Rayence RY1012WA Medical Image Processing Unit User Manual

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Document ID	2812394
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Document Description	Users Manual
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Document Type	User Manual
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Date Submitted	2015-11-13 00:00:00
Date Available	2015-11-13 00:00:00
Creation Date	2015-10-26 16:48:22
Document Lastmod	2015-10-26 16:48:22
Document Title	Users Manual
Document Author:	Kang-min_Hwang

1012WCA User manual
© Copyright 2013, 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.
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.
This is used to emphasize essential information. Be sure to read this
information to avoid incorrect operation.
This indicates a potentially hazardous situation which, if not heeded,
could result in death or serious injury to you or others.
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.
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.
Contents
1.
2.
3.
4.
5.
6.
7.
8.
9.
Introduction ....................................................................................1
(1)
(2)
(3)
(4)
(5)
(6)
(7)
Overview ........................................................................................ 1
Intended use.................................................................................. 1
Product features ........................................................................... 2
Product components .................................................................... 3
Components Description ............................................................. 5
Warning........................................................................................10
Caution ........................................................................................12
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
Preparing .....................................................................................15
Handling ......................................................................................16
Handle Assembly ........................................................................16
Before Exposure .........................................................................17
During Exposure .........................................................................18
Limit of Load ...............................................................................19
Disinfection and Cleaning .........................................................20
Others ..........................................................................................20
(1)
(2)
(3)
(4)
Mechanical Features ..................................................................21
Electrical Features ......................................................................21
Environmental requirement .......................................................24
PC Requirements ........................................................................24
(1)
(2)
(3)
(5)
(6)
Program setup ............................................................................25
Connection (Manual Trigger) .....................................................26
Connection (Auto Trigger) .........................................................34
IP set up .......................................................................................39
Using FPD_Manager (IP, SSID Change / Upgrade FW) ...........40
(1)
(2)
(3)
General Principle ........................................................................49
Calibration (Manual mode) ........................................................51
Calibration (Auto mode) .............................................................57
(1)
(2)
(3)
Get Image ....................................................................................62
View Images ................................................................................63
Get Recent Frame .......................................................................68
(1)
(2)
(3)
Recommend ................................................................................69
Switching power on / off ............................................................69
Storage ........................................................................................69
(1)
(2)
Safety standard ...........................................................................70
Electromagnetic Compatibility Information .............................72
(1)
(2)
(3)
FCC Notice (U.S.A) .....................................................................77
IC Notice (CANADA) ...................................................................79
R&TTE Notice (European Union) ..............................................80
Notes for Using the Detector ......................................................15
Technical Features ......................................................................21
Installation ...................................................................................25
Calibration ....................................................................................49
Image Acquisition Test ................................................................62
Operation ......................................................................................69
Safety Information .......................................................................70
Radio Frequency compliance ......................................................77
10. Maintenance .................................................................................81
(1)
(2)
(3)
(4)
(5)
Maintenance ................................................................................81
Cleaning .......................................................................................81
Inspection ....................................................................................82
Disposal or Recycling ................................................................83
Marking and labeling symbols ..................................................84
Appendix ..............................................................................................86
1. Introduction
(1) Overview
The 1012WCA 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.
(3) Product features

Wi-Fi (802.11a/g/n)

Based on a-Si TFT active matrix

Compact and light weight

Limiting Resolution

14/16-bit digital output

Easy integration
(4) Product components

Photo
Medical Image Processing Unit
Item
Quantity
Detector
Handle
Battery pack
Battery charger
Charger adapter
AGI

Cables


Item
Length Quantity
Link cable
7m
PInterface
cable
8m
USB
cable(A to 1.8m
B)
LAN cable
10m
AC Power
1.8m
cord
Trigger
cable
3m
Installation CD
Manual
Detector Library
(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. Link Cable Connector : Use for charging battery while detector is
in use(Connect between detector and power supply)
2. LED indicator: Indicating the state of detector.
3. Power & Mode Sleep Button
4. Handle unlock-lever : This is an unlock-lever to remove handle.
5. Handle : Hold this handle when carrying the sensor unit. It is
removable. (Horizon/Vertical)
6.
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.
7.
Shock sensor : Detector has built-in 2 Shock sensors. It detects
and records impact and mishandling of fragile
8.
Battery unlock-lever : This is an unlock-lever to remove battery.
9.
Battery : Lithium ion battery.
(2) Battery & Charger
1. Battery : Rechargeable Lithium Ion battery(Charging Time-3 hrs)
※ In the diagram above, the box shows where the remaining
battery percentage is displayed.
2. Battery Charger : Two port cradle type.
3. LED indicator : Displays battery charging status
※Wireless Module and Wireless Antenna
Wireless antennas:
The module adopts the latest 802.11n Dual-Band technology.
DUT does not support simultaneous transmission.
The transmitter of the module is powered by host equipment (Detector).
The antennas are 2 printed-dipole and correlated antennas.
Does not support beamforming.
※Wireless module:
The end product will use the in original certified transmitter module and will keep the original
authorization condition except the change in antenna of the module during the final end
product assembly.
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 colocated 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.
※5150~5250 MHz band is restricted to indoor operations only.
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.
Operations to just the specific band(s) : limited device Software program.
User cannot enable the other bands, because PC set up should be necessary.
(details for user manual_Ch.3 Installation and Calibration)
(6) 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.
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.
10
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.
11
(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.
12
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.
13
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
14
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, 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
(2) Handling
Handle the instrument carefully, as it may be damaged if
something is hit against it, dropped, or receives a strong jolt.
(3) Handle Assembly
※ Insert the handle always in the same direction.
16

