X68CRSCANNER2Computed Radiography Scanner

User Manual Dental Computed Radiography Reader Doc No. : TM-801-EN Rev 0.1.2 Nov. 2012 Part No. : CR-FPM-11-001-EN 3DISC, FireCR, Quantor and the 3D Cube are trademarks of 3D Imaging & Simulations Corp, South Korea, and its affiliates. All other trademarks are held by their respective owners and are used in an editorial fashion with no intention of infringement. The data in this publication are for illustration purposes only and do not necessarily represent standards or specifications, which must be met by 3D Imaging & Simulations Corp. All information contained herein is intended for guidance purposes only, and characteristics of the products and services described in this publication can be changed at any time without notice. Products and services may not be available in your local area. Please contact your local sales representative for availability information. 3D Imaging & Simulations Corp. strives to provide as accurate information as possible, but shall not be responsible for any typographical error. © Copyright 2010 3D Imaging & Simulations Corp, all rights reserved, printed, and published in South Korea by 3D Imaging & Simulations Corp. User Manual FireCR Dental TM-801-EN 2 3DISC Americas 22560 Glenn Dr, Suite 116 Sterling, VA 20164 USA Tel : 1-703-430-6080 E-mail : [email protected] Contact 815, Tamnip-Dong, Yuseong-Gu, Daejeon, Korea Tel : 82-42-931-2100 Fax : 82-42-931-2299 Website : www.3DISCimaging.com E-mail : [email protected] 3DISC Europe Gydevang, 39-41, 3450 Alleroed, Denmark Tel : 45-88-276-650 E-mail : [email protected] User Manual FireCR Dental TM-801-EN 3 The device complies with Part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Modifications not expressly approved by the manufacturer could void the user's authority to operated the equipment under FCC rules. User Manual FireCR Dental TM-801-EN 4 Warnings and Used Symbols To ensure the safety of patients, staff and other persons, any changes to software and hardware delivered by 3D Imaging & Simulations Corp. may only be made with prior written permission from 3D Imaging & Simulations Corp. Please read the respective manuals of the connected software, such as acquisition and diagnostic software, before starting to use the FireCR Dental system. The following symbols will be used throughout this manual: DANGER The functionality of the system can be destroyed in the case of incorrect use. If unauthorized changes have been made to delivered system and accessories, the warranty by 3D Imaging & Simulations Corp. becomes void. 3D Imaging & Simulations Corp. will not accept any responsibility or liability for the improper functioning of the product in such a case. WARNING The functionality of the system can be limited in the case of incorrect use. Hints that require special attention. NOTE Notes represent information that is important to know but which do not affect the functionality of the system. DANGER This equipment is indoor use only and all the communication wirings are limited to inside of the building. User Manual FireCR Dental TM-801-EN 5 General Safety Guidelines All the safety and operating instructions should be read carefully before this device is operated. This device has been designed and tested to meet strict safety requirements applicable to medical equipment, and has been supplied in a safe condition. To ensure personnel and patient safety, the device shall be operated and serviced in compliance with all procedures, warnings and precautions during all phases of operation and service of this device. Failure to comply to with safety guidelines may result in injury to service personnel, operator, or patient. 3D Imaging & Simulations Corp. assumes no liability for failure to comply. If this device is not used as specified, the protection provided by the device could be impaired. This device must be used in a normal condition only. Installation, service and operation of this device should only be undertaken by qualified trained personnel. The operator should study instructions and precautions carefully before starting to use the device listed here and throughout the manual. There are no user serviceable parts inside this device. The device should only be opened and serviced by qualified service personnel. Failure to heed this warning may result in injury to service personnel or damage to equipment, and void any and all warranties. If there is a service problem, please contact 3D Imaging & Simulations Corp. or authorized dealer. Do not spill liquids on the device, and never operate the device in a wet environment. Keep the device from radiators and heat sources. Use the device only with accessories supplied with this device. This device is intended to be grounded. Plug power cord into properly grounded electrical outlets. This cord is equipped with three-prong plugs to help ensure proper grounding. This device contains static sensitive components. Proper static handling procedures and equipment must be used when servicing this device. User Manual FireCR Dental TM-801-EN 6 Do not look inside of the device. If any of the following conditions occur, unplug the device from the electrical outlet and contact authorized service personnel.
The power cord or power adapter is damaged.
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Date: April 10, 2013 Federal Communications Commission 7435Oakland Mills Road Columbia MD 21046 c.c. Compliance CertificationServices CertificationDivision 47173 Benicia Street Fremont, CA94538,USA To whomit may concern: I, the undersigned, herebyauthorize Lab Manager Feel.Jeong( or Logan.Lee )of SGS Korea Co., Ltd and hereafter referred to as SGS Korea, to act onourbehalf in all manners relatingto application forequipment authorization, includingsigningofall documents relating to these matters. Anyand all acts carried outby Lab Manager Feel.Jeong ( or Logan.Lee )of SGS Korea Co., Ltdon ourbehalf shall havethe same effect as acts ofourown. I, theundersigned, hereby certify that we are notsubject to a denial offederal benefits, that includes FCC benefits, pursuantto Section 5301 of theAnti-Drug Abuse Act of 1988,21U.S.C. 853(a). In authorizing SGS Korea as ouragent, we still recognize that we areresponsible to: a)comply with therelevantprovisionsofthecertificationprogram; b)makeall necessary arrangements fortheconduct oftheevaluation,includingprovisionfor examiningdocumentationandaccess to all areas, records(includinginternalaudit reports) andpersonnel forthepurposes ofevaluation(e.g.testing,inspection,assessment, surveillance, reassessment) andresolutionofcomplaints; c)makeclaims regardingcertificationonly in respect ofthescopeforwhich certificationhas been granted; d)donotuse ourproduct certificationin such a manner as to bringtheCertificationDivision into disrepute andnotmakeanystatement regardingourproduct certificationwhich the CertificationDivisionmay consider misleadingorunauthorized; 3D Imaging & Simulations Corp. 815, Tamnip-dong,Yuseong-gu, Daejeon, Korea e)upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division; f)use certification only to indicate the products are certified as being in conformity with specified standards; g)endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner; h)ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division; i)keep a record of all complaints made known to the us relating to the product’s compliance with requirements of the relevant standard and to make these records available to the Certification Division when requested; j)take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification; k)document the actions taken. This authorization is valid until further written notice from the applicant. JungKook, KIM / Director Sincerely Yours,

