Claymount Optica 20 collimator Part numbers: 50250-1N-LLL 50251-1N-LLL C € 0120 Technical Manual‘Technical Manual TM50482 Sn se Claymount Date of release: 2016-17-09 Table of Contents 4. _ Introduction... Contact information... ‘Symbols used in this document Abbreviations .... bRoRS ‘Supplied components. 2. _ Product description... Description of the device Essential performance ‘Overview of the device Main dimensions Classifications ‘Aluminum equivalence 3. _ Operating instructions... 3.1. Powering ON and OFF. 3.2. Functions during OPERATING MODE. 4. Installation requirements. 43. Necessary recurrent testing 4.4, Installation preparations... 4.5. Mounting instructions 4.6. Internal fixation and packag 47. Electrical interface. 48. Alignment.. 4.9. Adjustments 4.10. DAP meter. 5. Mains isolation 6. _ Service, maintenance and cleaning 61. Maintenance interval 62. Maintenance checks 63. Validation check ... 64. Electrical system 65. Accessories. 66. Parts list for 50250-1N-LLL 67. Parts list for 50251-1N-LLL 7. Options 8, Disposal ESD and EMC compatity 84 82 83. EMC compatibility 9. _ Product label and symbols on the device. 9.1. Product label... 9.2. Symbols on the device 10. Technical specification... Rie CeeTechnical Manual: TMS0882 sane Claymount Date of release: 2016-11-09 Figure 1: External dimensions. Figure 2: Optica20 with red protective cap. Figure 3: Caliber in cross direction Figure 4: Caliber in long direction: Figure 5: Flange lock... Figure 6: Housing . Figure 7: Connection ground wire housing. Figure 8 Removing protective foam and tie-wraps. Figure 9: Schematic overview extemal light field control... Figure 10: Cable exit Figure 11: Connections (power, earth, external) . Figure 12: Location bottom shutters. Figure 13: Timers adjustment Figure 14: LED intensity adjustment... Figure 15: DAP meter installation Figure 16: Assembled Lead Bracket (DAP meter not shown)... All rights reserved ‘Atthough this manual is prepared with utmost care, Claymount Assemblies BV cannot be held accountable for errors or omissions. Claymount Assemblies BV cannot be held accountable for damages of any nature arising from the use, and/or use of any options other than original Claymount Assemblies BV products. Warranty The product has the warranty provisions of our general conditions. The warranty on your equipment will be void if: + Service and maintenance are not carried out according to the instructions and if repairs are not performed, or performed without proper validation. ‘+ Changes or modifications made without our prior written consent. ‘+ Non-original parts or other than the specified lubricants have been used. ‘+The equipment has been used improperly, carelessly or not in accordance with its nature and / or purpose, All consumables (e.g. bolts, nuts, screws, etc.) are excluded from warranty. PIs)‘Technical Manual: TM50462 Sin aie Claymount Date of release: 2016-11-09 1. Introduction 1.1. Contact information This manual provides all the technical information necessary for the correct installation, application and maintenance of the device. If you need additional information, need support or want to report a problem with the device, please contact your distributor or Claymount: ‘Claymount Assemblies B.V. ‘a vatian medical system brand ‘Anholtseweg 44, Address | 7091 HB Dinxperlo ‘The Netherlands Telephone _| +31 (0)315 659150 Name Fax #31 (0)315 659140 Email NUCAE office@Varian.com Website [ www.claymount.com 1.2. Symbols used in this document To ensure adequate and clear understanding of the information provided in this manual, the symbols listed below are used to indicate warnings, cautions, and notes that are important for correct and safe use of the device. WARNING: Warnings are directions which, if they are not followed, can cause fatal or serious injuries toa user, engineer, patient or any other person or can lead to a mistreatment. CAUTION: eo Cautions are directions which, if they are not followed, can cause damage to the device desoribed in this manual or any other equipment or goods and can cause environmental pollution. cE | Nove: Notes provide advice and highlight unusual points. A note is not intended as an instruetion, 1.3. Abbrevii EMC. Electromagnetic compatibility ESD Electro Static Discharge ME Medical Equipment SID Source Image Distance 1.4. General warnings, cautions and notes WARNING: A To