Odyssey & Quest Service Manual - Spectrum Medical X
Contents
1. Revision 2 6 Q Rad System Operator s Manual Quantum Medical Imaging Heat Dissipation Generators Cabinet Typical Heat Output 3600 BTU per hour Control Panel Typical Heat Output 130 BTU per hour X Ray Tube Max Heat Output 600 khu tube 2000 BTU per hour Tables QT 730 Typical Heat Output 40 BTU per hour from receptor QT 750 Typical Heat Output 400 BTU per hour QT 740 Typical Heat Output 100 BTU per hour Tube Supports QS 500 QS 550 200 BTU per hour Upright Cassette Holders Typical Heat Output 50 BTU per hour NOTE The above calculations are typical based upon average usage Air circulation around the electronic cabinets must be provided This includes the sides back front and top of cabinet System Operating Environment Ambient Temperature 10 40 C 50 104 F Relative Humidity 15 75 Atmospheric Pressure 700 1060 hPa Transport and Non Operating Environment Ambient Temperature 25 to 55 C 13 to 131 F Relative Humidity 5 95 Atmospheric Pressure 500 1060 hPa Q Rad System Operator s Manual Revision F Quantum Medical Imaging 2 7 System Configuration The Quantum Q Rad System consists of a combination of integrated radiographic components typically including an X ray generator X ray tube and tube support collimator radiographic table and an upright cassette holder Different types of image receptors may be utilized with the Q Rad Syst2. 2 18 RevisionF Q RadSystem Operator s Manual iv Quantum Medical Imaging Chapter d CHAPTER 1 SAFETY NOTICES 99 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 99 9 1 1 1 2 General Safety Information This product has been designed to meet stringent safety standards All medical electrical equipment requires proper installation operation and maintenance particularly with regard to safety It is vital that the user read understand note and where applicable strictly observe all Warnings Cautions Notes and Safety markings within this document and on the equipment and that the user strictly follow all safety directions in this manual to help ensure the safety of users and patients Every reasonable precaution has been taken during manufacture to safeguard the health and safety of persons who will operate this equipment The following precautions must be observed at all times Warnings Cautions Notes The following samples show how warnings cautions and notes appear in this document The text explains their intended use Indicates injury or death is possible if the instructions Warning are not obeyed Instructs users to refer to documentation if displayed without warning text Indicates that damage to equipment is possible if the Caution instructions are not obeyed Notes provide advice and highlight unusual points
3. 4994990 Q Rad System 5 Manual Quantum Medical Imaging Guidance and manufacturer s declaration electromagnetic immunity Conducted RF 3 Vrms 3 Vrms IEC 61000 4 6 150 kHz to 80 d 1 2VP MHz Radiated RF 3 V m 3 V m JP IEC 61000 4 3 80 MHz to 2 5 80 MHz to 800 MHz d 1 2vP GHz 800 MHz to 2 5 GHz d 2 3VP where P is the maximum output power rat ing of the transmitter in watts W accord ing to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compli ance level in each frequency range Interference may occur in the vicinity of equipment marked with the following sym bol 4 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless tele phones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the lo
4. A Note note is not intended as an instruction f Pb P The purpose of safety icons such as those shown below is to indicate at a glance the type of caution warning or danger Warning lonizing radiation indicates the possibility of increased levels of radiation Warning Dangerous voltage indicates the presence of high voltage Warning Warning hot surface Q Rad System Operator s Manual Revision F Quantum Medical Imaging 1 3 A WARNING Quantum Medical Imaging LLC disclaims all responsibility from any injury resulting from improper application of this equipment This equipment is sold to be used exclusively under the prescribed direc tion of a person who is licensed by law to operate equipment of this nature This equipment must be used in accordance with all safety procedures described in this manual and must not be used for purposes other than those described herein In the United States Federal law restricts this device to sale distribution and use by or on order of a licensed physician Quantum Medical Imaging LLC cannot assume responsibility for any mal functioning of this equipment resulting from improper operation mainte nance or repair or from damage or modification of its components Failure to observe these warnings may cause serious injuries WARNING X rays are hazardous to both patient and operator unless established safe exposure factors and operating instructions are observed Only
