Rayence RY1417W Medical Image Processing Unit User Manual
Rayence Co., Ltd. Medical Image Processing Unit Users Manual
Rayence >
Users Manual
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1417WGC
User / Installation Manual
Version 1
Date: 2014-03-24
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© Copyright 2014, 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.
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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.
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Contents
1. Introduction ................................................................................. 6
(1) Overview .................................................................................... 6
(2) Intended use .............................................................................. 6
(3) Product features ........................................................................ 7
(4) Product components ................................................................. 8
(5) Components Description ........................................................ 11
(6) Warning .................................................................................... 14
(7) Caution ................................................................................... 16
2. Notes for Using the Detector ..................................................... 19
(1) Preparing ................................................................................. 19
(2) Handling................................................................................... 21
(3) Before Exposure ...................................................................... 22
(4) During Exposure ..................................................................... 22
(5) Limit of Load ............................................................................ 23
(6) Disinfection and Cleaning ....................................................... 24
(7) Others ...................................................................................... 24
3. Technical Features .................................................................... 25
(1) Mechanical Features ............................................................... 25
(2) Electrical Features .................................................................. 25
(3) Environmental requirement .................................................... 29
(4) PC Requirements .................................................................... 29
4. Installation ................................................................................. 30
(1) Program setup ......................................................................... 30
(2) Connection (Manual Trigger) .................................................. 31
(3) Connection (Auto Trigger) ...................................................... 39
(5) IP set up ................................................................................... 44
(6) Using FPD_Manager (IP, SSID Change / Upgrade FW) .......... 45
5. Calibration ................................................................................. 51
(1) General Principle ..................................................................... 51
(2) Calibration ............................................................................... 53
6. Image Acquisition Test .............................................................. 58
(1) Get Image ................................................................................. 58
(2) View Images ............................................................................. 59
(3) Get Recent Frame .................................................................... 64
7. Operation ................................................................................... 65
(1) Recommend............................................................................. 65
(2) Switching power on / off ......................................................... 65
(3) Storage .................................................................................... 65
8. Safety Information ..................................................................... 66
(1) Safety standard ....................................................................... 66
(2) Electromagnetic Compatibility Information ........................... 68
9. Radio Frequency compliance .................................................... 73
(1) FCC Notice (U.S.A) .................................................................. 73
(2) IC Notice (CANADA) ................................................................ 75
(3) R&TTE Notice (European Union) ............................................ 76
10. Maintenance .............................................................................. 77
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(1) Maintenance ............................................................................ 77
(2) Cleaning ................................................................................... 77
(3) Inspection ................................................................................ 78
(4) Disposal or Recycling ............................................................. 79
(5) Marking and labeling symbols ................................................ 80
Appendix ........................................................................................... 82
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1. Introduction
(1) Overview
The 1417WGC 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.
(2) Intended use
Digital Flat Panel X-Ray 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 systems in all general purpose diagnostic
procedures. Not to be used for mammography.
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(3) Product features
Wi-Fi (802.11a/g/n)
Based on a-Si TFT active matrix
Compact (15.4mm thickness) and light weight (Typ. 3kg)
Limiting Resolution : 3.9 lp/mm
14/16-bit digital output
Easy integration
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(4) Product components
Medical Image Processing Unit
Photo
Item
Part Name
Quantity
Detector RD1417WGC 1
Battery pack RB37WHA 2
Battery charger
RC120WA 1
Charger
adapter PMP120-13-3 1
AGI RA001A 1
Power supply
box RP003A 1
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Cables
Item
Part Name
Length
Quantity
Link cable
7m 1
P-
Interface
cable
VRH017A 8m 1
USB
cable(A to
B)
VRH078A 1.8m 1
LAN
cable VRH027A 10m 1
AC Power
cord VRH018A/019A 1.8m 2
Installation CD
o Manual
o Detector Library
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Option
o Additional Battery
o Trigger cable
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(5) Components Description
The detector is designed to capture radiographic images.
Captured images are transmitted to PC using the wireless/wired
connection.
