DRTECH EVSWPCS User Manual
DRTECH
EVS 3643 / EVS 3643G
Safety and Regulatory Information
with User’s Manual
1
EVS 3643 User’s Manual To Customers
To Customers
Thank you for purchasing the DRTECH Radiography EVS 3643 (hereinafter, this Product). This User’s
Manual explains how to use the detector, x-ray interface unit, and other peripheral equipments. Before
using this product, be sure to read this manual thoroughly in order to utilize it more effectively. Also, please
read the Operation Manual for EVS Calibration and configuration Software (hereinafter, ECali1).
Important information on usage and maintenance 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 and image display monitors complying with IEC 60601-1 or IEC 60950-1 and under a system
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 performed in accordance
with the laws of the country or region in which the product is being used. The user is resposible for maintaining 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 consequential 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, compositions, and appearance of this product may change without prior notice.
DRT-MAN-073 2
EVS 3643 User’s Manual Contents
Contents
To Customers .......................................................................................................................................... 2
Contents ................................................................................................................................................... 3
Safety notices .......................................................................................................................................... 7
1. Safety Information .................................................................................. 8
1.1. Safety precautions ........................................................................................ 8
1.2. Notes for using the equipment ................................................................ 13
2. Introduction ............................................................................................ 16
2.1. Features ....................................................................................................... 16
2.2. Application specification .......................................................................... 16
2.3. System Configuration ................................................................................ 19
2.3.1. Basic Configuration .......................................................................................................................... 19
3. Product Description ............................................................................. 23
3.1. Product Components ................................................................................ 23
3.1.1. Auto Trigger Mode (AT Mode) ...................................................................................................... 23
3.1.2. Synchronization Trigger Mode (Sync. Mode) ....................................................................... 24
3.1.3. USB SW Mode ...................................................................................................................................... 25
3.1.4. Workstation (Recommended and minimum but NOT included) ................................ 26
3.1.5. Grid (Recommended but Not included) .................................................................................. 26
3.2. X-ray Imaging Condition ........................................................................... 27
4. Parts Name and Functions .................................................................. 28
4.1. Detector ....................................................................................................... 28
4.1.1. Detector Specification ..................................................................................................................... 28
4.1.2. Detector Component ........................................................................................................................ 29
4.2. Battery Charger and Battery Pack ........................................................... 30
4.2.1. Battery Charger ................................................................................................................................... 30
4.2.1.1. Battery Charger Specifications .................................................................................................................................. 30
4.2.1.2. Battery Charger Components ..................................................................................................................................... 30
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EVS 3643 User’s Manual Contents
4.2.2. Battery Pack .......................................................................................................................................... 31
4.2.2.1. Battery Pack Specification ........................................................................................................................................... 31
4.2.2.2. Battery Charger Components ..................................................................................................................................... 31
4.2.2.3. Charging Battery Pack .................................................................................................................................................... 32
4.3. Wireless Charging System ....................................................................... 33
4.3.1. EVS-WPCS ............................................................................................................................................. 33
4.3.1.1. EVS-WPCS Specifications ............................................................................................................................................ 33
4.3.1.2. EVS-WPCS Components ............................................................................................................................................... 33
4.3.1.3. TX / RX Module Specification ...................................................................................................................................... 34
4.3.1.4. RX Module Components ................................................................................................................................................ 34
4.3.1.5. EVS-WPCS Operations ................................................................................................................................................... 34
4.3.1.6. Attach Direction .................................................................................................................................................................. 35
4.3.1.7. Indicator LED Connector Description .................................................................................................................... 37
4.3.1.8. Indicator LED Connector Description (Isolation) ............................................................................................. 37
4.4. Power supply and SSU (System synchronization unit) ....................... 38
4.4.1. SSU Specifications ............................................................................................................................ 38
5. Operating Procedure ............................................................................ 39
5.1. Preparing to Use the Detector .................................................................. 40
