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PLEASE NOTE 1. The user is responsible for the use and maintenance of the product. We suggest that a member of the user’s staff be designated as being in charge of mainte- nance so as to ensure that the product is kept in a safe and good condition. Also, medical products must be used only by a qualified person. 2. Roentgenography, image processing, reading of image, and storage of data must be per- formed in accordance with the law of the country where the product is being used. Also, the u
Safety Information Regulations This instrument conforms to IEC 60601-1-2:2001. For U.S.A. and Canada • This instrument is a CLASS I EQUIPMENT according to UL60601-1 and CAN/CSA C22.2 No.601.1. • The following mark indicates that the instrument is a Type B Applied Parts. • The degree of protection against ingress of water is IPX0. • This equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. • The mode of operation is Cont
Safety Information Guidance and Manufacturer’s Declaration for EMC Directive Electromagnetic Emissions The CXDI-55G is intended for use in the electromagnetic environment specified below. The user of the CXDI-55G should assure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment – Guidance RF emissions GROUP 1 The CXDI-55G uses RF energy only for its internal func- CISPR 11 tion. Therefore, its RF emissions are very low and are not likely to cause any int
Safety Information Electromagnetic Immunity The CXDI-55G is intended for use in the electromagnetic environment specified below. The user of the CXDI-55G should assure that it is used in such an environment. IEC 60601 Compliance Immunity Test Electromagnetic Environment – Guidance Test Level Level Electrostatic dis- ±(2, 4, 6) kV ±(2, 4, 6) kV Floors should be wood, concrete or charge (ESD) contact contact ceramic tile. If floors are covered with syn- IEC 61000-4-2 thetic material, the relativ
Safety Information IEC 60601 Test Compliance Immunity Test Electromagnetic Environment – Guidance Level Level Conducted RF 3 Vrms 3Vrms Portable and mobile RF communications IEC 61000-4-6 150 kHz to 80 equipment should be used no closer to MHz any part of the CXDI-55G, including cables, than the recommended separation distance calculated from the equation Radiated RF 3 V/m 3 V/m applicable to the frequency of the trans- IEC 61000-4-3 80 MHz to 2.5 mitter. GHz Recommended separations distan
Safety Information Recommended Separation Distances The CXDI-55G is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the CXDI-55G can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communica- tions equipment (transmitters) and the CXDI-55G as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequen
Safety Information General Safety Information Follow the safety instructions in this manual and all warnings and cautions printed on the warning labels. Ignoring such cautions or warnings while handling the product may result in injury or accident. Be sure to read and fully understand the manual before use. Keep this manual for future reference. Meaning of Caution Signs This indicates a potentially hazardous situation which, if not heeded, could WARNING ! result in death or serious injury t
Safety Information Power Supply Be sure to turn OFF the power of each instrument before connecting or dis- connecting the cables. ! WARNING Also, do not handle them with wet hands. Otherwise, you may get an electric shock that may result in death or serious injury. Be sure to hold the plug or connector to disconnect the cable. If you pull the cable, the core wire may be damaged, resulting in fire or electric ! WARNING shock. Do not cut or process the cables. Also, do not place anything heavy,
Safety Information When Problem Occurs Should any of the following occur, immediately turn OFF the power of each instrument, unplug the power cable from the AC outlet, and contact Canon representative or distributor. • When there is smoke, odd smell or abnormal sound. ! WARNING • When liquid has been spilled into the instrument or a metal object has entered through an opening. • When the instrument has been dropped and it is damaged. Maintenance and Inspection For safety reasons, be sure to t
Safety Information Labels and Markings on the Instrument The CXDI-55G has a few labels and markings on it. Contents of those and positions where they are attached are indicated below. Sensor Unit Front This mark indicates that this is a Type B Applied Part according to UL60601-1 and EN60601-1. This unit can be installed in the patient environment. These marks indicate that the instrument must be handled with care. Do not jolt or apply excessive load to the instrument. Rear Name Label (9)
Contents Safety Information .................................................................................................... (1) Regulations ................................................................................................................................(1) Guidance and Manufacturer’s Declaration for EMC Directive ...................................................(2) General Safety Information ...................................................................................
1. Overview The Canon Digital Radiography CXDI-55G is a portable digital radiography that can take images of any part of the body. It directly converts the X-ray images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. – 1 –
2. Notes for Using the Instrument (1) Handling Handle the instrument carefully, as it may be damaged if something is hit against it, dropped, or receives a strong jolt. Also, handle the optional grid unit with care too. Do not pull the cable. Also, do not pull the sensor unit when the cable is tangled with something. Other- wise, the cable may be damaged, which may result in fire or electric shock. When transporting the instrument, do not allow the sensor cable relay connector to drag
2. Notes for Using the Instrument (3) During Exposure Do not apply excessive weight to the sensor unit. Otherwise, the sensor may be damaged. Limit of Load Uniform load: 150 kg over the whole area of sensor unit surface. Local load: 100 kg on an area 40 mm in diameter. Be sure to use the sensor unit on a flat place so it will not bend. Other- wise, the sensor may be damaged. Perform exposure after checking that the exposure conditions are optimally suited to this product. The sensitivity of
2. Notes for Using the Instrument (4) During Cleaning Do not use anything other than neutral detergent for cleaning the cover of the instru- ment. Otherwise, the coating will be corroded. (5) Storage Be sure to store the sensor unit and the optional grid unit in a safe place where it will not fall or drop. (6) Others Be sure to reconnect the cables to the proper connectors. Otherwise, the instrument may malfunction or may be damaged. For U.S.A. Rx only-Caution: Federal law restricts this devic
3. Description Sensor Unit This unit converts the X-rays into digital signals. d a e b f c g Name Description a Grip Hold this grip when carrying the sensor unit. b CFRP (Carbon Fiber Rein- The part of the patient’s body to which an image is to be forced Plastic) plate taken should be placed against this plate. This plate should be disinfected each time a different patient uses the instrument in order to prevent infection. c Sensor cable Connect this cable to the power box (sold separately)
4. Operation 4.1 Turning ON/OFF the Power of the System When turning ON/OFF the power of the sensor unit, refer to the Power Box (sold sepa- rately) Operation Manual. 4.2 Calibration Calibration is important to ensure that a good image is achieved with the CXDI-55G by obtaining the calibration data of the sensor unit. Perform calibration when exposure condi- tions have changed significantly. NOTE: For procedure for calibrating, refer to “Calibrating the Instrument” in the CXDI Series Operation
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