Manual, Service, OrthoScanHD 1000 (10000004) Part Number – 050‐0010 Initial Release Approvals Anita Eaves Pete Kilpatrick Originator Date: 4/2/10 QARA Date: 4/2/10 Anita Eaves Document Owner Date: 4/2/10 Rev Revision Date Revision Summary A 1/11/10 Release 8212 East Evans Road Scottsdale, AZ 85260 THE INFORMATION CONTAINED IN THIS SOP IS THE SOLE PROPERTY OF ORTHOSCAN. ANY REPRODUCTION IN PART OR AS A WHOLE WITHOUT THE WRITTEN PERMISSION OF ORTHOSCAN IS PROHIBITED. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 1 of 55 SERVICE MANUAL PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 2 of 55 OrthoScan‐HD Model 1000‐0004 Mini C‐arm Imaging System Service Manual 8212 East Evans Road Scottsdale, AZ 85260 Phone: 480‐503‐8010 fax: 480‐503‐8011 [email protected] www.orthoscan.com OrthoScan Service Department in the U.S. call toll free: +1-866-996-0472 PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 3 of 55 PROPRIETARY AND CONFIDENTIAL – The information contained in this document is the sole property of OrthoScan, Inc. Any reproduction in part or as a whole without the express written permission of OrthoScan, Inc. is prohibited. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 4 of 55 TABLE OF CONTENTS Introduction ......................................................................................................... 1 Product Specifications and Components ................................................................................ 2 ORTHOSCAN HD PRODUCT SPECIFICATIONS ................................................................................................................................................. 2‐1 OrthoScan Major Components ........................................................................................................................................ 2‐2 FLEX ARM COMPONENTS AND BACK PANEL CONNECTIONS .............................................................................................................................. 2‐3 Electronic Chassis Components ....................................................................................................................................... 2‐4 Removal/Replacement Instructions ....................................................................................... 3 EM Plate Removal ............................................................................................................................................................ 3‐1 Electronic Chassis Removal .............................................................................................................................................. 3‐2 Video CCA Removal .......................................................................................................................................................... 3‐3 Monitor Keyboard Assembly Removal ............................................................................................................................. 3‐4 X‐Ray Light Replacement ................................................................................................................................................. 3‐5 Monitor Arm Removal ..................................................................................................................................................... 3‐6 Monitor Arm Tension Adjustment ................................................................................................................................... 3‐7 Monitor Removal ............................................................................................................................................................. 3‐8 Printer Removal ............................................................................................................................................................... 3‐9 System Set‐Up ....................................................................................................................... 4 DICOM Setup ................................................................................................................................................................... 4‐1 Storage Provider Setup .................................................................................................................................................... 4‐2 Worklist Provider Setup ................................................................................................................................................... 4‐3 DICOM Print Provider Setup ............................................................................................................................................ 4‐4 Image Calibration .................................................................................................................. 