Drtech EVS 4343 / EVS 4343G: Safety and Regulatory Information With User's Manual

DRTECH
EVS 4343 / EVS 4343G

Safety and Regulatory Information
with User’s Manual
EVS 4343 User’s Manual To Customers
Thank you for purchasing the DRTECH Radiography EVS 4343 (hereinafter this Product). This User’s Manual
explains how to use the detector, x-ray interface unit, and other periperal 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

1. Only a physician or legally certified operator should use this product.
2. The equipment should be maintained in a safe and operable condition by maintenace personal.
3. Use only computers ans image display monitors complying with IEC 60601-1 or IEC 60950-1 and under
asystem configuration complying with IEC 60601-1-1. For details, consult your sales representative or local
DRTECH dealer.
4. Use only the dedicated cables. Do not use any cables other than those supplied with this product.
Disclaimer
1. 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.
2. Roentgenography, image processing, image reading, and image data storage must be performe in
accordance with the laws of the country or region in which the product is being used. The user is resposible
for manufacturing the privacy of image data.
3. In no event shall DRTECH be liable for personal physical harm or property damage that is sustained when
the instructions are not followed or the product is misused.
4. It is the resposibility of the attending physicians to provide medical care services. DRTECH will not be liable
for faulty diagnoses.
5. In no event shall DRTECH be liable for direct or indirect cosequential damages arising from the use or
unavailbility of this product. DRTECH shall not be liable for loss of image data for any reason.
6. 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.
7. Specifications, composition, and appearance of this product may change without prior notice.
DRT-MAN-066 2
EVS 4343 User’s Manual Conventions
To Customers…………………………………………………………….……………………………… 2
Contents……………………………………………………………………………………………..…… 3
Conventions………………………………………………………………….……………………..…… 5
1. Safety nformation……………….…………………………………………….…….6
1-1. Safety precautions……………………………………………………………………………..6
1-2. Notes for using the equipment……………………………………………………..……..….10
2. Introduction…………………………………………………………………...……..12
2-1. Features……………………………………………………………….……………………….12
2-2. Intended use…………………………………………………………. ………..…………..….12
2-3. System configuration………………………………………………………………..………..13
3. Product description………………………………………………………………..14
3-1. Product components………………………………………….…………..….…….…..……..15
3-2. X-ray imaging condition…….………………….……………………………..…..…………16
4. Parts name and functions………………………………………………………..17

4-1. Dete ct or spe cification …………………. ………………………………………. ….. 17
4-2. De t e c t o r co mp o n e n t …… …… …… …. … ……… …… …… ……… …… …… . …. . 1 8
4-3. D e t e c t o r d i me n si o n …… … … … … … . …… … … … … … … … … … …… … … . … . . 1 9
4-4. SSU (System syncronization unit)……………………………………..………….………20
5. Operating pocedure…….………………………………………………………..22
5-1. Preparing to use the detector……………………….…………………………………….…..23
5-2. Operating the detector…….………………………………………………..………….………23
5-3. Ending use of the detector…………………………………………………………………….27
5-4. Detector status list………………………………………………………………………………27
DRT-MAN-066 5
EVS1717 User’s Manual Contents
6. Extension facility….…….………………………………………………………..28
6-1. Sharing the detector among different systems………………..………….………28
6-2. AED mode……………………………………….………………………………………………29
6-3. Wiring connections……………………………………….………………………………….30
7. How to Install………………………..…….….…….………………………………32
8. Troubleshooting….……….….…….………………………………………………89
9. Maintenace ………….….…….……………………………………………………..90
10. Specification…………………………………………………………………………91
10-1.Main specifications……………………………………………………………………………91
EVS 4343 Detector…………………………………………………………………………….91
SSU(system syncronization unit)…………………………………………………………….92
10-2. Chrateristicss………………………………………………………………………………….93
11. Regulatory information………….….….…………………………………………94

11-1. Medical equipment safety standards……………………………………………………….94
■ Medical equipment classification………………………………………………………….94
■ Product safety standards…………………………………………………………………..94

11-2. Radio frequency (RF) compliance information………………………………………………95
Declaration comforty………………………………………………………………………….95
11-3. Labels and markings on the equipment………………………………………………………99
■ Detector………………………………………………………………………………………99
■ O t he r c o mp o n en t s o f t he EVS 43 4 3……………………………………. . 101

11-4. Guidance and manufacturer’s declaration for EMC………………………………………103
Electromagnetic emissions……………………………………………………………………103
Electromagnetic immunity…………………………………………………………………103
Electromagnetic separation distances………………………………………………………103
12. Warranty ………….….…….………………………………………………………..106
DRT-MAN-066 7
EVS1717 User’s Manual Contents
Safety notices
The following safety notices are used to emphasize certain safety instructions. Follow the safety instructions in
this user’s Manual along with warning and cautions sysbols. Ignoring such warnings or cautions while handling
the product may results in serious injury or accient. It is important for you to read and understand the contents of
this users manual before attemting to use the product.
This notice used to idendifiy conditions under which improper use

WARNING of the product may cause death or serious personal injury.
This notice used to idendifi\y conditions under which improper

CAUTION use of the product may cause minor personal injury.
This notice used to idendifiy conditions under which improper use

CAUTION of the product may cause property damage.
This is used to indicate a prohibited operation.
Prohibited
This is used to indicate an action that must be performed.
This is used to indicate important operations and restrictions.

IMPORTANT Be sure to read this notice to prevent property damage or malfunction.
This is used to indicate operations for reference and complementary

information.
User are recommended to read this notice
DRT-MAN-066 7
EVS 4343 User’s Manual 1. Safety information
1-1. Safety precautions
Follow these safeguards and properly use the equipment to prevent injury and damage to any equipment/data.
WARNING
Installation and environment of use
- Do not use or stroe the equipment near flammable chemical such as alcohol, thinner,
benzine, etc.
If chemicals are spilled or evaporate, it may result in fire or electric shock through contact
Prohibited with electric parts inside the equipment. Also, somedisinfectants are flammable. Be sure to
take care when using them.
- Do not connect the equipment with anything other than specified.
Doing so may result in fire or electric shock.
Power supply
- Do not use operate the equipment using any type of power supply other than the one
indicated on the rating label.
Otherwise, it may result in fire or electric shock.
Prohibited - Do not handle the equipment with wet hands.
You may experience an electric shock that could result in death or serious injury.
- Do not place heavy object such as medical equipment on cables and cords, or do not
pull, bend, bundle, or step on them to prevent their sheath from being damaged, and
do not alter them neither.
Doing so may damage the cords which could result in fire or electric shock.
- Do not supply power to more than one of equipment using the same AC outlet.
- Do not turn on the system power when condensation has formed on the equipment.
- Do not connect a multiple portable socket-outlet or extension cord to the system.

- 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 to each of equipment before connecting or

disconnecting the cords.
Otherwise, you may get an electric sock that could result in death or serious injury.
- Be sure to hold the plug or connector to disconnect the cord.

If you pull the cord, the core wire may be damaged, resulting in fire or electric shock.
DRT-MAN-066 6
WARNING
Handling
The system, in whole or in part, cannot be modified in any way without written approval from DRTECH.
- No modification of this equipment is allowed

- Never disassemble or modify the equipment.
Doing so may result in fire or electric shock. Also, since the equipment incorporates parts
that may cause electric shcok as well as other hazardous parts, touching them may cause
Prohibited death or serious injury.
- Do not place anything on top of the equipment.

The object may fall and cause an injury. Also if metal objects such as needles or clips fall
into he equipment, or if liquid isspilled, if may result in fire or electric shock.
- Do not hit or drop the equipment.

The may be damaged if it recieves a strong jolt, which may result in fire or electric shock if
the equipment is used without geing repaired.
- Have the patient take a sixed posture and do not let patient touch parts unnecessarily.
If the patient touched connectors or switches, it may result in electric shock or malfunction of
the equipment.
When a problem occurs

- Should any of the following occur, immediately turn OFF the power to each piece of
equipment, unplug the power cord from the AC outlet, and contact your sales
representative or local DRTECH dealer:
When there is smoke, an odd smell or abnormal sound
When liquid has been spilled into equipment or metal object has entered through an
opening.
When the equipment has been droppen and is damaged.
Maintenance and inspection
- When the equipment is going to be cleaned, be sure to turn OFF the power of each
equipment, and unpulg the power cord from the AC outlet. Never use alcohol,
benzine, thinner or any other flammable cleaning agent.
Prohibited Othewise, it may result in fire or electric shock
- Clean the plug of the power cord periodically by unplugging it from the AC outlet and
removing dust or dirt from the plug, its periphery and AC oulet with a dry cloth.
If the cord is kept plugged in for a long time in a dusty, humid or sootyplace, dust around the
plug will attract moisture, and this could cause insulation failure that could result in a fire.
- For safety reasons, be sure to turn OFF the power to each piece of equipment when
the insections indicated in this manual are going to be performed..
Otherwise, electric shocks may occur.
DRT-MAN-066 7
WARNING
Installation and environment of use
- Do not install the equipment in any of the locations listed below. Doing so may result
in failure or malfuction, equipment faillng, or fire or injury.
ㆍ Close to facilities where water is used
ㆍ where it may be exposed to direct sunlight
ㆍ Close to the air outlet of an air-conditioner or ventilation equipment
ㆍ Close to a eat source such as a heater
ㆍ where the power supply is unstable
ㆍ In a saline or sulfurous environment
ㆍ where temperature or humidity is high
ㆍ where there is freezing or condensation
ㆍ In area prone to vibration
ㆍ 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 equipment such as the battery charger, and access point unit cannot be
used in patient’s vicinity.
Patient Vicinity
Power supply
- Always connectthe three-core power cord plug to a grounded AC power outlet.
- To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth”.
- To make it easy to disconnect the plug at any time, avoid putting any obstacles near
the outlet. Otherwise, it may not be possible to disconnect the plug in an emergency.
- Be sure to ground the equipment to an indoor grounded connector. Also, be sure to
connect all the grounded for the system to a common ground.
- Do not use any power source other than the one provided with this equipment.
Otherwise, fire or electric shock may be caused due to leakage
Handling
- Do not spill liquid or chemicals onto the equipment or, in cases where the patient is
injured, allow it to come in contact with blood or body fluids.
In such a situation, protect the equipment with a disposable covering as necessary.
- Turn OFF the power to each piece of equipment for safety when not belong used.
DRT-MAN-066 8
CAUTION
Handling the equipment
The Equipment must be handled with care to avoid personal injury or damage to the internal image sensor.
- Handle the equipment carefully.

