Rayence RY1417WGA Medical Image Processing Unit User Manual

Download:
Mirror Download [FCC.gov]
Document ID	1934732
Application ID	X2mmZ3kE2TfFKxdzrhw0jw==
Document Description	User Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	476.36kB (5954512 bits)
Date Submitted	2013-04-08 00:00:00
Date Available	2013-10-05 00:00:00
Creation Date	2013-04-02 22:31:00
Producing Software	doPDF Ver 7.3 Build 387 (Windows 7 Business Edition (SP 1) - Version: 6.1.7601 (x86))
Document Lastmod	0000-00-00 00:00:00
Document Title	User Manual

Release Version 1.0.0
Medical Image Processing Unit
1417WGA
User Manual
© Copyright 2012, Rayence Co. Ltd.
All pages of this document contain proprietary and confidential
information of Rayence Corporation and are intended for exclusive use
by Rayence Corporation personnel or customers. Copying, disclosure to
others or other use is prohibited without the express written
authorization from Rayence Corporation. Please report any violations of
requirement to Rayence Corporation.
R-M-012-121030
Attention
For improvement of product performance, supplementation, or follow-up of information; the
contents of this manual are subject to change without separate prior notice.
Please note that our company has neither responsibility for any accidents nor obligation to
do free repair service for any damage of the equipment due to user's mistake, which resulted
from failure to follow the contents in this manual. Make sure to be familiar with the safety
precautions and usage procedures. Also note that the product may slightly differ from the
contents of this manual depending on specification.
The following marks are used for the effective use of the product in this manual.
Attention, consult accompanying documents.
This is used to emphasize essential information. Be sure to read this
information to avoid incorrect operation.
This indicates hazardous situation which, if not heeded, may result in
minor or moderate injury to you or others, or may result in machine
damage.
This indicates a potentially hazardous situation which, if not heeded, could
result in death or serious injury to you or others.
Federal Law restricts this device to sale by or the order of a radiologist or
any other practitioners licensed by the law of the state in which that
person practices to use or order the use of the device.
R-M-011-121030
Contents
Introduction ........................................................................................ 1
Intended use ...................................................................................... 1
Product features ................................................................................ 2
Product components ......................................................................... 3
Components Description................................................................... 5
Warning .............................................................................................. 8
Caution ............................................................................................. 10
Marking and labeling symbols ........................................................ 12
Notes for Using the Detector............................................................ 14
Preparing.......................................................................................... 14
Handling ........................................................................................... 15
Handle Assembly ............................................................................. 15
Before Exposure .............................................................................. 17
During Exposure .............................................................................. 17
Limit of Load .................................................................................... 19
Disinfection and Cleaning ............................................................... 20
Others............................................................................................... 20
Technical Features ........................................................................... 21
Mechanical Features........................................................................ 21
Electrical Features ........................................................................... 21
Environmental requirement............................................................. 24
PC Requirements ............................................................................. 25
Installation........................................................................................ 26
General interface ............................................................................. 26
Connection ....................................................................................... 27
IP set up ........................................................................................... 32
Using Web Manager (IP, SSID Change / Upgrade FW) ................... 33
Calibration ........................................................................................ 37
General Principle ............................................................................. 37
Calibration........................................................................................ 39
Image Acquisition Test..................................................................... 44
Program setup ................................................................................. 44
Get Image ......................................................................................... 45
View Images ..................................................................................... 46
Operation .......................................................................................... 51
Recommend ..................................................................................... 51
Switching power on / off.................................................................. 51
Storage ............................................................................................. 51
Information ....................................................................................... 52
Safety standard ................................................................................ 52
Electromagnetic Compatibility Information .................................... 54
FCC Notice ....................................................................................... 59
Maintenance ..................................................................................... 61
Maintenance ..................................................................................... 61
Cleaning ........................................................................................... 61
Inspection ........................................................................................ 62
Disposal or Recycling............ 오류! 책갈피가 정의되어 있지 않습니다.
R-M-012-121030
Appendix ........................................................................................... 64
Introduction
Overview
The 1417WGA is a wireless digital X-ray flat panel detector that
can generate images of any part of the body. The wireless
LAN((IEEE 802.11a/g/n) communication feature improves the
operability, and high-speed processing. This X-ray imaging
system consists of a scintillator directly coupled to an a-Si TFT
sensor. It makes high-resolution, high-sensitive digital images.
Intended use
For U.S.A.
1417WGA Digital Flat Panel X-Ray Detector is indicated for
digital imaging solution designed for human anatomy including
head, neck, spinal column, arm, leg and peripheral (foot, hand,
wrist, fingers, etc.). It is intended to replace film based
radiographic diagnostic systems and provide a case diagnosis
and treatment planning for physicians and other health care
professionals. Not to be used for mammography.
For European Union
This device provides digital X-ray imaging for diagnosis of
disease, injury, or any applicable health problem. The image is
obtained as the result of imaging X-rays passed through the
human body with an X-ray flat panel detector and importing a
digital signal output from the detector into the image processor.
R-M-011-121030
2
R-M-012-121030
Product features

Wi-Fi (802.11a/g/n)

Based on a-Si TFT active matrix

Compact (15.9mm thickness) and light weight (Typ. 3.6kg)

