Table of Contents
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Table of Contents
Related Manuals for Owandy Radiology CR2
Summary of Contents for Owandy Radiology CR2
- Page 1 EN INSTALLATION AND USER MANUAL 6958003403 Version 02, October 2018...
- Page 2 Revision history Manual code 6958003403 Rev. Date Page/s Modification description 16.05.2017 First release 14.09.2017 New logo Owandy-CR² 09.10.2018 Ethernet / USB version...
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Page 3: Table Of Contents
Index Introduction ............................5 1.1. Purpose of the guide ........................5 1.2. Symbols used in the guide ......................5 1.3. Applicable EEC regulations ......................6 1.4. Intended purpose ........................6 Safety aspects ............................. 7 2.1. General warnings ........................7 2.2. X-ray cautions ..........................8 2.3. - Page 4 10.2. Image quality specifications ....................38 The manufacturer, OWANDY RADIOLOGY, reserves the right to make modifications to its products or to their specifications in order to improve the performance, quality, or ease of production. Specifications of products or accessories may be modified without prior notice.
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Page 5: Introduction
1. Introduction Thank you for choosing OWANDY RADIOLOGY; we feel confident that the performances of this device can meet your requirements and can be fully satisfactory. The present guide contains a detailed description of all operating instructions and procedures for a correct use of the system, as well as all specifications relating to digital image treatment. -
Page 6: Applicable Eec Regulations
NOTE All information contained in the present manual is subject to variation without prior notice. OWANDY RADIOLOGY does not take any responsibility for direct, indirect, accidental damages which are consequent or relating to the supply or use of this information. -
Page 7: Safety Aspects
2. Safety aspects The device must always be used in accordance with the procedures explained in the present manual, and shall never be used for purposes other than those it was designed for. WARNING The user is responsible for the fulfillment of the legal requirements regulating the handling of the equipment. -
Page 8: X-Ray Cautions
2.2. X-ray cautions The phosphor plate used with Owandy-CR² system is used jointly with an intra-oral X-ray system. The operator during exposure must take all the appropriate x-ray precautions and protections to prevent damage to himself and the patient. DANGER Protection to x-rays is subject to government regulation. -
Page 9: Electrical Safety
The incorrect reassembly of the devices may cause risk of electrical shock. • Use only the provided original cables and accessories supplied with the system. The use of accessories not supplied by OWANDY RADIOLOGY may cause fires, electrical shocks, or accidents. It may also void the warranty. •... -
Page 10: Emc Compatibility Advertising
2.4. EMC compatibility advertising The Owandy-CR² has been designed and realized in accordance with the regulation of EN 60601-1-2 standard: “Electro-medical devices – Part 1: General safety standards- 2 Collateral standard: Electromagnetic compatibility- Regulations and tests” and is in compliance with it. Nevertheless, it is not guaranteed that in any particular installation interference may not arise. -
Page 11: Infection Risks
• Avoid the contact of the metallic part of the USB/LAN connectors with any part of the body. • Before making any USB/Ethernet connection, perform the ESD precautionary procedures: In case, discharge the static electricity stored by grounding. • Always connect or disconnect the system when device is off. •... -
Page 12: Laser Risk
2.7. Laser Risk The Owandy-CR² uses a 30mW laser diode to scan the phosphor image plate exposed to an x-ray. LASER (Light Amplification by Stimulated Emission of Radiation) is included in the source of non-ionized radiation. The ionized radiation emitted is coherent, aimed, and very intense. The directive CEI-EN 60825-1 defines the laser as"... -
Page 13: System Composition
3. System Composition Base system components are: - OWANDY CR 2 reader - Power Supply - USB license key - CD Installation SW - Starter kit (2 plates size 0 + 2 plates size 2 + 10 paper protections + 50 hygienic single-use protection sleeves). Always protect plates with dedicated disposable plastic sleeves before inserting the plates into the patient mouth. -
Page 14: Labeling