- Do not submerge the equipment in water
- The internal image sensor may be damaged if something hits against it, or if it is
dropped, or recieves a strong jolt.
- Do not place excessive weight on the detector.

Otherwise, the internal image sensor may be damaged.
<Load Limit>
Uniform load: 150 kg over the whole area Local load: 100 kg on an area 40 mm
of the detector in dimeter
- Be sure to use the detector on a flat surface do it will not bend. Otherwise, the
internal image sensor may be damaged. Be sure to securely hold the detector while
using it in upright positions. Otherwise, the detector may fall over, resulting in injury
to the user or patient, or may flip over, resulting in damage to the inner device.
DRT-MAN-066 9
1-2. Notes for using the equipment

When using the equipment, take the following precautions. Otherwise, problems may occur and the equipment
may not function correctly
System Diagnostic
The Ecali1 software runs a system diagnostic.

Run Ecali1 software after installing the system and 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

CAUTION performed every year.
Do not try to use the system if the system diagnostic is failed.
Calibration
To ensure optimal performance of the system, it is important to verify that the system is calibrated.
The owner is responsible for ensuring that the system calibration is

CAUTION performed after the system installation is completed or the system is
repaired. Do not try to use the system if system calibration is not performed.
Before exposure
- Be sure to check the equipment daily and confirm that it works properly.
- Sudden heating the room in clod area will cause condensation to form on the equipment. In this case, wait
until the condensation evaproates before performing an exposure. If the equipment is used while the
condensation formed on it, problems may occur in the quality of captureed image. When an air-conditioner
is used, be sure to raise/lower the temperature gradually so that a difference in temperature in the room and
in the equipment does not occur, to prevent condensation.
During exposure
Do not use the detector near devices generating a strong magnetic field. Doing so may produce image noise or
artifacts.
DRT-MAN-066 10
Electric Shock Hazards
- To reduce the electric shock hazard, the system must be connected to an electrical ground.
- A three onductor 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 electric shock. There are no operator
serviceable parts or adjustments inside the systems. Only trained and qualified personnel 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 to safety
Disinfection and cleaning
- Wipe it with a dry cloth slightly damed with a neutral detergent.
- Do not use solvents such as alcohol, thinner or benzene. Doing so may damge the surface of the equipment
- Do not clean the system with turning the power on.
Operating/storage environment
- Be sure to use and store this equipment under the conditions described below:.
Temperature Humidity Atmospheric pressure
Operating environment 5 to 35℃ 30 to 80% RH

Transport & Storage 700 to 1060 hPa
5 to 40℃ 30 to 85% RH
environment
- Do not expose this equipment to high temperatures and/or high humidity. Malfunction is occur.
- 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 about 3 years
Handling the equipment
-The equipment must be handle with care to avoid personel injury or damage to the internal image sensor.
DRT-MAN-066 11
EVS 4343 User’s Manual 2. Introduction
The EVS 4343 is designed to provide the highest resolution and sensitivity in the DRTECH Exprimer series.
2-1. Features
- The shape of the detector, which is identical to that of a conventional film cassette complying with ISO4090,
enables digital radiography in the existing analog radiography configuration
- The new sensor with 140 μm of pixel pitch and CsI (Cesium Iodide) ), Gadox (Gadolinium Oxysulfide) used
for the scintillator produces high resolution (approx. 9.43 Mega pixels) digital images within the effective
imaging area (430 x 430 mm) with low doses of X-rays
- Depending on the operating conditions at each site, the wiring unit (optional) enables the equipment to be
used through expansion to a wired connection
2-2. Application specification

Intended medical indication
The EVS 4343 Digital X-ray detector is designed for 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.
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
Not relevant, unless patient is agitated
user
DRT-MAN-066 12
Intended part of the body or type of tissue applied to or interacted with

1) Measurement site : body
2) Condition : Intact or wund skin
Intended user profile(Operator Profile)
Considerations Requirement description

Minimum - At least graduate of radiology college
Education
Maximum - No maximum
- Read and understand 'westernized Arabic' numerals when
written in Arial font
Minimum
Knowledge - Can distinguish of human body
- Understands hygiene
Minimum - Local language

Language understanding
Maximum - Understanding of manual that is writing in English
Minimum - Physician or legally certified operator

Experience
- Mild reading vision impairment or vision corrected to log MAR
0.2
- Average degree of aging-related short term memory
Permissible impairments Minimum
impairment
- Impaired by 40 % resulting in 60 % of normal hearing at 500
Hz to 2 kHz
10-EVS1MADB001 11
Intended conditions of use
Considerations Condition
l Operating conditions
- Temperature: +5 ºC to +35 ºC
- Barometric Pressure: 700 hPa to 1060 hPa
- Humidity: 30 % R.H. to 85 % R.H.
l Storage and delivery conditions
- Temperature: 5 ºC to +40 ºC
- Barometric Pressure: 700 hPa to 1060 hPa
Environment including hygienic requirements
- Humidity: 30 % R.H. to 85 % R.H.
l Non-sterile
l Multiple patient use
l Less than ten minute contact
l Indoor use only
l Ambient luminance range: 100 lx to 1500 lx
l Viewing angle: normal to the display ± 20°
l Reusable
Frequency of use
l 1 day: 200 shot
Location l In hospital environment
l Portable ME equipment to be used on a
Mobility
patient
10-EVS1MADB001 11
EVS 4343 User’s Manual 2. Introduction
2-3. System Configuration

Generally, the EVS 4343 detector is used in system configuration as illustrated below:
Figure 2.1 EVS 4343 configuration
DRT-MAN-066 13
EVS 4343 User’s Manual 3. Product description
EVS 4343 system consists of detector, system synchronization unit (SSU), CDs and relevant accessories. (Refer
to chapter 3-1 “Product Components” for CD information)
System Syncronize Unit
X-ray Detector (EVS 4343) Tether Interface (3 m)
(EVS-SSU01)
AC Power Cable (2m) USB Switch Box Hand Switch
LAN Cable Interface Cable (12 m) Generator Interface Cable

(Gigabit LAN 15 m) (Optional) (15m)
CD(Software / Calibration) Manual (Hard Copy)
Table 3.1 EVS 4343 packaging
DRT-MAN-066 14
3-1. Product component
Item Product name
EVS 4343(Scintillator: CsI : Tl) 4.5 kg
Flat panel detector

EVS 4343G(Scintillator: Gadox) 4.5 kg
System syncronization unit (SSU) EVS-SSU01 : 2.3 kg
Document: User ‘s Manual (PDF)

CD (Software / Calibration) Calibration Data: Defect Map, Gain, Post Offset, Pre Offset
Calibration & Configuration S/W: ECali1
User’s Manual Hard Copy
AC Power Cable (2m)

Generator Interface Cable (15m)
LAN Cable (15m, Direct, 1000BASE-T)
Accessories
Tether Interface Cable (3m)
Extension Tether Cable (12m, Optional)
License Dongle Key (USB)
Table 3.2 Product componets
WARNING
The use of accessories and cables other than those specified, with the exception of EVS 4343 accessories and
cables sold by DRTECH Co., LTD. as replacement parts for internal components, may result in increased
emissions or decreased immunity of the equipment. Accessory equipment connected to the analog and digital
interfaces must be certified according to the respective IEC standards. All combinations of equipment must be in
compliance with IEC 60601-1-1 system requirements. Any person who connects additional equipment to the
signal input or signal output ports configures a medical system, and is therefore responsible for ensuring that the
system complies with the requirements of the system standard IEC 60601-1. If in doubt, consult DRTECH
technical support representative.
DRT-MAN-066 15
Workstation (Recommended and minimum but NOT included)
Item Specification
Operating system Windows 7 64 bit SP1 (Professional Edition or higher)
CPU Intel Core i5 2600 or higher (or compatible CPU)
Memory 4GB or higher
Hard disk 1TB or higher

Gigabit (Detector only)
Intel® PRO 1000 Series (Gigabit LAN Card for network interface)
Min. Requirements: 1Gbps,
LAN card
Jumbo Frames: 9K
Receive Descriptors: 2K (higher than 1024)
This is not dedicated to DICOM
Monitor 1024 x 768 or higher
Optional disc drive CD or DVD R/W

Table 3.3 Workstation
Grid (Recommended but Not included)
Item Description
SID 100 / 130 / 150 / 180 cm
Ratio 8:1
Frequency 215 Line/inch

Inter spacer Al
Table 3.4 Grid spec.
3-2. X-ray Imaging condition
X-ray Energy Range
40kVp ~ 150kVp
Reliability (Lifetime Dose)

More than 74Gy (35uGy x 365days x 24hours x 60minutes x 60seconds/15sec)
DRT-MAN-066 16
EVS 4343 User’s Manual 4. Part name and function
4-1. Detector specification
Item Description
Model EVS 4343

Purpose General Radiography
Pixel Pitch 140 um
Scintillator CsI (Cesium Iodide) / Gadox (Gadolinium Oxysulfide)
Image Matrix Size 3072 × 3072 pixels
Effective Imaging Area (H x V) 430 x 430 mm
Image Acquisition and Transfer Time < 3 sec.
Spatial Resolution Min. 3.5 line pair/㎜
Power Supply DC +12V 2 A

Power Consumption 12 W
Network Interface 16 bit Digital Output Ethernet (1000BASE-T)
Dimensions (㎜) 460 (H) × 460 (V) × 15 (D)
Weight 4.5 kg
Environmental Requirements
Temperature: +10 ~ +35℃
Operation Humidity: 30 ∼ 85% RH(Without Condensing)
Atmospheric pressure: 700 ∼ 1060 hPa
Temperature: -15 ~ +55℃
Storage and Transportation(unpacked) Humidity: 10 ∼ 90% (Without Condensing)
†Tether Interface: Allows the detector to communicate with SSU via Ethernet cabling higher speed data transfer
is necessary
DRT-MAN-066 17
4-2. Detector component
The detector is designed to capture radiographic images.