Limiting Resolution : 3.9 lp/mm

14-bit digital output

Easy integration
R-M-012-121030
Product components

Photo
Medical Image Processing Unit
Item
Part Name
Quantity
Detector
SD1417WGA
Handle
Battery pack
RB37WH
Battery charger
RC120W
Charger adapter
PMP120-13-3
AGI
RA001A
R-M-012-121030



Cables
Item
Part Name
Length Quantity
Link cable
VRH076A
6m
PInterface
cable
VRH017A
8m
USB
cable(A to VRH078A
B)
1.8m
AC Power
VRH018A/019A
cord
1.8m
Installation CD
Manual
Detector Library
Additional Battery
Charger for the Car
Cover Bag
AP package
Option
R-M-012-121030
Components Description
The detector is designed to capture radiographic images.
Captured images are transmitted to PC using the wireless/wired
connection.
The SparkLAN WPEA-121N 802.11 a/b/g/n half mini PCI-e
module is implemented. It supports 2T2R (2 transmit 2 receive)
MIMO technology, which delivers throughput up to 300Mbps.
1417WGA (FCC ID: QIIRY1417WGA) in the RF module (FCC ID:
PPD-AR5BHB116) does not use DFS band.
The module adopts the latest 802.11n Dual-Band technology
(2.4Ghz and 5Ghz). The transmitter of the module is powered by
host equipment(Detector). The antennas are 2 printed-dipole
antennas.
(1) Detector
1. LED indicator: The LED indicates the state of detector.
i. Green on : Power on.
ii. Blue blinking : Wireless Connection.
iii. Orange on : Low battery.
2. Handle : Hold this handle when carrying the sensor unit. It is
removable.
3. Handle unlock-lever : This is an unlock-lever to remove handle.
R-M-012-121030
4. Link cable connector : This is a connector for Wire communication
and power supplying. Connect the detector to PC and SMPS(not
provided) using Link cable.
5.
CFRP(Carbon Fiber Reinforced Plastic) : The part of the patient’s
body to which an image is to be taken should be placed against this
plate.
6.
Power button : Power on / Power off switch.
7.
Shock sensor : Detector has built-in 4 Shock sensors. It detects
and records impact and mishandling of fragile
8.
Battery unlock-lever : This is an unlock-lever to remove battery.
(2) Battery & Charger
1. Battery : Lithium ion battery. The number of times being acquired
image is 600 images(@ cycle time : 15s). The batteries last 2.5
hours and are rechargeable.
2. Charger : Two port cradle type.
3. LED indicator :
i. Orange on : charging
ii. Green on : Charging is completed.
R-M-012-121030
(3) AGI
1. Trigger connector: This is a connector for synchronization
between detector and generator. Connect the AGI to the generator
using P-interface cable..
2. USB connector: This is a connector for communication between
AGI and PC. Connect the AGI to the PC using USB cable.
R-M-012-121030
Warning
Make sure
to observe
the following right
Environment of Use and Storage
Follow the specified process of operational instructions written in
this manual for the safety of the users and patients.
Does not use or store the instrument near any flammable
chemicals such as thinner, benzene, etc. Also, this instrument is
not a category AP or APG equipment. If chemicals are spilled or
evaporate, it may result in fire or electric shock through contact
with
electric
parts
inside
the
instruments.
Also,
some
disinfectants are flammable. Be sure to take care when using
them.
Connection
Do not connect the instrument with anything other than specified.
Otherwise, it may result in fire or electric shock.
Handling
Always be sure to keep checking the condition of the system and
the patient to ensure they are normal during the use of the
instrument. If any problem is found, take appropriate measures,
such as stopping the operation of the instrument, as required.
Never disassemble or modify the product as it may result in fire
or electric shock. Also, since the instrument incorporates parts
that may cause electric shocks and other hazardous parts,
touching them may cause death or serious injury.
Do not hit or drop the instrument. The instrument may be
damaged if it receives a strong jolt, which may result in fire or
electric shock if the instrument is used without being repaired.
R-M-012-121030
When Problem Occurs
Should any of the following occur, immediately turn OFF the
power of each instruments, unplug the power supply cord from
the AC outlet, and contact Rayence representative or distributor.

When there is smoke, odd smell or abnormal sound.

When liquid has been spilled into the instrument or a metal
object has entered through an opening.

When the instrument has been dropped and it is damaged.
Maintenance and Inspection
For safety reasons, be sure to turn OFF the power of each
Make sure
to observe
the following right.
instrument when the inspections indicated in this manual are
going to be performed. Otherwise, it may result in electric shock.
When the instrument is going to be cleaned, be sure to turn OFF
the power of each instrument, and unplug the power supply cord
from the AC outlet.
The instrument must be repaired by a qualified engineer only. If it
is not repaired properly, it may cause fire, electric shock, or
accident.
10
R-M-012-121030
Caution
Environment of Use and Storage
Do not install the instrument in a location with the conditions
listed below. Otherwise, it may result in failure or malfunction,
cause fire or injury.

Close to facilities where water is used.

Where it will be exposed to direct sunlight.

Close to air-conditioner or ventilation equipment.

Close to heat source such as a heater.

Prone to vibration.

Insecure place.

Dusty environment.

Saline or sulfurous environment.