5. Carestream z D uantum ME AL IMAGING Division of Carestream Q Rad System Operator s Manual The original release of this manual dated 2011 02 24 February 24 2011 was drafted in the English language by Quantum Medical Imaging LLC This manual is copyrighted and all rights are reserved No portion of this document may be copied photocopied reproduced translated or reduced to any electronic medium or machine readable form without prior consent in writing from Quantum Medical Imaging LLC Copyright 2012 QMI Quantum Medical Imaging LLC Division of Carestream 2002 B Orville Drive North Made In U S A Ronkonkoma NY 11779 7661 USA Phone 631 567 5800 Fax 631 567 5074 E mail info qmiteam com www quantummedical net 0473 Revision Date Type Of Modification A 2011 02 24 Initial Release B 2011 11 02 Added DX D DR configuration 2011 08 30 Added QG DIG DRX integration option D 2012 01 30 Incorporated ECO 2568 2609 E 2012 02 10 Renamed Operator Manual changed EU Representative F 2012 05 09 Updated per IEC 60601 1 2005 IEC 60601 1 3 IEC 60601 2 54 i thru iv F 1 1 thru 1 14 F 2 1 thru 2 18 F 444 4 HEHEHE HHH HEHEHE 4 HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH isionF Q Rad System Operator s Manual Revision Quantum Medical Imaging THIS PAGE INTENTIONALLY LEFT BLANK 4440
6. TABLE PORTABLE DETECTOR Q DRT WALL STAND Q DRT T TABLE DR IMAGING DETEC QR1 QR2 CARESTREAM DRX 1 IMAGING SYSTEM TOR SYSTEM PORTABLE WIRELESS CARESTREAM DRX 1 IMAGING SYSTEM FIXED 4343R SHH 000 HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HEHEHE HHH HEH EHH HHH EHH HHO 1 Revision Q Rad System 5 Manual z 2 10 Quantum Medical Imaging Intended Use The Quantum Q Rad System provides diagnostic quality images to aid the physician with diagnosis The system can be used to perform radiographic exposures of the skeleton including skull spinal column and extremities chest abdomen and other body parts The Q Rad Radiographic System is not indicated for use in mammography General Application Specification Patient Population Age Newborn to geriatric Weight Up to 294 8 kg 650 0 Ib Region of Body Produces images of any bone in the human body including the hand wrist arm foot ankle knee leg or spine Operator Requirements Education Training This equipment is sold to be used exclusively under the prescribed direction of a person who is licensed by law to operate equipment of this nature Application Location Professional use only indoor use only Physical Environment Refer to Q Rad System operating and non operating specifications in this chapter Frequency of Use Intermittent operation
7. for use in the presence of a flammable anesthetic mixture with air or with oxygen or with nitrous oxide Protection against Harmful Ingress of Water Ordinary enclosed equipment without protection against ingress of liquids MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT ELECTRIC SHOCK FIRE us MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601 1 1 AND Intertek CAN CSA C22 2 NO 601 1 The following symbols may be used for marking on this equipment or equipment documentation MR Earth ground Dangerous Voltage Protective Earth ground Type B Equipment Connection point for the neutral conductor on PERMANENTLY INSTALLED EQUIPMENT Non ionizing Radiation Consult operating instructions z D Ir Alternating current 9999999990969999999999999099099999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999 E Revision F Q Rad System Operator s Manual z 1 6 Quantum Medical Imaging Compatibility The equipment described in this manual must only be used in combination with other equipment or components if these are expressly recognized by Quantum Medical Imaging LLC as compatible Intended Operator This equipment is intended to be installed used and operated only in accordance with the safety procedures given within this manual for the purpose for which it was designed Before attempting to work with this equipment read understand note
8. 2 5 GHz d 1 2 4P d 1 2VP d 2 3VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation dis tance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people SHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH 6 6 6 4 HHH HEHEHE HHH HEHE HHH 4 Revision Q Rad System 5 Manual z 1 12 Quantum Medical Imaging Abbreviation Definition The following abbreviations and acronyms may be found in this document Their definition is explained below AEC Automatic Exposure Control Btu British Thermal Unit CR Computed Radiography d Distance DR Digital Radiography HF High Frequency hPa Hecto Pascal hr Hour kg Kilogram kHz Kilohertz KVA Kilovolt Ampere Ib Pound m Meter MHz Megahertz mm Millimeter OCP Operator Control Panel P Power RF Radio Frequency V Volt W Watt WE
