

• AS/NZS 3200.1.0

• IEC 60601-1-3:1994, 1st edition

• IEC 60601-1-4:1996, 1st edition

• IEC 60601-1-4/A1

• IEC 60601-2-7:1998, 2nd edition

• IEC 60601-2-28:1993, 1st edition

• IEC 60601-2-32:1994, 1st edition

• IEC 60601-1:2005, 3rd edition

• IEC 60601-1-3:2008,

• IEC 60601-1-6:2010.

• IEC 60601-2-65:2012

• ANSI/AAMI ES60601-1:2005

• CAN/CSA-C222.2 N. 60601-1:08

• IEC 60601-1-2:2007, 3rd edition

Certifications

ETL

Содержание X-MIND unity

Страница 1: ...OPERATOR S MANUAL Operator s manual X Mind unity VH 15 09 2017 NUN0EN010H ...

Страница 2: ...e original document ENGLISH Important All new editions and revisions of the manuals supersede the previous ones Refer to complete manuals and instructions For complete manuals and instructions www satelec com documents Scan the QR code to access the dedicated website www satelec com documents ...

Страница 3: ...NUN0EN010H MANUFACTURER de Götzen S 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 imaging italysupport acteongroup com ...

Страница 4: ...CT AND ALL THE MANUALS WITHOUT PRIOR NOTICE IT IS PROHIBITED TO MODIFY COPY REPRODUCE DISPLAY SHARE DISCLOSE AND PUBLISH THIS MANUAL AND ALL OTHER DOCUMENTS REFERRING TO X MIND unity IN ANY FORM WITHOUT PRIOR WRITTEN CONSENT BY de GÖTZEN S R L ACTEON Group THIS MANUAL MUST ALWAYS BE KEPT NEAR THE MEDICAL DEVICE FOR FUTURE REFERENCE de Götzen S r l ACTEON Group SHALL NOT BE HELD LIABLE FOR MISUSE O...

Страница 5: ...n operating the system CAUTION WARNING PLEASE NOTE PROHIBITION 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 x ray system s performance PLEASE NOTE PLEASE NOTE serves to give special indications to facilitate maintenance o...

Страница 6: ...ELECTED EXAM TYPE 32 5 7 1 PERIAPICAL EXAM 32 5 7 2 OCCLUSAL EXAM 32 5 7 3 BITEWING EXAM 33 5 8 CHECK THE SELECTED IRRADIATION TIME 33 5 9 CHECK THE DOSE AREA PRODUCT VALUES 33 5 10 ENABLE ACE MODE OPTIONAL SOPIX SOPIX2 INSIDE INSTALLED 34 5 10 1 IMPORTANT NOTES ABOUT ACE TECHNOLOGY AND X MIND UNITY 34 5 10 2 HOW TO USE THE X MIND UNITY WITH SOPIX SOPIX2 INSIDE ACE TECHNOLOGY 35 5 11 POSITIONING T...

Страница 7: ...y VH 15 09 2017 NUN0EN010H ANNEX A TECHNICAL DATA 61 A 1 TECHNICAL SPECIFICATIONS 61 A 2 INTENDED ENVIRONMENT 65 A 3 DIMENSIONS OF THE UNIT 66 A 4 LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES 71 A 5 DOSIMETRIC INDICATIONS 72 A 6 EMC COMPATIBILITY 76 ...

Страница 8: ...he informa tion in this manual is periodically updated any amendment will be included in subsequent publications without prior notice by de Götzen S r l ACTEON Group Contact your dealer to request the latest version of the manual In the event of errors please inform de Götzen S r l ACTEON Group promptly CAUTION WARNING This manual does not include all the recommendations and obligations concerning...

Страница 9: ...rs and relevant metrics which describe the performance of dental X ray system with regard to imaging properties and patient dose methods of testing and whether measured quantities related to those parameters complying with the specified tolerances are stated by the respective manufacturers and by the requirements specified by the respective applicable standards Radiographic films film processing d...