High temperature or humidity.

Freezing or condensation.
Do not place the storage case in a location with the conditions
listed below.

Where the cable of the sensor unit will be strongly pulled
when the sensor unit is put into the case, otherwise, the cable
may be damaged, resulting in fire or electric shock.

Where someone might get their foot caught in the cable of the
sensor unit. Otherwise they could trip over, resulting in injury
11
R-M-012-121030
Handling
Do not spill liquid or chemicals onto the instrument or, in cases
where the patient is injured, allow it to become wet with blood or
other body fluids, as doing so may result in fire or electric shock.
In such situation, protect the instrument with disposable covering
as necessary.
Wipe the CFRP plate of the sensor unit with ethanol or
glutaraldehyde solution to disinfect it each time a different patient
uses the instrument, in order to prevent infection.
Turn off the power of each instrument for safety when they are
not going to be used.
Maintenance and Inspection
For safety reasons, be sure to inspect the instrument before
using it. In addition, carry out a regular inspection at least once a
year.
Modifications
Any changes or modifications in construction of this device which
are not expressly approved by the party responsible for
compliance could void the user's authority to operate the
equipment.
12
R-M-012-121030
Marking and labeling symbols
Symbols
Meaning
Caution : “Attention, see instructions for use”
Manufacturer
Date of manufacture
Serial number
WEEE : Waste Electrical
and Electronic
Equipment
Authorized representative in the European
Community
CE symbol grants the product compliance to
the European Directive for Medical Devices
93/42/EEC as a class Ⅱa device. Authorized by
Notified Body SGS (code no.:0120) of British
non-ionizing radiation
13
R-M-012-121030
Labels
Detector label
Battery label
14
R-M-012-121030
Notes for Using the Detector
Preparing
Fully charge the battery pack. Charge the battery on the day of
examination or on the previous day.
 Battery slowly discharges even of not in use. The battery
pack may have expired if it discharges immediately after
being fully charged. You can purchase an optional battery
pack to replace an exhausted one.
 Be sure to fully charge the battery before use.
※ The battery charger, RC120W is designed for the
dedicated battery pack.
※ When the detector will not be used for some time, remove
the battery pack.
Attach the battery pack. Align the claw on the battery pack and
the groove on the battery bay. Insert the battery pack fully. Push
down the battery pack. Slide the lock lever toward (lock) side and
lock it.
15
R-M-012-121030
Handling
Handle the instrument carefully, as it may be damaged if
something is hit against it, dropped, or receives a strong jolt.
Handle Assembly
※ Insert the handle always in the same direction.

Handle Assembly
16
R-M-012-121030
Please confirm lever position. When the
handle is locked, the lever should be
same position with the right picture.
Insert the handle in
the same direction
If the
handle is
not locked,
the detector can be
dropped.
17
R-M-012-121030
Before Exposure
Be sure to check the equipment daily and confirm that it works
properly.
Sudden heating of the room in cold areas will cause
condensation to form on the instrument. In this case, wait until
condensation disappears before performing exposure. If the
instrument is used with condensation formed on it, problems may
occur in the quality of the instrument. When an air-conditioner is
going to be used, be sure to raise/lower the temperature
gradually so that a difference in temperature in the room and in
the
instrument
does
not
occur,
to
prevent
forming
of
condensation.
During Exposure
Do not use the detector near devices generating a strong
magnetic field. Doing so may produce image noise or artifacts.
Do not apply excessive weight to the sensor unit. Otherwise, the
sensor may be damaged.
18
R-M-012-121030
 Sleep Mode/Wake up
Do not
change
parameters
except “Control e”
Control “e” parameter : sleep time
0 : disabled (default)
1 : 1 sec
2 : 2 sec …
600 : 600 sec
 If you set sleep time, the detector goes to the sleep mode after “N” sec after
acquiring image
 If you want to wake up the detector, Press the power button(less than 1 second)
19
R-M-012-121030
Limit of Load
Uniform load: 150 kg over the whole area of sensor window.
Local load: 100 kg on an area 40 mm in diameter.
20
R-M-012-121030
Be sure to use the sensor unit on a flat place so it will not bend.
Otherwise, the sensor may be damaged.
Disinfection and Cleaning
Do not spray the detector directly with disinfectants or detergents.
Do not use anything other than neutral detergent for cleaning the
cover of the instrument. Otherwise, the coating will be corroded.
Others
Be sure to reconnect the cables to the proper connectors.
Otherwise, the instrument may malfunction or may be damaged.
21
R-M-012-121030
Technical Features
Mechanical Features
Size
450 x 417 x 15.9 mm
Weight
3.6 kg (not incl. Handle)
Encapsulation Material
Mg
Window Material
Carbon fiber plate with 1.2 mm thickness
Electrical Features
Detector
Sensor Type
Amorphous Silicon with TFT (Single Panel)
X-ray Converter
Gd2O2S:Tb
Total Pixel Number
2816 × 3328 pixels
Active Pixel Area
35.8 cm × 42.3 cm
Active Pixel Number
2270 × 3280 pixels
Pixel Pitch
127 μm
Limiting Resolution
Max. 3.9 lp/mm
Energy Range
40 - 150 kV
A/D Conversion
14 bits
Frame Rate
240 fph
Preview Time
< 3.0 sec
Charge Integration
Time
upto 4 sec
Max. Linear Dose
Typ. 70 μGy @ SID 1500 mm
Saturation Dose
Typ. 80 μGy @ SID 1500 mm
Data Interface
Wireless
Wi-Fi (802.11a/g/n)
Wired
Gigabit Ethernet