5.1.1. Standard Configuration ................................................................................................................... 40
5.1.2. Battery Pack .......................................................................................................................................... 41
5.1.2.1. How to Attach a Battery Pack ..................................................................................................................................... 41
5.1.2.2. How to Detach a Battery Pack .................................................................................................................................... 41
5.1.2.3. How to Charge Battery Packs ..................................................................................................................................... 42
5.2. Hardware Installation ................................................................................. 44
5.2.1. Connecting Device ............................................................................................................................ 44
5.2.1.1. Operating AP ........................................................................................................................................................................ 44
5.2.1.2. Operating SSU ..................................................................................................................................................................... 46
5.2.1.3. Functional Cable ................................................................................................................................................................ 49
5.2.2. Operating Detector ............................................................................................................................ 52
5.2.3. Image Data Retransmission .......................................................................................................... 57
5.3. Ending Use of the Detector ...................................................................... 58
5.4. Detector Initialization ................................................................................. 58
6. Extension Facility ................................................................................. 59
6.1. X-ray Generator Interface.......................................................................... 59
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EVS 3643 User’s Manual Contents
6.1.1. X-ray Exposure Mode ....................................................................................................................... 59
6.1.2. Auto Trigger(AT) Mode .................................................................................................................... 60
6.1.2.1. Recommendation of setting AT Sensing Area ................................................................................................... 61
6.1.3. Sync. Trigger Mode ........................................................................................................................... 62
6.1.3.1. SSU X-Ray Generator Interface Port Assignment ........................................................................................... 63
6.1.3.2. Timing of Signal ................................................................................................................................................................. 65
6.1.3.3. X-Ray Generator Interface Signal Circuits ........................................................................................................... 65
6.1.3.4. Recommended Circuit .................................................................................................................................................... 67
6.1.4. USB SW Mode ...................................................................................................................................... 68
6.1.4.1. Wiring USB SW Mode ...................................................................................................................................................... 69
6.1.4.2. Connector Description.................................................................................................................................................... 69
6.1.4.3. Connector Pin Assignment .......................................................................................................................................... 70
6.1.4.4. X-ray_UNIT ............................................................................................................................................................................ 70
6.1.4.5. Hand Switch .......................................................................................................................................................................... 70
6.1.4.6. PC USB .................................................................................................................................................................................... 71
6.2. Software Installation .................................................................................. 72
6.2.1. Software Classification ................................................................................................................... 72
6.2.2. Software Installation ......................................................................................................................... 72
6.3. Windows Environment Setting ................................................................ 73
6.3.1. Network Communication ................................................................................................................ 73
6.3.2. Disabling Sleep Mode on Monitor .............................................................................................. 76
7. Device Setting ........................................................................................ 77
7.1. AP Setting .................................................................................................... 77
7.1.1. AP Configuration ................................................................................................................................ 77
7.2. Detecting Setting ........................................................................................ 79
7.2.1. Detector Configuration .................................................................................................................... 79
7.2.2. Detector Power Save Management ........................................................................................... 81
8. Troubleshooting .................................................................................... 83
8.1. Failed to Turn the Detector On ................................................................. 83
8.2. Errors in Detector LED .............................................................................. 83
8.3. The LINK LED does Not Turn on .............................................................. 84
8.4. Rapid Consumption of Battery ................................................................ 84
8.5. Battery Pack or Installation Part of Battery is Getting Hot ................. 85
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EVS 3643 User’s Manual Contents
8.6. The Power Switch of SSU or Status LED is not working ..................... 85
9. Maintenance and Inspection ............................................................... 86
10. Specification ...................................................................................... 87