avoid the risk of electric shock, this equipment must only be connected to a medical grade power supply. See also chapter 5. www.claymount.com‘Technical Manual 7650482 Si Claymount Date of release: 2016-11-09 WARNING: enclosure. CAUTION: @ For transportation, always use the dedicated Claymount packaging to avoid damage to the device. qe NOTE: Due to the different collimator configurations, the pictures used may not always exactly represent the type of collimator that you have. 1.5. Supplied components ‘The device that you have purchased is packed in a transport box appropriately designed to ensure the integrity of the device. Please ensure that the package you received is intact and that there are no traces of moisture or visual damages to the device. Otherwise, you should immediately contact your distributor or Claymount. It is highly recommended to always use the original packaging during transport and for return shipments. Store the device in a cool dry environment until ready to install. ‘The packaging contains the following components: Reference 1 Optica20 collimator Standard model: '50250-1N-LLL (**) Standard + filter module: 50251-1N-LLL (**) 1 User Manual UM50481 1 Technical Manual TM50482 iD Strain relief 50381 1 Top shutter caliber 50383 1 ECDoC Declaration of Conformance ‘The catalogue number contains “1N-LLL”, which stands for a sequel number to define the configuration within the applicable model, e.g. laser, different front sticker, color, etc. LLL implicates regional versions. The main functionality and information is applicable to all sequel numbers within the mentioned catalogue number. 2. Product description 2.1. Description of the device ‘The Claymount Optica20 collimators are devices which are used to limit the size of the direct X-ray exposure to the patient and for reducing the scattered radiation, The Optica20 collimator contains a light source that shows the region which will be exposed and optional has a laser line for alignment with the Bucky. For measuring the SID, a measuring tape is provided. Additional, a fiter module can be provided for extra filtering of the X-ray beam. For the following device information, please refer to the User Manual (UM50481): Intended use and patient population Intended users Principle of operation Restrictions on use Pama ecseemaeiae - eee Claymount 2.2. Essential performance ‘The essential performance of the device is as follows: Malfunctioning of the device used in an imaging ME system will not result in an unacceptable risk. Therefore the device does not have an essential performance. 2.3. Overview of the device Below an overview of the device: Regular view: Bottom view: A Operating panel (front side) B ‘Mounting surface, including top shutters c Filter module (optional feature) D Accessory rails E Exit window light — X-ray field ite acoeesers res oncee! const sccosecas tsa Sznelon of 7 Dl Taey oi maiariaa Hires mm ‘The Optica20 also functions without accessories. ce ONOTE: ‘The operating panel may contain customized features (e.9. color, print layout, ...) Res Te“Technical Manual TMS0482 Optica 20 calimator Revision: 40 Date of release: 2016-11-09 2.4. Main dimensions Figure 1: External dimensions cE CNOTE: 2.5. Classifications Claymount Focal spot The dimensions for the top shutters are valid with shutters set at maximum opening Electrical safety classification Class | IEC 60601-1(") Emission classification CISPR11; Group 1, Class A IEC 60601-1(") ‘Mode of operation Continuous IEC 60601-1(°) Ingress protection classification P20 IEC 60529(*) Laser classification Class II 1EC60825-1(") CFR Title 21 ‘Subchapter J part 1040.10 Not intended for use in Oxygen Rich environment. Not suitable for Sterilization. (*) for exact version, see chapter 10 Res res‘Technical Manuel: TMS0482 some! Claymount Date of release: 2016-11-09 2.6. Aluminum equivalence \With standard configuration, The Optica20 collimator has the following aluminum attenuation equivalent: Optica20 4.2mm Al @ 75kV 3. Operating instructions 3.1. Powering ON and OFF The Optica20 does not have a switch to power on/off the device and is operational when the X-ray system is, powered on. The Optica20 can be powered off at any time, 3.2. Functions during OPERATING MODE Details on functions during OPERATING MODE can be found in the User Manual (UM50481). 