DRTECH EVS4343W User Manual
  1. Manuals
  2. Brands
  3. DRTECH Manuals
  4. Medical Equipment
  5. EVS4343W
  6. User manual

DRTECH EVS4343W User Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the EVS4343W and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for DRTECH EVS4343W

Summary of Contents for DRTECH EVS4343W

  • Page 2: Manual Information

    Information contained in this manual is confidential and the property of DRTECH Co, Ltd., which is only provided to the authorized customers of DRTECH Co, Ltd. The purpose of the manual is to assist the users to comprehensively utilize the product of DRTECH Co, Ltd. All information contained in the manual may not be altered or distributed without prior written consent of DRTECH Co, Ltd., and may not be disclosed to...
  • Page 3  In no event shall DRTECH be liable for direct or indirect consequential damages arising from the use or unavailability of this product. DRTECH shall not be liable for loss of image data for any reason.  In no event shall DRTECH be liable for any damage arising from moving, alteration, inspection or repair by a person other than authorized service engineers.
  • Page 4 Definition of Symbols Symbols Description Non-ionized radiation The Waste Electrical and Electronic Equipment Regulations indicate separate collection for electrical and electronic equipment. Protective Earth (Ground) Direct Current Alternating Current Equipotentiality Power Off Power On Read and understand all instructions and warning labels in the product documentation before using the equipment.

  • Page 5: Table Of Contents

    Table of Contents MANUAL INFORMATION ............................2 1. SAFETY AND REGULATORY INFORMATION ....................7 1.1 M ............................ 18 EDICAL QUIPMENT AFETY TANDARDS 1.1.1 Medical Equipment Classification ..........................18 1.1.2 Product Safety Standards ..............................18 1.2 D ............................... 20 ECLARATION OF ONFORMITY 1.2.1 Declaration of Conformity for EU Area........................
  • Page 6 3.1.4.1 AED Mode ........................................51 3.1.4.2 Recommendation of setting AED Sensing Area........................53 3.3 E ..............................54 NVIRONMENTAL EQUIREMENTS 3.3.1 Specifications of Workstation (Minimum and Recommended PC Requirements) ......... 54 3.3.2 Recommended Specifications of Grid ......................... 55 3.3.3 Recommended Exposure Condition ..........................55 3.4 B ................................

  • Page 7: Safety And Regulatory Information

    1. Safety and Regulatory Information Intended Use The EVS 4343W / EVS 4343WG / EVS 3643W / EVS 3643WG / EVS 4343WP / EVS 3643WP Digital X-ray detector is designed as a digital imaging solution, for providing radiographic diagnosis of the human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures.
  • Page 8 En outre, certains désinfectants sont inflammables. Assurez-vous de faire attention lorsque vous les utilisez. Do not connect the detector to any component, other than DRTECH’s  specified components. Doing so may result in fire or electric shock.
  • Page 9  Because the equipment cable is long, take care that cables do not become tangled during use. Also, be careful not to get your feet caught in the cable. Otherwise, it may cause a malfunction of the equipment or the injury of the user due to tripping over the cable.
  • Page 10 Power Supply Alimentation électrique WARNING AVERTISSEMENT  Do not operate the detector using any type of power supply other than the one indicated on the rating label. Otherwise, it may result in fire or electric shock. N'utilisez pas l'appareil avec un type d'alimentation autre que celui indiqué sur l'étiquette.
  • Page 11  Securely plug the power cord into the AC outlet. Branchez fermement le cordon d'alimentation dans la prise secteur.  If contact failure occurs, or if dust or metal objects come into contact with the exposed metal prong of the plug, fire or electric shock may result. En cas de défaillance du contact, ou si de la poussière ou des objets métalliques entrent en contact avec la broche métallique exposée de la fiche, il y a risque d’incendie ou de choc électrique.
  • Page 12 Battery Pack and Charger WARNING AVERTISSEMENT  Do not use the battery pack as a power source for equipment other than EVS 4343W / EVS 4343WG / EVS 3643W / EVS 3643WG detector. Be sure to use the battery pack dedicated to the EVS 4343W / EVS 4343WG / EVS 3643W / EVS 3643WG detector.
  • Page 13 The system, partially or in whole, cannot be modified in any ways without any written approval from DRTECH. Le système, partiellement ou intégralement, ne peut être modifié de quelque manière que ce soit sans l'accord écrit de DRTECH.  No modification of this equipment is allowed.
  • Page 14  Have the patient take a fixed posture and do not let patient touch the parts unnecessarily. If a patient touches connectors or switches, it may result in electric shock or malfunction of the detector. Demandez au patient de prendre une position figée et ne le laissez pas toucher des composants.
  • Page 15 Dans les cas suivants, mettez immédiatement chaque appareil hors tension, débranchez le câble d'alimentation de la prise secteur et contactez votre représentant commercial ou votre revendeur DRTECH: When smoke, an odd smell or abnormal sound occurs. Quand il y a de la fumée, une odeur étrange ou un son anormal When liquid has been spilled into the detector or foreign metal object has entered inside the detector.
  • Page 16 Maintenance and Inspection Entretien et révision WARNING AVERTISSEMENT  When cleaning the detector, be sure to turn OFF the power and unplug the power cord from the AC outlet. Do not use alcohol, benzene, thinner or any other flammable cleaning agents. Otherwise, it may result in fire or electric shock.
  • Page 17 Pediatric Patients WARNING AVERTISSEMENT  Health care professionals and hospital administrators take special care in reducing radiation exposure to pediatric patients by following these steps:  Discuss the rationale for the examination with the patient and/or parent to ensure a clear understanding of benefits and risks. ...

