WVAREX SClaymount oo. f we: : et - | |< | : lO 'a6'- 6 Optica 30 Optica 40 Optica 50 C im Technical Manual\WVAREX SClaymount MAGING (This page is intentionally eft blank)WVAREX SClaymount IMAGING Table of Contents 4. Introduction 8 1.1. Contact information. 6 1.2. Abbreviations o 1.3. Symbols used in this document 8 14. Advisory. 8 15. Radiation 8 1.6. General wamings, cautions and notes.......nnnmnnnennnn ee | 1.7. Labels and markings on the device nti sewn 1.8. Supplied components. a satel 13 2._ Device description.. so 7 . Baie 4 24. Intended Use nn 14 2.2. Description of the collimator... - 14 2.3. Principle of operation 15 2.4. Overview of the collimator. 15 2.5. Main dimensions fs 16 2.6. Aluminum equivalent... — ae 18 2.7. _ Restrictions on use. pe sess 18 2.8. Essential Performance. 18 2.9. Applied parts... 18 2.10. Known contraindication(s) cieiiaiciomcnent 1B 2.11. Classifications 18 3. _ Installation 3.1. Requirements for service personnel 3.2. Installation requirements 3.3. Installation instructions. 3.4. Installer responsibilities 3.5. Remove and re-mount the rear cover 3.6. Installation of cables... 3.7. Mounting a DAP meter... 3.8. Mounting the collimator to the X-ray tube 3.9. Calibration and collimator setup. 3.10. Xray beam Alignment. 3.11. Colimator Adjustments... 4. Electrical specificatio 41. Fuses, 4.2. — Power Supply. Mains isolation 43. Barthing.. nn 4.4. — CAN interface. 4.5. Housing interface 4.8. EMC compatibility 46.1. Deviations. 462. Allowances... 46.3. Precautions... 7 464. Emissions Compliance 465. Immunity Compliance .. 8. _ Operating instructions panes 5.1. Powering ON and OFF. 52. Status LED colour 5.3. Functions during OPERATING MODE. 2 c eeWVAREX SClaymount 6. Maintenance nn. : Seer Siete 61. Cleaning 5 “4 Cleaning procedures and agents 4 Cleaning recommendations 44 62. Preventive checks 44 6.3. Maintenance interval 45 64. Maintenance checks na ees AB 85. Necessary recent maintenance andor exng 45 6.6. Removal from host systeMM..unnssns 45 7. _ Troubleshooting and service... Bi eas 7.1. Troubleshooting, fault diagnosis 48 72. Error codes. 47 73. CAN protocol configuration apa 48 7-4. Claymount protocol and Service protocol. 8 8. Disposal 54 8. Specifications and accessories 55 9.1. Technical specifications. i ‘ ics ait ites toe. 92. Product label 56 Figure 1 Rear cover screws. 20 Figure 2 Collimator power supply cable and CAN cable installation. 24 Figure 3 Green CAN bus connector. 2 Figure 4 DAP meter installation. 23 Figure 5 Mounting the Colimator to the Xray tube . 5 Figure 6 Distance from X-ray tube focal point to colimator mounting plane. 26 Figure 7 Flange lock 2 Figure 8 Field light adjustment 35 Figure 9: rear view (product label). 56 Figure 10: Product label for Optica 40 57 Figure 11: Product label for Optica 30/50. z 57 a Peer asWVAREX SClaymount IMAGING All rights reserved Aithough this guide is prepared with utmost care, Claymount Assemblies BV assumes no responsibility 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 a cereW VAREX IMAGING ~Claymount 1.Introduction 1.1. Contact information This manual provides all the technical information necessary for the correct installation, application and maintenance of the Collmator This document is accompanying the Optica 30/40/60 series (see also §1.7). Additional to this Technical Manual a User Manual is supplementary to the INSTRUCTIONS FOR USE. IF you need additional information, need support or want to report a problem with the Collimator, please contact your distributor or Claymount: Name Claymount Assemblies B.V. a Varex Imaging brand ‘Address | Anholtseweg 44, 7091 HB Dinxperlo ‘The Netherlands Telephone | +31 (0)315 659150 Fax #31 (0)315 659140 E-mail netherlands cnc@vareximaging com Website | www.vareximagina com For support and service purposes, please note the following information: Mode! name X-ray Collimator Optica Part number. ‘Serial number: Main ‘Software versions: Display (00 apptcabe for Opa 30 and Sprea 30 ‘Model name, Part number and Serial number can be found on the product label, see §9.2 Optica 40: Software versions can be found in Service screen 3, see §3.8 Optica 30/40/50: Software versions can be found via CAN bus protocol, see §7.4WVAREX SClaymount IMAGING 1.2. Abbreviations CAN bus | Controller Area Network bus. A.communication network that allows remote control of the collimator. EMC Electromagnetic compatibility ESD Electro Static Discharge ME Medical Equipment Optica 30 | X-ray Colmator Optica 30 series Optica 40 | X-ray Collimator Optica 40 series Optica 50 | X-ray Colimator Optica 50 series PoB Printed Circuit Board. SID ‘Source to Image Distance. ‘The distance from the source of radiation (the focal spot of the x-ray tube) to the film or other image-receptor. ‘Synonym: Focal Film Distance (FFD) ‘SIPISOP | SIGNAL INPUTIOUTPUT PART part of ME EQUIPMENT, not being an APPLIED PART, intended to deliver or receive signals to or from other electrical equioment, for example, for display, recording or data processing This document contains terminology and definitions based on (international) standards. The terminology and definitions are formatted in capital letters (e.g. INTENDED USE). Terminology and definitions from the following standards are used: IEC 60601-1 Medical electrical equipment ~ Part 1: Generel requirements for basic safety and essential performance IEC 60601-1-2 | Medical electrical equipment ~ Part 1-2: General requirements for basic safety and essential performance ~ Collateral Standard: Electromagnetic disturbances — | Requirements and tests IEC 60601-1-3 | Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Colisteral Standard: Radiation protection in diagnostic X- ray equipment IEC 60601-2-54 | Medical electrical equipment — Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy IEC 62366 Medical devices - Application of usability engineering to medical devicesMAGING \WVAREX SClaymount 1.3. 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, actions and notes that are important for correct, ‘and safe use of the Collimator, WARNING: A 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: @ Cautions are directions which, if they are not followed, can cause damage to the Colimator described nthe manval Or any ther equipment or goods and can cause sruironmental poten ce | Nove: Notes provide advice and highlight unusual points. A note is not intended as an instruction, 4.4. Advisory ‘This manual must be read and understood by the users as defined in the INTENDED USE (see ‘section §2.1) and SERVICE PERSONNEL. This manual must be made avaiable tothe users and SERVICE PERSONNEL, ‘The users and service personnel must verify that all requirements according to the safety standards and regulatory legislation are met before use of the X-ray Collmator Optica 30/40/50 series. Host system marking andlor certification (e.g. CE-marking, NRTL certification, etc.) can be affected by installation of the X-ray Colimator Optica 30/40/50 series. Please consult the manufacturer of the host, system for advice on installation of the X-ray Collimator Optica 30/40/50 seres. Information regarding accidents that have occurred using the X-ray Collimator Optica 30/40/60 series must be reported to Claymount immediately. Claymount is not lable if the provided instructions are not complied with. Claymount is notable if one ‘or more of the folowing cases apply: ‘+ Modification or repairing of the X-ray Collimator Optica 30/40/50 series in any way other than described in this manual + Installation ofthe X-ray Collimator Optica 30/40/50 series which is not in accordance with the installation instructions as provided. Use of the X-ray Colimator Optica 30/40/50 series other than the INTENDED USE Installation of the X-ray Collimator Optica 30/40/50 series by SERVICE PERSONNEL that is not qualified ‘The X-ray Collimator Optica 30140/50 series is not subjected to regular inspection and maintenance. # Use of the X-ray Colimator Optica 30/40/50 series in a way which could not be reasonable foreseen by Claymount. ‘© Direct or indirect damage which are caused by not following the procedures and instructions in this manuel, 1.5. Radiation danger ‘The X-ray Collimator Optica 30/40/50 series are designed and manufactured according applicable standards to meet the safety legislation. However due to inherent radiation danger which cannot be eliminated, itis crucial to follow all safety procedures and instructions. To minimize the inherent danger of radiation, all procedures and instructions must be followed by the users and