Captured images are transmitted to the EVS 4343 image-capture computer using the wired data transfer
Figure 4.1 Detector component
A. Rear case decoration

B. Shock status indicator
C. Sataus indicators
AP: Optional.
Link: Shows detector registraion and connection status.
Ready:shows data comunication status
Power: Shows power on/off status of the detector.
Simultaneous blinking of two or more LED lamps indicates a system error.

D. AP Button: registration detector.
E. Connecter: Data communication and power supplying thought tether cable.
F. Back cover: Inspection window
.
DRT-MAN-066 18
4-3. Detector dimension
Figure 4.2 Detector dimension
DRT-MAN-066 19
EVS4343 User’s Manual 4. Part name and function
4-4. Power supply and SSU (System syncronization unit)
4-4-1 SSU Specifications
Description
Item SSU
(System synchronization unit)
Model EVS-SSU01
Power Supply Input: AC100 to 240V, 50/60㎐ Output: DC +12V 8.3A, 75W
Dimensions (W x H x D) 260 mm x 248 mm x 49 mm
Weight 2.3 kg
Environmental Requirements
Temperature: +10 ~ +35℃
Humidity: 30 ∼ 85% RH(Without Condensing)

Operation
Altitude: Max. 2 km
Temperature: -15 ~ +55℃
Storage and Humidity: 10 ∼ 90% (Without Condensing)

Transportation(unpacked)
Altitude: Max. 2 km
DRT-MAN-066 21
EVS 4343 User’s Manual 5. Operating procedure
The EVS 4343 Detector is properly adjusted at installation by the service engineer. If you encounter any
problems during normal operation or daily inspections, consult your sales representative or local DRTECH
dealer.
General workflow
The following workflow indicates the procedures after startup of the EConsole1 and other system
equipment
DRT-MAN-066 22
EVS4343 User’s Manual 5. Operating procedure
5-1. Preparing to use the detector
CAUTION Be sure to use only the dedicated power supply for the EVS-4343 detector
Standard Configuration
Configuring with SSU (power supply) to the detector
Make sure that the cable is placed to the connector (detector side)
Generator Interface
Detector
SSU
X-ray
System
Generator
Gigabit Ethernet
Cable supplied equipment
Hospital
Network
Viewer
Figure 5.1 EVS 4343 Configuration

5-2. Operating detector
1 Turn on the detector

Before operating the detector, start up the EConsole1
Turn on SSU
Power lamp(Blue) light up

Ready lamp(orange color) flashes
while booting the detector
and light down
DRT-MAN-066 23
2 Register the detector and make connection to the EVS control system
Registration
Press and realease the AP button
Link lamp flashes.
When the AP Lamp flashes 1 time in 2sec, wired mode status has showing.
Connection
Network connection between the detector and the

EVS control system is secured automatically
The link lamp lights up when the detector
is resistered and the communication
connection is established
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 Lamp flash, a communication error has occurred.
See Troubleshooting.
3 Conduct examination
For details about operation, refer to the Operation Manual for the ECali1.
i) Select the patient information or protocols on the
screen and start the examination.
DRT-MAN-066 24
EVS 4343 User’s Manual 5. Operating procedure
The READY lamp flashes during preparation

for examinations.
The READY lamp lights up when the

detector and EConsole1 change to
exposure ready status.
• Arrange the patient in the correct posture and position the detector aligning it with the target body part.
• Position the X-ray generator to adjust the exposure field.
• Check all conditions before exposure.
Make sure that four LED lamps (POWER, READY, LINK, AP) are lit. This means that the system is
ready to start an examination
A communication error has occurred when two or more lamps flash.
When the READY lamp (green color) flashes slowly, the detector is in detector selection status
(Sleep).
The detector enters detector selection status automatically when it has not been used for a certain
period of time.
ii) Press the exposure switch of the 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 ii).
ii) Click the button for ending the examination

images are stored automatically
• To conduct examination for another patient, repeat the step 3.
Sterilize the portion of the detector that has been in contact

IMPORTANT with a patient to prevent infection
DRT-MAN-066 25
5-3. Ending use of the detector
Turn off the detector

Press the SSU POWER button.
All the LED lamps are off.
Detector status list
Power Ready Link AP

Lamp type
Lamp Lamp Lamp Lamp
Color ■ Blue ■ Green ■ Orange ■ Green ■ Green
Power ON ○ х х х х
During detector registration ○ х ☆ ☆ ☆

Detector registration completed (1 Sec,) ○ ○ ☆ ○ ☆
Communication established ○ х ○ ☆
During exposure preparation ○ х ☆ ○ ☆

Ready status or performing an - ☆
○ ○ ○
examination (Ready)
Detector selection status (Sleep) ○ ★ - ○ -
During image data transmission ○ ○ / ★ - ★ -
Power OFF х х - х -
○ : Light on ☆ : Flashes (On/Off status changes every second)
х : Lights off ★ : Flashes slowly (On/Off status changes every 2 seconds)

- : Unspecified status
DRT-MAN-066 27
EVS 4343 User’s Manual 6. Extension facility
6-1. Sharing the detector among different systems

The EVS 4343 detector can be used in two or more systems in which protocols for the detector have
already been preset. For details, consult your sales representative or local DRTECH dealer
EVS 4343 Detector
X-ray X-ray
generator generator
SSU SSU
Hospital Network
Figure 6.1 Sharing the detector among different systems
DRT-MAN-066 29
EVS 4343 User’s Manual 6. Extension facility
6-3. AED mode

• AED mode can make exposure as using internal storage in the detector.
• The images can be transmitted to a PC and used by connecting the detector to Viewer. The transmitting
images in the detector are removed automatically.
• Image processing and correction are available after connecting the detector to Viewer
• As SSU is not connected to the system, DR Trigger in X-ray Interface cannot be used.
Figure 6.2 AED mode
DRT-MAN-066 30
EVS 4343 User’s 6. Extension facility
6-4. Wiring 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.
Figure 6.3 Wiring connection
For details about wired configuration, consult your sales representative or local DRTECH dealer.
DRT-MAN-066 31
EVS 4343 User’s Manual 7. How to Install
7-1. Hardware Installation

This section describes how to connect the EVS 4343 (Detector)
Installation of this equipment should be made by licensed and authorized

personnel.
CAUTION The products have Lower breaking capacity type. So do not install at the
building power system prospective short-circuit current exceeding 16 A or
35 A
7-1-1 EVS 4343
wiring
connection
1 Connect the one end of the generator interface cable to the X-ray port of SSU, and the other to the port of
the x-ray generator.
DRT-MAN-066 32
EVS 4343 User’s 7. How to Install
2 Connect the LAN cable to PC port of SSU, and the other to the LAN Card connector of workstation
assigned for the data transfer
3 To transmit image data and connect power with Tether Interface, connect the Tether interface cable to FPD
1 or FPD 2 of SSU
Tether
DRT-MAN-066 33
4 Connect the power cable to the AC pport of the SSU to supply power
This equipment must only be connected to a main power with protective
CAUTION earth
5 Turn on the power switch in the front of the SSU
DRT-MAN-066 34
7-2. ECali1 Installation

7-2-1 System Requirements
Table 7.1. System requirement
Items Minimum Recommended
CPU Intel i3-2100 Intel i5-3470
RAM 2 GB 4 GB
HDD 100 GB 500 GB
NVIDIA GeForce
VGA Intel HD GRAPHIC 2000
GT630 1GB
ODD CD-ROM DVD Recorder
Windows 7 Pro
OS Windows XP Pro SP2
32 / 64bit
Display Size 17 inch 23 inch
Display Resolution 1024 x 768 1920 x 1080
√ Efficient operation is not guaranteed for PCs that do not comply with the recommended specification.
7-2-2 Installation & Removal