4. Installation 4.1. Requirements for service personnel The Optica20 may only be installed, repaired and / or serviced by qualified personnel, ie * Authorized by the owner or manager of the device; * Authorized by the manufacturer / local dealer; + In possession of the diploma’s / certificates required by local legislation 4.2. Installation requirements The Optica20 can be installed using regular tooling. 4.3. Necessary recurrent testing There are no recurrent tests necessary for the Optica20. 4.4. Installation preparations A [Hexagonal socket key size 2 Housing iB Philips screwdriver size 2 Power connections Ic Hexagonal socket key size 3 Flange locks: 1D \Wrench size 7 Protective earth E Hexagonal socket key size 2.5 [Transparent window Roce eo rece s con ss om 2 NS 4 Figure 2: Optica20 with red protective cap Pre ec)se ” a Claymount NOTE: GP _ Make sure the internal packaging stays in place before proceeding with the installation preparations. 4, Release the three brass flange locks by unscrewing the hex socket screws (Tool C), 2. Remove the red protective cap. 3 Make sure the flange locks are in their start position (retracted as far as possible) before proceeding with installing the device onto the X-ray system. 4, Together with the X-ray tube specifications calculate which mounting spacers, § 6.5, to use on top of the Xray tube exit window face before installing the flange. 4.5. Mounting instructions WARNING: release from the X-ray system or to function incorrect. NOTE: ZH _ Prior to installation of the colimator, the X-ray tube and Imaging modality must be placed parallel to each other. Consult the accompanying documents of the X-ray system for procedure. NoTE: CS Anunpacked and unmounted collimator is sensitive to damage to the top shutters when the red protective cap is removed. If damage is suspected please use the alignment check too! to check i the position is correct. Installation can be done by single person. A good way to install the collimator onto the X-ray tube is when the X- ray tube exit window is facing upwards. ‘+ Start by checking the position of the top shutters, use the supplied caliber (PN50383).. Bh Figure 3: Caliber in cross direction Figure 4: Caliber in long direction Ee ONOTE: Position of the top shutters is ok when barely touching the caliber, a minor gap is also allowed, If this is not the case, carefully bend the top part of the applicable shutter(s) until it is in the correct position. Cyezy PRs aesOpice 20 calnator a mene Claymount ‘+ Place the mounting spacers (if required) with the holes aligned onto the mounting surface of the X-ray tube. Then the selected mounting flange and fix the whole with suitable countersunk screws (not included) fitting the thread of the mounting surface of the X-ray tube. Make sure sufficient thread is used ‘and that the flange is properly fixed onto the X-ray tube. ‘+ Carefully place the collimator with the top shutters down and centered over the flange. Make sure the top shutters do not hit the mounting flange and/or X-ray tube. ‘+ When using the fixed flange align the front side of the collimator with the front face of the X-ray tube to have a proper longitudinal alignment. Extend the flange locks (Figure 5) with the hexagon screws until the collimator is secured but not tightened. Check if the distance between the collimator housing and the mounting flange is equal in all directions. f UNA as Figure 5: Flange lock ‘+ When using the rotating flange (see its instructions for proper installations) and lock the collimator tightly in place with the three hexagon screws (use Too! C). 4.6. Internal fixation and packaging ‘To get the collimator ready for use, the internal fixation and packaging must be removed: 4. Remove the cover of the collimator with 6x screw, marked A on the metal housing as indicated in Figure 6. Use tool # A, DO NOT forget to disconnect the ground cable (see Figure 7). . 95: ae Core Figure 7: Connection ground wire housing Figure 6: Housing 2. Remove the protective foam, cut and remove the 3 red tie-wraps, see Figure 8. 