Manual MADE IN GERMANY

Transcription

1 Manual MADE IN GERMANY

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3 Contents Important Information 1. General Note on Conformity General Notes Disposal of appliance Correct Usage Incorrect Usage Using Peripheral Devices Use of Software Safety General Safety Notes Electrical safety instructions Warnings and Symbols Model identification plate Delivery Contents Disposable materials System requirements Monitor Minimum system requirements Technical Data Functional layout Functional Description Use of the Appliance 12. Working with DR Creating x-ray images Disinfection and Cleaning CCU Controller CCD sensor Surfaces and accessories Maintenance Recommended exposure times Trouble-shooting 16. Tips for Operators and Service Technician Mounting 9. Set-up Room for set-up Set-up Capabilities Mounting capabilities for the sensor holder Electrical connection Start-up and first use System requirements Installing the calibration software /08/ /30 3

4 1. General Important Information 1.1 Note on Conformity The product has been subjected to a conformity acceptance procedure in accordance with the relevant guidelines of the European Union for this appliance and conforms to the demanded fundamental requirements of these guidelines. 1.2 General Notes These Installation and Operating Instructions form an integral part of the appliance. They must be kept close to the unit at all times. Observing the installation and operating instructions is a precondition for the designated use and the correct operation of the appliance. New employees must be instructed. New personnel must be made aware of the contents, and they should be passed on to future operating staff. Safety for the operator as well as trouble-free operation of the unit are only ensured if use is made of original equipment parts. Furthermore, only the accessories described in the installation and operating instructions or approved by DÜRR MEDICAL for use with this appliance may be used. If other accessories are used, DÜRR MEDICAL can assume no warranty for the safe operation and reliable function. No claims for damages resulting therefrom will be accepted. DÜRR MEDICAL is responsible for the appliances from the point of view of safety, reliability and function only when installation, new settings, modifications, expansions and repairs are carried out by DÜRR MEDICAL or by a service centre authorised by DÜRR MEDICAL, and when the appliance is used and operated in accordance with the installation and operating instructions. These Installation and Operating Instructions conform to the relevant version of the equipment and the underlying safety standards valid at the time of going to press. All circuits, processes, names, software and appliances quoted are protected under industrial property rights. The translation of the installation and operating instructions has been made to the best of knowledge. The manufacturer bears no liabilities in the case of a mistake in the translation. The included German version of the installation and operating instructions is relevant. Reprinting of the installation and operating instructions, in whole or in parts, is only permitted with the written approval of DÜRR MEDICAL. Retain the packaging for possible return of the product to the manufacturers. Ensure that the packaging is stored away from children. Only the original packaging provides adequate protection during transport of the unit. If the appliance has to be returned to the manufacturers during the warranty period, DÜRR MEDICAL will accept no liability for damage occurring during transport resulting from poor packaging! 1.3 Disposal of appliance appliance The EU guideline 2002/96/EC - WEEE (Waste Electric and Electronic Equipment) of 27 January 2003 and its current implementation into national law determines that products are subject to the above-mentioned guideline and must be disposed of especially within the European Economic Area. Please address questions concerning the proper disposal of the product to DÜRR MEDICAL or to the dental trade / /08/13