9. DIG DRX COMPLIANCE LABEL REAR VIEW Revision F Q Rad System Operator s Manual 2 16 Quantum Medical Imaging Power Disconnection Refer to the following table for Q Rad System component power disconnection methods Table 2 5 DX D 500 Q Rad System Component Power Disconnection Method X ray Generator Single phase non Stored Energy QG 25 QG 25 5 QG 32 QG 32 5 QG 40 and QG 40 5 ON OFF circuit breaker 1 on generator cabinet X ray Generator Single phase Stored Energy X ray Generator Three phase QG 20 SE QG 32 SE QG 40 SE QG 50 SE QG 32 2 QG 32 3 QG 40 2 QG 40 3 QG 50 QG 50 2 QG 65 and QG 80 ON OFF circuit breaker 1 on generator cabinet ON OFF circuit breaker 1 on generator cabinet TechVision Supplemen tary Generator Control Panel QG TV Q QG TV IP Q QG TV F QG TV IP F QG TV C QG TV IP C ON OFF circuit breaker CB1 on generator cabinet Radiographic Table Non Elevating Tabletop QT 730 ON OFF circuit breaker CB1 on generator cabinet Standing Floor Mounted Radiographic Table QT 740 Unplug Line Cord Non Elevating Tabletop Radiographic Table QT 750 Unplug Line Cord Elevating Tabletop Tube Support Floor Wall QS 500 ON OFF circuit breaker Mounted CB1 on generator cabinet Tube Support Free QS 550 ON OFF circuit breaker CB1 on generator cabinet 9 999999999999999990699990909999999999069999099999999999999999999
10. HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH 4 9 9 9 9 9 9 HHH HHH HHH HHH HHH 9 9 9 9 99 HHH MAS Revision F Q Rad System Operator s Manual HH EI Quantum Medical Imaging Chapter 1 Safety Notices General Safety Information 1 3 Warnings Cautions 1 3 Regulatory Compliance 1 5 Classificatlol tide deer ee 440 1 6 Compatibility di edi 1 6 Intended 1 7 i gt te Se ar Blan ya 11771 1 7 Applicable Standards 1 7 Accompanying 1 7 Environmental 1 8 Electromagnetic Compatibility EN 60601 1 2 2007 IEC 60601 1 2 2007 1 8 Abbreviation 1 13 Chapter 2 General Information Instructions for 2 3 dw Du sa e de p DX ard oe ea da eo ww Q RA 2 4 Component 2 6 Generators 2 6 Generators Control 2 6 T
11. This chapter describes the configurations of the Q Rad Radiographic System which typically includes Quantum Medical Imaging HF Series X ray Generators radiographic tables free standing tube support upright cassette holder collimator X ray tube ion chamber when equipped with AEC option and image receptor Detailed instructions for successful integration of the compatible Quantum components are published in the Service Manuals for each of the various system components Table 2 1 Q Rad System Components User Service Documents X ray Generator Single phase non Stored Energy QG 25 QG 25 5 QG 32 QG 32 5 QG 40 QG 40 5 Odyssey DC30 010 Quest DC30 015 Q Vision DC30 101 Q Vision Odyssey DC30 011 Quest DC30 063 X ray Generator Single phase Stored Energy QG 20 SE QG 32 SE QG 40 SE QG 50 SE Odyssey DC30 010 Quest DC30 015 Q Vision DC30 101 Q Vision Odyssey DC30 011 Quest DC30 063 X ray Generator Three phase QG 32 2 QG 32 3 QG 40 2 QG 40 3 QG 50 QG 50 2 QG 65 and QG 80 Odyssey DC30 010 Quest DC30 015 Q Vision DC30 101 Q Vision Odyssey DC30 011 Quest DC30 063 TechVision Supple QG TV Q QG TV IP Q DC30 048 Quantum DC30 049 mentary Generator QG TV F QG TV IP F QG non integrated systems Control Panel TV C QG TV IP C DC30 120 Q Vision non integrated sys tems DC30 126 Carestream integrated systems Rad
12. and strictly observe all warnings cautions and safety markings on the equipment Users include those persons who actually handle the equipment and those who have authority over the equipment Training Users of this equipment shall have received adequate training on its safe and effective use before attempting to work with the equipment Training requirements may vary from country to country The User shall make sure that training is received in accordance with local laws or regulations that have the force of law Applicable Standards The Q Rad Radiographic System complies with e IEC 60601 1 2005 e IEC 60601 1 2 2007 e IEC 60601 1 3 2008 e IEC 60601 1 6 2010 IEC 62366 2007 Accompanying Documentation The documentation consists of a System Operator s manual this document System Service manual DC30 109 and related documentation depending on system configuration as shown in Chapter 2 GENERAL INFORMATION Table 2 1 The documentation shall be kept with the system for easy reference SHH SHH HHH HHH HHH HHH HHH HHH HHH HHH 4 4 HHH HHH HHH 4 4 4 HHH HEHE 4 9 HEHEHE HEHEHE HHH EHH 4944994 Q Rad System Operator s Manual Revision F Quantum Medical Imaging 1 7 Environmental Protection This equipment contains certain materials and chemical compounds incidental to the manufacture of electrical and electronic equipment and improper end of life disposal of such equipment can result
