DRTECH EVS4343W User manual

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Manual Information
Copyright
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
unauthorized personnel. Information contained in the manual may be subject to change without prior notice.
Copyright © 2019 DRTECH Co, Ltd. All rights reserved.
To Customers
Thank you for purchasing the DRTECH Radiography EVS4343W / EVS4343WG / EVS3643W / EVS3643G /
EVS 4343WP / EVS 3643WP(hereinafter this Product). This User’s Manual explains how to use the detector,
x-ray interface unit, and other peripheral equipment. Before using this product, be sure to read this manual
thoroughly in order to utilize it more effectively. Also, read the Operation Manual for EVS Calibration and
configuration Software (hereinafter ECali1).
Important information on usage 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 computers and image display monitors complying with IEC 60601-1 or IEC 60950-1
and under a system configuration complying with IEC 60601-1. For details, consult your sales
representative or local DRTECH dealer.
Use only the dedicated cables. Do not use any cables other than those supplied with this
product.
Disclaimer
In no event shall DRTECH be liable for any damage or loss arising from fire, earthquake, any
action or accident by a third party, any intentional negligent action by users, any trial usage, or
other usage under abnormal conditions.
Roentgenography, image processing, image reading, and image data storage must be
performed in accordance with the laws of the country or region in which the product is being
used. The user is responsible for maintaining privacy of image data.
In no event shall DRTECH be liable for personal physical harm or property damage that is
sustained, under any conditions when the instructions are not followed or the product is misused.
It is the responsibility of attending physicians to provide medical care services. DRTECH will not
be liable for fault diagnosis.

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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.
Specifications, compositions, and appearance of this product may change without prior notice.
Please contact us if there are any problems while using the product.
DRTECH Co, Ltd.
Customer Support Team
Website: http://www.drtech.co.kr
E-mail: [e-mail]
Tel: [phone]
Fax: [phone]

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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. Keep this manual for 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 is prohibited.
Authorized representative in the European Community
Serial Number
Date of manufacture
Manufacturer
For U.S.A standards
Federal law restricts this device to sale by or on the order of a licensed practitioner
For European Union (EEC Countries)
This mark shows that product is in compliance with the essential requirements and
other relevant provisions of Directive 93/42/EEC and “0120” shows the notified body
number for MDD.

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Table of Contents
MANUAL INFORMATION ........................................................................................................................................ 2
1. SAFETY AND REGULATORY INFORMATION ................................................................................................... 7
1.1 MEDICAL EQUIPMENT SAFETY STANDARDS....................................................................................................................................18
1.1.1 Medical Equipment Classification..................................................................................................................................18
1.1.2 Product Safety Standards ..................................................................................................................................................18
1.2 DECLARATION OF CONFORMITY .......................................................................................................................................................20
1.2.1 Declaration of Conformity for EU Area.......................................................................................................................20
1.2.2 FCC Compliance Statement..............................................................................................................................................22
1.3 LABELS AND MARKINGS ON THE EQUIPMENT ...............................................................................................................................23
1.3.1 Detector.....................................................................................................................................................................................23
1.3.2 Other components ...............................................................................................................................................................25
1.3.2.1 Battery Charger .......................................................................................................................................................................................25
1.3.2.2 Battery pack ..............................................................................................................................................................................................25
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 EVS-WPCS.................................................................................................................................................................................36
2.2 CHARACTERISTICS................................................................................................................................................................................37
2.3 INTENDED USE.....................................................................................................................................................................................38
3. OPERATING PROCEDURE.................................................................................................................................. 40
3.1 NOTES FOR USING THE EQUIPMENT.................................................................................................................................................40
3.1 SYSTEM CONFIGURATION...................................................................................................................................................................42
3.2 PARTS NAME AND FUNCTIONS.........................................................................................................................................................43
3.1.1 Product Components ..........................................................................................................................................................43
3.1.1.1 Detector Components..........................................................................................................................................................................44
3.1.1.2 EVS-CPDG Components......................................................................................................................................................................45
3.1.1.3 USB C to Lan Gender ...........................................................................................................................................................................46
3.1.1.4 Battery Charger Components........................................................................................................................................................... 47
3.1.1.5 Battery Pack Components..................................................................................................................................................................47
3.1.1.6 Charging Battery Pack..........................................................................................................................................................................47
3.1.1.7 EVS-WPCS Components......................................................................................................................................................................50
3.1.4 Additional Function..............................................................................................................................................................51

