KTR Radisen PEDRA-1417M User manual

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Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM
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User’s Manual
PEDRA-1417M Detector (Wired & Wireless)
Before using this equipment, be sure to read this user’s manual thoroughly.
Keep this user manual where it is easily accessible.

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To customers
Thank you for purchasing a PEDRA detector. This User Manual explains how to use the detector, X-ray interface
unit, and other peripheral equipment. Before using this product, be sure to read this manual thoroughly in order
to utilize it more effectively.
Important information on usage and management of the equipment
1 Only a physician or a legally certified operator should use this product.
2 The equipment should be maintained in a safe and operable condition by maintenance personnel.
3 Use only computers and image display monitors complying with IEC 60601-1 or IEC 60950-1. For details,
consult your sales representative or a distributor.
4 Use only the dedicated cables. Do not use any cables other than those supplied with this product.
5. professional health care environment.
Disclaimer
1. In no event shall Radisen be liable for damage or loss arising from a fire, earthquake, any action or
accident by a third party, any intentional or 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
responsible for maintaining the privacy of image data.
3. In no event shall Radisen 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 responsibility of the attending physicians to provide medical care services. Radisen will not be
liable for faulty diagnoses.
5. In no event shall Radisen be liable for direct or indirect consequential damages arising from the use
or unavailability of this product Radisen shall not be liable for loss of image data for any reason.
6. In no event shall Radisen 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.

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Note on installation
Request your sales representative or distributor to install this product.
Notes on disposal of this product
Disposal of this product in an unlawful manner may have a negative impact on human health and the
environment. When disposing this product, therefore, be absolutely sure to follow the procedure which
is in conformity with the laws and regulations applicable in your area.
European Union (and EEA*) only
This symbol indicates that this product is not to be disposed with your household
waste, according to the WEEE Directive (2002/96/EC) and your national law. This
product should be handed over to a designated collection point, e.g., on an
authorized one-for-one basis when you buy a new similar product or to an
authorized collection site for recycling electrical and electronic equipment (EEE).
Improper handling of this type of waste could have a negative impact on the
environment and human heath due to potentially hazardous substances that are
generally associated with EEE. At the same time, your cooperation in the correct
disposal of this product will contribute to the effective usage of natural resources.
For more information on where you can drop off your waste equipment for
recycling, please contact your local city office, waste authority, approved WEEE
scheme, or your household waste disposal service.
*EEA: Norway, Iceland, and Liechtenstein
Trademarks
The Radisen name and Radisen logo are registered as trademarks of Radisen.
Copyright
All rights reserved.
Under copyright laws, this manual may not be reproduced, in whole or in part, without the
written permission of Radisen.
RadiSen

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Content
Safety and Regulatory.......................................................................................................................................................7
Safety Notices ...................................................................................................................................................................7
Regulatory ...........................................................................................................................................................................7
1 Safety Information..................................................................................................................................................8
1.1 Safety precautions ..............................................................................................................................................8
1.2 Symbols and detail of marking ................................................................................................................ 12
1.3 Notes for using the equipment................................................................................................................ 12
2 Introduction............................................................................................................................................................. 18
2.1 Features ................................................................................................................................................................. 18
2.2 Intended use ....................................................................................................................................................... 18
2.3 Detector Description....................................................................................................................................... 19
2.4 Power & Control Box (PEDRA-PCON) Description........................................................................ 21
2.5 Battery Charger (PEDRA-BC001) Description ................................................................................... 23
2.6 Battery (PEDRA-BT001) Description ...................................................................................................... 23
2.7 Components ........................................................................................................................................................ 24
2.8 Workstation (Recommended).................................................................................................................... 26
2.9 Grid (Recommended not included) ...................................................................................................... 27
3 Detector Installation ........................................................................................................................................... 28
3.1 Preparations ........................................................................................................................................................ 28
1. Charge /Attach the battery pack ........................................................... 28
3.2 Connection........................................................................................................................................................... 31
3.2.1 Tether Connection............................................................................... 31
3.2.2 Wireless Connection ........................................................................... 32
3.2.3 Detector AP Connection .................................................................... 33
3.3 PEDRA-PCON Connection............................................................................................................................ 34