5 Appendix A ....................................................................................................................................................................... 5‐1 Procedure ......................................................................................................................................................................... 5‐2 Preparation of Collimator ................................................................................................................................................ 5‐3 Iris Adjustment ................................................................................................................................................................. 5‐4 Camera Adjustment.......................................................................................................................................................... 5‐5 Completion of Collimator ................................................................................................................................................. 5‐6 Collimator Alignment ....................................................................................................................................................... 5‐7 System QC Documentation .................................................................................................... 6 Radiation QC Document .................................................................................................................................................. 6‐1 Collimation Template ....................................................................................................................................................... 6‐2 Schematics ....................................................................................................................................................................... 6‐3 PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 5 of 55 OrthoScan can provide service directly. This version of the service manual is intended for use on machines manufactured after May 2008. Precautions Repair.1 Introduction Purpose This service manual provides service information for major components and sub‐assemblies of the OrthoScan‐ HD Model 1000‐0004 mini c‐arm imaging system. Service by unauthorized service personnel will void any remaining warranty. or on machines prior to this date which have been updated to the OS1005 system. calibration or other types of service must always be carried out by suitably qualified personnel. Scope This document and the diagrams and schematics contained herein are written for technical personnel. such as biomedical engineers. maintenance. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 6 of 55 . Equipment Classification Class 1 Device Water ingress protection classification Ordinary Equipment Mode of operation Continuous Operation Electric shock protection classification Type B applied part POWER REQUIREMENTS Nominal rated line voltage 100 / 120 / 230 V~ (autosensing) Frequency 50 Hz or 60 Hz Line voltage regulation + 10% daily line reg.5 mm Aluminum equivalent Focal spot 50 microns Field of view operator selectable collimation of 10 cm (4 in) or 15 cm (6 in) Rated peak tube potential 80 kVp Tube kVp range 40 to 75 kVp Tube current range 40 to 100 µA (0. A Page 7 of 55 .100 mA) Deviation from indicated values kV + 7%.1mA continuous duty X-ray source Superior SXR-80 X-ray tube window 0. ≤2A at 230 V~ 120 V~: Bel Fuse 5ET 4 or Littlefuse 0213 0004(P) 230 V~: Bel Fuse 5ET 2 or Littlefuse 0213 0002(P) Mains Fuses X-RAY SPECIFICATIONS Duty cycle at 75 kVp / 0. Current < 4A at 120 V~. µA + 10% PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev.1 OrthoScan‐HD 1000 Product Specifications NOTE: Product design and specifications are subject to change without notice. ≤5A at 100 V~.2 PRODUCT SPECIFICATIONS AND COMPONENTS 2.04 to 0.75 mm Beryllium Beam filtration 2. the owner/user is responsible for compliance of the equipment.7 in) C-arm Depth of Arc 46 cm (18. or plug the system into a different outlet so that the circuit is not shared with the other equipment. may cause or receive interference.2 in) Height 147 cm (58 in) Width 78 cm (30. non-condensing IMAGING SPECIFICATIONS Image Intensifier High sensitivity Cesium Iodide Image processing Digital Monitor Diagonal viewing size monochrome LCD Video System 1k by 1k CCD video camera Video Output Signal HDMI / VGA WEIGHTS AND DIMENSIONS Source to Intensifier Distance (SID) 45 cm (17. as required. Call the phone number listed on the cover of this manual if you have questions concerning electrical power for the system. A Page 8 of 55 . if not installed and used in strict accordance with the manufacturer’s instructions. or use other measures.94 in) C-arm Free Space 35 cm (13. If any modification is made.72 in) Source to Skin Distance (SSD) 10 cm (3.5 in) Weight 180 kg (400 lb) Shipping Weight 194 kg (430 lb) Ground Clearance 18 cm (7 in) Power Cord Length 610 cm (20 ft) Footprint 79 cm x 101 cm (40 in x 31 in) ELECTROMAGNETIC COMPATIBILITY This equipment generates and uses radio frequency energy and. try to correct the interference by one or more of the following steps: relocate the equipment with respect to other equipment in the room. Changes or modifications to this equipment not expressly approved by the agency responsible for compliance could void the authority of the owner/user to operate the equipment. If this equipment seems to cause or receive interference when turned on (which may be determined by turning equipment off and on). PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. ENVIRONMENTAL SPECIFICATIONS Storage Conditions Temperature Range 0˚C to 55˚C (32˚F to 131˚F) Relative Humidity of >10% to < 100% (no condensation) Atmospheric Pressure of 500hPa to 1060hPa Operating Temperature (Ambient) 15º to 32ºC (59º to 90ºF) Operating Humidity (Ambient) 20% – 80% relative humidity. 2 OrthoScan Major Components The major components of the OrthoScan‐HD 1000 mini c‐arm imaging system are shown below: A X-Ray Source Assembly I Power Switch B Image Intensifier J Printer (Optional) C Collimator K Retractable Power Cable D Orbital Lock L Back Panel Connections E Flex Arm M Brake F Keyboard N Cabinet G X-Ray On Light O Laser Aperture H Flat-Screen Monitor PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 9 of 55 .2. A Page 10 of 55 . 2. forearm. Wrist Forearm Elbow Shoulder Back Panel Connections A B C D Ground Probe Ethernet Port for PACS VGA Output Fuses PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev.3 Flex Arm Components Flex arm is comprised of the wrist joint. elbow joint and shoulder as depicted below. A Page 11 of 55 .4 Electronic Chassis Components Front‐ with cord reel removed Front‐ with Video CCA removed B B A B C E D A‐ B‐ C‐ D‐ E‐ Video CCA (915‐0013‐01) Cooling Fans (920‐0078) Wireless footswitch CCA (240‐0054)‐ if equipped EMI filter (230‐0013) Power control board (910‐0009) PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. 2. Rear Completed electrical chassis H G F F‐ Torroid isolation transformer (230‐0011) G‐ Powerbox power supply (260‐0026) H‐ Meanwell power supply (260‐0031) PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 12 of 55 . Power Switch USB Panel Mount USB to Monitor Hub Monitor Power HDMI PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev.3 REMOVAL/REPLACEMENT INSTRUCTIONS 3. A Page 13 of 55 .1 EMI Plate Removal Tools needed: (1) Ratchet w/ 10mm socket (1) ¼” nut driver (1) Small Phillips screwdriver (1) Large Phillips screwdriver (1) Nut Driver Remove back panel by loosening the 4 spring loaded screws Remove Monitor connections as depicted below. A Page 14 of 55 . Remove EMI shield by loosening 2 self tapping screws (401‐0940) using the 10mm ratchet 8. Disconnect HDMI cable from pass through on EMI plate HDMI pass through Disconnect 4‐position power switch receptacle connector PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. Power Switch Receptacle Connector Disconnect 2‐pos monitor power connection Monitor Power Receptacle Connector Disconnect three USB cables from “J31” location on Video CCA to the three USB PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 15 of 55 . blue ‐ negative. *Brown ‐ live. A Page 16 of 55 .3 USB connections Feed thru Couplers on the bottom side of the EMI shield Disconnect the three printer power cables from the 920‐0063 cable to the 250‐0058 Black Outlet Connector. & green / yellow – ground PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. Printer Power Supply Connector Disconnect green / black 2‐pos X‐Ray light connector from “J2” location on Video CCA X-Ray Light Connector At this point the EMI plate can be completely removed and set aside. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 17 of 55 . 2 Removing Electrical Chassis Tools: (1) Ratchet w/ 10mm socket (1) ¼” nut driver (1) Small Phillips screwdriver (1) Large Phillips screwdriver (1) 10mm Nut Driver (1) 7/16 open end wrench Before removing the electrical chassis first remove the EMI plate as described in section xx. A Page 18 of 55 . PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. 