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 © 2017 DRTECH Co, Ltd. All rights reserved.

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.
 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: drtech@drtech.co.kr
Tel: +82-31-779-7449
Fax: +82-31-779-7790

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Definition of Symbols

Symbols Description

Non-ionized radiation

The Waste Electrical and Electronic Equipment Regulations indicates separate

collection for electrical and electronic equipments.

Protective Earth (Ground)

Direct Current

Alternating Current

Equipotentially.

Power Off.

Power On

Read and understand all instructions and warning labels in the product documentat
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

This mark indicates that the product complies with UL 60601-1 1 and CAN/CSA C22.2
No.601.1,that
that specifies protection against fire, electric shock, and mechanical hazards.

For European Union (EEC Countries)

It indicates that this EVS-4343 is in compliance with the essential requirements and
other relevant provisions of Directive 1999/5/EC and 93/42/EEC. “0120” shows the
notified body number for MDD.

DRT-MAN-066
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 Table of Contents
MANUAL INFORMATION ........................................................................................................................................ 2

1. SAFETY AND REGULATORY INFORMATION ................................................................................................... 5

1.1 MEDICAL EQUIPMENT SAFETY STANDARDS .................................................................................................................................... 11

1.1.1 Medical Equipment Classification .................................................................................................................................. 11
1.1.2 Product Safety Standards .................................................................................................................................................. 11
1.2 DECLARATION OF CONFORMITY ....................................................................................................................................................... 13
1.3 L ABELS AND MARKINGS ON THE EQUIPMENT ............................................................................................................................... 16
1.3.1 Detector ..................................................................................................................................................................................... 16
1.3.2 Other components of the EVS 4343 ............................................................................................................................ 18
1.3.2.1 SSU ................................................................................................................................................................................................................ 18
1.4 ELECTROMAGNETIC EMISSIONS ......................................................................................................................................................... 19
1.5 ELECTROMAGNETIC IMMUNITY.......................................................................................................................................................... 20

2. OPERATING PROCEDURE .................................................................................................................................. 22

2.1 PARTS NAME AND FUNCTIONS ......................................................................................................................................................... 25

2.1.1 Product Components .......................................................................................................................................................... 26
2.1.1.1 Detector Components .......................................................................................................................................................................... 27
2.2 BEFORE USING THE DETECTOR ........................................................................................................................................................... 28
2.3 OPERATING THE DETECTOR ................................................................................................................................................................ 28
2.4 TURNING OFF THE DETECTOR ............................................................................................................................................................ 30
2.5 DETECTOR STATUS LIST ....................................................................................................................................................................... 31
2.5.1 Detector Status List .............................................................................................................................................................. 31
2.6 ADDITIONAL FUNCTION...................................................................................................................................................................... 32
2.6.1 AED Mode ................................................................................................................................................................................ 32
2.6.2 Wired Connections ............................................................................................................................................................... 33

3. MAINTENANCE ................................................................................................................................................... 34

3.1 DAILY INSPECTION AND MAINTENANCE ......................................................................................................................................... 34

3.2 REGULAR INSPECTION AND MAINTENANCE ................................................................................................................................... 34
3.3 IRREGULAR INSPECTION AND MAINTENANCE ................................................................................................................................ 34

4 DETECTOR SPECIFICATIONS .............................................................................................................................. 35

4.1 MAIN SPECIFICATIONS ........................................................................................................................................................................ 35

4.1.1 Detector ..................................................................................................................................................................................... 35
4.1.2 SSU (system synchronization unit) ................................................................................................................................ 38
4.2 CHARACTERISTICS ................................................................................................................................................................................ 39
4.3 APPLICATION SPECIFICATION ............................................................................................................................................................. 40

5. REVISION HISTORY ............................................................................................................................................ 42

DRT-MAN-066 4/44
1. Safety and Regulatory Information

Intended Use

The EVS 4343 Digital X-ray

ray detector is designed as a digital imaging solution, for providing general
radiographic diagnosis of 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 al

along
ong 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 sing personal injury or product damage, be sure tto
o read this manual
carefully before using the product.

Safety Symbols

This indicates a potentially hazardous situation which may cause serious personal injury
or death if misused.
WARNING

This indicates a potentially hazardous situation which may cause minor personal injury if
misused
CAUTION

CAUTION This indicates a potentially hazardous condition which may cause product damage.

This indicates a prohibited operation.

PROHIBITED

This indicates an action that must be performed.

This indicates important operations and restrictions.

Be sure to check this sign to prevent product damage or malfunction.
IMPORTANT

This indicates the information about the basic operations of the detector for its user’s
reference. Users are recommended to rea read this notice.

