Fuji Film 01000007 Flat Panel Sensor User Manual 05 Short Term Confidential RIC 24C
Fuji Film Corporation Flat Panel Sensor 05 Short Term Confidential RIC 24C
05 (Short-Term Confidential) User Manual_RIC 24C
For Safe Operation Flat Panel Sensors RIC RIC RIC RIC RIC 35G 43G 35C 43C 24C System Configuration (Product Overview) Basic Operation Operation Manual 1st Edition : March 2017 Daily Inspection and Maintenance Appendix Maintenance and Inspection This Operation Manual describes details on how to operate the flat panel sensor and cautions to be observed when operating it. After reading this manual, store it nearby the flat panel sensor so that you can see it whenever necessary. ii Flat Panel Sensors Operation Manual 897N200608 Introduction The indirect-conversion flat panel sensor is a device which acquires a general radiograph. The flat panel sensor is a component of RIC. Available flat panel sensor is RIC 35G/RIC 43G/RIC 35C/RIC 43C/RIC 24C. RIC 35G, RIC 43G, RIC 35C, RIC 43C and RIC 24C: Wireless communication mode or wired communication mode is available. When used in wireless communication mode, an access point and battery pack (optional) are required. Each flat panel sensor complies with IEC 62220-1 (MEDICAL ELECTRICAL EQUIPMENT CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - ) as a general X-ray radiography equipment. The detector of flat panel sensors features 150 micron pixel pitch, a wide 16-bit dynamic range and exposure times up to 3.8 seconds. This Operation Manual includes descriptions of matters necessary when using the flat panel sensor such as the equipment overview, operation procedures and precautions to observe, as well as daily inspections and maintenance. Accompanying documents were originally drafted in the English language. Installation may only be conducted by authorized service personnel. CAUTIONS 1. No part or all of this manual may be reproduced in any form without prior permission. 2. The information contained in this manual may be subject to change without prior notice. 3. INNOLUX Corporation shall not be liable for malfunctions and damages resulting from installation, relocation, remodeling, maintenance, and repair performed by other than dealers specified by INNOLUX Corporation. 4. INNOLUX Corporation shall not be liable for malfunctions and damages of INNOLUX Corporation products due to products of other manufacturers not supplied by INNOLUX Corporation. 5. INNOLUX Corporation shall not be liable for malfunctions and damages resulting from remodeling, maintenance, and repair using repair parts other than those specified by INNOLUX Corporation. 6. INNOLUX Corporation shall not be liable for malfunctions and damages resulting from negligence of precautions and operating methods contained in this manual. 7. INNOLUX Corporation shall not be liable for malfunctions and damages resulting from use under environment conditions outside the range of using conditions for this product such as power supply, installation environment, etc. contained in this manual. 8. INNOLUX Corporation shall not be liable for malfunctions and damages resulting from natural disasters such as fires, earthquakes, floods, lightning, etc. This system is classified as a medical device under EC Directive 93/42/EEC. Process waste correctly, as stipulated by local law or any regulations that apply. Caution : R x Only in the United States (Federal law restricts this device to sale by or on the order of a physician.) Flat Panel Sensors Operation Manual 897N200608 iii Open-Source Software Contained in This Product This product contains third party’s software that is made available as open source software or free software. This software is provided “as is” with no warranty of any kind as to its merchantability or fitness for any particular purpose. For the information on open source software contained in this product, please see the attached DVD. Source codes for certain type of open source software used in this product are available at delivery cost. If you would like to receive such source codes, please contact INNOLUX dealer or the service representatives at the agency from which you purchased this product. (Please be noted that any inquiries concerning the contents of source codes should be directed to original licensors of open source software.) Note : INNOLUX has successfully performed verification and validation testing on all third party software and has confirmed its suitability to be used in this system. Trademarks All company names and product names described in this manual are the trademarks or registered trademarks of INNOLUX Corporation or their respective holders. Windows is the registered trademark of US Microsoft Corporation in the U.S.A. and other countries. Copyright © 2016-2017 INNOLUX Corporation. All rights reserved. iv Flat Panel Sensors Operation Manual 897N200608 Contents Introduction���������������������������������������������������������������������������������������������������������������������������iii Chapter 1 For Safe Operation 1.1 1.2 Safety���������������������������������������������������������������������������������������������������������������������� 1-1 Electromagnetic Compatibility (EMC)���������������������������������������������������������������������� 1-8 1.2.1 RIC���������������������������������������������������������������������������������������������������������������������������1-8 Chapter 2 System Configuration (Product Overview) 2.1 Flat Panel Sensor���������������������������������������������������������������������������������������������������� 2-1 2.1.1 2.2 2.3 System Configuration����������������������������������������������������������������������������������������������2-1 Names and the Functions��������������������������������������������������������������������������������������� 2-2 Locations of Labels and Signs�������������������������������������������������������������������������������� 2-3 2.3.1 2.3.2 2.3.3 Locations of Labels��������������������������������������������������������������������������������������������������2-3 Safety and Other Symbols���������������������������������������������������������������������������������������2-5 Symboles de sécurité et autres�������������������������������������������������������������������������������2-6 Chapter 3 Basic Operation 3.1 Preparing the Flat Panel Sensor����������������������������������������������������������������������������� 3-1 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.2 Type of Flat Panel Sensor���������������������������������������������������������������������������������������3-1 Number of the Connectable Flat Panel Sensors�����������������������������������������������������3-1 Inserting/Removing the Flat Panel Sensor into/ from the Radiographic Examination Stand��������������������������������������������������������������3-1 Charging the Battery Pack for the Flat Panel Sensor����������������������������������������������3-3 Installing/Removing the Battery Pack for the Flat Panel Sensor������������������������������������3-4 Starting Up and Shutting Down the Flat Panel Sensor������������������������������������������� 3-6 3.2.1 3.2.2 3.2.3 Starting Up ��������������������������������������������������������������������������������������������������������������3-6 Performing an Exposure �����������������������������������������������������������������������������������������3-6 Shutting Down ��������������������������������������������������������������������������������������������������������3-6 Chapter 4 Daily Inspection and Maintenance 4.1 Daily User Inspection and Maintenance����������������������������������������������������������������������4-1 4.1.1 Periodical Inspection������������������������������������������������������������������������������������������������4-1 Appendix A Specifications A.1 Specifications����������������������������������������������������������������������������������������������������������A-1 A.1.1 A.1.2 A.1.3 A.1.4 A.1.5 A.1.6 A.2 Reduced Equivalent (Flat Panel Sensor)���������������������������������������������������������������� A-1 Power Supply Conditions���������������������������������������������������������������������������������������� A-1 Environmental Conditions��������������������������������������������������������������������������������������� A-1 Image Performance������������������������������������������������������������������������������������������������ A-2 Load Restriction������������������������������������������������������������������������������������������������������ A-2 Radio Waves���������������������������������������������������������������������������������������������������������� A-2 External View and Weight���������������������������������������������������������������������������������������A-3 A.2.1 Flat Panel Sensor��������������������������������������������������������������������������������������������������� A-3 Flat Panel Sensors Operation Manual 897N200608 Appendix O U se of Optional Items O.1 Optional Items ������������������������������������������������������������������������������������������������������� O-1 Maintenance and Inspection Radio frequency (RF) compliance information Compliance with Part 15 of FCC Rules and Industry Canada licence-exempt RSS standard(s).