Installation prerequisites
ü Windows 7
Windows 7 users must set the User Account Control (herein after ‘UAC’) permission and disable the
firewall.
1) UAC Setting
① Click the start icon
② Click ‘Control Panel’
③ Select ‘User Accounts’
④ In the User Accounts window, click ‘User Accounts’
⑤ In the User Accounts task window, click ‘Change User Account Control Setting’
⑥ Adjust the slider to the ‘Never notify,’ and then click ‘OK’.
DRT-MAN-066 35
2) Disabling the Firewall
① Click the Start icon
③ Click ‘Security’
④ Click ‘Windows Firewall’
⑤ Click ‘Turns Windows Firewall on or off’ on the left
⑥ Click ‘Off (not recommended),‘ and then click ‘OK’
ü Windows 8
Windows 8 users must set the User Account Control (herein after ‘UAC’) permission,
Disable the firewall and run the program as the system administrator.
3) UAC Setting
① Click ‘Setting’ on the right hand menu
③ Select ‘User Accounts’
④ In the User Accounts window, click ‘User Accounts’
⑤ In the User Accounts task window, click ‘Change User Account Control Setting’
⑥ Adjust the slider to the ‘Never notify,’ and then click ‘OK’
4) Disabling the Firewall
① Click ‘Setting’ on the right hand menu
③ Click ‘Security’
④ Click ‘Windows Firewall’
⑤ Click ‘Turns Windows Firewall on or off’ on the left
⑥ Click ‘Off (not recommended),‘ and then click ‘OK’
5) Run as Administrator
Windows 8 users must run the Installation File and Program as the Administrator
Install the program by right clicking (press and hold, if touch screen) and
selecting ‘Run as Administrator’
After completing the installation, set the icon, so that it always runs as administrator
DRT-MAN-066 36
① Right click (press and hold, if touch screen) the shortcut icon
② Click ‘Properties’
③ Click the ‘Advanced’ icon in the ‘Shortcut’ tab‘
④ Check the ‘Run as administrator’ box, click on ‘OK’
7-1-3. Installation
Run the provided setup file.
Figure7.1. ECali1 Setup File
√ At least 2GB of available HDD space is required for the proper installation of ECali1!
√ Windows 8 users must run the file as ‘administrator’.
→Right-click the file, select ‘Run as administrator’ in the menu.
Figure 7.2. Setup Wizard Window
DRT-MAN-066 37
Figure7.3. ① Language & ② Number of Detector Setting
Figure7.4. Setting of the Model of the First Detector
DRT-MAN-066 38
Figure7.5. Installation Path Setting
Figure 7.6. Start Menu Folder Selection
DRT-MAN-066 39
Figure7.7. Additional Task Setting
Figure 7.8. Verification of Settings
DRT-MAN-066 40
Figure 7.9. Installation Window
Figure7.10. Installation Window
DRT-MAN-066 41
Figure 7.11. Installation Window
Figure7.12. Installation Window
DRT-MAN-066 42
7-1-4 Settings Post Installation
1) Windows 8 users must set ECali1 so that it runs as administrator.
①Right click (press and hold) the ‘ECali1.exe’ in the installation destination (in C:\Cali1 by default).
②‘Click ‘Properties’.
③Select ‘Advanced’ in the ‘Shortcut’ tab.
④Check the ‘Run as administrator’ box, then click ‘OK’
7-1-5 IP Address Configuration

It is required when using a EVS 4343 detector using an Ethernet Interface.
The IP Address of the Network Adapter connected with the EVS 4343 Detector System installed on the
PC should be configured.
For Windows 7, Control Panel – Network Connections – Network and Sharing Center – Manage Network
Connections on the left menu bar – Right click on the network connected to the Detector – Properties –
Double click Internet Protocol Version 4 (TCP/IPv4)
Figure7.13. IP Address Configuration

ü ② IP Address: 192.168.250.XXX
For F600: 192.168.250.100

Others: 1 ≤ XXX ≤ 254 (Excluding 150 and 200)
ü ③ Subnet mask: 255.255.255.0
DRT-MAN-066 43
EVS 4343 User’s Manual 7. Calibration & Configuration S/W
7-1-6 Uninstall ECali1

1) Click ‘Uninstall ECali1’ in Windows start menu – All Programs - ECali1
Figure 7.14. Uninstall ECali1
2) Click ‘Yes’ and proceed with uninstall when a window appears verifying the removal of the
program.
Figure7.15. Uninstall ECali1
DRT-MAN-066 44
7-2 ECali1 Operation & Detector Integration

7-2-1 Program Start-up
In order to run the program, you can select ECali1 in Windows Menu – All Programs – ECali1
Folder, or by double clicking ECali1.exe in C:\ECali1 (or the customized installation path)
Figure7.16. ECali1 Start-up

Note
→An error notification as in Figure 7.17. Pixel / Gain map File Notification) will be presented during the
initial start-up of the program.
→It is a normal notification informing the absence of Pixel map file and Gain map file, so proceed by
clicking ‘OK’.
Figure 7.17. Pixel / Gain map File Notification
Note
Please install the additional software in accordance with the specification of your OS if the program does
not operate after proper installation
For Windows XP SP3, Windows 7, and Windows 8:

ü VC2008SP1 Runtime (vcredist_x86.exe)
http://www.microsoft.com/en-us/download/details.aspx?id=5582
For Windows XP SP2:

ü Wireless LAN API package
ü Microsoft Core XML Service (MSXML) 6.0
ü VC2008SP1 Runtime (vcredist_x86.exe)
DRT-MAN-066 45

For Windows XP SP1 or earlier OS:

ü ECali1 will only operate in Windows XP SP2 and later environments. Please install Service
Pack 2 or 3 if you are using Windows XP.
ü We do not guarantee proper operation of ECali1 in OS earlier than Windows XP
7-2-2 Detector Connection

1) The Detector which will be utilized should be registered prior to operating the program.
2) A Registration and Configuration window for the Detector will appear during the initial start-up of
the program.
3)This configuration window is available through Configuration in the Option menu, and please refers
to 1) Detector Configuration for detailed information.
Figure7.18. Detector Registration
ü ⓑ displays the registered Detector.
ü If a specific item requires editing, select the Model to be edited in ⓐ and click ⓓ Edit.
ü Select a Model in ⓐ and click ⓒ Add in order to add a Detector.
ü The most recently registered model will be deleted if ⓔ Delete is selected.
DRT-MAN-066 46
ü Changes in configurations must be saved.
ü Save the changes in configuration by selecting the save icon below
Figure 7.19. Configuration Save icon
ü When the save button is selected, a program restart message will appear.
Restart the program by selecting ‘OK’.
DRT-MAN-066 47
ü Verify Detector Connection after restarting the program.
ü Open the ‘Log’ tab after connecting and powering on all necessary devices including the Detector.
Figure7.20. Detector Connection Log
ü The Detector has been successfully integrated if a ‘Ready to Capture!’ appears in the window as
seen in the figure.
DRT-MAN-066 48
7-3 Grid Configuration
1)Grid type must be configured for each registered Detector..
2)The Grid type is set as ‘None’ by default, so this step may be skipped if a Grid isn’t used.
3) Grid configuration may be completed in the ‘Detector #’ tab.

# will be designated with alphabets of A, B, C, ….
Figure7.21. Grid Configuration

4 ) Please verify the Model and Grid of the registered Panel since a limited number of Detectors
may use the Grid with the use of multiple Detectors.
DRT-MAN-066 49
5) Filter file must be registered after the configuration of Type.
Figure7.22. Registering Grid Filter File
① Select the Filter file by selecting ‘…’ as in the figure.
② A file compatible with the configured Grid Type must be selected.

③ Filter file is located in the [ECali1 Installation Folder]\Filter Folder.
④ It is in the C:\ECali1\Filter folder by default.
Figure 7.23. Filter File
6) Input the ⓐ Lines/Inch and ⓒ Angle in accordance with the Grid Type. The ⓑ cm to Inch
button may be utilized to alter the units when entering the Lines/Inch, if the cm unit is known.
DRT-MAN-066 50
Figure7.24. Additional Grid Configuration
7) Save and restart the program after completing the configuration.
DRT-MAN-066 51
7-4 Map File Registration
Open the configuration tab for each registered Detector though Option Menu – configuration and
opening the Configuration window.
Figure7.25. MAP File Destination Configuration
Use the ‘…’ on the right or manually enter in a new directory to change the destination
name. Please set it as a file used or provided by the X-ray acquisition software.
Save the changes in configuration using the save button below after designating a
destination for all registered Panels.
Figure7.26. Save Button
ECali1 will automatically restart when the changes in configuration has been saved.
DRT-MAN-066 52
7-5 ECali1 UI Overview

7-5-1 Main Screen of the Program
The main screen of ECali1 is as illustrated in [7.27].
Figure 7.27. Main Screen of ECali1
Category Title Reference
ⓐ Menu
Menu (p. 49)
ⓑ Toolbar
Toolbar (p. 53)
ⓒ Pixel Map Toolbar
Pixel Map Toolbar and Pixel Viewer (p. 59)
ⓓ Thumbnail Thumbnail (p. 60)
ⓔ Image Viewer Image Viewer (p. 61)
ⓕ Pixel Viewer
Pixel Map Toolbar and Pixel Viewer (p. 59)
ⓖ Mini Map / Pixel Value 7-7 Mini Map and Pixel Value (p. 63)
ⓗ Histogram Histogram (p. 64)
ⓘ Status Bar
Status Bar (p. 65)
DRT-MAN-066 53
1) Menu
Corresponds to ⓐ in [Figure 7.27] and comprised of 5 menus, which are File, Tools, Option,
Detector and Help.
A. File Menu
Figure 7.28. File Menu
Table 7.1. File Menu Descriptions
Menu Descriptions
Load pixel map Loads the Pixel map file.
Save pixel map Saves the Pixel map file.
Load gain map Loads the Gain map file.
Load panel map Loads the Panel map file.
Load raw image Loads the RAW image file in .IMG1 format.
Saves the currently selected image as a RAW image file in .IMG

Save raw image
format.
Exit Exits ECali1.
1.IMG file: Image Data file that has 16 bit gray-level pixel value
DRT-MAN-066 54
B.Tools Menu
Figure 7.29. Tools Menu
Table 7.2. Tools Menu Descriptions
Menu Descriptions
Initiates the Gain Map Calibration.