  • Page 18: Medical Equipment Safety Standards

    1.1 Medical Equipment Safety Standards 1.1.1 Medical Equipment Classification Type of protection Class I ME Equipment against electrical shock Degree of protection Type B Applied Parts (Applied Part: Detector panel) against electrical shock Degree of protection IP54 against ingress of water Mode of operation Continuous Operation Not suitable for use in the presence of a flammable anesthetic...
  • Page 19 Medical device – Application of usability engineering to IEC 62366:2007 + A1:2014 medical devices Medical device – Application of risk management to medical EN ISO 14971:2012 devices DRT-MAN-093 19/74...

  • Page 20: Declaration Of Conformity

    1.2 Declaration of Conformity 1.2.1 Declaration of Conformity for EU Area DRT-MAN-093 20/74...
  • Page 21 The EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP may be operated in: Abbreviations 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),...

  • Page 22: Fcc Compliance Statement

    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.

  • Page 23: Labels And Markings On The Equipment

    1.3 Labels and Markings on the Equipment The EVS EVS 4343W / EVS 4343WG / EVS 3643W / EVS 3643WG detector and other components have labels and markings on them. Their contents and locations are indicated in the following chapters. Any label removal or evidence of attempting to remove the label will void the warranty of the product.
  • Page 24 Figure 2. EVS 4343W Standard & Gadox Label Figure 3. EVS 3643W Standard & Gadox Label Caution: Do not jolt or apply excessive load. DRT-MAN-093 24/74...

  • Page 25: Other Components

    1.3.2 Other components 1.3.2.1 Battery Charger 1.3.2.2 Battery pack 1.3.2.3 EVS-WPCS DRT-MAN-093 25/74...

  • Page 26: Precautions Regarding Electromagnetic Waves

    No field serviceable component inside - Do not attempt to open the case. Mise en garde: Aucune composante réparable sur le terrain à l'intérieur - N'essayez pas d'ouvrir le boî tier. CAUTION MISE EN GARDE 1.4 Precautions regarding electromagnetic waves The Product is intended for use in the electromagnetic environment specified below.
  • Page 27 Electromagnetic immunity The Product is intended for use in the electromagnetic environment specified below. The user of the Product should assure that it is used in such an environment. IEC 60601 Test Electromagnetic Immunity Test Compliance Level Environment – Guidance Level Floors should be wood, concrete or Electrostatic...

  • Page 28: Detector Specifications

    être observés pour vérifier qu'ils fonctionnent normalement. Use of accessories, transducers and/or cables that are not spec ified or provided by the DRTECH of Product could result in increased electromagnetic emissions or decreased electromagnetic immunity of product and result in improper opration.

