Operative Manual - Csn Industrie srl
Contents
1. remove any residue and clean the sensor by rubbing it carefully with soap and water carefully disinfect the sensor in accordance with the disinfection products manufacturer s instructions Warning avoid the immersion of the sensor in liquids for cleaning It is allowed immersion in water but only for few seconds Radiovideography sensor RX4 User Manual Page 6 of 10 FHO57 Revision of October 2012 INDUSTRIE Disinfection products It is recommended cleaning with 70 isopropyl alcohol Note According to the Medical Devices Directive disinfection products are considered as device accessories and consequently fall within the scope of the Directive First level disinfection products this requirement does not relate to final disinfection must not contain aldehydes CSN Industrie s r l recommends the use of CE marked disinfectants Radiovideography sensor RX4 User Manual Page 7 of 10 FHO57 Revision of October 2012 INDUSTRIE INSPECTIONS AND VERIFICATION OF THE IMAGING SYSTEM ACCORDING TO CURRENT STANDARD CSN Industrie s r l does not consider himself responsible for the effects on safety reliability and performances of the products if Assembly operations extensions readjustments modifications or repairs are not carried out by persons authorized by him electrical installation of the relevant room does not comply with appropriate requirements products2. INDUSTRIE User Manual RX4 RADIOVIDEOGRAPHY SENSOR Managing Editor Francesco Combe FHO57 Revision of October 2012 CSN Industrie S r l Via Aquileja 43 B 20092 Cinisello Balsamo MI Tel 39 02 6186111 Fax 39 02 61290676 e mail export csn industrie it INDUSTRIE INDEX page GEINE RAUSING 1 1G 5 3 MARKING AND PABEING SYMBOI 3 A occa Beas 4 DESCRIPTION OF THE PRODUCT tice secure ssa at 4 TECHNICAL CHARACTERISTICS curs tia titan tenets 4 LIST SPARE PART Stes 5 CLEANING AND DISINFECTION 6 INSPECTIONS AND VERIFICATION OF THE IMAGING SYSTEM ACCORDING TO CURRENT STANDARD 8 DIRECTIVE 93 42 EEC CONCERNING MEDICAL DEVICES c scsccsesscsssssescssssssssssessssssesseseestsseseestssestesnees 8 HARDWARE INSTALLATION 9 ELECTROSTATIC DISCHARGES 10 MINIMUM SYSTEM REQUIREMENTS 10 GIN ROR UIA TTY 10 Radiovideography sensor RX4 User Manual Page 2 of 10 FHO57 Revision of October 2012 INDUSTRIE GENERAL NOTICE The firm CSN Industrie s r l shall not be held responsible for the consequences resulting from not applying the prescriptions contained in this installation manual or in the user manu
3. the sensor new protective cover must be used for each patient For maximum efficiency it is recommended that protective covers which have been specially designed for the diameter and length of the sensor or handpiece be used Do not remove protective covers pulling the cable of the sensor These covers have to be removed by cutting them gently or using the special tear if provided by the covers manufacturer Never place an RX4 sensor neither in an autoclave or dry heat it will be seriously damaged Do not sterilize with UV units Please carefully disinfect the sensor the cable the sensor side only as well as the accessories before the use with each patient The disinfection procedure comprises two steps First level of disinfection remove the protective cover from the sensor and the relevant accessories and make sure that there is no residues of blood saliva tissue or secretions on it After an accurate check prepare a disinfecting solution in accordance with the manufacturer s instructions carefully disinfect the sensor in accordance with the disinfection products manufacturer s instructions Second level of disinfection The final disinfection procedure must be carried out in the event the protector is torn or if there is any residue of blood saliva secretions or tissue on the sensor prepare a disinfecting solution according to the manufacturer s instructions
