OPERATOR’S MANUAL OPERATOR’S MANUAL • x-mind dc • 06/2021 • NXDCEN010I
ENGLISH Language of the original document: ENGLISH Important: All new editions and revisions of the manuals supersede the previous ones Refer to complete manuals and instructions Page 2 of 64 For complete manuals and instructions www.acteongroup.com OPERATOR’S MANUAL • x-mind dc • 06/2021 • NXDCEN010I Scan the QR code to access the dedicated website www.acteongroup.
ENGLISH MANUFACTURER de Götzen S.r.l. 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 YOUR LOCAL ACTEON AUSTRALIA NEW ZEALAND AUTHORIZED SPONSOR ACTEON AUTRALIA/NEW ZEALAND info@au.acteongroup.com CHINA ACTEON CHINA beijing@cn.acteongroup.com FRANCE SOPRO - ACTEON GROUP cs@acteongroup.com GERMANY ACTEON GERMANY info@de.acteongroup.com INDIA ACTEON INDIA info@in.acteongroup.
ENGLISH THE RADIOGRAPHIC SYSTEM DESCRIBED IN THIS MANUAL REFERS BOTH TO A WALL INSTALLATION AND TO THE MOBILE VERSION. de Götzen S.r.l. RESERVES ITSELF THE RIGHT TO MODIFY THE PRODUCTION AND THE MANUAL WITHOUT NOTICE. IT IS PROHIBITED TO MODIFY, COPY, REPRODUCE, DISPLAY, SHARE, DISCLOSE AND PUBLISH THIS MANUAL AND ALL OTHER DOCUMENTS REFERRING TO “x-mind dc” IN ANY FORM WITHOUT PRIOR WRITTEN CONSENT BY de GÖTZEN S.r.l. THE MANUAL MUST ALWAYS BE KEPT NEAR THE MEDICAL DEVICE FOR FUTURE REFERENCE. de Götzen S.
ENGLISH CONTENTS CONTROL PANEL.................................................................................................. 6 1. PRELIMINARY INFORMATION....................................................................... 7 1.1. INFORMATION FOR THE OPERATOR................................................................................................................... 7 1.1.1. INDICATIONS FOR USE......................................................................................................
ENGLISH CONTROL PANEL DISPLAY KEY TO DECREASE EXPOSURE TIME KEY TO INCREASE EXPOSURE TIME TUBEHEAD TYPE INDICATOR TUBEHEAD SELECTION RADIOGRAPHIC CURRENT INDICATOR RADIOGRAPHIC DISTANCE INDICATOR RADIOGRAPHIC VOLTAGE INDICATOR SELECTION OF PATIENT TYPE SAVE IN MEMORY OCCLUSAL EXAM MAXILLARY LOWER TEETH BITE - WING EXAM DIGITAL X-RAY CONVENTIONAL X-RAY X-RAY OUPTUT SIGNAL PAUSE INDICATOR MANDIBULARY LOWER TEETH MALFUNCTION INDICATOR Page 6 of 64 OPERATOR’S MANUAL • x-mind dc • 06/2021 • NXDCEN
ENGLISH 1. PRELIMINARY INFORMATION Before beginning to use the x-mind dc radiographic system, it is mandatory to carefully read and follow the instructions contained herein, so as to obtain the best possible performance and to assure the safety of the patient, operator, device and environment. LEGEND Always pay close attention to the CAUTION WARNING PLEASE NOTE messages when operating the system.
ENGLISH 1.1.1. INDICATIONS FOR USE x-mind dc is an X-ray equipment for dental intra-oral X-ray imaging, particularly, x-mind dc is an extra-oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of teeth, jaw and oral structures. From a clinical point of view, x-mind dc can be applied in routine dental radiography examinations involving the diagnosis, treatment, i.e. surgical or interventional, of disease of the teeth, jaw and oral cavity structures.
ENGLISH Device specific features and instructions x-mind dc provides the following specific design features and instructions that enable safer use of our device with pediatric patients: Design feature important to pediatric imaging Chapter Adult/Child patient selection: child selection adapts the exposure time reducing the overall dose delivered to the patient.