10.1. Main Specifications ................................................................................. 87
10.1.1. EVS 3643 X-ray Detector ............................................................................................................. 87
10.1.2. Battery Charger System .............................................................................................................. 88
10.1.3. Battery Pack ...................................................................................................................................... 89
10.1.4. EVS-WPCS ......................................................................................................................................... 90
10.1.5. SSU (System Synchronization Unit) ..................................................................................... 91
10.2. Charateristics ........................................................................................... 92
10.3. Packing ...................................................................................................... 93
10.3.1. Product Configuration List ........................................................................................................ 93
10.3.2. Assemble Package ........................................................................................................................ 94
10.3.3. Detector Panel Package .............................................................................................................. 95
10.3.4. Component Box Assemble Package .................................................................................... 96
10.3.4.1. AP Box Component ....................................................................................................................................................... 96
10.3.4.2. Battery Box Component .............................................................................................................................................. 96
11. Regulatory Information .................................................................... 97
11.1. Medical Equipment Safety Standards .................................................. 97
11.2. Radio Frequency(RF) Compliance Information .................................. 99
11.3. Labels and Marking on the Equipment .............................................. 103
11.3.1. Detector ............................................................................................................................................. 103
11.3.2. Battery Charger and Battery Pack ....................................................................................... 105
11.3.2.1. Battery Charger .............................................................................................................................................................. 105
11.3.2.2. Battery Pack ..................................................................................................................................................................... 105
11.3.3. EVS-WPCS ....................................................................................................................................... 106
11.3.4. SSU ...................................................................................................................................................... 106
11.3.5. Symbol Description ..................................................................................................................... 107
11.4. Guidance and Manufacturer’s Declaration for EMC ........................ 108
12. Warranty ........................................................................................... 112
DRT-MAN-073 6
EVS 3643 User’s Manual Conventions
WARNING
This notice used to idendifiy conditions under which improper use of the
product may cause death or serious personal injury.
CAUTION
This notice used to idendifi\y conditions under which improper use of the
product may cause minor personal injury.
CAUTION
This notice used to idendifiy conditions under which improper use of the
product may cause property damage.
Prohibited
This is used to indicate a prohibited operation.
This is used to indicate an action that must be performed.
IMPORTANT
This is used to indicate important operations and restrictions.
Be sure to read this notice to prevent property damage or malfunction.
This is used to indicate operations for reference and complementary
information.
Users are recommended to read this notice.
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 symbols. 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
user’s manual before attemting to use the product.
DRT-MAN-073 7
EVS 3643 User’s Manual 1. Safety Information
WARNING
Installation and environment of use
Prohibited
- Do not use or store the equipment near flammable chemical such as alcohol, thinner,
benzine, etc.
If chemicals are spilled or evaporated, it may result in fire or electric shock through contact with
electric parts inside the equipment. Also, some disinfectants are flammable. Be sure to take care
when using them.
- Do not connect the equipment to anything other than specified connectoins.
Doing so may result in fire or electric shock.
Power supply
Prohibited
- Do not 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.
- 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 equipments on cables and cords, or do not
pull, bend, bundle, or step on them. These precautions are required to be followed to
prevent sheathes of cables and cords from being peeled. Do not alter the cables and
cords.
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.
Doing so may result in fire or electric shock.
- Do not turn on the system power when condensation has formed on the equipment.
Doing so may result in fire or electric shock.
- Do not connect multiple portable socket-outlets or extension cords to the system.
Doing so 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 to each of equipment 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 to disconnect the cord.
If you pull the cord, the core wire may be damaged, resulting in fire or electric shock.
1. Safety Information
1.1. Safety precautions
Follow these saftey guides and properly use the equipment to prevent injury and damage to any equipment/data.
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EVS 3643 User’s Manual 1. Safety Information
WARNING
Handling
The system, in whole or in parts, cannot be modified in any ways without any written approval from DRTECH.
Prohibited
- 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 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 is spilled, may result in fire or electric shock.
- Do not hit or drop the equipment.
The product may be damaged if it recieves a strong jolt. Using a damaged equipment without
repair may result in fire or electric shock.
- 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
equipment.
When a problem occurs
- If any of the following problems 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, when an odd smell or abnormal sound occurs.
When liquid has been spilled into equipment or metal object has entered through an opening.
When the equipment was dropped and damaged.
Maintenance and inspection
Prohibited
- 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 agents.
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. Clean the peripherals and AC oulet with a dry cloth.
If the cord is kept plugged in for a long time in a dusty, humid or a sooty place, objects around the
plug will attract moisture, and this could cause insulation failure that could result in a fire.