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3.4 Turn on the detector...................................................................................................................................... 36
1. Detector status list ................................................................................... 36
3.5 Turn on the Battery Charger...................................................................................................................... 37
4 Detector Operation S/W Setting (PEDRA-DMS) ................................................................................. 38
4.1 Installation............................................................................................................................................................ 38
4.2 PEDRA Detector Manager ........................................................................................................................... 38
4.3 Calibration Procedure .................................................................................................................................... 45
5 Operation.................................................................................................................................................................. 49
5.1 Wireless Standard Configuration and Operation ........................................................................... 49
5.2 AED Mode Configuration and Operation in wired mode.......................................................... 50
5.3 Manual Mode Configuration and Operation in wired mode................................................... 51
5.4 Detector AP Configuration and Operation ........................................................................................ 52
6 Troubleshooting.................................................................................................................................................... 53
6.1 General ................................................................................................................................................................... 53
6.2 Detector................................................................................................................................................................. 53
6.3 Power& Control Box (PEDRA-PCON).................................................................................................... 53
6.4 Battery Charger ................................................................................................................................................. 53
7 Maintenance............................................................................................................................................................ 54
Daily inspection ......................................................................................................................................................... 54
Function test ............................................................................................................................................................... 55
8 Information.............................................................................................................................................................. 56
8.1 Service information......................................................................................................................................... 56
8.2 Warranty................................................................................................................................................................ 57
9 Revision History .................................................................................................................................................... 58
Annex.1 Generator Interface....................................................................................................................................... 59
1. X-ray SYNC........................................................................................................................................................... 59
2. Tether Cable Pin assignment..................................................................................................................... 59
Appendix.2 Detector IP setting................................................................................................................................. 60

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Appendix.3 Specifications ............................................................................................................................................ 61
1. PEDRA-1417M Specifications .................................................................................................................... 61
2. PEDRA-17F Dimensional diagram ........................................................................................................... 62
3. PEDRA-PCON...................................................................................................................................................... 63
4. Battery Pack ........................................................................................................................................................ 64
5. Battery Charger ................................................................................................................................................. 65
Appendix.4 Label and Symbols................................................................................................................................. 66
1. Detector................................................................................................................................................................. 66
2. Power & Control Box (PEDRA-PCON) .................................................................................................. 67
3. Battery Charger ................................................................................................................................................. 68
4. Battery Pack ........................................................................................................................................................ 68
5. Shipment Label.................................................................................................................................................. 69
Annex . 5 Regulatory Information........................................................................................................................... 70
1. Medical equipment safety standards.................................................................................................... 70
Annex .6 Serial Number (S/N) composition ...................................................................................................... 72
Annex .7 Guidance and Manufacturer’s Declaration for EMC................................................................. 74
Annex. 8 X-ray condition (Referenced) ................................................................................................................ 77
Annex. 9 Wireless Communication Specification............................................................................................ 78
Annex. 9 Default value of detector initialization ............................................................................................ 78

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Safety and Regulatory
Safety Notices
The following safety notices are used to emphasize certain safety instructions. Follow the safety instructions
in this manual along with warnings and cautions symbols. Ignoring such warnings or cautions while
handling the product may results in serious injury or accident. It is important for you to read and under-
stand the contents of this manual before attempting to use the product.
Warning
This notice is used to indicate a potentially hazardous situation which may cause death, severe
personal injury or substantial property damage if the instructions are ignored.
Caution
This notice is used to indicate a potentially hazardous situation which may cause minor personal
injury or substantial property damage if the instructions are ignored.
Regulatory
Caution
Federal law restricts this device to sale by or on the order of a physician.

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1 Safety Information
1.1 Safety precautions
This product is designed and manufactured to ensure maximum safety of operation and to meet all the
safety requirements applicable to electronic medical equipment. Follow these safeguards and properly use
the equipment to prevent injury or damage to any equipment or data.
Warning
Installation and environment of use
Do not use or store the device near flammable chemicals such as alcohol, thinner, benzene, etc. If
chemicals are spilled or evaporate, it may result in a fire or electric shock through contact with electric
parts inside the device. Also, some disinfectants are flammable. Be sure to take care when using them.
Do not connect the device with anything other than specified.
Doing so may result in fire or electric shock.
Always be alert when operating this device. If a malfunction occurs, do not use this device until
qualified personnel correct the problems.
The product should be installed, maintained, and serviced according to manufacturer maintenance
procedures and by manufacturer personnel or other qualified maintenance personnel approved in
writing by manufacturer. Operation and maintenance should be done in strict compliance with the
operation instructions contained in the manual.
The system, in whole or in part, cannot be modified in any way without written approval from manufacturer.
Adapter
Do not operate the device using any type of adapter other than the one indicated on the rating label.
Otherwise, it may result in a fire or electric shock.
Do not handle the product with wet hands. You may experience an electric shock that could result in
death or serious injury.
Do not place a heavy object such as medical device on cables and cords, and do not pull, bend, bundle,
or step on them. Doing so may damage their sheath. If you alter them, it may damage the cords which
could result in a fire or electric shock.