5 1.4 Correct Usage The device is meant exclusively for the creation of x-ray images in the practises and clinics of veterinary medicine. The device is only to be used in enclosed, dry rooms.. Correct Usage of the appliance also involves observing the Installation and Operating Instructions and adhering to those instructions concerning set-up, operating and maintenance. Every usage which is not in accordance with the Correct Usage above will lead to the guarantees and warranties becoming null and void. The operator is liable for any damage arising through incorrect usage. Correct Usage also involves observing all local and national regulations concerning health and safety at work and radiation prevention. 1.5 Incorrect Usage The device is not meant for operation in medical or dental sectors for humans. Any other or additional utilisation, especially the radioscopy, mammography and dental applications do not apply as intended usage. The manufacturer is not liable for any damages arising from incorrect usage. The operator bears all risks and liabilities. The device are not to be operated in rooms containing hazards of igniting flammable mixtures (e.g. anaesthetics). 1.6 Using Peripheral Devices Only peripheral devices (computer, monitor, printer) may be connected to this appliance which conform to standard IEC ( 60950/1). Appliances may only be connected together or connected to other system parts where the safety of patients, operators and also the environment is ensured. Where the absolute safety for operator, patient or environment is not apparent then the operator is expected to call on expert advice, e.g. from the manufacturer or an expert, that such connections are safe before proceeding. 1.7 Use of Software Only one of the X-Ray software versions released by DÜRR MEDICAL (e.g. Vet- Exam, Vet-Exam Intra) can be used. Use of any other software must be expressly approved by DÜRR MEDICAL. Further information can be found on the internet under See system requirements for computer systems in combination with Dürr Medical - CR Systems, Order No /01 or on the Internet. The operating systems Windows XP Professional / Home from Service Pack 3 up and Windows Vista 32-bit Home Premium or better are supported. 2010/08/ /30 5

6 2. Safety 2.1 General Safety Notes The appliance has been developed and designed in such a way that dangers are effectively ruled out if operated in accordance with the intended use. In spite of this, we feel it is our duty to mention the following safety measures in order to prevent any possible danger. When using this appliance all local and relevant regulations must be observed! Opening, converting or modifying the appliance in any way is strictly prohibited. DÜRR MEDICAL can assume no warranty or liability for modified or adapted appliances. The operation of modified appliances can be punishable by law. In the interests of troublefree operation the operator is responsible for observing these regulations. Installation must be carried out by a technical expert. Before every use the operator must check the functional safety and the condition of the appliance. The operator must be knowledgeable in the operation of the appliance. The product is not designed to be used in medical treatment areas where there exists the danger of explosion. Areas where explosions could occur are those where flammable anaesthetic substance, skin cleansers, oxygen and skin disinfectants are present. This appliance is not to be used in areas where the atmosphere could cause fire. 2.2 Electrical safety instructions The appliance may only be connected to a correctly installed earthed safety socket. Before connecting to the electricity supply the appliance must be inspected and checked that the supply voltage and the supply frequency correspond to that of the local electrical supply. Before initial use and start-up the appliance and all supply lines must be checked for any signs of damage. Damaged supply lines and connections must be replaced immediately. Hazards caused by electrical components and toxic or poisonous substances! CCD sensors with damages to the housing or on the cable are not to be used again. CCD sensors with damages to the housing or on the cable are not to be used again. When using the appliance observe all the relevant electrical safety procedures / /08/13

7 3. Warnings and Symbols In the operating instructions the following warnings and symbols have been used: Information and/or mandatory regulations or prohibitions for the prevention of personal injury or substantial property damage Information and/or instructions or prohibitions regarding personal safety or extensive material damage. Only use once (disposable) Model identification plate The model identification plate can be found to the rear side of the device in the middle. The following designations or signs exist on the model identification plate: REF Order No. / Model No. SN Serial No. Ground-free application part type BF Observe accompanying documentation Date of manufacturer 2 Dispose of correctly according to EU-guidelines (2002/96/EG - WEEE) CE label without notified body number IP20 Fuse type 2010/08/ /30 7

8 4. Delivery Contents DR 6 with sensor DR 6.1 (Order no.: ): CCU Controller Sensor DR 6.1 with respective calibration CD System Kit USB cable 3 m Power unit Mains cable EUR Mains cable GB Holder for CCU Controller Sensor holder Nubs for table set-up Hygienic protective covers (100 pieces) Hook and pile fastener Holding prism or DR 6 with sensor DR 6.2 (Order no.: ): CCU Controller Sensor DR 6.2 with respective calibration CD Disposable materials Hygienic protective covers (100 pieces.) Hygienic protective covers (500 pieces.) System requirements For the operation of the scanner, the following components and requirements are necessary. 5.1 Monitor The monitor is not included in the scope of supply with the DR 6 Monitors with higher light intensity and a broad contrast are to be used in accordance with standard Bright room light, direct sunlight and reflections decrease the ability to diagnose the x-rays Minimum system requirements See provided information sheet Order No /01 System Kit USB cable 3 m Power unit Mains cable EUR Mains cable GB Holder for CCU Controller Sensor holder Nubs for table set-up Hygienic protective covers (100 pieces) Hook and pile fastener Holding prism / /08/13

