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DRT-MAN-093 

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1.2.2 FCC Compliance Statement 

 

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. 

 

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. 

 

FCC ID 

FCC ID 

Model 

Remark 

RYK-WUBR508N 
(Contains FCC ID) 

EVS  4343W  /  EVS  4343WG  / 
EVS 4343WP 
EVS  3643W  /  EVS  3643WG  / 
EVS 3643WP 

Component Modular Information 
Manufacturer: Sparklan 
Model Name: WUBR-508N 

RNH-EVSWPCS 

EVS WPCS 

 

 

WARNING 

Changes or modifications not expressly approved by the party responsible for compliance could 

void the user’s authority to operate the equipment. This transmitter must not be co-located or 

operating in conjunction with any other antenna or transmitter. 

 

Specific absorption rate (SAR) 

This  device  meets  FCC  limits  for  exposure  to  radio  waves.  It  is  designed  not  to  exceed  the 

limits  for  exposure  to  radio  waves  (radio  frequency  electromagnetic  field)  adopted  by  the 

Federal  Communications  Commission.  This  equipment  chould  be  installed  and  operated  with 

minimum distance 0mm between the radiator & your body. The radio wave exposure guidelines 

use a unit of measurement known as the Specific absorption rate, or SAR. The SAR limits for 

mobile devices is 1.6W/kg. Tests for SAR are conducted using standard operation position with 

the  device  transmitting  at  its  highest  certified  power  level  in  all  tested  frequency  bands.  The 

highest SAR value under the FCC guidelines for this device model is listed below : 

BODY SAR

 

0.210 W/kg

 

 

Summary of Contents for EVS3643G

Page 1: ......

Page 2: ...and management of equipment Only a physician or legally certified operator should use this product The equipment should be maintained in a safe and operable condition by maintenance personal Use only...

Page 3: ...hall DRTECH be liable for any damage arising from moving alteration inspection or repair by a person other than authorized service engineers Specifications compositions and appearance of this product...

Page 4: ...or future reference Product contains specific materials that are suitable for recycling Should be treated with care because if mistreated it might explode Keep away from fire and flames Heavy loading...

Page 5: ...1 3 2 3 EVS WPCS 25 1 4 PRECAUTIONS REGARDING ELECTROMAGNETIC WAVES 26 2 DETECTOR SPECIFICATIONS 28 2 1 MAIN SPECIFICATIONS 29 2 1 1 Detector 29 2 1 2 Battery Charger 34 2 1 3 Battery Package 35 2 1 4...

Page 6: ...ctor and make connection to the EVS control system 58 3 5 2 3 Conduct examination 59 3 6 POWERING OFF THE DETECTOR 61 3 7 DETECTOR STATUS LIST 61 3 7 1 Detector Status List 61 3 7 2 Power Mode Indicat...

Page 7: ...s personal injury death or substantial product damage if misused Cette notice est utilis e pour d signer les conditions dans lesquelles une utilisation incorrecte du produit peut causer la mort ou des...

Page 8: ...e d alimentation autre que celle fournie avec cet appareil Cela risque de provoquer un incendie ou un choc lectrique Do not install the equipment in any of the locations listed below Doing so may resu...

Page 9: ...ce que les c bles ne s emm lent pas pendant l utilisation Veillez galement ne pas vous coincer les pieds dans le c ble Sinon cela risque de provoquer un dysfonctionnement de l appareil ou des blessure...

Page 10: ...ich could result in fire or electric shock Ne placez pas d objets lourds tels que des appareils m dicaux sur les c bles d alimentation ne tirez pas dessus ne les pliez pas ne les regroupez pas et ne m...

Page 11: ...tral et provoquer un incendie ou un choc lectrique To avoid the risk of electric shock this equipment must only be connected to supply mains with protective earth Pour viter tout risque de choc lectri...

Page 12: ...r or other chemicals Otherwise fire or electrical shock may occur Do not allow dirt or metal objects such as hair pins clips staples or keys to contact the terminals Otherwise battery explosion or lea...

Page 13: ...ectrique De plus tant donn que l appareil comprend des pi ces susceptibles de provoquer une d charge lectrique ainsi que d autres pi ces dangereuses leur contact peut provoquer des blessures graves vo...