3. Proceed to §4.7 for the electrical interface and when ready re-mount the external housing, WARNING: A Check if the Ground wire is connected property, see Figure 7 UPL eeTechnical Manual: TM50482 Sa se Claymount Date of release: 2016-11-09 CAUTION: ® For transportation, it is highly recommended to fix the internal construction identical as original packed, Figure 8 Removing protective foam and tie-wraps 4.7. Electrical interface The electrical interface is established with a 5-pin connection block positioned at the right hand back side. A ring type crimp terminal suitable for M3.5 screw must be used for connecting the cable side to the connection block. Depending on the applied cable length an appropriate wire core diameter must be used. The strain relief insert supplied with the collimator can be used to secure the cable. This strain relief is suitable for wire diameter 06.2 up to @7.4mm (1/4 up to 9/32") + The BLACK wire must be connected to the return of the power supply. ‘+ The RED wire must be connected to the positive side of the power supply. + For external control of switching on the indicator (ight) field, the following options are available: ‘© Connect the TL & COM connection to have the same functionality as the push button at the front cover. © Connect the DL & COM connection to have direct control over the indicator field, CAUTION: oe The (light) field indication is not intended for continuous use. In case of the direct external connection, takes this into notion. Pin# [Signal [Color Ratings E [Ground (return) [Black ae lr [+ Power supply [Rea fr [Timer light control [Green [com |Common (return) [Blue [See Figure 9 oe [Direct light control [Yeliow ee‘Technical Manuel: TM50482 Se sane -Claymount r* Figure 11: Connections (power, earth, external) Figure 10: Cable exit + Connect the protective earth (Green / Yellow) colored cable with adequate current capabilities to the protective earth connection point. This point is labeled with ©) located next to the power connections, use a ring type terminal suitable for M4 for connection. Tool D can be used for securing the terminal between the washers. Perform a functional check if the light field is visible and the laser line" is visible. ‘+ Route the cable through the strain relief and secure the cable properly (see Figure 10) without with parts inside the collimator. The collimator is now ready to align with the center of the X-ray beam (focal spot). ER ONOTE: In case a rotating flange is used, proceed with §4.9 4.8. Alignment ‘To align the collimator to the X-ray beam itis necessary to do the following: Check that the collimator placed ‘exactly centered to the focal spot of the tube. This can be done by placing a small tube about 20mm long and 8 ‘mm in diameter in the center of the imaging area. This area must be positioned perpendicular to the X-ray beam. When the image shows a perfect circle the focal spot is exactly centered. At this stage the visible cross “ifthe collimator is supplied with the line laser.Reso Claymount Date of release: 2016-11-09 - from the transparent window is irrelevant. Once centered secure the collimator in place by tightening the flange tek Ine Xray fel played shows decrease in pit vali that might be du to shadows rom the to shuts) in this case unmount the collimator and use the caliber for Longitudinal and Cross top shutters to check for correct position (see §4.5). 4.9. Adjustments The light field and the X-ray field are factory calibrated to coincide. The dimension of the light and X-ray field must match in both size and symmetry. The following actions will assist you in check and adjustment: ‘© Check with the light field on if nearly closed shutters coincide with the center marking as described in §0, + If this does not match readjust the position of the bottom shutters using the hex socket screws (use too! E) in Figure 12. Move the relevant bottom shutter to a convenient position to reach the screws, release - relocate and tighten the hex socket screw until correct position is obtained. Figure 12: Location bottom shutters * With the outer housing removed (§ 4.5) set the light field to about 30x30 om. at 1 meter SID and mark location the four corners with radiopaque markers. Make an exposure with a technique adequate to display the markers. Measure the dimension of all markers relevant to the center of the detector and check that all is within 2% of the light field dimensions (IEC60601-2-54 § 203.8.102.6). (Sharp visualization of the markers eases this procedure). ‘The light field size can be adjusted to fit the X-ray field size with the hex setting sorews E as indicated in Figure 14. Rotating clockwise will enlarge the light field. Adjust the left and right hex setting screws equally