DRT-MAN-066
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Installation and Environmental Use
 Do not operate or store the detector near flammable chemicals or substances such
as alcohol, thinner, benzene, etc.
WARNING  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.
 Do not connect the detector to any component, other than DRTECH’s specified
components. Doing so may result in fire or electric shock.
PROHIBITED  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.
- Close to fluid or places where fluids is used
- Where
here it may be exposed to direct sunlight
- Close to the air outlet of an air
air-conditioner
conditioner or ventilation equipment
- Close
lose to heat sources such as a heater
- Where
here the power supply is unstable
- In a saline or sulfurous environment
- Where
here temperature or humidity is high
- High condensation or extreme cold environment
- In area prone to vibration
- On an incline or in an unstable area
 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.
 Non-medical
medical equipment such as the battery charger, and access point unit cannot be
used in patient’s vicinity.

<Patient Vicinity>

DRT-MAN-066
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Power Supply
 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.
 Do not handle the detector with wet hands. You may experience an electr electric shock
that could result in serious physical injury or death.
 Do not place heavy objects such as medical equipments on cables and cords. Do not
WARNING
pull, bend, bundle, or step on them. These precautions are required to be followed to
prevent cable and cord ssheaths
heaths from being peeled. Do not alter the cables and
cords. Otherwise, it may damage the cords which could result in fire or electric shock.
 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.
 Do not turn on the system power when condensation has formed on the detector.
PROHIBITED Otherwise, it may result in fire or electric shock.
 Do not connect multiple portable socket
socket-outlets
outlets or extension cords to the system.
Otherwise, it may result in fire or electric shock.

 Securely plug the power cord into the AC outlet.

 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.
 Be sure to turn OFF the power before connecting or disconnecting the cords.
Otherwise, you may get an electric shock that could result in death or serious injury.
 Be sure to hold the plug or connector when disconnecting the cord. If you pull the
cord,, the core wir
wire
e may be damaged, resulting in fire or electric shock.
 To avoid the risk of electric shock, this equipment must only be connected to supply
WARNING
mains with protective earth.
 To make it easy to disconnect the plug at any time, avoid putting any obstacles near
the outlet. Otherwise,
therwise, it may not be possible to disconnect the plug in an emergency.
 Bee sure to ground the equipment to an indoor grounded connector. Also, be sure to
connect
nect all the earth connections for the system to a common ground.
 To avoid the risk of electric shock, this equipment must only be connected to a power
supply that maintains protective earth.
 The product has lower breaking capacity type. So do not intall at the building power
system prospective short
short-circuit current exceeding 35A.

Handling
 The system, partially or in whole, cannot be modified in any ways without any written
approval from DRTECH.
 Never dissemble or modify the equipment. Ignoring this warning may cause fire or
electric shock, which may result in severe personal injury or death by touching the
WARNING
components that cause electric shock.
 Do not place any object on top of the equipment. The object may fall and cause an
injury.
njury. If metal objects such as needles or clips fall into the detector or if liquid spills, it
may result in fire or electric shock.
PROHIBITED  Do not hit or drop the equipment. The product may be damaged if it receives a strong
jolt. Using a damaged detector withou
withoutt repair may result in fire or electric shock

DRT-MAN-066
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  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.
 Do not spill liquid or chemicals onto the equipment. Especially in cases that the
patient is injured, which requires the equipment to come in contact
co with blood or body
fluids, protect the equipment with a disposable cover as necessary.
 Turn OFF the power to each piece of equipment for safety when not being
be used.
 Handle the equipement carefully.
 Do not submerge the equipement in water.
 The internal image sensor may be damaged if something hits against it, or if it is
dropped, or receives a strong jolt.

 Be sure to use the detector on a flat surface to ensure that the detector is not
bended. Otherwise, the internal image sensor may be damaged. Be sure to securely
WARNING hold the detector while using it in upright position. Otherwise, the detector may fal
fall
over, resulting in personal injury, or may flip over, resulting in damage to the inner
components.
 Do not place excessive weight on the detector. Otherwise, the internal image sensor
may be damaged.

DRT-MAN-066
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When a problem occurs
 If any of the following problems occur, immediately turn OFF the power, unplug the
power cord from the AC outlet, and contact your sales representative or local
DRTECH dealer:
WARNING
- When smoke, an odd smell or abnormal sound occurs.
- When liquid has been spilled into the detector or foreign metal object has entered
inside the detector
- When the equipment was dropped and damaged.

DRT-MAN-066
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Maintenance and Inspection

WARNING  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. Othe
Otherwise,
wise, it may result in fire or electric shock.

PROHIBITED

 Clean the plug of the power cord periodically by unplugging it from the AC outlet and
removing dust or dirt from the plug. Clean the peripherals and AC ou outlet with a dry
WARNING cloth. If the cord is kept plugged in for a long time in a dusty, humid or a sooty place,
objects
jects around the plug will attract moisture, and this could cause insulation failure
that may result in a fire.
 For safety reasons, be sure to turn OFF the power when performing the inspections
indicated in this manual. Otherwise, electric shock may occur.

