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Revision Reason for changes Chapter Page Document Datum First release 20150318 Update according to 20150409 OMNERA, 20150327 Text corrected Alpha - Compo- 6-5, 6-8, Apha/Beta Move- 20150813 Beta.Table dimensions nent Speci- ments, Table Top updated fication, Technical Specifica- tion Planning Guide 0180-095-485 OMNERA™400T Rev.
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All third-party brand names, product names, or logos appearing in this manual are the trademarks or registered trademarks of their respective owners. Canon® is a registered trademark of Canon, Inc. and may also be a registered trademark or a trademark in other countries.
Introduction Page 1-1 Introduction Intended Use The System is a stationary X-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The System is not intended for mammography. System Overview The Figure 1-1 shows the main parts of the System. Figure 1-1 Ceiling suspended x-ray tube sup- Wallstand...
Environment Specifications Page 2-1 Environment Specifications Placement of Non-medical Components Non-medical components may not be placed inside the patient environment according to reg- ulations and standards (IEC 60601-1). The standard defines a sphere of 1.5 m around the patient as the patient environment. The Ceiling support can be operated across the entire rail grid, i.e.
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Environment Specifications Page 2-2 Installation Cube If it is not possible to mount the System in the ceiling, an installation cube is needed. There are two standard heights. For more information, please contact the Manufacturer. The ceiling height configuration must be chosen when the System is ordered. Table 2-2 Ceiling height (mm) Vertical column stroke Installation cube...
Environment Specifications Page 2-3 Ceiling / Floor / Wall Specifications The performance of the System is highly depending on the pre-installation work that has to be done on the ceiling, floor and wall. The Manufacturer does not take responsibility of the ceiling, floor or wall construction. The Manufacturer recommends the ceiling, floor and wall to be leveled 1mm/m.
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Environment Specifications Page 2-4 Ceiling Specifications The Ceiling suspended x-ray tube support requires a ceiling with sufficient load capacity (not within the scope of this document), e.g. concrete. If the ceiling construction is not sufficient, an Installation cube solution is available. The Installation cube solution is to be ordered as an option.
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Environment Specifications Page 2-5 0-250 0-250 Ø12,2 (2x) Figure 2-3 Ceiling rails Y mounted directly to the ceiling. 1. Ceiling suspended unit rail (Y) 2. Fixation block OMNERA™400T 0180-095-485 PlanningGuide...
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Environment Specifications Page 2-6 Table 2-3 Length traverse rail X 4000mm 3000mm 3000mm 2748mm (Low ceiling) Length ceiling rail Y 5000m 5000m 4000mm 3748mm Minimum nr. of fix points / Y rail Measure A 850-1100mm 850-1100mm 850-1100mm 850-1100mm Measure B 2800-3200mm 1800-2200mm 1800-2200mm 2778mm NOTE!
Environment Specifications Page 2-7 Floor Specifications The Table and the Wallstand must be installed on a solid base with sufficient load capacity (not within scope of this document), e.g. concrete. The floor must be able to withstand the pull forces supplied on the expansion bolts. The pull forces for the components are listed in Table 2-4, see also Fig.
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Environment Specifications Page 2-8 NOTE! Marking template Wallstand (Isolation Plate). The Isolation plate for the Wallstand shall only be used as a marking template and not as a drilling template, due to the large hole size. 3667.5 Figure 2-6 Installation cube Planning Guide 0180-095-485 OMNERA™400T...
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Environment Specifications Page 2-9 Mounting point Force Table Force Wallstand Installation Cube 5 kN Table 2-4 For the Table and the Wallstand M10 expansion bolts are provided. Manufacturer specifica- tions and the “Service and Installation manuals”, included at delivery for both components, must be observed.
Environment Specifications Page 2-10 Wall Specifications The walls are normally only used for mounting the cable outlets for the Ceiling suspended x- ray support, the Wallstand and the System cabinet. Therefore, the only specification for the walls, is that it must be possible to mount and secure the cable outlets. Screws, bolts or similar for mounting the cable outlets, must be supplied (not included in shipment).
Environment Specifications Page 2-11 Electrical Building Installation The Machinery Directive 2006/42/EC requires the System to be fitted with means to isolate it from all energy sources. NOTE! When Service or Maintenance will be performed the technician shall lock the equipment from all energy sources.
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Environment Specifications Page 2-12 Generator Minimum Generator Minimum Minimum Minimum Apparent Series and Recom- Momen- Recom- Recom- Recom- Mains Mains Voltage mended tary Line mended mended mended Resistance Ω Mains Current Generator Distribution Ground Discon- Service Trans- Wire Size nect to Rating former Rat- Genera-...