SERVICE PERSONNEL. eos 6MAGING WVAREX SClaymount ‘The user and SERVICE PERSONNEL must ensure that all possible measures are taken to ensure health and safety of patient and user. 1.6. General wari gs, cautions and notes > WARNING: The collimator is intended to be mounted to an X-ray system that can be installed in an X-ray room, which has its own restrictions and safety measures specific to protect against ionizing radiation. Follow local and hospital regulations and instructions. WARNING: This manual identifies the elements of safety and operating instructions that must be followed by the organization that mounts the collimator to an X-ray system. Follow and apply instructions to ensure the safe and proper operation of the collimator. Use the instructions for use of the X-ray system that will be used in combination with the collimator for identification of any training related to the combined use of the collimator and the X-ray system WARNING: Do not use the collimator for other use than is described in the intended use section. Any other use is considered as "Improper Use” WARNING: Do not modify this equipment without authorization of the manufacturer. ‘Any change or modification carried out by unauthorized personnel may introduce serious hazards. When changes or modification are carried out by unauthorized personnel, Claymount cannot be held responsible for injuries or damage to equipment. WARNING: Disconnect power supply before opening collimator. WARNING: Do not use the collimator ifthe status LED is coloured red. WARNING: Do not use the collimator ifthe status LED or the light field projection is of low luminance. WARNING : Be aware that the light intensity level must be according to local regulations. WARNING: Possibly hazardous optical radiation emitted. The collimator contains field light power LED of Risk Group 2. Do not stare at operating lamp. May be harmful to the eyes. Be extra careful with unconscious patients because they protect their eyes to the light source. ;nnot blink their eyes to WARNING: The collimator contains a Class 1 laser or Class 2. (Depending on optional feature) Do not stare into the laser beam Be extra careful with unconscious patients because they cannot blink their eyes to protect their eyes to the light source. > >) Pm PP | he WARNING ‘ways monitor the patient when the collimator is in use. al: TMS056)W VAREX IMAGING -Claymount WARNING: The light field source inside the collimator becomes hot. 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. WARNING: To avoid the risk of electric shock, this equipment must only be connected to protective earth, WARNING: Use of components and accessories other than those specified in this Technical Manual may lead to unexpected performance of the collimator, WARNING: ‘The temperature of the enclosure can become more then 41 °C CAUTION: Do not use the collimator if any part is damaged, is making noise or vibrates. CAUTION: Do net use the collimator in oxygen-rich environments, andior in presence of flammable gases, CAUTION: The collimator is not intended for sterilization. CAUTION: The collimator is powered through an external power supply at 24 V DC. CAUTION: If the enclosure is mechanically damaged DO NOT USE. In case of doubt, before taking any action, please contact your distributor or Claymount, NOTE: Always keep this manual and read it before using the collimator. {| {OlOCo eo PP PP | NOTE: Please contact your distributor or Claymount when the product label or other markings fon the outside of the collimator are missing. Requirements for SERVICE PERSONNEL The device may only be installed, repaired or serviced by qualified SERVICE PERSONNEL, ie. ‘Authorized by the RESPONSIBLE ORGANIZATION of the device; Authorized by the manufacturer In possession of the diploma’s / certificates required by national and local legislation. WARNING: PERSONNEL,WVAREX SClaymount IMAG ING 1.7. Labels and markings on the device Manufacturer Date of manufacture Serial number Catalogue number. CE-mark directive 93/42/EC; conformity assessment by notified body 0120 (optional feature) SGS recognized component for US & Canada, registration number 710383 (optional feature) Identification of compliance with FCC 47 CFR Part 15 (optional feature) CAUTION: Federal iaw restricts this device to sale by or on the order of a Physician. (optional feature) Identification of compliance with the provisions for EU WEEE directive DC supply voltage indication, Protective earth, Follow the instructions for use Reading the instructions for use is crucial for a correct and safe use of the colimator ‘Warning: Laser emission, possibly hazardous optical radiation emission (optional feature) ‘Warning: Identifies the exit point of the laser beam (optional feature) Explanatory waming for hazardous optical radiationWVAREX SClaymount IMAGING Explanatory warning for laser radiation (optional feature) Indication cross shutters Indication long shutters Operate field light indicator (Optica 20/40 series only) It 4 BS | vanuatconta © Automatic Control, uN Bick asr ON into it ‘Symbol to indicate the selected image field size. ‘Setup collimator. wat 4 << Return to previous screen. Cancel numeric keyboard value. ~ ‘Accept numeric keyboard value < Delete entered digit on numeric keyboard. Restart collimator. ‘When displayed in an error message: cae Continue to use the collimator with limited functionalityWVAREX SClaymount IMAGING 1.8. Supplied components ‘The device that you have purchased is packed in a transport packaging appropriately designed to ‘ensure the integrity of the device. Please ensure that the package you received is intact and that there ‘ate no traces of moisture or visual damiages to the device. Othennise, you should immediately contact, your distributor or Claymount.Itis highly recommended to always use the original packaging during ‘transport and for return shipments. See §9 for storage conditions if the device is not used directly. Be ‘advised by your distributor or Claymount for any accessories availabe. ‘The packaging contains the following components: ae =a ae 4 | XayCollimator Optica | CF002 : Configuration with automatic fiters 30,40 or 50 CF 004 : Configuration without automatic filters UNXXXXX (where XXXXX stands for a sequel code, eee extensions can be added, depending on language) TMXXXXX (where XXXXX stands for a sequel code, 1 [Petrie Mere extensions can be added, depending on language) [4 [Accessory kit Optional. Content is depending on the series 1 | EcDoc EC Declaration of Conformity eTWVAREX SClaymount IMAGING 2. Device description 2.1, Intended use ‘The device is intended to be used in medical diagnostic applications with restrictions to human diagnostics. The device is intended to be used as accessory of an X-ray system in a professional healthcare facil environment. The device is intended to restrict the dimensions of a diagnostic X-ray field by limiting the primary X-ray beam. The limitations of use are specified in §2.7. The device is not intended to be used in fluoroscopy applications; near active HF Surgical Equipment or in the RF shielded room of a system for magnetic resonance imaging, where the intensity of Electromagnetic Disturbances is high. Use, other than above, is identfied as abnormal use. The intended user of the device is defined as the operator of an X-ray system. The operator shall be ‘qualified andlor trained to operate the X-ray system. 