External photos of EUT Front view of EUT Rear view of EUT Top view of EUT Bottom view of EUT Side view of EUT

FCC/IC Label FCC/IC Label Drawing 3D Imaging & Simulations Corp. Model: FireCR Dental FCC ID: X68CRSCANNER2 This device complies with part 15 of the FCC Rules. 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. Made in Korea FCC/IC Label FCC/IC Label Drawing 3D Imaging & Simulations Corp. Model: Dental CR FCC ID: X68CRSCANNER2 This device complies with part 15 of the FCC Rules. 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. Made in Korea FCC/IC Label FCC/IC Label Drawing 3D Imaging & Simulations Corp. Model: Planmeca Proscanner FCC ID: X68CRSCANNER2 This device complies with part 15 of the FCC Rules. 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. Made in Korea

Internal photos of EUT Inner view of EUT Top view of LCD PCB Bottom view of LDC PCB Top view of head PCB Bottom view of head PCB Top view of Power PCB Bottom view of Power PCB Top view of bulb & LED Bottom view of front motor Top view of lens PCB Bottom view of reader Top view of scan part PCB Bottom view of scan part PCB PCB ANTENNA Top view of DC-DC converter PCB Bottom view of DC-DC converter PCB Top view of sub PCB1 Bottom view of sub PCB1 Top view of sub PCB2 Bottom view of sub PCB2 Top view of sub PCB3 Bottom view of sub PCB3