- For safety reasons, be sure to turn OFF the power to each piece of equipment when the
inspections indicated in this manual are going to be performed.
Otherwise, electric shock may occur.
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EVS 3643 User’s Manual 1. Safety Information
WARNING
Battery pack and charger
- Do not use the battery pack as a power source for equipment other than EVS 3643 detectors. Be
sure to use only the dedicated battery pack for the EVS 3643 detector.
- The battery charger is designed for the dedicated battery pack. Do not use the battery charger
other than the dedicated one. Otherwise, a battery explosion or a battery leak may occur,
resulting in fire or electrical shock.
- Do not operate the battery charger using any type of power supply other than the one indicated
on the rating label.
- Do not handle the product with wet hands.
- Do not attempt to disassemble, alter, or apply heat to the product.
- Avoid dropping or subjecting the product to severe impacts. To avoid the risk of injury, do not
touch the internal parts of the battery if it has been cracked.
- Stop using the battery pack immediately if it emits smoke, a strange smell, or otherwise behaves
abnormally.
- Do not let the battery pack and battery charger come into contact with water or other liquids and
do not allow them to get wet.
- Do not clean with substances containing organic solvents such as alcohol, benzene, thinner, or
other chemicals. Otherwise, fire or electrical shock may occur.
- Do not allow dirt or metal objects (such as hair pins, clips, staples or keys) to contact the
terminals. Otherwise, battery explosion or leakage of electrolyte may occur, resulting in fire,
injury or pollution of surrounding area. If the battery leaks and the electrolytes come into contact
with your eyes, mouth, skin or clothing, immediately wash it away with running water and seek
medical attention.
- Do not leave, store, or place the product in a location near heat sources, or in a place subject to
direct sunlight, high temperature, high humidity, excessive dust, or mechanical shock. Otherwise,
battery leakage, overheating or damage to the product may occur, resulting in electrical shock,
burns, injury or fire.
- Do not attempt to use a battery pack that has deteriorated. Using a battery pack that has
exceeded its life cycle may lead to overheating, fire or explosion.
- The Lithium ion/polymer battery is recyclable.
- Battery slowly discharges even if not in use.
- The useful battery life can expire if it discharges immediately after being fully charged. You can
purchase an optional battery pack to replace an exhausted one.
- The battery pack is a consumable item. If a fully charged battery is consumed quickly, use a new
and fully charged battery pack.
- Be sure to charge the battery periodically (once a year) if it is not used for an extended period of
time. The battery pack cannot be charged if it has been over discharged.
- Before discarding the battery pack, cover the terminals with adhesive tape or other insulators.
Contact with other metal materials may cause fire or explosion.
DRT-MAN-073 10
EVS 3643 User’s Manual 1. Safety Information
WARNING
Installation and environment of use
- Do not install the equipment in any of the locations listed below. Doing so may result in
malfuction, equipment faillng, 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 heat 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 areas prone to vibration.
ㆍ On an inclined surface 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 injury of the user due to tripping over
the cable.
- Non-medical equipment such as the battery charger, and access point unit, Wireless
Charging System cannot be used in patient’s vicinity.
Patient Vicinity
Power supply
- Always connect the 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 power
supply that maintains 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 earth connections 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. In cases when the patient is injured,
do not allow liquid or chemicals to come in contact with blood or body fluids.
Doing so may result in fire or electric shock.
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 being used.
DRT-MAN-073 11
EVS 3643 User’s Manual 1. Safety Information
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 of the detector
Local load: 100 kg on an area
of 40 mm in diameter
- Be sure to use the detector on a flat surface that does not bend.
Otherwise, the internal image sensor can 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-073 12
EVS 3643 User’s Manual 1. Safety Information
System Diagnostic
Calibration
Before exposure
CAUTION
The owner is responsible for ensuring that the system diagnostic is
performed every year.
Do not try to use the system if the system diagnosis failed.
CAUTION
The owner is responsible for ensuring that the system calibration is
performed whenever the system installation is completed or the system is
repaired. Do not try to use the system if system calibration is not
performed.