Under RQA5 condition (70kVp, 21mmAl)

Preview time may vary by complex factors
22
R-M-012-121030
Battery
Size
232.5 x 132.8 x 7 mm
Weight
Typ. 0.3 kg
Input
12.5 VDC
Output
11.1 VDC
Charging time
Typ. 2.5 hours
Capacity
Typ. 3400 mAh
The number of times
being acquired image
600 images
The Battery level can be displayed on the LED status of battery.
If the battery level goes down under 25%, please charge the
battery
Battery level
Display
75~100 %
50~75 %
25~50 %
0~25 %
Charger
Size
267.5 x 100 x 77 mm
Weight
Typ. 0.86 kg
Input
20 VDC
Output
11.1 VDC
Adapter
Size
160 x 76 x 43.7mm (cable length: 1.28m)
Weight
Typ. 0.92 kg
Input
100~240 VAC, 47~63 Hz, 1.4~0.6A
Output
20 VDC, Max 6.0A
23
R-M-012-121030
Wireless Spec
Standard
802.11a/g/n compliance
Peak Rate
300Mbps
Frequency
2.4 GHz / 5 GHz
Bandwidth
20MHz/40MHz
MIMO
2x2
※ Recommended Maximum operable distance : 7m
(From the Access Point)
※
5150~5250 MHz band is restricted to indoor operations only. (for FCC)
5150~5250 MHz band is restricted to indoor operations only. (for CE)
5150~5250 MHz is indoor use only. (for Japan)
24
R-M-012-121030
Environmental requirement
Storage condition
Item
Min.
Temperature
Typ.
Max.
Unit
-20
55
℃
Humidity
10
80
Pressure
70
106
Note
H.R.
kPa
16ms,
Shocks
(Wrapping
condition)
10G
1000times, in
(25G)
6directions,
non-Driving
10-150Hz,
Vibrations
(Wrapping
condition)
2G
10Sweeps,
(10G)
1min/Octave,
XYZ axis
Operation condition
Item
Min.
Temperature
Typ.
Max.
Unit
35
℃
Humidity
30
75
Pressure
70
106
Note
H.R.
kPa
※ Regularly changed parts : Battery (warranty 6 months)
25
R-M-012-121030
PC Requirements

Processor : At least Intel Pentium IV HT with 2.8GHz, Intel
Core Duo / Core 2 or comparable AMD Dual Core processor

At least 2 GB RAM

At least 40 GB hard disk for the software, in addition to the
required archive capacity for image storage

Upper that Intel® Gigabit Network card

Graphics card/monitor : Resolution of at least 1,280 x 1,024
pixels in True Color mode