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Environment Specifications Page 2-13 Figure 2-8 Medical part of equipment (can be installed inside Patient environment) and Non- medical part of equipment (Not to be installed inside Patient environment). OMNERA™400T 0180-095-485 PlanningGuide...
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Environment Specifications Page 2-14 Cable Duct Specifications All cables shall be enclosed in cable channels, cable ducts or conduits according to regulations (IEC 60601-1). The following notes shall be considered; • Avoid cross-overs and forming of cable coils. • Use appropriate dimensions. •...
Installation and Servicing space Page 3-1 Installation and Servicing space Wallstand Tiltable Image Receptor Holder Front - Rear Directon If different values apply for a fixed detector, these are specified within brackets. FPD Backside 1178 Grid Ion chamber SID 1200-2000 Figure 3-1 OMNERA™400T 0180-095-485...
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Installation and Servicing space Page 3-2 Tiltable Detector Holder (Canong CXDI 401 G/C) Front - Rear Direction. Grid Ion chamber SID 1200-2000 Figure 3-2 Planning Guide 0180-095-485 OMNERA™400T...
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Installation and Servicing space Page 3-3 Exposure with Tilted Detector Holder (Canon CXDI portable FPD) The space for tilted exposure, see below. Exposure center Figure 3-3 OMNERA™400T 0180-095-485 PlanningGuide...
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Installation and Servicing space Page 3-4 Exposure with Tilted Detector Holder (Canon CXDI 401 C/G) The space for tilted exposure, see below. Exposure center Figure 3-4 Planning Guide 0180-095-485 OMNERA™400T...
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Installation and Servicing space Page 3-5 Tiltable Detector Holder (Canon CXDI Portable FPD) Left - Right Direction With grid-loading slot on the left-hand side (default). Side grip handle Arm rest Detector tray 900 or more more Figure 3-5 OMNERA™400T 0180-095-485...
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Installation and Servicing space Page 3-6 Tiltable Detector Holder (Canon CXDI 401G/C) Left - Right Direction With grid-loading slot on the left-hand side (default). Side grip handle Arm rest Grid load direction Detector 620 or more more Figure 3-6 Planning Guide 0180-095-485 OMNERA™400T...
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Installation and Servicing space Page 3-7 Tiltable Detector Holder (Canon CXDI Portable FPD) Left - Right Direction With the grid-loading slot on the right-hand side. Arm rest Side grip handle Detector tray 180 or more 660 or more Figure 3-7 OMNERA™400T...
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Installation and Servicing space Page 3-8 Tiltable Detector Holder (Canon CXDI 401 G/C) Left - Right Direction With the grid-loading slot on the right-hand side. Arm rest Side grip handle Detector Grid load direction more 336 or more Figure 3-8...
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Installation and Servicing space Page 3-9 Non-tiltable Detector Holder (Canon CXDI Portable FPD) Front - Rear Direction FPD backside 1016 Ion chamber Grid SID 1200-2000 Figure 3-9 OMNERA™400T 0180-095-485 PlanningGuide...
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Installation and Servicing space Page 3-10 Non-tiltable Detector Holder (Canon CXDI 401 G/C) Front - Rear Direction Detector 1016 Ion chamber Grid SID 1200-2000 Figure 3-10 Planning Guide 0180-095-485 OMNERA™400T...
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Installation and Servicing space Page 3-11 Non-tiltable Detector Holder (Canon CXDI Portable FPD) Left - Right Direction With the grid-loading slot on the left-hand side (default). Side grip handle Arm rest Detector tray 900 or more more Figure 3-11 OMNERA™400T...
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Installation and Servicing space Page 3-12 Non-tiltable Detector Holder (Canon CXDI 401 G/C) Left - Right Direction With the grid-loading slot on the left-hand side (default). Side grip handle Arm rest Grid load direction Detector 620 or more more Figure 3-12...
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Installation and Servicing space Page 3-13 Non-tiltable Detector Holder (Canon CXDI Portable FPD) Left - Right Direction With the grid-loading slot on the right-hand side. more 660 or more Figure 3-13 OMNERA™400T 0180-095-485 PlanningGuide...
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Installation and Servicing space Page 3-14 Tiltable Detector Holder (Canon CXDI 401 G/C) Left - Right Direction With the grid-loading slot on the right-hand side. Side grip handle Arm rest Grid load direction Detector more 336 or more Figure 3-14...