(1) Detector
1. Wireless antennas
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.
*Wireless module information:
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.
1417WGC in the RF module does not use DFS band.
*RF module (FCC ID: PPD-AR5BHB116)
2. Battery unlock-lever : This is an unlock-lever to remove battery.
3. Power button : Power on / Power off switch.
4. LED indicator: The LED indicates the state of detector.
i. Green on : Power on.
ii. Blue blinking : Wireless Connection.
iii. Orange on : Low battery.
5. Link cable connector : This is a connector for wire communication
and power supplying. Connect the detector to the power supply
using Link cable.
6. Reset button : This is a button for factory reset.
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(2) Battery & Charger
1. Battery : Lithium ion battery. The number of times being acquired
image is 960 images(@ cycle time : 15s). The batteries are
rechargeable
The charging time = 3 hours.
2. Charger : Two port cradle type.
3. LED indicator :
i. Orange on : charging
ii. Green on : Charging is completed.
(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 or trigger cable
2. USB connector: This is a connector for communication between
AGI and PC. Connect the AGI to the PC using USB cable.
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(4) Power supply box
1. Power plug connector: Connect with AC power supply cord
2. LAN connector : Ethernet port for transmitting the image/command
between detector and PC
3. Link cable connector: Power connector for detector operating
4. LED indicator: Four LEDs to display the status
※ Changeable part: Fuse T3.15 AL 250V
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(6) Warning
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.
To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
Wireless connection
SSID & PSK value should match to Router’s setting. (Refer to the
Ch.4.(2)). If these values are not matched with Detector and
Router, the connection is not allowed for security.
Avoid using co-channel or adjacent-channel with other wireless
devices for high quality wireless performance.
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.
Make sure
to observe
the following right
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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.
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
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.
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(7) 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
Non-medical equipment such as the battery charger, access
point cannot be used in patient’s vicinity.
Make sure
to observe
the following right.
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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.
This device is contraindicated in pregnant woman.
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.
Battery
Do not let the detector or battery come in contact with
liquids. Liquids can get into the detector’s circuits, leading to
corrosion. Even when the detector appears to be dry and
appears to operate normally, the circuitry could slowly corrode
and pose a safety hazard. If the detector and/or battery get wet,
have them checked by your service provider or contact Rayence,
even if they appear to be working properly.
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Do not place your battery in or near a heat source. Excessive
heating can damage the detector or the battery and could cause
the detector or the battery to explode. Do not dry a wet or damp
battery with an appliance or heat source such as a microwave
oven, hair dryer, iron, or radiator.
Do not dispose of the detector or the battery in a fire. The
detector or the battery may explode when overheated.
Never use any charger or battery that is damaged in any way.
Important! Use only Rayence-approved batteries, and recharge
your battery only with Rayence-approved chargers which are
specifically designed for your detector.
Use of a non-Rayence-approved battery or charger may
present a risk of fire, explosion, leakage, or other hazard.
Rayence's warranty does not cover damage to the detector
caused by non-Rayence-approved batteries and/or chargers
Misuse or use of incompatible batteries and charging
devices could result in damage to the equipment and a
possible risk of fire, explosion, or leakage, leading to serious
injuries, damages to your detector, or other serious hazard.
Check the battery status frequently to avoid battery empty. (Refer
to the Ch.3.(2) Electrical Features) When the low battery LED of
detector is turned on, change the battery or charge the battery
using cable
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2. Notes for Using the Detector
(1) 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, RC120WA 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 and cover.
<Insert battery>
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<Remove battery>
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(2) Handling
Handle the instrument carefully, as it may be damaged if
something is hit against it, dropped, or receives a strong jolt.
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(3) 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.
Room temp. 70℉ / 21℃ is recommended.
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.
(4) 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.
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(5) 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.
Be sure to use the sensor unit on a flat place so it will not bend.
Otherwise, the sensor may be damaged.
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(6) 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.
(7) Others
Be sure to reconnect the cables to the proper connectors.
Otherwise, the instrument may malfunction or may be damaged.