OS : Windows XP, vista, 7(32/64 bit)
26
R-M-012-121030
Installation
The Detector is composed of sensitive electronic parts and
Portable
Imaging
processing
unit must be
installed in a way
that enables the
user to achieve
optimal use
components. It is recommended to use the product in a clean
place and to exercise caution to ensure that it is not affected by
dust or liquids. It is recommended to Use a dry and soft cloth to
clean the detector housing.
General interface
※ The 1417WGA(incl. WLAN module) is as Client, and AP(Access Point) needs to be
bought by local end-user. Since the AP is set up as the locally available frequency,
the module just uses the frequency received from AP.
27
R-M-012-121030
Connection
Power Connection
A. Connect the battery pack or power cable to the equipment.
B. Connect the USB cable from your PC to AGI.
※ Be sure to sure only the dedicated battery pack, RB37WH
for 1417WGA.
Wireless Communication
A. AP Router(Line sharer) setting
- SSID : Griffon
- Internal network
- IP address : 2.2.2.1
- Subnet mask : 255.255.255.0
- Dynamic IP allocation range : 2.2.2.2~2.2.2.254
- Pre-Shared Key(Password) : project302
- Authentication methods : WPAPSK or WPA2PSK
- Password methods : TKIP/AES
- AP IP : 2.2.2.1
- Channel (Frequency)
- Avoid crowded channel
(Using wireless detector under crowded channel result
in low performance)
- If available, Use ‘Auto-Channel Selection’ function
of router to find optimal channel
28
R-M-012-121030
B. Reception Indicator
Link LED flickering
Blink Speed : Slow – Low link quality
Fast – High link quality
C. Checking Link Quality
- After wireless connection is established, perform ‘Get Bright’
in ‘Calibration’ tap.
- Check the value named ‘Wireless Signal’ in black log screen.
Wireless Signal = Link Quality (Max. 100)
The value ‘Wireless
Signal’ will be
displayed here
29
R-M-012-121030
Trigger Connection
A. Connect the P-interface cable to the generator
X-ray Generator Connection
Make
assurance
doubly sure
SIGNAL RATING
before connection.
Connect the P-interface cable between the AGI box and X-ray
generator.
A. Wired Mode 1 : P-interface cable mode
Operating description
30
R-M-012-121030
The window time can be changed. Refer to the following pictures
31
R-M-012-121030
Exposure
Time(*clk)
1333333 is
designate to 0.5sec
32
R-M-012-121030
IP set up
[My Network Places] → [Properties] → [Local Area Connection]
→ [Properties] → [Internet Protocol (TCP/IP)]
→ [Use the following IP address]
IP address : Obtain an IP address automatically
IP address : Obtain an IP address automatically
33
R-M-012-121030
Using Web Manager (IP, SSID
Change / Upgrade FW)
Change IP Address of Detector
A. Turn on Detector and connect to PC
(wired connection is recommended)
B. After detector boot up, Launch web-browser
(Optimized for Chrome/Internet Explorer)
C. Connect to “http://[Detector’s IP]“
D. Select IP address to change from drop-down menu
34
R-M-012-121030
E. Click “SUBMIT”
F. Restart detector(Turn Off then On)
Change SSID and PSK(Pre-Shared Key)
A. Turn on Detector and connect to PC
(wired connection is recommended)
B. After detector boot up, Launch web-browser
(Optimized for Chrome/Internet Explorer)
C. Connect to “http://[Detector’s IP]“
D. Select SSID to set
(This value should match to Router’s setting)
35
R-M-012-121030
E. Type Pre-Shared Key to set (Password)
(This value should match to Router’s setting
Default:project302 )
F. Click “SUBMIT”
G. Restart detector(Turn Off then On)
Upgrade Firmware
A. Turn on Detector and connect to PC
(wired connection is recommended)
36
R-M-012-121030
B. After detector boot up, Launch web-browser
(Optimized for Chrome/Internet Explorer)
C. Connect to “http://[Detector’s IP]“
D. Select firmware file by click “Choose File” button.
(Released file is named ‘fw_ppc’)
E. Click ‘Upload File’ button
F. Click ‘Flash Write’ button
G. Restart detector(Turn Off then On)
37
R-M-012-121030
Calibration
General Principle
X-ray
detector
should be
used at stable state
within driving
temperature range.
Acquire the X-ray
images after power
on and 5 minutes
warming up to
obtain high quality
images.
Notation
Calibration can be done by image acquisition S/W. The gainoffset correction (under calibration) will be done with one dark, at
least one bright and object frame.
Parameter
Description
Offset
Dark image, acquired image without X-ray exposure
Bright
Acquired image with X-ray exposure
Object
Bright image with object, will be calibrated
Gain
Gain of imaging system, offset subtracted image
Offset correction
Offset subtract
Gain correction
Compensate gain variance of pixel
38
R-M-012-121030
Bright Calibration Point
The
calibration
range of
bright is can be
select by which
exposure level is
maximum level that
user want to use. If
the maximum level
of user want to use
is ‘20000’ in this
case the level is
contained in Bright
point of ‘4’(refer
‘Table 5 : Median
value’). The meaning
is you don’t have to
make bright point
for ‘5’ and ‘6’(In this
case, it will be does
not working if you
get image on higher
level than maximum
bright point.)
To gain correction, bright frame and dark frame should be
acquired. The dark frame is needed only one frame. The bright
frame is recommended to be acquired more than 8 different
levels of median values of bright frames. The X-ray source
condition will be recommended the tube energy level of 70kVp
with variable tube current and exposure time. To acquire at least
3 frames at same condition will be recommended. The median
values of bright frames are below.
(Additional 21mm Al filter is recommended for calibration)
Point
Median Value
[LSB]
850 ~
1150
1850~
2150
2850 ~
3150
3850 ~
4150
5850~
6150
7850 ~
8150
9850 ~
10150
11850~
12150
The Purpose of Bright Calibration
The center of the non calibrated image is brighter than the edge
due to hill effect of X-ray exposure. Generally, the intensity of Xray flux at center region of exposed area is higher than
surroundings due to the X-ray expose like cone shape. A
calibration process is used to compensate for this effect.
Generally, called it ‘Flat Field Correction’(Bright calibration).
39
R-M-012-121030
Calibration
Describe the calibration step by step.
1st Step
Move to “Calibration” tap, and push “Get Dark” button. Acquire
dark frame, the “dark.raw” will be generated at “\cal\” folder.
40
R-M-012-121030
Click
button [Get
Bright]. It
will produce frame
with name %CAL%
xNNNNNA.raw,
where NNNNN is
median pixel’s value
within current
image borders after
offset calibration
(cut frame edges are
never used during
calibration). Suffix
‘A’ (it also could be
‘B’,’C’ etc) avoids
casual coincidence
of file names.
2nd Step
Push “Get Bright” button at different six of X-ray condition. The Xray condition should be set or tested before, same as the level of
‘1.2’. Push “Get Bright” button at least 3 times at same condition,
and then the offset subtracted bright (gain) is generated which of
filename is “xNNNNNA.raw(Refer to NOTE)
41
R-M-012-121030
3rd step
After 2nd step, the “Generate” button will be activated. Click the
button “Generate”, and then calibration point will be generated
which of file name is “A ‘# of point’_ ‘median value of generated
point’” like file of bright frame. The acquired bright frames within
tolerance value which is variance of median level of acquired
bright frames will be averaged and generated to a calibration
point. The tolerance value can be edited.
After making
calibration point the
“Generate” button will
be disabling.
42
R-M-012-121030
4th step
After 3rd step, Change Bad Pixels Removal Tab, Click the button
“Generate Auto BPM”, and then Defect Map will be generated
which of file name is “BPM.raw “ at the “\cal\” folder.
43
R-M-012-121030
5th step
For additional Defect correction, if “BPMM.raw” is existed at the
install CD, copy to the “\cal\” folder.
6th step
On Acquisition Tab. Check the box “Offset Calibration”, “Gain
Calibration”, and “Bad Pix Map” for activate to each calibration
and Bad Pixels Removal. Otherwise, it will does not working
when going to pre-processing .
44
R-M-012-121030
Image Acquisition Test
Program setup
To acquire images, run _vadav.lnk program.
Please set the following figures