Page 14: ...t en contact avec du sang ou d autres liquides organiques Cela risque de provoquer un incendie ou un choc lectrique Dans une telle situation prot gez l appareil avec un rev tement jetable si n cessair...

Page 15: ...a problem occurs Lorsqu un probl me survient WARNING AVERTISSEMENT If any of the following problems occur immediately turn OFF the power unplug the power cord from the AC outlet and contact your sales...

Page 16: ...t with a dry cloth If the cord is kept plugged in for a long time in a dusty humid or a sooty place objects around the plug will attract moisture and this could cause insulation failure that may resul...

Page 17: ...ON FDA CODE NEONATES NEWBORNS UP TO ONE MONTH NEO INFANTS ONE MONTH TO TWO YEARS INF CHILDREN TWO YEARS TO TWELVE YEARS CHI ADOLESCENTS TWELVE YEARS TO SIXTEEN YEARS ADO OTHER OTHER AGE GROUP STUDIED...

Page 18: ...012 CAN CSA C22 2 No 60601 1 14 Medical electrical equipment Part 1 General requirements for basic safety and essential performance IEC 60601 1 2 Ed 4 2014 Medical electrical equipment Part 1 2 Collat...

Page 19: ...DRT MAN 093 19 74 IEC 62366 2007 A1 2014 Medical device Application of usability engineering to medical devices EN ISO 14971 2012 Medical device Application of risk management to medical devices...

Page 20: ...DRT MAN 093 20 74 1 2 Declaration of Conformity 1 2 1 Declaration of Conformity for EU Area...

Page 21: ...s Belgium BE Bulgaria BG Czech Republic CZ Denmark DK Germany DE Estonia EE Ireland IE Greece EL Spain ES France FR Croatia HR Italy IT Cyprus CY Latvia LV Lithuania LT Luxembourg LU Hungary HU Malta...

Page 22: ...UBR508N Contains FCC ID EVS 4343W EVS 4343WG EVS 4343WP EVS 3643W EVS 3643WG EVS 3643WP Component Modular Information Manufacturer Sparklan Model Name WUBR 508N RNH EVSWPCS EVS WPCS WARNING Changes or...

Page 23: ...indicated in the following chapters Any label removal or evidence of attempting to remove the label will void the warranty of the product 1 3 1 Detector Figure 1 EVS 4343W EVS 3643W Markings This mar...

Page 24: ...DRT MAN 093 24 74 Figure 2 EVS 4343W Standard Gadox Label Figure 3 EVS 3643W Standard Gadox Label Caution Do not jolt or apply excessive load...

Page 25: ...DRT MAN 093 25 74 1 3 2 Other components 1 3 2 1 Battery Charger 1 3 2 2 Battery pack 1 3 2 3 EVS WPCS...

Page 26: ...ronment Emission Test Compliance Electromagnetic Environment Guidance RF emissions CISPR11 GROUP 1 The Product uses RF energy only for its internal function Therefore its RF emissions are very low and...

Page 27: ...270 315 0 UT for 1 cycles 40 UT for 5 cycles 70 UT for 25 30 cycles 0 UT for 250 300 cycles Mains power quality should be that of a typical commercial or hospital environment If the user of the EVS 43...

Page 28: ...aire ce produit et l autre appareil doivent tre observ s pour v rifier qu ils fonctionnent normalement Use of accessories transducers and or cables that are not spec ified or provided by the DRTECH of...

Page 29: ...DRT MAN 093 29 74 2 1 Main specifications 2 1 1 Detector Dimensional Diagram Unit mm...

Page 30: ...DRT MAN 093 30 74 Figure 4 Detector Dimension...

Page 31: ...WP CsI Cesium Iodide EVS 4343WG EVS 3643WG Gadox Gadolinium Oxysulfide Interface Wireless Gigabit Ethernet Wired Lan Cable Energy Range kVp 40 150 Typical Dynamic Range Gy 50 Active Area mm EVS 3643W...

Page 32: ...8 4 2 0lp mm EVS 3643W 42 5 2 0lp mm EVS 3643WG 47 8 2 0lp mm EVS 3643WP 42 9 2 0lp mm Cycle time Sec 8 5 sec EWT X ray window time at 0 5sec X ray Window Sec 60 sec Preview Time Sec 1 sec Frame Rate...