�������������������������������������������������������������������������������������������������������������������������� 2 Compliance with 2014/53/EU����������������������������������������������������������������������������������������������� 4 vi Flat Panel Sensors Operation Manual 897N200608 Chapter 1 For Safe Operation 1.1 Safety Before using the flat panel sensor, read this section thoroughly to ensure that you use the product properly. For Safe Operation Electric Shock Warnings and Cautions WARNING This product is internal power supply equipment. To avoid electric shocks, users should always take the following precautions: ● Do not open any covers when it is not necessary. ● Install the equipment in a location where it will not be exposed to water. WARNING Do not install the battery pack with dew condensation on the flat panel sensor. Otherwise, fire or electric shock may result. WARNING Do not use the equipment in a location where metal particles could come into the equipment. This may cause an electric shock. WARNING Do not disassemble or remodel the equipment. Otherwise, fire or electric shock may result. Keep away from the parts inside the product, which may cause electric shock. If you touch them accidentally, death or severe injury may result. WARNING Do not hit or drop the flat panel sensor or subject it to severe shock. Otherwise, the flat panel sensor may be damaged. If the damaged flat panel sensor is used, fire or electric shock may result. In addition, do not apply strong pressure onto the flat panel sensor. If applied, the flat panel sensor deforms and the waterproof function may be compromised. WARNING/AVERTISSEMENT Do not use the flat panel sensor without the battery packs. If the battery packs are not attached, an electric shock may result. N’utilisez pas le détecteur à panneau plat sans les batteries. Si les batteries ne sont pas connectées, un choc électrique risque de se produire. WARNING Make sure to use the optional parts and accessories recommended by INNOLUX Corporation. Failure to use the optional parts and accessories recommended by INNOLUX Corporation may result in damage to the flat panel sensor and/or electric shock and injury. For details on the precautions for using the optional parts and accessories recommended by INNOLUX Corporation, see the Operation Manual for the optional parts and accessories. Flat Panel Sensors Operation Manual 897N200608 1-1 CAUTIONS Keep the flat panel sensor away from patient’s body fluids, chemicals, water, etc. Otherwise, it may become damaged, causing fire or electric shock. If necessary, protect the flat panel sensor by covering it with a disposable bag. Explosion Warnings WARNING For Safe Operation Because the flat panel sensor is not explosion-proof, do not use combustible and explosive gases near the flat panel sensor. WARNING Flammable gasses may stay in the room after disinfection. If you turn the system on just after disinfection, ensure that the room is well ventilated before powering on the system. Warnings for Abnormalities WARNING If any of the following occurs, immediately remove the battery pack, and then contact our official dealer or INNOLUX Representative. ● When smoke, strange odor, or abnormal sound is present. ● When a foreign object (such as a metal object) or liquid enters the product. ● When the equipment is dropped or hit and is damaged. Avertissements relatifs aux anomalies AVERTISSEMENT Si l’une des conditions répertoriées ci-après se produit, retirez immédiatement la batterie, puis contactez notre revendeur agréé ou notre représentant INNOLUX. ● En cas de présence de fumée, d’une odeur étrange ou d’un bruit anormal. ● En cas de pénétration d’un corps étranger (comme un objet métallique) ou d’un liquide dans le produit. ● En cas d’endommagement de l’équipement suite à une chute ou à un impact. Installation Precautions CAUTIONS Do not install the equipment in a location with the following conditions. ● Where the temperature changes sharply. ● Close to heat sources such as a heater. ● Where the equipment may be exposed to water due to water leakage or ingress. ● Where corrosive gas may be generated. ● Where there is excessive dust. ● Where the equipment is subject to frequent or excessive vibration/shock. ● Where the equipment is exposed to direct sunlight. ● Where there is no ventilator. 1-2 Flat Panel Sensors Operation Manual 897N200608 CAUTIONS Use the flat panel sensor on a flat place. Otherwise, the flat panel sensor may fall down, causing damage to the flat panel sensor or personal injury. CAUTIONS For veterinary or mobile applications, contact our official dealer or INNOLUX Representative. CAUTIONS For Safe Operation When the devices are used outdoors in wireless communication mode, contact our official dealer or INNOLUX Representative. CAUTIONS/ATTENTION Do not place any object in a place where removal of the power cable is prevented. Ne placez aucun objet à un emplacement gênant le débranchement du câble d’alimentation. CAUTIONS To ensure optimal image quality, it is recommended that you do not use the flat panel sensor near devices (motor, transformer, switching supply, etc.) that generate electromagnetic noise. Connection Instructions WARNING Make sure that the devices to be connected to the flat panel sensor are authorized for connection. WARNING When the flat panel sensor is used in wired communication mode, connect it only to the devices specified by our official dealer or INNOLUX Representative. System Isolation Instructions WARNING To ensure complete system isolation, never install any unauthorized accessories or other such items. When it is necessary to install authorized accessories or optional items, contact our official dealer or INNOLUX Representative. WARNING Keep equipment other than those used for patients out of their reach to ensure appropriate system isolation. WARNING In normal use, have a patient take a proper positioning for exposure. The operator should operate the system in a place where safety from radiation is ensured. The operator should also make sure before exposure that no one but the patient is in the exposure area and the operating area of the system. Flat Panel Sensors Operation Manual 897N200608 1-3 Software Precautions CAUTIONS Do not install additional software to the system. Do not uninstall any of the software preinstalled in the system. The system is preinstalled with the appropriate software. If other software is installed or if the existing software is uninstalled, various operational errors may result. For Safe Operation Disinfection Instructions WARNING Confirm that the respiratory density of disinfectant including solvent is under legal regulation. Certain disinfectants may damage health. When using a disinfectant, follow instructions supplied by the manufacturers. WARNING Do not use the following disinfectants at the time of disinfection. Doing so may damage the flat panel sensor and quality, performance and safety of the flat panel sensor cannot be assured. ● Chloric disinfectant which is strongly corrosive to metals and rubber parts. ● Disinfectant whose uses on metals, plastics, and coating are forbidden according to the instructions supplied with the disinfectant. ● Formalin gas and disinfectant sprays that may get inside the flat panel sensor. Disinfectant ethanol is recommended for disinfection. Carefully