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.
• The Ecali1 software runs a system diagnosis.
• Run Ecali1 software after installing the system, at least once a year. If an error occurs, report the detailed error
information to DRTECH local dealer or distributor.
• To ensure optimal performance of the system, it is important to verify that the system is calibrated.
• You can process calibration with the calibration data CD (provided).
• Be sure to check the equipment on a daily basis and confirm that it works properly.
• Suddenly 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
forms, problems may occur in the quality of captured images. When an air-conditioner is used, be sure to
raise/lower the temperature gradually so that a significant change in temperature in the room and in the
equipment does not occur, to prevent condensation.
DRT-MAN-073 13
EVS 3643 User’s Manual 1. Safety Information
During exposure
Image Backup
User Limitation
Electric Shock Hazards
• Do not use the selected frequency chanel (2.4GHz and 5GHz dual band) for other wireless devices.
Mutual interference may affect the image data transmission rate.
• Do not use the detector near devices generating a strong magnetic field. Doing so may produce image noise or
artifacts.
• To avoid missing images which might result in patient being exposed to additional doses of radiation, it is
important to send the images to PACS or back up the images by filming or by using external storage devices
such as CD, DVD, HDD, USB, etc.. This should be done as a routine operation for every patient. If the hard disk
of your workstation is about to full, the operator should backup images and manually delete the images as
administrator to make room on the hard disk for new images.
• The Ecali1 software has the technician mode which could only be operated by inputting the correct PASSWORD.
The technician mode should be operated by the personnel who are qualified by DRTECH.
• To reduce electric shock hazards, the system must be connected to an electrical ground.
• A three-contact conductor 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 There are no serviceable parts inside
equipments and adjustments should not be made. Only trained and qualified personnel should be permitted
access to the internal parts of the system.
• To reduce electric shock hazards, product is required to be well insulated with the use of appliance coupler, mains
plug, and other seperable connections.
DRT-MAN-073 14
EVS 3643 User’s Manual 1. Safety Information
Disinfection and cleaning
Operating/storage environment
Temperature
Humidity
Atmospheric pressure
Operating environment
10 to 35 ℃
30 to 85 % RH
700 to 1060 hPa
Transportation &
Storage environment
-15 to 55 ℃
10 to 90 % RH
500 to 1060 hPa
Notes on disposal
Handling the equipment
• 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 while the power is on.
• Be sure to use and store this equipment under the conditions described below:
• Do not expose this equipment to high temperatures and/or high humidity. Malfunction can 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.
• Disposal of this product in an unlawful manner may have a negative impact on health and on the environment.
Therefore, when disposing this product, be absolutely sure to follow the procedure which complies with the laws
and regulations applicable in your area.
• The expected life span of EVS 3643 system is about 3 years.
• The equipment must be handled with care to avoid personel injury or damage to the internal image sensor.
• The EVS 3643 Wireless is an advanced wireless digital radiographic equipment in the DRTECH Exprimer series.
This equipment is designed to provide the highest resolution and sensitivity in the series. In addition, the wireless
LAN (IEEE 802.11n*) communication feature improves the operability, and high-speed processing.
DRT-MAN-073 15
EVS 3643 User’s Manual 2. Introduction
Intended medical indication
Intended patient population
Considerations
Requirement description
Age
Paediatric to geriatric
Weight
>20 kg
Health
Not relevant
Nationality
Multiple
Sex
Not relevant
Patient state
Patient is user
Patient is not user
Patient is not
user
Not relevant, unless patient is agitated
2. Introduction
2.1. Features
• Wireless LAN communication (IEEE 802.11n*) includes a lightweight and thin detector that is easy to handle.
• The shape of the detector, which is identical to that of a conventional film cassette complying with ISO4090,
enables digital radiography to apply to 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. 7.86 Mega pixels) digital images within the effective imaging
area (358 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.
At the time of installation, set a specific channel in the frequency band of 5.0 GHz before using the LAN.