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Do not connect a multiple portable socket-outlet or extension cord to the system.
Doing so may result in a fire or electric shock.
Warning
Handling
Never disassemble or modify the device. Doing so may result in a fire or electric shock. Also, since the
device incorporates parts that may cause an electric shock as well as other hazardous parts, touching
them may cause death or serious injury.
Do not place anything on top of the device. The object may fall and cause an injury. Also, if metal objects
such as needles or clips fall into the device, or if liquid is spilled, it may result in a fire or electric shock.
Do not hit or drop the device. The device may be damaged if it receives a strong jolt. if the device is
used without being repaired this may result in a fire or electric shock.
Have the patient take a fixed posture and do not let him or her touch parts unnecessarily. If the
patient touches connectors or switches, it may result in electric shock or malfunction of the device.
When a problem occurs
Should any of the following occur, immediately turn OFF the power to each piece of device, unplug the
power cord from the AC outlet, and contact our sales representative or distributor.
When there is smoke, an odd smell or abnormal sound.
When liquid has been spilled into the device or a metal object has entered through an opening
When the device has been dropped and is damaged
Maintenance and inspection
When the device is going to be cleaned, be sure to turn OFF the power of each equipment and unplug
the power cord from the AC outlet. Never use alcohol, benzene, thinner, or any other
flammable cleaning agent. Otherwise, it may result in a 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 outlet with a dry cloth.
If the cord is kept plugged in for a long time in a dusty, humid or sooty place, 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 device when the inspections in-
dicated in this manual are going to be performed. Otherwise, electric shocks may occur.

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Warning
Installation and environment of use
Before authorizing any person to operate the system, verify that the person has read and fully un-
derstood the User Manual. The owner should make certain that only properly trained and fully qualified
personnel are authorized to operate the equipment. An authorized operators list should be main-
tained.
It is important that this User Manual be kept at hand, studied carefully, and reviewed periodically by
the authorized operators.
Do not install the equipment in any of the locations listed below. Doing so may result in failure or
malfunction, device falling, fire, or injury.
Close to facilities where water is used
Where it will be exposed to direct sunlight
Close to the air outlet of an air-conditioner or ventilation device
Close to a heat source such as a heater
Where the power supply is unstable
In a dusty environment
In a saline or sulfurous environment
Where temperature or humidity is higher than the operating temperature
Where there is freezing or condensation
In areas prone to vibration
On an incline or in an unstable area
Because the device 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 device or injury to the user from
tripping over the cable.
Non-medical equipment such as the Power supply cannot be used in patient’s vicinity.
Warning
Handling

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Do not spill liquid or chemicals onto the detector. In cases where the patient is injured, do not allow it
to come in contact with blood or other body fluids.
Doing so may result in a fire or electric shock. In such a situation, protect the device with a
disposable covering as necessary.
Turn OFF the power to each piece of equipment for safety when not being used.
Do not submerge the device in water.
The internal image sensor may be damaged if the equipment is hit, dropped, or receives a strong jolt.
Also, do not place excessive weight on the detector.
<Load Limit>
Uniform load: 150kg over the whole area Local load: 100kg on an area 40 ㎜
of the detector surface in diameter

B
e
s
u
r
e
to use the detector on a flat surface so 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.

