Rayence RY1012WCA Medical Image Processing Unit User Manual

Rayence Co., Ltd. Medical Image Processing Unit User Manual

User_Manual

Release Version 1.0.6 Medical Image Processing Unit 1012WCA User Manual
R-M-011-121030 © Copyright 2012, Rayence Co. Ltd. All pages of this document contain proprietary and confidential information of Rayence Corporation and are intended for exclusive use by Rayence Corporation personnel or customers. Copying, disclosure to others or other use is prohibited without the express written authorization from Rayence Corporation. Please report any violations of requirement to Rayence Corporation.
R-M-011-121030 Attention For improvement of product performance, supplementation, or follow-up of information; the contents of this manual are subject to change without separate prior notice. Please note that our company has neither responsibility for any accidents nor obligation to do free repair service for any damage of the equipment due to user's mistake, which resulted from failure to follow the contents in this manual. Make sure to be familiar with the safety precautions and usage procedures. Also note that the product may slightly differ from the contents of this manual depending on specification. The following marks are used for the effective use of the product in this manual. Attention, consult accompanying documents. This is used to emphasize essential information. Be sure to read this information to avoid incorrect operation. This indicates hazardous situation which, if not heeded, may result in minor or moderate injury to you or others, or may result in machine damage. This indicates a potentially hazardous situation which, if not heeded, could result in death or serious injury to you or others. Federal Law restricts this device to sale by or the order of a radiologist or any other practitioners licensed by the law of the state in which that person practices to use or order the use of the device.
R-M-011-121030 Contents Introduction ........................................................................................ 1 Intended use ...................................................................................... 1 Product features ................................................................................ 2 Product components ......................................................................... 3 Components Description................................................................... 5 Warning .............................................................................................. 8 Caution ............................................................................................. 10 Marking and labeling symbols ........................................................ 12 Notes for Using the Detector ............................................................ 14 Preparing .......................................................................................... 14 Handling ........................................................................................... 15 Handle Assembly ............................................................................. 15 Before Exposure .............................................................................. 17 During Exposure .............................................................................. 17 Limit of Load .................................................................................... 19 Disinfection and Cleaning ............................................................... 20 Others ............................................................................................... 20 Technical Features ........................................................................... 21 Mechanical Features ........................................................................ 21 Electrical Features ........................................................................... 21 Environmental requirement ............................................................. 24 PC Requirements ............................................................................. 24 Installation........................................................................................ 25 General interface ............................................................................. 25 Connection ....................................................................................... 25 IP set up ........................................................................................... 31 Using Web Manager (IP, SSID Change / Upgrade FW) ................... 32 Calibration ........................................................................................ 36 General Principle ............................................................................. 36 Calibration ........................................................................................ 38 Image Acquisition Test ..................................................................... 43 Program setup ................................................................................. 43 Get Image ......................................................................................... 44 View Images ..................................................................................... 45 Operation .......................................................................................... 50 Recommend ..................................................................................... 50 Switching power on / off .................................................................. 50 Storage ............................................................................................. 50 Information ....................................................................................... 51 Safety standard ................................................................................ 51 Electromagnetic Compatibility Information .................................... 53 FCC Notice ....................................................................................... 53 Maintenance ..................................................................................... 60 Maintenance ..................................................................................... 60 Cleaning ........................................................................................... 60 Inspection ........................................................................................ 61 Disposal or Recycling...................................................................... 62 Appendix ........................................................................................... 63
1 R-M-011-121030 Introduction 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. Intended use For U.S.A. 1012WCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, spinal column, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography. For European Union This device provides digital X-ray imaging for diagnosis of disease, injury, or any applicable health problem. The image is obtained as the result of imaging X-rays passed through the human body with an X-ray flat panel detector and importing a digital signal output from the detector into the image processor.