read the instructions and cautions supplied with the disinfectant before use. For details on the disinfectant, contact a INNOLUX dealer or the service representatives at the agency from which you purchased the disinfectant. CAUTIONS If flat panel sensor is not disinfected, it may lead secondary infection. Be sure to disinfect with ethanol after use. CAUTIONS Clean the sensor unit of the flat panel sensor with ethanol for disinfection, etc. for each patient to prevent infection. Precautions for Charging the Battery Pack CAUTIONS ● Use the battery charger recommended by INNOLUX Corporation. For details on operations, refer to the instruction manual for the battery charger. ● Do not charge the battery pack near fire or under strong sunshine. If the built-in protection mechanisms are activated by a high temperature, the battery pack cannot be charged. Also, if the built-in protection mechanisms are damaged, the battery pack may be charged with extremely high current and voltage, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite. ● To charge the battery pack, be sure to use the designated battery charger and to observe the charging conditions specified by INNOLUX Corporation. If the battery pack is charged in other conditions (temperature or voltage/current higher than specified, remodeled battery charger, etc.), the battery pack may be overcharged or charged with extremely high current, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite. 1-4 Flat Panel Sensors Operation Manual 897N200608 ● Immediately stop charging the battery pack, if charging is not completed within the specified time. Otherwise, the battery pack may overheat, emit smoke, explode or ignite. ● Do not use the flat panel sensor near the power cable. ● Do not use a faulty or broken battery charger or AC adapter. Battery Pack Instructions WARNING For Safe Operation ● Battery pack requires regular checkup and replacement. Battery capacity begins to wane after a period of time. ● If this equipment is not in use for while, store it with the battery pack removed. Not removing the battery pack may cause malfunction. CAUTIONS Observe the following precautions when using the battery pack (optional). ● The battery pack is used with the flat panel sensor. Do not use them in other combinations. ● Charge the battery pack only with the designated battery charger. If the battery pack is charged under the charging conditions (voltage, current and charging method) different from those specified by INNOLUX Corporation, the battery pack may emit smoke, ignite, explode or leak fluid. ● Store the battery pack in a cool and dark place. Recharge the stored battery pack every six months or every year. Otherwise a decrease in battery capacity or other problems may result. ● Do not leave the removed battery pack in the car or other places exposed to high temperature. If the battery pack is used or stored in a place where it is exposed to high temperature, the battery pack may emit smoke, ignite, explode or leak fluid. ● Use or store the battery pack only in the environmental conditions specified by INNOLUX Corporation. If the battery pack is used or stored in a place where it is exposed to high temperature, the battery pack may emit smoke, ignite, explode or leak fluid. ● When disposing of the battery pack, consult our official dealer or INNOLUX Representative. ● Do not disassemble or remodel the battery pack. The battery pack is equipped with built-in safety and protection mechanisms. If they are damaged, the battery pack may overheat, emit smoke, explode or ignite. ● Be careful not to drop the battery pack. The patient may be injured. ● Do not touch the terminal of the battery pack directly. There is a risk of electric shock. ● Do not connect the positive (+) and negative (-) terminals with a wire or any metal object. Do not carry or store the battery pack together with metal objects such as necklaces or hairpins. Otherwise, the battery pack may short-circuit and overcurrent may flow, causing the battery pack to overheat, emit smoke, explode or ignite. Metal objects such as necklaces or hairpins may also become hot. ● Do not throw the battery pack into fire or expose it to excessive heat. Otherwise, its insulator may melt, its gas release vent or safety mechanisms may be damaged, and/or its electrolyte may catch fire, causing the battery pack to overheat, emit smoke, explode or ignite. ● Do not use or leave the battery pack in a place where it is exposed to high temperature (80°C or higher), such as fire or a heater. If the resin separator is damaged due to heat, the battery pack may short-circuit, causing it to overheat, emit smoke, explode or ignite. ● Do not immerse the battery pack in water or seawater, and do not allow it to become wet. If the built-in protection mechanisms are damaged, the battery pack may overheat, emit smoke, explode or ignite. ● Do not pierce the battery pack with a nail, hit it with a hammer, or step on it. Otherwise, the battery pack may be damaged or deformed and short-circuit, causing it to overheat, emit smoke, explode or ignite. ● Do not subject the battery pack to strong impact or throw it. If the built-in protection mechanisms are damaged, the battery pack may be charged with extremely high current and voltage, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite. Flat Panel Sensors Operation Manual 897N200608 1-5 ● Do not use an apparently damaged or deformed battery pack. Otherwise, the battery pack may overheat, emit smoke, explode or ignite. ● Do not solder the battery pack directly. Otherwise, its insulator may melt, or its gas release vent or safety mechanisms may be damaged, causing the battery pack to overheat, emit smoke, explode or ignite. ● Do not reverse the positive (+) and negative (-) terminals. Otherwise, the battery pack may be reverse-charged during charging. As a result, abnormal chemical reactions may occur inside the battery pack, or extremely high current may flow during discharging, causing it to overheat, emit smoke, explode or ignite. ● The battery pack has a predetermined polarity. If you cannot connect the battery pack to the battery charger or other equipment, do not connect the battery pack forcefully. Make sure that the terminals are correctly oriented. If the battery pack is connected in reverse, it will be reverse-charged, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite. ● Do not connect the battery pack to an electrical outlet or cigarette lighter socket in a car. Overcurrent may flow to the battery pack due to high voltage applied, causing the battery pack to overheat, emit smoke, explode or ignite. ● Do not use the battery pack for equipment other than those specified. Otherwise, the guaranteed performance will be reduced and/or the service life will be shortened. Depending on the equipment to which the battery pack is connected, extremely high current may flow, causing the battery pack to be damaged, overheat, emit smoke, explode or ignite. ● If the electrolyte leaked from the battery pack enters the eyes, do not rub them. Wash the eyes immediately with clean water such as tap water, and consult a doctor. Otherwise, eye injury may result. ● Do not use the battery pack in combination with a primary battery such as a dry battery or other battery of a different capacity, type and/or brand. Otherwise, the battery pack may be overcharged during charging, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite. ● Do not put the battery pack in a microwave oven or high-pressure container. Otherwise, the battery pack may be rapidly heated or damaged, causing it to overheat, emit smoke, explode or ignite. ● If the battery pack leaks or emits an unusual odor, remove it from fire immediately. Otherwise, the leaked electrolyte may catch fire, causing the battery pack to overheat, emit smoke, explode or ignite. ● If you notice an unusual odor, heat, discoloration, deformation or any other abnormality during use, charging or storage, remove the battery pack from the equipment or battery charger, and stop using it. Otherwise, the battery pack may overheat, emit smoke, explode or ignite. ● Do not use the battery pack exposed to a strong magnetic field of an MRI system, etc. ● Do not use the battery pack immersed in liquid. For Safe Operation Other Warnings and Cautions WARNING No modification of this equipment is allowed. CAUTIONS Install the system in accordance with what is provided by IEC 60601-1:2005 + A1:2012 Chapter 16. Contact our official dealer or INNOLUX Representative for installation (except the flat panel sensor) of the system. CAUTIONS Do not hit or drop the flat panel sensor. Otherwise, injury or damage to images, etc. may result. 