Gain map calibration
Please refer to7-10 Gain Calibration for more details.
Generates a Filtered Gain Map 2 using the currently loaded Gain Map.
Will not operate if the loaded Gain Map is a Filtered Gain Map.
Create FGain map
The generated Filtered Gain Map is saved in the configured Gain Map
destination of the Detector (Panel) set in Configuration.
Filter calibration Run the Grid Filter Calibration task.
Filter calibration Run the Grid Filter Calibration using raw files.
using files
Adjusts the magnifying ratio of the image displayed in the Image Viewer
Scale Fit
domain.
Adjusts the magnifying ratio of the image displayed in the Image Viewer
domain to set the size of the image corresponding to its actual size.
Scale 1:1
The Pixel displayed on the screen will be identical to the actual Pixel of the
Detector.
Saves the configured scale ratio in the current Image Viewer and applies it to
Fixed Scale the subsequent images.
2 Filtered Gain Map: Gain Map maintaining the uniformity of the image even if the uniformity of the X-
ray source is different, by applying filtering to the Gain Map
DRT-MAN-066 55
C. Option Menu
Figure 7.30. Option Menu
Table 7.3. Option Menu Descriptions
Menu Descriptions
Opens the Configuration window.
Configuration Please refer to. 7-12 Configuration for more details regarding
Configuration.
Initiates Engineer Mode of ECali1 for Advanced Configuration.
Engineer Mode
Requires the input of a password.
Initiates the Terminal Emulator which allows the internal
Terminal Mode
configuration of the Detector.
Sets the Grid Pattern Algorithm application. If a check mark (√) is
Remove grid available as noted in the figure, the algorithm is applied (ON). This
ON/OFF category must be ON if Grid is utilized.
Activates AED mode to allow image acquisition.

AED – Acq mode
Inactivates AED mode and reverts to Standby.

AED – Stay mode
Converts the status of the Detector to Ready.

Ready
The Detector performs Exposure.

Exposure
Cancels the Ready status of the Detector and reverts to Standby.

Ready cancel
DRT-MAN-066 56
D. Detector Menu
Figure 7.31. Detector Menu
① Select the active Detector from the registered Detector (Panel).

② Number of Menus reflecting the number of registered Detectors through Option – Configuration
- General will be generated. Only one Detector may be selected
E. Help Menu
Figure7.32. Help Menu
Table 7.5. Help Menu Descriptions
Menu Descriptions
Displays the ECali1 manual.
The manual is in PDF format, thus Adobe Reader program
Manual
will be required.
http://get.adobe.com/kr/reader/
About Will display the version information of ECali1.
* Requires internet connection.
Check update
Checks and installs updates for ECali1.
DRT-MAN-066 57
7-5-2 Toolbar
Corresponds to ⓑ in [7.27] and provides most used menus as Toolbar icons.
Figure 7.33. Toolbar
Table 7.6. Toolbar Icon Descriptions

Icon Descriptions
Performs Gain map calibration.

Corresponds to the Gain map calibration in the Tools Menu.
Performs Grid Calibration.

Corresponds to the Grid map calibration in the Tools Menu.
Loads and applies the Pixel map file.

Corresponds to the Load pixel map in the File Menu.
Stores the currently applied Pixel map as a file.

Corresponds to the Save pixel map in the File Menu.
Loads and applies the Gain map file.

Corresponds to the Load Gain map in the File Menu.
Loads and displays the projected image from the file.

Corresponds to the Load raw image in the File Menu.
DRT-MAN-066 58
Stores the currently projected image as a file.

Corresponds to the Save raw image in the File Menu.
This category must be ON when using the Grid.

Corresponds to the Remove grid ON/OFF in the Tools Menu.
Adjusts the magnifying ratio of the image in ⓔ to fit on screen.

Corresponds to the Scale Fit in the Tools Menu.
Adjusts the magnifying ratio of the image in ⓔ to actual size of the

image.
Corresponds to the Scale 1:1 in the Tools Menu.
* Only available when the selected Detector (Panel) supports AED mode.
* Only available when AED mode is active.
Changes the status of the Detector to acquire images. Corresponds to
the AED - Acq mode in the Options Menu.
* Only available when AED mode is active.
Converts the Detector to Standby mode.
Corresponds to the AED - Stay mode in the Options Menu.
This category must be activated when using AED mode.
DRT-MAN-066 59
7-5-3 Pixel Map Toolbar and Pixel Viewer

Corresponds to ⓒ and ⓕ in [Figure 7.27], and utilized when creating a Pixel Map.
Figure7.34. Pixel Map Toolbar
Figure 7.35. Pixel Viewer
The selected area from the Image Viewer will be magnified and displayed in the Pixel Viewer.
Please refer to 7-11 Pixel Correction for more details and methods of generating Pixel Maps.
DRT-MAN-066 60
7-5-4 Thumbnail
Corresponds to ⓓ in [Figure 7.27].
Displays the Thumbnail of the projected image, and allows the user to select a specific image
between multiple images.
If there are a significant number of projected images, a scroll button on the top and bottom
allows the user to select a specific image.
Select the Thumbnail to be deleted and select ‘Delete’ if a re-projection is required during the
calibration. The selected image will be deleted and a re-projection may be performed.
The following information will be displayed if an image is loaded from a file.
u The file name will be displayed on the top left.

u STD: Standard Deviation Value of the Pixel value of the image.
u Mean: Mean value of the pixel value of the image.
Figure 1.36. Thumbnail
Figure 7.37. Thumbnail Information
DRT-MAN-066 61
7-6 Image Viewer

Corresponds to ⓔ in [Figure 7.27].
Figure 7.38. Image Viewer
DRT-MAN-066 62
Displays the projected image and supports the following functions.
Table 7.7. Image Viewer Function & Control Method
Function Control Method
Magnify Roll the mouse wheel forward in the Image Viewer.

Reduce Roll the mouse wheel backwards in the Image Viewer.
Move Image Left click, drag and drop the image in the Image Viewer.
W/L3 Width Increase Drag the right mouse button down.
W/L Width Reduction Drag the right mouse button up.
W/L Left Shift Drag the right mouse button left.
W/L Right Shift Drag the right mouse button right.
Magnify Pixel Double click the left mouse button in the area within the Image Viewer
in order to magnify the selected are in the Pixel Viewer screen.
3 W/L: Window Leveling

DRT-MAN-066 63
7-7 Mini Map and Pixel Value

Corresponds to ⓖ in [Figure 7.27]
7-7-1 Mini Map
Figure 7.39. Mini Map

Allows the users to verify the area currently being viewed in the Image Viewer. The area within the
green dotted boarder is the area currently displayed in the Image Viewer.
7-7-2 Pixel Value
Figure 7.40. Pixel Value

Displays the pixel value of the location the mouse cursor is hovering in the Image
Viewer or the Pixel Viewer.
DRT-MAN-066 64
7-8 Histogram
Corresponds to ⓗ in [Figure 7.24]
Displays the Histogram of the selected image
Figure7.41. Histogram
Supports Dynamic or Static mode subsequent to the Windows Leveling conditions
7-8-1 Dynamic
The minimum and maximum values will be fixed while the Histogram values may be adjusted if
Window Leveling is attempted in the Image Viewer while in Dynamic mode.
7-8-2 Static
The Histogram values will be fixed while the minimum and maximum values may be adjusted if
Window Leveling is attempted in the Image Viewer while in Static mode.
DRT-MAN-066 65
7-9 Status Bar

Corresponds to ⓘ in [Figure 7.27]
Figure7.42. Status Bar
7-9-1 Image Information Display
① ② ③ ④ ⑤
Displays various information of the image
① Current axis and Pixel value of the mouse cursor

Displayed as (X : [X Axis] Y : [Y Axis]) = [Pixel Value]
② Mean: Mean Pixel Value of the image
③ STD: Standard Deviation of the Pixel value of the image
④ Min: Minimum value of the image Histogram
⑤ Max: Maximum value of the image Histogram
⑥ Peak: The Peak value and its Position of the image Histogram
Displayed as [Peak Value] at [Position]
7-9-2 Detector Status Display
* Supports only Ethernet Type and F600.
A green light will be displayed if the Detector is able to take a projection and a red
light will be displayed if the Detector is unable to take a projection.
DRT-MAN-066 66
7-9-3. Map File Loading Display
Green light will be displayed if a Map file required for Calibration has been loaded and the
red light will be displayed if it has not been loaded.
ü Gain: Gain Map Loading

ü Pixel: Pixel Map Loading
ü Panel: Panel Map Loading
If a Filtered Gain Map has been loaded in place of a Gain Map, the following
FGain will be displayed.
DRT-MAN-066 67
7-10 Gain Calibration
Gain Calibration Procedure will update or modify the x-ray characteristics to be combined
at the field to enhance the acquired image quality.
7-10-1 Gain Calibration Preparation
1)Detector and Grid Configuration

The Detector and Grid configuration must be completed prior to performing Gain
Calibration. Please refer to for details pertaining to the configuration.
2)MAP Data Location Configuration

The provided Pixel Map (*.MAP) and Gain Map (*.GMP) should be Loaded prior to
performing Gain Calibration. The destination location of the Map file provided by the
X-ray image acquisition software (EConsole1 and etc.) should be registered in
configuration.
Please refer to
7-4 Map File Registration for more details
DRT-MAN-066 68
7-10-2 Gain Calibration
Actual X-ray must be shot to project an image in order to perform Gain Calibration.
The Gain Calibration projection conditions are as follows. [Table 7-8]
Table 7.8. Gain Calibration Condition
Conditions Descriptions
Projection must be taken without the application of Grid.
(Cautions) The Grid Type must be set ‘None’ in Configuration -
Grid application
Detector - Grid selection - Type before Gain Calibration, and must
be restored after Gain Calibration.
Subject Projection must be done without a subject
X-ray exposure X-ray exposure is required
Adjust the mean pixel value of the projected image to be between

X-ray radiation dose 3,000 ~ 4,000
X-ray Condition example) 70kVp, 200mA, 2mAs
SID Stand: 150 cm, Table: 100 cm
Default Value: 7 counts

Number of
Configuration possible in Configuration - General - Calibration -
projections
Count.
Default Value: 60 Seconds

Configuration possible in Configuration - General - Calibration -
Projection interval
Interval.
Collimator should be open maximally

Other things X-ray should be set to be exposed in the whole Detector
Detector should be aligned in the center
DRT-MAN-066 69
1) Detector Selection
Select the Detector to perform the Gain Calibration from the Detector Menu.
Figure 7.43. Detector Selection
2) Starting Gain Map Calibration

Next, select Gain map calibration from Tools Menu or select the shortcut icon.
Figure7.44. Starting Gain Calibration
A notification message will appear. Select ‘OK’.
Figure 7.45.. Gain Calibration Start Notification
DRT-MAN-066 70
Next, ECali1 alerts whether the radiation dose is appropriate or whether it should be automatically
calculated. Proceed by selecting ‘OK’.
Figure 2. X-ray Radiation Dose Check Activation
Next, a main screen will appear.