ENGLISH 1.3. WARRANTY CODITIONS Inappropriate use or any arbitrary tampering with the equipment exempt de Götzen S.r.l., as manufacturer of the x-mind dc radiographic system, from any service under warranty or from any other liability. The warranty is valid only if the following precautions are taken: - any repairs, modifications, adjustments, recalibrations must be performed only by de Götzen S.r.l.
ENGLISH CAUTION GENERAL REQUIREMENTS RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the x-mind dc radiographic system. Training and preparation of personnel is responsibility of THE RESPONSIBLE ORGANIZATION. x-mind dc radiographic system is an X-ray generator and must be used and handled only by specialised surgeons, dentists and authorized personnel, who meet the requirements provided by the national laws in force in the country of installation.
ENGLISH CAUTION PROTECTION AGAINST RADIATIONS “The general principles regarding safety and protection of workers and people” must always be applied when using the unit: 1. Justification of the practice 2. Protection Optimisation 3. Reduction of the limits of individual dose and risks The x-mind dc is a medical device that generates X-rays; therefore, both the patients and the operator are exposed to risks due to ionizing radiation. The physician must assess the actual need for X-ray exposure.
ENGLISH CAUTION MECHANICAL RISK Before removing the tubehead from the positioning arm, RELEASE THE SPRING. The sudden opening of the joint may cause damage to people and/or things. Check that the installation of the unit complies with the mechanical specifications of the support (walls, ceiling, etc..) where it is installed. Adjustments or any kind of attempt of repairing or disassembling must only be performed by qualified and authorized service personnel.
ENGLISH CAUTION EMC COMPATIBILITY EMC requirements must be considered and the x-mind dc must be installed and used accordingly with the specific EMC information provided in the accompanying documents. The device complies with the EMC (Electromagnetic Compatibility) requirements, according to IEC 60601- 1-2. Radio transmitting equipment, cellular phones etc. shall not be used in close proximity of the unit as they could influence the performance of the system.
ENGLISH 2. RADIOGRAPHIC SYSTEM The x-mind dc radiographic system guarantees the maximum safety both for the operator and the patient.
ENGLISH 2.1. SYSTEM COMPONENTS Fig. 1 x-mind dc radiographic system (Fig. 1) consists of: 1. x-mind dc TIMER The timer is the control panel used to manage the exposure times and to safely use the tubehead. To make the exposure, the control button with safety key is available. The timer can be connected to n° 2 cc tubeheads. 2. BRACKET The horizontal bracket is available in 3 different lengths (110 cm, 80 cm, 40 cm) and represents the support for the pantograph arm.
ENGLISH During X-ray exposition, the collimator cone comes in contact with the skin of the patient. Before each exam, it is necessary to apply to the cone a disposable protective cover designed to cover the end part of the X-ray generator. Such protection is useful to avoid crosscontamination (from patient to patient). 2.1.1.
ENGLISH 2.2. IDENTIFICATION TAGS The identification tags on the tubehead, on the timer and on the cone indicate the model number, the serial number, the manufacturing date and the main technical characteristics.
ENGLISH PICTOGRAMS USED SYMBOL INDICATING THE MANUFACTURER THIS SYMBOL GUARANTEES THAT THE RADIOGRAPHIC SYSTEM COMPLIES WITH THE REGULATIONS CONTAINED IN THE EUROPEAN DIRECTIVE EEC 93/42 REGARDING MEDICAL DEVICES SIZE OF THE FOCAL SPOT THE DEGREE OF PROTECTION AGAINST DIRECT AND INDIRECT ELECTRIC CONTACTS IS B TYPE SYMBOL INDICATING THE SERIAL NUMBER SYMBOL INDICATING DANGER DUE TO IONISING RADIATIONS X-ray EMISSION (IEC 60417) PAUSE (IEC 60417) ATTENTION, REFER TO THE ATTACHED DOCUMENTS INSTRUCTIO
ENGLISH 3. CONFIGURATION The x-mind dc radiographic system is provided in the “standard mode” configuration. On the control panel the LED relevant to the following exposure parameters will light up: No.