DRT-MAN-066
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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

against electrical shock (Applied Part: Detector panel)

Degree of protection
IPX0
against ingress of water

Mode of operation Continuous Operation

Not suitable for use in the presence of a flammable anesthetic

Flammable anesthetics
mixture with air or with oxygen or nitrous oxide

1.1.2 Product Safety Standards

USA and Canada

ANSI/AAMI ES60601-1:2005/(R)2012 and

Medical Electrical Equipment - Part 1 (IEC 60601-1:2005,
A1:2012,, C1:2009/(R)2012 and
Mod)
A2:2010/(R)2012

Medical electrical equipment - Part 1 (Adopted IEC 60601-

CAN/CSA-C22.2 No. 60601-1:14 - 1:2005, third edition, 2005-12, incl. Am1:2012, with Canadian
deviations), Third Edition

IEC 60601-1(ed.2 am1+ am2+ co1) Medical electrical equipment-Part1: General requirements
for safety

IEC 60601-1:2005(ed.3)+co1+co2 Medical electrical equipment-Part 1: General requirements

for safety

IEC 60601-1-2: 2007(ed.3) Medical electrical equipment-Part 1-2: Collateral standard:

Electromagnetic compatibility

IEC 62304:2006-Ed.1.0
Medical device software-software life cycle processes

ISO 14971:2012 Medical device – Application of risk management to medical

devices

DRT-MAN-066 11/44
European Union
(93/42/EEC as amended by 2007/47/EC) Medical Device
MDD (Medical Device Directive)
Directive

Medical devices – Quality management systems –

EN ISO 13485:2012
Requirements for regulatory purposes

Medical electrical equipment - Part 1: General requirements

EN 60601-1: 2006
for safety

Medical electrical equipment- Part1: General requirements

IEC 60601-1: 2005(ed.3)+CO1+CO2
for safety

Medical electrical equipment -Part 1-2: Collateral standard:

IEC 60601-1-2: 2007(ed.3) Electromagnetic compatibility-Requirements and tests

IEC 62304:2006 Medical device software-Software life cycle processes

Medical device – Application of risk management to medical

ISO 14971: 2012
devices

DRT-MAN-066 12/44
1.2 Declaration of Conformity

U.S.A. FCC Part 15 Subpart B Class A

Canada RSS-210

Australia AS4268

Singapore IDA TS-14

For U.S.A. and Canada

• FCC/IC Compliance
This device complies with Part 15 of the FCC Rules and RSS
RSS-Gen
Gen of IC Rules. Operation is subject to the
following two conditions:

1. This device may not cause harmful interference.

2. This device must accept any interference received, including interference that may cause
undesired operation.

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 correc
correct the interference at
his own expense.

 FCC WARNING
Changes or modifications not expressly approved by the party resp
responsible
onsible for compliance could void the
user’s authority to operate the equipment.
This transmitter must not be co-located
located or operated in conjunction with any other antenna or transmitter.
.
• Disposal
Disposal of this product in an unlawful manner may have nenegative
gative effects on health and on the environment.
When disposing of this product, therefore, be absolutely sure to follow the procedure which is in conformity
with the laws and regulations applicable in your area.

The expected life span of EVS 4343 system is about 3 years.

For European Union (and EEA)

Hereby, DRTECH Inc., declares that this EVS 4343 is in compliance with the
English
essential requirements and other relevant provisions of Directive 1999/5/EC.