Note that the available frequency band for this standard varies, depending on the local radio laws,
regulations and system requirements.
2.2. Application specification
The EVS 3643 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.
DRT-MAN-073 16
EVS 3643 User’s Manual 2. Introduction
Intended part of the body or type of tissue applied to or interacted with
Intended user profile(Operator Profile)
Considerations
Requirement description
Education
Minimum
- At least graduate of radiology college
Maximum
- No maximum
Knowledge
Minimum
- Read and understand 'westernized Arabic' numerals when
written in Arial font
- Can distinguish of human body
- Understands hygiene
Maximum
- No maximum
Language understanding
Minimum
- Local language
Maximum
- Understanding of manual that is writing in English
Experience
Minimum
- Physician or legally certified operator
Maximum
- No maximum
Permissible impairments
Minimum
- Mild reading vision impairment or vision corrected to log MAR
0.2
- Average degree of aging-related short term memory
impairment
- Impaired by 40 % resulting in 60 % of normal hearing at 500
Hz to 2 kHz
1) Measurement site : body
2) Condition : Intact or wund skin
DRT-MAN-073 17
EVS 3643 User’s Manual 2. Introduction
Intended conditions of use
Considerations
Condition
Environment including hygienic requirements
Operating conditions
- Temperature: +5 ºC to +35 ºC
- Barometric Pressure: 700 hPa to 1060 hPa
- Humidity: 30 % R.H. to 85 % R.H.
Storage and delivery conditions
- Temperature: 5 ºC to +40 ºC
- Barometric Pressure: 700 hPa to 1060 hPa
- Humidity: 30 % R.H. to 85 % 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°
Frequency of use
Reusable
1 day: 200 shot
Location
In hospital environment
Mobility
Portable ME equipment to be used on a
patient
DRT-MAN-073 18
EVS 3643 User’s Manual 2. Introduction
Hospital Network
X-Ray Exposure
Battery charger stand
AP
Detector
2.3. System Configuration
2.3.1. Basic Configuration
Generally, the EVS 3643 detector is used in system configuration as illustrated below:
Figure 2.1 EVS 3643 System Configuration
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EVS 3643 User’s Manual 2. Introduction
Wireless Connection
- Use of multiple WLAN devices within the same frequency band may cause interference within
each wireless communication and slow down the transmission speed
- Do not cover or block the wireless module of the detector. Otherwise, the transmission speed or
operable distance may reduce.
- Recommended maximum operating distance of wireless communication, between the detector
and Access Point (AP), is 8 meters.
Wired Connection
The wired connection is more suitable for stabilized communication when the detector is set in a
bucky stand or on a table.
than the wireless connection.
enables the battery pack to be continously supplied with power while using the detector.
drastically.
• EVS 3643 wireless detector transmits images and data by wireless communication.
• A battery pack should be installed in the detector to use it under the wireless configuration.
• Up to 2 battery packs can be charged simultaneously from a battery charger.
• Connect EVS 3643 wireless detector and SCU / or Functional cable with a tether interface cable to make a wired
configuration.
• As the tether interface cable supplies power, a battery pack is not needed to be inserted in the detector.
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EVS 3643 User’s Manual 2. Introduction
X-ray Detector (EVS 3643)
Battery Charger
(EVS-BCS)
Battery Pack
(EVS-MBP)
Wireless Charging System
: Optional
Power adaptor (12V, 7.08A)
+ AC Power Cable(2m)
LAN Card(PCIe Giga-bit LAN)
LAN Cable (CAT.7, 15m)
Access Point
(TP-LINK TL-WDR4300)
System Synchronization Unit
(EVS-SSU01): Optional
Tether Interface(3m)
: Optional
EVS 3643 Wireless system consists of detector, system synchronization unit (SSU), CDs and relevant accessories.