to keep the light field symmetrical to the focal spot Figure 14: LED intensity adjustment Figure 13: Timers adjustment ‘+The Light field intensity can be adjusted by the potentiometer A. in the slit behind the Line laser opening (see Figure 14). Clockwise brightens and anticlockwise reduces the light intensity within 170 Lux # 30% ‘+The timer for the light field and the Bucky line can be adjusted by two potentiometers located on the PCB at the back of front housing (see Figure 13). The potentiometers A are located left and right of the Laser insert (faced from the X-ray exit side). To adjust the persistence of the light field use the left one and the right one for the Bucky line. Rotating clockwise lengthens the time. Pee esTeco Tot ze een a laymount Date of release: 2016-11-09 - «fais cect mount he cover ofthe climator an (when required) center the cos of he ransparent Gressar win by loosing ots tcalod fo accessors rls (oe Figue 8, ME * A, Poston fe window corcty and tghen tesco aga a DAP mets (ove 8410) chock hate cablo raving dos ol hteere win timer svucue. Al wok is done and the colimlor now ray forse WARNING: 4.10. DAP meter Ifa DAP meter is placed this must be done before remounting the cover. Follow the next steps to mount a DAP meter, see Figure 15: 4. Disassemble the four screws and four washers indicated by "F” 2. Disassemble the Lead Bracket 3. Release the rear two screws “ " and remove the front two screws NOTE: BP The Cotimatoris prepared for mourting a DAP meter wit a size of 177x177mm, 4. Position the DAP meter (including accessory ral flanges) on the Fixation Rails. Position the DAP cable at the rear right 5. Remount the two front screws and tighten all (4x) screws “G" to fix the DAP in place. To property fixate the DAP meter, washers or equivalent fling materials can be used (depending on model and type). 6. Guide the DAP meter cable with a 7mm grommet in location Y through the cover. 7. Secure the DAP meter cable by using cable ties which can be mounted to the M3 threaded standoffs, indicated by "x". 8. Replace the Lead Bracket, pay attention to the correct position of the bracket, see Figure 16 9. Remount the four screws and four washers indicated by "F” WARNING: indicated by “F*, see also Figure 16 10. Remount the cover according to the instructions § 4.9. 5 Flax) Figure 15: DAP meter installation RS eT‘Technical Manual: TM50882 mee Claymount Date of release: 2016-11-09 Figure 16: Assembled Lead Bracket (DAP meter not shown) 5. Mains isolation ‘The Optica20 shall only be connected to the secondary supply of an IEC60601-1 compliant ME system. Supply mains connection is not applicable for the Optica20. 6. Service, maintenance and cleaning WARNING: A Service may only be executed by qualified service personnel. Ensure that the device is powered off before removing the cover to check the inside of the collimator. pas order’ and have the device repaired prior to further use. 6.1. Maintenance interval ‘The device requires general maintenance and/or checks every 6 months. Eee)‘Technigal Manuel: TM50482 eoncaee Li lay mount Dato of release: 2016-11-09 6.2. Maintenance checks ‘Action Checkpoints ‘Visual inspection on all outer parts = No damage - Clean = _ Fixed in place Visual inspection of all electronic parts = No damage - Clean -_ Fixed in place ‘Check on all mounting points = No damage - Fixed in place - Fasteners stil tightened ‘Check electronic functionality ~ Ensure that light field and laser (if applicable) switches on for the set time once the button is pressed. = Verify if ight and laser (if applicable) switches off once the button is pressed for #2 seconds. Check drive components for shutter movements | - For all parts: no excessive wear, smooth operation ~ If required, lubricate linear guiding by applying thin layer of oil onto rail. Use ‘mineral oll base with thickeners acc. to DIN51825 (K1K, K2K). - If required, lubricate bevel gear toothed wheels with Sumitec 219 or equivalent. = Check tension of toothed belts ‘Accessory rails = Check on excessive wear = Clean = Fixed in place = _ Check functionality locking lever Mirror & transparent window = Check on wear caused by X-ray beam, verify if luminosity and/or contrast value of ight beam is within expected values ‘Check on light field X-ray alignment = See § 0 and 4.9 6.3. Validation check Run a validation check: 41, Switch on light indication field, mark the outiine with e.g, four hexagon keys and mark the center. 