DRT-MAN-066
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 DRTECH Inc. tímto prohlašuje, že tento EVS 4343 je ve shodě se základními
Česky
požadavky a dalšími příslušnými ustanoveními směrnice 1999/5/ES.
Undertegnede DRTECH Inc. erklærer herved, at følgende udstyr EVS 4343
Dansk
overholder de væsentlige krav og øvrige relevante krav i direktiv 1999/5/EF.
Hiermit erklärt DRTECH Inc., dass sich das Gerät EVS 4343 in Übereinstimmung
Deutsch mit den grundlegenden Anforderungen und den übrigen einschlägigen
Bestimmungen der Richtlinie 1999/5/EG befindet.
Käesolevaga kinnitab DRTECH Inc. seadme EVS 4343 vastavust direktiivi
Eesti 1999/5/EÜ põhinõuetele ja nimetatud direktiivist tulenevatele teistele
asjakohastele sätetele.
Por medio de la presente DRTECH Inc. declara que el EVS 4343 cumple con los
Español requisitos esenciales y cualesquiera otras disposiciones aplicables o exigibles de
la Directiva 1999/5/CE.
ΜΕ ΤΗΝ ΠΑΡΥΣΑ DRTECH Inc. ΔΗΛΩΝΕΙ ΤΙ EVS 4343 ΣΥΜΜΡΦΩΝΕΤΑΙ ΠΡΣ
Ελληνική ΤΙΣ ΥΣΙΩΔΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΙΠΕΣ ΣΕΤΙΚΕΣ ΔΙΑΤΑΕΙΣ ΤΗΣ ΔΗΓΙΑΣ
1999/5/ΕΚ.
Par la présente DRTECH Inc. déclare que l’appareil EVS 4343 est conforme aux
Français exigences essentielles et aux autres dispositions pertinentes de la directive
1999/5/CE.
Con la presente DRTECH Inc. dichiara che questo EVS 4343 è conforme ai
Italiano requisiti essenziali ed alle altre disposizioni pertinenti stabilite dalla direttiva
1999/5/CE.
Ar šo DRTECH Inc. deklare, ka EVS 4343 atbilst Direktivas 1999/5/EK
Latviski
butiskajam prasibam un citiem ar to saistitajiem noteikumiem.
Šiuo DRTECH Inc. deklaruoja, kad šis EVS 4343 atitinka esminius reikalavimus ir
Lietuviu
kitas 1999/5/EB Direktyvos nuostatas.
Hierbij verklaart DRTECH Inc. dat het toestel EVS 4343 in overeenstemming is
Nederlands met de essentiële eisen en de andere relevante bepalingen van richtlijn
1999/5/EG.
Hawnhekk, DRTECH Inc., jiddikjara li dan EVS 4343 jikkonforma malhtigijiet
Malti
essenzjali u ma provvedimenti ohrajn relevanti li hemm fid-Dirrettiva 1999/5/EC.
Alulírott, DRTECH Inc. nyilatkozom, hogy a EVS 4343 megfelel a vonatkozó
Magyar
alapvetõ követelményeknek és az 1999/5/EC irányelv egyéb elõírásainak.
Niniejszym DRTECH Inc. oswiadcza, ze EVS 4343 jest zgodny z zasadniczymi
Polski
wymogami oraz pozostalymi stosownymi postanowieniami Dyrektywy 1999/5/EC.
DRTECH Inc. declara que este EVS 4343 está conforme com os requisitos
Português
essenciais e outras disposições da Directiva 1999/5/CE.
DRTECH Inc. izjavlja, da je ta EVS 4343 v skladu z bistvenimi zahtevami in
Slovensko
ostalimi relevantnimi dolocili direktive 1999/5/ES.
DRTECH Inc. týmto vyhlasuje, že [typ zariadenia] splna základné požiadavky a
Slovensky
všetky príslušné ustanovenia Smernice 1999/5/ES.
DRTECH Inc. vakuuttaa täten että EVS 4343 tyyppinen laite on direktiivin
Suomi 1999/5/EY oleellisten vaatimusten ja sitä koskevien direktiivin muiden ehtojen
mukainen.
Härmed intygar DRTECH Inc. att denna EVS 4343 står I överensstämmelse med
Svenska de väsentliga egenskapskrav och övriga relevant bestämmelser som framgår av
direktiv 1999/5/EG.
Hér með lýsir DRTECH Inc. yfir því að EVS 4343 er í samræmi við grunnkröfur
Íslenska
og aðrar kröfur, sem gerðar eru í tilskipun 1999/5/EC.

DRT-MAN-066 14/44
 DRTECH Inc. erklærer herved at utstyret EVS 4343 er i samsvar med de
Norsk
grunnleggende krav og øvrige relevante krav i direktiv 1999/5/EF.

The EVS 4343 may be operated in:

AT BE BG CY CZ DK EE FI
FR* DE GR HU IE IT LV LT
LU MT NL PL PT RO SK SI
ES SE GB IS LI NO CH

* In France, outdoor use of this equipment is prohibited.

For Singapore: Complies with IDA Standards N1624-10

DRT-MAN-066 15/44
1.3 Labels and Markings on the Equipment
The EVS 4343 43 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.

1.3.1 Detector

Detector Panel
Active Area
(430 x 430 mm)

Figure1. EVS 4343 Labels and Markings

This mark indicates that this is Type B Applied Part according to UL 60601
60601-1 and
EN 60601-11

This Mark indicates that this equipment must be handled with care

DRT-MAN-066
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 Figure2. EVS 4343 Standard Label

Figure3. EVS 4343 Gadox Label

Caution: Do not jolt or apply excessive load.

DRT-MAN-066
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 MEDICAL
Certification mark that indicates the product complies with UL 60601-1
60601
EQUIPMENTUL60601-1
CAN/CSA C22.2 No.601.1 and CAN/CSA C22.2 No.601.1, that specifies protection against fire, electric
41C4
shock, and mechanical hazards.

.2 Other components of the EVS 4343

1.3.2

1.3.2.1 SSU

Bottom View
Figure4. SSU Label

Caution: Do not jolt or apply excessive load.

DRT-MAN-066
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1.4 Electromagnetic Emissions

Guidelines and Manufacturers : Electromagnetic emission

The EVS 4343 is intended for use in the electromagnetic environment specified below. The user of the EVS
4343 should assure that it is used in such an environment.

Emission Test Compliance Electromagnetic Setting: Guidelines

The EVS 4343 uses RF energy only for its internal

RF emissions
GROUP 1 function. Therefore, its RF emissions are very low and are not likely
CISPR11
to cause any interference in nearby electromagnetic equipment.