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3.1.4.1 AED Mode..................................................................................................................................................................................................51
3.1.4.2 Recommendation of setting AED Sensing Area......................................................................................................................53
3.3 ENVIRONMENTAL REQUIREMENTS ....................................................................................................................................................54
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 BEFORE USING THE DETECTOR...........................................................................................................................................................56
3.5 OPERATING THE DETECTOR ................................................................................................................................................................57
3.5.1 Genral Workflow....................................................................................................................................................................57
3.5.2 Operating the detector ......................................................................................................................................................58
3.5.2.1 Powering on the detector ..................................................................................................................................................................58
3.5.2.2 Register the detector 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 Indicator ........................................................................................................................................................62
3.7.3 Signal Strength Indicator...................................................................................................................................................62
3.7.4 Battery Remains Indicator.................................................................................................................................................................63
3.8 ADDITIONAL FUNCTION......................................................................................................................................................................63
3.8.1 Lossless AED/AWC Mode..................................................................................................................................................64
3.8.1.1 Recommendation of setting AED Sensing Area......................................................................................................................66
3.9 PRODUCT INSTALLATION ....................................................................................................................................................................67
3.9.1 Connecting Device .................................................................................................................................................................................... 67
3.9.1.1 Operating AP............................................................................................................................................................................................67
4. TROUBLE SHOOTING......................................................................................................................................... 69
5. MAINTENANCE................................................................................................................................................... 70
5.1 DAILY INSPECTION AND MAINTENANCE .........................................................................................................................................70
5.2 REGULAR INSPECTION AND MAINTENANCE ...................................................................................................................................70
5.3 IRREGULAR INSPECTION AND MAINTENANCE ................................................................................................................................70
6. PACKAGING......................................................................................................................................................... 71
7. REVISION HISTORY............................................................................................................................................ 72

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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. This device is not intended for mammography applications.
Safety Notices
Follow the safety instructions in this manual along with the following warning and cautions signs. Ignoring
instructions, warnings, or cautions while handling the product may result in serious injury, accident, or product
damage. To avoid any accident causing personal injury or product damage, be sure to read this manual
carefully before using the product.
Safety Symbols
WARNING
AVERTISSEMENT
This indicates a potentially hazardous situation which may cause serious personal
injury, death or substantial product damage if misused.
Cette notice est utilisée pour désigner les conditions dans lesquelles une utilisation
incorrecte du produit peut causer la mort ou des blessures graves.
CAUTION
MISE EN GARDE
This indicates a potentially hazardous situation which may cause minor personal
injury if misused.
Cette notice est utilisée pour désigner les conditions dans lesquelles une utilisation
incorrecte du produit peut causer des blessures mineures.
CAUTION
MISE EN GARDE
This indicates a potentially hazardous condition which may cause product damage.
Cette notice est utilisée pour désigner les conditions dans lesquelles une utilisation
incorrecte du produit peut causer des dommages matériels.
PROHIBITED
INTERDICTION
This indicates a prohibited operation.
This indicates an action that must be performed.
IMPORTANT
This indicates important operations and restrictions.
Be sure to check this sign to prevent product damage or malfunction.
This indicates the information about the basic operations of the detector for its
user’s reference. Users are recommended to read this notice.