(Refer to chapter 3-1 “Product Components” for CD information)
Table 2.1. EVS 3643 Packaging
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EVS 3643 User’s Manual 2. Introduction
Tether Extension Cable
( 7m )
: Optional
Generator Cable (15m)
: Optional
Functional cable (0.5 m)
+ Power Adaptor: Optional
USB Switch Box Options
- USB Switch Box
- Hand Switch
- USB Cable(1m)
- Generator Cable(1.2m)
CD(Software / Calibration)
User’s Manual (Hard Copy)
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EVS 3643 User’s Manual 3. Production Description
Part name
Remark
Flat panel detector
EVS 3643(Scintillator : CsI : Tl) 2.74 kg
EVS 3643G(Scintillator : Gadox) 2.74 kg
System synchronization unit (SSU)
EVS-SSU01 : 2.3 kg
Battery charger
EVS-BCS : 0.5 kg
Battery pack
EVS-MBP : 0.24 kg
Wireless Charging System
EVS-WPCS : 0.15 kg
CD (Software / Calibration)
Document : User ‘s Manual (PDF)
Calibration Data : MAP, PMP, GMP
Software : Econsole1, Ecali1
User’s Manual
Supported in all Modes
License Dongle Key (USB)
Needed for activating Econsole1
Tether Interface Cable (3m)
Supported in all Modes
Extension Tether Cable (7m)
Supported in all Modes
LAN Cable (15m)
Supported in all Modes
AC Power Cable (2m)
Supported in all Modes
WARNING
The use of accessories and cables other than those specified, with the exception of EVS 3643 Wireless 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.
3. Product Description
3.1. Product Components
3.1.1. Auto Trigger Mode (AT Mode)
Table 3.1. Product componets for Auto Trigger Mode
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EVS 3643 User’s Manual 3. Production Description
Part name
Remark
Flat panel detector
EVS 3643(Scintillator : CsI : Tl) 2.74 kg
EVS 3643G(Scintillator : Gadox) 2.74 kg
System synchronization unit (SSU)
EVS-SSU01 : 2.3 kg
Battery charger
EVS-BCS : 0.5 kg
Battery pack
EVS-MBP : 0.24 kg
Wireless Charging System
EVS-WPCS : 0.15 kg
CD (Software / Calibration)
Document : User ‘s Manual (PDF)
Calibration Data : MAP, PMP, GMP
Software : Econsole1, Ecali1
User’s Manual
Supported in all Modes
License Dongle Key (USB)
Needed for activating Econsole1
Tether Interface Cable (3m)
Supported in all Modes
Extension Tether Cable (7m)
Supported in all Modes
LAN Cable (15m)
Supported in all Modes
AC Power Cable (2m)
Supported in all Modes
Generator Cable (15m)
Supported in Sync. Mode
3.1.2. Synchronization Trigger Mode (Sync. Mode)
Table 3.2. Product componets for Synchronization Trigger Mode
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EVS 3643 User’s Manual 3. Production Description
Part name
Remark
Flat panel detector
EVS 3643(Scintillator : CsI : Tl) 2.74 kg
EVS 3643G(Scintillator : Gadox) 2.74 kg
System synchronization unit (SSU)
EVS-SSU01 : 2.3 kg
Battery charger
EVS-BCS : 0.5 kg
Battery pack
EVS-MBP : 0.24 kg
Wireless Charging System
EVS-WPCS : 0.15 kg
USB Switch Box
EVS-USB01
Supported in USB Mode
CD (Software / Calibration)
Document : User ‘s Manual (PDF)
Calibration Data : MAP, PMP, GMP
Software : Econsole1, Ecali1
User’s Manual
Supported in all Mode
License Dongle Key (USB)
Need for Econsole1
Hand Switch
Supported USB Mode
Tether Interface Cable (3m)
Supported in all Modes
Extension Tether Cable (7m)
Supported in all Modes
LAN Cable (15m)
Supported in all Modes
AC Power Cable (2m)
Supported in all Modes
USB Cable (1m)
Supported in USB Mode
X-ray Cable (3m)
Supported in USB Mode
3.1.3. USB SW Mode
Table 3.3. Product componets for USB SW Mode
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EVS 3643 User’s Manual 3. Production Description
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
LAN card
Gigabit (Detector only)
Intel® PRO 1000 Series (Gigabit LAN Card for network interface) Min.