Proceed with the X-ray projection at this point in order to acquire an image.
Figure 7.473. Projection Standby Main Screen
The program automatically determines the appropriateness of the X-ray radiation dose when the
image is acquired.
Figure7.48. X-ray Radiation Dose Verification Notification
DRT-MAN-066 71
Figure7.49. Notification for Low X-ray Radiation Dose
If provided with a notification of low radiation dose, please select ‘OK’ then increase the X-ray
radiation dose and re-project.
A notification will also appear if the X-ray radiation dose is high. Please select ‘OK’ then reduce the X
ray radiation dose and re-project.
Figure 7.50. Notification for Appropriate X-ray Radiation Dose
If the X-ray radiation dose is appropriate, please select ‘OK’ and proceed with the projections.
Figure 7.51. Notification Informing 7 Images Requirement
A notification informing the requirement of 7 images will appear. The required number of images may
be set in Configuration.
DRT-MAN-066 72
Select ‘OK’ and proceed with the projections of 7 images.
Figure 7.52. Starting the Gain Calibration Projection
Figure7.53. Standby post Projection of 1 Image
Stand by until the next designated projection after the initial projection.
Figure7.54. Projection Standby Timer
The next projection will take place after the projection standby timer disappears. The projection
standby time may be set in configuration.
DRT-MAN-066 73
The Gain Calibration results are automatically saved as Gain Map (*.GMP) when all required images are
projected and the existing files are backed-up.
Figure7.55. Notification for Gain Calibration Completion
The existing GMP files are backed up in the [ECali1 Installation Folder]\MAP folder.
The file name is as follows. [7-56]
Figure7.56. Example of a Back-up File
DRT-MAN-066 74
7-11 Pixel Correction

If there are pixel defects or line defects needed to be calibrated, users can correct them manually.
7-11-1 Pixel Correction Preparation

1) Detector and Grid Configuration
The Detector and Grid configuration must be completed prior to performing Pixel correction
2)Map Data Location Configuration

The provided Pixel Map (*.MAP) should be Loaded prior to performing Pixel Correction.
The destination location of the Map file provided by the X-ray image acquisition
Software (EConsole1 and etc.) should be registered in Configuration.
DRT-MAN-066 75
7-11-2 Pixel Correction Performance
At least 1 count of RAW image acquired through X-ray Exposure is required to perform Pixel Correction.
Table 7.4. Pixel Correction Conditions
Condition Descriptions
Grid application Projection must be taken without the application of Grid
Subject Projection must be done without a subject
X-ray exposure X-ray exposure is required
More than 1 count.

Number of
(One for check and correct defects, and others to verify
projection
correction)
Other things Collimator should be open
DRT-MAN-066 76
1) Detector Selection
Select the Detector to perform the Pixel Correction from the Detector Menu.
Figure7.56. Panel Selection
2) Pixel Correction
Acquire the image by performing an X-ray projection from the main screen.
Figure 7.57. Projection Standby Screen
Figure 7.58. Image Acquisition Screen post Projection
DRT-MAN-066 77
Figure 7.59. Display the Horizontal Line Defect Area in Pixel Viewer
A defect of a point or line may exist for each Detector. [7-59] illustrates a Horizontal Line Defect.
There are 3 types for Pixel Correction.
Figure 7.60. Pixel Defects
DRT-MAN-066 78
The following are utilized to perform Pixel Correction. [Figure7-61]
Figure 7.61. Pixel Correction Icon
Pixel Correction is performed in the following process.
① Display the Pixel Defect in the Pixel Viewer
② Select the appropriate shortcut icon
③ Ctrl+Left Click the area of Defect in the Pixel Viewer
Figure 7.62. Pixel Correction (Horizontal Line Defect)
DRT-MAN-066 79
The selected Defect will be displayed in green.

The selected Defect will be displayed in blue if the Defect is already saved.
Figure7.63. Example Post Performance of Pixel Correction
Perform Pixel Corrections for all existing Defect and save to complete the process.
Figure 7.64. Save Pixel Map
DRT-MAN-066 80
7-12 Configuration
The Configuration will appear through Option Menu - Configuration.
Figure7.65. Configuration
ü ⓐ: Configuration detailed tab
ü ⓑ: Save the modified contents and close the window.
Automatically restart the program when necessary.
ü ⓒ: Close the window without saving the contents.
DRT-MAN-066 81
7-12-1 General
Configure the number and type of Detector being utilized.

In addition, Configuration matters required in the process of calibration may be modified.
Figure 7.66. General
DRT-MAN-066 82
1) Detector Configuration
Figure 7.67. Detector Configuration
Table 7-10. Model Configuration Descriptions
Category Descriptions
① Type of Panel Model which will be added or modified
② Type of Panel added (registered)
③ Adds the Panel Model selected in ①
Modifies the Model of the Panel selected in ②
④
Here, the Model is replaced by the Model selected in ①
Deletes the most recently registered Panel.
⑤
(With disregards to selection, the item at the bottom of the list will be deleted.)
DRT-MAN-066 83
2) Calibration Configuration
Figure7.68. Calibration Configuration
Table 7-5. Calibration Configuration Descriptions
Configures the number of images to be project when performing Gain/Grid

①
Calibration. The Default value is 7 counts.
Checks the X-ray radiation dose when performing Gain Calibration and provides
② an option for re-projection if the radiation dose is unfit.
It is recommended for accurate Calibration.
Configures the interval between each image projections when performing

③
Gain/Grid/Panel Calibration. The default value is 60 sec.
④ Select whether to set the Grain Map as Filtered Gain Map or Gain Map.
DRT-MAN-066 84
7-12-2 Options
Figure 7.69. Options Configuration
Table 7-6. Options Descriptions
① Configures the use of Auto Update function.
② Configures the use of the virtual keyboard for Touch environments.
③ Selects the editing method utilized during the Pixel Map Calibration process.
④ Selects the port connected with USB Switch Box.
Checks ‘Fix Min / Max’ and inputs Min and Max pixel value to use fixed window
⑤
level.
DRT-MAN-066 85
7-13 Detector
Allows the modification of necessary configuration for each Detector. Number of tabs
corresponding to the number of registered Panels through Configuration – General will be
generated.
Figure 4. Configuration – Changes in the Number of Panel Tabs
The following may be configured through Panel Configurations
ü Map files save path

Save path of the Map file required for Calibration
ü Edge cut setting
The boarders of the image
ü Grid selection
Configurations relevant to the type of Grid and Filter Type being used
ü F600 Model Configuration
Configurations only for F600
DRT-MAN-066 86
7-13-1 Map File Path
Figure7.71. Map File Path
Table 7.7. Map File Path Descriptions
Configures the save path of the Pixel Map file.

①
The File Dialogue may be opened by selecting ‘…’ on the right.
Configures the save path of the Gain Map file.

②
Configures the save path of the Panel Map file.

③
Previous Map files are backed-up when Map files are saved multiple times.
④ Utilized when restoring the Map file with the previous file.
However, restore cannot be processed if a backed-up Map file does not exist.
DRT-MAN-066 87
7-13-2 Edge Cut Setting
Figure 7.72. Edge Cut Setting
Fixed placement of a boarder on the image.

The Pixel value and width may be designated in this configuration.
Table 7.8. Edge Cut Setting Descriptions
Configures the Threshold Value of the image.

The default is determined by each model.
①
If the Pixel Value of the image imported from the Detector exceeds 11000, the
values will be automatically adjusted to 11000 if this value is set to 11000.
Configures the Pixel Value of the additional boarder which will be placed on
② the image.
The default value is 11000.
Configures the width of the top, bottom, left and right boarder. Unit is in Pixel.
③
The Default value is all 10.
DRT-MAN-066 88
EVS 4343 User’s Manual 8. Troubleshooting
When you encounter problems or error messages in the ECali1 while using this equipment, search the
table below for the problem or error message and try the solutions.
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.
Cause/Error messages in
Symptom Remedy
the EVS Control Software
Failed to turn on. Power calbe is not attached Attach a power cable with SSU
The communication circuit is Register the detector and make connection
LINK lamp does not light up not secured to the ECali1.
Data transmission error has The detector cable is firmly connected to
While the POWER lamp the detector.
occurred.
lights, READY and LINK The SSU is turned on.
Exposure preparation error Confirm that the cables with the X-ray
lamps flash. has occurred. / Error Code: interface unit are connected securely and the
21 X-ray interface box is turned on.
All the LED lamps flash.
Two LED lamps flash and
Turn off the detector and Hardware error has occurred
Turn off the detector and turn it on again.
/Error Code: other than 21
turn it on again.
the other flashes slowly.
DRT-MAN-066 89
EVS 4343 User’s Manual 9. Maintenance
Maintenance and inspection
In order to ensure that the equipment is used safely and normally, be sure to inspect the equipment before
use. If any problem is found during the inspection and cannot be corrected, please contact your sales
representative or local DRTECH dealer.
�Daily inspection
For safety reasons, be sure to turn OFF the power to each piece of
WARNING equipment before the following. Otherwise, an electric shock may result.
Cable
1) Ensure that cables are not damaged and cable jackets are not torn.
2) Ensure that the power cord plugs are securely connected to both the equipment AC inlet and the AC
outlet.
Detector
1) Ensure that there are no loose screws or breaks.
2) Ensure that there is no dust or foreign matter on the external connector.
3) Ensure that there are no breaks or short-circuits in the power supply conector.
After turning on the power
Be sure to start the ECali1 before performing the following inspection.
1) Perform test exposure.
�Monthly inspection
1) Conduct a Performance Test.
2) Regularly conduct a Self-diagnosis. For details, refer to the Setup Guide for the EVS Control Software.
�Yearly inspection
1) Perform a Performance Test or Self-diagnosis using a phantom or resolution chart, etc.
�Irregular inspection
Calibration
1) Perform Calibration when exposure conditions have changed significantly.
For details, refer to the Setup Guide for the ECali1.
DRT-MAN-066 90
EVS4343 User’s Manual 10. Specifications
10-1. Main specifications
EVS 4343 X-ray detector

