Rayence RY1012WA 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.
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.
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.
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. 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.
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(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
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(4) Product components
Photo
Item
Quantity
Detector
1
Handle
1
Battery pack
2
Battery charger
1
Charger adapter
1
AGI
1
Medical Image Processing Unit
3
Item
Length
Quantity
Link cable
7m
1
P­Interface cable
8m
1
USB cable(A to B)
1.8m
1
LAN cable
10m
1
AC Power cord
1.8m
2
cable
3m
1
Cables
Installation CD
o Manual o Detector Library
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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. 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.
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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 patients 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.
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(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
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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 users 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 persons 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.
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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)
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Make sure to observe the following right
(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 Routers 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.
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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 patients vicinity.
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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 detectors 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, RC120W is designed for the
dedicated 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.
When the detector will not be used for some time, remove
the battery pack.
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(2) Handling
A
B
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.
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Handle Assembly Type 1
Insert the handle in
the same direction
A
If the
handle is
not locked, the detector can be dropped.
Please confirm lever position. When the
handle is locked, the lever should be
same position with the right picture.
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
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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.
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(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.
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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.
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3. Technical 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
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
- Wired
Wi-Fi (802.11a/g/n)
Gigabit Ethernet
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
(1) Mechanical Features
(2) Electrical Features
Detector
Under RQA5 condition (70kVp, 21mmAl) Preview time is not included post-processing time
Battery
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Capacity
Typ. 3400 mAh
The number of times
being acquired image
1060 images (@cycle time = 15s)
Display
Battery level
75~100 %
50~75 %
25~50 %
0~25 %
Size
267.5 x 100 x 77 mm
Weight
Typ. 0.7 kg
Input
20 VDC
Output
12.6 VDC
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
The Battery level can be displayed on the LED status of battery.
If the battery level goes down under 25%, please charge the battery
Charger
Adapter
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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
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.
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