Installation and Servicing space Page 3-15 Table Front - Rear / Left - Right Direction In the figure below, a lateral space required for: mounting/dismounting the table top is not con- sidered. When the table top is to be mounted/dismounted for installation and maintenance, a space of 2424 mm or more need to be reserved, either on the right or the left of the Table, as a longitu- dinal space of the table top.
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Installation and Servicing space Page 3-16 Height Direction 711 / 816 / Config.1 Config.2 Config.3 X-ray tube SID: 1000-1500 Distance depending roof height AEC chamber Image receptor surface Table top Grid Image unit 540 - 850 Figure 3-16 The x-ray transmission area of the table top is as shown below. Table top profile X-ray transmission area 641 808...
Page 4-1 Anchoring Locations Anchor locations in the installation space and the servicing space are shown below. Wallstand Tiltable Detector holder (Canon CXDI Portable FPD) With grid/detector-loading slot on the left-hand side (default). 226 or more Anchor location Side grip handle...
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Anchoring Location Page 4-2 Tiltable Detector Holder (Canon CXDI 401 G/C) With grid-loading slot on the left-hand side (default). 226 or more Anchor location Side grip handle Arm rest Grid load direction Detector 709 or more 473 or more 620 or more...
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Anchoring Location Page 4-3 Tiltable Detector Holder (Canon CXDI Portable FPD) With grid/detector loading slot on the right-hand side. 226 or more Anchor location Arm rest Side grip handle Detector tray 293 or more 1033 or more 660 or more...
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Anchoring Location Page 4-4 Tiltable Detector Holder (CXDI 401 G/C) With grid-loading slot on the right-hand side. 226 or more Arm rest Side grip handle Detector Grid load direction 278 or more 709 or more more 336 or more Figure 4-4 Planning Guide 0180-095-485 OMNERA™400T...
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Anchoring Location Page 4-5 Non-tiltable Detector Holder (CXDI Portable FPD) With grid/detector-loading slot on the left-hand side (default). 226 or more Anchor location Side grip handle Arm rest Detector tray 1033 or more 473 or more 900 or more more Figure 4-5 OMNERA™400T 0180-095-485...
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Anchoring Location Page 4-6 Non-tiltable Detector Holder (CXDI 401 G/C) With grid-loading slot on the left-hand side (default). 226 or more Anchor location Side grip handle Arm rest Grid load direction Detector 709 or more 473.65 or more 620 or more more Figure 4-6 Planning Guide...
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Anchoring Location Page 4-7 Non-tiltable Detector Holder (CXDI Portable FPD) With grid/detector-loading slot on the right-hand side. 226 or more Anchor location 293 or more 1033 or more more 660 or more Figure 4-7 OMNERA™400T 0180-095-485 PlanningGuide...
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Anchoring Location Page 4-8 Non-tiltable Detector Holder (CXDI 401 G/C) With grid-loading slot on the right-hand side. 226 or more Anchor location Side grip handle Arm rest Grid load direction Detector 278 or more 710 or more more 336 or more Figure 4-8 Planning Guide 0180-095-485...
Room Layout Page 5-1 Room Layout Installation Proposal The layout proposals, displayed in the drawings on the next pages, are chosen to optimize the performance of the System with usability and ergonomics in mind. The chosen layout proposal considers the tube heel-effect, cable conduits, work space etc, as well as safety issues such as wall clearance and possible collision zones.
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Room Layout Page 5-2 Room Layout 1 4200 2252 Back Orientation point 2100 (*1x) Front (*7) 428 (*2) 768 (*2) (*8) min -80 (*8) 352(*9) (*8) Pos A min 260 (*8) 352(*9) Current Wall stand setup: Tilt, left loaded Focal spot coverage, Beta pos A 4200 Orientation point 2252...
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Room Layout Page 5-3 Wallstand loading and positioning should be carefully planned since it will have large impact on the final layout of the room. If the use of armrest is restricted to one side, it is also possible to move the Wallstand closer to wall or Table. If a non-tilt Wallstand is used, there will be more space to place it, since the foot print is smaller and horizontal projection doesn’t have to be considered.
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Room Layout Page 5-4 Room Layout 2a 4200 2252 Back Orientation point 2100 (*1x) Front (*7) 428 (*2) Pos B 768 (*2) Pos D Pos A 672 (672-2552LL) (*8) 452 (452-2333LL) (*8) (792-2923RL) (*8) (81-2213RL) (*8) 1220 (1220-3101LL) (*5) 1100 (1100-2980LL) (*5) (849-2981RL) (*5) (1220-3351RL) (*5) Current Wall stand setup: Non tilt, left loaded...