13. limited primarily by loading characteristics specific to tube type used in the system Mobility Stationary Cleaning Preventive Inspection and Maintenance Instructions for cleaning preventive inspection and routine maintenance of Q Rad Radiographic System are included in each of the system component user s and service manuals indicated in Table 2 1 Instructions for Disposal of Waste Equipment In the European Union this symbol indicates that when the last user wishes to discard this product it must be sent to appropriate facilities for recovery and recycling Contact your local representative for additional information on the collection and recovery programs available for this product 4 HHH HHH HHH HHH 4 HHH HHH HHH HHH HHH 4 HHH 4 9 4 9 4 9 9 9 HEHEHE 4 9 HHH HHH HHH HHH SD is Q Rad System Operator s Manual Revision F Quantum Medical Imaging 2 11 Labeling Each component of the Q Rad System has its own rating plate serial label The following table provides the general location of the rating plate serial label on each of the various types of components that could be incorporated in a Q Rad System Table 2 4 Q Rad System Components Labeling Guide Q Rad System Q Rad GENERATOR CABINET Q RAD SYSTEM LABELS REGULATORY LABEL CONFIGURATION LABEL X ray Generator Single phase non Stored Energy BEEN QG 25 QG 25 5 iu 06 32 QG 32 5 40 40 5 Single phase
14. qualified and authorized personnel shall operate this system In this context qualified means those legally permitted to operate this equipment in the jurisdiction in which the equipment is being used and authorized means those authorized by the authority controlling the use of the equip ment Full use must be made of all radiation protection features devices systems procedures and accessories It is important that everyone having anything to do with x radiation be properly trained and fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from NCRP Publications 7910 Woodmont Ave nue Suite 800 Bethesda Maryland 20814 3095 www ncrp com and of the International Commission on Radiological Protection www icrp org and take adequate steps to protect against injury A WARNING X ray equipment may cause injury if used improperly The instructions con tained in this manual must be read and followed when operating this unit Personal radiation monitoring and protective devices are available You are urged to use them to protect against unnecessary x ray exposure 4444 HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH 6 HHH HHH HHH HHH HHH HHH HEHEHE HEHEHE 4 4 4 4 6 4 EHH HHH 4494446 6 or Revision Q Rad System 5 Manual z 1 4 Quantum Medical Imaging WARNING Exterior surfaces of the X ray Tube can rise in
15. system component user s manual indicated in Table 2 1 SHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH 4 6 4 EHH 66 0 6 HHH 6 HHH EHH HHH EHH OHO SD 7 Q Rad System Operator s Manual Quantum Medical Imaging Revision F 2 18 lt End of Document gt
16. 3 Table 2 4 Q Rad System Components Labeling Guide Radiographic Upright QW 420 Cassette Holder QW 420 S QW 420 D QW 400 A A 2 A A A 2 TUBE N SIDE VIEW RIGHT Collimator Manual PROGENY MC 150 HUESTIS 150MC RALCO R108 484 DHHS Collimator Automatic PROGENY Linear l Linear IV HUESTIS 32211 1 COMPLIANCE LABEL Rear Panel cf A Sar Revision F Q Rad System Operator s Manual 2 14 Quantum Medical Imaging Table 2 4 Q Rad System Components Labeling Guide 000000000 000 OOH HEF EHH HEHEHE EEE OOH Q Rad System Operator s Manual Quantum Medical Imaging 0000000 000040 HEHEHE EEE EOE OD X ray tube RAD 92 COMPLIANCE LABEL LOCATIONS TOSHIBA E7239X 7242 P A lam 7252 7254 E7869X N 1 DUNLEE DA 1092 DA 1036 J m JI U W REAR VIEW CABINET FRONT Digital Image Detector Q DRT Cabinet Q DRT T Q FDR Q FDR T COMPLIANCE LABEL DATAPLATE 44 HEHEHE HEHEHE HEHEHE HEHEHE HEHEHE HEHEHE HHH EHH a Revision F 2 15 Table 2 4 Q Rad System Components Labeling Guide Integration Option Q Rad DRX Series QG