2.2. Description of the collimator ‘The collimator is an automatic, square-field, mult-leat, X-ray collimator and is suitable for installation con stationary X-ray equipment. ‘The collimator mounting plane is intended at 80 mm (3.14") from the focus of the X-ray tube. The X-ray field is limited by 4 pairs of shutters which are covered with lead. ‘Two pairs of lead shutters are located near the focus of the X-ray beam; two pairs are located near the exit window of the collimator. The latter shutters serve to accurately define the X-ray field edges. “The main electronic system consists of@ single PCB (Collimator main board). This board provides the motorized postioning ofthe shutters which are controlled by two stepper mators and positioned by the intended users. The X-ray field can be adjusted manually with the two knobs (30/40 Series only) on the collimator front ppanel or remotely. The field size can be selected with SID and field dimension input, see the applicable User Manual. fechnical Manual: TMS056)WVAREX SClaymount MAGING 2.3. Principle of operation The colimator field dimension is established by 4 pairs of lead covered shutters that can be positioned through the control knobs on the front of the collimator (30/40 Series only). The following symbols are used to indicate each shutter pair Cross shutters, ‘The bold lines indicate the shutter pair seen from the top-side of the collimator. Long shutters ‘Symbol used to indicate the light button switch Operate light field Press the button to activate the light which will indicate the X-ray diagnostic area. ‘Symbol used to indicate the laser button switch Press the button (on touch screen) to activate the single line laser. l@§ I} YX. | Operate laser line(s) (optional) NX | (optica 40 only) 1%. | Additional fitration (optional) | Additional fitration can be selected by pressing | (optica 40 ony | the button (on tous seen) te change ration .4. Overview of the collimator Fixing flange Control knob, Cross shutters (Optica 30/40 Series only) Contra! knob, Long shutters (Optica 30/40 Series only) Enclosure ‘Status LED (Optica 30/40 Series only) Push button for activation of the Light field and the Bucky laser (Optica 30/40 Series only) moo @ >WW VAREX SClaymount MAGING Measuring tape, for determining the SID. Pull out the end hook and place it against the designated surface (e.g, table, wall stand, etc.) Read the SID size at the measuring tape aperture of the enclosure front H Bucky laser shutter to close the laser aperture | Accessory rails, for a maximum of 2 accessories with a width of 177 mm 4 Accessory lock, for locking the accessory A Prior to inserting accessories in the accessory rails check the fit and locking, Hazard of faling accessory. k Touch screen (Optica 40 Series only) A Use of the measuring tape: ‘The type of measuring tape used is @ standard measuring tape. The tape used in the collimator star's with values that correspond to the focus/collimator lower edge distance; maximum measurement with the tape is 2 m. Forcing and/or extending the tape beyond this point could cause the following inconveniences: «Breakage of the tape or, ‘© Distortion of the tape or, « Impossibilty of retracting the tape into its housing © NOTE: Donot extend the tape beyond the indication of 2.0 m @ NOTE: High speed release of the tape might damage the tape 2.5. Main dimensions ca NOTE: The top shutter dimensions are applicable for fully opened shutters,WVAREX SClaymount Collimator Optica 40 Collimator Optica 30/50 ‘The Optica 30 and 50 models have the same dimensions as the Optica 40. This Optica 30 model is delivered without a display. This Optica 50 model is delivered without a display, control knobs, LED button and status LED.\W VAREX SClaymount IMAGING 2.6.Aluminum equivalent ‘The Aluminum equivalent (or ATTENUATION EQUIVALENT) can be found on the product label. The location of the product label can be found in §9.2. The ATTENUATION EQUIVALENT is expressed in [mm] aluminum 2.7. Restrictions on use RF communication devices should be kept at a minimum distance of 30 cm. Otherwise the performance of the device can be negatively influenced. 2.8. Essential Performance ‘The X-ray Collimator Optica 30/40/50 series does not have essential performance. 2.9. Applied parts ‘The X-ray Collimator Optica 30/40/50 series do not have applied parts. 2.10.Known contraindication(s) Contraindications of the X-ray system continue to apply (see X-ray system documentation). ‘Additional the Optica 30/40/50 series introduces matter inthe primary X-ray beam which primary results in addtional Xray scatter Additional X-ray scatter causes a radiation risk. The Optica 90/40/60 «series is mitigating the radiation risk by shielding the addtional scater and Imitng the size of the primary X-ay beam and also confining the scatter generated from the X-ray tube (housing). 2.11.Classifications Electrical safety classification Class | IEC 60601-1 ‘Applied Part Not applicable IEC 60601-1 Mode of operation Continuous operation TEC 6060-1 Ingress protection classification 1P20 IEC 60529 Laser classification Class 1/ Class 2 (optional | 1EC 60825-1 feature Field light classification Risk Group 2 EC 62471 [Not intended for use in Oxygen Rich environment Not suitable for SterilizationWVAREX SClaymount MAGING 3. Installation 3.1. Requirements for service personnel ‘The Collimator may be installed, repaired and / or serviced by qualified personnel only. 3.2. Installation requirements ‘The Colimator can be installed using regular tooling 3.3. Installation instructions AA | wasn: The ctiretor contains snsive lector, Teke measures o prevent ESD Before the collimator can be used, it needs to be properly installed, The installation requires a number of steps that must be executed in this sequence: 4. Installation of cables: a. Power supply (see §3.6) b._ CAN bus interface (only required for remote control use, see §3.6). 2. Mounting the collimator to the X-ray tube (see §3.8) 3. Calibration of the rotation sensor (see §3.9). The cross and long shutters and touch screen tre calibrated during manufacturing and do not need to be calibrated during installation. However, if there is a need for re-calibration, follow the instruction provided in §3.9, 4, Setup the configuration for the colimator on with parameters available on Service screen 1 » Service screen 2 and Service screen 3 (see §3.8) 5. Complete tables provided in §1.1 with contact information and colimator configuration, 3.4. Installer responsibilities ‘+ Validation of minimum fitration of the X-ray system (X-ray tube, collimator and possible fiers) ‘must be performed on a complete X-ray system, ‘+ Validation of system X-ray leakage is to be performed following the installation of the system components. ‘+ Correct installation of the collimator according to the instructions provided in this Technical Manual ‘+ Proper EMC performance of the X-ray system, 3.5. Remove and re-mount the rear cover For maintenance and installation of cables, the rear cover of the collimator has to be removed to access the inside of the collimator. ‘Steps to remove the rear cover of the collimator 4. Remove the screws as indicated in the figure below. 2. Carefully remove the rear cover, ‘Steps to re-mount the rear cover of the collimator 4. Carefully relocate the rear cover. 2. Re-insert and tighten the screws as indicated in the figure below, aWVAREX SClaymount IMAGING | rt Figure 1 Rear cover screws 3.6. Installation of cables Cables for power supply and CAN bus must be connected to the green CAN bus connector that is pre- assembled inside the collimator (see §1.8). The connector can be reached when the rear cover of the collimator is removed (see §3.5 for instructions). The instructions for electrical isolation (see chapter 4, Electrical ) shall be taken into account, WARNING: Disconnect power supply before opening collimator WARNING: To avoid electromagnetic interference, follow the cable specification! WARNING: Cables and terminals used for the connection of the collimator must be Suitable for operation at temperatures of 70 °C. WARNING: Incorrect power supply could damage the electronic timer and/or the lamp andlor electrical motor DC/Stepper. WARNING: Collimator supply is protected by a fuse. See §4.1 WARNING: Power supply cable must be designed to carry the collimator supply current ‘and should meet IEC80601-1 requirements PPPrPrer ft le requirements ‘© Shielded cable, twisted wires, data pair and one common ‘© Cable size: The supplied strain reliefs (See §1.8) will fit round cables with a diameter of approximately 5,6 - 7.4 mm. otherwise unpredictable behaviour may occur.WVAREX SClaymount NG Strain relief bracket CAN cable grounding clamp Blind plug or Protective earth terminal Strain relief Figure 2 Collimator power supply cable and CAN cable installation ‘Steps to install the power supply cable and (if needed) the CAN bus interface cable, see Figure 2 for part explanation, Remove the rear cover according instructions in §3.5 ‘Remove the areen CAN bus connector Feed the cable through the rear cover. Remove a Blind plug Apply a strain relief as supplied in the Accessory kit (see §7.8) on the power supply cable. Feed the power supply cable through the strain relief bracket. ‘Strip the power supply cable Connect 24 V and 0 V wire to the green CAN bus connector, according to the pin assignment table in the section below, Connect earth wire to the protective earth terminal (EHF | Note: When the CAN bus cable also needs to be installed, follow the instructions described below otherwise move on to step 1. Feed the CAN bus interface cable through the rear cover. 