ENGLISH Certain exposure values which depend on the selection of the operating parameters have been predefined: • • • • cone (8”/12”) type of patient (ADULT/CHILD) radiographic tecnique intra-oral test PLEASE NOTE These values have to be considered as “recommended”: it is possible to change these values if necessary.
ENGLISH 4. INSTRUCTIONS FOR USE 1° - TURN ON Bring the main switch located on the upper part of the timer to the “I” position (ON) Bring the key switch to the “I” position (ON) 1. the green light turns on, indicating that the system is powered 2. the LEDs of the set parameters automatically light up 3.
ENGLISH 2° - CHECK THE SELECTED PARAMETER Before making the exposure, check that the parameter selected on the control panel (from Step 1 to Step 8) are suitable for the radiographic exam.
ENGLISH STEP 4 : check the selected radiographic voltage The LED of the radiographic voltage should be turned on LED 60kV ON indicates that the radiographic system is set with the high contrast radiodiagnostic technology LED 70kV ON indicates that the radiographic system is set with the low contrast radiodiagnostic technology to change the selection press again the button PLEASE NOTE 60kV mode can be selected with the x-mind dc radiographic system only.
ENGLISH STEP 6 : check the selected type of patient The LED of the desired type of patient should be turned on LED CHILD ON indicates that the radiographic system is set for a child patient (see chapter 5). LED ADULT ON indicates that the radiographic system is set for an adult patient (see chapter 5). to change the selection press again the button PLEASE NOTE After the modification, default exposure values will be automatically changed.
ENGLISH DIGITAL TECHNIQUE (SENSOR) The LED should be turned on to change the selection press the button for 3 s: an acoustic signal (beep) will confirm the change PLEASE NOTE With digital sensors it is advisable to use a radiographic current of 4mA (refer to STEP 5) PLEASE NOTE Expecially with pediatric patients, evaluate the opportunity to use the fastest image receptor possible: E- or F-speed film or digital sensors PLEASE NOTE After the modification, default exposure values will be automatically changed
ENGLISH OCCLUSAL EXAM The LED of the selected type of test should be turned on LED MANDIBULA ON radiographic system is set for occlusal exam of the lower jaw LED MAXILLA ON radiographic system is set for occlusal exam of the upper jaw to change the selection press again the button BITE-WING EXAM The LED of the selected type of test should be turned on LED ANT ON radiographic system is set for anterior bite-wing exam LED POST ON radiographic system is set for posterior bite-wing exam to change the selectio
ENGLISH 7° - MAKE THE EXPOSURE 1. Take the control button of the timer relevant to the selected tubehead and keep a safety distance (at least 2 meters) from the tubehead, in order to be able to constantly check the radiographic exposure 2. Advise the patient to remain still 3.
ENGLISH 4.1. EXPOSURE WITH THE WIRELESS X-RAY BUTTON To o make an exposure using the wireless X-ray button, proceed as follows: 1. MATCHING PROCEDURE: press and release the wireless X-ray button. The green LED will turn on, indicating that the communication with the timer was successful. 2. SAFETY DISTANCING: move away at the desired distance (no greater than 5m), in the opposite direction of the X-ray beam. 3. MAKE X-RAY EXPOSURE: press the X-ray emission button and hold it down during the entire exposure.
ENGLISH ! WARNING If battery fluid leaks, replace the batteries using protective gloves. ! WARNING Always replace two batteries of the same type and manufacturer at the same time. 4.2. CONE REPLACEMENT 1. Unlock the FIXATION screw using Allen key; 2. Remove the cone rotating it in anticlockwise direction; 3. Place the new cone rotating it in clockwise direction ! WARNING Be sure to completely rotate it in clockwise direction.