1-6 Flat Panel Sensors Operation Manual 897N200608 CAUTIONS Be sure to inspect the system periodically. To assure optimum performance of the flat panel sensor, it is necessary to systematically perform maintenance and inspection. For information on maintenance and inspection, contact our official dealer or INNOLUX Representative. CAUTIONS Do not perform maintenance and inspection while the equipment is used for a patient. For Safe Operation CAUTIONS The institution where the equipment is installed is responsible for its use and maintenance. In addition, this equipment should not be used by persons other than doctors or suitably trained staff. CAUTIONS Be careful not to expose the flat panel sensor to X-ray without a subject. CAUTIONS Although the flat panel sensor conforms to IPX3, no warranty is given as to the prevention of water intrusion in the flat panel sensor. If the flat panel sensor is splashed with water, wipe off moisture and ensure that the flat panel sensor is completely dry before use. Contraindications and Prohibitions No contraindications present. Classification ● According to the type of protection against electrical shock Internal power supply equipment ● According to the degree of protection against electrical shock Type B applied part ● According to the degree of protection against harmful ingress of water IP00 (The flat panel sensor conforms to IPX3) ● According to the degree of safety of application in the presence of a flammable anesthetics mixture with air or with oxygen or nitrous oxide. Equipment not suitable for use in the presence of a flammable anesthetics mixture with air or with oxygen or nitrous oxide. ● According to the mode of operation CONTINUOUS OPERATION Flat Panel Sensors Operation Manual 897N200608 1-7 1.2 Electromagnetic Compatibility (EMC) 1.2.1 RIC This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2 (EN 60601-1-2), Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by tuning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving device. • Increase the separation between the equipment. • Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. For Safe Operation If the problem cannot be solved with the above measures, stop using this equipment and consult the manufacturer, our official dealer or INNOLUX Representative for help. WARNING ● Do not place devices generating electromagnetic wave near this equipment. ● If a device(s) other than those specified is connected, predetermined EMC performance cannot be guaranteed. 1-8 Flat Panel Sensors Operation Manual 897N200608 Further Information for IEC 60601-1-2 (EN 60601-1-2) 1. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents. 2. Portable and mobile RF communications equipment can affect medical electrical equipment. 3. Information regarding the cable affecting EMC is as follows. Name Connected Device Network Cable Maximum Length 20m (65.6 ft) Between the RICPB and the Image processing unit * 2m (6.56 ft) Cat5e or more, UTP type and straight cable For Safe Operation Between the RICMP and the RICMC General Specification * When the distance between the RICPB and the RICMC is 2 meters or more, install a commercially available HUB. In that case, use a cable with a maximum length of 2 meters between the RICPB and HUB, and a cable with a maximum length of 20 meters between HUB and the RICMC. 4. The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by INNOLUX Corporation as replacement parts for internal components, may result in increased emissions or decreased immunity of the RIC. 5. The RIC should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the RIC should be observed to verify normal operation in the configuration in which it will be used. 6. Basic performance of the equipment and the system After image data are acquired from the flat panel sensor, data correction is performed by the control cabinet, and the image is saved in and displayed on the image processing unit. 7. Test items (Tables 1 to 4) Table 1 Guidance and manufacturer’s declaration - electromagnetic emissions The RIC is intended for use in the electromagnetic environment specified below. The customer or the user of the RIC should assure that they are used in such an environment. Emissions test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Complies Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies Electromagnetic environment - guidance The RIC uses RF energy only for their internal function. Therefore, their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Class B The RIC is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Flat Panel Sensors Operation Manual 897N200608 1-9 Table 2 Guidance and manufacturer’s declaration - electromagnetic immunity The RIC is intended for use in the electromagnetic environment specified below. The customer or the user of the RIC should assure that they are used in such an environment. Immunity test IEC 60601-1-2 test level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6kV contact ±8kV air ±6kV contact ±8kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. For Safe Operation Electrical fast transient/burst IEC 61000-4-4 ±2kV for power supply lines ±1kV for input/output lines ±2kV for power supply lines ±1kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1kV line(s) to line(s) ±2kV line(s) to earth ±1kV line(s) to line(s) ±2kV line(s) to earth Mains power quality should be that of a typical commercial or hospital environment. 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 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 s <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 s Mains power quality should be that of a typical commercial or hospital environment. If the user of the RIC requires continued operation during power mains interruptions, it is recommended that the RIC be powered from an uninterruptible power supply or a battery. 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Power frequency (50/60Hz) magnetic field IEC 61000-4-8 3 A/m NOTE: UT is the a.c. mains voltage prior to application of the test level. 1-10 Flat Panel Sensors Operation Manual 897N200608 Table 3 Guidance and manufacturer’s declaration - electromagnetic immunity The RIC is intended for use in the electromagnetic environment specified below. The customer or the user of the RIC should assure that they are used in such an environment. Immunity test IEC 60601-1-2 test level Compliance level 3 Vrms 150 kHz to 80 MHz 3 Vrms Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of the RIC, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. For Safe Operation Conducted RF IEC 61000-4-6 Electromagnetic environment - guidance Recommended separation distance d = 1.2 d = 1.2 80 MHz to 800 MHz d = 2.3 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the RIC is used exceeds the applicable RF compliance, the RIC should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the RIC. b Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m. Flat Panel Sensors Operation Manual 897N200608 1-11 Table 4 Recommended separation distances between Portable and mobile RF communications equipment and the RIC The RIC is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the RIC can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the RIC as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter For Safe Operation 0.01 0.1 10 100 Separation distance according to frequency of transmitter 150 kHz to 80 MHz d = 1.2 0.12 0.38 1.2 3.8 12 80 MHz to 800 MHz d = 1.2 0.12 0.38 1.2 3.8 12 800 MHz to 2.5 GHz d = 2.3 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 1-12 Flat Panel Sensors Operation Manual 897N200608 Chapter 2 System Configuration (Product Overview) 2.1 Flat Panel Sensor 2.1.1 System Configuration DIGITAL RADIOGRAPHY RIC System Configuration (Product Overview) Flat panel sensor Access point Battery charger Image processing unit • The products in can be installed in patient environment. • Up to five flat panel sensors can be connected. • The RICMC is installed on the image processing