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3. Technical Features
(1) Mechanical Features
Size 460 x 384 x 15.4 mm
Weight 3 kg
Encapsulation Material
Carbon fiber plate with 1.8 mm thickness
Window Material Carbon fiber plate with 1.8 mm thickness
(2) Electrical Features
Detector
Sensor Type Amorphous Silicon with TFT (Single Panel)
X-ray Converter Gd2O2S:Tb
Total Pixel Number 3328 × 2816 pixels
Total Pixel Area 422.7 x 357.6 mm
Effective Pixel Number
3268 × 2756 pixels
Effective Pixel Area 415.0 x 350.0 mm
Pixel Pitch 127 μm
Limiting Resolution Max. 3.9 lp/mm
Energy Range 40 - 150 kV
A/D Conversion 14/16 bits
Preview Time < 2.0 sec (wired)
< 5.0 sec (wireless)
Data Interface
- Wireless
- Wired
Wi-Fi (802.11a/g/n)
Gigabit Ethernet
Power consumtion Typ. 15W (Max. 30W)
Under RQA5 condition (70kVp, 21mmAl)
Preview time is not included post-processing time
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Power Supply
Size 188 x 92 x 41.5 mm
Weight 0.46kg
Input 110~220VAC (50/60Hz)
Output Typ. 24VDC (Max 1.9A)
Battery
Size 263.2 x 127.8 x 6 mm
Weight Typ. 0.3 kg
Input 12.5 VDC
Output 11.1 VDC
Charging time Typ. 3 hours
Capacity Typ. 3400 mAh
The number of times
being acquired image 960 images (@cycle time = 15s)
The Battery level can be displayed on the LED status of battery.
If the battery level goes down under 25%, please charge the
battery
Display Battery level
75~100 %
50~75 %
25~50 %
0~25 %
Charger
Size 200 x 100 x 150 mm
Weight Typ. 0.85 kg
Input 20 VDC
Output 12.5 VDC
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Adapter
Size 160 x 76 x 43.7mm (cable length: 1.28m)
Weight Typ. 0.73 kg
Input 100~240 VAC, 47~63 Hz, 1.4~0.6A
Output 20 VDC, Max 6.0A
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Wireless Spec
Standard
802.11a/g/n compliance
Without DFS (5.25GH to 5.35GHz and 5.47
to 5.725) Band
Peak Rate 300Mbps
Frequency 2.4 GHz / 5 GHz
Bandwidth 20MHz/40MHz
MIMO 2x2
※ Recommended Maximum operable distance : 10m
(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)
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(3) Environmental requirement
Item Min. Typ. Max. Unit Note
Temperature
(Storage) -10 50 ℃
Temperature
(Operation) 5 40 ℃
Humidity
(Storage) 10 80 %
H.R.
Humidity
(Operation) 30 75 %
H.R.
Vibrations
(Wrapping
condition)
2G
(8G)
10-150Hz,
10Sweeps,
1min/Octave,
XYZ axis
※ Regularly changed parts : Battery (warranty 6 months)
(4) 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 3GB of RAM requirement (4GB for 32 BITS OS and
8GB for 64 BITS OS recommended)
At least 500GB for application and archiving. Recommended
500GB for applications and secondary drive of 1TB for image
archiving..
Dual 10/100/1000 network card system required. One for
network (Internet) and one for the DR Panel communication
Graphics card / monitor: Resolution of at least 1,600 x 900 for
desktop and 1366 x 768 for laptop. For diagnostics purpose
we recommend 1920 x 1080 resolution (2 mega pixels)
monitor
Microsoft® Windows 7 32BIT/64BIT
No antivirus except for Microsoft® Security Essentials.
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4. Installation
The Detector is composed of sensitive electronic parts and
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.
(1) Program setup
Detector’s IP : Wireless - 2.2.2.100 Wired – 2.2.2.101
Detector‘s number of ADC : 0
Detector’s size of image : 3328x2816
Figure 1: Setup
Portable
Imaging
processing
unit must be
installed in a way
that enables the
user to achieve
optimal use
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(2) Connection (Manual Trigger)
Power Connection
A. Connect the battery pack or power cable to the equipment.
* In wired mode, the frame ground is necessary.