ENGLISH 5. EXPOSURE VALUES The chart indicates the x-mind dc radiographic system predefined exposure values. (refer to Chapter 3) I INCISOR Ba ANTERIOR BITE-WING C CANINE Bp POSTERIOR BITE-WING P PREMOLAR Oa OCCLUSAL ANTERIOR M MOLAR Op OCCLUSAL POSTERIOR Suggested Adult/Child1 patient type selection: CHILD For child patients up to 12-year-old ADULT For adolescent (greater than 12 through 21-year-old) and adult patients PLEASE NOTE The default exposure times can be modified.
ENGLISH 12” LONG CONE (SSD = 31cm) CONVENTIONAL RADIOGRAPHIC TECHNIQUE (FILM) ADULT 3,200 2,500 2,000 1,600 1,250 1,000 0,800 0,630 0,500 0,400 0,320 0,250 0,200 0,160 0,125 0,100 0,080 0,063 0,050 0,040 0,032 (sec) 0,025 EXPOSURE TIMES 0,020 PROGRAMMED 70kV - 8mA FILM D MAXILLA MANDIBLE I MAXILLA I FILM E CP I MANDIBLE I MAXILLA I CP CP Bp FILM F MANDIBLE I CP M Ba Bp M CP CP Bp M Ba Ba M Op - Oa M Op - Oa M Op - Oa ADULT 60kV - 8mA FILM D
ENGLISH CHILD 3,200 2,500 2,000 1,600 1,250 1,000 0,800 0,630 0,500 0,400 0,320 0,250 0,200 0,160 0,125 0,100 0,080 0,063 0,050 0,040 0,032 (sec) 0,025 EXPOSURE TIMES 0,020 PROGRAMMED 70kV - 8mA FILM D MAXILLA MANDIBLE FILM E FILM F CP I I MAXILLA MANDIBLE I MAXILLA I MANDIBLE I CP Bp M CP Ba CP Bp M Ba M CP CP I Bp Ba M Op - Oa M Op - Oa M Op - Oa CHILD 3,200 2,500 2,000 1,600 1,250 1,000 0,800 0,630 0,500 0,400 0,320 0,250 0,20
EXPOSURE TIMES (sec) MANDIBLE Page 34 of 64 Bp M Ba MAXILLA I I SENSOR CP CP Bp M Ba M Op - Oa 0,800 1,000 1,250 1,600 2,000 2,500 3,200 0,800 1,000 1,250 1,600 2,000 2,500 3,200 PROGRAMMED 0,630 CHILD 0,630 Oa 0,500 70kV - 4mA 0,500 - 60kV - 4mA M Op Oa 60kV - 4mA OPERATOR’S MANUAL • x-mind dc • 06/2021 • NXDCEN010I 3,200 2,500 2,000 1,600 1,250 1,000 0,800 0,630 0,500 0,400 0,320 0,250 Ba 0,400 Op M 0,400 CP 0,320 SENSOR Bp 0,320 M CP 0,250 I 0,250 Oa
ENGLISH 8” SHORT CONE (SSD = 20cm) CONVENTIONAL RADIOGRAPHIC TECHNIQUE (FILM) ADULT 1,250 1,600 2,000 1,250 1,600 2,000 3,200 1,000 1,000 3,200 0,800 0,800 2,500 0,630 0,630 2,500 0,500 0,500 0,400 0,320 0,250 0,200 0,160 0,125 0,100 0,080 0,063 0,050 0,040 0,032 (sec) 0,025 EXPOSURE TIMES 0,020 PROGRAMMED 70kV - 8mA FILM D MAXILLA MANDIBLE FILM E FILM F CP I I MAXILLA MANDIBLE I MAXILLA I MANDIBLE I CP Bp M CP Ba CP Bp M Ba M CP CP I Bp Ba M Op
ENGLISH CHILD 0,400 0,500 0,630 0,800 1,000 1,250 1,600 2,000 2,500 3,200 0,400 0,500 0,630 0,800 1,000 1,250 1,600 2,000 2,500 3,200 0,320 0,250 0,200 0,160 0,125 0,100 0,080 0,063 0,050 0,040 0,032 (sec) 0,025 EXPOSURE TIMES 0,020 PROGRAMMED 70kV - 8mA FILM D MAXILLA MANDIBLE FILM E FILM F CP I I MAXILLA MANDIBLE I MAXILLA I MANDIBLE I CP Bp M CP Ba CP Bp M Ba M CP CP I Bp Ba M Op - Oa M Op - Oa M Op - Oa CHILD 0,320 0,250 0,20
EXPOSURE TIMES (sec) MANDIBLE Ba MAXILLA I I SENSOR CP CP Bp M Ba M Op - Oa OPERATOR’S MANUAL • x-mind dc • 06/2021 • NXDCEN010I 3,200 3,200 2,000 2,000 2,000 2,000 3,200 1,600 1,600 1,600 1,600 3,200 1,250 1,250 1,250 1,250 2,500 1,000 1,000 1,000 1,000 2,500 0,800 0,800 0,800 0,800 2,500 0,630 0,630 0,630 0,630 2,500 0,500 0,500 0,500 0,200 0,160 0,500 0,200 0,160 0,125 0,100 0,080 0,063 0,050 0,040 0,032 0,025 0,020 0,400 PROGRAMMED 0,400 C