3.x Once EMI plate has been removed remove fuse box and disconnect all of the cables from the fuse box. Wireless footswitch sensor cable Next disconnect all umbilical cable connections Ground wires‐ PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. If present disconnect the wireless footswitch sensor cable.With fuse box removed check to see if unit is equipped with a wireless receiver. A Page 19 of 55 . Camera cable‐ HVPS Signal cables and HVPS power connection Disconnect VGA from “J2” on top of video CCA PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 20 of 55 . A Page 21 of 55 . Tube head image button connection‐ Wired foot switch connection‐ Disconnect 920‐0028 blue CAT 5 cable from back of the fuse panel to “P7” location at the top of the chassis PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. Disconnect signal / VGA cable from 15‐PIN location adjacent to hard drive Remove cord reel w/three bolts using a 7/16 wrench (white arrows) and 1 brown. A Page 22 of 55 . blue and green(grnd) electrical connection. then swing cord reel out of the way. At this point user can loosen four 401‐0940 #14 x ¾” self taping screws (red arrows) and remove electrical chassis PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. 3 Video CCA Removal Disconnect ground wires Disconnect 920‐0028 blue CAT 6 cable from back of the fuse panel to “P7” location at the top of the chassis Disconnect VGA from “J2” on top of video CCA PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev.3. A Page 23 of 55 . Disconnect LVDS camera cable from D‐sub connector at “P2” location on Video CCA LVDS Camera Cable Disconnect square brick HVPS signal connector from “P3” location on Video CCA HVPS Signal Wires Figure 22 PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 24 of 55 . A Page 25 of 55 . Disconnect 3‐pos HVPS power connector from “J1” location on Video CCA HVPS Power Figure 23 Disconnect 2‐pos X‐Ray handle image button connector with red wires from “J11” position on Video CCA X-ray handle image button signal connector Figure 24 PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 26 of 55 .Disconnect standard footswitch cable from “J3” location on Video CCA Disconnect wireless footswitch image and documentation connections Wireless foot switch document connection Wireless foot switch Xray connection PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. Disconnect gray and white 10 second delay connection 10 second delay connection Disconnect signal / VGA cable from 15‐PIN location adjacent to hard drive PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 27 of 55 . A Page 28 of 55 . Disconnect 11 position connector from “J1” on Video CCA Disconnect two fan power cables from “J23” and “J2” on Video CCA Disconnect 4 position red connector from “J14” on video CCA being careful not to interfere with ribbon cable 4 position red connector located behind ribbon cable PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. then the 4 position power cable is connected to the rear of the drive. A Page 29 of 55 . Video CCA can now be removed by loosening 4 nuts securing Video CCA to electrical chassis PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev.Disconnect 4 position hard drive power cable NOTE: If unit is equipped with a solid state drive. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. Monitor Power From Cart DVI Cable From Cart USB From Keyboard USB Extension From Cart Once cables have been disconnected remove 10‐32 x 1/2” screw (401‐0462) and anti rotate washer.3.4 Monitor keyboard assembly Removal To remove monitor keyboard assembly. A Page 30 of 55 . first remove monitor cable cover and disconnect the cables as depicted below. To replace simply disconnect light than unscrew light housing from bracket.5 X‐Ray light replacement X‐ray light is screwed into monitor arm support bracket. A Page 31 of 55 . PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev.3. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. Once the cables are free the arm is just a press fit into the top of the chassis/tray (see circled area below) Monitor arm can now be removed from cabinet by lifting up on the whole assembly.6 Monitor Arm Removal Tools: Wire cutters To remove monitor arm first remove zip ties securing cables to monitor arm to allow cables to hang freely.3. A Page 32 of 55 . As depicted below loosening the screw will strengthen the tension and tightening the screw will loosen the tension. A Page 33 of 55 .7 Monitor Arm Tension Adjustment If monitor height does not stay in place the tension can be adjusted with the screw located in the knuckle.3. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. Monitor Power From Cart DVI Cable From Cart USB From Keyboard USB Extension From Cart Figure 3‐40 Once all of the cable are free unscrew four M4. first remove monitor cable cover and disconnect the cables as depicted below.7x25 screws to remove monitor Monitor screws Figure 3‐41 Installation is the reverse of removal. A Page 34 of 55 .8 Monitor Removal Tools: Allen wrench set Wire cutters Zip ties To remove monitor keyboard assembly. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. 3. Printer USB Printer power Installation is the reverse of removal. replacement Tools: Large and small Philips head screw driver Remove back panel using large Philips head screw driver. A Page 35 of 55 . PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. 