2 R-M-011-121030 Product features  Wi-Fi (802.11a/g/n)  Based on a-Si TFT active matrix  Compact (18mm thickness) and light weight (Typ. 3.15kg)  Limiting Resolution : 3.9 lp/mm  16-bit digital output  Easy integration
3 R-M-011-121030 Product components  Medical Image Processing Unit Photo Item Part Name Quantity Detector SD1012WCA 1 Handle - 1 Battery pack RB37WH 2 Battery charger RC120W 1 Charger adapter PMP120-13-3 1 AGI RA001A 1
4 R-M-011-121030  Cables Item Part Name Length Quantity Link cable VRH076A 6m 1 P-Interface cable VRH017A 8m 1 USB cable (A to B) VRH078A 1.8m 1 AC Power cord VRH018A/019A 1.8m 1  Installation CD o Manual o Detector Library  Option o Additional Battery o Charger for the Car o Cover Bag o AP package
5 R-M-011-121030 Components Description The detector is designed to capture radiographic images. Captured images are transmitted to PC using the wireless/wired connection. (1) Detector 1. LED indicator: The LED indicates the state of detector. i. Green on : Power on. ii. Blue blinking : Wireless Connection. iii. Orange on : Low battery. 2. Handle : Hold this handle when carrying the sensor unit. It is removable. (Horizon / Vertical) 3. Handle unlock-lever : This is an unlock-lever to remove handle. 4. Link cable connector : This is a connector for Wire communication
6 R-M-011-121030 and power supplying. Connect the detector to PC and SMPS(not provided) using Link cable. 5. CFRP(Carbon Fiber Reinforced Plastic) : The part of the patient’s body to which an image is to be taken should be placed against this plate. 6. Power button : Power on / Power off switch. 7. Shock sensor : Detector has built-in 4 Shock sensors. It detects and records impact and mishandling of fragile 8. Battery unlock-lever : This is an unlock-lever to remove battery. (2) Battery & Charger 1. Battery : Lithium ion battery. The number of times being acquired image is 600 images(@ cycle time : 15s). The batteries last 2.5 hours and are rechargeable. 2. Charger : Two port cradle type. 3. LED indicator : i. Orange on : charging ii. Green on : Charging is completed.
7 R-M-011-121030 (3) AGI 1. Trigger connector: This is a connector for synchronization between detector and generator. Connect the AGI to the generator using P-interface cable.. 2. USB connector: This is a connector for communication between AGI and PC. Connect the AGI to the PC using USB cable.
8 R-M-011-121030 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. Handling Always be sure to keep checking the condition of the system and the patient to ensure they are normal during the use of the instrument. If any problem is found, take appropriate measures, such as stopping the operation of the instrument, as required. Never disassemble or modify the product as it may result in fire or electric shock. Also, since the instrument incorporates parts that may cause electric shocks and other hazardous parts, touching them may cause death or serious injury. Do not hit or drop the instrument. The instrument may be damaged if it receives a strong jolt, which may result in fire or electric shock if the instrument is used without being repaired. Make sure to observe the following right
9 R-M-011-121030 When Problem Occurs Should any of the following occur, immediately turn OFF the power of each instruments, unplug the power supply cord from the AC outlet, and contact Rayence representative or distributor.  When there is smoke, odd smell or abnormal sound.  When liquid has been spilled into the instrument or a metal object has entered through an opening.  When the instrument has been dropped and it is damaged. Maintenance and Inspection For safety reasons, be sure to turn OFF the power of each 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. Make sure to observe the following right.