  • Page 29: Main Specifications

    2.1 Main specifications 2.1.1 Detector [Dimensional Diagram] (Unit: mm) DRT-MAN-093 29/74...
  • Page 30 Figure 4. Detector Dimension DRT-MAN-093 30/74...
  • Page 31 Detector Specifications  Panel & Electronic Item Unit Detail EVS 4343W / EVS 4343WG / EVS 4343WP Model EVS 3643W / EVS 3643WG / EVS 3643WP Purpose General Radiography EVS 4343W / EVS 4343WG / EVS 3643W / EVS 3643WG: a-Si TFT array 2D Matrix Array EVS 4343WP / EVS 3643WP:...
  • Page 32  Performance Item Unit Detail 52.8 (@1.0lp/mm / @RQA5, 3.5μGy) EVS 4343W 25.1 (@1.0lp/mm / @RQA5, 3.5μGy) EVS 4343WG 50.0 (@1.0lp/mm / @RQA5, 3.5μGy) EVS 4343WP Typical DQE 53.3 (@1.0lp/mm / @RQA5, 3.5μGy) EVS 3643W 25.9 (@1.0lp/mm / @RQA5, 3.5μGy) EVS 3643WG 53.1 (@1.0lp/mm / @RQA5, 3.5μGy) EVS 3643WP...
  • Page 33  X-ray System Requirements Contents Requirements Power frequency 30 ~ 240 kHz 40 ~ 150 kVp mA Range 10 ~ 1000 mA Generator Exposure Time 0.001~10 sec mAs Range 0.1~1000 mAs ± 5 % Accuracy Stepping Motor Moving Spring Operating Type CAM Motor type Bucky Static(Fixed)

  • Page 34: Battery Charger

    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 Weight 0.5 kg DRT-MAN-093...

  • Page 35: Battery Package

    2.1.3 Battery Package Item Description Model EVS-MBP-Y Cell Type Lithium Polymer Number of Cells 2S1P (2series 1 Parallel) Rated Power Supply Output : DC +7.4 V Approx. 500 cycles of use (complete charge/discharges 1 Lifetime cycle) Dimensions (W x H x D) 163 mm x 148 mm x 7 mm Weight 0.24 kg...

  • Page 36: Evs-Wpcs

    2.1.4 EVS-WPCS Item Description Note Model EVS-WPCS Dimensions (W x H x D) 115.8 mm x 94.8 mm x 12 mm Weight 0.15 kg Charging Transceiver IC Freescale MWTC1012 Medium Power Charging Receiver IC Freescale MWPR1516 Medium Power WPC Qi Specification WPC MP-A2 Standard.

  • Page 37: Characteristics

    2.2 Characteristics  Typical Patient Doses - Typical patient doses are equivalent to 500-1000 speed film/screen systems.  Sensitometric Characteristics and Dynamic Range - EVS 4343W / EVS 4343WG EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP wireless responds linearly against the exposure range for 500-1000 speed film/screen where it can depict the clinical information.

  • Page 38: Intended Use

    2.3 Intended Use  Intended Patient Population Considerations Requirement Description Paediatric to Geriatric Health Not relevant Nationality Multiple Not relevant Patient is user Patient is not user Patient state Patient is not user Not relevant, unless patient is agitated  Intended Part of the Body or Type of Tissue Applied to or Interacted with Measuring site: body Condition: Intact or wound skin...
  • Page 39  Intended Conditions of Use Considerations Condition Operating conditions - Temperature: +10 ºC to +35 ºC - Barometric Pressure: 700 hPa to 1060 hPa - Humidity: 20 % R.H. to 85 % R.H. Storage and delivery conditions Environment including - Temperature: -15 ºC to +55 ºC hygienic requirements - Barometric Pressure: 500 hPa to 1060 hPa - Humidity: 10 % R.H.

  • Page 40: Operating Procedure

    System Diagnostic The Ecali1 software generates a system diagnostic. Run Ecali1 software after installing the system and execute the program at least once a year. If an error occurs, report the detailed error information to DRTECH local dealer or distributor.
  • Page 41  To reduce the risk of electric shock, the system must be connected to an electrical ground.  A three-phase AC power cable is supplied with this system to provide the proper electrical grounding. The power cable must be plugged into an UL-approved three-contact electrical outlet. ...

  • Page 42: System Configuration

    3.1 System Configuration The Product is used in system configuration as illustrated below. Figure 5. EVS W Series Single Detector Configuration  Do not connect other products to the remaining Lan port on the Ethernet Switching Hub. It may affect the image transmission of the detector. ...

  • Page 43: Parts Name And Functions

    3.2 Parts Name and Functions 3.1.1 Product Components Components Model No. Functions Note EVS 4343W EVS 4343WG Imaging device with Gigabit EVS 4343WP Flat Panel X-ray Detector Ethernet signal interface to the EVS 3643W operating PC EVS 3643WG EVS 3643WP Battery Charger A device to charge a battery EVS-BCS...

  • Page 44: Detector Components

    L’utilisation d’accessoires et de câbles autres que ceux stipulés, à l’exception des accessoires et des câbles de la série EVS A vendus par DRTECH Co., LTD. en tant que pièces de rechange pour les composants internes, peut entraî ner une augmentation des émissions ou une diminution de l'immunité de l'appareil. Les équipements accessoires connectés aux interfaces analogiques et numériques doivent être certifiés...