RF emissions
Class A
CISPR11

The EVS 4343 System is suitable for use all establishments other
Harmonic
than domestic and those directly connected to the public low-voltage
emissions Class A
power supply network that supplies buildings used for domestic
IEC 61000-3-2
purposes

Voltage
fluctuations/
*1
flicker emissions
IEC 61000-3-3
* 1: Applies to regions where the rated voltage is 220 V or higher. Not applicable to regions where the rated
voltage is less than 220V.

DRT-MAN-066 19/44
1.5 Electromagnetic Immunity

The EVS 4343 System is used in the following electromagnetic settings.

Users of the EVS 4343 System should check whether their systems are used in these settings.

IEC 60601 Test Electromagnetic

Immunity Test Compliance Level
Level Environment – Guidance

Electrostatic Floors should be wood, concrete or

discharge ±(2, 4, 6) kV contact ±(2, 4, 6) kV contact ceramic tile. If floors are covered
(ESD) ±(2, 4, 8) kV air ±(2, 4, 8) kV air with synthetic material, the relative
IEC 61000-4-2 humidity should be at least 30%.

Electrical fast ±2 kV for power ±2 kV for power

Mains power quality should be
transient/ supply lines supply lines
that of a typical commercial or
burst ±1 kV for input/output ±1 kV for input/output
hospital environment.
IEC 61000-4-4 lines lines

±1 kV differential ±1 kV differential Mains power quality should be

Surge
mode mode that of a typical commercial or
IEC 61000-4-5
±2 kV common mode ±2 kV common mode hospital environment

<5% UT <5% UT
(>95% dip in UT) for (>95% dip in UT) for
Mains power quality should be
0.5 cycle. 0.5 cycle.
that of a typical commercial or
Voltage dips, short 40% UT 40% UT
hospital environment. If the user
interruptions and (60% dip in UT) for (60% dip in UT) for
of the EVS 4343 requires
voltage 5 cycles 5 cycles
continued operation during power
variations on power 70% UT 70% UT
mains interruptions, it is
supply input lines (30% dip in UT) for (30% dip in UT) for
recommended that the EVS 4343
IEC 61000-4-11 25 cycles 25 cycles
be powered from an
<5% UT <5% UT
uninterruptible power supply
(>95% dip in UT) for (>95% dip in UT) for
5 sec. 5 sec.
Power frequency Power frequency magnetic fields
(50/60Hz) magnetic should be at levels characteristic of a
3 A/m 3 A/m
field typical location in a typical
IEC 61000-4-8 commercial or hospital environment.

DRT-MAN-066 20/44
 The RF communications equipment
should be used no closer to any
part of the EVS 4343 including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.
Recommended separations distance
d=1.2 √P
d=1.2 √P 80 MHz to 800 MHz
Conducted RF 3 Vrms d=2.3 √P 800 MHz to 2.5 GHz
3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance
Radiated RF 3 V/m in meters (m).
3 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey a,
should be less than the
compliance level in each
frequency range b.
Interference may occur in the
vicinity of equipment marked with
the following symbol:

Note: The UT is the main AC voltage before the test standards have been applied.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflections from structures, object and people.

DRT-MAN-066 21/44
2. Operating Procedure

Notes for using the equipment

When using the equipment, take the following precautions. Otherwise, problems may occur and the equipment
may not function properly.

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.

The owner is responsible for ensuring that the system diagnostic is perfor
performed at least
once a year.. Do not try to use the system if an error is detected.
CAUTION
The owner is responsible 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
CAUTION system calibration is not performed.

Calibration
To ensure optimal performance of the system, it is important to verify that the system is calibrated.

Before exposure
 Make sure to check the equipment daily and confirm that it works properly.
 When moisture-laden
laden air comes into contact with a cold surface, it will cause condensation to form
on the equipment. In this case, wait until the condensation evaporates before performing an
exposure.
 If the equipment is used while the condensat
condensationion formed on it, problems may occur in the quality of
the captured image.
 When an air-conditioner
conditioner is used, be sure to raise/lower the temperature gradually so that
temperature changes will not affect the product and prevent condensation prevent condensati
condensation.

 The owner is responsible for ensuring that the system diagnostic is performed
every year. Do not try to use the system if an error is detected.
 The owner is responsible for ensuring that the system calibration is performed after
CAUTION the system installation is completed or the system is repaired. Do not try to use the
system if system calibration is not performed.

During exposure
Do not use the detector nearby devices generating a strong magnetic field. Doing so may produce image
noise or artifacts.

Electric Shock Hazards

 To reduce the risk of electric shock, the system must be connected to an electrical ground.

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  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.
 Do not disassemble or modify the product as it may result in fire or an electric shock. There are no
operator serviceable parts or adjustments inside the system. Only a trained and qualified person
should be permitted access to the internal parts of the system.
 If an APPLIANCE COUPLER or Mains Plug or other separable plug is used as the isolation means
for safety

Disinfection and cleaning

 Wipe it with a dry cloth slightly damped with a neutral detergent.
 Do not use solvents such as alcohol, thinner or benzene. Doing so may damage the surface of the
equipment.
 The power should be switched off and equipment should be unplugged before cleaning.
 The exterior of the array can be cleaned with common hospital decontamination solutions including 5%
of ButylCellosolve. A 0.55% Benzalkonium 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 solution, and wipe the panel.