17. 9999999999999999999906999990699990999999999999999999999999999999999 s M Revision Q Rad System Operator s Manua evision Quantum Medical Imaging Table 2 5 DX D 500 Q Rad System Component Power Disconnection Method Radiographic Upright Cassette Holder Non Tilting Collimator Manual QW 420 QW 420 S QW 420 D QW 400 Progeny MC150 Huestis 150MC Ralco R108 ON OFF circuit breaker 1 on generator cabinet ON OFF circuit breaker 1 on generator cabinet Collimator Automatic Progeny Linear Progeny Linear IV Huestis Programmable 32211 Unplug Line Cord ACS Power Supply amp Junction Box X ray tube Dose Area Product Meter optional Toshiba E7239X 7242 7252 7254 E7869X Varian RAD 14 RAD 60 RAD 92 Dunlee DA 1092 DA1036 Vacutec Display Unit VacuDAP OEM QD1 2 Vacutec lon Chamber Vac uDAP OEM QD1 1 ON OFF circuit breaker 1 on generator cabinet Unplug Line Cord Carestream Digital Imaging System DRX 1 Quick Reference Card for the Carestream DRX 1 System document 8G8318 Carestream DRX 1 System Safety and Regulatory Information with Hardware User s Guide document 7H8166 Carestream DRX 1 System Battery Charger User s Guide document 8H6193 Detachable Parts and Accessories Instructions for detachable parts and accessories of Q Rad Radiographic System are included in each of the
18. EE Waste Electrical and Electronic Equipment Q Rad System Operator s Manual Revision F Quantum Medical Imaging 1 13 THIS PAGE INTENTIONALLY LEFT BLANK SHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH 4 4 4 HHH HEHE 4 HEHE 6 6 4 6 X E Revision Q Rad System Operator s Manual 1 14 Quantum Medical Imaging Chapter 2 CHAPTER 2 GENERAL INFORMATION 9 9 9 9 19 99 9 HH SH 1 9 99 99 909 909 99 919 99 99 1 9 19 99 99 909 99 19 909 0 0 0 6 2 1 Instructions for Use The instructions for using Quantum s Q Rad Radiographic System including an explanation of the function of controls displays and signals and the sequence of operation are contained in each of the system component user s manual indicated in Table 2 1 WARNING This equipment must be operated with reasonable care A Manufacturer s equipment recommendations described in this manual must be observed WARNING Use a focal spot to film distance as large as possible in order to A keep the absorbed dose to the patient as low as reasonably achievable WARNING During each exposure the individual operating the X ray A machine must exit the radiographic operatory and stand behind a leaded wall 000000000 000000 44 EEE HEF EEF HEE OOD 644 4400442004 200 444 02040 440 Q Rad System Operator s Manual Revision F Quantum Medical Imaging 2 3 Overview
19. QT1 QT 730 QT 740 QT 750 TUBE SUPPORT 051 QS 500 QS 550 WALL STAND QW1 QW 420 QW 420 D QW 420 S QW 400 X RAY TUBE TU1 TOSHIBA E7239X E7242X E7252X E7254X E7869X VARIAN RAD 14 RAD 60 RAD 92 DUNLEE DA 1092 DA 1036 494 HHH HHH HHH HHH HHH HHH HHH HHH HHH 1111100000 4944644 HOD 1010000000000 06 6 4 BE Revision Q Rad System Operator s Manual z 2 8 Quantum Medical Imaging Table 2 2 Q Rad Floor Mounted System COLLIMATOR QC1 PROGENY MC150 MC150 PINNACLE LINEAR II LINEAR IV RALCO R 108 464 DHHS HUESTIS 150MC MANUAL CM 32211 QM1 DAP QD1 VacuDAP OEM DISPLAY ION CHAMBER VacuDAP ION CHAMBER ION CHAMBER 1 AID ICX 1153 IMAGE RC1 GRID CABINET R50 17GC RECEPTOR BUCKY CABINET PROGENY KLB10 08011 KLB10 08013 Q Rad DRX Series Integrated Radiography System The Q Rad DRX Series Integrated Digital Radiography DR System combines the Q Rad System s HF Series X ray Generator and Carestream DRX 1 Digital Imaging Systems by way of a common user interface QG DIG DRX Software running on the Carestream DRX 1 Digital Imaging System s Workstation computer When QG DIG DRX Software is implemented all user interaction except PREP and EXPOSE with the HF Series X ray Generator is accomplished via the Digital Imaging System s touchscreen computer thereby eliminating the need for a separate generator Operator Control Panel The Q Rad DRX Series I
20. Stored GENERATOR Energy COMPLIANCE QG 20 SE QG 32 SE LABEL QG 40 SE QG 50 SE Three phase QG 32 2 QG 32 3 QG 40 2 QG 40 3 QG 50 QG 50 2 QG 65 and QG 80 494 HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH 6 4 4 6 EHH HHH EHH HHO SD Revision F Q Rad System Operator s Manual z 2 12 Quantum Medical Imaging Table 2 4 Q Rad System Components Labeling Guide TechVision QG TV F Supplementary Gener QG TV IP F ABEL pum s ator Control Panel QG TV C QG TV IP C 2 ont 5 2 us SIDE VIEW FRONT VIEW LEFT Radiographic Table Fixed Non Float Tabletop QT 730 compliance label Radiographic Table Non Elevating Tabletop 740 N Elevating Tabletop ABEL QT 750 REAR VIEW Tube Support QS 500 Floor Mounted QS 550 9 COMPLIANCE LABEL LABEL 2 bl FREE STANDING TUBE STAND SIDE VIEW TUBE STAND QS 550 RIGHT QS 500 SHH SHH HHH HHH HHH HHH HHH HHH HHH 4 HHH HHH HHH HHH HHH HHH HHH 4 4 4 4 9 4 4 6 HHH HHH HHH HHH HHH Q Rad System Operator s Manual Revision F Quantum Medical Imaging 2 1