ENGLISH 6. PROGRAMMING DEFAULT EXPOSURE VALUES ! WARNING The 23 programmed exposure times cannot be modified in the x-mind dc radiographic system, since they are defined in conformity with the regulation in force concerning X-ray intra-oral equipment. Meanwhile it is possible to customize the default exposure values. (refer to Chapter 3) ! WARNING After customizing, the “Chart of default exposure values” (refer to Chapter 5) are not valid any more.
ENGLISH EXAMPLE 12” LONG CONE (SSD = 31cm) - CONVENTIONAL RADIOGRAPHIC TECHNIQUE (FILM) PREDEFINED DEFAULT EXPOSURE VALUES ADULT 1,600 2,000 1,600 2,000 3,200 1,250 1,250 3,200 1,000 1,000 2,500 0,800 0,800 2,500 0,630 0,630 0,500 0,400 0,320 0,250 0,200 0,160 0,125 0,100 0,080 0,063 0,050 0,040 0,032 (sec) 0,025 EXPOSURE TIMES 0,020 PROGRAMMED 70kV - 8mA FILM D MAXILLA MANDIBLE FILM E FILM F CP I I MAXILLA MANDIBLE I MAXILLA I MANDIBLE I Bp M CP Ba CP Bp C
ENGLISH 6.1. RESTORING ORIGINAL VALUES 1 . Turn off the timer 2. Turn the timer on keeping the key pressed OFF 3 . “OFF” appears on the display 4. Release the key 5. Press again the key ON 6 . “ON” appears on the display 7 .
ENGLISH 7. DIAGNOSTIC With x-mind dc radiographic system it is possible to visualise certain functional parameters. To visualise them proceed as follows: 1. press simultaneously and keep pressed the keys (17) MAXILLA MOLAR (47) MANDIBULARY MOLAR 2.
ENGLISH 8. ERROR MESSAGES An anomaly is indicated as follows: - emission of an intermittent acoustic signal (beep) - MALFUNCTIONING INDICATOR LED intermittently turns on - the error code (E ….) appears on the display) - all control panel functions are inhibited In this case turn off the timer and then turn it back on. If the error persists, refer to the following table. The following chart gives a list of error messages that may appear while x-mind dc radiographic system is working.
ENGLISH E42 EEPROM DATA NOT SAVED PROPERLY CALL THE “ASSISTANCE SERVICE” E43 CORRUPTED EEPROM DATA CALL THE “ASSISTANCE SERVICE” E44 OVERVOLTAGE ERROR CALL THE “ASSISTANCE SERVICE” E45 ANODE VOLTAGE OUT OF TOLERANCE CALL THE “ASSISTANCE SERVICE” E46 ANODE CURRENT OUT OF TOLERANCE CALL THE “ASSISTANCE SERVICE” E47 CONTROL CONNECTOR CALL THE “ASSISTANCE SERVICE” E48 PROBLEM IN THE REFERENCE VOLTAGE CALL THE “ASSISTANCE SERVICE” ERR MAJOR ERROR ALL FUNCTIONS ARE DISABLED CALL THE “ASSIST
ENGLISH 9. VERIFICATION OF THE EXPOSURE FACTORS In order to guarantee safety of the radiographic system, it is necessary to set up a periodic control schedule of the exposure factors. The RESPONSIBLE ORGANIZATION is required to organise and observe a control schedule of the exposure factors as detailed in this chapter. All the following controls must be performed every 12 months. CAUTION During these procedures X-rays will be emitted.