2. Take a reference photo. 3. Check and compare if the reference photo coincides with the expected result (e.g. intial reference photo) and ifthe light field still matches the X-ray beam. When this is not the case, please align the collimator as described in §0 and re-run the validation check 6.4. Electrical system ‘On request, more detailed information is available for servicing the device. Contact your distributor or ‘Claymount. 6.5. Accessories The Optica20 is supplied without any accessories. The following accessories are available: ‘Mounting flange fixed (height 25mm) PN 50385 Longitudinal and lateral float 2 mm, Rotating mounting flange (height 1mm) PN 50174 Mounting spacer 1.0mm PN 50130 Mounting spacer 1.5mm PN 50131 ye Ta)Technical Manuel: TMS0482 ie Claymount Date of release: 2016-11-09 6.6. Parts list for 50250-1N-LLL item nr. | Partnr. | Description 50261 _| inner part flange lock 50462 _| Front cover (customer specific PN available upon request) 50380 _| Knob assembly 50355 _| Front mask (customer specific PN available upon request) 50346 _ | Measuring tape 50444 | Timer PCB 18552_| Laser 50349 _ | Power PCB (including LED) 50351 _ | Timing belt L=265mm 10 | 50347 _| Front face mirror 14 | 50352 | Timing belt L=200mm. 12 | 50325 _| Accessory rail Right 13 | 50296 _| Accessory lock spring 14 | 50327 _| Accessory rail Left 15 | 50354 _ | Plexiglas crosshair 16 | 50342 _| Sticker leaflet English (other languages available upon request) Eeewat ss See enn Claymount 6.7. Parts list for 50251-1N-LLL NOTE: FF Shy product specie parts are mentioned below. For all other standard pats, please see § 6.6. Item nr. | Part nr. Description 17__ [50463 Front cover, filter (customer specific PN available upon request) 18 | 50393 ‘imm A fiter 19 | 50394 0.1mm Cu fiter 20 _ | 50389 Filter disc 21 | 50395 2mm A fiter 6.8. Cleaning Cleaning with a damp cloth is recommended. Use neutral cleaning products and do not soak the device with liquid 6.9. Disinfection Disinfection with a damp cloth with Isopropyl alcohol is recommended. Before using a disinfectant, check at a spot on the back of the device if the disinfectant will not damage the plastic and coated metal surfaces, Do not soak the device with liquid. Ty Rar eu)‘Technical Manual: TM50482 a Claymount Date of release: 2016-11-09 7. Options Contact Claymount for available options, e.g. customer-specific color, front sticker, etc. 8. Disposal, ESD and EMC compatibility 8.1. Disposal This device contains substances that can be hazardous to the environment and care should be taken when disposed of. ‘The device is marked with the following symbol: Follow local regulations regarding disposal of devices that contain electronic parts. 8.2. ESD WARNING: ‘The device contains sensitive electronics. Ensure that ESD protective measures are in place when the device is installed or serviced to prevent damage to the device. 8.3. EMC compatibility ‘The device conforms to EN IEC 60601-1-2:2007 for EMC compatibility and must be installed and put into service according to the EMC information provided in this manual. WARNING: The device can be affected by communication equipment and mobile telephones. Presence of ‘equipment which is not certified according to EN IEC 60601-1-2 near the Optica20 during operation can have a negative impact on the device performance. WARNING: Not taking EMC measures into account on the wiring may result in increased EMISSIONS or decreased IMMUNITY. EN IEC 60601-1-2 must be followed for being complaint with EMC guidelines, WARNING: A If the device is adjacent to or stacked with other equipment it should be observed to verify normal ‘operation in the configuration in which it will be used 19/24 www.claymount.comsana wes Ee ene Claymount Below applicable tables from EN 60601-1-2:2007 are listed. Guidance and manufacturer's declaration ~ electromagnetic emissions ‘The Optica20 is intended for use inthe electromagnetic environment specified below. The customer or user ofthe Optica20 should assure that ts used in such an environment. Emissions test ‘Compliance Electromagnetic environment - guidance RF emissions Group + ‘The Optica20 uses RF energy only for its intemal function. Therefore, its RF CISPR it temissions are very low and are not ikely to cause any interference in nearby