4. Labeling Owandy-CR² identification label presents on the bottom side: 9458900021 9458900022 Symbols present on labels have the following meaning: Important information: follow the Direct current instructions printed in this manual The CE marking certifies that this product complies with European directive 93/42 Manufacturer designation Product reference Manufacturing date... -
Page 15: Introduction To The System
5. Introduction to the system Owandy-CR² is the latest OWANDY RADIOLOGY device used for the acquisition and processing of digital intra-oral images. It is the newest unit generation based on a Windows platform, with a great modularity. In case the customer uses their own PC, it is necessary to check that its technical features meet or surpass with the ones described in the present chapter (see paragraph 5.2.1) to allow the system correct functioning. -
Page 16: Technical Features
5.4. Technical features Owandy-CR² scanner model Certification and class MDD 93/42 – Ann. IX Rule16: Classification IIa Spot Size 30 µm A/D Conversion 16 bit input Power supply 24 V ±10% Current absorbed Power absorbed 24 W Dimensions and weight of the unit •... -
Page 17: Installation
If not, the system might not work, or perform incorrect operations, different from the ones described in this manual. OWANDY RADIOLOGY will not be held responsible for malfunctioning due to such reasons. 6.2. Software connection The assembling of Owandy-CR² is very easy and it could be made in a few minutes. - Page 18 • For ethernet unit: At first connection, PC’s network card must be on the same sub-net of the unit. Default configuration of the unit: IP: 192.168.0.253 subnet mask: 255.255.255.0 The network card must be compatible with 100Mbit/s or Gigabits network and its speed connection configured either as autodetection or 100Mbit/s.
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Page 19: Setup Guidelines
6.3. Setup guidelines The computer and the screen with which the Owandy-CR² is used, should preferably be situated close to the chair, within the field of vision of the practitioner, to allow for immediate use. Provide visual access for the patient to be able to share the radiological information with him/her. -
Page 20: Installation Of The Driver And The Software
6.4.1. Installation of the driver and the software The Owandy-CR² drivers are compatible with Windows 7, 8 and 10 operating systems – 32 and 64 bits. Automatic installation: insert the Driver CD-ROM in the CD-ROM-drive. The interface will launch automatically and will guide you through the different installation steps. -
Page 21: Driver Update
6.4.2. Driver update If you need to update your Driver: Insert the Driver CD-ROM or download the driver on our website www.owandy.com/support. Navigate to the “\setups\CR_XRAYS_BOX” directory on the CD-ROM. Launch “setup.exe”. Click on “Install or Reinstall” and follow the instructions on-screen User manual –... -
Page 22: Configuration In The Quickvision Imaging Software
6.5. Configuration in the QuickVision imaging software To be able to use your kit with the QuickVision imaging software you must configure your equipment. Start the imaging software (double-click on the desktop icon or use the link in Start / Programs / QuickVision). -
Page 23: Network Configuration
6.6. Network configuration 6.6.1. From software To open the Network Configuration menu: • Start the imaging software (double-click on the desktop icon or use the link in Start / Programs / QuickVision). • Click on the “Configuration” button in the main screen. •... -
Page 24: Use
7. Use 7.1. Precautions WARNING Make sure the sensitive surface (the blue surface) of the plates is directed towards the X-ray generator. Be careful not to damage the plates when removing the hygienic protective sleaves. Even though the plates are quite resistant to impacts, it is strongly recommended to not let them fall on the floor. -
Page 25: Use Of The Owandy Xio Standalone Software
7.2. Use of the Owandy XIO StandAlone software 7.2.1. Modes of operation The unit can function in two ways: • Through the Twain protocol (for scanners): to use this mode select “Owandy Intra Oral X-rays…” in the TWAIN acquisition option of your imaging software. Subsequently start the TWAIN acquisition; the interface is identical to that of the independent mode described below. -
Page 26: Standalone Toolbar
7.2.2. Standalone toolbar It is possible to display the toolbar by clicking with the right mouse button on the sensor icon in the taskbar. The colour of the toolbar indicates the state of the unit: USB & Ehternet unit: disconnected USB unit: unit in scanning mode Ethernet unit: unit in scanning mode or connection pending USB &... -
Page 27: Configuration Menu