Operating/storage environment
 Be sure to use and store the equipment under the conditions described below.

Operation Storage Transit

Temperature 10 to 35℃ -15 to 55℃ -15 to 55℃

30 to 85% RH 10 to 90% RH 10 to 90% RH

Humidity
(Without Condensing) (Without Condensing) (Without Condensing)

Atmospheric pressure 700 to 1060 hPa 500 to 1060 hPa 500 to 1060 hPa

 Do not expose the equipment to high temperatures and/or high humidity. This may cause the product
to mulfunction.
 When not in use, keep the detector, handle unit, and grid in a designated location or in a location
where they are safe and cannot fall down.

Notes on disposal
 Disposal of this product in an unlawful manner may have a negative impact on health and on the
environment. When disposing of this product, therefore, be absolutely sure to follow the procedure
which is in conformity with the laws and regulations applicable in your area.
 The expected life span of EVS 4343 is over 3 years.

Handling the equipment

The equipment must be handled with care to avoid personal injury or damage to the internal image sensor.

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General Workflow
The following workflow indicates the procedures after startup of EConsole1 and other system equipments

▶ Preparing to use the detector

1)
: A procedure in order to register the detector
Make connection the power supply to the detector To a specific digital radiography system
Turn on the SSU
2)
: Network connection between the EVS 4343
▶ Operating the detector
detector and the EConsole1

3)
: Selection of EVS 4343
1. Resister1) the detector and make connection2) to the
EConsole1 power supply to the detector from the Exprimer series detector
Selection of wired data transfer

2. Conduct Examination

Loop back procedure

for each patient
Select or resister the patient information

Select the protocol (selection3) of the detector)

- Arrange the patient in the correct posture

- Position the X-ray generator to adjust the
exposure field
- Check all the conditions

Loop back procedure

Check the captured images for each body part
List the images
Transmit the images

Sterilize the portion of the detector that

has been in contact with a patient
Conduct the next examination
▶ Ending use of the detector

For details, refer to the

Turn off the SSU operation manual or
setup guide of the
EConsole1

Figure5. EVS 4343 General Workflow

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2.1 Parts Name and Functions

The EVS 4343 detector is used in system configuration as illustrated below.

Generator Interface

Detector

SSU

X-ray
System
Generator

Gigabit Ethernet

Cable supplied equipment

Hospital
Network
Viewer

Figure 6. EVS 4343 System Configuration

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 2.1.1 Product Components

Components Functions Note

Flat Panel Detector Imaging device with Gigabit Ethernet signal

EVS 4343 / EVS 4343G interface to the operating PC

 A connecting device which receives power

from an external input main and supplies
System synchronization power to the panel via a POE cable.
unit (SSU)  It transfers images to the operating PC via
EVS SSU Gigabit Ethernet cable.
 When using in Sync. Trigger Mode, it
synchronize the detector and generator.
USB Switch Box (Optional)
USB SW Box Set
A device to synchronize the detector and Hand Switch (Optional)
(Optional)
generator in USB Hand Switch Mode USB Cable (1m) (Optional)
EVS USB01
X-ray Cable (3m) (Optional)

A device to allow the communication between

LAN Card
SSU / detector and PC

① Debugging Cable + Gender

② Extension Tether Cable (7m) (Optional)
③ Power supply cord
Cables
④ LAN Cable (15m)
⑤ Generator Interface Cable (15m) (Optional)
⑥ Generator Extension Cable (0.5m) (Optional)

 Document : User Manual

 Interface software (Econsole1 or Other UI (PDF)
SW)  Calibration Data : MAP,
CD
 Viewer software supports image acquisition, PMP, GMP
Econsole, Ecali
pre-view, calibration, and image correction.  Software :
 It can also support interface communications. Econsole1(Optional),
Ecali1

License Dongle Key Needed to activate Ecnsole1 (Optional),

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 2.1.1.1 Detector Components

The detector is designed to capture radiographic images. Captured images are transmitted to the EVS 4343
image-capture computer using the wireless/wired data transfer.

Figure 7. Detector Components

A. Shock status indicator

B. Sataus indicators
 Link: Shows detector registration and connection status.
 Ready:shows data communication status
 Power: Shows power on/off status of the detector.

Simultaneous blinking of two or more LED lamps indicates a system error.

C. Connecter: Data communication and power supplying through tether cable.

D. Lower Case : Company Identity

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2.2 Before using the detector

Be sure to use only the specified power supply dedicated for the EVS 4343 detector.
CAUTION
Wired Connection
- Connect EVS 4343 43 and PC with a tether interface & Functional cable to make a
wired configuration.

2.3 Operating the detector

1) Turn on the detector

Before operating the detector, start up the EConsole1

- Turn on the SSU.

- The POWER lamp (Blue) lights up while booting the detector.