Страница 10: ...lines contained in all the manuals provided with the X MIND unity device CAUTION Non compliance of any of the above mentioned rules and all the indications provided by the manufacturer in the documentation or suc cessively in written paper or electronic format will result in voiding the warranty of the product and the manufacturer will be discharged from any obligation including consequential dama...

Страница 11: ...tors shall be held liable for any damage and or accidents and or degeneration of patients or operators health or of the surrounding environment The RESPONSIBLE ORGANIZA TION 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 oper...

Страница 12: ...on of patients or operators health or of the surrounding environ ment CAUTION PROTECTION AGAINST RADIATIONS The General principles for safeguarding and protecting the personnel and patients must always be applied during the use of the X ray unit 1 Justification of the practice 2 Optimization of protection principle ALARA principle 3 Individual risk and dose limits The X MIND unity is a medical dev...

Страница 13: ...03 8 5 4 of the IEC 60601 2 65 in case you re using the X MIND unity device together with the integrated Sopix Sopix2 Inside sensor it is mandatory to install and use the original rectangular beam limiting device provided by the manufactu rer of the X MIND unity CAUTION MECHANICAL RISK Pay extreme attention to the tension of the internal spring of the scissor arm in order to avoid the arm opening ...

Страница 14: ...ment not complying with the leakage current requirements in IEC 60601 1 shall be kept outside the patient environment i e at least 1 5 m from the patient support Any person who connects external equipment to signal input signal output or other connectors has formed a system and is therefore res ponsible for the system to comply with the requirements If in doubt contact qualified medical technician...

Страница 15: ...ectants must be used let the vapors completely disperse before turning on the x ray 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 and performed by authorized and quali fied personnel using ONLY genuine original spare parts of de Götzen S r l de Götzen S r l proscribes improper unauthorized modifications...

Страница 16: ...diations thanks to the immediate activation of the safety device and the ACE option if enabled protection against continuous service since the system is designed according to standards to not be used in radioscopy protection for the operator against irradiation due to the extendable hand control and cable which allows for a safety distance of more than 2 meters 6 ft protection against accidental s...

Страница 17: ... the scissor arm Its shaft is fixed in a dedicated section in the middle of the timer top or bottom and allows for 180 movement 3 PANTOGRAPH TYPE ARM SCISSOR Due to the new shape and mechanism of the articulating arm it can be ajusted in height and depth for easy and precise movement to any position It is equipped with internal balancing springs and made of extruded aluminum arms covered by PC ABS...

Страница 18: ...nicians on the field with the optional Sopix Sopix2 Inside intraoral x ray digital sensors manufactured and sold by SOPRO Acteon Group which are equipped with the ACE technology 6 COLLIMATOR CONE Beam Limiting Device Made of transparent polycarbonate or PC ABS it allows for correct focal spot to skin distance dimension direction and centering of the x ray beam implementation of different x ray tec...

Страница 19: ...VH 15 09 2017 NUN0EN010H 2 2 IDENTIFICATION TAGS The identification tags on the tube head timer and cone indicate the model number serial number the manu facturing date and the symbols of the main technical characteristics Labels for Europe Labels for USA ...

Страница 20: ...anual X Mind unity VH 15 09 2017 NUN0EN010H ENGLISH X MIND unity global label X MIND unity Control Unit Timer Label X MIND unity X ray source Label BEAM LIMITING DEVICE LABEL TUBEHEAD GRADUATED SCALE ETL LABEL AND X RAY WARNING ...

Страница 21: ...wheelie bin identifies a product placed on the market after the 13th of August 2005 see IEC EN 50419 2005 This product is subjected to Council Directive 2012 19 EC WEEE and implementation standards in force in your country The product must be disposed of or recycled to protect the environment Contact your sup plier Size of the focal spot small Hazardous Voltage Electrostatic discharge sensitive de...

Страница 22: ...2012 of March 9th 2013 PUSHING PROHIBITED FUSE LABEL Replaceable Fuse Rating 100V 240V T10A H 250V NOTE The fuse label is located in close proximity to the main switch CAUTION WARNING In the event the line fuse needs replacement you must observe all ratings and specifications declared by de Götzen S r l Call the technical support service for assistance as shown on pages 3 and 4 of this manual ...