4. RKS is a trademark of CSN Industrie s r l 5 property Microsoft MS DOS and Windows are trademarks or registered trademarks of Microsoft Corporation All other names mentioned in this work are used only for the purposes of identification and may be trademarks or registered trademarks of their respective owners DESCRIPTION OF THE PRODUCT RX4 is an intraoral sensor which is very simple to use you just have to connect the cable to the USB port of the pc and you are ready to capture images of the highest quality Apical bevelled edges rounded casing and highly flexible cable make RX4 the ideal tool for any type of positioning ensuring the highest possible comfort to your patient RX4 is managed by the powerful diagnostic software CSN OS which saves the scanned images directly into DICOM TECHNICAL CHARACTERISTICS Applicable classifications according to standard EN 60 601 1 Type of protection against electric shock CLASS I Grade of protection level against electrical shock TYPE BF Grade of protection against penetration of liquids Ordinary unit Disinfection method See the specific paragraph Functioning method Continous Technical characteristics Active area mm 30x20 Matrix CMOS Scintillator CSI iodurum cesium Resolution pixels 1500x1000 Line pair gt 20 Pixel size micron About 20x20 Cable length m 2 Image data bit 16 Radio
5. al in particular for bodily damage loss of profits interruption of operations loss of data or any other loss of a financial nature Given the continuous development of its products CSN Industrie s r l reserves the right to improve this manual and any of the products mentioned therein at any moment without need of justification or of notifying the persons concerned MARKING AND LABELLING SYMBOLS SYMBOL 1 This warning symbol Caution consult supporting documents is a reference to the present document The use of accessories which do not meet the equivalent RX4 safety requirements may incur a reduction in the level of safety of the whole system The choice of accessories must take account of their use around the patient and the verification of their conformity with the harmonised standard EN 60 601 1 and EN 60 601 1 1 Strict adherence to Caution consult supportin f 1 PP 9 the PC installation and usage requirements in this manual will ensure that document Pic 1 i the system complies with these standards SYMBOL 2 Type BF As the RX4 sensor is type BF applied part it is reported the corresponding standardised label on the package Pic 2 This symbol means that RX4 sensor contains electronic components sensitive to electrostatic which may damage them Please refer to precautions for use Radiovideography sensor RX4 User Manual Page 3 of 10 FHO57 Revision of October 2012 INDUSTRIE TRADEMA
6. are not used in accordance with the instructions for use RX4 sensor has been designed in compliance with the European and international medical standards To avoid any risk to the user and to the patient any system associated to the RX4 must be CE marked see details on Hardware installation chapter Contents of the kit sensor sensor holders protective sheaths wall support Check the conformity of the electricity network with current standards in the country of installation Guarantee transportation and safety conditions Our products are guaranteed ex works in their original packaging The firm CSN Industrie s r l may not be held responsible for any damages resulting from transportation DIRECTIVE 93 42 ECC CONCERNING MEDICAL DEVICES RX4 sensors are products belonging to Class I of the Directive on Medical Device it is an active device invasive by natural orifice for temporary use and intended for diagnostic purposes The applicable European norms are the General Safety and Electromagnetic Compatibility regulations EN 60601 1 and collaterals RX4 is considered as an ordinary device according to the degree of protection against harmful penetration of water Radiovideography sensor RX4 User Manual Page 8 of 10 FHO57 Revision of October 2012 INDUSTRIE HARDWARE INSTALLATION Enviroment After the installation the system must not present any risk for the patient or the operator That is why The PC in which ou
7. connector of RX4 into the USB port of the pc External unit It is possible that a pc could not supply necessary power to power the sensor through the USB port In this case it is necessary the use of an external unit hub It is recommended to switch off the low voltage power supply when you finish to work Switching on and switching off To switch on or off the parts of the system it is necessary they are all switched off PC and external unit if any ELECTROSTATIC DISCHARGES When the RX4 sensor is not connected to the PC it should be placed in its holder in its case Do not touch the display screen and the RX4 sensor simultaneously as this may severely damage the sensor MINIMUM SYSTEM REQUIREMENTS Windows SP3 Windows Vista 32 64 bit 5 2 Windows 7 32 64 Operative system bit 5 1 Intel Centrino Duo Memory 4GB RAM USB port 2 0 Free space on HD 80 GB Video memory 512 MB MONITOR QUALITY Different monitor sizes 15 17 19 21 as well as different tubes qualities standard high contrast high definition are available for computer today RX4 image quality is proportional to tube quality To obtain the highest level of performance you should use a high contrast and high definition monitor Radiovideography sensor RX4 User Manual Page 10 of 10 FHO57 Revision of October 2012