3. removal. Disconnect printer power and USB cables. Once screws have been removed printer can be slid out.9 Printer – installation. Once back panel has been removed unscrew two Philips head screws that hold printer in place. 2). PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. Figure 8.4 SYSTEM SET‐UP 4.1) and press return on the keyboard. and select the “system configuration” option.2: system settings dialog box The “hospital name” field corresponds to the Institution Name (0008. Modality Setup Figure 8. the system settings dialog box will appear (see figure 8.0080) tag in the DICOM header field.1 DICOM Setup DICOM setup is performed through the “system configuration” menu. right‐click anywhere on the screen.1: Password dialog Once the password has been accepted. A password is required to access this menu – OrthoScan can supply this upon request. Enter this password into the password dialog box (refer to figure 8. A Page 36 of 55 . To access this menu. e.2 Storage Provider Setup Click the storage provider setup tab. Note: entering a hostname will only work if DNS has been configured on the c‐arm.0060) tag in the DICOM header field After making changes. After entering the data into the fields. A Page 37 of 55 . figure 8.3: storage provider setup tab “Provider Description” is a descriptive name for the server. 4.1010) tag in the DICOM header field the “Modality” field corresponds to the Modality (0008. “Provider Port Number” is the port number used on the storage commitment provider “Provider AE Title” is the AE title of the storage commitment provider. press the “Add” button to save the data. Multiple storage commitment providers can be setup and stored. “Anytown PACS Server” “Provider Hostname” is either the hostname or IP address of the storage commitment provider.the “AE title” is the AE title assigned to the OrthoScan mini c‐arm the “Station Name” field corresponds to the Station Name (0008.g. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. click the Apply button at the bottom left to save the changes. “Anytown Worklist Provider” “Provider Hostname” is either the hostname or IP address of the worklist provider. After entering the data into the fields. A Page 38 of 55 . 4. Multiple worklist providers can be setup and stored. “Provider Port Number” is the port number used on the worklist provider “Provider AE Title” is the AE title of the worklist provider.4: storage provider setup tab “Provider Description” is a descriptive name for the worklist server.3 Worklist Provider Setup Click the storage provider setup tab. press the “Add” button to save the data. figure 8. e. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. Note: entering a hostname will only work if DNS has been configured on the c‐arm.g. press the “Add” button to save the data. figure 8. Multiple print service providers can be setup and stored. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 39 of 55 .g. e.4. After entering the data into the fields. “Anytown Blue Film Printer” “Provider Hostname” is either the hostname or IP address of the print service provider. “Provider Port Number” is the port number used on the print service provider “Provider AE Title” is the AE title of the print service provider.4 DICOM Print Provider Setup Click the storage provider setup tab. Note: entering a hostname will only work if DNS has been configured on the c‐arm.4: print provider setup tab “Provider Description” is a descriptive name for the print service provider. Symbol Description This symbol indicates that safety equipment or clothing is required for this step.1 Appendix A Image Calibration Purpose This document describes how to correctly and safely perform an alignment and adjustment of Image Intensifier and Collimator on an assembled OrthoScan‐HD1000. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. Radiation hazard. A Page 40 of 55 . Related Documents 010‐0108 Image calibration Worksheet Authorities and Responsibilities Only trained authorized personnel perform the following alignment and adjustments procedures. equipment and safety precautions before proceeding. Definitions There are various symbols used throughout this document to indicate important steps in the procedure. All OrthoScan HD‐1000 must undergo this process. Electrical hazard. Table 1. Proper radiation protective garments may also need to be worn when needed. Scope Only trained and authorized personnel shall perform the following procedure of Image Calibration.5. A radiation detection badge shall always be worn throughout this procedure. It is important that you read through this entire document to be familiar with the procedure.3 defines these symbols and describes their meaning. The following safety equipment and clothing should be available: • latex gloves • lead apron • safety glasses In addition to this. wearing the correct safety clothing and using the correct safety equipment. If you are ever in doubt about how to proceed. Always clean tools and equipment. and oral ingestion can cause long‐term mental health effects. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. Ensure that you maintain a safe distance from others that may be passing to avoid exposure. and wash your hands when you are finished. Never put your hands near your mouth until you have washed your hands. When working with high voltage (anything above 50v). Therefore. always ensure that you have informed the people working around you. A Page 41 of 55 . Lead is a poisonous material. take the time to familiarize yourself with the steps involved. ask a supervisor or colleague. by following these safety precautions. you can significantly reduce the risk to yourself. you should wear a radiation exposure tracking badge. However. A radiation badge should always be worn when performing x‐ray calibration procedures. Never sacrifice the safety of yourself or those around you. The main dangers you will be faced with are: • high voltages • exposure to lead • radiation exposure • dangers associated with using tools Before proceeding with any part of the procedures.Table 1. Before continuing. and make sure they are aware of what to do in case of an emergency. This is for your safety and theirs – you benefit from having someone available should something go wrong. always wear latex gloves when working with lead. and make yourself aware of any potential hazards involved. make sure you are aware of how to use it correctly and safely.3: Symbol Definitions 5. and the surface you were working on. and they benefit by making sure that they keep a safe distance from what you are working on. please be aware of your surroundings. or unsure about what safety precautions to take. Before using any tool or equipment. Radiation exposure may not be eminent the moment of exposure but can cause many health effects. after you finish working with lead.2 Procedure Safety The calibration and testing involves many significant dangers. Loosen but do not remove the other two screws.1‐1: Rotated C 2. two set screws to free the Intermediate Collimator. Qty: 1 OrthoScan C‐Arm ready for Image Calibration Tools: 1. Loosen. so that only the Base Collimator remains. Remove one 6‐32 screw from each of the Intermediate Collimator Clamps. 5/64” Allen Key 2. Remove the 6‐32 screw and washer that secures the Intermediate Collimator to the Base Collimator. Retain the screw and washer for they will be reinstalled later in the procedure. See Figure 2. Retain these screws for they will be re‐installed later in the procedure. Remove the Intermediate Collimator.1‐3. e. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. See Figure 2.1‐2 and Figure 2. d. a. 5. The Intermediate Collimator should be free and easily removed at this point. c. Rotate the clamps so that they are away from the Intermediate Collimator. 7/64” Allen Key Procedure: 1. b. but do not remove.3 Preparation of Collimator Objective: To properly remove Intermediate Collimator to isolate the II Camera alignment process Parts: 1. Rotate the C‐arm so that the II Camera is at the top and the HVPS is at the bottom. A Page 42 of 55 . Figure 2.1‐3. proceed to the Iris and Camera Adjustment processes.1‐2: Removal of Intermediate Collimator Figure 2. Figure 2. At this stage. camera alignment is facilitated by the removal of the beam limiting device. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev.1‐3: Intermediate Collimator removed Note: With the Intermediate Collimator removed. A Page 43 of 55 . Once the camera is aligned. the Intermediate Collimator can be re‐installed and aligned. 6 5. Parts: 1. A Page 44 of 55 . If equipped with a Narragansett/Toshiba image intensifier proceed to step 5. The following step is only performed if the unit is equipped with a Thales image intensifier that fails. Using a 1/16” Allen Key. Loosen.4 Iris Adjustment Objective: Properly adjust Iris settings on the Image Intensifier Camera. Tools: 1. Lower the C‐Arm so that the top of the II Camera is accessible. 2. but do not remove the set screw. Qty: 1 OrthoScan C‐Arm ready for Image Calibration with Intermediate Collimator removed. 1/16” Allen Key Procedure: 1. penetrate the Loctite covering the screw indicated in Figure 2.1‐4. Figure 2.1‐4: Lens Adjustment set screw PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. Figure 2. Slowly rotate Clockwise until it stops. 5. 6.1‐5. Note: If Lens Adjustment is difficult to rotate. Rotate the Lens adjustment first Counter‐Clockwise approximately and ¼” to loosen Loctite. A Page 45 of 55 . See Figure 2. the set screw may not be loosened enough. 3. Insert the Allen key into one of the multiple holes that line the Lens Adjustment above the set screw. Re‐tighten Lens Adjustment set screw. Note: Do not over‐tighten set screw.1‐5: Rotating Lens Adjustment 4. 