unit. For the image collecting console, see the System Operation Manual. Flat Panel Sensors Operation Manual 897N200608 2-1 2.2 Names and the Functions Names and the functions of the flat panel sensor are described below. * Exposure plane is shown in this figure. Applied part Battery pack level indicator Status lamp System Configuration (Product Overview)Connector for wired communication Flat panel sensor Name Flat panel sensor Description The RIC 35G and RIC 43G incorporate a GOS indirect panel. The RIC 35C, RIC 43C and RIC 24C incorporate a CsI indirect panel. Battery pack level indicator Connector for wired communication Only the dedicated power supply unit specified by our official dealer or INNOLUX Representative can be connected. Name Status lamp Description Indicates the equipment status by LEDs. READY (Green) On Blinks for 1.0 second Off On (Blue) POWER (The power on/off state of the Off flat panel sensor is displayed.). READY POWER ERROR LINK ERROR (Orange) LINK (White) Blinks for 1.0 second Off On Off Exposure possible During exposure sequence Not ready Power ON Power OFF Error occurred Normal Connected Communication not possible. * When the battery pack is not attached, all LEDs are off. HINT For details on the battery pack level indicator, see “3.1.6 Lamp Indications on the Flat Panel Sensor”. 2-2 Flat Panel Sensors Operation Manual 897N200608 2.3 Locations of Labels and Signs Locations of labels and signs affixed to each flat panel sensor, and the relevant safety signs are shown below. 2.3.1 Locations of Labels Flat panel sensor (RIC 35G) Flat panel sensor (RIC 43G) Serial Number Label Serial Number Label RIC 35G Caution Label RIC 43G Caution Label Battery Cover Label Battery Cover Label RIC 35G Identification Label RIC 43G Identification Label System Configuration (Product Overview) Flat panel sensor (RIC 35C) Flat panel sensor (RIC 43C) Serial Number Label Serial Number Label RIC 35C Caution Label RIC 43C Caution Label Battery Cover Label Battery Cover Label RIC 35C Identification Label RIC 43C Identification Label Flat panel sensor (RIC 24C) Serial Number Label RIC 24C Identification Label RIC 24C Cation Label Battery Cover Label RIC 35G Identification Label RIC 43G Identification Label RIC 35C Identification Label RIC 43C Identification Label RIC 24C Identification Label Flat Panel Sensors Operation Manual 897N200608 2-3 SN Serial Number Label Battery Cover Label System Configuration (Product Overview) RIC 35G/RIC 43G/RIC 35C/RIC 43C Caution Label RIC 24C Caution Label Battery pack (optional) Battery pack Rating Label SE Battery Dummy Cover Identification Label Battery Pack Rating Label * The label varies, depending on the battery pack. SE Battery Dummy Cover Identification Label 2-4 Flat Panel Sensors Operation Manual 897N200608 2.3.2 Safety and Other Symbols The following safety symbols are used in the labels or on its body. Symbol Description CE marking Protective earth (ground) Direct current This symbol indicates that the equipment is a Type B Applied Part. System Configuration (Product Overview) Ready (To indicate the machine is ready for operation.) Electric energy General mandatory action sign This symbol indicates that this product is not to be disposed of with your household waste, according to the WEEE Directive (2002/96/EC) and your national law. This product should be handed over to a designated collection point. Improper handling of this type of waste could have a possible negative impact on the environment and human health due to potentially hazardous substances that are generally associated with EEE. At the same time, your cooperation in the correct disposal of this product will contribute to the effective usage of natural resources. For more information about waste, please contact our official dealer or INNOLUX Representative. Year of manufacture Caution for local load / Do not drop the flat panel sensor to the user/patient Entire surface load This symbol includes RF transmitters or indicates equipment that intentionally applies RF electromagnetic energy for diagnosis or treatment. Refer to Instruction Manual/Booklet This symbol indicates that the part is not a battery. This symbol instructs the user not to disconnect the SE cable during use. Flat Panel Sensors Operation Manual 897N200608 2-5 2.3.3 Symboles de sécurité et autres Les symboles de sécurité suivants sont utilisés sur les étiquettes ou sur le corps de l’équipement. Symbole Description Marquage CE Protection via mise à la terre (masse) courant continu System Configuration (Product Overview) Ce symbole indique que l’équipement est une pièce appliquée de type B. Prêt (Pour indiquer que la machine est prête à être utilisée.) Énergie électrique Symbole général d’action obligatoire Ce symbole indique que ce produit ne doit pas être mis au rebut avec les déchets ménagers, conformément à la directive DEEE (2002/96/CE) et à la législation nationale en vigueur. Ce produit doit être remis à un centre de collecte approprié. Une manipulation incorrecte de ce type de déchet peut avoir un impact négatif sur l’environnement et sur la santé humaine, en raison des substances potentiellement dangereuses généralement associées aux EEE. Votre coopération pour la mise au rebut correcte de ce produit contribuera en outre à une utilisation efficace des ressources naturelles. Pour en savoir plus sur les déchets, contactez notre revendeur agréé ou notre représentant INNOLUX. Année de fabrication Attention relative à une charge placée de façon localisée / Ne faites pas tomber le détecteur à panneau plat sur l’utilisateur/le patient Charge sur l’intégralité de la surface Ce symbole inclut les émetteurs RF ou indique un équipement émettant intentionnellement de l’énergie électromagnétique RF à des fins de diagnostic ou de traitement. Consultez le mode d’emploi Ce symbole indique que la pièce n’est pas une batterie. Ce symbole indique à l’utilisateur de ne pas débrancher le câble de branchement d’abonné pendant l’utilisation. 2-6 Flat Panel Sensors Operation Manual 897N200608 Chapter 3 Basic Operation 3.1 Preparing the Flat Panel Sensor This section describes how to prepare the flat panel sensor. 3.1.1 Type of Flat Panel Sensor RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C The battery pack (optional) is required when the flat panel sensor is used in wireless communication mode. 3.1.2 Number of the Connectable Flat Panel Sensors Basic Operation To enable the flat panel sensor, its ID needs to be registered in advance by our official dealer or INNOLUX Representative. Up to a hundred flat panel sensors can be registered. Up to five flat panel sensors can be connected. 3.1.3 Inserting/Removing the Flat Panel Sensor into/from the Radiographic Examination Stand Follow the procedure below to insert/remove the flat panel sensor into/from the radiographic examination stand. For details, see the Operation Manual for the radiographic examination stand CAUTIONS For the positioning at the time of inserting/removing the flat panel sensor, see the Operation Manual for the radiographic examination stand. CAUTIONS Make sure that the flat panel sensor is installed in the radiographic examination stand securely. CAUTIONS Be careful not to have your fingers caught when inserting/removing the flat panel sensor into/ from the radiographic examination stand. CAUTIONS When pulling out/pushing in the tray of the radiographic examination stand after setting the flat panel sensor on it, be careful not to drop the flat panel sensor or damage the tray. Flat Panel Sensors Operation Manual 897N200608 3-1 CAUTIONS Before inserting/removing the flat panel sensor into/from the radiographic examination stand, pull out the tray completely. Otherwise, the flat panel sensor may be damaged. [1] Upright type Basic Operation Set the flat panel sensor to the upper part of the tray. Push the tray back into place after setting the flat panel sensor. Remove the flat panel sensor after use. CAUTIONS When inserting the flat panel sensor into the radiographic examination stand, direct the exposure plane toward the X-ray tube. Pull out the tray. Tray Insert the flat panel sensor into the cassette receive with the green mark of the flat panel sensor up, and then move it downwards. Green mark Pull out the tray, push the cassette receive downwards, and then remove the flat panel sensor. Push the tray back into