10 R-M-011-121030 Caution Environment of Use and Storage Do not install the instrument in a location with the conditions listed below. Otherwise, it may result in failure or malfunction, cause fire or injury.  Close to facilities where water is used.  Where it will be exposed to direct sunlight.  Close to air-conditioner or ventilation equipment.  Close to heat source such as a heater.  Prone to vibration.  Insecure place.  Dusty environment.  Saline or sulfurous environment.  High temperature or humidity.  Freezing or condensation. Do not place the storage case in a location with the conditions listed below.  Where the cable of the sensor unit will be strongly pulled when the sensor unit is put into the case, otherwise, the cable may be damaged, resulting in fire or electric shock.  Where someone might get their foot caught in the cable of the sensor unit. Otherwise they could trip over, resulting in injury
11 R-M-011-121030 Handling Do not spill liquid or chemicals onto the instrument or, in cases where the patient is injured, allow it to become wet with blood or other body fluids, as doing so may result in fire or electric shock. In such situation, protect the instrument with disposable covering as necessary. Wipe the CFRP plate of the sensor unit with ethanol or glutaraldehyde solution to disinfect it each time a different patient uses the instrument, in order to prevent infection. Turn off the power of each instrument for safety when they are not going to be used. Maintenance and Inspection For safety reasons, be sure to inspect the instrument before using it. In addition, carry out a regular inspection at least once a year. Modifications Any changes or modifications in construction of this device which are not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
12 R-M-011-121030 Marking and labeling symbols Symbols Meaning Caution : “Attention, see instructions for use” Manufacturer Date of manufacture Serial number WEEE : Waste Electrical and Electronic Equipment Authorized representative in the European Community CE symbol grants the product compliance to the European Directive for Medical Devices 93/42/EEC as a class Ⅱa device. Authorized by Notified Body SGS (code no.:0120) of British non-ionizing radiation
13 R-M-011-121030 Labels Detector label Battery Pack Battery Charger
14 R-M-011-121030 Notes for Using the Detector Preparing Fully charge the battery pack. Charge the battery on the day of examination or on the previous day.  Battery slowly discharges even of not in use. The battery pack may have expired if it discharges immediately after being fully charged. You can purchase an optional battery pack to replace an exhausted one.  Be sure to fully charge the battery before use. ※ The battery charger, RC120W is designed for the dedicated battery pack. ※ When the detector will not be used for some time, remove the battery pack. Attach the battery pack. Align the claw on the battery pack and the groove on the battery bay. Insert the battery pack fully. Push down the battery pack. Slide the lock lever toward (lock) side and lock it.
15 R-M-011-121030 Handling Handle the instrument carefully, as it may be damaged if something is hit against it, dropped, or receives a strong jolt. Handle Assembly ※ Insert the handle always in the same direction. B A
16 R-M-011-121030  Handle Assembly Type 1  Handle Assembly Type 2 Insert the handle in the same direction Insert the handle in the same direction A B Please confirm lever position. When the handle is locked, the lever should be same position with the right picture. 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.
17 R-M-011-121030 Before Exposure Be sure to check the equipment daily and confirm that it works properly. Sudden heating of the room in cold areas will cause condensation to form on the instrument. In this case, wait until condensation disappears before performing exposure. If the instrument is used with condensation formed on it, problems may occur in the quality of the instrument. When an air-conditioner is going to be used, be sure to raise/lower the temperature gradually so that a difference in temperature in the room and in the instrument does not occur, to prevent forming of condensation. During Exposure Do not use the detector near devices generating a strong magnetic field. Doing so may produce image noise or artifacts. Do not apply excessive weight to the sensor unit. Otherwise, the sensor may be damaged.
18 R-M-011-121030  Sleep Mode/Wake up Control “e” parameter : sleep time - 0 : disabled (default) - 1 : 1 sec - 2 : 2 sec … - 600 : 600 sec  If you set sleep time, the detector goes to the sleep mode after “N” sec after acquiring image  If you want to wake up the detector, Press the power button(less than 1 second) Do not change parameters except “Control e”
19 R-M-011-121030 Limit of Load Uniform load: 150 kg over the whole area of sensor window. Local load: 100 kg on an area 40 mm in diameter.
20 R-M-011-121030 Be sure to use the sensor unit on a flat place so it will not bend. Otherwise, the sensor may be damaged. Disinfection and Cleaning Do not spray the detector directly with disinfectants or detergents. Do not use anything other than neutral detergent for cleaning the cover of the instrument. Otherwise, the coating will be corroded. Others Be sure to reconnect the cables to the proper connectors. Otherwise, the instrument may malfunction or may be damaged.