2. Feed the CAN bus interface cable through a strain relief as supplied in the Accessory kit (see 81.8) 3. Feed the CAN bus interface cable through the strain relief bracket. 4._ Strip the end of the CAN bus interface cable shielding to the grounding clamp Connect the CAN bus interface cable to the Green CAN bus connector according to the pin assignment table below. Re-mount the green CAN bus connector Mount the CAN shielding grounding clamp fa CAN termination resistor is needed: Set the jumper on the Connection board between pin 4 and pin 2, see Figure 3. 9, Mount the strain relief(s) 10. Ensure that the protective earth terminal (see Figure 3) is properly connected to the safety earth line, HH | Note: Strip length ofthe cable insulation must be accordingly to connect the cable 5. 6 7. 8.\W VAREX SClaymount IMAGING 11. Close the rear cover according instructions in §3.6. Pin assignment for the green CAN bus connector |__ CAN termination jumper, Pin number 1 |— Connection board Pin number 8 Pin number: 7 2 3 4 5 6 7 8 Pin label: oc Cc c+ 24v 24V ov ov ov Interface CAN bus Power supply CAN- | CAN-Low | CAN-High Description: | common | can.) | (cane) | VOC | VOC | avOC | avec | oveIMAGING WVAREX SClaymount 3.7. Mounting a DAP meter The Collimator is prepared for mounting the DAP meter 1570015 of Vacutec and KermaX-plus of IBA. ‘Steps to install the DAP meter, see Figure 4 for part explanation: 1. Remove the rear cover according instructions in §3.5 2. Pull both protective earth connectors from the enclosure connection tabs 3. Loosen the hexagon screws (approx. 3 turns). Hexagon screw wrench size: 5.5 mm. 4. Carefully lit the DAP meter guiding’s and insert the DAP meter (SH | Note: Check that the DAP meter tabs are fully captured in the recesses (Figure 4) ‘asten the hexagon screws 5 6._Reconnect both protective earth connectors to the enclosure connection tabs 7. Close the rear cover according instructions in §3.5 DAP meter guiding Connection tab Protective earth connector Recess for DAP meter DAP guide's highlighted orange Figure 4 DAP meter installation ee ets Pe SeWVAREX SClaymount 3.8. MAGING Mounting the collimator to the X-ray tube A WARNING: Carefully follow the collimator mounting instructions and make sure that the collimator is correctly mounted. Incorrect mounting may lead to dangerous situations such a falling or malfunctioning of the collimator. Itis advised to mount the collimator with the X-ray tube exit window facing upwards. In this X-ray tube position, the mounting can be done by one person. ‘The following materials are needed for mounting the collimator to the X-ray tube, see also §1.8 and Figure 5. 4, Mounting flange and lead insert 2. Countersunk screws (4x) 3, Mounting spacers (if needed, see section “mounting spacers") SS Note: Mounting spacers, fiting the supplied mounting flange must be ordered separately. ‘The mounting flange and lead insert are mounted on the X-ray tube by 4 countersunk screws, The collimator is mounted to the mounting flange by 3 fixing wedges, see Figure §WVAREX SClaymount Xray be Mounting spacer(s) Mounting fange Leed insert Nounting serems hing fang Mounting pine Mounting screw M6 {DIN7991 or 1$010642) ‘Mounting fange Lead insert Figure § Mounting the Collimator to the X-ray tube Mounting spacers ‘Apply mounting spacers to adjust the distance from the collimator mounting plane and the X-ray tube {focal point The colimator mounting plane distance must be 80 mm + 1 mm (3.15" # 0.039") from the focal point of the X-ray tube. ‘Steps to determine the mounting spacers needed, see for distance explanation Figure 6: 4. Determine “ht” mm] _ : Distance from the X-ray tube focal point to the tube port face. 2. Determine *h2" [mm] = Height of the mounting flange. 3. Calculate "h3 [mm]: Space to be filed up with spacers: h3 = 80 —h1 — h2 4. Select the mounting spacers to fil he space “h3. Allowable tolerance is + 1 mm. aeW VAREX IMAGING Claymount 0mm (4 am) Figure 6 Distance from X-ray tube focal point to collimator mounting plane Mounting of the. 4. Place the mounting spacers (when required) on the tube 2. Place the mounting flange and lead insert on top 3. Fix ll with the countersunk screws to the X-ray tube. Ensure that sufficient thread is used and the screws fix the flange property to the X-ray tube mounting surface. Warning: To ensure the safety of the operator and the patient, the Technical Manual of the ray tube must be consulted for instructions on fastening torque and locking. (GF | NOTE: When an existing mounting ange is used, eneue that the led inser not damaged, ‘Mount the col ‘After the mounting flange and mounting spacers are fixed to the X-ray tube, the collimator can be ‘mounted on the mounting flange. Warning: To ensure the safety of the operator and the patient, the instructions must be followed correctly. Hazard of falling collimator. Unscrew the set screws (3x) until all flange locks are fully retracted. Carefully place the collimator with the top shutters down and centered over the mounting flange. 3. Extend the flange locks (Figure 7) with the set screws until the collimator is secured but not tightened. Centre the collimator to the mounting flange. Tighten al set screws equally until the colimator is held firmly on the mounting flange. os Warning: Make sure that the flange locks extend over the mounting flange. Appropriate tightening of the set screws ensures secure mounting of the collimator.ING WVAREX SClaymount Figure 7 Flange lock 3.9. Calibration and col This section is only applicable for Optica 40. For Calibration and Setup of the Optica 30 and 50, see CAN bus Service Protocol Messages, §7.3. ‘Acoass to Service screens for calibration and parameter setup The collimator has 3 Service screens for calibration, parameter setup and embedded software revisions. These screens are protected by a password. When the correct password is entered, Service screen 1 is displayed. ator setup ‘The next Service screen canbe entered by selecting the button El The previous Sorc sre can te eee by seetng he bitoni Enter the following password code: 7091 Manu a ae\WVAREX SClaymount IMAGINWVAREX SClaymount Service screen 1 Calibration of cross shutters Calibration of the cross shutters is done on the Cross Shutters Calibration Screen. Warning: Not completing all indicated calibration steps will leave the collimator un- calibrated, AA | Waring: 2s of lcicalpover i ave the colimaterun-cabraes Steps to calibrate cross shutters: 1. Measure and position the collimator at an SID between 90 cm and 180 om. 2. Set the SID on the touch screen to the measured value (see applicable User Manual for more details on SID selection), 3. Enter Service screen 1, select button Ges and confirm calibration to enter the Cross ‘Shutters Calibration Screen. 4. Cross calibration to minimal size (closed position): ‘a. Open the long shutters a litle by turning the control knob. . Carefully close the cross shutters completely with the control knobs. Verify this by the field light: when completely closed, the field light should not be visible on the table. When the crate ehuters ate completely closed, selet the bust I in te Cross Shutters Calibration Screen. The collimator wll perform the cross zero calibration. Wait unt the shutters are stopped moving before continuing wit the next step. 5. Gross calibration to the maximum calibration size (open position) (Open the long shutters a litle by turning the control knob, . Adjust the field size to an actual measured value of 43 cm forthe cross shutters with the control nab. Verity this by the field light, When the eras shutters are at43cm, setae the bution En tne cross Shuters Caltraton Screen The colimaor wil eto te eros max clbrton ‘Wait until the shutters are stopped moving before continuing with the next step. 6. Compete ross shuts cairaton by slecing but:W VAREX IMAGING Claymount Calibration of long shut Calibration of the long shutters is done on the Long Shutters Calibration Screen. Waring: Not completing all indicated calibration steps will eave the collimator un- calibrated AQ | weamioa: 25 t tecic poner wave the colar uated Steps to calibrate long shutters: 4, Measure and position the collimator at an SID between 90 cm and 180 cm, 2, Set the SID on the touch screen to the measured value (see applicable User Manual for more details on SID selection). 