Страница 23: ...s manual X Mind unity VH 15 09 2017 NUN0EN010H CONTROL PANEL OVERVIEW 1 STATUS LED 2 INFORMATION DISPLAY 3 LOADING FACTORS AND RADIOGRAPHIC TECHNIQUE BUTTONS 4 FUNCTIONAL AND EXPOSURE TIME BUTTONS 5 TYPE OF PATIENT 6 TYPE OF EXAM 3 3 ...

Страница 24: ...0 30cmSSD Type of cone installed circular beam output or rec tangular beam output Digit display Units of measurement of the irradiation time se conds It is positioned below and to the left of the irradiation time display Units of measurement relevant to the Dose Area Pro duct mGy cm2 Exp time scale customization Remote exposure switch installed 1 1 The SSD distance depends on the type of beam limi...

Страница 25: ...ey mA set key Memo key Increase or decrease exp time Pushed simulta neously shows DAP 3 4 TYPE OF PATIENT Child Small patient key Adult Normal patient key 3 5 TYPE OF EXAMS Maxilla incisors Mandibula incisor Maxilla premolar Mandibula premolar Maxilla molar Mandibula molar Occlusal exam maxilla mandibula Bite wing exam ant post ...

Страница 26: ... the control panel display The leds of the set parameters automatically illuminate The exposure time is clearly shown on the display CAUTION If an error is detected when the system is turned on the anomaly is indicated as follows Intermittent beeping sound Intermittent flashing of the MALFUNCTION indicator the error code E appears on the display refer to Chapter 8 all the control panel functions a...

Страница 27: ... NOTE If the timer remains inactive for a few minutes it switches to the stand by mode Press any key on the control panel to restore it to the operative armed mode Before taking an x ray exposure always check that the parameters selected and displayed on the control panel see the following steps below are suitable for the x ray examination being performed ...

Страница 28: ...ent 4mA 7mA typical suggested 6 mA 7mA Selection of the x ray detector type F d FILM D Speed F e FILM E Speed F f FILM F Speed Dig Digital X Ray Sensor PSP Phosphor plates When the integrated Sopix Sopix2 Inside sensor is installed and properly connected you can run the X MIND unity with the ACE system activated the ACE code inside the list of selected type of supported detector F d F e F g F f DI...

Страница 29: ...the programmed exposure times MAY NOT be modified Certain exposure values have been predefined which depend on the selection of the operating parameters cone 8 12 type of patient ADULT CHILD x ray technique intra oral exam type PLEASE NOTE If one so desires it is possible to change these values by means of the dedicated key buttons previously indicated Possible modifications of the exposure values...

Страница 30: ...d information will be completely incorrect 5 2 CHECK THE SOURCE TO SKIN DISTANCE Make sure the cone being used matches the type indicated by the cone length icon which should be illuminated on the control panel at this time source skin distance SSD Icon 20 cm 8 ON Indicates that the selected tube head is equipped with 8 20cm SSD cone Icon 30 cm 12 ON Indicates that the selected tube head is equipp...

Страница 31: ...ed value press mA key until you reached the desired value It is possible select x ray current among these values 4 7mA 1mA step 4 mA 5 mA 6 mA 7 mA 5 5 CHECK THE SELECTED TYPE OF PATIENT The led at the bottom of the key relevant to the selection of the desired patient size should be illuminated or led CHILD ON indicates that the x ray system is set for a patient with a small physique led ADULT ON ...

Страница 32: ...ital x ray sensors PSP indicates that the x ray system is set for use with external phosphor plates Changing the selection To change the selected value press the dedicated key until reaching the desired setting PLEASE NOTE After the modification the default exposure values will be automatically changed 5 7 CHECK THE SELECTED EXAM TYPE 5 7 1 PERIAPICAL EXAM The led at the bottom of the selected tee...