Detector’s IP : 2.2.2.100

Detector‘s number of ADC : 26

Detector’s size of image : 2816 X 3328
45
R-M-012-121030
Get Image
On Acquisition tab, click the “Get Image” button to get image.
After click the button, you can see pop-up window, which is
display window time and process of acquiring image.
46
R-M-012-121030
View Images
Frame- and image-files have extension “raw” and contain pixel
data in signed 14-bits little-endian format. One could view those
files in Photoshop or another image editor.
47
R-M-012-121030
Common controls and displayed statistics

Pixel_Min – minimum pixel value in frame- or image- data

Pixel_Max – maximum pixel value

Pixel_Black – if a pixel ≤ Pixel_Black then it is displayed as
black (RGB 0, 0, 0)

Pixel_White – if a pixel ≥ Pixel_Black then it is displayed as
black (RGB 255, 255, 255)
48
R-M-012-121030
Histogram’s presentation
Relative Histogram Scale [H]=1000 means that the distance
depicted as “H” on the drawing matches 1% of total number of
pixels. Respectively [H]=100 means that “H” matches 0.1% of
pixels and [H]=500 means that “H” matches 0.5% of pixels.
49
R-M-012-121030
Marker type “S”
Displays local surround of selected location
Marker type “R”
Display profile chart of a row.
50
R-M-012-121030
Marker type “C”
Display profile chart of a column.
51
R-M-012-121030
Operation
Recommend
X-ray detector should be used at stable state within driving
temperature range.
Acquire the X-ray images after power on and 5 minutes warming
up to obtain high quality images.
Switching power on / off

All connection should be done, before turn on the power.

Press the power button by more than 3 sec, when power
on/off.

The green light of the LED indicator on the detector is on, the
detector power is on.

The blue light of the LED indicator on the detector is blinking,
the detector is getting prepared to work and initialize.

After power off, separate the battery.
Storage
Store the sensor unit in clean and dry place. Ensure that storage
place should be not affected by dust or liquids.
52
R-M-012-121030
Information
Safety standard
Do not
touch
signal
input, signal output
or other connectors,
and the patient
simultaneously.
External equipment
intended for
connection to signal
input, signal output
or other connectors,
shall comply with
relevant IEC
Standard.
This equipment has been tested and found to comply with the
limits for medical devices in IEC 60601-1-2:1994. These limits
are designed to provide reasonable protection against harmful
interference in a typical medical installation.
This equipment generate, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to other devices in
the vicinity. However, there is no guarantee that interference will
not occur in a particular installation. If this equipment does cause
harmful interference to other devices, which can be determined
by turning the equipment off and on, the user is encouraged to try
to correct the interference by one or more of the following
measures:

Reorient or relocate the receiving device.

Increase the separation between the equipment.

Connect the equipment into an outlet on a circuit different
from that to which the other devices are connected.

Consult the manufacturer or field service technician for help
(e.g., IEC 60950-1 for IT equipment and IEC 60601-1 series for
medical electrical equipment.)
In addition, all such combination system shall comply with the
standard IEC 60601-1 and/or IEC 60601-1 harmonized national
standard or the combination. If, in doubt, contact qualified
technician or your local representative.
53
R-M-012-121030

Type of protection against electric shock: Class I equipment

Classification according to the degree of protection against
ingress of water as detailed in the current edition of IEC 529:
IPX0, ordinary equipment

This equipment is not suitable for use in the presence of
flammable anesthetic s or oxygen.