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Installation and Environment of Use
Installation et environnement d'utilisation
WARNING
AVERTISSEMENT
PROHIBITED
INTERDICTION
Do not operate or store the X-ray detector in or around flammable
chemicals or substances such as alcohol, thinner, benzene, etc.
N'utilisez pas et n’entreposez pas l’appareil à proximité de produits chimiques
inflammables tels que de l'alcool, des diluants, de la benzine, etc.
If chemicals are spilled or evaporated, it may result in fire or electric
shock, caused by their contacts with electric parts inside the detector.
Some disinfectants are also flammable. Be cautious when using them.
Si des produits chimiques sont renversés ou s'évaporent, cela peut provoquer
un incendie ou une électrocution par contact avec des pièces électriques à
l'intérieur de l'appareil. 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.
Ne connectez pas l'appareil une source d'alimentation autre que celle fournie
avec cet appareil. Cela risque de provoquer un incendie ou un choc électrique.
Do not install the equipment in any of the locations listed below. Doing so
may result in fire, personal injury, or malfunction of the equipment.
N'installez pas l'appareil dans l'un des emplacements énumérés ci-dessous.
Cela pourrait entraîner une défaillance ou un dysfonctionnement de l'appareil,
un incendie ou des blessures.
- Close to fluid or places where fluids is used
Près des installations où l'eau est utilisée
- Where it may be exposed to direct sunlight
à la lumière directe du soleil
- Close to the air outlet of an air-conditioner or ventilation equipment
Près de la sortie d'air d'un climatiseur ou d'un appareil de ventilation
- Close to heat sources such as a heater
Près d'une source de chaleur telle qu'un radiateur
- Where the power supply is unstable
Là où l'alimentation est instable
- In a saline or sulfurous environment
En milieu salin ou sulfureux
- Where temperature or humidity is high
Là où la température ou l'humidité est élevée
- High condensation or extreme cold environment
en cas de gel ou de condensation
- In area prone to vibration
Dans les zones sujettes aux vibrations
- On an incline or in an unstable area
Sur une pente ou dans une zone instable

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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.
En raison de la longueur du câble de l’appareil, veillez à ce que les câbles ne
s'emmêlent pas pendant l'utilisation. Veillez également à ne pas vous coincer
les pieds dans le câble.
Sinon, cela risque de provoquer un dysfonctionnement de l'appareil ou des
blessures de l'utilisateur s’il trébuche sur un câble.
Non-medical equipment such as the battery charger, and access point unit
cannot be used in patient’s vicinity.
Les appareils non médicaux tels que le chargeur de batterie et l’unité de point
d’accès ne peuvent pas être utilisés à proximité du patient.
<Patient Vicinity>
<Proximité avec le patient>

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Power Supply
Alimentation électrique
WARNING
AVERTISSEMENT
PROHIBITED
INTERDICTION
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. Sinon, cela risque de provoquer un incendie ou un choc électrique
Do not handle the detector with wet hands.
You may experience an electric shock that could result in serious physical
injury or death.
Ne manipulez pas l'appareil avec les mains mouillées.
Vous pourriez subir un choc électrique pouvant entraîner la mort ou des
blessures graves.
Do not place heavy objects such as medical equipments on cables and
cords. Do not pull, bend, bundle, or step on them. These precautions are
required to be followed to prevent cable and cord sheaths from being
peeled. Do not alter the cables and cords. Otherwise, it may damage the
cords which could result in fire or electric shock.
Ne placez pas d'objets lourds tels que des appareils médicaux sur les câbles
d’alimentation, ne tirez pas dessus, ne les pliez pas, ne les regroupez pas et ne
marchez pas dessus pour éviter d'endommager la gaine. Ne les modifiez pas
non plus. Cela risque d’endommager les câbles et provoquer un incendie ou un
choc électrique
Do not supply power to more than one device simultaneously by using the
same AC outlet. Otherwise, it may result in fire or electric shock.
N'alimentez pas plus d'un appareil utilisant la même prise secteur. Cela risque
de provoquer un incendie ou un choc électrique.
Do not turn on the system power when condensation has formed on the
detector. Otherwise, it may result in fire or electric shock.
Ne branchez pas l’alimentation du système lorsque de la condensation s'est
formée sur l'appareil. Cela risque de provoquer un incendie ou un choc
électrique
Do not connect multiple portable socket-outlets or extension cords to the
system. Otherwise, it may result in fire or electric shock.
Ne connectez pas plusieurs prises secteur portables ou rallonges au système.
Cela risque de provoquer un incendie ou un choc électrique.