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1.2 Symbols and detail of marking
Symbol Description
Direct Current
Alternating Current
This mark indicates that this equipment must be handled with care.
Do not jolt or apply excessive load to the equipment.
General warning sign
Attention, consult accompanying documents
Read and understand all instructions and warning labels in the product documen-
tation before using the equipment. Keep manual for future reference.
This mark indicates that this is a Type B Applied Part according to UL 60601-1 and EN
60601-1.
Indicates the temperature limits to which the medical device can be safely
exposed.
This mark indicates that the equipment must be collected separately under the
Directive on Waste Electrical and Electronic Equipment 2002/96/EC (WEEE) in the
European Union. (For European Union)
Indicates the medical device manufacturer, as defined in EU Directives
90/385/EEC,93/42/EEC and98/79/EC.
Indicates the date when the medical device was manufactured.
Indicates the Authorized representative in the European Community.
This mark shows compliance of the essential requirement and other relevant provi-
sions of Directive 93/42/EEC.
1.3 Notes for using the equipment

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When using the device, take the following precautions. Otherwise, problems may occur and the
device may not function correctly.
Image Backup
To avoid missing images which might result in the patient being exposed to additional doses of ra-
diation, it is important to backup images by filming or using a CD or DVD option. This should be done
as a routine operation for every patient.
If the hard disk of your workstation is about to be full, the operator should backup images and delete them
to make storage (memory) space on the hard disk for new information (patient).
User Limitations
The PEDRA-DMS (Detector Managing Software) has the technician mode and this mode should be
operated by the personnel who are qualified by the manufacturer
Disposal
Disposal of this product in an unlawful manner may have negative effects on human health and 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.
Before exposure
Be sure to check the device daily and confirm that it works properly.
Sudden heating of the room in cold areas will cause condensation to form on the equipment. In this case,
wait until the condensation evaporates before performing an exposure. If the equipment is used while
condensation is formed in it, 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 difference
between the temperature in the room and in the equipment does not occur, which prevent con-
densation.
During exposure
This device is not protected (sealed) against liquids such as blood and medicine in the operating room.
If necessary, wrap the equipment in a disposable cover when using.
Do not use the detector near devices generating a strong magnetic field. Doing so may produce image
noise or artifacts.
Cleaning and Disinfection

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After using the detector and its peripheral device for examination, wipe the patient contact surfaces of the
detector and peripheral device (attached handle included), by disinfectants such as IPA and ethanol to prevent
infection. For details on how to sterilize, consult a specialist.
Use a dry cloth slightly damped with such disinfectants to wipe the surface of the detector and its
peripheral equipment.
Do not spray the detector directly with disinfectants or detergents.
Do not clean the detector with substances containing organic solvents such as alcohol, benzene, thinner, or
other chemicals. Otherwise, it may result in an unwanted fire or electrical shock or structural weakening of
the detector.
Do not use an abrasive brush, scraper, or acid/alkaline cleaner when cleaning the detector and other
equipment.
Do not clean the detector with its power on.
Pediatric Application
Every request should be reviewed by a pediatric radiologist prior to beginning the examination to ensure that
an appropriate study is being performed.
If the technologist notices an unusual request, he or she must contact a pediatric radiologist.
Examples, include orders- a Full Cervical, Thoracic, and Lumbar Spine series. The pediatric radi-
ologist should contact the ordering physician and decide which study is best for the pediatric
patient.
The technologist should use a proper technique considering the patient’s size to decrease the radiation dose
when he or she acquires diagnostic images.
ALL pediatric patients shall be shielded for their X-ray examinations, except for when the shield will
obscure the region of interest, as in a pelvic or SI joint X-ray for trauma or arthritis, or when it is physically
or clinically unreasonable to shield the patient. For routine Hip X-Rays, ALL male children shall have their
scrotum shielded using the small gonadal shield while females may not be shielded because doing so
would obscure the hips.
To minimize motion in infants and young children, swaddle the infant. Use distraction tools to
improve cooperation and projectors with child-friendly themes, music, toys with flashing lights or
music, child- friendly images on the ceiling or walls, singing, counting, and a parent reading and
talking to the child through the console all can help reduce anxiety and comfort the child.
A scoliosis series will consist of a single frontal standing view of the spine. No lateral view or supine view
is needed, unless specifically asked for by the Orthopedist or Radiologist. If the female’s breasts can be
shielded without obscuring the spine, breast shields should be used.
Operating/storage environment