2) Register the detector and make connection to the EVS control system

- During the detector registration, the READY lamp (Orange) lights up and the LINK lamp (Green) blinks.

- Connection: Network connection between the detector and the EVS control system is secured
automatically. The LINK (Green) and READY (Green) lamp light up when the detector has been resistered
and the communication connection has been established.

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 The LINK lamp does not light up when the detector is not registered or the communication connection
is not established.

When the READY and LINK lamps blink, a communication error has occurred.

3) Conduct examination

For details about operation, refer to the User Manual for the EConsole1.

① Select the patient information or protocols on the screen and start the examination.
- When the detector is ready for exposure, the READY lamp (Green) lights up.

- 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 before exposure.
- Make sure that three LED lamps (POWER, READY, LINK) are lit. This means that the system is ready
to start an examination

A communication error has occurred when two or more lamps flash.

DRT-MAN-066 29/44
② Press the exposure switch of the X
X-ray generator. Images captured with the detector are
transmitted to the EConsole1 and appear on the monitor.

- Check the images on the monitor.

- If any uncompleted protocols remain, repeat the procedure(②).

③ Click the button for ending the examination images are stored automatically
- To conduct examination for another patient, repeat the step
step(③).

Sterilize the portion of the detector that has been in contact with a patient to prevent
infection
IMPORTANT

2.4 Turning off the detector

• Turn off the detector

- Press the POWER button of the detector

detector.
- All the LED lamps should be off.

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2.5 Detector status list
2.5.1 Detector Status List

Power Ready Link AP

Lamp type
Lamp Lamp Lamp Lamp

Color ■ Blue ■ Green ■ Orange ■ Green ■ Green

Power ON O X X X X

During detector registration O X O ☆ X

Detector registration completed (1 Sec) O O X O X

During exposure preparation O X O O X

Ready status or performing an

O O X O X
examination (Ready)

During image data transmission O X O O X

Power OFF X X X X X

О : Light on Х : Lights off ☆ : Blinking (On/Off status changes every second)

DRT-MAN-066 31/44
2.6 Additional function

2.6.1 AED Mode

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 transmits the image data.
AED Mode
2. No signal used (No need of connector interface cable)
• You can use AED mode without connecting the generator with USB SW Box
or SSU physically.

Figure 8. AED Mode Configuration

DRT-MAN-066 32/44
  Make sure to follow operating environment requirements (Temp. : 10 ~ 35℃)
35
 If you use AED Mode out of operating environmental requirements, unwanted image
can be acquired without xx-ray image acquiring process.
 Do not hit or drop the equipment. Unwanted images can be acquired in the AED
Mode if it receives a strong jolt.
 If you image a thick object in the AED Mode with low X
X-ray
ray tube voltage, an image
may not be acquired.
 AED performance is proportional to KV energy. Therefore, it is recommended to
CAUTION
increase KV as much as possible and relatively decr
decrease
ease mA and ms.
 When you set xx-ray
ray exposure area towards the direction of the detector, the center
block of the detector should be included in the X
X-ray
ray exposure area. Otherwise, you
may not acquire an image.
 The minimum X X-ray exposure area should be wider than 4cm X 8cm on the center
block of detector.

2.6.2 Wired Connections

The EVS 4343 detector has a cable connector. Wired configuration is suitable for use where the detector is
set in a Bucky stand and table in place of a film cassette. In this configuration, for the reason that data
communication and power supply are made via a cable, users do not have to be concerned about power. This
reduces the time and labor involved in charging and replacing.

X-ray Generator
System

SSU

Detector

Generator
Tether Interface Cable Interface
Gigabit
Ethernet

Hospital
Network
Viewer

Figure 9. Wiring connection

For details about wired configuration, consult your sales representative or local DRTECH dealer.

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3. 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.

3.1 Daily Inspection and Maintenance

For safety reasons, be sure to turn OFF the power to each piece of equipment before the
following procedures. Otherwise, an electric shock may result.
WARNING

 Cable
- Ensure that cables are not damaged and cable jackets are not torn.
- Ensure that the power cord plugs are securely connected to both the equipment AC inlet
and the AC outlet
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 or short
short-circuits
circuits in the power supply connector.

 After turning on the power

- Be sure to start ECali1 before performing the following inspection.
- Perform exposure testing.

3.2 Regular Inspection

ection and Maintenance
 Monthly Inspection
- Ensure that there are no loose screws or broken parts.
- Ensure that there is no dust or foreign substance on the external connector.

 Yearly Inspection
- Perform a Performance Test or Self
Self-diagnosis
diagnosis Test using a phantom or resolution chart,
etc.

3.3 Irregular Inspection and Maintenance

 Calibration
- Perform Calibration when exposure conditions have changed significantly.
For details, refer to the Setup Guide for ECali1.