[Dimensional diagram] (unit mm)
DRT-MAN-066 91
EVS 4343 User’s Manual 10 Specifications
SSU (System Syncronization Unit)
[Dimensional diagram] (unit mm)
Rated power supply

Input: 100-240 VAC, 50/60Hz
Output: DC +12 V 8.3A, 75W
DRT-MAN-066 92
EVS 4343 User’s Manual 10 Specifications
10-2. Charateristics
(1) Typical patient doses
Typical patient doses are equivalent to 500-1000 speed film/screen systems.
(2) Sensitometric characteristics and Dynamic range

EVS 4343 responds linearly against the exposure range for 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.
(3) Spatial resolution properties

- EVS 4343 Standard
A typical MTF value at 2 lp/mm, than 35%.
- EVS 4343 Gadox Version

A typical MTF value at 2 lp/mm, than 30%.
The level of uncertainty is estimated as less than ±10%.
(4) DQE
- EVS 4343 Standard
A typical DQE value at 0 lp/mm is 60%.
- EVS 4343 Gadox Version

A typical DQE value at 0 lp/mm, than 32%.
The level of uncertainty is estimated as less than ±10%.
The product safety standards that apply to the EVS 4343, which includes the following equipment, are as
followings.
• Detector
• SSU
• Wiring unit (sold separately, optional unit)
DRT-MAN-066 94
EVS 4343 User’s Manual 11. Regulatory information
11-1. Medical equipment safety standards

�Medical equipment classification
Type of protection against electrical
Class I ME Equipment
shock
Degree of protection against electrical Type B Applied Parts
shock (Applied Part: Detector panel)
Degree of protection against ingress of
IPX0
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
�Product safety standards

USA and Canada
Medical electrical equipment - Part1:General requirements for
IEC 60601-1:2005/A1:2012
safety
UL 60601-1 Ed.1.0:2003 Medical electrical equipment-Part 1:General requirements for
CAN/CSA-C22.2 No.601.1-M90 (R2005) safety
Medical electrical equipment-Part 1-1:Collateral standard:
IEC 60601-1-1 Ed.2.0:2000
Safety requirements for medical electrical systems
Medical electrical equipment-Part 1-2:Collateral
IEC 60601-1-2 Ed.2.1:2004
standard: Electromagnetic compatibility-Requirements and tests
Medical electrical equipment-Part1:Collateral standard: General
IEC 60601-1-3 Ed.1.0:1994 requirements for radiation protection in diagnostic X-ray
equipment
Medical electrical equipment - Part 1-4:Collateral Standard:
IEC 60601-1-4 Ed.1.1:2000
Programmable electrical medical systems
Biological evaluation of medical devices
ISO 10993-1:2009 Part 1: Evaluation and testing within a risk management
ISO 10993-5:2009 process
ISO 10993-10:2010 Part 5: Tests for in vitro cytotoxicity
Part 10: Tests for irritation and delayed-type hypersensitivity
RA-EVS-UM-100 95
European Union
Council Directive 93/42/EEC of 14 June 1993 as amended by
MDD(93/42/EEC)
Directive 2007/47/EC concerning medical devices
Medical devices -- Quality management systems –
EN ISO 13485:2012/AC:2012
Requirements for regulatory purposes
Medical electrical equipment - Part1:General requirements for
EN 60601-1:2006/A1:2013
safety
Medical electrical equipment – Part 1-2: General requirements
for basic safety and essential performance – Collateral
EN 60601-1-2:2007/AC2010
standard: Electromagnetic compatibility – Requirements and
tests
Medical electrical equipment - Part 1-6:Collateral Standard:
EN 60601-1-6:2010
Usability
Medical electrical equipment – Part 2-54: Particular
EN 60601-2-54:2009 requirements for the basic safety and essential performance of
X-ray equipment for radiography and radioscopy
Medical electrical equipment – Characteristics of digital X-ray
EN62220-1:2004 imaging devices – Part 1: Determination of the detective
quantum efficiency
EN 62304:2006/AC2008 Medical device software-Software life cycle processes
Medical device - Application of usability engineering to medical
EN 62366:2008
devices
Medical device - Application of risk management to medical
EN ISO 14971:2012
devices
Biological evaluation of medical devices
EN ISO 10993-1:2009 Part 1: Evaluation and testing within a risk management
EN ISO 10993-5:2009 process
EN ISO 10993-10:2010 Part 5: Tests for in vitro cytotoxicity
Part 10: Tests for irritation and delayed-type hypersensitivity
DRT-MAN-066 95

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-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 correct the interference at his own expense.
FCC WARNING:
Changes or modifications not expressly approved by the party responsible for compliance could void the
user’s authority to operate the equipment.
This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.
.
Disposal
Disposal of this product in an unlawful manner may have negative 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 is about 3 years.
DRT-MAN-066 96
�For European Union (and EEA)

Hereby, DRTECH Inc., declares that this EVS-4343 is in compliance with the essential
English
requirements and other relevant provisions of Directive 1999/5/EC.
DRTECH Inc. tímto prohlašuje, že tento EVS 4343 je ve shodě se základními požadavky a
Česky
dalšími příslušnými ustanoveními směrnice 1999/5/ES.
Undertegnede DRTECH Inc. erklærer herved, at følgende udstyr EVS 4343 overholder de
Dansk
væsentlige krav og øvrige relevante krav i direktiv 1999/5/EF.
Hiermit erklärt DRTECH Inc., dass sich das Gerät EVS 4343 in Übereinstimmung mit den
Deutsch grundlegenden Anforderungen und den übrigen einschlägigen Bestimmungen der Richtlinie
1999/5/EG befindet.
Käesolevaga kinnitab DRTECH Inc. seadme EVS 4343 vastavust direktiivi 1999/5/EÜ
Eesti
põhinõuetele ja nimetatud direktiivist tulenevatele teistele asjakohastele sätetele.
Por medio de la presente DRTECH Inc. declara que el EVS 4343 cumple con los requisitos
Español
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 ΤΙΣ
Ελληνική
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 exigences
Français
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 requisiti essenziali
Italiano
ed alle altre disposizioni pertinenti stabilite dalla direttiva 1999/5/CE.
Ar šo DRTECH Inc. deklare, ka EVS 4343 atbilst Direktivas 1999/5/EK butiskajam prasibam
Latviski
un citiem ar to saistitajiem noteikumiem.
Šiuo DRTECH Inc. deklaruoja, kad šis EVS 4343 atitinka esminius reikalavimus ir kitas
Lietuviu
1999/5/EB Direktyvos nuostatas.
Nederlan Hierbij verklaart DRTECH Inc. dat het toestel EVS 4343 in overeenstemming is met de
ds essentiële eisen en de andere relevante bepalingen van richtlijn 1999/5/EG.
Hawnhekk, DRTECH Inc., jiddikjara li dan EVS 4343 jikkonforma malhtigijiet essenzjali u ma
Malti
provvedimenti ohrajn relevanti li hemm fid-Dirrettiva 1999/5/EC.
Alulírott, DRTECH Inc. nyilatkozom, hogy a EVS 4343 megfelel a vonatkozó alapvetõ
Magyar
követelményeknek és az 1999/5/EC irányelv egyéb elõírásainak.
Niniejszym DRTECH Inc. oswiadcza, ze EVS 4343 jest zgodny z zasadniczymi wymogami
Polski
oraz pozostalymi stosownymi postanowieniami Dyrektywy 1999/5/EC.
Portuguê DRTECH Inc. declara que este EVS 4343 está conforme com os requisitos essenciais e
s outras disposições da Directiva 1999/5/CE.
Slovensk DRTECH Inc. izjavlja, da je ta EVS 4343 v skladu z bistvenimi zahtevami in ostalimi
o relevantnimi dolocili direktive 1999/5/ES.
Slovensk DRTECH Inc. týmto vyhlasuje, že [typ zariadenia] splna základné požiadavky a všetky
y príslušné ustanovenia Smernice 1999/5/ES.
DRTECH Inc. vakuuttaa täten että EVS 4343 tyyppinen laite on direktiivin 1999/5/EY
Suomi
oleellisten vaatimusten ja sitä koskevien direktiivin muiden ehtojen mukainen.
Härmed intygar DRTECH Inc. att denna EVS 4343 står I överensstämmelse med de
Svenska 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 og aðrar kröfur,
Íslenska
sem gerðar eru í tilskipun 1999/5/EC.
DRTECH Inc. erklærer herved at utstyret EVS-4343 er i samsvar med de grunnleggende krav
Norsk
og øvrige relevante krav i direktiv 1999/5/EF.
DRT-MAN-066 97
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 98