Page 33: ...10 sec mAs Range 0 1 1000 mAs Accuracy 5 Bucky Operating Type Moving Stepping Motor Spring CAM Motor type Static Fixed Trey size mm 460 mm 460 mm 15 5 mm or higher Grid Ratio 5 1 6 1 8 1 10 1 12 1 15...

Page 34: ...4 74 2 1 2 Battery Charger Item Description Model EVS BCS Simultaneous Charging Battery Pack 2 EA Charging Time 3 hours Rated Power Supply DC 12 V 6 A Max Dimensions W x H x D 180 mm x 255 mm x 35 mm...

Page 35: ...ption Model EVS MBP Y Cell Type Lithium Polymer Number of Cells 2S1P 2series 1 Parallel Rated Power Supply Output DC 7 4 V Lifetime Approx 500 cycles of use complete charge discharges 1 cycle Dimensio...

Page 36: ...MWPR1516 Medium Power WPC Qi Specification WPC MP A2 Standard Rx Tx Distance Coil to Coil Typ 4mm 1mm Max 8mm Center to Center Typ 4mm Max 8mm Input Voltage DC 12V 10 over 3A or Adaptor XP Power AHM8...

Page 37: ...or 500 1000 speed film screen where it can depict the clinical information It means that products fully cover a dynamic range of 0 2 20 Gy at least User Friendly OLED Display With its clear status ind...

Page 38: ...ion Minimum At least a bachelor s degree in radiology Knowledge Minimum Read and understand Western Arabic numerals written in Arial font Can distinguish human body Understands hygiene Language unders...

Page 39: ...H to 85 R H Storage and delivery conditions Temperature 15 C to 55 C Barometric Pressure 500 hPa to 1060 hPa Humidity 10 R H to 90 R H Non sterile Multiple patient use Less than ten minute contact Ind...

Page 40: ...sible for ensuring that the system calibration is performed after the system installation is completed or the system is repaired Do not try to use the system if system calibration is not performed Il...

Page 41: ...alkonium Chloride 0 63 Sodium Hypochlorite or 70 alcohol solution can also be used To apply the cleaning solution power down the system and disconnect from the power source moisten cloth with the solu...

Page 42: ...guration Do not connect other products to the remaining Lan port on the Ethernet Switching Hub It may affect the image transmission of the detector The following technical specifications represent rec...

Page 43: ...o the detector in Wireless Mode 2 EA Wireless Charging System EVS WPCS A device to wirelessly charge a battery pack that is attached to the detector Optional Component USB C to Lan Gender with PD Incl...

Page 44: ...ul s l exception des accessoires et des c bles de la s rie EVS A vendus par DRTECH Co LTD en tant que pi ces de rechange pour les composants internes peut entra ner une augmentation des missions ou un...

Page 45: ...creen E AP Button Can select different wireless connection options for the detector Connection options Wireless using AP Wireless using detector s internal AP Portable mode F Power Button Turn Detecto...

Page 46: ...4 3 1 1 3 USB C to Lan Gender Item Description Model EVS CPDG USB PD Specification Support PD Ver3 0 USB Version USB 2 0 Ethernet Support 100 1000BASE T Dimensions W x H x D 45 8 mm x 70 2 mm x 21 6 m...

Page 47: ...battery swap 3 1 1 6 Charging Battery Pack The battery pack supplies power to the detector Be sure to use only the dedicated battery pack and fully charge it before use Connect the power adaptor to t...

Page 48: ...daptor that is certified with IEC 60950 or IEC 60601 1 CAUTION MISE EN GARDE Do not insert the battery pack into the charger in the opposite direction If battery pack insertion failure occurs the conn...

Page 49: ...detector is turned off Securely attach the battery into the detector or charger If contact failure occurs or if dust or metal objects come into contact with the exposed connector pins of the detector...

Page 50: ...the charger and bottom of the battery pack Align the left and right side of battery pack to the charger Push down the battery pack Vertical Direction Detachment Grab the battery pack 2 Pull out the b...

Page 51: ...r detects actual amount of X rays without any connection to the X ray generator and then performs image acquiring to the extent of image acquisition time and transits the image data 2 No signal used N...

Page 52: ...ez l acquisition d image d un objet pais en mode DSA avec une tension de tube rayons X faible il est possible que vous ne puissiez pas acqu rir d image AED performance is proportional to KV energy The...