21. ables s us hes Se eee 2 6 Tube SUDDOMSs as kx ebsites boos ewe C3 E ees eee eee 2 6 Upright Cassette Holders 2 6 Heat ets uu Sass adem dad deen Came deed 2 7 ana ea 2 7 X Ray 2 7 CC 2 7 Tube 5 2 7 Upright Cassette Holders 2 7 Q Rad System Operator s Manual Revision F Quantum Medical Imaging iii System Operating 2 7 Transport and Non Operating Environment 2 7 System Configuration 2 8 Q Rad Floor Mounted System 2 8 Q Rad DRX Series Integrated Radiography System 2 9 Intended Use wa surani sdei dee bade 2 11 General Application Specification 2 11 Cleaning Preventive Inspection and Maintenance 2 11 Instructions for Disposal of Waste Equipment 2 11 zs sda d E v 9A Saws 2 12 Power 2 17 Detachable Parts and
22. al commercial or hospital environment If the user of the Q Rad Radiographic Sys tem requires continued opera tion during power mains interruptions it is recommended that the Q Rad Radiographic System be powered from an uninterruptible power supply or battery Power frequency 50 60 Hz IEC 61000 4 8 3 A m 3 A m NOTE Ur is the A C mains voltage prior to application of the test level Power frequency magnetic fields should be at levels char acteristic of a typical location in a typical commercial or hospital environment Guidance and manufacturer s declaration electromagnetic immunity The Q Rad Radiographic System is intended for use in the electromagnetic environment specified below The customer or the user of the Q Rad Radiographic System Q Rad Radiographic System should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance 4999999 Revision 1 10 Portable and mobile RF communications equipment should be used no closer to any part of the Q Rad Radiographic System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance
23. cation in which the Q Rad Radiographic System is used exceeds the applicable RF compliance level above the Q Rad Radiographic System should be observed to verify normal operation If abnor mal performance is observed additional measures may be necessary such as re orienting or relocat ing the Q Rad Radiographic System b Over the frequency range 150 kHz to 80 kHz field strengths should be less than 3 V m 4949994 9 Q Rad System Operator s Manual Revision F Quantum Medical Imaging 1 11 Recommended separation distances between portable and mobile RF communications equipment and the Q Rad Radiographic System The Q Rad Radiographic System is intended for use in an electromagnetic environment in which radi ated RF disturbances are controlled The customer or the user of the Q Rad Radiographic System Q Rad Radiographic System can help prevent electromagnetic interference by maintaining a minimum dis tance between portable and mobile RF communications equipment transmitters and the Q Rad Radio graphic System as recommended below according to the maximum output power of the communications equipment Rated maximum output power Separation distance according to frequency of transmitter of transmitter m di 150 kHz to 80 2 80 MHz to 800 MHz 800 MHz to
24. em including computed radiography CR receptors as well as conventional analog film cassettes Q Rad Floor Mounted System The Q Rad Floor Mounted system is configured around either a free standing floor mounted tube support Model 05 550 a wall ceiling mounted tube support Model 05 500 Because the free standing version does not require wall attachment for support it provides enhanced freedom of movement in the patient vicinity for the operator Recumbent examinations are accomplished utilizing an elevating Model QT 750 or the non elevating Model QT 740 and QT 730 radiologic tables Standing weight bearing examinations are performed using an upright non tilting Model QW 420 Series chest stand cassette holder The X ray generator is available in various power output and operator control panel types with the typical configuration including a 80 kW output generator with an Odyssey operator control Table 2 2 Q Rad Floor Mounted System GENERATOR QG1 SINGLE PHASE QG 25 1 QG 32 1 QG 40 1 STORED ENERGY QG 20 SE QG 32 SE QG 40 SE QG 50 SE THREE PHASE QG 32 2 QG 32 3 QG 40 2 QG 40 3 QG 50 3 QG 65 3 QG 80 3 GENERATOR 1 QUEST SERIES QG 200 QG 250 QG 320 CONTROL PANEL QG 400 QG 500 ODYSSEY SERIES QG 3200 QG 4000 QG 5000 QG 6500 QG 8000 Q VISION SERIES QGV 32 QGV 40 QGV 50 QGV 65 QGV 80 SUPPLEMENTAL OCP2 QG TV IP F GENERATOR CONTROL PANEL TECHVISION TABLE
25. hat it is used in such an environment CISPR 11 Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The Q Rad Radiographic System uses RF energy only for their internal functions Therefore the RF emis sions are very low and are not likely to cause any interference in nearby electronic equipment 000000 000 HHH OEE EEE HHH HOH HHH 9999 999 HHH 999 900955 Revision F 1 8 Q Rad System Operator s Manual Quantum Medical Imaging Guidance and manufacturer s declaration electromagnetic emissions RF emissions CISPR 11 Class A Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Class A Complies The Q Rad Radiographic System is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Guidance and manufacturer s declaration electromagnetic immunity The Q Rad Radiographic System is intended for use in the electromagnetic environment specified below The customer or the user of the Q Rad Radiographic System should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electros