Mode of operation: continuous operation
54
R-M-012-121030
Electromagnetic Compatibility Information
Guidance and manufacturer’s declaration - electromagnetic emissions
The EUT is intended for use in the electromagnetic environment specified below.
The customer or the user of the EUT should assure that it is used in such an environment.
Immunity Test
RF Emissions
CISPR 11
Compliance
Group 1
Electromagnetic Environment - Guidance
The EUT uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment
Class A
The EUT is suitable for use in ail establishments, including
domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes
Harmonic emissions
IEC 61000-3-2
Complies
Voltage fluctuations/
Flicker emissions
Complies
The EUT is suitable for use in ail establishments, including
domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes
The EUT is suitable for use in ail establishments, including
domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes
RF Emissions
CISPR 11
IEC 61000-3-3
55
R-M-012-121030
Guidance and manufacturer’s declaration - electromagnetic immunity
The EUT is intended for use in the electromagnetic environment specified below.
The customer or the user of the EUT should assure that it is used in such an environment.
The EUT is intended for use in the electromagnetic environment specified below.
The customer or the user of the EUT should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2
Test level
±6kV Contact
±8kV air
Compliance level
±2kV for power
supply lines
± 1kV for
input/output
lines
±1kV differential
mode
±2kV common
mode
±2kV for power
supply lines
± 1kV for
input/output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
±1kV differential
mode
±2kV common
mode
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltage
variations
on power supply
input lines
IEC 61000-4-11
<5% Uт
(>95% dip in Uт)
for 0.5 cycle
40% Uт
(60% dip in Uт )
for 5 cycle
70% Uт
(30% dip in Uт)
for 25 cycle
<5% Uт
(<95% dip in
Uт )
for 5 s
<5% Uт
(>95% dip in Uт)
for 0.5 cycle
40% Uт
(60% dip in Uт )
for 5 cycle
70% Uт
(30% dip in Uт)
for 25 cycle
<5% Uт
(<95% dip in Uт )
for 5 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the EUT
image intensifier requires continued
operation during power mains
interruptions, it is recommended that
the EUT image intensifier be
powered from an uninterruptible
power supply or a battery.
Power
frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±6kV Contact
±8kV air
Electromagnetic environment guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
NOTE Uт is the a.c. mains voltage prior to application of the test level.
56
R-M-012-121030
Guidance and manufacturer’s declaration - electromagnetic immunity
The EUT is intended for use in the electromagnetic environment specified below.
The customer or the user of the EUT should assure that it is used in such an environment.
Immunity test
IEC
60601-1-2
test level
Compliance
level
Electromagnetic environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the EUT,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance :
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80MHz
V1=3Vrms
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5GHz
E1=3V/m
 3.5 
d  P
 V1 
 3.5 
d    P 80MHz to 800MHz
 E1 
7
d    P 800MHz to 2.5GHz
 E1 
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 meters (m).
Field strengths from fixed RF transmitters, as detera
mined by an electromagnetic site survey,
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol :
NOTE 1) At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
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 EUT is used exceeds the applicable RF compliance level above, the EUT should
be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the EUT.
Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m.
57
R-M-012-121030
Recommended separation distances
communications equipment and the EUT
between
portable
and
mobile
RF
There is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the EUT can help Prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the EUT as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter [m]
IEC 60601-1-2
Frequency of
Transmitter
150kHz to 80MHz
80MHz to 800MHz
800MHz to 2.5GHz
Equation
 3.5 
d  P
 V1 
 3.5 
d  P
 E1 
7
d  P
 E1 
Rated maximum
output power of
transmitter
[W]
V1=3Vrms
E1=3V/m
E1=3V/m
Separation Distance
Separation Distance
Separation Distance
(meters)
(meters)
(meters)
0.01
0.116
0.1166
0.2333
0.1
0.368
0.3687
0.7378
1.166
1.1660
2.3333
10
3.687
3.6872
7.3785
100
11.660
11.6600
23.333
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
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 EUT is used exceeds the applicable RF compliance level above, the EUT should
be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the EUT.
Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m.
Name
Shield Type
Length
Notes
Link cable
Shielded
6m
Provided with wiring unit.
P-interface cable
Non-shielded
8m
Provided with X-ray interface unit.
USB cable (A to B)
Non-shielded
1.8 m
Provided with AGI unit.
AC power cord (220V)
Shielded
1.8 m
Provided with charger unit.
58
R-M-012-121030
Immunity and Compliance Level
Immunity test
IEC 60601-1-2
Test Level
Actual Immunity Level
Compliance Level
Conducted RF
IEC 61000-4-6
3Vrms
150kHz to 80MHz
3Vrms
3Vrms
Radiated RF
IEC 61000-4-3
3Vrms
80MHz to 2.5GHz
3V/m
3V/m
Guidance and manufacturer’s declaration - electromagnetic immunity
The EUT is intended for use in the electromagnetic environment specified below.
The customer or the user of the EUT should assure that it is used in such an electromagnetic
environment.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601-1-2
Test level
3 Vrms
150kHz to
80MHz
Compliance
level
3 Vrms
150 kHz to
80MHz
3V/m 80MHz
to 2.5GHz
3V/m 80MHz
to 2.5GHz
Electromagnetic environment - guidance
The EUT must be used only in a shielded location
with a minimum RH shielding effectiveness nad, for
each cable that enters the shielded location with a
minimum RF shielding effectiveness and, for each
cable that enters the shielded location.
Field strengths outside the shielded location from
fixed RF transmitters, as determined by an
electromagnetic site survey, should be less than
3V/m.
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
NOTE 2) It is essential that the actual shielding effectiveness and filter attenuation of the shielded
location be verified to assure that they meet the minimum specification.
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 outside
the shielded location in which the EUT is used exceeds 3V/m, the EUT should be observed to verify
normal operation.
If abnormal performance is observed, additional measures may be necessary, such as relocating the
EUT or using a shielded location with a higher RF shielding effectiveness and filter attenuation.
59
R-M-012-121030
Radio Frequency compliance
FCC/IC Notice (U.S.A and CANADA)

FCC Part 15 Subpart C §15.247 and IC RSS-210 Issue 7
FCC Part 15 Subpart E §15.407 and IC RSS-210 Issue 7