Страница 33: ...l 5 9 CHECK THE DOSE AREA PRODUCT VALUES The DAP values mGy cm2 relevant to the combination of the technique factors and settings selected for the exposure can be checked by simultaneously pressing the following keys shown belowon the x ray control unit keyboard of the X MIND unity The DAP value will be shownd on the display instead of the exposure time The icon relevant to the units of measuremen...

Страница 34: ...ge to property or the environment Furthermore the managers of the facility customers or collaborators shall be held liable for any damage and or accidents and or degeneration of patients or operators health or of the surrounding environment PLEASE NOTE The ACE technology implemented in the X MIND unity Sopix Sopix2 Inside integration was developed to correct exposure times ONLY and not to change t...

Страница 35: ...perator must always verify communication between Sopix Sopix Inside and X Mind unity by making sure the ACE logo on the control unit displays is illuminatedthe ACE logo on the control unit display before each acquisition CAUTION The operator must set up the appropriate exposure times according to the type of examination CAUTION Please perform the exposure using an activated x ray sensor to transfe...

Страница 36: ...pro Imaging 5 If the operator wants to use another detector or to deactivate the ACE technology automatic stop feature temporaly the operator must switch to the appropriate detector support on the control unit As soon as the Sopix Sopix2 Inside is still connected and operative this change will be active only for one shot The X Ray detector support type will automatically switch into ACE mode again...

Страница 37: ... on the X MIND unity control unit For one exposure select the DIG icon support on the X MIND unity control unit For consecutive exposures disconnect Sopix Sopix2 Inside USB cable Follow strictly Please follow the exact instructions provided by Sopro Acteon Group when acqui ring imageswith multiple Sopix famly of sensors connected to the same PC C Sopix Sopix Inside AND other manufacturers sensors ...

Страница 38: ...Page 38 of 79 Operator s manual X Mind unity VH 15 09 2017 NUN0EN010H ENGLISH Combination B Combination C ...

Страница 39: ...sensors will be armed and ready for exposure at the same time Please only use the Sopix Sopix2 Inside sensor when the ACE icon is illuminated on the X Mind unity display In case accidentally is exposed the external sensor to prevent accidental radation exposure to the patient or office staff while the ACE mode is active the X MIND unity stops the exposure automatically after 20ms ...

Страница 40: ... in order to maintain precise positioning during the examination and also to help the operator avoid common errors by specifically directing the X ray beam toward the receptor CAUTION The disposable protection covers used for any type of x ray detector support can cause dangerous injuries even death if swallowed Please use the disposable protectors as recommended by their respective manufacturers ...

Страница 41: ...ed parallel to the long axis of the tooth in question and the central x ray beam should be directed perpendicular to the long axis of the tooth 5 12 2 BISECTING ANGLE TECHNIQUE The bisecting angle technique is based on the principle of aiming the central ray of the x ray beam at right angles to an imaginary line which bisects the angle formed by the longitudinal axis of the tooth and the plane of ...

Страница 42: ...isassembled or assembled improperly This can endanger the safety of the patient and or operator Sopix Sopix Inside sensor holder properly installed 5 13 POSITIONING THE X RAY GENERATOR AND COLLIMATOR BEAM LIMITING DEVICE CAUTION WARNING Before each examination it is mandatory to use a disposable protecting sheath device over the collimator cone Beam Limiting Device that is designed to cover the en...

Страница 43: ...the process positioning the patient the x ray generator and collimator exposing the x ray detector film digital sensor plates and processing the film or the digital image acquisition and processing chain CAUTION It is mandatory for the operator to check the parameters before making any exposure with either the local or remote exposure switch CAUTION Always maintain audio and visual contact with th...

Страница 44: ...e Switch PLEASE NOTE If the X RAY button is released before the end of the selected exposure time the exposure is immediately interrupted and an error mes sage appears on the display 1 At the end of the exposure the yellow led momentarily illuminates indicating the PAUSE state 2 The display indicates the actual exposure time 3 All the timer functions are inhibited until the PAUSE led extinguishes ...