7.2.3. Configuration menu A right-click on the icon in the taskbar or on the standalone toolbar displays the configuration menu: X-ray sensor Displays the standalone intraoral toolbar. Once checked, the StandAlone program will be launched each time Start when Windows starts your computer is started. -
Page 28: Image Transfer Interface
7.2.4. Image transfer interface Options of the image transfer interface: Image display When an image is selected, it is displayed on a blue background. “Load” button Transfers the selected image to the software program. Cancels the image selection and starts the toolbar for a new acquisition “Cancel”... -
Page 29: Acquisition Of An Image
7.3. Acquisition of an image 7.3.1. Acquisition procedure The image acquisition goes through several steps: Before being able to acquire an image with the plates, you need to start the computer to which it is connected and start the imaging software. Check that the standalone toolbar or the icon in the task bar is green. -
Page 30: Exposure Times
7.4. Exposure times Recommended exposure times in seconds for the Owandy Radiology X-ray generators: Description (Current/Voltage) Owandy-RX (6mA / 60-65-70KV) Exposure Time tables Pediatric Adult Lower incisor / canine 0.05 – 0.10 0.07 – 0.16 Lower premolar 0.06 – 0.11 0.08 –... -
Page 31: Preparing The Phosphor Plate
7.5. Preparing the Phosphor Plate WARNING Before inserting the phosphor plate into the cover inspect the plate for any scratches or visual defects. The plate must also be correctly cancelled and free of previous images. WARNING Use always paper protection of the same size of phosphor plate. If different size is used the plate can be stuck into the equipment. -
Page 32: Phosphor Plate Exposure
7.6. Phosphor Plate Exposure Place the image plate into the patient’s mouth at the desired position to obtain the required image. REMEMBER the back side of the hygienic cover with the sealed flap must be furthest away from the x-ray source. WARNING Pay attention to the plate orientation. -
Page 33: Reading The Phosphor Plate
7.7. Reading the phosphor plate WARNING Before inserting the image plate in the scanner, make sure that the plate and the protective cover have the same size. If the size of the plate and the cover are mixed, the plate will remain stuck into the scanner. In such case, follow the procedure described in the "Troubleshooting"... -
Page 34: Owandy-Cr² Led Sequence
7.8. Owandy-CR² led sequence The Owandy-CR² unit can advise the operator about all the different system status (errors, functions, etc). The different system status modes can be obtained by the external leds mounted in the front of the system and the following table explains their meaning: Standard Working Sequence ID LED Colour / Colori LED... -
Page 35: Maintenance Instructions
8. Maintenance instructions Owandy-CR² must be properly used in order to ensure safety and prevent damage to the system. Besides, the operators will have to look periodically after all the system safety standards, in order to ensure its perfect working. The following table indicates all maintenance and prevention actions to be performed, as well as periodicity and personnel in charge of such actions. -
Page 36: Cleaning And Disinfection
9. Cleaning and disinfection Owandy-CR² does not require daily cleaning and disinfection, but the phosphor plate used by the patient must be protected by a dedicated disposable protective cover before positioning into the mouth of the patient. When the exam is finished dispose of the protective cover as it must NEVER be re-used. Particular care must be devoted to the phosphor plates, although protected by the dedicated mono-use envelope it is however positioned into the patients’... -
Page 37: Troubleshooting
10. Troubleshooting 10.1. General Owandy-CR² might present problems during its use, and their solution might require the assistance of a qualified technician. The following guide indicates checks and actions you can perform if the system does not operate correctly. WARNING In order to prevent any possible damages or injury to the operator or to the system, do not attempt to solve problems by yourselves when it is clearly indicated the authorized Service Agent assistance is needed. -
Page 38: Image Quality Specifications
10.2. Image quality specifications Symptom Cause / Solution The images are cut off, e.g.: The plate is badly positioned with regard to the X-ray beam. • Reposition the plate, making sure it is well within the field of the Xray beam. •... - Page 39 This page is intentionally left blank for your notes: User manual – Rev 02 Page 39/40...
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