8. pace around the central unit to allow it to be properly ventilated For the best image quality and visual comfort it is recommended that you turn your screen away from direct reflections interior or exterior lighting CAUTION all the standard USB characteristics have been taken into account at the design time Despite this some PC and computer manufacturers could produce PC partially compliant to these standards Industrie s r l therefore does not consider himself responsible in case of such wrong configurations PC motherboards Additional earth connection No specific installation is required Additional safety measures to be applied on installation Mobile mains socket outlets for multiple sockets Depending on the power consumption of RX4 system ensure that it is compatible with the power which the outlet for multiple sockets can support Mobile mains sockets outlets for multiple sockets must not be placed on the ground Radiovideography sensor RX4 User Manual Page 9 of 10 FHO57 Revision of October 2012 INDUSTRIE The mobile mains sockets outlets supplied with the system must only be used to provide power to apparatus which is part of the RX4 system If another piece of apparatus is plugged into the RX4 system multiple socket excess electrical consumption may cause damage such as causing the cabling and the connectors to melt or creating a risk of electrocution Installing the sensors Insert the
9. r imaging systems are installed as well as all its peripherals must be marked IEC 950 Otherwise all equipments not complying with its standard must be connected to an insulation transformer IEC989 holding voltage 1500 V in a permanent manner the piece or pieces of equipment must not be separable from the transformer except with the help of a tool Verify the documentation of the pieces of equipment associated with the RX4 that there is no limitation of use that might concern the safety of persons The PC and all pieces of equipment connected to it must be placed outside of the patient s environment more than 1 50 meters 5 feet from the chair Only the sensor handpiece and x ray generator be in the patient vicinity as they are marked CE IEC 601 1 If the pieces of equipment to which the RX4 is connected are connected to the power supply a multiple outlet extension the latter must not be placed on the floor and only elements of the system may be connected to it These elements must not be separable from the multiple outlet extension except with the help of a tool or the multiple outlet extension must be connected to an insulating transformer IEC989 Holding voltage 1500 V This multiple outlet must be designed for a current of at least 2200 VA Refer to your computer s installation manuals for instructions on the IT system PC and screen You must leave enough s
10. videography sensor RX4 User Manual Page 4 of 10 FHO57 Revision of October 2012 INDUSTRIE Functioning and storage conditions Temperature from 20 C to 70 C recommended from 15 to 35 C Storage with package Relative humidity lower than 75 without condensation It is recommended to store the sensor in Storage Genco Out of package container in low humidity away from electrostatic Temperature from 0 C to 35 C Warning Functioning If the sensor works for a long period its temperature could increase even of 10 C avoid to operate with environment temperature over 35 C to prevent the sensor could exceed 45 C Supply through USB port Minimum USB2 0 DC 4 5 5 5 V 480mA max LIST OF SPARE PARTS Consumables Disposable protection sheaths Sensor pals Sensor holders CSN Industrie upon request could supply the list of components as well as any other useful information to all users Radiovideography sensor RX4 User Manual Page 5 of 10 FHO57 Revision of October 2012 INDUSTRIE CLEANING AND DISINFECTION INFORMATION Caution the sensors and accessories delivered are not sterile It is recommended that the following general rules are followed in order to guarantee maximum health safety for the patient At each use it is indispensable to apply new protector the sensor This protector has the form of a finger stall that slips over
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