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Room Layout Page 5-5 The Wallstand has a detector holder with loading from the left side, enabling the operator to work from an optimal position at all times A System installed in a room with similar size and with the components placed as described in Figure 5-2, usually requires 16 m cable length, which also is the standard configuration, see also System connections in chapter 5.
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Room Layout Page 5-6 Room Layout 2b 4200 2252 Back Orientation po t 2100 (*1x) Front (*7) 1654 428 (*2) Pos B 768 (*2) Pos D Pos A 672 (672-2552LL) (*8) (792-2923RL) (*8) 452 (452-2333LL) (*8) (81-2213RL) (*8) 1220(1220-3101LL) (*5) 1100 (1100-2980LL) (*5) (849-2981RL) (*5) (1220-3351RL) (*5)
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Room Layout Page 5-7 The Wallstand has a detector holder with loading from the left side enabling the operator to work from an optimal position at all times. Working with the Wallstand detector holder tilted, will require additional operations to get the x-ray tube and the image receptor aligned (rotation of the beta axis) due to the placing of the Wallstand.
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Room Layout Page 5-8 Room Layout 3 3500 2252 660 (660-830LL) (*5) 1673 (*1x) 412 (412-582LL) (*6) 1425 (*3) Orientation point (*7) Pos B Pos A Pos D Head 248 (*4) 412 (412-582RL) (*6) 660 (660-830RL) (*5) Focal spot coverage, Beta pos A Current Wall stand setup: Tilt left loaded in lower corner.
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Room Layout Page 5-9 Wallstand loading and positioning should be carefully planned, since it will have large impact on the final layout of the room. If the use of armrest is restricted to one side it is also possible to move Wallstand closer to wall or Table. If recommended dimensions are overridden, necessary notifications, warnings and instruc- tions have to be considered.
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Room Layout Page 5-10 Room Layout 4 3500 2252 1673 (*1x) 1425 (*3) Orientation point (*7) Pos B Pos D Head 248 (*4) Pos A 3002 (*8) 250 (*9) Focal spot coverage, Beta pos A Current Wall stand setup: Tilt right loaded Focal spot coverage, Beta pos B Orientation point Figure 5-5...
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Room Layout Page 5-11 Wallstand loading and positioning should be carefully planned since it will have large impact on the final layout of the room. If the use of armrest is restricted to one side it is also possible to move Wallstand closer to wall or Table. If recommended dimensions are overridden, necessary notifications, warnings and instruc- tions have to be considered.
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Room Layout Page 5-12 Room Layout 5 3500 2252 250 (*1) 3002 (*3) (*6) Pos B Pos D Pos A 248 (*2) Focal spot coverage, Beta pos A Current Wall stand setup: Tilt left loaded Focal spot coverage, Beta pos B Figure 5-6 This layout should be used if the System configuration consists of a Ceiling suspended unit, Wallstand with tilt and a movable Table.
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Room Layout Page 5-13 Wallstand loading and position should be carefully planned since it will have large impact on the final layout of the room. If the use of armrest is restricted to one side it is also possible to move Wallstand closer to wall or Table.
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Room Layout Page 5-14 Room Layout 6 3000 1945 2940 81.5 769 (*2x) rientation point Pos B Pos A Pos D 269 (*3) Head 750 (*1) 250 (*1) Current Wall stand setup: Tilt right loaded Focal spot coverage, Beta pos A Focal spot coverage, Beta pos B Orientation point Figure 5-7...
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Room Layout Page 5-15 Lateral projections from behind the Table are also restricted due to the limited space available. The table top must be pushed to the front to be able to position the tube for a lateral projection, but even then the position flexibility is restricted. The detector holder has a right loading configuration in this layout.
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Room Layout Page 5-16 Room Layout 7 3000 2930 1945 1100 (*2x) Orientation point Pos B Pos A Pos D Head 125 (*3) 750 (*1) 250 (*1) Current Wall stand setup: Tilt right loaded Focal spot coverage, Beta pos A Focal spot coverage, Beta pos B Orientation point Figure 5-8...
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Room Layout Page 5-17 The table top must be pushed to the front to be able to position the tube for a lateral projection, but even then the position flexibility is restricted. The detector holder has a right-loading configuration in this layout. For cable length, see System Connections on page 18.
Room Layout Page 5-18 System Connections Cables The cables from the Ceiling suspended unit have two configurations; 16 m or 24 m. The cable configuration is selected when the System is ordered. The length of the cables is measured between the generator and the X-ray tube. The lengths, displayed in the column “Length from outlet”...