ENGLISH Dose in air is: SOURCE-SKIN DISTANCE 31 cm = 12” 60 kV – 4 mA = 2,2 mGy/s ± 30% 70 kV – 4 mA = 3 mGy/s ± 30% 60 kV – 8 mA = 4,5 mGy/s ± 30% 70 kV – 8 mA = 5,5 mGy/s ± 30% 20 cm = 8” 60 kV – 4 mA = 4,5 mGy/s ± 30% 70 kV – 4 mA = 6 mGy/s ± 30% 60 kV – 8 mA = 9 mGy/s ± 30% 70 kV – 8 mA = 12 mGy/s ± 30% STEP 3 – Checking the exposure time (s) The exposure time is measured with a “non invasive” instrument.
ENGLISH 10. MAINTENANCE 10.1. SUGGESTED MAINTENANCE In order to guarantee safety of the radiographic system, it is necessary to set up a maintenance schedule. The RESPONSIBLE ORGANISATION is responsible for planning and observing a maintenance schedule which must be executed by qualified technicians who must be able to certify their work with a “Conformity Declaration”. CAUTION Run an inspection on the radiographic system and on its operation when it is installed and every twelve months.
ENGLISH CAUTION • To ensure both the patient’s and operator’s safety as well as preserving a high image quality, the device must always be well maintained as described in the accompanying documents. For other maintenance operations, refer to the installation and maintenance manual.
ENGLISH 11. REPAIR AND DISPOSAL 11.1. REPAIR In case of a malfunction, send the defective part following specific instructions provided by the technical support or using the original packaging to: de Götzen S.r.l. Via Roma 45 21057 OLGIATE OLONA (VA) ITALY Tel. +39 0331 376760 Fax +39 0331 376763 E-mail: imaging.italysupport@acteongroup.com CAUTION It is strictly prohibited to attempt repairs to any electronic or mechanical parts by yourself.
ENGLISH ANNEX 1 A1.
ENGLISH HEATING AND COOLING CURVES X-ray TUBE X-ray tube model CEI OX70-G7 TOSHIBA DG-073-DC Focal spot size (IEC 336) 0,7 mm 0,7 mm Anode angle 16° 20° Anod material tungsten tungsten Heating/cooling curves TOSHIBA DG-073B-DC CEI OX70-G7 Tube rating charts Tube anode rating charts according to TOSHIBA DG-073BDC official datasheet and maximum rated values 70 kV, 8 mA, 3,2 s.
ENGLISH DEVICE POWER SUPPLY Type of power supply single phase, alternate Supply nominal voltage 230 V 115 V Maximum voltage variation ±10% Line voltage regulation ≤ 3% Nominal current 5,2 A @ 230 V 9,5 A @ 115 V Supply voltage frequency 50/60 Hz Maximum line current (measured @ 70 kV, 8 mA, 3,2 s) 9,5 A @ 115 V Technical factors for maximum line current 70 kV, 8 mA Absorbed power 1,2 kVA @ 230 V 1,1 kVA @ 115 V Apparent resistance 0,5 Ω @ 230 V 0,2 Ω @ 115 V Protection fuses (F1 – F2 – F
ENGLISH COLLIMATOR CONE TECHNICAL DATA Source-skin distance (SSD) short cone long cone rectangular cone 20 cm (8’’) 31 cm (12’’) 31 cm (12’’) X-ray beam dimension short cone long cone rectangular cone ≤ 60 mm ≤ 60 mm 44x35 mm WIRELESS X-RAY BUTTON Technology RF, ISM frequency Operating frequency 433,92 MHz Rated RF power output Max 8 dBm Power supply 2 batteries AAA 1.