electronic equipment RF emissions Cass A “The Optica20 issuable for use in all establishments other than domestic, CISPR it ‘and those directly connected tothe public low-voltage power supply network ‘that supplies buldings used for domestic purposes, Harmonic emissions | Not Applicable basi = E IEC 61000-3.2 Voltage fluctuations’ | Not Applicable flicker emissions IEC 61000-3.3, Guidance and manufacturer's declaration — electromagnetic Immunity “The Optica20 is intended for use inthe electromagnetic environment specified below. The customer or user of the OpticaZ0 should assure that itis used in such an environment. Immunity test TEC 60601 ‘Compliance lovel Electromagnetic environment - guidance Test level Eleatrosiaie “£6 KV contact += 6KV contact Floors should be wood, concrete or ceramic tle. discharge (ESD) | + gv air £8kVair It floors are covered with synthetic material, the TEC 61000-4-2 relative humicty should be atleast 30 %, Electrical fast +£2kV forpower supply | #2KV for power supply | Mains power quality should be that ofa typical ‘ransientourst | lines lines ‘commercial or hospital environment. TEC 61000-4-4 | £1 kV forinputoutput | + T KV forinputloutput lines lines ‘Suge “£1 KV line(s) toline(s)_| Not Applicable Mains power quality shouldbe that of atypical 1EC6100045 — | + a4Vtine(6) to earth ‘commercial or hospital environment. Voltage dips, shor | <5% UT >95% dip In| Not Applicable Mains power quailty shouldbe that ofa typical intoptons and | UT) for 0,5 eycle ‘commercial or hospital environment. Ifthe user of voltage variations | 40 % UT (60% dip in ‘the Optica20 requires continued operation during fon power supply | UT) power mains interruptions, tis recommended input ines for 5 cycles that the OpticaZ0 be powered from an tecei000-411 | 70%UT (30% dpin Uninterruptible power supply ora battery. un) {or 25 cycies <5 % UT (95 % dip in UT) for 55 Power irequency | 3Aim 3am Power requency magnetic elds should be at (60/60 Hz) levels characteristic of atypical location in a ‘magnetic fle 'ypical commercial or hospital envionment NEC 61000-48 NOTE: UTis the ac. mains voltage prior to application ofthe test le 20/24 — www.claymount.comTechnical Manual: TM50482 ma eS lay mount Date of release: 2016-11-09 {Guidance and manufacturer's declaration - electromagnetic immunity “The Optia20 is intended for use nthe elactromagnetc envionment specified below. The customer or usr ofthe Opica20 should assure that tis used in such an environment immunity test_| IEG 60601 Testlovel_| Compliance level Elecromegnais ondronmont- guidance Porlabe and mobile RF communications ‘equipment shoud be see no osero ary part of the Optca20, inuding cables, than the recommended separation distance calculated {fom the equation applicable tothe frequency of the transmit. Recommended separation distance e219 (4 = 1.174 80 Miz to 800 MZ Conducted RF | 8 Vims 3mm 4= 2.33 WP 800 Miz t0 26 GHz 00468 | ts0 hte eOMte where P isthe masimum output power rating of aa 0 hHe 100 the tranemiter in wats (W)aooorng tothe ‘vansmer manufacturer and és the recommended separation distance meters (). Radiated RF 3Vim 3Vim Field strengths from fired RF transmitter, a3 ec 6100043 | soMHzto2SGHz | S0MHzt02.5GHz _| determined by an electromagnetic ste survey, a Ee should be less than the compliance level in each frequency range.” Interference may occurin the vciy of equipment marked with the folowing symbol NOTE 1 At80 MHz and 800 Miz, the higher frequency range applies. NOTE 2 These guidelines may not apply in ll situations. Electromagnetic propagation is affected by absocption and reflection from structures, objects and people * Field strengths trom fied transmits, such as base stations for radio (celularcordless) telephones and land mobile radios, ‘amateur racio, AM and FM radio broadcast and TV broadcast cannol be precited theoraicaly with accuracy. To assess the tlectromagnetic environment due to fixed RF transmittrs, an electromagnetic ste survey should be considered. I the measured flé strength inthe location in which the OptioaZ0 is used exceeds the applicable RF compliance level above, the (pticaZ0 shou be observed to very normal operation. If abnormal performance is observed, addtional measures may be necessary, such as reorienting or relocating the Optica20. ® Over the frequency range 150 kHz to 80 MHz, fed strengths should be loss than 3 