B. Connect the USB cable from your PC to AGI.
※ Be sure to sure only the dedicated battery pack, RB37WH
for 1417WGC.
Wireless Communication
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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
B. Reception Indicator
Link LED flickering
Blink Speed : Slow – Low link quality
Fast – High link quality
C. Checking Link Quality & Battery Remain
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- 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)
- Check the value named ‘Battery Remain’ in black log screen.
Battery Remain = Battery Remain(Max. 100)
The value ‘Wireless
Signal’ will be
displayed here
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Software Setting
Figure 2: Davinci Setting
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Trigger Connection
A. Connect the P-interface cable or trigger cable to the generator
X-ray Generator Connection
A. Mode 1 : P-interface cable mode
Connect the P-interface cable between the AGI box and X-ray
generator.
Operating description
Make
assurance
doubly sure
SIGNAL RATING
before connection.
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The window time can be changed. Refer to the following pictures
Exposure
Time(*clk)
4999999 is
designate to 0.5sec
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B. Mode 2 : Trigger cable mode
Connect the Trigger cable between the X-ray enable connector of
AGI with X-ray generator.
Figure 8: <2nd example> wiring for the interface between portable generator & detector
Connection description
Signal New Label Old Label Color Input / Output
READY IN
12V~24VDC R.E.C. +12-24V Red Input
READY IN Ready Input Signal Black Input
READY
DONE
READY DONE Exposure Output SW1 Green Output
READY DONE COM
Exposure Output SW2 Blue Output
Table 3 : Connection description
Make
assurance
doubly sure
SIGNAL RATING
before connection.
AGI
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Operating description
Figure 3 : Timing chart
t1: It will be occurred when exposure switch is pushed completely
after.
t2: Window time of detector is varying 0 sec ~ 5 sec. which can
be control by S/W. (Editing parameter: Exposure Time – Refer to
the NOTE)
Expose relay switch ON time (Window Time) and X-ray
exposure time must be same.
t2 time can be control by S/W
The window time can be changed. Refer to the following pictures
Exposure
Time(*clk)
4999999 is
designate to 0.5sec
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(3) Connection (Auto Trigger)
Power Connection
A. Connect the battery pack or power cable to the equipment.
* In wired mode, the frame ground is necessary.
※ Be sure to sure only the dedicated battery pack, RB37WH
for 1417WGC.
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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
B. Reception Indicator
Link LED flickering
Blink Speed : Slow – Low link quality
Fast – High link quality
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C. Checking Link Quality & Battery Remain
- 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)
- Check the value named ‘Battery Remain’ in black log screen.
Battery Remain = Battery Remain(Max. 100)
The value ‘Wireless
Signal’ will be
displayed here
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Software Setting
Figure 4: Davinci Setting
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Important Note
In AUTO TRIGGER MODE, the trigger will be forced not to
acquire images when detector senses vibration or shock.
In READY mode, Detector will automatically switch to WAIT
mode when detector senses vibration or shock, so that user won’t
acquire images in WAIT mode although X-ray exposure applies.
WAIT mode switches back to READY mode after 2-3 seconds.
If you don’t want to use ANTI-SHOCK FUNCTION, please click
OPTION “1c”
IF you don’t use ANTI-SHOCK FUNCTION, you are able to get
images regardless detector senses vibration or shock. However,
you should keep in mind there is also a possibility images can be
acquired by vibration or shock without X-ray exposure.