21 R-M-011-121030 Technical Features Mechanical Features Size 395 x 337 x 18 mm Weight 2.85 kg (incl. Battery pack) Encapsulation Material Mg Window Material Carbon fiber plate with 1.4 mm thickness Electrical Features Detector Sensor Type Amorphous Silicon with TFT (Single Panel) X-ray Converter CsI:Tl Total Pixel Number 2080 × 2560 pixels Active Pixel Area 25.9 cm × 32.0 cm Active Pixel Number 2040 × 2520 pixels Pixel Pitch 127 μm Limiting Resolution Max. 3.9 lp/mm Energy Range 40 - 150 kV A/D Conversion 16 bits Frame Rate 240 fph Preview Time < 2.0 sec Charge Integration Time upto 4 sec Max. Linear Dose Typ. 60 μGy @ SID 1500 mm Saturation Dose Typ. 70 μGy @ SID 1500 mm Data Interface - Wireless - Wire Wi-Fi (802.11a/g/n) Gigabit Ethernet  Under RQA5 condition (70kVp, 21mmAl)  Preview time may vary by complex factors
22 R-M-011-121030 Battery Size 232.5 x 132.8 x 7 mm Weight Typ. 0.3 kg Input 12.5 VDC Output 11.1 VDC Charging time Typ. 2.5 hours Capacity Typ. 3400 mAh The number of times being acquired image 600 images The Battery level can be displayed on the LED status of battery. If the battery level goes down under 25%, please charge the battery Display Battery level 75~100 % 50~75 % 25~50 % 0~25 % Charger Size 267.5 x 100 x 77 mm Weight Typ. 0.86 kg Input 20 VDC Output 11.1 VDC Adapter Size 160 x 76 x 43.7mm (cable length: 1.28m) Weight Typ. 0.92 kg Input 100~240 VAC, 47~63 Hz, 1.4~0.6A Output 20 VDC, Max 6.0A
23 R-M-011-121030 Wireless Spec Standard 802.11a/g/n compliance Peak Rate 300Mbps Frequency 2.4 GHz / 5 GHz Bandwidth 20MHz/40MHz MIMO 2x2 5.15~5.25 GHz band is restricted to indoor operations only. (for FCC) 5.15~5.350 GHz band is restricted to indoor operations only. (for CE) 5.15~5.350 GHz is indoor use only. (for Japan) ※ Recommended Maximum operable distance : 7m (From the Access Point)
24 R-M-011-121030 Environmental requirement Item Min. Typ. Max. Unit Note Temperature -10 50 ℃ Humidity 10 80 % H.R. Pressure 70 106 kPa Shocks (Wrapping condition) 10G (25G) 16ms, 1000times, in 6directions, non-Driving Vibrations (Wrapping condition) 2G (10G) 10-150Hz, 10Sweeps, 1min/Octave, XYZ axis ※ Regularly changed parts : Battery (warranty 6 months) PC Requirements  Processor : At least Intel Pentium IV HT with 2.8GHz, Intel Core Duo / Core 2 or comparable AMD Dual Core processor  At least 2 GB RAM  At least 40 GB hard disk for the software, in addition to the required archive capacity for image storage  Upper that Intel® PRO/100VE Network card  Graphics card/monitor : Resolution of at least 1,280 x 1,024 pixels in True Color mode  OS : Windows XP, vista, 7(32/64 bit)
25 R-M-011-121030 Installation The Detector is composed of sensitive electronic parts and components. It is recommended to use the product in a clean place and to exercise caution to ensure that it is not affected by dust or liquids. It is recommended to Use a dry and soft cloth to clean the detector housing. General interface Connection Power Connection A. Connect the battery pack or power cable to the equipment. B. Connect the USB cable from your PC to AGI. ※ Be sure to sure only the dedicated battery pack, RB37WH for 1012WCA. Portable Imaging processing unit must be installed in a way that enables the user to achieve optimal use
26 R-M-011-121030 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 R-M-011-121030 C. Checking Link Quality - After wireless connection is established, perform ‘Get Bright’ in ‘Calibration’ tap. - Check the value named ‘Wireless Signal’ in black log screen. Wireless Signal = Link Quality (Max. 100) The value ‘Wireless Signal’ will be displayed here
28 R-M-011-121030 Trigger Connection A. Connect the P-interface cable to the generator X-ray Generator Connection Connect the P-interface cable between the AGI box and X-ray generator. A. Wiring Mode 1 : P-interface cable mode Make assurance doubly sure SIGNAL RATING before connection.
29 R-M-011-121030 Operating description The window time can be changed. Refer to the following pictures
30 R-M-011-121030 Exposure Time(*clk) 1333333 is designate to 0.5sec
31 R-M-011-121030 IP set up [My Network Places] → [Properties] → [Local Area Connection] → [Properties] → [Internet Protocol (TCP/IP)] → [Use the following IP address] IP address : Obtain an IP address automatically IP address : Obtain an IP address automatically

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