2. Enter Sone screen 1 select but ana cont catbaton to erie te Long ‘Shutters Calibration Sereen 4. Long calibration to minimal size (closed poston): a. Open the cross shutters a little by turning the control knob. b. Carefully cose the long shuters completely with the control knobs. Very this by the feld ight when completely closed, the fed ght should not be visible on the table ¢. Whenthe long shits ae comply cote, elect ne tn A i ong Shutters Caliration Screen, The collimator will perform the long zero calibration. Wait Until the shutters are stopped moving before continuing with the next step, 5. Long calibration to the maximum calioration size (open position): Open the cross shutters a litle by turing the control knob, . Adjust the field size to an actual measured value of 43 om for the long shutters with the control knob. Verify this by the field light. When than shat art 3 on, sth buon Ee ong Shuto Calibration Screen. The collimator will perform the long max calibration. Wait until the shutters are not moving anymore before continuing with the next step. 6. Complete ong shutters ealbraton by selecing buton:WVAREX Sflaymount IMAGIN Calibration jon sensor Calibration of the rotation sensor is done on the Rotation Sensor Calibration Soren. Warning: Do not select +90° (vertical calibration) and 0° (horizontal calibration) A sequentially without rotating the colimator to the corresponding postion This results in unreliable values on the touch screen, calibrated Ne ‘Steps to calibrate the rotation sensor j\ ‘Warning: Not compieting all indicated calibration steps will leave the collimator un- 1g: Loss of electrical power will leave the collimator un-calibrated 1. Enter Sorce secon 1, select uton III ond con slctono ene he Rotation Sensor Calibration Screen. 2. Horizontal calibration: Place the collimator in the horizontal calibration position: re | 3. Vertical calibration Place the collimator in the vertical +80° calibration position: ‘When the collimator is positioned to +90” position, select on the touch screer 4 campletethe cation sensor clbraton by selecting biter: ea poner rere)W VAREX SClaymount IMAGING Calibration of the touch screen During manufacturing, the touch screen is calibrated to be used as expected. When there is a need to re-calibrate the touch screen (e.g. when not responding as expected), follow the next steps to re- calibrate the touch screen (note: this is not part of the Service screen 1): 4. Power OFF the collimator. 2. Press the Push button to activate the Light field and bucky laser (see §2.4) and keep it pressed (release it in step 6) 3. Power ON the collimator. 4. When the Start-Up Screen is displayed on the touch screen, touch the touch screen once. 5. When the error message appears, select 6 When the Touch Screen Calibration Screen is displayed, release the field and bucky laser activation button, and follow the instructions and select the cross symbols displayed. When calibration is completed, the Main Screen is shown. Power OFF and ON again before use. Field light illumination level Select a value for field light illumination level after the text “Lamp Level’. The actual selected value has box around the value. Field light ilumination time Select 2 value for field light illumination time in seconds after the text "Lamp (s)". The actual selected value has a box around the value. CAN bus speed Select a value for CAN bus speed after the text “CAN kbit/s)’. The actual selected value has @ box ‘round the value, It values ‘Set parameter to the default values: Lamp Level 3 Lamp time (s) 20 CAN bus baud rate 500 kbis Background colour Blue Font colour White Backlight (%) 80\WVAREX Sclaymount Service screen 2 This section contains the description of functions available on the Service screen 2. Background colour ‘The background colour of the collimator can be adjusted through 3 pre-set selections or by entering the values for RGB (Red Green Blue) colours. After selection, the selected background colour is visible on the touch screen. When the RGB field is selected, the user is prompted to enter numeric RGB (in the range of 0 - 255) values for the background colour. Field to select background pre-set values Field to enter background RGB values Font colour Select a font colour used to display text on the touch screen. After selection, the selected font colour is visible on the touch screen. Backlight ilumination percentage Select a value for touch screen illumination percentage after the text “Backlight (%4)’. The actual selected value has a box around the value, CAN protocol support ‘Asupported CAN protocol can be made active by entering the applicable protocol ID in the CAN Protocol number field. For further information about the Claymount Protocol (Protocol ID: 0), see §7.4. For other CAN protocols, consult your distributor or Claymount, Ifan invalid ID is entered, a waming message "1000" shows for 2 seconds. A | warning: eisng 2 nonmtchng GAN ProtocoDwilead te perfomance problems of release: 2018-10-2 Ee) ceeWVAREX SClaymount IMAGING Service screen 3 ‘Show Logo With this setting, the logo on the Main screen can be made invisible(Off) or visible(On). The default setting is: On Show Inclino With this setting, the Inclino box on the Main screen can be made invisible(Off) or visible(On). ‘The default setting is: On Software revisions are shown in the lower left corner: Main: contains the version for the main board. Display: contains the version for the display module If the Main version is not shown, either the display and main versions are not compatible or there is no ‘communication between the display module and the main board. Warning: Do not use the device in case there is no communication between display ‘module and the main board Remark: The versions shown in the image above are not the actual versions for your device, this is only an example! 3.10.X-ray beam Alignment Centering the imaging modality to the beam the X-ray tube. Take adequate precautions to ensure that the human body is not exposed ‘Warning: The procedure described in this section requires that X-rays are produced by A to X-tadiation, direct or indirect Please, consult the X-ray systern manual to align the imaging modality to the X-ray beam. Alternatively, the following instructions are provided When the collimator is mounted on the X-ray system, fully open the shutters. ‘To check alignment of the imaging modality to the X-ray beam itis necessary to do the following ‘= Place a small metal tube approximately 20mm long and 8 mm in diameter in the center of the imaging modality. © When X-rayed and the image shows a perfect circle, the focal spot is exactly centered. renmagingWVAREX SClaymount 3.11.Collimator Adjustments of the Light field indication to X-ray field The Collimator X-ray field and the light field are factory calibrated. Ensure the calibration meets local legistation. Calibration setting: ‘The total discrepancies between the edges of the X-ray field and the corresponding edges of the Light Field do not exceed 2% of the distance of the measured plane of the Light Field from the Focal Spot. Verification of the Light field indication to X-ray field ‘The X-ray images taken in §3.10 are used to verify the light field to X-ray field accuracy. In case the light field does not match the X-ray field, perform the following: Check the if distance (spacing) from the focal spot of the X-ray tube to the collimator mounting Plane is 80 + 1 [mm] (3.15" + .039 ") 4. Light field larger than X-ray field Remount the collimator to the X-ray system (see §3.8) using less spacer(s) and repeat the test image procedure (see §3.10) and verify the sizes. 2. Light field smaller than X-ray field: Remount the collimator to the X-ray system (see §3.8) using additional spacer(s)and repeat the test image procedure (see §3.10) and verify the sizes. Field light size fine adjustment Fine adjustment of the field light size can be done after removal of the rear panel (see §3.5). The field light size can be adjusted by loosening the positioning screws of the field light bracket as indicated in Figure 8. Adjusting is done by means of 2 screws, socket head wrench (size 2). After the field light size is adjusted, carefully tighten the positioning screws without moving the field light. Feld ight bracket Figure 8 Field light adjustmentWW VAREX SClaymount IMAGING 4. Electrical specification This chapter described the electrical specifications ofthe collimator. Information regarding electrical Connection can be found in §4.1, §4.2 and §4.3. Description of interfaces can be found in §4.4 §4 5 Section §4.6 describes EMC compatibility 4.1. Fuses ‘The collimator is equipped with an auto resettable fuse to protect the collimator for too high power consumption, Resetting is done by a power OFF - ON cycle, The collimator has no replaceable fuses. In case of a suspected broken fuse and a power cycle does not result in a functional collimator, the ‘main board is broken, and the collimator needs to be retumed to Claymount for repair. 