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(5) 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
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(6) Using FPD_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 FPD_Manager.exe
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C. Check the “IP Change” and type current IP address as below
D. Type IP address to set
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E. Click “Start Setting” button
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 FPD_Manager.exe
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C. Check the “SSID change” and write current IP address as
below
D. Type SSID and PSK to set
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E. Click “Start Setting” button
F. Restart detector(Turn Off then On)
Upgrade Firmware
A. Turn on Detector and connect to PC
(wired connection is recommended)
B. After detector boot up, Launch FPD_Manager.exe
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C. Check the “SSID change” and write current IP address as
below
D. Select firmware or FPGA file by click “select” button.
Click “Start Setting” button
E. Restart detector(Turn Off then On)
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5. Calibration
(1) General Principle
Notation
Calibration can be done by image acquisition S/W. The gain-
offset 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
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.
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Bright Calibration 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 2 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
2 frames at same condition will be recommended. The median
values of bright frames are below.
(Additional 21mm Al filter is recommended for calibration)
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 X-
ray 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).
Point 1 2 3 4
Median Value [LSB
500 ~
1000
2900 ~
3400
6200~
6700
9500 ~
10000
Table
5 : Median value
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 ‘6500’ in this case
the level is
contained in Bright
point of ‘3’(refer
‘Table 5 : Median
value’). The meaning
is you don’t have to
make bright point
for ‘4’(In this case, it
will be does not
working if you get
image on higher
level than maximum
bright point.)
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(2) Calibration
Describe the calibration step by step.
1st Step
Click on the “Get Dark” button. The acquired dark frame
“dark.raw” will be generated in the “\cal\” folder.
Figure 5: Get dark
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2nd Step
Push “Get Bright” button at different four of X-ray condition. The
X-ray condition should be set or tested before, same as the level
of ‘1.2’. Push “Get Bright” button at least 2 times at same
condition, and then the offset subtracted bright (gain) is
generated which of filename is “xNNNNNA.raw(Refer to NOTE)
Figure 6: Get bright.
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.
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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.
Figure 7: Generate
After making
calibration point the
“Generate” button will
be disabling.
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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.
Figure 8: Bad pixels removal
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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”, “Bad Pix Map” for activate to each calibration and
Bad Pixels Removal. Otherwise, it will does not working when
going to pre-processing .
Figure 9: Application of calibration
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6. Image Acquisition Test
(1) 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.
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(2) View Images
Frame- and image-files have extension “raw” and contain pixel
data in signed 16-bits little-endian format. One could view those
files in Photoshop or another image editor.
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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)
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Histogram’s presentation
Relative Histogram Scale [H]=1000 means that 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.
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Marker type “S”
Displays local surround of selected location
Marker type “R”
Display profile chart of a row.
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Marker type “C”
Display profile chart of a column.
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(3) Get Recent Frame
If the image is not transferred to the PC after exposure because
of connection fail (wire or wireless). You can get a recent frame
again.
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7. Operation
(1) 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.
The calibration should be performed every 6 months
(2) 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.
(3) Storage
Store the sensor unit in clean and dry place. Ensure that storage
place should be not affected by dust or liquids.
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8. Safety Information
(1) Safety 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.
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.
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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
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(2) 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
T
est
Compliance
Electromagnetic
E
nvironment
-
G
uidance
RF Emissions
CISPR 11
Group 1 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
RF Emissions
CISPR 11
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 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
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
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
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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
Compliance level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6kV Contact
±8kV air
±6kV Contact
±8kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power
supply lines
± 1kV for
input/output
lines
±2kV for power
supply lines
± 1kV for
input/output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV differential
mode
±2kV common
mode
±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.
NOTE Uт is the a.c. mains voltage prior to application of the test level.
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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
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to
80MHz
3 V/m
80 MHz to
2.5GHz
V1=3Vrms
E1=3V/m
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 :
P
V
d
1
5.3
P
E
d
1
5.3 80MHz to 800MHz
P
E
d
1
7 800MHz to 2.5GHz
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 deter-
mined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of equipment
marked with the following symbol :
NOTE 1) At 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.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the 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.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V
1
] V/m.
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Recommended separation distances between portable and mobile RF
communications equipment and the EUT
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
Equation
Rated maximum
output power of
transmitter
[W]
150kHz to 80MHz
P
V
d
1
5.3
V1=3Vrms
Separation Distance
(meters)
80MHz to 800MHz
P
E
d
1
5.3
E1=3V/m
Separation Distance
(meters)
800MHz to 2.5GHz
P
E
d
1
7
E1=3V/m
Separation Distance
(meters)
0.01 0.116 0.1166 0.2333
0.1 0.368 0.3687 0.7378
1 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.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the 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.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m.
