RX2 HP - Csn Industrie srl
Contents
1. INDUSTRIE User Manual RADI OVI DEOGRAPHY SENSOR RX2 HP Managing editor Francesco Combe 11 Revision of december 2006 CSN INDUSTRIE sr via Aquileja 43 B 20092 Cinisello B MI tel 02 6186111 fax 02 618611250 e mail csn csn industrie it e INDUSTRIE INDEX page GENERAL NOTICE up Eu aM Ma A R tate M dU ALD Cd 3 MARKING AND LABELLING SYMBOLS asi scan citet dti be c edet ee quein 3 TRADEMARKS Sou ec tU EU Terme 3 TECHNICAL CHARACTERISTICS us hoec utin eee ettet tuo a dete utu C Hoe 4 HST OESPAREPARTSOXOOBPE oe Pob boss bri 4 HEALTH AND DISINFECTION INFORMATION eene tentent treten tette tete 5 INSPECTIONS AND VERIFICATION OF THE IMAGING SYSTEM ACCORDING TO CURRENT STANDARD 6 DIRECTIVE 93 42 ECC CONCERNING MEDICAL DEVICES ceeeenetetnet eterne tenen 6 HARDWARE JNSTAEEATION aet iun dan d Me e mE 8 ELECTROSTATIC DISCHARGES pue M LE een 10 MINIMUM SYSTEM REQUIREMENTS cscsssscssssessessesessescssescssssesssssseesssessesseseaveetssesssesssansasessseessnesseaeess 10 MONITOR QUANT ctore Le ood 10 DECLARATION ct non bk ba ce dale tas aces 11 Radiovideography sensor RX2 HP User manual 2 11 FH011 Revision of December 2006 INDUSTRIE GENERAL NOTI CE The firm CSN Industrie s r l shall not be held responsible for the consequences resulting from2. 128MB reccomended The RX2 HP image display nneds a minimal resolution of 1024x768 and 16M colours colours 32 bit Caution when you use SVGA Plug amp Play cards and Plug amp Play monitors the monitor s refresh rate is gauged on the maximum supported frequency between 75 and 100 Hz MONI TOR QUALI TY Different monitor sizes 15 17 19 21 as well as different tubes qualities standard high contrast high definition are available for computer today RX2HP image quality is proportional to tube quality To obtain the highest level of performance you should use a high contrast and high definition monitor which can be recognised by its deep black tube As the monitor is the last link in the digital radiology chain you shoul pay very close attention to it Radiovideography sensor RX2 HP User manual 10 11 FH011 Revision of December 2006
3. actives and alcool INSPECTIONS AND VERI FI CATION OF THE I MAGI NG 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 The electrical installation of the relevant room does not comply with appropriate requirements products are not used in accordance with the instructions for use The RX2HP imaging card has been designed to comply with the European and international medical standards To avoid any risk to the user and to the patient any system associated to the RX2HP must be CE marked see details on Hardware installation chapter Content of kits refer to the check list delivered with the hardware 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 DI RECTI VE 93 42 ECC CONCERNI NG MEDI CAL DEVI CES Radiovideography sensor RX2 HP User manual 6 11 FH011 Revision of December 2006 e INDUSTRIE RX2HP is a product belonging to Class I of the Directive on Medical Device it is
4. an active device invasive by natural orifice for temporary use and intended for C diagnostic purposes The applicable European norms are the General Safety and Electromagnetic Compatibility regulations EN 60601 1 and collaterals RX2HP is considered as an ordinary device according to the degree of protection against harmful penetration of water Radiovideography sensor RX2 HP User manual 7 11 FH011 Revision of December 2006 e INDUSTRIE HARDWARE I NSTALLATI ON Enviroment After the installation the system must not present any risk for the patient or the operator That is why The PC in which our imaging systems are installed as well as all its peripherals must be CE 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 in the documentation of the pieces of equipment associated with the RX2HP 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 can be in the patient vicinity as they are marked CE IEC 601 1 If the pieces of
5. equipment to which the RX2HP is connected are connected to the power supply via 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 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 space 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 CAUTI ON the supplied boards are PCI standard that means it has been taken into account all the standard characteristics at the design time particularly the size of the slots Despite this some PC and computer material manufacturers are producing motherboards with inaccessible slots PCI because of a wrongly positioned component on the motherboard Csn Industrie s r l therefore does not consider himself responsible in case of such wrong configurations PC motherboards However for information only in case it is impossible to insert the board RX2HP PCI CE in one of the available slots relative to one