4.2. Power Supply ‘The power supply must be connected to the Power and Communications connector, see §3.6. See §9.1 for electrical ratings. Mains isolation ‘The collimator shall only be connected to secondary circuit voltages (see §9.1 for the max. electrical ratings) of an IEC60801-1 compliant ME system which are separated from the mains supply by 2 Means Of Patient Protection (2MOPP). A connection to supply mains is not applicable for the Collimator. 4.3. Earthing “The colimator shall be connected to Protective Earth. A PE-terminalis provided for connecting the PE wire, see §3.6 for the location. 4.4, CAN interface ‘There is no isolation barrier between CAN-bus which is intended to be connected to the internal electronics of a medical X-Ray system. Any other isolation requirements must be provided by the medical X-Ray system according IEC60601-1, ‘The CAN-bus is not intended to be a SIP/SOP, but must be seen as an internal bus of the X-Ray system. Ifthe intention is to use the CAN-bus as a SIP/SOP, additional isolation has to be provided 4.5. Housing interface ‘The collimator provides 2 MOPP of insulation between the electronics and the outside of the housing, 4.6. EMC compatibility “The device conforms to IEC 60601-1-2:2014 for EMC compatibilty and must be installed and put into service according to the EMC information provided in this manual. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 om (12 inches) to any part of, the X-ray Collimator Optica 20/40/50 series, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result WARNING: Not taking EMC measures into account on the wiring may result in increased EMISSIONS or decreased IMMUNITY. IEC 60601-1-2:2014 must be followed for being complaint with EMC guidelines.WVAREX SClaymount IMAGING WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use.is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING: A Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial (HF | areas and hospitals (CISPR 11 class A). Itt is used in @ residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-requency communication services. The user might need to take mitigation measures, such as relocating or re-orienting tho equipment. 4.6.1 Deviations No deviations from IEC60601~ 48.2.Allowances No allowances from IEC60601-1-2:2014 are used. 4.8.3.Precautions Precautions to be taken to prevent adverse events to the PATIENT and the OPERATOR due to Electromagnetic Disturbances are listed inthe column ‘Electromagnetic environment — guidance" in the tables below. 4.6.4.Emissions Compliance 2:2014 are applied Guidance and manufacturer's declaration electromagnetic omissions “The Optica 30/40/50 i intended for use in the electromagnetic environment speciied bolow. The customer or user ofthe (Optica 30/40/50 shoul assure tha its used in such an environment, Ericson et Salen Tecromagralic envionment gilda TE emisaere group Gout Te Ona 204050 sees ses RF ene) on fs sal cere Toten Theetoe ts Rremisto te ey owas wea Tht caae ty neers nary Cerone or Fens ane Gossm The EMISSIONS crrocirtn of We Open 304080 srs Sera Ina sutbi tru hindu reat or teem (SPR Tas ill ewed havea enonios ter ren ‘Harmonic emissions (Not Applicable CISPR 11 class B is normally required) this equipment might not ecmmeas offer adequate protection to radio-frequency communication series The er raph uate uns peo racer nach ‘ge tee : Yala tater! Natagpeabe | $cc cetootere re sereme? eomess ae peice eter)WW VAREX SClaymount IMAGING 46.5.1mmunity Compliance “Guidance and manufacturer's declaration ~ electromagnetic immunity - ENCLOSURE PORT “The Optica 30/40/60 series is intended for use in the electromagnetic environment specfiod below. The customer or user of the Optica 20/40/50 seis should assure thal ls used in such an environment Iromunity test Compliance Test level Electromagnetic environment - guidance Elecrostatc EBRV contact Floors should be wood, concrete or ceramic te. I foors are discharge ESO) | La gy. a. wv, e18ky_ | covered wth synthetic materia, the elaive humidity should be TEC e1000-42 SP ASWABIEIERY | test 50%, Proximiy feds iam | Seenex table below Portable RF commurications equipment (including peripherals RP wireless fuchas antenna cables ard extemal antennas) shoud be Used ‘communications no closer than 20 om (12 inches) equipment Ec 61000.4.3 Power fequency | 80m Power frequency magnet felds shoud be al loves (60160 He) magnotic characteristic of @fypseal location ina ypcal commercial or fle hospital envanmert TEC 6100-48 Guidance and manufacturers declaration ~ electromagnetic Immunity — Compliance Test Levels for ENCLOSURE PORT IMMUNITY to RF wiroless communications equipment Test . canton | MESO | —oitancy | are eat] ent | Sewiew | Woda IR) ot ey fo” | ave fen iat ‘un Pale wodlaton™ es | se0-000 | Tevradoo 18 03 7 tsk GMRS 460; a laa 181 Sovaton oo | o-oo | URsgt | ssc 2 03 2 bal Pulse Modulation" 745 | roe—ray | MTEBant 1s, | Pave Metiaton® | 5 03 ° 70 ante a Ss aaROH TTeTeAGDD" | Puse Moadaton® eo| eoo-s60 | “benseo 2 0a Py Conte, = LTE Band 5. 8He ara outa = Gents 1305, | Puse Moasaton® Eun 00, 1700-1860 | SSH 120 2 os Fa 1970 wreBerdta.| arrie fe owns ‘Suctoon Wa | use Meten™ 24so | 2400-2570 | aoeti up: 2 os Pa mrib2s LTE Band 7 ae = Pulse Modulation e500 | 500-seo0 | WANsv2tt 02 os ° — atte For some sendees, only the uplink equencies are included The carla s modulated using @ 50 % duty cyie square wave signalWVAREX SClaymount MAGING Guidance and manufacturer's declaration ~ electromagnetic Immunity ~ Power and Signal PORTS ‘The Optica 30/40/50 series i inlended for use inthe electromagnetic envionment specid below. The customer or user of the Optica 90/40/50 series should assure thal t's Used in such an environment a eo ee See, [ENE | eimiaiieescoee aemete moss, Tec st00042 SPACES, ESIVSASHY [Eso n. Be seam fawice erm IEC 61000-4-4 signal ports eee on a ee uresoes oe Ma Se ess ep est an = by RF fields ote ante 00 bate compliance level in each frequency range. owas @®) a Feces aiamare sme amt Scape a “tam. before modulation is applied The ISM (ndustrial, scientific and mectcal) bands between 150 kHe and 80 MHz are 6,765 MHz to 6,795 MHz; 13.553 Maz to 18,567 Miz; 26.957 MHz to 27,283 lH and 0,66 RIHz to 40,70 Ik. The amateur radio bands between 0,15 Miz and 80 Mz ae 1,8 M2 10 20 iz. 3.5 M2 to $,0 Mi. 5.3 MP2 1 84 Mle, 7 RIM2 to 7,3 Nz, 10,1 Ni to 10,15 MHz, 14 MHz to 142 Miz, 18,07 Miz to 18,17 MHz, 21,0 Mz to 21,6 MHz, 24,89 MH2 1 26.99 MH2, 28,0 MHz to 28,7 Nz and 50,0 WH to 54.0 M2, "Fle strength from fied transmiters, such 2s base stations for radio (celularlcordless) telephones and land motile ‘ads, amateur radio, AM and FM radio broadcast and TV broadcast cannet be predicted thecatcally wth accuracy. To ‘assess the electromagnetic environment cue to fixed RF tranemites, an electromagnetic ite survey should be ‘considered. I the measured fed strength in the lecation in which the Optica 30/40/50 Is Used exceeds the applicable RF ‘compliance level above, the Optica 30/40/50 series shoule be coserved to very normal operation. abnormal performance is observed, addtional measures may be necessary, such as fe-ofening or relocating the Optice 3040/50 NOTE. “These guidelines may not apply inal stuaions. Electromagnetic propagation is affected by absorption and reflection from stuetures, objects and peopleWVAREX SClaymount MAGING 5. Operating instructions 5.1. Powering ON and OFF POWER ON: ‘When the power supply to the collimator is switched ON, the collimator performs @ power-ON self-test for important functions of the collimator. During the power-ON self-test (which takes a few seconds), the status LED is flashing green and a Siart-Up Screen is displayed on the touch screen The result of the power-ON self-test can be: Successful: The colour of the status LED (30/40 Series only) is green (not flashing), additional fitering Is not applied and the shutters are completely closed, Only applicable for Optica 40: The Main Screen is shown, ‘The collimator is ready for use and is now in OPERATING MODE. Not successful ‘Afault condition is detected during the power-ON sel-test and the colour of the status LED is red. Only applicable for Optica 40: A error popup window is shown, see figure below. nical Manual: T5056 are mee earn) es\W VAREX IMAGING =Claymount The Collimator is not ready for use