Name Shield Type Length Notes
Link cable Shielded 6 m Provided with wiring unit.
P-interface cable Non-shielded
8 m 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.
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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 IEC 60601-1-2
Test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150kHz to
80MHz
3V/m 80MHz
to 2.5GHz
3 Vrms
150 kHz to
80MHz
3V/m 80MHz
to 2.5GHz
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.a
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.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength 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.
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9. Radio Frequency compliance
(1) FCC Notice (U.S.A)
Test standards
- 47CFR Part 15.107 (b) / 47CFR Part 15.109 (g) Class A.
- FCC Part 15 C Section 15.247, Operation within the bands
902–928 MHz, 2400–2483.5 MHz, and 5725–5850 MHz
- FCC Part 15 C Section 15.407, Operation within the bands
902–928 MHz, 2400–2483.5 MHz, and 5725–5850 MHz
FCC ID: QIIRY1417W
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.
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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
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).
When you use the detector with wire mode, the wireless function is
automatically off.
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(2) IC Notice (CANADA)
Test standards
- ICES-003 Issue 4
- IC RSS-210 Issue 7, Operation within the bands
902–928MHz, 2400–2483.5 MHz, and 5725–5850 MHz
- IC RSS-210 Issue 7, Operation within the bands 902–928 MHz,
2400–2483.5 MHz, and 5725–5850 MHz
IC: 10742A-1417W
This Class A digital apparatus complies with Canadian ICES-003
Host device of the approved module shall be marked with the following
item:
Contains Transmitter Module Radio Certification No. : 4104A-AR5BHB116
This device complies with Industry Canada licence-exempt RSS
standard(s). Operation is subject to the following two conditions: (1) this
device may not cause interference, and (2) this device must accept any
interference, including interference that may cause undesired operation
of the device.
Le present appareil est conforme aux CNR d'Industrie Canada
applicables aux appareils radio exempts de licence. L'exploitation est
autorisee aux deux conditions suivantes : (1) l'appareil ne doit pas
produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout
brouillage radioelectrique subi, meme si le brouillage est susceptible
d'en compromettre le fonctionnement.
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(3) R&TTE Notice (European Union)
Test standards
- EN 62311
- ETSI EN 301 489-1
- ETSI EN 301 489-17
- ETSI EN 300 328
- ETSI EN 301 893
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10. Maintenance
(1) 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.
(2) Cleaning
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.
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.
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.
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(3) Inspection
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 User
Vendor
Cycle
Check that cables are not
damaged or cover of cables is
not torn
O Daily
Check that the plugs and locks
of connectors are not loose O Daily
Check that the cover or parts
are not damaged and not loose O Daily
Check the LED indicator O Daily
Check the bad pixel map O Half year
Check the performance of the
instrument by performing
exposures using a phantom or a
resolution chart
O Yearly
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(4) 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.
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(5) Marking and labeling symbols
Symbols Meaning
Caution : “Attention, see instructions for use”
Alternate current
Protective earth (Ground)
Off (power : disconnect from the main switch)
On (power : connect to the main switch)
Warning
Caution
Note
Manufacturer
Date of manufacture
Serial number
TYPE B Equipment
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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 Ⅱb device and
1999/5/EC. Authorized by Notified Body SGS
(code no.:0120) of British
Recognized Component Mark for Canada and
the United States
non-ionizing radiation
For KOREA
Korea Certification
For JAPAN
Product Safety of Electrical Appliance & Materials
For JAPAN
Telecom Engineering Center (TELEC) :
Technical Regulations Conformity Certification
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Appendix
Dimension [unit : mm]
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Rayence Co., Ltd.
14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea
www.rayence.com
Rayence Co., Ltd.
14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea
www.rayence.com