Страница 45: ...osure switch 1 Safety key switch CAUTION If a remote exposure switch is installed and the system is on both the remote and local exposure switches are activated If the ready and the remote switch icon are illuminated on the control unit the system will emit x rays when the remote exposure switch is pressed It is mandatory to disable the control unit by turning the safety key to 0 and remove the ke...

Страница 46: ...nal information concerning the functioning of the X MIND unity light please refer to the Installation Maintenance Manual 5 15 TRANSPORT AND POSITIONING OF THE MOBILE STAND X MIND Unity has also mobile version and it is sustained by the stand as shown in the following figure Generally X Mind Unity mobile version can be in the two following positions 1 Transport position 2 Operative position The fol...

Страница 47: ...n using the handle 5 Activate brakes of all four wheels PROHIBITION Pushing prohibited pushing or leaning the device using other parts respect to the handle or with the brakes activated or with the scissor arm opened could overbalance the equipment 6 Plug the power supply cable 7 Perform the settings and the x ray exposure as described in section 5 operating instruction ...

Страница 48: ...type of x ray examination being performed Before performing an intraoral radiograph by any Digital X ray sensor CMOS or CCD or Phosphor Plates PSP the operator must imperati vely verify and eventually adjust the preprogrammed exposure time setting of the X MIND Unity along with the instructions in the accompa nying document of the sensor PLEASE NOTE When selecting the kV you can follow this genera...

Страница 49: ...5 kV 7 mA Child Adult Child Adult Child Adult Maxillary Incisor 0 16 s 0 25 s 0 1 s 0 16 s 0 08 s 0 125 s Premolar 0 2 s 0 32 s 0 125 s 0 2 s 0 1 s 0 16 s Molar 0 25 s 0 32 s 0 16 s 0 25 s 0 125 s 0 16 s Mandibular Incisor 0 1 s 0 16 s 0 063 s 0 1 s 0 05 s 0 08 s Premolar 0 125 s 0 2 s 0 08 s 0 125 s 0 063 s 0 1 s Molar 0 16 s 0 25 s 0 1 s 0 16 s 0 08 s 0 125 s Bitewing Anterior 0 125 s 0 2 s 0 08...

Страница 50: ... Bitewing Anterior 0 04 s 0 05 s 0 04 s 0 05 s 0 08 s 0 1 s Posterior 0 05 s 0 063 s 0 05 s 0 063 s 0 1 s 0 125 s Occlusal Maxillary 0 08 s 0 1 s 0 08 s 0 1 s 0 16 s 0 2 s Mandibular 0 08 s 0 1 s 0 08 s 0 1 s 0 16 s 0 2 s 6 2 LONG CONE 12 INCHES 30 CM SDD 12 inches 30 cm SSD FILM D FILM E FILM F 70 kV 6 mA Child Adult Child Adult Child Adult Maxillary Incisor 0 25 s 0 4 s 0 16 s 0 25 s 0 125 s 0 2...

Страница 51: ... 0 5 s Mandibular Incisor 0 32 s 0 5 s 0 2 s 0 32 s 0 16 s 0 25 s Premolar 0 4 s 0 63 s 0 25 s 0 4 s 0 2 s 0 32 s Molar 0 4 s 0 63 s 0 25 s 0 4 s 0 2 s 0 32 s Bitewing Anterior 0 4 s 0 5 s 0 25 s 0 32 s 0 16 s 0 25 s Posterior 0 4 s 0 63 s 0 25 s 0 4 s 0 2 s 0 32 s Occlusal Maxillary 0 8 s 1 s 0 5 s 0 63 s 0 4 s 0 5 s Mandibular 0 8 s 1 s 0 5 s 0 63 s 0 4 s 0 5 s 12 inches 30 cm SSD SOPIX2 Inside ...

Страница 52: ...er for all the other film or sensor types for which no customizing has been applied the default exposure values in the charts are still valid To programm the new exposure values of the film or sensor type that iscurrently selected press either of the following keys Thebelow symbols being illuminated shown on the display represent the possibility to modify the exp values scale PLEASE NOTE When eith...