7. 11. Check the image displayed for any blemishes.425 inch torque. Turn C‐Arm Unit ON by pressing the monetary green switch once.425 inch pounds. Rotate C‐arm back to its original position with II at the bottom and HVPS at the top. Use the image displayed on screen to determine what adjustments are needed to eliminate any black sections of the image.5 Camera and II Adjustment Objective: To properly adjust the II Camera Parts: 1. Repeat steps 3 – 7 until the image displayed has no black sections or is within specification limits. 5.5. 8. rotate the image using the Image Rotate Keys on the Keyboard and ensure that all frames are free of black sections. 3mm T‐handle Allen Procedure: 6 Places – *Camera Cover Screws (white circles) 4 Places – Camera Mounting Screws (Red boxes) Figure 2. A Page 46 of 55 . 4. Tools: 1. ensure all screws are fully secure. Repeat steps 3 ‐ 4. Once all black sections are eliminated or are within specification limits. If any discrepant issues are visible. 13. Connect the Power Cord and Foot Switch to the unit. tighten the adjacent camera * cover screws (6 places) to 4. 6. or anything that is out of the ordinary.1‐6: Top view of II Camera 1. II Camera is aligned and Unit is ready for Collimation alignment. Wait for system to boot up and you have the OrthoScan Screen displayed with the text “Press footswitch to begin…” 3. In addition to applying the torque to mounting screws. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. 2. 10. 9. Take an image by momentarily pressing the foot switch. 12. Qty: 1 OrthoScan C‐Arm ready for Image Calibration with Intermediate Collimator removed. Adjust the camera and re‐tighten the mounting screws (4 places) to 4. black or white pixels. Slightly loosen the four mounting screws enough so that you can barely move the camera. If necessary repeat steps 3‐7. If necessary steps 3 ‐ 12 may need to be repeated. turn unit off and troubleshoot. While imaging. Turn unit off. 7. Figure 2. Re‐install the Slide Clamp and secure it with six 6‐32 x 3/8“ Button HD socket Screws (P/N:401‐ 0521).050” Allen Key 4. Qty: 6 6‐32 x 3/8 “ Button HD socket Screw (P/N:401‐0521) (two were removed in section 2. 5/64” Allen Key 2. Qty: 1 #8 x 3/8” OD Flat Washer (P/N: 410‐0021) (removed in section 2. 2.1) 5.1.5. 4. The two ball Plunge set screws may need to be adjusted accordingly to allow smooth motion and proper operation of the ball plungers in both positions of the slide. Apply a thin layer of Bearing Grease to the top. Ensure that the Slide moves freely.1) 6.1) 7. .2‐1: 4” Slide 5.1) 4. Qty: 1 OrthoScan C‐Arm ready for Collimation 2. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev.2‐1. Obtain the Intermediate Collimator that was removed previously and remove the two 6‐32 x 3/8 “ Button HD Socket Screw that secure the Slide Clamp. Qty: 1 6‐32 x 5/8” SHCS (P/N: 401‐0637) (removed in section 2.6 Completion of Collimator Objective: To properly re‐install and adjust the Intermediate Collimator to finalize the installation of the Collimator Parts: 1. See Figure 2. 9.2‐2. 3. See Figure 2. A/R Bearing Grease Tools: 1. Rotate C‐arm so that II is at the top and HVPS is at the bottom. 7/64” Allen Key 3. Remove the Slide Clamp and the assembled 4” Slide. Qty: 2 0‐80 x ¼” SHCS (P/N: 401‐0605) 8.) 3. Re‐install slide to the interior of the Intermediate Collimator. Qty: 1 #8 x 3/8” OD Flat Washer (P/N: 410‐0021) (removed in section 2. 6. 8. bottom and sides of the 4” Slide. A Page 47 of 55 . Clean excess grease that may have built up on interior of circular opening. Qty: 1 Intermediate Collimator (removed in section 2. Small Flathead Screwdriver Procedure: 1. 2‐2: Top view of assembled Intermediate Collimator 10.2‐3. The grease can easily attract foreign materials and other contaminates. Leave them snug. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. Refer to Figure 2. Figure 2. 14. Do not fully secure these screws. Use proper precautions to ensure no foreign material enter the Collimator assembly. Rotate the two Intermediate Collimator Clamps so that it overlaps the Intermediate Collimator and the mounting holes align. Lay the Intermediate Collimator in the interior of the Collimator Base. so that the openings of the two are overlaying.1 step 2e. 15. Secure the Intermediate Collimator by finger‐tightening the two set screws of the Collimator Base that were loosened previously in section 2. Re‐install the 6‐32 x 5/8” SHCS (P/N: 401‐0637) (removed in section 2. 11. 13.1‐2. A Page 48 of 55 . Note: Use caution once the grease has been applied to the slide. 12.1). Secure the Clamps with two 6‐32 x 3/8“ Button HD Socket Screws.1) and #8 x 3/8” OD Flat Washer (P/N: 410‐0021) (removed in section 2.1‐2. Secure the 4” Mode Switch with two 0‐80 x ¼” SHCS (P/N: 401‐0605) to the mounting holes indicated in Figure 2. They may need to be loosened later. See Figure 2. 