9 6. Technical Data Electrical Rated connection data AC voltage (VAC) Rated current (A) ,1 Frequency (Hz) Operating mode (% ED) Cable length Power unit - CCU controller (m) DC protective low voltage / Current (V/mA) ,5/<500 Power consumption CCU Controller Standby (W) Ready to capture (W) Dimensions CCU Controller W x H x D (mm) x 118 x 36 Climate conditions Operation Temperature ( C) Humidity (%) Air pressure (hpa) Sea level (m) max Climate conditions Storage and transport Temperature ( C) to 60 Humidity (%) Air pressure (hpa) Sea level (m) max Fuse types/ - classes Fuse type IP20 Protection class.. ll, application part model BF Sensor DR 6.1 Dimensions W x H x D (mm) without cable outlet x 39 x 6.5 Active sensor surface W x H (mm) x 30 Cable length (m) Stability > images Image properties (depending on the operating mode): Pixel size (µm) x 22 Number of pixels x 1368 = Theoretical resolution (LP/mm) Pixel size (µm) x 44 Number of pixels x 684 = Theoretical resolution (LP/mm) Sensor DR 6.2 Dimensions W x H x D (mm) without cable outlet x 43 x 6.5 Active sensor surface W x H (mm) x 36.8 Cable length (m) Stability > images Image properties (depending on the operating mode): Pixel size (µm) x 22 Number of pixels x 1640 = Theoretical resolution (LP/mm) Pixel size (µm) x 44 Number of pixels x 820 = Theoretical resolution (LP/mm) Connection to PC (USB 2.0) Cable length m (Standard) / 5 m (Accessory) Connection PC USB-Port Transmission time based on sensor size and setting (s) /08/ /30 9

10 7. Functional layout 9 c 9 b 9 a CCU Controller 2 CCD sensor 3 PC 4 USB cable 5 Power unit 6 Mains cable 8. Functional Description The system is supplied with power by a power unit (5) (green LED (9a) illuminated). The 3 m long cable from the CCD sensor (2) is inserted in the CCU controller (1). The CCU controller is connected with a free USB interface on the PC (3) via a USB cable (4). The CCD sensor is provided with and positioned with a hygienic protective cover. Imaging capabilities of DR 6 must then be activated in the x-ray software. This is indicated by the yellow LED (9c). 7 Sensor holder 8 Holder for CCU Controller 9a Ready for operation (green LED) 9b Fault (red LED) 9c Ready for operation (yellow LED) With X-rays, the x-rays are converted to beams of light by the scintillator (luminescent material) applied on the CCD sensor. The image information is the digitalised, saved in the CCU controller and then transferred to the PC. If an error occurs during the process, the image information is sent again. During the data transmission, no further capturing is possible / /08/13

11 9. Set-up Mounting 9.1 Room for set-up Danger of short circuit due to build up of condensation. The system can only be put into operation once the appliance has warmed up to room temperature. Do not subject the CCD sensor to major temperature differences (heating max. 3 C/min). Exception: Standard heating from room temperature approximately 20 C to body temperature approximately 37 C during the application. Do not subject the system to direct sunlight or heat. Utilise only in a room that is designed respectively (e.g. x-ray room). Do not use in the open. The room for set-up is not to contain any major interference fields (e.g. strong magnetic fields), this could lead to faults in the device. The socket-outlet provided for the power unit must be easily accessible. 2010/08/ /30 11