Handle Assembly Type 1
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.

Handle Assembly Type 2
(4) 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 airconditioner is going to be used, be sure to raise/lower the
temperature gradually so that a difference in temperature in the
17
room and in the instrument does not occur, to prevent forming of
condensation.
(5) 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
(6) 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.
19
Be sure to use the sensor unit on a flat place so it will not bend.
Otherwise, the sensor may be damaged.
(7) 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.
(8) Others
Be sure to reconnect the cables to the proper connectors.
Otherwise, the instrument may malfunction or may be damaged.
20
3. Technical Features
(1) Mechanical Features
Size
395 x 337 x 18 mm
Weight
2.7 kg (not incl. Handle)
Encapsulation Material
Mg
Window Material
Carbon fiber plate with 1.5mm thickness
(2) Electrical Features
Detector
Sensor Type
Amorphous Silicon with TFT (Single Panel)
X-ray Converter
CsI:Tl
Total Pixel Number
2560 × 2048 pixels
Total Pixel Area
325 x 260 mm
Effective Pixel Number
2520 × 2008 pixels
Effective Pixel Area
320 x 255 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
Wi-Fi (802.11a/g/n)
Wired
Gigabit Ethernet

Under RQA5 condition (70kVp, 21mmAl)

Preview time is not included post-processing time
Battery
Size
232.2 x 130.9 x 7 mm
Weight
Typ. 0.3 kg
Input
12.6 VDC
Output
11.1 VDC
Charging time
Typ. 2.5 hours
21
Capacity
The number of times
being acquired image
Typ. 3400 mAh
1060 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
Battery level
Display
75~100 %
50~75 %
25~50 %
0~25 %
Charger
Size
267.5 x 100 x 77 mm
Weight
Typ. 0.7 kg
Input
20 VDC
Output
12.6 VDC
Adapter
Size
160 x 76 x 43.7mm (cable length: 1.28m)
Weight
Typ. 0.8 kg
Input
100~240 VAC, 47~63 Hz, 1.4~0.6A
Output
20 VDC, Max 6.0A
22
Wireless Spec
802.11a/g/n compliance
Standard
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
※ Maximum wireless signal rate derived from IEEE standard specifications.
Actual data throughput will Network conditions and environmental factors,
including volume of network traffic, building materials and construction, and
network overhead, lower actual data throughput rate.
※Recommended Maximum operable distance : 10m (From the Access Point)
※Wireless Module and Wireless Antenna
※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: 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.1012WCA in the RF
module does not use DFS band.
23
(3) Environmental requirement
Item
Temperature
(Storage)
Temperature
(Operation)
Humidity
(Storage)
Humidity
(Operation)
Vibrations
(Wrapping
condition)
Min.
Typ.
Max.
Unit
-10
50
℃
40
℃
10
80
30
75
Note
H.R.
H.R.
10-150Hz,
2G
10Sweeps,
(8G)
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.
24
4. 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.
(1) Program setup