Страница 53: ...he name of the first parameter is shown in the bottom of the display 3 Use the key to scroll through the parameters 4 When the TIME RESTORE parameter is displayed press the key to enter that parameter 5 The icons start blinking 6 Use the keys to select yes or no 7 To restore the unit to the factory default settings select YES and press the key to confirm and save the selection 8 Press the key to e...

Страница 54: ...ce away from the x ray beam press and hold in the exposure key The CAL IN PROGRESS message will appears on the display Exp Led is illuminated and an intermittent acoustic sound is emit ted 3 At the end of the procedure the acoustic sound stops and the CAL SUCCESS message appears on the display 4 When the pause light goes out the control unit will resume back to standard functioning mode and is rea...

Страница 55: ...tus is fixed or restored Some errors can be cleared by pressing the reset button on the keypad Le graphique suivant comprend une liste de message d erreur pouvant apparaître lors du fonctionnement du système radiographique X MIND unity The following chart gives a list of error messages that will appear should the X MIND unity experience a malfunction The error codes have the following format The l...

Страница 56: ...e timeout Exposure button released beforehand after an exposure YES E115 wrong parameters in generator Exposure parameters kV mA exposure time mode does not match with the ones set in the control box YES E116 generator reset during emission inverter has been resetted during an exposure YES E117 calibration start fail Calibration YES E118 calibration too long Calibration time too long YES E119 butt...

Страница 57: ...n exposure YES E215 generator internal power supply 12V internal voltage too low NO E216 generator internal power supply 12V internal voltage too high NO E217 generator mode Wrong exposure enabling signal activation YES E218 safe circuit fail Security interlock fault NO E219 tube current too low Mean anodic current too low YES E220 tube current too high Mean anodic current too high YES E221 no tub...

Страница 58: ...authorized authorized professional technicians It is the RESPONSIBLE ORGANIZATIONS s responsibility to arrange for this service and to assure that the personnel performing this function are fully qualified to service X MIND unity x ray equipment The RESPONSIBLE ORGANIZATION must always carry out routine maintenance on a daily basis to ensure optimal device performance These checks must be performe...

Страница 59: ... product is marked with the symbol shown above This product must not be disposed of together with domestic waste It must be taken to a special waste collection centre to be recovered and recycled The crossed out wheelie bin identifies a product placed on the market after the 13th of August 2005 see IEC EN 50419 2005 This product is subjected to Council Directive 2012 19 EC WEEE and natio nal imple...

Страница 60: ...angle and the reference axes are shown in the figure below LONG CONE cylindrical and rectangular SHORT CONE cylindrical and rectangular The tolerances of the focal spot on the reference axes are 0 5mm Dimensions of the area of the x ray beam output according to the shape of the beam limiting device Cylindrical Beam Limiting device Ø 60 mm Rectangular Beam Limiting device 44x35 mm 11 11 ...

Страница 61: ...ltage Generator when operated at that X ray Tube Voltage 65 kVp 7 mA Highest X ray Tube Current together with the highest X ray Tube Voltage obtainable from the High Voltage Generator when operating at that X ray Tube Current 7 mA 65 kVp The Combination of X ray Tube Voltage and X ray Tube Current which results in the highest electric output power 65 kVp 7 mA The lowest Current Time Product or the...

Страница 62: ...UN0EN010H ENGLISH Heating and cooling curve of the X Mind unity X Ray source Assembly X Ray Tube Housing X RAY TUBE X ray tube model TOSHIBA D 041 Focal Spot Size IEC 336 0 4 mm Anode Angle 12 5 Anode material Tungsten Maximum Rating Charts of the Toshiba D 041 ...

Страница 63: ...e follow the instructions in the following chapter ADVANCED SETTINGS of the X MIND unity Installation and Maintenance manual DEVICE POWER SUPPLY and ELECTRICAL CLASSIFICATION Supply voltage 100 V à 240 V Supply voltage frequency 50 60 Hz Maximum Line Current technique factors that constitute maximum line current condition 65kV 7mA 2s 8 5 A 100 V Standby current 100 mA Maximum Adsorbed Power 850 VA...

