Local and national safety regulations concerning the installation and use of dental x-ray equipment must be met.
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1 Date of Issue: 1/2/2013 Page 1 of 5 TECHNICAL INFO Products: CRANEX D Subject: Pre-Installation Requirements Number: 1031b-US Description These instructions are provided for service/marketing personnel who wish to confirm that the site where CRANEX D is to be installed is suitable. This same information is found in the CRANEX D Installation Manual. Requirements General Requirements Local and national safety regulations concerning the installation and use of dental x-ray equipment must be met. Do not install the unit in an environment where corrosive or explosive vapors are present. If the CRANEX D will be used with a 3rd party imaging application software not produced by SOREDEX, the 3rd party imaging software must comply with all applicable local laws and regulations on patient information software. This includes, for example, the Medical Device Directive 93/42/EEC and/or FDA. The Unit The room in which the unit is to be installed, and the position from where the user will take exposures, must be correctly shielded from the radiation that is generated when the unit is operated. Since radiation safety requirements vary from country to country and state to state, it is the responsibility of the installer to ensure that all safety regulations are met. The room should be equipped with proper power input line. Units are typically operated at 230 VAC (+/-10%) mains voltage. Circuit breaker size should be suitable for the current/mains fuses (8AT@230VAC) of the CRANEX D. Some are wired for 115VAC (+/-10%) and fused at 16AT@115VAC. The unit is supplied in one box: Length Width Height 73 in (185 cm) 32 in (80 cm) 40 in (100 cm) The packaged unit weighs 353 lbs. (160 kg) The installed unit weighs 330 lbs. (150 kg) Make sure that the floor in the room where the unit is to be used can support the weight of the unit. Also make sure that the wall to which the unit is attached and the fixing hardware used to attach the unit to the wall can withstand a continuous pull-out force of at least 660 lbs. (300 kg).
2 Date of Issue: 1/2/2013 Page 2 of 5 Make sure that there will be enough space at the front and sides of the unit to allow patient entry and exit. Patients using wheelchairs will require more space around the Cephalometric unit than standing patients. The unit MUST be attached to the wall with two brackets, one on the top of the column (89.8 / 228 cm from the floor) and one at the bottom of the column (24.6 / 62.5 cm from the floor). If there is no wall backing for the lower wall bracket, a Floor Brace (supplied with machine) must be employed. Use 5/16 in (8 mm) minimum diameter fixing hardware (NOT SUPPLIED) to attach the unit to the wall. The type and length of hardware must be suitable for the wall to which the unit will be fixed. NOTE: If the wall is made of thin material, you may have to use a reinforcing backing plate on the rear of the wall to hold the securing screws, bolts, or nuts. NOTE: The ceph units cannot be modified from the left-hand side to the right-hand side. Units must be ordered with correct ceph orientation. NOTE: The height of the unit is 91 (231 cm). If the ceiling in the room where the unit is to be installed is lower than this, the height of the unit must be reduced by shortening the leg. NOTE: The fiber optic cable connects to the unit at the left, upper, rear of the moving Z-carriage. If the cable has to enter the wall, the height of the entry point should be about 74 inches above the floor. If the cable does not enter the wall, the delicate cable should be routed so that it is not under foot where it can be damaged. NOTE: The fiber optic cable connects to the unit at the left, upper, rear of the moving Z-carriage. The PC The PC that is to be used with the CRANEX D must be installed in a location that meets all local and national safety requirements with regards the connection of a PC to an x-ray device. The operator should see both the patient and monitor during the exposure. The length of the standard fiber optic cable between the PC and the CRANEX D is 32.8 ft. (10m). Optional cables P/N 69061US ft. (15 m) or P/N 69061US ft. (20 m) can be ordered if needed. Minimum computer requirements: OPERATING SYSTEM - Windows 7 Professional (32 bit or 64 bit - SP1); - Windows XP Professional (32 bit - SP3) CPU -2.0 Ghz Intel Dual Core Processor or better; or AMD equivalent RAM - 2 GB (32 bit) or 3 GB (64 bit) [3 GB (32 bit) or 4 GB (64 bit) recommended] DISK DRIVE - 20 GB available space DVD/CD-ROM DRIVE - DVD +/- RW recommended
3 Date of Issue: 1/2/2013 Page 3 of 5 DISPLAY ADAPTER MB or better (integrated on board graphics or dedicated GPU) NETWORK CONNECTION - 10/100/1000 Mbit/s Ethernet NIC MONITOR x 768, 24-bit Tru Color, 17 (1280 x 1024, 19" or 22 flat panel recommended) HUMAN INTERFACE DEVICES - USB keyboard and 2-button mouse MOTHER BOARD - Must have one available PCI slot, full or half height The PCI card is supplied with the Cranex D. The dimensions are 4 ¾ long by 2 ½ tall. There are also Two mounting brackets available for full height PC s and half height PC s. NOTE: The connection of the unit to the PC must meet EN requirements. NOTE: The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: - use of the accessory in the PATIENT VICINITY - evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC and/or IEC harmonized national standard - only interface cables provided by the manufacturer shall be used.
4 Date of Issue: 1/2/2013 Page 4 of 5 Installation Tools, Setup Tools and Installation Hardware The following tools and hardware are required to install and set up the unit: NOTE: THESE ITEMS ARE NOT INCLUDED WITH THE UNIT Hardware - Minimum 5/16 in (8mm) fixing hardware (4pcs) for attaching the wall bracket and leg to the wall. Standard Tools - Electric drill - Allen key set (Hexagon socket wrenches) mm. - Flat blade screwdriver - Torx screwdrivers T20, (T25, T30) - Spirit level, pliers, wire cutters Special Tools & Optional - Alignment tool - part number (needed for ceph adjustments) - Ball and pin phantom - part number (needed only for pan realignment)
5 24 " ( / / 7 High: 68 8 " ( 7 Low: 37 8 " ( 86 " ( 1750mm) 950mm) 90 " ( 89 " ( 91" (2311mm) Date of Issue: 1/2/2013 Page 5 of 5 Upper Wall Bracket 3 /4 2279mm) Lower Wall Bracket 5 /8 2200mm) Max 1 /2 2300mm) Max 5 /8 625mm) Floor Brace (If needed)
6 22 1/4 " (565mm) 1 26 /2 " (675mm) Date of Issue: 1/2/2013 Page 6 of 5 3 /8 923mm) 46 " ( 36 " ( 72" (1825mm) 16" (406mm) 9" (228mm) 55" (1395mm) 7 /8 1190mm) 17" (430mm) Please note: All measurements from wall shown are minimum distances. The mounting rods on the wall brackets have an additional 3/4 inch ( 20mm) of threaded length to accommodate walls that are not plumb. 34" (860mm)
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