  • Page 45: Evs-Cpdg Components

    B. Battery Pack: Supply electrical power to the detector while using wireless communication C. Status Indicators ▪ Power: Show power on/off status of the detector. ▪ Ready: Show data communication status and ready status of the detector - Light ON: Detector is ready - Light OFF: Detector is busy ▪...

  • Page 46: Usb C To Lan Gender

    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 mm Weight 0.1 kg DRT-MAN-093 46/74...

  • Page 47: Battery Charger Components

    3.1.1.4 Battery Charger Components A. Power Indicator : Indicate the power on/off status.. B. Charging Indicator : Indicate the charging status. C. Battery Compartment : Insert the battery pack to charge. D. DC Input : Connect the DC Adaptor to supply electrical power to the battery charger 3.1.1.5 Battery Pack Components A.
  • Page 48   Securely plug the power cord into the power source. If contact failure occurs, or if dust or metal objects come into contact with the exposed metal prongs of the plug, fire or electrical shock may occur. WARNING AVERTISS-EMENT ...
  • Page 49 1) Turn the battery lock knob 90 degrees counter-clockwise. 2) Pull up the battery pack grabbing the knob.  Make sure to turn off the detector before detaching a battery pack. Press and hold the power button for about 2 seconds. All status LED lamps will be turned off when the detector is turned off.

  • Page 50: Evs-Wpcs Components

    Vertical Direction (Attachment)  Stand the battery pack upright to reveal the battery charged connector.  Check the yellow-green arrows on the charger and bottom of the battery pack.  Align the left and right side of battery pack to the charger. ...

  • Page 51: Additional Function

    ③ Power Connection Cable ④ Debug Connector: For debugging ⑤ ID Switch: Device ID setting dip switch ⑥ Indicate LED Connector: For cradle (Optional) ⑦ Indicate LED Connector: For system (Optional) 3.1.4 Additional Function Mode Description 1. The detector 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.
  • Page 52  Make sure to follow operating environment requirements (Temp. : 10 ~ 35℃) Veillez à respecter exigences l'environnement d'exploitation (Température : 10 ~ 35℃)  If you use AED Mode out of operating environmental requirements, unwanted image can be acquired without x-ray image acquiring process. Si vous utilisez le mode DSA en dehors des conditions environnementales, vous pouvez acquérir des images non désirées sans processus d'acquisition d'images à...

  • Page 53: Recommendation Of Setting Aed Sensing Area

    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 below figures. DRT-MAN-093 53/74...

  • Page 54: Environmental Requirements

    3.3 Environmental Requirements 3.3.1 Specifications of Workstation (Minimum and Recommended PC Requirements) Item Specification Operating system Windows 7 64 bit SP1 (Professional Edition or higher) Intel Core i5 3470 or higher (or compatible CPU) Memory 8GB or higher Hard disk 1TB or higher Gigabit (Detector only) Intel®...

  • Page 55: Recommended Specifications Of Grid

    3.3.2 Recommended Specifications of Grid Item Recommended Specification 100 cm / 130 cm / 150 cm / 180 cm Ratio 10 : 1 Frequency 103 line/inch, 120 line/inch, 215 line/inch Inter spacer Table 1 Grid spec 3.3.3 Recommended Exposure Condition Item Recommended Condition X-ray Energy Range...

  • Page 56: Before Using The Detector

    3.4 Before using the detector  Be sure to use only the specified power supply dedicated for the Product. Veillez à n'utiliser que l'alimentation appropriée du détecteur produit. CAUTION MISE EN GARDE  Wireless Connection EVS W series transmits images and data by wireless communication. Battery pack should be installed in the detector to use it under the wireless configuration.

  • Page 57: Operating The Detector

    3.5 Operating the detector 3.5.1 Genral Workflow The following workflow indicates the procedures for acquiring a clinical image after startup of EConsole1 and other system equipments · Preparing to use the detector Attach a fully-charged battery pack to the detector. : A procedure in order to register the detector to a specific digital radiography system ·...

  • Page 58: Operating The Detector

    3.5.2 Operating the detector Operation Network Lamp Type Ready Busy Link ■Green ■Orange ■Blue ■Green Color * The Network lamp is divided into two different lamps; AP (Blue) and LINK (Green) lamps. 3.5.2.1 Powering on the detector  Before operating the detector, start up the EConsole1 Press and hold the POWER button (approx.