26. in environmental contamination Therefore this equipment should not be disposed of as ordinary household waste but should instead be delivered to a designated electrical and electronic waste disposal or recycling center For further information on disposing of electrical and electronic waste contact the cognizant authority within the jurisdiction Electromagnetic Compatibility 60601 1 2 2007 60601 1 2 2007 The Q Rad Radiographic System is intended for use in the electromagnetic environment specified below As such Q Rad Radiographic System must be installed and put into service according to the information provided in the accompanying Service Manual Unauthorized changes to this product Do not make any modifications Portable and mobile RF communications equipment can affect medical electrical equipment It is therefore recommended that the operation of equipment of this type such as mobile telephones cordless microphones and other similar mobile radio equipment be restricted from the vicinity of this device Use of accessories transducers and cables other than those specified in the accompanying documents may result in increased emissions or decreased immunity of the equipment Guidance and manufacturer s declaration electromagnetic emissions The Q Rad Radiographic System is intended for use in the electromagnetic environment spec ified below The customer or the user of the Q Rad Radiographic System should assure t
27. iographic Table QT 750 DC30 006 DC30 007 Elevating Tabletop Radiographic Table QT 740 DC30 006 DC30 007 Non Elevating Table top Radiographic Table QT 730 DC30 003 DC30 003 Non Elevating Table top Tube Support Floor QS 500 DC30 034 DC30 005 Wall Mounted Tube Support Free QS 550 DC30 034 DC30 009 Standing Floor Mounted SHH 040 HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HEHEHE HHH 6 6 4 HEHEHE 4 4 6 HEHEHE 6 6 HHH EHH 9 9 ee Revision Q Rad System Operator s Manual 2 4 Quantum Medical Imaging Table 2 1 Q Rad System Components User Service Documents 7252 7254 E7869X Varian RAD 14 RAD 60 RAD 92 Dunlee DA 1092 DA 1036 Radiographic Upright QW 420 QW 420 S QW DC30 039 DC30 040 Cassette Holder 420 D QW 400 Collimator Manual Progeny MC150 00 02 1078 00 02 1078 Huestis 150 CM 21 001 CM 21 001 Ralco R108 MTR108 MTR108 Collimator Automatic Progeny Linear II 00 02 1559 00 02 1559 Progeny Linear IV 00 02 1517 00 02 1517 Collimator Program Huestis 32211 CM 21 002 CM 21 002 mable X ray tube Toshiba E7239X 7242 Refer to data sheet pro Refer to data sheet vided with tube provided with tube DX D 500 Q Rad Digital DRX Series Integration Software QG DIG DRX Optional QG DIG DRX DC30 123 DC30 123 Dose Area Product DAP meter Optio
28. nal Vacutec VacuDAP OEM DAP std fl tw_BA011 3 doc DAP std fl tw_BA011 3 doc 4449 HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH 4 4 4 HHH HEHE 4 9 HHH EHH HHH EHH HEHEHE HHH HOD 4944994 Q Rad System Operator s Manual Quantum Medical Imaging Revision F 2 5 Component Weights Generators Cabinet Single Phase non Stored Energy SE units 32 40 and 50 kW SE units Three Phase units Generators Control Panel Odyssey without pedestal Odyssey with pedestal Quest without pedestal Quest with pedestal Q Vision TechVision Option Tables Model QT 730 Model QT 740 Model QT 750 Tube Supports Model QS 550 Model QS 500 Upright Cassette Holders Model QW 420 Model QW 420 S Model QW 420 D Model QW 400 135 2 kg 298 0 Ib 195 5 kg 431 0 Ib 172 4 kg 380 0 Ib without internal High Speed Starter HSS 176 0 kg 388 0 Ib with internal High Speed Starter HSS 2 3 kg 5 0 Ib 11 3 kg 25 0 Ib 1 8 kg 4 0 Ib 10 9 kg 24 0 Ib 5 9 kg 13 0 Ib 4 3 kg 9 5 Ib 79 4 kg 175 0 Ib 158 8 kg 350 0 Ib 226 8 kg 500 0 Ib 272 2 kg 600 0 Ib 230 4 kg 508 0 Ib 102 1 kg 225 0 Ib 102 1 kg 225 0 Ib 90 7 kg 200 0 Ib 45 4 kg 100 0 Ib 000000000 02 00