place. Cassette receive 3-2 Flat Panel Sensors Operation Manual 897N200608 [2] Bed type Push the tray back into place by using the handle after setting the flat panel sensor. Remove the flat panel sensor after use. CAUTIONS When inserting the flat panel sensor to the radiographic examination stand, direct the exposure plane upwards. Pull out the tray by using the handle. Hold the handle and pull out the tray. Remove the flat panel sensor while pulling the cassette stopper, and then push the tray back into place. Tray Basic Operation Pull the cassette stopper, and set the flat panel sensor so that its center mark is aligned with the center of the stopper. Cassette stopper Center mark 3.1.4 Charging the Battery Pack for the Flat Panel Sensor Use the battery charger recommended by INNOLUX Corporation. For details on operations, refer to the instruction manual for the battery charger. Flat Panel Sensors Operation Manual 897N200608 3-3 3.1.5 Installing/Removing the Battery Pack for the Flat Panel Sensor Follow the procedure below to install/remove the battery pack for the flat panel sensor. When installing/removing the battery pack, place the flat panel sensor on a flat place. Do not remove the battery pack until a processed image appears in the window of the image processing unit after the exposure. Remove the battery cover. Place the flat panel sensor with the back side facing upward and press the “●” portion of the lock lever. When installing the battery pack, do not press the lock lever. Pushing the battery pack in with the guide marks misaligned may damage the connector terminal. Basic Operation Lock lever When attaching the battery pack, make sure that the waterproof packing attached to the connector terminal of the flat panel sensor is aligned properly. When the battery pack is installed in the flat panel sensor, the power is automatically turned on. Slide the lock lever in the direction of the arrow to remove the battery cover. Guide marks Battery pack •T o remove the battery pack, perform the same procedure as Step 1 (removing the battery cover). •T o install the battery cover, perform the same procedure as Step 2 (installing the battery pack). Install the battery pack. Slide the battery pack along the dent of the battery section of the flat panel sensor toward the connector terminal. Align the guide mark of the battery pack with that of the flat panel sensor, and push the battery pack in to install it. Make sure that battery pack is securely installed. 3-4 Flat Panel Sensors Operation Manual 897N200608 3.1.6 Lamp Indications on the Flat Panel Sensor This section explains the indications of the battery pack level indicator. For other lamp indications, see “2.2 Names and the Functions”. ■ Battery pack level indicator LED0 LED3 LED2 LED1 (When the battery pack is being charged) LED1, 2, 3: Lit in green Available time of the flat panel sensor: 60 minutes or more LED3: Blinking in green, LED1, 2: Lit in green Available time of the flat panel sensor: 30 minutes or more but less than 60 minutes LED2: Blinking in green, LED1: Lit in green Available time of the flat panel sensor: Less than 30 minutes LED1: Blinking in green Basic Operation Fully charged, available time of the flat panel sensor: More than 3 hours (When the battery pack is not charged) Available time of the flat panel sensor: 60 minutes or more LED1, 2, 3: Lit in green Available time of the flat panel sensor: 20 minutes or more but less than 60 minutes LED1, 2: Lit in green Available time of the flat panel sensor: Less than 20 minutes LED1: Lit in green Available time of the flat panel sensor: 10 minutes or less LED0: Lit in orange Flat Panel Sensors Operation Manual 897N200608 3-5 3.2 Starting Up and Shutting Down the Flat Panel Sensor This section explains how to start up and shut down the Flat Panel Sensor. 3.2.1 Starting Up Attach a fully charged battery pack to the flat panel sensor. The POWER status lamp on the flat panel sensor is lit in blue. Start up the flat panel sensor with the initial settings properly made by our official dealer or INNOLUX Representative. 3.2.2 Performing an Exposure Basic Operation When performing an exposure, make sure that the READY status lamp on the flat panel sensor is lit. 3.2.3 Shutting Down Remove the battery pack from the flat panel sensor and set the battery pack in the battery charger. The POWER status lamp on the flat panel sensor is lit. 3-6 Flat Panel Sensors Operation Manual 897N200608 Chapter 4 Daily Inspection and Maintenance 4.1 Daily User Inspection and Maintenance During maintenance and inspection, strictly observe precautions contained in “Chapter 1 For Safe Operation” in this manual for you to use the flat panel sensor under best conditions. 4.1.1 Periodical Inspection Inspection Every Three Months Once every three months, remove any dirt or dust accumulated in each part of the equipment using a vacuum cleaner or air duster, clean each part with a slightly moistened soft cloth and then wipe off any moisture with a dry cloth. See “2.2 Names and the Functions” (page 2-2). Daily Inspection and Maintenance CAUTIONS Be sure to turn off the power before cleaning each part of the device. No. Unit Flat panel sensor CAUTIONS Ensure sufficient space when cleaning the equipment on a table, etc. Flat Panel Sensors Operation Manual 897N200608 4-1 4 Daily Inspection and Maintenance 4-2 Flat Panel Sensors Operation Manual 897N200608 Specifications Appendix A A.1 Specifications Specifications of the flat panel sensor are shown below. A.1.1 Reduced Equivalent (Flat Panel Sensor) Peak reduced equivalent on the front panel of the flat panel sensor: 0.5 mmAl A.1.2 Power Supply Conditions Rated voltage Input current : 6-12V : 2.73A A.1.3 Environmental Conditions (1) Operating Conditions Temperature : 15°C (15%RH) - 30°C (80%RH) Humidity : 15%RH (15°C) - 80%RH (30°C) (no dew condensation) Atmospheric pressure : 700hPa - 1060hPa Appendix A Specifications (2) Non-operating Conditions (Environmental conditions under which power can be supplied) Temperature : 5°C - 35°C Humidity : 10%RH - 80%RH (no dew condensation) Atmospheric pressure : 700hPa - 1060hPa (3) Storage Conditions Temperature : -30°C - 50°C Humidity : 10%RH - 90%RH (no dew condensation) Atmospheric pressure : 700hPa - 1060hPa CAUTIONS hen the flat panel sensor is used in high temperature condition for long period of time, it may cause image artifacts and/or failure of the device. Flat Panel Sensors Operation Manual 897N200608 A-1 A.1.4 Image Performance Each flat panel sensor complies with IEC 62220-1 (MEDICAL ELECTRICAL EQUIPMENT CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - ) as a general X-ray radiography equipment. To ensure optimal image quality, it is recommended that you do not use the flat panel sensor near devices (motor, transformer, switching supply, etc.) that generate electromagnetic noise. A.1.5 Load Restriction Entire surface load : RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C : 300kg (661.5 lb) Local load : RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C : 120kg (264.6 lb) / ø40mm (1.6in.) (Based on INNOLUX measurement specifications) CAUTIONS Do not apply an excessive force to the exposure plane. The sensor inside the flat panel sensor may be damaged, and it may not be possible to make an exposure properly. A.1.6 Radio Waves The flat panel sensor uses the following types of radio waves. Flat panel sensor Appendix A Specifications Wireless specification IEEE802.11n Transmit frequency 5.2, 5.3, 5.6, 5.8, 2.4 GHz Modulation OFDM Frequency tolerance ±20 ppm Data transfer rate 35 Mbps Transfer power 17 dBm or less CAUTIONS ● Transmit frequencies available vary, depending on the country. ● Radio waves available outdoors vary, depending on the country where the system is used. ● When the RIC and any other wireless equipment are operating on the same frequency channel in a hospital, it may take time to show an image on the image processing unit monitor. A-2 Flat Panel Sensors Operation Manual 897N200608 A.2 External View and Weight The external view and weight of the each flat panel sensor are shown below. Specifications, dimensions and weight are subject to change for improvement without prior notice. A.2.1 Flat Panel Sensor Width (mm(in.)) Depth (mm(in.)) Height (mm(in.)) Weight (kg(lb)) Flat panel sensor (RIC 35G) 460(18.1) 384(15.1) 