rayence 1012WCA User manual

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. Introduction....................................................................................1
(1) Overview........................................................................................1
(2) Intended use..................................................................................1
(3) Product features...........................................................................2
(4) Product components....................................................................3
(5) Components Description.............................................................5
(6) Warning........................................................................................10
(7) Caution ........................................................................................12
2. Notes for Using the Detector ......................................................15
(1) Preparing.....................................................................................15
(2) Handling ......................................................................................16
(3) Handle Assembly........................................................................16
(4) Before Exposure.........................................................................17
(5) During Exposure.........................................................................18
(6) Limit of Load ...............................................................................19
(7) Disinfection and Cleaning .........................................................20
(8) Others ..........................................................................................20
3. Technical Features ......................................................................21
(1) Mechanical Features ..................................................................21
(2) Electrical Features......................................................................21
(3) Environmental requirement.......................................................24
(4) PC Requirements........................................................................24
4. Installation ...................................................................................25
(1) Program setup ............................................................................25
(2) Connection (Manual Trigger).....................................................26
(3) Connection (Auto Trigger).........................................................34
(5)IP set up.......................................................................................39
(6) Using FPD_Manager (IP, SSID Change / Upgrade FW) ...........40
5. Calibration ....................................................................................49
(1) General Principle........................................................................49
(2) Calibration (Manual mode) ........................................................51
(3) Calibration (Auto mode).............................................................57
6. Image Acquisition Test................................................................62
(1) Get Image ....................................................................................62
(2) View Images ................................................................................63
(3) Get Recent Frame.......................................................................68
7. Operation......................................................................................69
(1) Recommend ................................................................................69
(2) Switching power on / off............................................................69
(3) Storage ........................................................................................69
8. Safety Information .......................................................................70
(1) Safety standard...........................................................................70
(2) Electromagnetic Compatibility Information.............................72
9. Radio Frequency compliance ......................................................77
(1)FCC Notice (U.S.A) .....................................................................77
(2) IC Notice (CANADA)...................................................................79
(3) R&TTE Notice (European Union) ..............................................80

10. Maintenance.................................................................................81
(1) Maintenance................................................................................81
(2) Cleaning.......................................................................................81
(3) Inspection....................................................................................82
(4) Disposal or Recycling................................................................83
(5) Marking and labeling symbols ..................................................84
Appendix..............................................................................................86

1
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.

2
(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

3
(4) Product components
Medical Image Processing Unit
Photo
Item
Quantity
Detector
1
Handle
1
Battery pack
2
Battery charger
1
Charger adapter
1
AGI
1

4
Cables
Item
Length
Quantity
Link cable
7m
1
P-
Interface
cable
8m
1
USB
cable(A to
B)
1.8m
1
LAN cable
10m
1
AC Power
cord
1.8m
2
Trigger
cable
3m
1
Installation CD
oManual
oDetector Library

5
(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.

6
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.

7
(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

8
※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 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.
※5150~5250 MHz band is restricted to indoor operations only.

9
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)

10
(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

11
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.

12
(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.

13
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.

14
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