Requirements : 1Gbps
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
Item
Description
SID
100 / 130 / 150 / 180 cm
Ratio
10 : 1
Frequency
125 Line/inch
Inter spacer
Al
3.1.4. Workstation (Recommended and minimum but NOT included)
Table 3.4. Workstation
3.1.5. Grid (Recommended but Not included)
Table 3.5. Grid specifications
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EVS 3643 User’s Manual 3. Production Description
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)
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EVS 3643 User’s Manual 5. Operating Procedure
Item
Description
Model
EVS 3643 / EVS 3643G
Purpose
General Radiography
Pixel Pitch
140 ɥm
Scintillator
CsI (Cesium Iodide) / Gadox (Gadolinium Oxysulfide)
Image Matrix Size
2560 × 3072 pixels
Effective Imaging Area (H x V)
358 x 430 mm
Image Acquisition and Transfer Time
< 3 sec.
Spatial Resolution
Min. 3.5 line pair/㎜
Rated Power Supply
Wireless
Wired
DC +12V, 2 A MAX.
Powered by the battery pack (4,000 mAh)
Powered by SSU using tether interface
Powered by Power adopter using tether interface
Power Consumption
Max. 24 W
Network Interface
Gigabit
Dimensions (㎜) [±0.5 mm]
386 (H) × 460 (V) × 14.5 (D)
Weight
2.98 kg
Environmental Requirements
Operational
Temperature: +10 ~ +35℃
Humidity: 30 ∼ 85% RH (Without Condensing)
Atmospheric pressure: 700 ∼ 1060 hPa
Storage and Transportation(unpacked)
Temperature: -15 ~ +55℃
Humidity: 10 ∼ 90% (Without Condensing)
Atmospheric pressure: 500 ∼ 1060 hPa
4. Parts Name and Functions
4.1. Detector
4.1.1. Detector Specification
Table 4.1. Detector Specifications
†Tether Interface:
Allows the detector to communicate with SSU via Ethernet cabling when wireless communications is not available or
when higher speed data transfer is necessary
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EVS 3643 User’s Manual 5. Operating Procedure
4.1.2. Detector Component
The detector is designed to capture radiographic images.
Captured images are transmitted to the EVS 3643 image-capture computer using the wireless/wired data transfer
Figure 4.1. Detector Components
A. Wireless antena : Transmits image data with wireless comunication (IEEE802.11n).
B. Battery Pack : Supplies electrical power to the detector while using wireless communication
C. Satatus indicators
• Power : Shows power on/off status of the detector.
• Ready : Shows data communication status and ready status of detector
(Lights on indicates that detector is busy, lights off means detector is ready)
• Link : Shows detector’s registraion and connection status.
• AP : Lamp indicating Wired/ Wireless mode (2.4 GHz / 5 Hz)
D. AP Button: Can register detector among different wireless connection options.
(Connection options: Wireless using AP/ Wireless using detector’s internal AP/ Portable mode)
E. Power Button : Turns Detector on / off
F. Connecter : Data communication and power supplying through tether cable
G. WPCS Window : Wireless Charging Rx Window
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EVS 3643 User’s Manual 5. Operating Procedure
Item
Description
Model
EVS-BCS
Simultaneous Charging
Battery Pack 2 EA
Charging Time
3 hours
Rated Power Supply
DC +12 V, 6 A Max.
Dimensions (W x H x D)
180 mm x 255 mm x 35 mm
Weight
0.5 kg
A
B
D
C
4.2. Battery Charger and Battery Pack
4.2.1. Battery Charger
4.2.1.1. Battery Charger Specifications
Table 4.2. Battery Charger Specifications
4.2.1.2. Battery Charger Components
A. Power indicator : Indicates the power on/off status..
B. Charging indicator : Indicates the charging status.
C. Battery compartment : Insert the battery pack to charge.
D. DC Input : Connect the DC adapter to supply electrical power to the battery charger
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Figure 4.2. Battery Charger
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