Страница 64: ...ted to sterilization Operation mode Continuous operation with intermittent X ray loading NFPA 70 Classification Momentary Operation 5s WARNING NEVER CONNECT the X Mind Unity to the mains without first checking the voltage setting as indicated on the labels Incorrect voltage set tings will cause irreversible damage to the X Mind unity electronics DEGREE OF PROTECTION PROVIDED BY ENCLOSURES Accordin...

Страница 65: ... the device to reach the room temperature before reconnecting it to the mains voltage and applying power CLINICAL ENVIRONMENT CONDITIONS OPERATING CONDITIONS Temperature 10 C 50 F 40 C 104 F Relative humidity 25 75 Atmospheric pressure 850 1060 hPa TRANSPORTATION ENVIRONMENT CONDITIONS Temperature 0 C 32 F 50 C 122 F Relative humidity see clinical environment conditions Atmospheric pressure 500 10...

Страница 66: ...010H ENGLISH A 3 DIMENSIONS OF THE UNIT FRONT VIEW REST POSITION BOTTOM MOUNT A 40cm 16 bracket 79cm 31 80cm 31 bracket 119cm 46 110cm 43 bracket 149cm 59 FRONT VIEW REST POSITION TOP MOUNT B 40cm 16 bracket 79cm 31 80cm 31 bracket 119cm 46 110cm 43 bracket 149cm 59 ...

Страница 67: ...EW OPEN TOP MOUNT C1 LONG CONE 40cm 16 bracket 140cm 55 80cm 31 bracket 180cm 71 110cm 43 bracket 210cm 83 C2 SHORT CONE 40cm 16 bracket 150cm 59 80cm 31 bracket 190cm 75 110cm 43 bracket 220cm 87 C3 FULL SIZE 40cm 16 bracket 188cm 74 80cm 31 bracket 228cm 90 110cm 43 bracket 258cm 102 ...

Страница 68: ...e 68 of 79 Operator s manual X Mind unity VH 15 09 2017 NUN0EN010H ENGLISH SIDE VIEW CLOSED TOP MOUNT D 40cm 16 bracket 60cm 24 80cm 31 bracket 100cm 39 110cm 43 bracket 130 51 SIDE VIEW OPEN BOTTOM MOUNT ...

Страница 69: ...racket 180cm 71 110cm 43 bracket 210cm 83 E2 SHORT CONE 40cm 16 bracket 150cm 59 80cm 31 bracket 190cm 75 110cm 43 bracket 220cm 87 E3 FULL SIZE 40cm 16 bracket 188cm 74 80cm 31 bracket 228cm 90 110cm 43 bracket 258cm 102 SIDE VIEW CLOSED BOTTOM MOUNT F 40cm 16 bracket 60cm 24 80cm 31 bracket 100cm 39 110cm 43 bracket 130 51 ...

Страница 70: ...Page 70 of 79 Operator s manual X Mind unity VH 15 09 2017 NUN0EN010H ENGLISH FRONT VIEW REST POSITION MOBILE G no bracket 141cm 55 ...

Страница 71: ...iation and intended for diagnostic radiology the system is classified as Class IIb DHHS Radiation performance standards 21 CFR Subchapter J IEC 60601 1 1988 2nd edition IEC 60601 1 A1 IEC 60601 1 A2 CSA C22 2 601 1 M90 and S1 A2 UL 60601 1 2003 AS NZS 3200 1 0 IEC 60601 1 3 1994 1st edition IEC 60601 1 4 1996 1st edition IEC 60601 1 4 A1 IEC 60601 2 7 1998 2nd edition IEC 60601 2 28 1993 1st editi...

Страница 72: ...sponding loading factors are selected If the ACE technology intervenes and stops the X ray emission the effective value of DAP is calculated and displayed after the exposition As per paragraph 203 6 4 6 of the IEC 60601 2 65 the overall deviation from the estimated air kerma is within 50 BLD SHAPE Circular SSD mm 200 kV 60 65 70 mA 7 6 5 4 7 6 5 4 6 5 4 Time s DAP mGy cm 0 02 3 8 3 3 2 7 2 2 4 4 3...

