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.
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.
Contents Introduction ���������������������������������������������������������������������������������������������������������������������������iii Chapter 1 For Safe Operation 1.1 1.2 Safety ���������������������������������������������������������������������������������������������������������������������� 1-1 Electromagnetic Compatibility (EMC) ���������������������������������������������������������������������� 1-8 1.2.
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).
Chapter 1 For Safe Operation 1.1 Safety 1 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.
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 1 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.
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. 1 CAUTIONS For Safe Operation When the devices are used outdoors in wireless communication mode, contact our official dealer or INNOLUX Representative.
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. 1 For Safe Operation Disinfection Instructions WARNING Confirm that the respiratory density of disinfectant including solvent is under legal regulation. Certain disinfectants may damage health.
● 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 1 WARNING For Safe Operation ● Battery pack requires regular checkup and replacement. Battery capacity begins to wane after a period of time.
● 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.
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. 1 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.
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.
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.
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 1 Electrostatic discharge (ESD) IEC 61000-4-2 ±6kV contact ±8kV air ±6kV contact ±8kV air Floors should be wood, concrete or ceramic tile.
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.
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.
Chapter 2 System Configuration (Product Overview) 2.1 Flat Panel Sensor 2.1.1 System Configuration 2 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.
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 2 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.
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.
SN Serial Number Label 2 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.
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) 2 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.
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) 2 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.
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 3 Basic Operation To enable the flat panel sensor, its ID needs to be registered in advance by our official dealer or INNOLUX Representative.
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. 3 [1] Upright type Basic Operation 3 Set the flat panel sensor to the upper part of the tray. 4 Push the tray back into place after setting the flat panel sensor. 5 Remove the flat panel sensor after use.
[2] Bed type 3 Push the tray back into place by using the handle after setting the flat panel sensor. 4 Remove the flat panel sensor after use. CAUTIONS When inserting the flat panel sensor to the radiographic examination stand, direct the exposure plane upwards. 1 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.
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. 1 Remove the battery cover. Place the flat panel sensor with the back side facing upward and press the “●” portion of the lock lever.
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”.
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 1 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 3.2.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
[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 telje
[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.
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.
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.