12 9.2 Set-up Capabilities Wall-mount Mount for CCU controller (8) to the wall with screws and wall anchors and put the CCU controller (1) into the mount from above. 8 3 Table Set-up Adhere the provided rubber pads (10) onto the rear of the CCU controller (1). Set the CCU controller (1) on the rubber pads Tube mounts The mount for the CCU controller (8) can be mounted on either a horizontal or a vertical tube (17) using a hook and pile fastening and a holding prism (16), e.g. fastened on the configuration rod. Push the CCU controller (1) into the mount from above / /08/13

13 9.3 Mounting capabilities for the sensor holder Fastening on the holder of the CCU controller The sensor holder can be fastened on the holder for the CCU controller using the provided fastening material. 6 Wall-mount The sensor holder can be fastened to the wall or the treatment unit e.g. with glue-on pads or screw and wall anchor /08/ /30 13

14 10. Electrical connection The power unit of the DR 6 is only to be connected to the power after cabling the individual components. Insert the plug-in connector of the USB cable into the socket of the CCU controller (11) Insert the plug-in connector of the USB cable into a free USB interface on the PC. Position the plug-in connector of the sensor into the socket of the CCU controller (13). Do not drop the CCD sensor or subject to pressure. Insert the plug-in connector of the power unit into the socket of the CCU controller (12). Insert the power connector into the power unit and the other end into the socket. The green LED on the CCU controller must be illuminated / /08/13

15 11. Start-up and first use 11.1 System requirements All connected components must meet minimum requirements for DR 6 Order No.: / Installing the calibration software Each CCD sensor is provided with its own individual calibration software. This software must be installed on the PC. See the provided installation and configuration instructions for installing the calibration software Order No.: / /08/ /30 15

16 Use of the Appliance 12. Working with DR 6 The CCD sensor can be used with or without right-angle holder (upon request). To prevent any position faults, we recommend using a right angle holder. If the DR 6 is operated with VETExam Intra or via CREasy, x-ray images can either be created in high resolution mode (22.7 LP/mm) or standard mode (11.35 LP/ mm). The transmission time is 4 to 16 seconds depending on the sensor size and setting. 9 c 12.1 Creating x-ray images 9 b Start the PC Start the x-ray software. 9 a Select the required scanning mode. Actuate capturing capabilities of DR 6 in the x-ray software. Avoidable exposure dose: Before the image is taken, both LEDs (yellow and green) must be illuminated on the CCU controller (1), otherwise the image cannot be saved and the image must also be repeated. 11 LED descriptions Green (9a) Ready for operation Yellow (9c) Capturing capability Red (9b) Fault / /08/13

17 Position the CCD sensor (2) in the right angle holder (14) Do not drop the CCD sensor or subject to pressure. Position the hygienic protective cover (15) over the right angle holder with the CCD sensor (2) or only over the CCD sensor. Position the CCD sensor. Hygienic protection: Hygienic protection covers should be used for reasons of infection. 12 Hygienic protective covers are not to be reused. Create exposure values on the x-ray appliance. Trigger the X-ray exposure. The CCD sensor automatically detects when x-ray radiation occurs and automatically transfers the image to the software. The CCU controller is not ready to capture on the PC during the transmission of image data (yellow LED not illuminated). As soon as the yellow LED is illuminated, the system is ready for capturing again. 2010/08/ /30 17