15(0.6) 2.95(6.5)*1 Flat panel sensor (RIC 43G) 460(18.1) 460(18.1) 15(0.6) 3.65(8.0)*1 Flat panel sensor (RIC 35C) 460(18.1) 384(15.1) 15(0.6) 2.95(6.5)*1 Flat panel sensor (RIC 43C) 460(18.1) 460(18.1) 15(0.6) 3.65(8.0)*1 Flat panel sensor (RIC 24C) 328(13.0) 268(10.6) 15(0.6) 1.5(3.3)*1 *1 The weight of the battery pack is included. Unit: mm(in.) 460(18.1) 15(0.6) 460(18.1) Flat panel sensor (RIC 35G) Flat panel sensor (RIC 43G) 460(18.1) 15(0.6) 460(18.1) 15(0.6) 384(15.1) 460(18.1) Flat panel sensor (RIC 35C) Appendix A Specifications 384(15.1) 460(18.1) 15(0.6) Flat panel sensor (RIC 43C) Flat Panel Sensors Operation Manual 897N200608 A-3 Unit: mm(in.) 15(0.6) 268(10.6) 328(13.0) Flat panel sensor (RIC 24C) RIC 35G/RIC 35C 20 (0.8) 288(11.3) 20.45 (0.8) 230.4(9.1) 17.45 (0.7) Appendix A Specifications A-4 17.55 (0.69) 16.75 (0.66) Effective area 20 (0.8) Effective area RIC 24C Flat Panel Sensors Operation Manual 897N200608 17.55 (0.69) 17.25 (0.68) 425.4(16.7) 17.25 (0.68) 425.4(16.7) 17.25 (0.68) Effective area 424.8(16.7) 17.25 (0.68) 350.4(13.8) 16.75 (0.66) The effective area of the flat panel sensor is as shown in the figure below. RIC 43G/RIC 43C Appendix O Use of Optional Items O.1 Optional Items Name Battery pack Description A battery pack for the flat panel sensor. For precautions, charging and installing/removing, see pages 1-4, 1-5, 1-6, 3-3 and 3-4. Appendix O Use of Optional Items Flat Panel Sensors Operation Manual 897N200608 O-1 Appendix O Use of Optional Items O-2 Flat Panel Sensors Operation Manual 897N200608 Maintenance and Inspection 1 Maintenance and Inspection Items Assigned to Specified Dealer For periodical inspection of the equipment and necessary arrangements, consult our official dealer or local representative. Periodical Maintenance Make sure that the periodical maintenance and inspection assigned to our official dealer or INNOLUX Representative are performed as specified. Maintenance and Inspection Items Assigned to Specified Dealer Periodical Maintenance and Inspection Items Period Checking of the image Every year Checking of the operation record by referring to the error log Every year Checking of the flat panel sensor Every 2 years * It is recommended that the battery pack be replaced, if the battery storage capacity becomes lower than 60%. The battery pack should be replaced when the operable time is less than the following. ● RIC 35G/RIC 43G/RIC 35C/RIC 43C/RIC 24C : 100 minutes (1 hour and 40 minutes) * Refer to the operable time displayed on the image processing unit when the battery pack is fully charged and no exposure menu is registered. * Depending on the usage environment, etc., the displayed time is slightly different from the actual operable time. (Reference) Time for battery pack replacement 120 Battery storage capacity [%] 100 80 60 40 Time for replacement: Less than 100 minutes (1 hour and 40 minutes) 20 30 60 90 120 150 180 210 240 Operable time [Minute] Flat Panel Sensors Operation Manual 897N200608 Maintenance and Inspection The cycles of periodical maintenance and inspection and of parts replacement differ depending on the usage and the daily operation time. For details, contact our official dealer or INNOLUX Representative. Radio frequency (RF) compliance information Compliance with Part 15 of FCC Rules and Industry Canada licence-exempt RSS standard(s). This device complies with Part 15 of FCC Rules and Industry Canada’s licence-exempt RSSs. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Le présent appareil est conforme à la partie 15 des règles de la FCC et aux normes des CNR d’Industrie Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes : (1) l’appareil ne doit pas produire de brouillage, et (2) l’appareil doit accepter tout brouillage subi, même si le brouillage est susceptible d’en compromettre le fonctionnement. FCC CAUTION Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. The available scientific evidence does not show that any health problems are associated with using low power wireless devices. There is no proof, however, that these low power wireless devices are absolutely safe. Low power Wireless devices emit low levels of radio frequency energy (RF) in the microwave range while being used. Whereas high levels of RF can produce health effects (by heating tissue), exposure of low-level RF that does not produce heating effects causes no known adverse health effects. Many studies of low-level RF exposures have not found any biological effects. Some studies have suggested that some biological effects might occur, but such findings have not been confirmed by additional research. RIC 35G/RIC 43G/RIC 35C/RIC 43C/RIC 24C has been tested and found to comply with FCC/IC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines and RSS-102 of the IC radio frequency (RF) Exposure rules. Les connaissances scientifiques dont nous disposons n’ont mis en évidence aucun problème de santé associé à l’usage des appareils sans fil à faible puissance. Nous ne sommes cependant pas en mesure de prouver que ces appareils sans fil à faible puissance sont entièrement sans danger. Les appareils sans fil à faible puissance émettent une énergie fréquence radioélectrique (RF) très faible dans le spectre des micro-ondes lorsqu’ils sont utilisés. Alors qu’une dose élevée de RF peut avoir des effets sur la santé (en chauffant les tissus), l’exposition à de faibles RF qui ne produisent pas de chaleur n’a pas de mauvais effets connus sur la santé. De nombreuses études ont été menées sur les expositions aux RF faibles et n’ont découvert aucun effet biologique. Certaines études ont suggéré qu’il pouvait y avoir certains effets biologiques, mais ces résultats n’ont pas été confirmés par des recherches supplémentaires. RIC 35G/RIC 43G/RIC 35C/RIC 43C/RIC 24C a été testé et jugé conforme aux limites d’exposition aux rayonnements énoncées pour un environnement non contrôlé et respecte les règles les radioélectriques (RF) de la FCC lignes directrices d’exposition et d’exposition aux fréquences radioélectriques (RF) CNR-102 de l’IC. Maintenance and Inspection Compliance with FCC requirement 15.407(c) and IC requirment RSS-210 A9.4.4 Data transmission is always initiated by software, which is the passed down through the MAC, through the digital and analog baseband, and finally to the RF chip. Several special packets are initiated by the MAC. These are the only ways the digital baseband portion will turn on the RF transmitter, which it then turns off at the end of the packet. Therefore, the transmitter will be on only while one of the aforementioned packets is being transmitted. In other words, this device automatically discontinue transmission in case of either absence of information to transmit or operational failure. Conformité à la norme CNR-210 A9.4.4 La transmission des données est toujours initiée par le logiciel, puis les données sont transmises par l’intermédiaire du MAC, par la bande de base numérique et analogique et, enfin, à la puce RF. Plusieurs paquets spéciaux sont initiés par le MAC. Ce sont les seuls moyens pour qu’une partie de la bande de base numérique active l’émetteur RF, puis désactive celui-ci à la fin du paquet. En conséquence, l’émetteur reste uniquement activé lors de la transmission d’un des paquets susmentionnés. En d’autres termes, ce dispositif interrompt automatiquement toute transmission en cas d’absence d’information à transmettre ou de défaillance. Flat Panel Sensors Operation Manual 897N200608 Radio waves in the 5.2GHz and 5.3GHz frequency bands can be used indoors only. Les bandes de fréquences 5.2GHz et 5.3GHz ne peuvent être utilisées qu’en intérieur. High-power radars are allocated as primary users (i.e. priority users) of the bands 5250-5350 MHz and 5650-5850 MHz and that these radars could cause interference and/or damage to LE-LAN devices. Les radars de haute puissance sont designes comme utilisateurs principaux (c’est-a dire utilisateurs prioritaires) pour les bandes 5250-5350 MHz et 5650-5850 MHz, et que ces radars peuvent provoquer du brouillage et/ou des dommages aux dispositifs LAN-EL. Frequency Tolerance : ±20ppm (This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.) Maintenance and Inspection Flat Panel Sensors Operation Manual 897N200608 Compliance with 2014/53/EU Manufacture’s Name: INNOLUX Corporation Manufacture’s Address: No.3, Sec. 