Vim, ‘Recommended separation distances between portable and mobile RF communications equipment and the Optica20 “The Optica20 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the OpticaZ0 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OpticaZ0 as recommended below, ‘2ccording tothe maximum output power ofthe communications equipment. Rated maximum output Separation distance according to frequency of transmitter (m) rower emter 7150 KH to 60 MH ‘80 Miz to 600 MHz 800 Miz to 25 GHz a=1.479P ATP d=2330P oot on7 on7 0.288 on 0.368 0369 0737 fl 17 1a 238 70 3.68 3.68 737 100 17 17 Bs For transmitters rated at @ maximum output power not listed above, the recommended separation distance din meters (m) can be estimated using the equation applicable to the frequency ofthe iransmiter, where P isthe maximum output power rating of the transmitter in watts (W) according tothe transmitter manufacturer. NOTE 1 At80 MHz and 800 MHz, the separation distance forthe higher frequency range applies. NOTE 2 These guidelines may not apply in all stuations. Electromagnetic propagation i affected by absorption and reflection from structures, objects and people. PT NT)Technical Manual: TM50482 SL ane Claymount 9. Product label and symbols on the device 9.1. Product label ae EXC €. KE Row rw omoentcom 710383 REF XXXXxX-NN-LLL Model: XXXXXXXXXXXXX SN] WOXXXXXX/E-XX IPXX XX VIXXVA cl] yyvy-vm-pp Min. inherent filtration Al. Equiv.: X.Xmm Al XX kV X-ray rating up to: 150 kVp (© 990%XXXXAAKRXK(11)XHOK 21) WOXAXXHNIEX, ee oNom ‘The product label as shown is representing the layout and accompanying explanation. The attached label on the collimator shows the specific information valid for your device. all Manufacturer el] Date of manufacture REF] Catalogue number SN Serial number C Ein | 0& mark directive 99/42/EC; conformity assessment by noted body 0120 Follow the instructions for use Reading the instructions for use is crucial for a correct and safe use of the collimator Identification of compliance with the provisions for EU WEEE directive Indicates the type and value of the supply voltage Warning: Laser emission, possibly hazardous optical radiation emission identifies the exit point of the laser beam (optional feature) [Explanatory warning for hazardous optical radiation De‘Techical Manuel: TM50482 Optica 20 collimator Revision: 40 Date of release: 2016-11-08 Claymount |Explanatory warning for laser radiation (optional feature) Indication cross shutters open Indication cross shutters closed Indication tong shutters open Indication long shutters closed Bea) te IC te) ‘Operate laser line (optional feature) Operate field light indicator Indication for measuring tape position Pb. CAUTION: Federal law restricts this device to sale by or on the order of a physician. D & 'SGS recognized component for US & Canada, registration number 710383 -) Identification of compliance with FCC 47 CFR Part 15 Ree eeTechnical Manual: TM50482 Sige ene Claymount Date of release: 2016-11-09 10. Technical specification Materials ABS, POM, stainless steel, aluminum, lead Power source 24 VDC + 10% Power consumption Max. 24 VA. Application Limiting primary X-ray beam, part of an X-ray system Light field luminosity 2 160 x Field size Max. 48x48cm @ 1m SID Weight 28kg Size £230x267x177mm (WxDxH) Ambient temperature: 15-40 °C Operation environment Relative humidity: 30 - 95 %, non-condensing Atm. Pressure: 750 - 1030 hPa ‘Ambient temperature: -20- 60°C. Storage Relative humidity: 30 ~ 95 %, non-condensing Atm. Pressure: 750 - 1030 hPa EN-IEC 60601-1:2006 +A11:2011 +A1:2013 EN-IEC 60601-1-2:2007 EN-IEC 60601-1-3:2008 Applicable standards EN-IEC 60601-2-54:2009 EN-IEC 60825-1:2007 EN-IEC 60825-1:2014 EN-IEC 62471:2008 Contact details Claymount Assomblles B.V. Claymount Americas Corp. Claymount High Voltage ‘The Netherlands usa Technology (Beijing) Co., Lt T434 (0)315 659 150, ‘Tt 630271 9723 China F 431 (0315 659 140 44 630 271 9995 +86 10 6780 2708, NLCAE.office@Varian.com USCAULoffice@Varian.com 7486 10 6780 2129, F 485 1067802170 [CNAG.office@Varian.com Claymount Italy Claymount Assemblies Philippines Italy Ine. T+39 051 632 01 23, Philippines F439 051 63225 48, 7-463 49 5024 520 ITCAl.ofice@Varian.com 7-463 49 5024 521 F +63 49 5024 500 F +832 8076472 PHCAPoffice@Varian.com © 2016 by Claymount All Rights reserved. 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