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4 Detector Specifications

4.1 Main specifications

4.1.1 Detector
[Dimensional Diagram] (Unit: mm)

Figure 10. Detector Dimension

DRT-MAN-066
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 Detector Specifications
 Panel & Electronic

Item Unit Detail

Model - EVS 4343

Purpose - General Radiography

2D Matrix Array - a-Si TFT array

Directly Deposited CsI (Cesium Iodide)
Scintillator -
Gadox (Gadolinium Oxysulfide)
Energy Range kVp 40 - 150

Typical Dynamic Range μGy 0.2-20

Active Area mm 430 x 430 mm

Pixel Pitch μm 140

Resolution pixel 3,072 (W) × 3,072 (L)

A/D Conversion Bits 14

Input Voltage Volt DC +12V, 2 A MAX.

Power Consumption Watt 10 (Max)

 Performance

Item Unit Detail

EVS 4343 ≥ 45%@ 0.5lp/mm

Typical DQE %
EVS 4343G ≥ 25%@ 0.5lp/mm

EVS 4343 ≥ 35% @ 2lp/mm

Typical MTF %
EVS 4343G ≥ 30% @ 2lp/mm (※ Truview ART applied)

Cycle time Sec ≤ 9 sec. (※ EWT(X-ray window time) at 0.5sec.)

X-ray Window Sec ≤ 60 sec.

Preview Time Sec ≤ 2 sec. (※ EWT at 0.5sec.)

Frame Rate - 1frame (Static mode)

Data Output/Interface - Gigabit Ethernet

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  Mechanical

Item Unit Detail

Overall Dimension [±0.5 mm] mm 460 (W) × 460 (L) × 15 (D)

Weight kg 4.5

Tether Interface:
It allows the detector to communicate with SSU via Ethernet cable when higher speed
data transfer is necessary.

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 4.1.2 SSU (system synchronization unit)

SSU (System Synchronization Unit)

[Dimensional Diagram] (Unit mm)

Figure 11. SSU Dimension

System Synchronization Unit Specifications

Description
Item
SSU
(System synchronization unit)
Model EVS-SSU01

Power Supply Input: 100-240 VAC, 50/60Hz Output: DC +12 V 8.3A, 75W

Dimensions (W x H x D) 260 mm x 248 mm x 49 mm

Weight 2.3 kg

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4.2 Characteristics

 Typical Patient Doses

- Typical patient doses are equivalent to 500-1000 speed film/screen systems.

 Sensitometric Characteristics and Dynamic Range

- EVS 4343 responds linearly against the exposure range of 500-1000 speed film/screen where it
can depict the clinical information. It means that EVS 4343 fully covers a dynamic range of 0.2-20
μGy at least.

 Spatial Resolution Properties

- EVS 4343 Standard: A typical MTF value at 2 lp/mm is over 35%.
- EVS 4343 Gadox Version: A typical MTF value at 2 lp/mm is over 30%.

 DQE
- EVS 4343 Standard: A typical DQE value at 0.5 lp/mm is over 45%.
- EVS 4343 Gadox Version: A typical DQE value at 0.5 lp/mm is over 25%.

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4.3 Application Specification

 Intended Patient Population

Considerations Requirement Description

Age Paediatric to geriatric

Weight >20 kg

Health Not relevant

Nationality Multiple

Sex 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

1) Measuring site : body
2) Condition : Intact or wound skin

 Intended User Profile (Operator Profile)

Considerations Requirement Description

Education Minimum  At least a bachelor's degree in radiology

 Read and understand Western "Arabic numerals" written in Arial font

Knowledge Minimum  Can distinguish human body
 Understands hygiene

Language Minimum  Local language

understanding
Maximum  Understand the manual in English

Experience Minimum  Physician or certified operator

 Mild reading vision impairment or corrected vision to log MAR 0.2

Permissible  Average degree of age-related short term memory impairment
Minimum
impairments  Impaired by 40 % resulting in 60 % of normal hearing at 500 Hz to 2
kHz

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  Intended Conditions of Use

Considerations Condition

 Operating conditions
- Temperature: +10 ºC to +35 ºC
- Atmospheric Pressure: 700 hPa to 1060 hPa
- Humidity: 30 % R.H. to 85 % R.H.
 Storage and delivery conditions
- Temperature: -15 ºC to +55 ºC
- Barometric Pressure: 500 hPa to 1060 hPa
Environment including hygienic requirements - Humidity: 10 % R.H. to 90 % R.H.
 Non-sterile
 Multiple patient use
 Less than ten minute contact
 Indoor use only
 Ambient luminance range: 100 lx to 1500 lx
 Viewing angle: normal to the display ± 20°
 Reusable
Frequency of use
 1 day: 200 shot

Location  In hospital environment

Mobility  Portable ME equipment to be used on a patient

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5. Revision History

Revision Date Descriptions

01 Feb. 11. 2014 Initial Release

02 Oct. 2. 2016 Include G-Type & Change label

03 Jun. 7. 2017 Change agent in Europe

04 Aug. 24. 2018 Change format & Change label

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 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 7449 / Fax : +82 31 779 7490

DRTECH Europe GmbH

Am Kronberger Hang 2, 65824 Schwalbach am Taunus, Germany

DRT-MAN-066 43/44
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