ENGLISH ANNEX 2 A2. INTENDED ENVIRONMENT CAUTION x-mind dc is for INDOOR USE ONLY. If the x-mind dc has been stored at a temperature below +10°C (+50° F) for more than a few hours, enough time must be allowed for 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.
ENGLISH ANNEX 3 A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES x-mind dc: X-ray equipment for dental intraoral radiography is classified as: Directive MDD 93/42 EEC Annex IX, article 10 21CFR 872.1800 SOR 98/282 rule 8 TG(MD) Regulations 2002 Schedule 2 part 4.3 Class IIb II II IIb IEC/EN 60601-1:2005 + A1:2012 (3.1 edition) IEC/EN 60601-1-3:2008 + A1:2013 (2.1 edition) IEC/EN 60601-1-6:2010 + A1:2013 (3.1 edition) IEC 62366: 2007 IEC 60601-2-65:2012 A1:2017 (1.
ENGLISH ANNEX 4 A4. DOSIMETRIC INDICATIONS The radiation exposure is reported in terms of Dose Area Product (DAP), which takes into account the entire area of the X-ray beam and the total amount of X-ray radiation incident on the patient. The DAP is obtained by multiplying the Air Kerma by the corresponding X-ray beam area, which is dependent by the typology of beam limiting device installed.
ENGLISH 0,63 29,37654 58,75308 37,55096 75,10193 0,8 37,30354 74,60708 47,68376 95,36753 1 46,62942 93,25885 59,60471 119,2094 1,25 58,28678 116,5736 74,50588 149,0118 1,6 74,60708 149,2142 95,36753 190,7351 2 93,25885 186,5177 119,2094 238,4188 2,5 116,5736 233,1471 149,0118 298,0235 3,2 149,2142 298,4283 190,7351 381,4701 BLD Shape Circular SSD (mm) 200 kV mA 60 4 70 8 4 8 DAP (mGy*cm2) Time (s) 0,02 2,281096 4,562192 2,915842 5,831685 0,025 2,85137
ENGLISH BLD Shape Rectangular SSD (mm) 310 kV mA 60 4 70 8 4 8 DAP (mGy*cm2) Time (s) 0,02 0,580458 1,160916 0,741979 1,483957 0,025 0,725573 1,451145 0,927473 1,854947 0,032 0,928733 1,857466 1,187166 2,374332 0,04 1,160916 2,321833 1,483957 2,967915 0,05 1,451145 2,902291 1,854947 3,709893 0,063 1,828443 3,656886 2,337233 4,674466 0,08 2,321833 4,643665 2,967915 5,935829 0,1 2,902291 5,804582 3,709893 7,419787 0,125 3,627864 7,255727 4,637367 9,274733
ENGLISH ANNEX 5 A5.
ENGLISH Guidance and manufacturer’s declaration – electromagnetic immunity x-mind dc is intended to be used in the electromagnetic environment specified below. The customer or x-mind dc operator must ensure that the device is used in this type of environment.
ENGLISH Guidance and manufacturer’s declaration – electromagnetic immunity x-mind dc is intended to be used in the electromagnetic environment specified below. The customer or x-mind dc operator must ensure that the device is used in this type of environment.
ENGLISH Recommended separation distances between portable and mobile RF communication equipment and x-mind dc medical device These devices are intended to be used in environments where radiated RF interference is controlled.
ENGLISH ANNEX 6 A6.
ENGLISH Lateral view (open) Bottom mount B 40 cm (16’’) bracket 178 cm 80 cm (31’’) bracket 220 cm 110 cm (43’’) bracket 247 cm The system can also be mounted with the timer on the top. For details, refer to the Installation and Maintenance Manual.
ENGLISH ANNEX 7 A7.
0051 de Götzen S.r.l. 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.