29. ntegrated System consists of either a fixed DR Detector and or a Portable DR Detector and a Workstation Computer The DR System is connected to the Quantum X Ray Generator by way of a software interface module Table 2 3 Q Rad System DRX Series Integration GENERATOR QG1 SINGLE PHASE QG 32 1 QG 40 1 STORED ENERGY QG 32 SE QG 40 SE QG 50 SE THREE PHASE QG 32 2 QG 32 3 QG 40 2 QG 40 3 QG 50 3 QG 65 3 QG 80 3 GENERATOR CON 1 WITH DRX 1 WORKSTATION TROL PANEL QG DIG DRX SUPPLEMENTAL OCP2 QG TV IP C QG TV IP F GENERATOR CON TROL PANEL TECH VISION TABLE QT1 QT 730 QT 740 QT 750 00000000 000 000 HEHE EEE HHH HEHEHE FED EEE HEHEHE EEE EEE HEHEHE HEE EEE HEE Q Rad System Operator s Manual Quantum Medical Imaging Table 2 3 Q Rad System DRX Series Integration TUBE SUPPORT 051 FLOOR MOUNTED QS 500 QS 550 WALL STAND QW1 QW 420 QW 420 D QW 420 S X RAY TUBE TU1 TOSHIBA E7239X E7242X E7252X E7254X E7869X VARIAN RAD 14 RAD 60 RAD 92 DUNLEE DA 1092 DA 1036 COLLIMATOR QC1 PROGENY MC150 MC150 PINNACLE LINEAR II LINEAR IV RALCO R 108 464 DHHS HUESTIS 150MC MANUAL 32211 PROGRAMMABLE DAP QD1 VacuDAP OEM DISPLAY ION CHAMBER VacuDAP ION CHAMBER ION CHAMBER 1 AID 1153 RC1 FIXED DETECTOR Q FDR WALL STAND DETECTOR CABINET Q FDR T
30. ration of the equipment must be thoroughly familiar and comply completely with the currently established safe exposure factors and procedures described in publications such as Subchapter J of Title 21 of the Code of Federal Regulations Diagnostic X Ray Systems and Their Major Components and NCRP Report No 102 Medical X Ray Electron Beam and Gamma Ray Protection for Energies Up to 50 MeV Equipment Design and Use as revised or replaced in the future This equipment must only be used in rooms that comply with all applicable laws or regulations that have the force of law concerning electrical safety for this type of equipment Scheduled maintenance is essential to the assurance of continued integrity of this equipment with respect to regulatory compliance The continuance of certified performance to the regulatory standard is incumbent upon the user s diligent conformance to recommended maintenance instructions 444 HHH HHH HHH HHH 4 4 HHH HHH 4 4 4 HHH FHF 4 HHH 0 HHH HEHEHE 4 6 4 Q Rad System Operator s Manual Revision F Quantum Medical Imaging 1 5 Complies with EC Directive 93 42 EEC for Medical Devices FDA Center for Devices and Radiological Health CDRH Title 21 CFR Subchapter J EU Authorized Representative Carestream Health France 1 rue Galil e 93192 NOISY LE GRAND CEDEX France Classification This product has been classified as Class I Type B This equipment is not suitable
31. tatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood con crete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or IEC 61000 4 4 1 kV for input output 1 kV for input output hospital environment lines lines Surge 1 kV differential mode 1 kV differential mode Mains power quality should be IEC 61000 4 5 2 kV common mode 2 kV common mode that of a typical commercial or hospital environment 49 HHH 4 HHH HHH HHH HHH HHH HHH HHH HHH 6 HEHEHE HEHEHE HEHEHE 6 6 9 4 60 Q Rad System Operator s Manual Quantum Medical Imaging Revision F 1 9 Guidance and manufacturer s declaration electromagnetic immunity Voltage dips short interruption and voltage variations on power supply input lines IEC 60601 4 11 lt 5 Ur gt 95 dip for 0 5 cycle 40 60 96 dip in for 5 cycles 70 30 dip in lt 5 Ur gt 95 dip in for 5 s lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 60 dip in for 5 cycles 70 30 dip in lt 5 Ur gt 95 dip in for5s Mains power quality should be that of a typic
32. temperature to levels where the operator or patient could suffer burns Avoid contact with the tube housing A WARNING Changes additions or maintenance to the equipment carried out by per sons without appropriate qualifications and training and or using unap proved spare parts may lead to serious risk of injury and damage to the equipment as well as making the warranty void Regulatory Compliance This certified Quantum Medical Imaging LLC medical device has been designed manufactured and calibrated to comply with governing Federal Regulations 21 CFR Subchapter J and the performance standards attendant thereto Upon installation all certified products require the filing of Form FD 2579 Report of Assembly of a Diagnostic X ray System by the assembler i e the installer with the appropriate agencies the Installation Quality Assurance Checklist must also be completed and properly distributed upon installation A copy of each form pink copy is provided to the user The installation report is completed by the installer and returned to Quantum Medical Imaging LLC Those responsible for the planning of x ray equipment installations must be thoroughly familiar and comply completely with NCRP Report No 49 Structural Shielding Design and Evaluation for Medical Use of X Rays and Gamma Rays of Energies up to 10 MeV as revised or replaced in the future Those authorized to operate test participate in or supervise the ope
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