Report Number :F690501/RF-RTL006383-1Page:2of20 The results shown in this test report refer only to the sample(s) tested unless otherwise stated. This test report cannot be reproduced, except in full, without prior written permission of the Company. SGS Korea Co., Ltd. (Gunpo Laboratory) 18-34, Sanbon-dong, Gunpo-si, Gyeonggi-do, Korea, 435-040 Tel. +82 31 428 5700 / Fax. +82 31 427 2371www.ee.sgs.com/korea INDEX TABLE OF CONTENTSPage 1. General Information ----------------------------------------------------------------------3 2. Transmitter AC Power Line Conducted Emissions-------------------------------5 3. Radiated Emissions----------------------------------------------------------------------13 4. Frequency Stability------------------------------------------------------------------------17 5. 20㏈Bandwidth-------------------------------------------------------------------------- 19 Report Number :F690501/RF-RTL006383-1Page:3of20 The results shown in this test report refer only to the sample(s) tested unless otherwise stated. This test report cannot be reproduced, except in full, without prior written permission of the Company. SGS Korea Co., Ltd. (Gunpo Laboratory) 18-34, Sanbon-dong, Gunpo-si, Gyeonggi-do, Korea, 435-040 Tel. +82 31 428 5700 / Fax. +82 31 427 2371www.ee.sgs.com/korea 1. General Information 1.1. Testing laboratory SGS Korea Co., Ltd. (Gunpo Laboratory) -Wireless Div. 3FL, 18-34, Sanbon-dong, Gunpo-si, Gyeonggi-do, Korea 435-040 All SGS services are rendered in accordance with the applicable SGS conditions of service available on request and accessible athttp://www.sgs.com/en/Terms-and-Conditions.aspx. Phone No.:+82 31 428 5700 Fax No.:+82 31 427 2371 1.2. Details of Applicant Applicant: 3D Imaging & Simulations Corp. Address: 815, Tamnip-dong,Yuseong-gu, Daejeon, Korea Contact Person: Kim, Young-Sul Phone No.: +82 10 9087 0703 1.3. Description of EUT Kind of Product Computed Radiography Scanner Model Name FireCR Dental (Add models : Dental CR, Planmeca Proscanner) Serial Number N/A Power Supply AC 120 V Frequency Range 13.562㎒ Modulation Technique ASK Number of Channels 1 Antenna Type Internal Type 1.4. Declaration by the manufacturer Model nameInformation FireCR Dental- Basic model Dental CR, Planmeca Proscanner - H/W and S/W are same to basic model. - It has only different model name. Report Number :F690501/RF-RTL006383-1Page:4of20 The results shown in this test report refer only to the sample(s) tested unless otherwise stated. This test report cannot be reproduced, except in full, without prior written permission of the Company. SGS Korea Co., Ltd. (Gunpo Laboratory) 18-34, Sanbon-dong, Gunpo-si, Gyeonggi-do, Korea, 435-040 Tel. +82 31 428 5700 / Fax. +82 31 427 2371www.ee.sgs.com/korea 1.5. Test Equipment List EquipmentManufacturerModelS/NCal Date Cal Interval Cal Due. Signal GeneratorR&S SMR40100540 Jan. 05, 2013 Annual Jan. 05, 2014 Spectrum AnalyzerR&SFSV30101004Jul. 05, 2012AnnualJul. 05, 2013 Temperature Chamber JEIO TECHTH-ME-100(1ph)S040281Jul. 25, 2012 Annual Jul. 25, 2013 Horn AntennaR&SHF 907 100208Aug. 13, 2012 Biennial Aug. 13, 2014 Loop AntennaR&SHFH2-Z2100118Aug. 24, 2011BiennialAug. 24, 2013 Trilog AntennaSCHWARZBECKVULB91639163-390Apr. 19, 2011BiennialApr. 19, 2014 Preamplifier H.P. 8447D2727A05143Jul. 18, 2012AnnualJul. 18, 2013 AttenuatorAeroflex / Weinschel 89-20-12407 Aug. 07, 2012AnnualAug. 07, 2013 Two-Line V-Network R & S ENV216101180May. 14, 2012 Annual May. 14, 2013 Test ReceiverR&SESU40100075Feb. 15, 2013 Annual Feb. 15, 2014 AC power SupplyKIKUSUIPCR500MQJ001755Jul. 07, 2012 Annual Jul. 07, 2013 Preamplifier R&S SCU 1810070Aug. 06, 2012AnnualAug. 06, 2013 Anechoic ChamberSY Corporation L × W × H (21.5 m × 13.0 m × 9.0 m) N/A N.C.R. N/A N.C.R. 1.6. Summary of Test Results The EUT has been tested according to the following specifications: Applied standard : FCC Part15 subpart C Standard sectionTest itemResult 15.207Transmitter AC Power Line Conducted EmissionComplied 15.225(a)(b)(c)(d) 15.209 Radiated emissionComplied 15.225(e)Frequency StabilityComplied 15.215(c)20㏈Bandwidth- 1.7. Test report revision RevisionReport numberDescription 0F690501/RF-RTL006383Initial 1F690501/RF-RTL006383-1 Added AC power line & 2nd Harmonic Spurious emission data Report Number :F690501/RF-RTL006383-1Page:5of20 The results shown in this test report refer only to the sample(s) tested unless otherwise stated. This test report cannot be reproduced, except in full, without prior written permission of the Company. SGS Korea Co., Ltd. (Gunpo Laboratory) 18-34, Sanbon-dong, Gunpo-si, Gyeonggi-do, Korea, 435-040 Tel. +82 31 428 5700 / Fax. +82 31 427 2371www.ee.sgs.com/korea 2. Transmitter AC power line conducted emission 2.1. Test Setup 2.2. Limit According to §15.207(a) for an intentional radiator that is designed to be connected to the public utility (AC) power line, the radio frequency voltage that is conducted back onto the AC power line on any frequency or frequencies, within the band 150㎑to 30㎒, shall not exceed the limits in the following table, as measured using a 50 uH/50 ohm line impedance stabilization network (LISN). Compliance with the provision of this paragraph shall on the measurement of the radio frequency voltage between each power line and ground at the power terminal. The lower applies at the boundary between the frequency ranges. Frequency of Emission (㎒) Conducted limit (㏈μV) Quasi-peakAverage 0.15 – 0.5066-56*56-46* 0.50 – 5.005646 5.00 – 30.06050 * Decreases with the logarithm of the frequency. Main power source Shield room enclosure to Test Receiver Table height 0.8 m 0.4m LISN EUT Report Number :F690501/RF-RTL006383-1Page:6of20 The results shown in this test report refer only to the sample(s) tested unless otherwise stated. This test report cannot be reproduced, except in full, without prior written permission of the Company. SGS Korea Co., Ltd. (Gunpo Laboratory) 18-34, Sanbon-dong, Gunpo-si, Gyeonggi-do, Korea, 435-040 Tel. +82 31 428 570…

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Test setup photos of EUT Photo of Field Strength & Spurious Emission Test for below 30 MHz Photo of Field Strength & Spurious Emission Test for above 30 MHz Photos of AC conducted power line test