and is now in ERROR MODE. Some fault conditions Could permit limited use of the collimator, This is however not advised. See ERROR MODE and §7.2 for more details about error messages. Yes No Main screen ‘Main screen with error popup window Figure only applicable for Optica 40 OPERATING MODE: This is the normal operating mode of the collimator. This mode is entered either through successful POWER ON (fully functional) or after accepting a fault condition (partly functional). The colour of the status LED is green. See §5.3 for more details about the functionality that is. available during OPERATING MODE. ERROR MODE: When a fault condition is detected, this mode is entered the colour of the status LED is red. Only applicable for Optica 40: The collimator shows a message on the touch screen. The fault conditions are indicated by a number and explained in §7.2. (Figure only applicable for Optica 40) (GP NOTE: only the frst detected fault condition is cisplayed on the touch screen (not applicable for Optica 30)WW VAREX SClaymount IMAGING (HP NOTE: [tis important to send the folowing information to Claymount fr analysis ‘© Error code. When the warning symbol close to the setup button is displayed, the last displayed error message can be viewed again by selecting the warning symbol. ‘= Version of the main software; avaliable on the Service Screen 3, see this Technical Manual (§3.9). ‘= Version of the display software, displayed on the touch screen during power-on (not applicable for Optica 30). POWER.OF! ‘There is no shutdown procedure for the collimator. The collimator can be switched OFF at any time without damaging the collimator by switching OFF the power supply to the collimator.WVAREX SClaymount 5.2. Status LED colour ‘The status LED (30/40 Series only) indicates the Collimator modes. The table below explains the status LED indications. During the POWER-ON self-test and normal OPERATING MODE, the collimator software can detect fault conditions. For troubleshooting see §7. Green, flashing, frequency 1 H2, | No fault condition, the colimator is performing its power-ON setf- POWERON | “50% OFF | test. 50% ON Poe Green _| Collimator performs as expected Red fe ‘A aut condition is detected. The colimator is not able to perform ERROR eeaipactisd MODE | Green, flashing, | Fo, ir Fomueney Hg, | For trouble shooting see §7.1 90% OFF 10% ON 5.3. Functions during OPERATING MODE ‘The operating Collimator functions during OPERATING MODE can be found in the applicable User Manual.W VAREX SClaymount IMAGING 6. Maintenance 6.1. Cleaning Cleaning procedures and agents Follow local, national and organizational procedures regarding cleaning. The following agents are safe touse: Isopropanol Ethyl alcohol The cleaning agents above may be diluted with water for cleaning purposes. WARNING: A Use of cleaning agents other than described to be save may result in damaging the collimator or possible injury o the user Cleaning recommendations = Make sure the collimator is switched OFF (see §5.1 for instructions) WARNING: A Use of abrasive cleaning could result in deterioration of the collimator. E.g. the crosshair window can be damaged which will result in reduction of light field illumination, = Donot use abrasive cleaning products. = Use a damp soft cloth to clean the collimator, this will reduce the possibilty for liquids to enter the collimator. Use a dry soft cloth to remove any residuals fram the coliimator. 6.2. Preventive checks It is recommended to perform preventive checks on a regular basis. The interval of these checks shall be tailored to the application and frequency of use. [- re Visual inspection on all outer parts | No damage of parts ‘Check electronic functionality 4, Ensure that light field and lasers) (if applicable) switches on for the set time once the button is pressed. 2. Verify if light and laser(s) (if applicable) switches off once the button is pressed. Check shutter movements \Verify if the cross and long shutter are moving smoothly Check filter movement (if applicable) | Verify f the fiters are moving smoothly Check drive components for shutters | No excessive wear and smooth operation Accessory rails 1. Check on excessive wear 2. Check functionality locking lever eo pee teraWVAREX SClaymount MAGING Mirror & transparent window Check on wear caused by X-ray beam, verify i luminosity and/or contrast value of light beam is within expected values Check on light field X-ray alignment _| See §3.9 and §3.10 6.3. Maintenance interval The collimator does not require any special maintenance actions. It is recommended to perform a yearly quality check (see §6.4) on the collimator. 6.4. Maintenance checks Itis recommended to perform maintenance checks on a regular basis. The interval ofthese checks shall be tailored to the application and frequency of use. fisual inspection on all outer parts No damage Clean Fixed in place No damage Clean Foced in piace No damage | Foced in piace Fasteners tightened Check electric functionality 1. Ensure that ight field switches on forthe set time after button activation 2. Ensure that bucky laser switches on for the set time after button activation Visual inspection of all electrical parts Check on all mounting points erelernclene Check drive components for shutters | No excessive wear and smoath operation ‘Accessory 1. No excessive wear 2. Clean 3. Fixed in place 4. Check functionality of locking lever Mirror & transparent window ‘Check on wear caused by X-ray beam, verify if luminosity andfor contrast value of light beam is within expected value 6.5. Necessary recurrent maintenance and/or testing ‘There are no necessary recurrent maintenance and/or tests identified by the manufacturer. No maintenance is necessary with respect to Electromagnetic Disturbances. Follow national and local regulations or organizational procedures regarding recurrent maintenance andlor testing of electricalimedical equipment. 6.6. Removal from host system Ifthe collimator needs to be removed from the host system, follow the directions from §3.8 in reverse order. WARNING: A When the flange locks are untightened make sure the collimator is supported. eanWVAREX SClaymount MAGING 7. Troubleshooting and service This chapter describes troubleshooting and service. 7.1, Troubleshooting, fault diagnosis ‘After performing a repair, check all calibration settings (see §3.9) and preform a re-calibration if needed. The following repairs may require re-calibration: X-ray tube is exchange Power LED replacement Bucky laser replacement Plexiglas window replacement © Mirror (assembly) replacement In case a fault condition is detected, the colour of the status LED (30/40 Series only) will change and an error code is displayed. The table below provides explanations and instructions for troubleshooting Error codes are listed in §7.2. Status [itt nacelle Pre Explanation Colimator power Supply is eut-of. (No power supply) Instructions 1. Check if the Collimator is connected to the power supply. YES: Proceed with the next step. NO: Connect the power supply. The Collimator will now preform a self- | test (Green, flashing, LED) After the selt-est, proceed with step 5 OFF | 2. Disconnect the power supply Collimator for 1 minute (fuse reset) 3. Reconnect the power suppiy. The Colimator will perform a self-test (Green, flashing, LED). 4. Check ifthe status LED is ON YES (LED ON): Proceed with step 5 NO: (LED OFF): Contact your distributor or Claymount 5. Check if the collimator is functioning properly, see §5.2 OPERATING MODE: Problem solved ERROR MODE: See applicable Status LED indication for follow up. rea _| Eaolanation Fault condition is detected by the collimator. The collimator is not able to perform a8 expected. The first detected fault condition is displayed on the touch screen. or Instructions Green, flashing, | Select the following on the touch screen: frequency 1 Hz, | 90% 0FF "| Bi Restart the ctimator c ee Ae tone Cee Revision: 30 PeerIM AGING WVAREX SClaymount 10% ON Continue with limited functionality. After selection, the touch screen shows a warning symbol. The warning symbol will be removed when the fault condition is resolved, Depending on the fault condition, use of the collimator with limited functionality is possible. Colour of the status LED: ‘Red. ‘The last known shutter position of one of the shutter pairs is < 8 cm. Turing the ccontrol knobs might result in a green fiashing status LED. Green, flash ‘The last known shutter position of one of the shutter pairs is 8 cm. Itis not ‘advised to use the collimator, although use with limited functionality is possible. NOTE: The displayed value of the X-ray field size on the touch screen is CHF not reliable. The size of the X-ray field must be checked by using the light field indication. 