Detector’s IP : Wireless - 2.2.2.100 Wired – 2.2.2.101

Detector’s size of image : 2560x2048
Figure 1: Setup
25
(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.
* When you use the detector with wired mode, the WLAN
function is automatically off.
B. Connect the USB cable from your PC to AGI.
※ Be sure to sure only the dedicated battery pack, RB37WH
for 1012WCA.
26
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
27
C. Checking Link Quality & Battery Remain
- After wireless connection is established, perform ‘Get Image’
in ‘Calibration & Acquisition’ 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
28
Software Setting (manual trigger)
Figure 2: Davinci Setting
29
Trigger Connection
A. Connect the P-interface cable or trigger cable to the generator
X-ray Generator Connection
Make
assurance
doubly sure
SIGNAL RATING
before connection.
A. Mode 1 : P-interface cable mode
Connect the P-interface cable between the AGI box and X-ray
generator.
Operating description
30
The window time can be changed. Refer to the following pictures
Exposure
Time
500msec is
designate to 0.5sec
31
B. Mode 2 : Trigger cable mode
Connect the Trigger cable between the X-ray enable connector of
Make
assurance
doubly sure
SIGNAL RATING
before connection.
AGI with X-ray generator.
AGI
Box
Figure 8: <2nd example> wiring for the interface between portable generator & detector
Connection description
Signal
New Label
Old Label
Color
Input / Output
12V~24VDC
R.E.C. +12-24V
Red
Input
READY IN
Ready Input Signal
Black
Input
READY DONE
Exposure Output SW1
Green
Output
READY DONE COM
Exposure Output SW2
Blue
Output
READY IN
READY
DONE
Table 3 : Connection description
32
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
500msec is
designate to 0.5sec
33
(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 1012WCA.
34
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
35
C. Checking Link Quality & Battery Remain
- After wireless connection is established, perform ‘Get Image’
in ‘Calibration & Acquisition’ 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
36
Software Setting (Auto trigger)
Figure 4: Davinci Setting
37
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
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.
38
(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
39
(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
40
C. Check the “IP Change” and type current IP address as below
D. Type IP address to set
41
E. Click “Start Setting” button
F. Click “예 (Y) ” button
G. Click “확인” button
H. Restart detector(Turn Off then On)
42
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
43
C. Check the “SSID change” and write current IP address as
below
D. Type SSID and PSK to set
44
E. Click “Start Setting” button
I. Click “예 (Y) ” button
F. Click “확인” button
G. Restart detector(Turn Off then On)
45
Upgrade Firmware
A. Turn on Detector and connect to PC
(wired connection is recommended)
B. After detector boot up, Launch FPD_Manager.exe
46
C. Check the “SSID change” and write current IP address as
below
D. Select firmware or FPGA file by click “select” button
47
E. Click “Start Setting” button
F. Click “예 (Y) ” button
G. Click “확인” button
H. Restart detector(Turn Off then On)
48
5. Calibration
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.
(1) General Principle
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
49
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 ‘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.)
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)
Point
Median Value [LSB
500 ~
1000
2900 ~
3400
6200~
6700
9500 ~
10000
Table 5 : Median value
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).
50
(2) Calibration (Manual mode)
Describe the calibration step by step.
1st Step
A. Push “Calibration” button
B. Push “Manual Mode” button
51
C. Click on the “Calibration” button. The acquired dark frame
“dark.raw” will be generated in the “\cal\” folder.
Figure 1: Get dark
52
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 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 2: Get bright.
53
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 3: Generate
After making
calibration point the
“Generate” button will
be disabling.
54
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 4: Bad pixels removal
55
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 5: Application of calibration
56
(3) Calibration (Auto mode)
Describe the calibration step by step.
1st Step
A. Push “Calibration” button
Figure 1: Calibration
57
B. Click “Start” button to acquire a dark frame then “dark.raw”
will be generated in the “\cal\” folder.
Figure 2: Auto calibration start
C. When after the dark frame is acquired the pop up will be comes up
as ‘figure 3’
Figure 3: Bright acquisition
58
D.
When ‘Bright acquiring bright frame’ is shown, Exposure X-ray to
create Bright points as RED box on ‘Figure 4’
bright point made
by average value of
4 bright frames in
same condition,
therefore, 16frames
will be needed to
make 4 bright points
Suitability of the acquired bright frames are shown at the message
box as ‘figure 5’, please check the message box for each steps. If
calibration is successful, the pop up will appeared as ‘figure 6’
Figure 4: Bright median value
59
Figure 5 Bright acquisition message
Figure 6 Calibration complete
60
2nd step
For additional Defect correction, if “BPMM.raw” is existed at the
install CD, copy to the “\cal\” folder.
3rd 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 7: Application of calibration
61
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.
62
(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.
63
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)
64
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.
65
Marker type “S”
Displays local surround of selected location
Marker type “R”
Display profile chart of a row.
66
Marker type “C”
Display profile chart of a column.
67
(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.
68
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.
69
8. Safety Information
(1) 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.
70

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
71
(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 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
72
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.
73
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 [V 1] V/m.
74
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.
75
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.
76
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: QIIRY1012WCA
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:
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.
77
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.
78
(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-1012WCA
This Class A digital apparatus complies with Canadian ICES-003
Host device of the approved module shall be marked with the following
item:
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.
79
(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
80
10.
Maintenance
(1) Maintenance
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.

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
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.
81
(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
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
82
(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.
83
(5) Marking and labeling symbols
Symbols
Meaning
Refer to instruction manual/ booklet
Alternate current
Protective earth (Ground)
Off (power : disconnect from the main switch)
On (power : connect to the main switch)
Warning
Caution
Read carefully
Manufacturer
Date of manufacture
Serial number
84
non-ionizing radiation
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
Recognized Component Mark for Canada and
the United States
CE symbol for wireless
For KOREA
Korea Certification
For JAPAN
Product Safety of Electrical Appliance & Materials
For JAPAN
Telecom Engineering Center (TELEC) :
Technical Regulations Conformity Certification
85
Appendix
Dimension
[unit : mm]
86
Rayence Co., Ltd.
14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea
www.rayence.com
87

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