The EVS 4343 detector and other components have labels and markings on them.
Their contents and locations are indicated below.
Detector Panel
Active Area
(430 x 430 mm)
Applied Part
Applied Part
DRT-MAN-066 100
Detector Case
(460 x 460 mm)
< EVS 4343 Standard >
< EVS 4343 Gadox Version >
DRT-MAN-066 96
Caution:
Do not jolt or apply excessive load.
The Waste Electrical and Electronic Equipment Regulations indicates separate

collection for
electrical and electronic equipment.
MEDICAL
Certification mark that indicates the product complies with UL 60601-1
EQUIPMENTUL60601-1
CAN/CSA C22.2 No.601.1
41C4
and CAN/CSA C22.2 No.601.1, that specifies protection against fire, electric
shock, and mechanical hazards.
For European Union (EEC Countries)

Hereby, DRTECH Inc., declares that this EVS-4343 is in compliance with the
essential equirements and other relevant provisions of Directive 93/42/EEC.
“0120”
shows the notified body number for MDD.
MANUFACTUED: Year and Month of production

(S/N) Serial number in six digits
Protective Earth (Ground)
Direct Current
Alternating Current
Equipotentially.
Attention, Consult accompanying documents.
Power Off.
Power On
Read and understand all instructions and warning labels in the product
documentation before using the equipment.
Keep manual for future reference
DRT-MAN-066 96
�Other components of the EVS 4343

SSU
Caution:
Do not jolt or apply excessive load.
The Waste Electrical and Electronic Equipment Regulations indicates separate

collection for
electrical and electronic equipment.
MANUFACTUED: Year and Month of production
(S/N) Serial number in six digits
DRT-MAN-066 101
Protective Earth (Ground)
Direct Current
Alternating Current
Equipotentially.
Attention, Consult accompanying documents.
Power Off.
Power On
Read and understand all instructions and warning labels in the product
documentation before using the equipment.
Keep manual for future reference
DRT-MAN-066 102
11-4. Guidance and manufacturer’s declaration for EMC

Electromagnetic emissions
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 Environment - Guidance

The EVS 4343 uses RF energy only for its internal
RF emissions function.
GROUP 1
CISPR11 Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electromagnetic equipment.
RF emissions
Class A
CISPR11
Harmonic emissions
Class A The EVS-4343 is suitable for use in all
IEC 61000-3-2 establishments other than domestic and those directly
Voltage fluctuations/ connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
flicker emissions *1
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 220 V.
Electromagnetic immunity
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.
IEC 60601 Test Electromagnetic

Immunity Test Compliance Level
Level Environment – Guidance
Floors should be wood,
concrete or ceramic tile. If
Electrostatic discharge ±(2, 4, 6) kV contact ±(2, 4, 6) kV contact floors are covered with
(ESD)
±(2, 4, 8) kV air ±(2, 4, 8) kV air synthetic material, the relative
IEC 61000-4-2
humidity should be at least
30%.
±2 kV for power ±2 kV for power
Electrical fast transient/ Mains power quality should be
supply lines supply lines
burst that of a typical commercial or
IEC 61000-4-4 ±1 kV for input/output ±1 kV for input/output hospital environment.
lines lines
±1 kV differential ±1 kV differential Mains power quality should be
Surge that of a typical commercial or
mode mode
IEC 61000-4-5 hospital environment
±2 kV common mode ±2 kV common mode
NOTE: UT is the a.c. mains voltage prior to application of the test level.
DRT-MAN-066 103
EVS4343 User’s Manual
IEC 60601 Test Electromagnetic

Immunity Test Compliance Level
Level Environment – Guidance
<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
40% UT 40% UT
Voltage dips, short hospital environment. If the user
(60% dip in UT) for (60% dip in UT) for
interruptions and voltage of the EVS 4343 requires
5 cycles 5 cycles
variations on power continued operation during power
70% UT 70% UT
supply input lines mains interruptions, it is
(30% dip in UT) for (30% dip in UT) for
IEC 61000-4-11 recommended that the EVS 4343
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 magnetic fields
Power frequency
should be at levels characteristic of a
(50/60Hz) magnetic field 3 A/m 3 A/m
typical location in a typical
IEC 61000-4-8
commercial or hospital environment.
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 in
Radiated RF 3 V/m 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 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-066 104
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the EVS 4343 is used
exceeds the applicable RF compliance level above, the EVS 4343 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the EVS 4343.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
DRT-MAN-066 108
DRTECH Inc. warrants that this product will be free from defects in materials and workmanship for a period of
twelve (12) months from the date of delivery. If any such product proves defective during this warranty period,
DRTECH Inc. at its option, either will repair the defective product without charge for parts and labor, or will
provide a replacement in exchange for the defective product. In order to obtain service under this warranty,
Customer must notify DRTECH Inc. of the defect before the expiration of the warranty period and make suitable
arrangements for the performance of service. Customer shall be responsible for packaging and shipping the
defective product to the service center designated by DRTECH Inc. with shipping charges prepaid. DRTECH Inc.
shall pay for the return of the product to customer if the shipment is to a location within the country in which the
DRTECH Inc. designated service center is located. Customer shall be responsible for paying all shipping
charges, duties, taxes, and any other charges for products returned to any other locations.
This warranty shall not apply to any defect, failure, or damage caused by improper or inadequate maintenance
and care. DRTECH Inc. shall not be obligated to furnish service under this warranty to repair damage resulting
from attempts by personnel other than DRTECH Inc. or its representatives to install, repair, or service this
product, to repair damage resulting from improper use or connection to incompatible equipment or power source;
or to service a product that has been modified or integrated with other products when the effect of such
modification or integration increases the time or difficulty of servicing the product.
THIS WARRANTY IS GIVEN BY DRTECH Inc. WITH RESPECT TO THIS PRODUCT IN LIEU OF ANY OTHER
WARRANTIES, EXPRESS OR IMPLIED. DRTECH Inc. AND ITS VENDOR DISCLAIM ANY IMPLIED
WARRANTIES OF MERCHANTABLILITY OR FITNESS FOR A PARTICULAR PURPOSE. DRTECH Inc.
RESPONSIBILITY TO REPAIR OR REPLACE DEFECTIVE PRODUCTS IS THE SOLE REMEDY PROVIDED
TO THE CUSTOMER FOR BREACH OF THIS WARRANTY. DRTECH AND ITS VENDORS WILL NOT BE
LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES IRRESPECTIVE OF
WHETHER VIEWORKS CO., LTD OR THE VENDOR HAS ADVANCE NOTICE OF THE POSSIBILITY OF
SUCH DAMAGES.
There are no warranties which extend beyond the description mentioned in this document.
DRT-MAN-066 108
Revision History
Revision Date Descriptions
1.0 Feb. 11. 2014 Initial Release
2.0 Jul. 25. 2016 Add to GoS model, Delete to Wireless function
DRT-MAN-066 108
DRTECH Corporation.
Suite No.2 3 Floor, 29
Dunchon-daero541beon -gil,
Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Web Site : http://www.drtech.co.kr
Customer Support Team
E-mail : drtech@drtech.co.kr
Tel : +82 31 730 6805 / Fax : +82 31 730 6899
EXAMION GmbH
Erich-Hherion Stuttgart. 37 in 70736 Fellbach. Germany
DRT-MAN-066 108

Drtech EVS 4343 / EVS 4343G: Safety and Regulatory Information With User's Manual

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Drtech EVS 4343 / EVS 4343G: Safety and Regulatory Information With User's Manual

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DRTECH

EVS 4343 / EVS 4343G

Important information on usage and management of equipment

4. Parts name and functions………………………………………………………..17

11. Regulatory information………….….….…………………………………………94

■ Medical equipment classification………………………………………………………….94

■ Product safety standards…………………………………………………………………..94

■ O t he r c o mp o n en t s o f t he EVS 43 4 3……………………………………. . 101

12. Warranty ………….….…….………………………………………………………..106

This notice used to idendifiy conditions under which improper use

This notice used to idendifi\y conditions under which improper

This notice used to idendifiy conditions under which improper use

This is used to indicate a prohibited operation.

This is used to indicate an action that must be performed.

This is used to indicate important operations and restrictions.

This is used to indicate operations for reference and complementary

- Do not connect a multiple portable socket-outlet or extension cord to the system.

- Securely plug the power cord into the AC outlet.

- Be sure to turn OFF the power to each of equipment before connecting or

- Be sure to hold the plug or connector to disconnect the cord.

- No modification of this equipment is allowed

- Do not place anything on top of the equipment.

- Do not hit or drop the equipment.

When a problem occurs

- Handle the equipment carefully.

- Do not place excessive weight on the detector.

1-2. Notes for using the equipment

The Ecali1 software runs a system diagnostic.

The owner is responsible for ensuring that the system diagnostic is

The owner is responsible for ensuring that the system calibration is

Electric Shock Hazards

Disinfection and cleaning

- Wipe it with a dry cloth slightly damed with a neutral detergent.

- Do not clean the system with turning the power on.

Temperature Humidity Atmospheric pressure

Operating environment 5 to 35℃ 30 to 80% RH

Handling the equipment

2-2. Application specification

Intended patient population

Considerations Requirement description

Health Not relevant

Sex Not relevant

Patient is user Patient is not user

Intended part of the body or type of tissue applied to or interacted with

2) Condition : Intact or wund skin

Intended user profile(Operator Profile)

Considerations Requirement description

Minimum - Local language

Minimum - Physician or legally certified operator

Intended conditions of use

2-3. System Configuration

Figure 2.1 EVS 4343 configuration

AC Power Cable (2m) USB Switch Box Hand Switch

LAN Cable Interface Cable (12 m) Generator Interface Cable

CD(Software / Calibration) Manual (Hard Copy)

Table 3.1 EVS 4343 packaging

3-1. Product component

Item Product name

EVS 4343(Scintillator: CsI : Tl) 4.5 kg