Page 53: ...3 53 74 3 1 4 2 Recommendation of setting AED Sensing Area Standard Environment We suggest the collimated area on detector is wider than 4cm X 8cm and keep along the vertical direction as shown in bel...

Page 54: ...n or higher CPU Intel Core i5 3470 or higher or compatible CPU Memory 8GB or higher Hard disk 1TB or higher LAN card Gigabit Detector only Intel PRO 1000 Series Gigabit LAN Card for network interface...

Page 55: ...120 line inch 215 line inch Inter spacer Al Table 1 Grid spec 3 3 3 Recommended Exposure Condition Item Recommended Condition X ray Energy Range 100 cm 130 cm 150 cm 180 cm Reliability Lifetime Dose 1...

Page 56: ...pack should be installed in the detector to use it under the wireless configuration Up to 2 battery packs can be charged simultaneously from a battery charger Wired Connection Connect EVS W Series an...

Page 57: ...Selection of EVS 3643W wireless from the Exprimer series detector Selection of wireless wired data transfer Select or register the patient information Select the protocol selection3 of the detector A...

Page 58: ...n the AP lamp is blinking once in 2 seconds system is in wired mode When the AP lamp is blinking twice in 2 seconds system is in wireless mode AP_1 When the AP lamp is blinking 3 times in 2 seconds sy...

Page 59: ...y status Arrange the patient in the correct posture and position the detector aligning it with the target body part Position the X ray generator to adjust the exposure field Check all conditions befor...

Page 60: ...ure mode before the shooting Mode Description AED Auto Exposure Detection Mode Click the button for ending the examination images are stored automatically To conduct examination for another patient re...

Page 61: ...7 Detector status list 3 7 1 Detector Status List Lamp Type Operation Network Ready Busy AP Link Color Green Orange Blue Green Power ON O X X X During detector registration X O Detector registration...

Page 62: ...ds between the wireless module and the wireless access point If there is any obstacle remove it If the problem cannot be resolved ask for consultation to your sales representative or local DRTECH deal...

Page 63: ...ly battery 40 49 Only battery 30 39 Only battery 20 29 Only battery 10 19 Only battery Warning message is popped up at the bottom right Recommend to change the battery 0 9 Only battery Warning message...

Page 64: ...rder and the images can be transmitted to the PC after connecting the detector to the PC The transmitted images in the detector are removed automatically Image processing and correction are available...

Page 65: ...ec une tension de tube rayons X faible il est possible que vous ne puissiez pas acqu rir d image AED performance is proportional to KV energy Therefore it is recommended to increase KV as much as poss...

Page 66: ...detector is wider than 4cm X 8cm and keep along the vertical direction as shown in figure 15 Figure 15 Stand Environment with AED Mode Table Environment We suggest the collimated area on detector is w...

Page 67: ...how to connect the EVS 4343W EVS 3643W system Detector 3 9 1 1 Operating AP 1 Connect the LAN cable to ethernet port not internet of AP and the other to the LAN Card connector of workstation assigned...

Page 68: ...on Wireless On Off switch and push the Power button CAUTION MISE EN GARDE This equipment must only be connected to the power with protective earth Cet appareil ne doit tre branch qu une prise secteur...

Page 69: ...ck the results Replace other Detectors and check the results Replace corresponding devices Ready LED Orange lamps of detector are blinking 3 time sec Internal hardware errors of the detector Consult w...

Page 70: ...let and the AC outlet Detector Ensure that there are no loose screws or broken parts Ensure that there is no dust or foreign substance on the external connector Ensure that there are no broken parts o...

Page 71: ...oxing Please handle the box containg the product with care Note The packaging that came with the product should not be damaged or discarded as it is needed for after sales service or for exchanging th...

Page 72: ...2019 09 10 Initial Release 01 2019 09 09 Addition of EVS 3643WP EVS 4343WP model in manual 02 2019 10 11 Update of regulatory information FCC 03 2019 10 14 Update of regulatory information EU and man...

Page 73: ...9 Dunchon daero541beon gil Jungwon gu Seongnam si Gyeonggi do Republic of Korea Website http www drtech co kr Customer Support Team E mail drtech drtech co kr Tel 82 31 779 7448 Fax 82 31 779 7490 DRT...

Page 74: ...DRT MAN 093 74 74...

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