FCC ID: QIIRY1417WGA
5.15- 5.25 GHz band is restricted to indoor operations only.
Host device of the approved module shall be marked with the following
item: Contains Transmitter Module FCC ID: PPD-AR5BHB116
Compliance with FCC requirement 15.407(c)
Data transmission is always initiated by software, which is the passed
down through the MAC, through the digital and analog baseband, and
finally to the RF chip. Several special packets are initiated by the MAC.
These are the only ways the digital baseband portion will turn on the RF
transmitter, which it then turns off at the end of the packet. Therefore,
the transmitter will be on only while one of the aforementioned packets
is being transmitted. In other words, this device automatically
discontinues transmission in case of either absence of information to
transmit or operational failure.
This device complies with part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not cause
harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
FCC CAUTION
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.
When installing it in a mobile equipment
This equipment complies with FCC radiation exposure limits set forth for
an uncontrolled environment and meets the FCC radio frequency (RF)
Exposure Guidelines in Supplement C to OET65. This equipment has
very low levels of RF energy that it deemed to comply without maximum
60
R-M-012-121030
permissive exposure evaluation (MPE). But it is desirable that it should
be installed and operated keeping the radiator at least 20cm or more
away from person’s body (excluding extremities: hands, wrists, feet and
ankles).
To satisfy FCC RF Exposure requirements for mobile and base station
transmission devices, a separation distance of 20cm or more should be
maintained between the antenna of this device and persons during
operation. To ensure compliance, operation at closer than this distance
is not recommended.
The antenna(s) used for this transmitter must not be co-located or
operating in conjunction with any other antenna or transmitter.
61
R-M-012-121030
Maintenance
Maintenance

Maintenance of the detector should be done by an authorized
service provider

If the Detector Panel is defective, the detector will be
returned as is to the manufacturer for repair

Clean the equipment with a dry soft cloth, or a soft cloth
lightly moistened with mild detergent solution. Do not use any
type of solvent, such as benzene

This equipment and accessories are to be disposed of safely
after the life span of them and national regulation must be
observed.

For safety reasons, be sure to inspect the instrument before
using it. In addition, carry out a regular inspection at least
once a year.

Arrange the detector and power supply link cable to prevent
the damage of the cable’s rubber tube. For example, do not
press the cable under the legs of the table or the people.

This equipment must only be connected to a supply mains
with protective earth.
Cleaning
When the
instrument
is going to
be cleaned, be sure
to turn OFF the
power of each
instrument, and
unplug the power
cable from the AC
outlet. Otherwise,
fire or electric shock
may result.
Cover
Clean the cover by the left warning box, if it is dirty.
CFRP of Detector
Wipe the CFRP plate of the sensor unit with ethanol or
glutaraldehyde solution to disinfect it each time a different patient
uses the instrument, in order to prevent infection. If you are using
disinfectant other than those specified above, or you are mixing
another disinfectant with ethanol, please also consult a specialist,
because they may harm the CFRP plate.
62
R-M-012-121030
Inspection
For
safety
reasons, be
sure to turn OFF the
power of the
detector when the
following
inspections are
going to be
performed.
Otherwise, it may
result in electric
shock.
In order to ensure that the instrument is used safely and normally,
please be sure to inspect the instrument before use. If any
problem is found during the inspection, please take measures
indicated in this chapter. If problem still cannot be corrected,
please contact Rayence representative or distributor. It is
recommended that a record of the inspection be kept by making
copies of the check lists in this section, or making a separate
check list.
Inspection chart
Inspection
Check
that
User
cables
are
Vendor
Cycle
not
damaged or cover of cables is
Daily
Daily
Daily
Daily
not torn
Check that the plugs and locks
of connectors are not loose
Check that the cover or parts
are not damaged and not loose
Check the LED indicator
Check the bad pixel map
Half year
Yearly
Check the performance of the
instrument
by
performing
exposures using a phantom or a
resolution chart
63
R-M-012-121030
Disposal or Recycling
Follow local governing ordinances and recycling plans regarding
the disposal or recycling of device components.
Disposal of old Electrical & Electronic Equipment
(Application in the European Union and other
European
countries
with
separate
collection
system.) This symbol indicates that this product shall not be
treated as household waste. Instead, it shall be handed over to
the applicable collection point for the recycling of electrical and
electronic equipment. By ensuring this product is disposed of
correctly, you will help prevent potential negative consequences
for the environment and human health, which could otherwise be
caused by inappropriate waste handling of this product. For more
detailed information about recycling this product, please refer to
local governing ordinances and recycling plans.
64
R-M-012-121030
Appendix
Dimension
[unit : mm]
65
R-M-012-121030
Medical Image Processing Unit
1417WGA
Rayence Co., Ltd.
14, Samsung 1ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea
www.rayence.com
66
R-M-012-121030

---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.5
Linearized                      : No
Page Count                      : 70
Page Layout                     : OneColumn
Page Mode                       : UseNone
Producer                        : doPDF Ver 7.3 Build 387 (Windows 7 Business Edition (SP 1) - Version: 6.1.7601 (x86))
Create Date                     : 2013:04:02 22:31:00+09:00

EXIF Metadata provided by EXIF.tools