6. not applying the prescriptions contained in this installation manual or in the user manual 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 MARKI NG AND LABELLI NG SYMBOLS A warning standardised label see figure 1 symbol 1 supplied with each kit must be placed so as to be clearly visible on any medical apparatus such as the PC containing the RX2HP card which is part of the system and liable pose a risk of electric shock 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 RX2HP 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 Caution consult supporting EN 60 601 1 1 Strict adherence to the PC installation and usage documents requirements in this manual will ensure that the system complies with these Pic 1 standards SYMBOL 2 Type BF e As the RX2HP sensor is a type BF applied part it is reported the corre
7. of these configurations it is recommended to try and to verify the other slots PCI Additional earth connection No specific installation is required Additional safety measures to be applied on installation Mobile mains socket outlets for multiple sockets Radiovideography sensor RX2 HP User manual 8 11 FH011 Revision of December 2006 INDUSTRIE Depending on the power consumption of RX2 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 The mobile mains sockets outlets supplied with the system must only be used to provide power to apparatus which is part of the RX2HP system If another piece of apparatus is plugged into the RX2HP 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 acquisition USB box of the RX2 HP system The PC must be equipped with a suitable USB interface Connect the USB module to an USB port using the USB cable included with the RX2 HP sensor Installing the sensor Insert the RX2 HP sensor connector into the external unit ref 2 Power supply for RX2 HP cards It is possibile a personal computer can t supply the USB modul necessary power In this case is necessary to use an external power supplier We reccomend to switc
8. arefully 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 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 Disinfection products 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 RX2 HP User manual 5 11 FH011 Revision of December 2006 e INDUSTRIE First level of disinfection Watery disinfectant containing quaternary ammonium compounds 10 PES OU similar product not ionic surface active agents and cleansing alkaline compounds Second level of disinfection HELIPUR H PLUS N or similar Watery concentrated disinfectant for instruments with aldehydes product surface
9. h off the low tension power supply when you finish to work Switching on and switching off To use the RX2 HP sensor the USB module must be switched on position I of the On Off power button To connect or disconnect the system parts is necessary they are all switched off PC and external unit Switch It has 3 positions left switched on powered by USB cable middle switched off right switched on powered by external unit Light indicator LED On USB module there is a LED indicating the follow operative modalities switched off suspend mode USB module not active red idle sleep mode the module is switched on but it isn t powering the sensor orange standby mode the module is waiting for acquire an image green data transfer mode the module is sendind to the PC the acquired image Radiovideography sensor RX2 HP User manual 9 11 FH011 Revision of December 2006 e INDUSTRIE ELECTROSTATI C DI SCHARGES When the RX2HP sensor is not connected to the PC it should be placed in its holder or in its case Do not touch the display screen and the RX2HP sensor simultaneously as this may severely damage the sensor MI NI MUM SYSTEM REQUI REMENTS Operative system Windows CPU Pentium4 o later Memory 512MB RAM 1 024MB reccomended USB port 2 0 with eventually compatibility 1 1 Free space on HD 20GB 80GB reccomended VRAM 32MB
10. sion cable Sensor Spare parts Low tension power supply option CSN Industrie engage himself to give to all the user on demand the list of the components or any other helpful information Radiovideography sensor RX2 HP User manual 4 11 FH011 Revision of December 2006 e INDUSTRIE HEALTH AND DI SI NFECTI ON I NFORMATI ON 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 a new protector on the sensor This protector has the form of a finger stall that slips over the sensor A 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 Never place an RX2 HP sensor in an autoclave it will be seriously damaged The RX2 HP sensor and accessories must be carefully disinfected for 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 c
11. sponding standardised label Pic 2 TRADEMARKS RX2 and RX2 Mega Px are trademark of CSN Industrie s r l s 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 Radiovideography sensor RX2 HP User manual 3 11 FH011 Revision of December 2006 INDUSTRIE TECHNI CAL CHARACTERI STI CS licable classifications accordino to standard EN 60 601 1 Type of protection against electric shock CLASS T 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 Functioning and storage conditions Functioning Temperature 0 C to 50 C Relative umidity 30 to 7596 Storage Temperature 20 to 70 C USB port power supply USB1 1 DC 4 5 5 5 V 420mA max USB2 0 DC 4 5 5 5 V 480mA max External card power supply option 5 VDC 21A EIAJ RC5320A conector voltage class 2 internal device Classification Class I Type B LIST OF SPARE PARTS RX2 HP Consumables Disposable protection sheaths Options 1 5 m around 5 cable 8 m around 26 sensor exten
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