  • Page 59: Conduct Examination

     The LINK (Green) lamp does not light up when the detector is not registered or the communication connection is not established.  When the READY (Green) and AP (Blue) lamp are blinking and LINK (Green) lamp does not light up, a communication error has occurred. 3.5.2.3 Conduct examination For details about operation, refer to the User Manual for the EConsole1.
  • Page 60 Check the images on the monitor. If any uncompleted protocols remain, repeat the procedure(②). Choose the exposure mode before the shooting. Mode Description Auto Exposure Detection Mode ③ Click the button for ending the examination images are stored automatically. To conduct examination for another patient, repeat the step(③). ...

  • Page 61: Powering Off The Detector

    3.6 Powering off the detector • Turn off the detector ① Press the POWER button of the detector. ② All the LED lamps should be off. - Select the POWER OFF button from Econsole1. - Power plug off of POE adaptor from the outlet. 3.7 Detector status list 3.7.1 Detector Status List Operation...

  • Page 62: Power Mode Indicator

    (Unstable) Communication If the problem cannot be resolved, ask for speed is lowered consultation to your sales representative or local DRTECH dealer. Confirm that detector and the access point are turned on. No signal or No Link Disconnected If the problem cannot be resolved, ask for...

  • Page 63: Battery Remains Indicator

    Only battery Change the battery before the battery is discharged. Change the battery. No Battery or Unknown If the problem cannot be resolved, ask for consultation Error to your sales representative or local DRTECH dealer. 3.8 Additional function DRT-MAN-093 63/74...

  • Page 64: Lossless Aed/Awc Mode

    Mode Description 3. The detector detects actual amount of X-rays without any connection to the X-ray generator. AED/AWC Mode 4. No signal used (No need of connector interface cable) 3.8.1 Lossless AED/AWC Mode AED Mode is available for acquiring images without any connection to X-ray generator. Generator interface cable is not required.
  • Page 65  Make sure to follow operating environment requirements (Temp. : 10 ~ 35℃) Veillez à respecter exigences l'environnement d'exploitation (Température : 10 ~ 35℃)  If you use AED Mode out of operating environmental requirements, unwanted image can be acquired without x-ray image acquiring process. Si vous utilisez le mode DSA en dehors des conditions environnementales, vous pouvez acquérir des images non désirées sans processus d'acquisition d'images à...

  • Page 66: Recommendation Of Setting Aed Sensing Area

    3.8.1.1 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 figure 15. Figure 15. Stand Environment with AED Mode Table Environment We suggest the collimated area on detector is wider than 4cm X 8cm, and keep along the horizontal direction as shown in figure 16.

  • Page 67: Product Installation

    3.9 Product Installation 3.9.1 Connecting Device This section describes how to connect the EVS 4343W / EVS 3643W system (Detector). 3.9.1.1 Operating AP Connect the LAN cable to ethernet port (not internet) of AP, and the other to the LAN Card connector of workstation assigned for the data transfer.
  • Page 68 Turn on Wireless On/Off switch and push the Power button. This equipment must only be connected to the power with protective earth. Cet appareil ne doit être branché qu’à une prise secteur avec terre de protection. CAUTION MISE EN GARDE DRT-MAN-093 68/74...

  • Page 69: Trouble Shooting

    If the problem persists, turn off the detector and consult your sales representative or local DRTECH dealer. Please refer to the details of the problem or error messages.

  • Page 70: Maintenance

    In order to ensure that the equipment is used safely, be sure to inspect the equipment before use. If any problem is detected during the inspection and cannot be corrected, please contact your sales representative or local DRTECH dealer. 5.1 Daily Inspection and Maintenance For safety reasons, be sure to turn OFF the power to each piece of equipment before the following procedures.

  • Page 71: Packaging

    6. Packaging Operational issues may occur if inappropriate force is applied to the product during unboxing. Please handle the box containg the product with care. WARNING AVERTISS-EMENT 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 the product with new product.

  • Page 72: Revision History

    7. Revision History Revision Date Descriptions 2019.09.10 Initial Release 2019.09.09 Addition of EVS 3643WP / EVS 4343WP model in manual 2019.10.11 Update of regulatory information(FCC) 2019.10.14 Update of regulatory information(EU) and manual composition 2019.11.20 Update of regulatory information(FCC) DRT-MAN-093 72/74...
  • Page 73 DRTECH Co, Ltd Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29 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...
  • Page 74 DRT-MAN-093 74/74...

This manual is also suitable for:

Evs4343wgEvs4343wpEvs3643wEvs3643gEvs3643wp

Table of Contents

Save PDF