Страница 73: ...9 4 9 4 1 3 3 0 063 5 4 4 6 3 9 3 1 6 3 5 4 4 5 3 6 6 2 5 2 4 1 0 08 6 8 5 8 4 9 3 9 8 6 9 5 7 4 6 7 8 6 5 5 2 0 1 8 5 7 3 6 1 4 9 9 9 8 5 7 1 5 7 9 8 8 2 6 5 0 125 10 7 9 2 7 6 6 1 12 4 10 6 8 9 7 1 12 2 10 2 8 1 0 16 13 7 11 7 9 8 7 8 15 9 13 6 11 4 9 1 15 6 13 10 4 0 2 17 1 14 7 12 2 9 8 19 9 17 1 14 2 11 4 19 6 16 3 13 1 0 25 21 4 18 3 15 3 12 2 24 9 21 3 17 8 14 2 24 4 20 3 16 3 0 32 27 3 23 ...

Страница 74: ...12 9 11 1 9 2 7 4 15 12 9 10 7 8 6 14 7 12 3 9 8 0 16 16 5 14 1 11 8 9 4 19 2 16 5 13 7 11 18 8 15 7 12 5 0 2 20 6 17 7 14 7 11 8 24 20 6 17 1 13 7 23 5 19 6 15 7 0 25 25 8 22 1 18 4 14 7 30 25 7 21 4 17 1 29 4 24 5 19 6 0 32 33 28 3 23 6 18 9 38 4 32 9 27 4 21 9 37 7 31 4 25 1 0 4 41 2 35 3 29 4 23 5 48 41 1 34 3 27 4 47 1 39 3 31 4 0 5 51 5 44 1 36 8 29 4 60 51 4 42 9 34 3 58 9 49 1 39 3 0 63 64...

Страница 75: ...3 9 3 1 5 3 4 4 3 5 0 125 5 8 5 4 1 3 3 6 8 5 8 4 9 3 9 6 7 5 6 4 5 0 16 7 4 6 3 5 3 4 2 8 7 7 5 6 2 5 8 5 7 1 5 7 0 2 9 3 8 6 6 5 3 10 8 9 3 7 7 6 2 10 7 8 9 7 1 0 25 11 6 9 9 8 3 6 6 13 5 11 6 9 6 7 7 13 3 11 1 8 9 0 32 14 9 12 8 10 6 8 5 17 3 14 8 12 4 9 9 17 14 2 11 3 0 4 18 6 15 9 13 3 10 6 21 7 18 6 15 5 12 4 21 3 17 8 14 2 0 5 23 3 20 16 6 13 3 27 1 23 2 19 4 15 5 26 6 22 2 17 7 0 63 29 3 2...

Страница 76: ...the electromagnetic environment specified below The customer or the operator of X MIND unity must ensure that the device is used in this type of environment Emission test Conformity Electromagnetic environment guidance RF emissions CISPR 11 Group 1 X MIND unity uses RF energy only for inter nal operation RF emissions are extremely and attenuated are not likely to generate interference with electro...

Страница 77: ...cial or hospital applications Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode Not relevant for common mode Mains power quality should conform to that of typical com mercial or hospital applications Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 ...

Страница 78: ...e in metres m Field strength from fixed RF transmitters as determined by an electromagnetic site surveya must be below the compliance level corresponding to each frequency range b Interference can occur in the proximity of equipment marked with the following symbol Notes At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in every situation Electromagnetic propa...

Страница 79: ...e according to transmitter frequency 150 kHz à 80 MHz d 1 2 P 80 MHz à 800 MHz d 1 2 P 800 MHz à 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 24 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 In the event of transmitters whose maximum nominal output power coefficient does not fall within the indicated parameters the recommended separation distance in metres m can be determined by means of the eq...

Страница 80: ...3 de Götzen S r l A company of ACTEON Group Via Roma 45 21057 OLIGATE OLONA VARESE ITALY Tel 39 0331 376 760 Fax 39 0331 376 763 E Mail imaging italysupport acteongroup com www acteongroup com ...

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