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Room Layout Page 5-19 From Cable channel Conduit, diame- Length from outlet cross section ter (min) (max) (min) 1320mm 60mm 6m (16m) and 13m (24m) Table 525mm 70mm 420mm 70mm C. Room 81mm 45mm The length of the cables between the outlet and the system cabinet, restricts where the system cabinet can be placed.
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Component Specification Page 6-3 Movements Ceiling Wagon Movements The manual movements of the ceiling wagon is defined by the dimensions of the ceiling wagon itself and of which rail configuration that is selected. The movement range is also limited by the mechanical end stops that are placed on the ends of each rail.
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Component Specification Page 6-4 Vertical Movement Range To be able to accomodate three different ceiling heights, one short and one long column are used. The shorter column is used in configuration 1 and 2 whereas the longer column is used in configuration 3.
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Component Specification Page 6-5 Alpha/Beta Movements The Alpha movement has a total stroke of 337º, limited by fixed mechanical end stops. The Alpha movement has three mechanical indexes (-90º, 0º, 90º). The current Alpha angle is al- ways shown in the display, placed in front of the x-ray tube. The Beta movement has a total stroke of 343º, limited by a mechanical end stop.
Component Specification Page 6-6 Wall Attachment Cable Hose Placement The wall attachment of the Ceiling suspended unit is designed to be placed on the wall. The placement of the wall attachment is critical due to the optimized length of the cables. The wall attachment shall be placed as high as possible from the floor and on the distance (B) according to Figure 6-4 B = A/2...
Component Specification Page 6-7 Table Foot end Head end Figure 6-5 Table hand control (X/ Table top (X/Y/Z) Emergency stop Y/Z) Image receptor holder Foot control, kick list Vertical lift Foot control table top (X/Y/Z) OMNERA™400T 0180-095-485 Planning Guide...
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Component Specification Page 6-8 General Specifications 500 +20/–10mm 2424 mm 500 +20/–10mm Figure 6-6 850 +20/–10 mm 540 +20/–10 mm Figure 6-7 • Table top dimensions = W2424 x H540 - 850mm (with the table top) • Table frame dimensions = W795 x L1570 x H520mm (without the table top) •...
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Component Specification Page 6-9 • Vertical travel speed = up to 40 mm/sec • Table top weight = 47 kg • Table weight = 150 kg • Table weight = 171 kg (including the imaging unit of approximately 21 kg) Movements Table Top •...
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Component Specification Page 6-12 Movements The Wallstand is supplied with a counter-weighted vertical movement. The movement is locked via an electro-mechanical brake which is normally active, thus the brake must be acti- vated (released) before moving. The tilt option enables the Wallstand to be used as a complement for a complete System so- lution (including a Table), but may also be used as a supplement since the tilting function en- ables vertical projections, e.g.
Technical Specifications Page 7-1 Technical Specifications System Electrical Characteristics Mains voltage for the System 400V 3N, 50-60 Hz 400V 3~ 480V 3~ 150A (Short term peak value), recom- mended fuse 63 A thermal breaker). Environmental Requirements Ambient transport and storage temperature -40 C - +70 Ambient operating temperature C - +40...
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Technical Specifications Page 7-2 Classification Classification according to IEC 60601-1 Class Class I equipment. All dead metal parts of the equipment are electrical connected to protective earth. Applied part Type B Protection against ingress of wter IPXO Mode of operation Intermediate use 20%, max 1 min ON / 4 min OFF Use of anesthetics mixtures...
Technical Specifications Page 7-3 Table Column Lowest table top position (from the floor to 540 +20/-10 mm the table top surface) Column (Z stroke) 310 +40/-20 mm Max travel speed 25 mm/s Table Top Aluminium equivalence <= 0.9 mm Table top dimension 2424 X 808 mm Table top transparent area 2360 X 601mm...
Technical Specifications Page 7-4 Wallstand General Column, Z stroke 1470 +40/-10 mm (non-tilt) Rotation range detector arm (alpha) -20º - 90º Configuration Wallstand The Wallstand is the mechanical part of an X-ray system. Weight Wallstand Maximum 180 kg (160 +20/-20 kg). Counterweight dependant Maximum 30 kg Image receptor holder...
Transport Specifications Page 8-1 Transport Specifications Crates Dimensions and Weight Crate Dimensions mm Weight kg Ceiling suspended W800 x H1300 x D1500 x-ray tube support Table W800 x H850 x D2150 Table top W900 x H100 x D2500 Wallstand W800 x H1150 x D2420 System Cabinet W870 x H1330 x D720 Traverse...
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Transport Specifications Page 8-2 Planning Guide 0180-095-485 OMNERA™400T...