7.2. Error codes ‘The table below shows error codes that can be displayed on the touch screen. Restarting the collimator may resolve the fault condition 1-49 | POWER ON settiest fault | 80, 51,52 _| Internal memory faut. Data memory is unexpectedly loaded with default values. WARNING: Because all values in the data memory are loaded with default values, this fault requires: 83 A + re-caliration ofthe rotation sensor (see §3 9). + re-calibration ofthe cross shutters (see §3 9) + re-calibration ofthe long shutters (see §3.9) + wien needed, re-adjustment of parameters 60 Internal communication fault 70 Long andlor crass shutter sensor(s) fault. 100___| Lower fiter sensor(s) fault 101 ___| Upper iter sensors) fault 102 __| Lower iter postioning timeout faut. 103___| Upper fiter postioning timeout faut. “104 | Lower andlor upper itr fault while fiters are not expected to move. 200__| Light field and bucky laser activation button stuck. eaeWVAREX SClaymount ING 7.3. CAN protocol configuration For using the Claymount CAN protocol, the protocol ID must be set to ‘0' (which is also the default value). The protocol ID can be set in Service screen 2 or sending a service CAN message. collimator. Ay | tis: Sess ore i to mec pater ie After selection, the protocol is active within 1 second. Additional to the supported protocols a service protocol is available, which is always active. With the service protocol, the collimator CAN speed and CAN message ID can be selected for the Claymount protocol and Service protocol ‘The calibration functions can be accessed through the Service protocol. The next paragraphs describe the Claymount protocol and Service protocol 7.4. Claymount protocol and Service protocol ‘General definitions The Claymount protocol can be selected with protocol ID ‘0’ All Claymount CAN messages containing the following information: CANID [DLC |Byie0 | Byte1 |Byte2 | Byte |Byte4 | Bytes | Bytes | Byte7 CAN | Data | Claymount [Data | Data | Data | Data | Data | Data | Data Identifor | Length | Message | Byieo | Bytet | Bye2 | Bytes | Bytes | Byes | Bee Code | Identiter oxo00- | 8 oao- | ox00- | ox00- | ox00- | 0109- | ox00- | ox00- | ox00- o«FF oF fore lore lor lorr fore [ore | oF ‘The Claymount protocol and the service protocol always use the same CAN ID. The CAN ID and speed can be configured via a CAN configuration message. After 2 new configuration, the settings will be saved in EEPROM. After a firmware update the EEPROM can be re-intialized, the CAN settings will then be set to default. Defauit settings are: CAN ID = ox76c CAN speed = S00 kbit/s Message Data In the protocol the following is assumed: * Bit7 is MSB and bit 0 is LSB. + When a status is given bitwise, 1 = TRUE / ON and 0 = FALSE / OFF. + When a shutter setting is defined in byte, 0 = closed and 255 = max posttion * When bitwise more than one status can be set; the first bit which is set (counting from bit 0), is master For example, when bit 0 is toggle and bit 1 is off and both bits are 1, the software will only toggle because bit 0 is set and the rest will not be checked. Message Identifiers Overview of message identifiers: 1 a) Functional messages received by the collimator 100 - 199 Functional messages transmitted by the collimator 200 - (84 Configuration messages received by the collimator Service protocol Protocol ID is not available, because this protocol is not selectable and always active. 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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: [ose Sat) Follow national and local regulations regarding disposal of electronic equipment. Packaging material shall be recycled according national and local regulations.\W VAREX IMAGING = Claymount 9. Specifications and accessories This chapter gives specifications (technical and product label information) and information about available accessories 9.1. Techi ations Stainless steel, aluminium, copper, lead, brass, leaded Materials bronze, plastics (ABS) Power source 24V DC + 10% Power consumption 35VA Xray rating up to 150 kVp Application Stationary equipment for radiography and fluoroscopy Collimation ‘Square field muttlayer Mounting plane distance from focus | 801 mm ‘Aluminum equivalent contribution to total fitering Min, Al 1.2 mm ray beam = 75 kV) ‘Additional Fitration (ray beam = 75 KV; ENS0S01-1-3:2008 57.3, §7.5) 1 mmAl+0.1 mm Cu 1 mmAl+0.2mm Cu Combined 2 mm Al+0.3 mm Cu Manual selection and remote control (both motorized) (CF002 configuration only) Confinement of extra-focal radiation (Setfocus distance, SID 11m; EN 60601-2-54:2009 §203.8.4) < 150 mm ‘Square X-ray field selection Min: 00 x 00 em Max: 48 x 48 om (# 1.% at 1m SID) (foreach 43x43 em at 900m SID) Motor controlled shutters Yes Motor controlled additional tering | Yes (€F002 configuration riy) (CF002 configuration only) Yes Knobs for manual setting (2040 Series nb) Remote control (CAN-bus) Input for additional setting Touch sorean (40 Seriae oa) Light field source White power LED Timer and control to limit light source | Yes exposure time to prevent overheating (default 20 see. asustable) Light field indicator illumination (Wurination atm from the focus Field size at 25x35 om, EN 60607-2-54:2009 §203.8.102.5) 2 230 bx, at 100 % power setting of light field source Light field indicator-contrast (Edge contrast seting 35x35 om atim SID; EN 60601-2-54:2008 §203.8.102.5) bart Troe rnrs SeadWVAREX — SClaymount wiieeremreny [2x 90 Linear light projection Laser Class 1 (EN-IEC 60825-1) (optional feature) {To align cotimator wth image recepton Laser Class 2 (EN-IEC 60825-1) (optional feature) SID precision of measurement with retractable tape <2%SID ¢Ne0601-13.2008 $8.52) Leakage radiation (811 m, Xray beam = 150 kVp, 4 mA; 50.5 mGyih ENSOGO1-1-3:2008 $12.4) Collimator rotation (beam axis) ‘Optional with rotating flange (+/- 90°) Remote control interface Yes (via CAN bus) Maximum load for accessory rails 70N ‘Weight 8.0kg Size 230 x 320 x 210 mm (wx dx h) Ambient temperature: 10-40 °C Operation environment Relative humidity: 30-95 %, non-condensing Aim, Pressure 700 - 1080 hPa ‘Ambient temperature: -20- 470°C Storage Relative humidity: 30-95 %, non-condensing ‘Atm, Pressure 700-1080 hPa 9.2. Product label ‘The product label is located on the rear-side of the collimator: Location of product label Figure 9: rear view (oroduct label) WARNING: A Ifthe product label is missing or not readable contact your distributor or Claymount ‘The figure below shows the information provided on the product label. eae ort ceeWVAREX Claymount oes ECE; et FE k.. fretenwame | VAREX| ume simagingcem Vane tx Model: OPTICA 40 Medical Device REF] 000x-NN-LLL SN ] 20000000000 === 24 VDC / 80VA Min, inherent filtration co] yvv-mw-pp Al. Equi: 1.2mmAl/75 kV X-ray rating up to: 150 kVp —1P20 (€1)0%900000000%X(11)20000X (24) WOXHKXXIE KK ‘roduc compin nh aedrmon of 21 OF Shap aan ming pots ft on ee of rower comobes a CFR Toa so an eso sector cvatonspusuants Lar Nts Wessel p28 Figure 10: Product label for Optica 40 pa inle W p4 C Ge S KE Kx... french” | VAREXY mm Model: OPTICA XX Medical Device [REF] 20000-NN-LLL SN] X2x000000000x NCL See Min, inherent filtration col YYYY-MM-DD Al. Equis.: 1.2mmAl/ 75 kV X-ray rating up to: 150 kVp 1P20 (01) OXXQCOOCOOOOX (11 OOOO (21) WO XO E- KK ‘hie product comptes wth he requremens 021 CFR Subchapter Jf eatin emiting product fet on te te "is proc copes wr GPR Tous and ud neoprene percanoaarNekes sf taed Sy Se SN Figure 11: Product label for Optica 30/50WVYAREX = SClaymount (This page is intentionally left blank)WYAREX Sclaymount (This page is intentionally left blank)W VAREX IMAGING Contact details Claymount Assemblies BLY. ‘The Netherlands ‘T #31 (0)315 659 150, F +34 (0)916 659 140 Netherlands [email protected] Claymount High Voltage Technology (Beijing) Co., Ltd China 7 +86 10 6780 2708 +86 10 6780 2129 F +36 106780 2170 China. NC@vare> © 2018 by Claymount Assemblies BV Claymount Glaymount Americas Corp. usa T1847 279.5100 F +41 630.271 9995 ‘[email protected] Claymount Assemblies Philippines Inc. Philippines 7 #83 49 6024 620 7-483 49 5024521 F #63 49 6024 600, F463 28078472 Philippines. [email protected] All Rights reserved. No part of this document may be reproduced or transmitted in any form or by any ‘means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of Claymount