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The device is mainly for use in X-ray exposure rooms and hospital wards. To use it in other places, consult
our sales representative or a distributor.
Be sure to use and store this equipment under the conditions described below:
Parameter Factor Value Units
AC/DC Adapter setting
(when supplying from t
he
output source of Adapter)
Voltage +/-10% of rated
voltage Vac
Frequency 50/60 Hz
Environmental
Pressure
Operation 700 to 1060 hPa
Storage/Ship 500 to 1060 hPa
Humidity
Operation 20 to 75 % RH
Storage/Ship 10 to 95 % RH
Temperature
Operation 10 to 40 °C
Storage/Ship -15 to 55 °C
Contact duration by
operator 10 s ≤ t < 1 min
Operator Accessible Part Enclosure of Power Supply and X-ray Detector
Contact duration by
Patient 1 min ≤ t < 10 min
Patient Accessible Part Enclosure of X-ray Detector (PC Film)
Material Group IIb
Pollution Degree 2
Overvoltage Category II(When supplying from Power Supply)
Max. working condition
(Digital X-ray Flat Panel
Detector & Power Supply
for wired communication)
Continuous operated with fully charged
battery and cycles for image capture
and transmission from Detector to PC
Max. working condition
(Digital X-ray Flat Panel Continuous cycles for image capture and transmission from Detector to PC

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Detector & Power Supply
for wireless
communication)
Do not expose this device to high temperatures and/or high humidity. Malfunctions may 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.
Others
Do not use this device in combination with peripherals such as defibrillators or large electric motors as
these may cause power-supply noise or power supply voltage variations. Doing so may prevent normal
operation of this equipment and peripherals.
Patient Population
• Age: Infant to geriatric.
For purposes of this user manual, we are defining pediatric subpopulations as shown below.
Pediatric Subpopulation Approximate Age Range
newborn birth to 1 month of age
infant 1 month to 2 years of age
child 2 to 12 years of age
adolescent 12-21 years of age
•Adult patient, Body type (age 22 or above)
Body type is divided considering the patient height and weight which are shown as below BMI (body mass
index) table.
• Health: Patients requiring an X-ray may have conditions ranging from mild trauma to chronic, life threatening
illnesses.
BMI Weight Status
Below 18.5 Underweight
18.5 – 24.9 Normal
25.0 – 29.9 Overweight
30.0 and Above Obese

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2 Introduction
PEDRA 1417M detector is a digital X-ray flat panel detector which has 35 ㎝ x 43 ㎝ imaging area and com-
municates with wired and wifi communication feature, Giga-bit Ethernet communication method through
connecting a tether cable and wifi router. The device intercepts x-ray photons and the scintillator emits visible
spectrum photons that illuminate an array of photo (a-SI)-detector that creates electrical signals. After the
electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor.
This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and
transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient
diagnosis, all kinds of information management, and sharing of image information on network.
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 143 μm of pixel pitch and CsI (Cesium Iodide) / GdOS (Gadolinium Oxysulfide)used for
the scintillator produces high-resolution digital images within the effective imaging area (CsI: 350 x 430
㎜) 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.
Wireless LAN communication (IEEE 802.11 a/b/g/n) includes thin detector that is easy to handle.
At the time of installation, set a specific channel in the double frequency band of 2.4 ㎓/5 ㎓ 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 Intended use
The PEDRA 1417M detector is indicated for digital imaging solution designed for general radiographic
system for human anatomy. It is intended to replace film or screen based radiographic system in all
general-purpose diagnostic procedures. It is not to be used for mammography.

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2.3 Detector Description
The detector is designed to capture radiographic images.
Captured images are transmitted to the viewer computer through a wired and wireless con-
nection.
A. POWER button: Controls the detector power on/off
B. Status indicators
a. Power LED: Indicates power on/off status
(Blue).
b. Network LED: Network Connection status
of wired mode (Green)
c. Exposure status : Shooting signal of dark
and X-ray (Yellow)
d. Wifi LED: Wireless status of AP mode
(Green)
e. Battery LED: Battery power (Green)

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C. Tether port: Allows the detector to communicate with the Power Supply via tether cabling
(Gigabit Ethernet)1000 BASE-T).
D. Wifi Antenna
E. Battery Connector
(1) Battery connection parts
(2) AP mode On/Off button: User can select AP mode or Wifi (or tether) mode.
(3) SD card Slot : saved images storage
E