18 13. Disinfection and Cleaning Only use disinfection and cleaning agents specifically approved or manufactured by DÜRR MEDICAL. Other disinfection- and cleaningpreparations can damage the CCD sensor or the CCU controller. Using other disinfection- and cleaningpreparations is unintended usage. The manufacturer is not liable for any damages arising from incorrect usage. The operator bears all risks and liabilities. Do not put sensor in an autoclave. Do not immerse disinfect sensor. Do not clean or disinfect sensor in ultrasonic bath. Do not spray the connecting plug of the CCD sensor! Remove large bits of contamination before disinfecting with a soft, lint-free cloth CCU Controller Damage to the CCU controller: No liquid is allowed to contact the inside of the device. Liquid can damage the system. Therefore, do not spray the CCU controller with cleaning- and disinfection-solutions or put it in an autoclave or an immersion bath CCD sensor The CCD sensor can be disinfected with disinfectant wipes. Damage to the CCD sensor: Disinfect as described in the operating instructions for the disinfectant. Otherwise, it can cause damages to the CCD sensor. Quick surface disinfectant Orochemie B60 Ready-to-use solution Disinfectant wipes Orochemie B30 Ready-to-use cloths 13.3 Surfaces and accessories For disinfecting surfaces (plug-in connections, cable, etc.), use disinfectant wipes (e.g. Orochemie B30) or a spray disinfectant (e.g. Orochemie B60) on a soft, lint-free cloth as an alternative. 14. Maintenance No maintenance is possible by the user. Upcoming maintenance intervals must be performed by a service technician that has been authorised by DÜRR MEDICAL or in the factory of DÜRR MEDICAL. Before commissioning, the entire system is to be checked for possible damages. If there is any damage, the system is not to be put into operation. Disinfection should be carried out with disinfectant wipes (e.g. Orochemie B30) or alternatively using disinfectant spray (e.g. Orochemie B60) on a soft, lint-free cloth / /08/13

19 15. Recommended exposure times Avoidable exposure: The maximum exposure time of 500 ms is not be exceeded. The image can become unusable if the exposure time is too long. Check the following appliance-specific standard values and adapt as required. Reference conditions: House cat (approx. 6 kg) to medium sized dog (approx. 20 kg) The exposure times indicated in the table for tube length 20 cm were determined with a dental x-ray unit with DC emitter (focal point 0.7 mm; tube length 20 cm). The exposure times for tube length 30 cm were calculated from the exposure times for tube length 20 cm. Parameter DC-emitter, 7 ma, tube length 20 cm Recommended exposure time (s) DC-emitter, 7 ma, tube length 30 cm recommended exposure time (s) upper jaw 60kV 70kV 60kV 70kV incisors pre-molars 0, molars , lower jaw 60kV 70kV 60kV 70kV incisors pre-molars 0, molars 0, Where it is possible to set the x-ray tubes to 60 kv, this setting should be selected. The usual exposure values for F-Film (e.g. Kodak Insight) can be used. 2010/08/ /30 19

20 Trouble-shooting 16. Tips for Operators and Service Technician Any repairs above and beyond routine maintenance must be carried out by suitably qualified personnel or one of our service technicians. Problem Probable cause Solution 1. LED (9a) on the CCU controller (1) not illuminated. 2. LED (9b) glows red. Power supply of the CCU controller (1) is faulty. CCU controller (1) Control program not loaded Plug in power unit (5). Ensure that the power supply plug-in connector is seated correctly on the CCU controller (1). Check socket outlet for functionality. Unplug the power unit (5) for 10 seconds and then plug it in again. Change power unit. Change CCU Controller (1). Unplug the power unit (5) for 10 seconds and then plug it in again. Change CCU Controller (1). 3. LED (9b) glows red. 4. LED (9c) glows yellow. 5. LED (9c) is not glowing. 6. LED (9c) is illuminated in yellow after triggering the x-ray. No image is transferred. 7. Program outputs error message for data communication. Power supply problem DR 6 is not yet activated by the x-ray software. An image is the image memory of the CCU controller (1) (as long as the LED (9a) is illuminated and green). Image was not saved. Data transmission between CCU controller (1) and PC (3) is interrupted. Ensure that the power supply plug-in connector is seated correctly on the CCU controller (1). Change power unit. Change CCU Controller (1). Start the software x-ray module to activate the CCU controller (1). Start the x-ray module of the software, the image is read. The image may not have to be allocated properly. Check the connection of the sensor to the CCU controller (1). Check the connection cable of the sensor for damage. Change sensor. Check the cabling for contact and damage: Connect the plug-in connector of the CCU controller (1) / /08/13

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24 Dürr NDT GmbH & Co. KG Höpfigheimer Straße Bietigheim-Bissingen, Germany Tel: Fax: Division DÜRR MEDICAL