2‐4: Completed Installation of Collimator Assembly PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. set screw on Slide is adjusted to the correct length. Figure 2. and slide is flush against walls of the Intermediate Collimator when engaged.2‐3: Switch mounting holes 16. A Page 49 of 55 .Figure 2. Engage 4” Slide to ensure Switch is activated. 7/64” Allen Key Figure 2. A Page 50 of 55 . 5/64” Allen Key 2. Qty: 1 OrthoScan C‐Arm ready for Collimator Alignment Tools: 1. Parts: 1.7 Collimator Alignment Objective: To properly and correctly perform the Collimator Alignment. 5.2‐3: Adjustment Screws PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. If necessary steps 4 ‐7 may need to be repeated. Procedure: 1. Simple adjustment steps are explained in Table 2. Adjustment Forward Back Step 1 Loosen screw '1' and '2' Loosen screw '3' and '4' Left Loosen screw '7' Right Loosen screw '5' and '6' Step 2 Tighten screw '3' and '4' Tighten screw '1' and '2' Tighten screw '5' and '6' Tighten screw '7' Table 2. 5. Turn Unit back ON. While imaging. Repeat steps 3‐12 in 4” mode with the slide moved forward.If required repeat steps 4 – 5 until the image displayed has no black sections or is within specification limits. 13. Repeat step 3. 8. 15. Turn Unit OFF by pressing green monetary switch once.3: Basic Adjustments 7. A Page 51 of 55 . Before taking any image the following should always be observed of the Collimator Assembly: • The locking screw indicated by a circle in Figure 2. 2.2‐3 should always be snug and resting against the Intermediate Collimator sidewalls. Rotate C‐arm back to its original position with II at the bottom and HVPS at the top. Adjust the Intermediate Collimator by loosening and/or tightening the set screws and locking screw. Further adjusting may be needed. Electric shock and High Voltage is present. 12. 4. • All set screws indicated by rectangles in Figure 2. 11. 14. • Collimator Slide is locked in its position. Note: Do not attempt to adjust set screws while machine is powered ON. Then pressing the monetary green switch once. Using the image displayed on screen determine what adjustment is needed to eliminate any black sections of the image. Turn C‐Arm unit ON by switching the main switch to the ON position. ensure all screws are fully tightened. ensure all rotation angles are free of black sections.3.2‐3 should always be snug and not too tight to allow movement of the Intermediate Collimator. rotate the image using the Image Rotate Keys and ensure that all frames are free of black sections. While imaging. Take an image by momentarily pressing the foot switch. Note: Keep all metal and body parts away from the HVPS Control CCA and cables. 9. 10. Electric shock and High Voltage is present. 3. engaging the ball plungers in either 4” or 6” mode. • Collimator Clamps are snug against the Intermediate Collimator. Once all black sections are eliminated or are within specification limits in both 4” and 6” mode. Turn unit off. Unit has completed the Collimation procedure and is ready for Labeling and Panel Installation PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. If necessary repeat steps 3‐6. Wait for system to boot up and the OrthoScan Screen displayed. 6. Repeat step 3. as tightening all screws may tweak the position of the Intermediate Collimator slightly. 6 SYSTEM QC DOCUMENTATION 6.8 3.9 66 61. Indicated kV Observed kV Acceptable Range (kV) Observed mR/s Acceptable Range (mR/s) 56 52.6 Leakage and Scatter Survey Meter Test Equip ID___________ Cal Due Date_________ Tube leakage at 1m mR/hr.1 Use the manual kV/µA buttons to select the 66kV step. A Page 52 of 55 .4 75 69.4 – 70.0 – 59. Maximum 10mR/hr Unit Passed: _____ Date / Tested By: / Time : Reference: 020‐0019 PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev.9 1. Maximum 10mR/hr Scatter at 1m mR/hr. µA 100 Exposure Detector Test Equip ID____________ Cal Due Date_________ Base Test Equip ID______________ Cal Due Date: NA Use the manual kV/µA buttons to select the indicated kV steps and record the observed kV and mR/s values in the table below.6 2.4 – 1.0” Max.4 – 70. kV 75 Max.7 – 5.5 – 3.8 – 78. Exposure 1 Exposure 2 Exposure 3 Exposure 4 Acceptable Range 61.1 Radiation QC Document THIS DOCUMENT IS VALID FOR THE FOLLOWING RANGE ONLY: Machine Serial Number: ________________ Source to Detector Distance 18. Make 4 successive exposures and record the observed kV values in the table below. 6. A Page 53 of 55 .2 COLLIMATION TEMPLATE y 1 cm 7 cm 5 cm 3 cm 6 cm 2 cm x 8 cm 4 cm PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. 6. A Page 54 of 55 .3 SCHEMATICS PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. PROPRIETARY AND CONFIDENTIAL 050‐0010 Rev. A Page 55 of 55 .