1, Huansi Rd., Tainan City, Southern Taiwan Science Park, 74147, Taiwan (R.O.C.) declares that the product: Model Number: RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C The product complies with the requirements of the RE Directive 2014/53/EU. The shipment schedule country is as follows. AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MK MT NL NO PL PT RO SE SI SK TR [BG] Bulgarian [CS] Czech [DA] Danish [DE] German [EN] English [ES] Spanish [ET] Maintenance and Inspection Estonian [FI] Finish С настоящето, INNOLUX, декларира, че RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C е в съответствие със съществените изисквания и другитеприложими разпоредби на Директива 2014/53/EC. INNOLUX tímto prohlašuje, že RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C splňuje základní požadavky a všechna příslušná ustanoveni Směrnice 2014/53/EU. Undertegnede INNOLUX erklærer herved, at følgende udstyr RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C overholder de væsentlige krav og øvrige relevante krav i direktiv 2014/53/EU. Hiermit erklärt INNOLUX, dass sich das Gerät RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C in Übereinstimmung mit den grundlegenden Anforderungen und den übrigen einschlägigen Bestimmungen der Richtlinie 2014/53/EU befindet. Hereby, INNOLUX, declares that this RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU. Por la presente, INNOLUX, declara que este RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C cumple con los requisitos esenciales y otras exigencias relevantes de la Directiva 2014/53/UE. Käesolevaga kinnitab INNOLUX seadme RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C vastavust direktiivi 2014/53/EL põhinõuetele ja nimetatud direktiivist tulenevatele teistele asjakohastele sätetele. INNOLUX vakuuttaa täten että RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C tyyppinen laite on direktiivin 2014/53/EU oleellisten vaatimusten ja sitä koskevien direktiivin muiden ehtojen mukainen. Flat Panel Sensors Operation Manual 897N200608 [FR] French [EL] Greek [HU] Hungarian [HR] Croatian [IS] Icelandic [IT] Italian [LV] Latvian [LT] Lithuanian [МК] Macedonian [MT] Maltese [NL] Dutch [NO] Norwegian [PL] Polish [PT] Portuguese [RO] [SK] Slovak ΜΕ ΤΗΝ ΠΑΡΟΥΣΑ Ο ΚΑΤΑΣΚΕΥΑΣΤΗΣ INNOLUX ΔΗΛΩΝΕΙ ΟΤΙ RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ ΤΙΣ ΟΥΣΙΩΔΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ ΣΧΕΤΙΚΕΣ ΔΙΑΤΑΞΕΙΣ ΤΗΣ ΟΔΗΓΙΑΣ 2014/53/EE A INNOLUX ezzennel kijelenti, hogy a RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C típusú beren-dezés teljesíti az alapvető követelményeket és más 2014/53/EU irányelvben meghatározott vonatkozó rendelkezéseket. Ovime, INNOLUX, potvrđuje da je RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C u sukladnost sa osnovnim zahtjevima i drugim važnim odredbama Direktive 2014/53/EU. Hér með lýsir INNOLUX yfir því að RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C er í samræmi við grunnkröfur og aðrar kröfur, sem gerðar eru í tilskipun 2014/53/EU Con la presente INNOLUX dichiara che questo RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C è conforme ai requisiti essenziali ed alle altre disposizioni pertinenti stabilite dalla direttiva 2014/53/UE. Ar šo INNOLUX deklarē, ka RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C atbilst Direktīvas 2014/53/ES būtiskajām prasībām un citiem ar to saistītajiem noteikumiem. Šiuo INNOLUX deklaruoja, kad šis RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C atitinka esminius reikalavimus ir kitas 2014/53/ES Direktyvos nuostatas INNOLUX, изјавува дека овој RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C е во согласност со суштинските барања и други релевантни одредби на Директивата 2014/53/EU. Hawnhekk, INNOLUX, jiddikjara li dan RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C jikkonforma mal-ħtiġijiet essenzjali u ma provvedimenti oħrajn relevanti li hemm fid-Dirrettiva 2014/53/UE. Hierbij verklaart INNOLUX dat het toestel l RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C in overeenstemming is met de essentiële eisen en de andere relevante bepalin-gen van richtlijn 2014/53/EU. INNOLUX erklærer herved at utstyret RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C er i samsvar med de grunnleggende krav og øvrige relevante krav i direktiv 2014/53/EU. Niniejszym INNOLUX deklaruje że RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C jest zgodny z zasadniczymi wymaganiami i innymi właściwymi postanowieniami Dyrektywy 2014/53/UE. Eu, INNOLUX, declaro que o RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C cumpre os requisitos essenciais e outras provisões relevantes da Directiva 2014/53/UE. Prin prezenta, INNOLUX, declară că aparatul RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C este în conformitate cu cerinţele esenţiale şi cu alte prevederi pertinente ale Directivei 2014/53/UE. INNOLUX týmto vyhlasuje, že RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C spĺňa základné požiadavky a všetky príslušné ustanovenia Smernice 2014/53/ EÚ. Flat Panel Sensors Operation Manual 897N200608 Maintenance and Inspection Romanian Par la présente, INNOLUX déclare que l’appareil RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C est conforme aux exigences essentielles et aux autres dispositions pertinentes de la directive 2014/53/UE. [SL] Slovenian [SV] Swedish [TR] Turkish INNOLUX izjavlja, da je ta RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C v skladu z bistvenimi zahtevami in drugimi relevantnimi določili direktive 2014/53/EU. Härmed intygar INNOLUX, att denna RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C är förenligt med de grundläggande kraven och andra relevanta bestämmelser i direktivet 2014/53/EU. İşbu belge ile INNOLUX, bu RIC 35G, RIC 43G, RIC 35C, RIC 43C, RIC 24C ürününün 2014/53/AB sayılı Yönerge’nin temel şartlarıyla ve diğer ilgili hükümleriyle uyumlu olduğunu beyan eder. Maintenance and Inspection Flat Panel Sensors Operation Manual 897N200608 Innolux EC Declaration of Conformity Manufacturer : Innolux Corporation Address : Product : RIC 35G, RIC 35C, RIC 43G, RIC 43C, RIC 24C Model No. : RIC 35G, RIC 35C, RIC 43G, RIC 43C, RIC 24C Applicable Product Units : Serial No. ***0001 or later Control Software: 0X0221 or later We, Innolux Corporation, herewith declare under our sole responsibility that the product(s) identified in this declaration conforms to the provisions of the following Directive and Standards. Directive : RE Directive: 2014/53/EU Standards : SAR EN 62311:2008 Radio EN 300 328 V1.9.1 EN 301 893 V1.8.1 EMC EN 301 489-1 V1.9.2 EN 301 489-17 V2.2.1 Safety EN 60601-1:2006/A1:2013 Place and Date of issue [Area], Tiwan [date] Signature : Name : Function : Innolux Corporation Maintenance and Inspection Flat Panel Sensors Operation Manual 897N200608 INNOLUX No.3, Sec. 1, Huansi Rd., Tainan City, Southern Taiwan Science Park, 74147, Taiwan (R.O.C.) INNOLUX Optoelectronics Europe B.V. Jupiterstraat 106, 2132 HE Hoofddorp, The Netherlands EU Importer INNOLUX Optoelectronics Europe B.V. Jupiterstraat 106, 2132 HE Hoofddorp, The Netherlands INNOLUX MEDICAL SYSTEMS U.S.A., INC. 419 WEST AVENUE, STAMFORD CT 06902, U.S.A.
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.6 Linearized : No Create Date : 2017:03:21 10:26:00+09:00 Creator : Adobe InDesign CS6 (Windows) Modify Date : 2017:03:27 13:42:08+09:00 Has XFA : No XMP Toolkit : Adobe XMP Core 5.2-c001 63.139439, 2010/09/27-13:37:26 Instance ID : uuid:01340862-12ab-48e2-9bfe-68611e2f58f7 Original Document ID : adobe:docid:indd:35e36e10-3bfd-11e1-ad3b-c5c162091af4 Document ID : xmp.id:F9A2F348D50DE711A0D9FC725FDC5E89 Rendition Class : proof:pdf Derived From Instance ID : xmp.iid:F8A2F348D50DE711A0D9FC725FDC5E89 Derived From Document ID : xmp.did:05801174072068118083C9E109E5AA44 Derived From Original Document ID: adobe:docid:indd:35e36e10-3bfd-11e1-ad3b-c5c162091af4 Derived From Rendition Class : default History Action : converted History Parameters : from application/x-indesign to application/pdf History Software Agent : Adobe InDesign CS6 (Windows) History Changed : / History When : 2017:03:21 10:26+09:00 Metadata Date : 2017:03:27 13:42:08+09:00 Creator Tool : Adobe InDesign CS6 (Windows) Format : application/pdf Producer : Adobe PDF Library 10.0.1 Trapped : False Page Count : 46EXIF Metadata provided by EXIF.tools