Chapter 1 Safety Notices
Contents
1. HEH HEHEHE HHH EH FEF HHH EEE HHH EH HHH EHH HEE HHH HEH EOE HHH EHH HHH HHH OHH HHH OHH HHH OHH HOH HHH 4 HHH OOO HHH OOD X ray Tube Stand Operator s Manual Revision F Quantum Medical Imaging 1 5 SSIF MEDICAL ELECTRICAL EQUIPMENT a le WITH RESPECT TO ELECTRIC SHOCK FIRE MECHANICAL HAZARDS ONLY IN ACCORDANCE C UL yg WITH UL 60601 1 AND CAN CSA C22 2 NO 601 1 9 98UA The following symbols may be used for marking on this equipment or equipment documentation Earth ground Type B Equipment Protective Earth ground Enable Longitudinal Tube amp Q gt Motion A 4 Enable Tube Angulation Enable Vertical Tube Q Motion 9 Motion A Enable Tube Motion in All y Enable Transverse Tube Q Directions Motion Enable Rotation of Vertical Column Motion Non ionizing radiation Enable Auto Stop Function lt Q 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 and strictly observe all warnings cautions and safety markings on the equip ment Users include those persons who2. 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 TOOTH HEHEHE EHH HHH EHH HEF HEH HHH EHH HEH HEHEHE EHH EHH HHH EOE HEH EEE HEH 444 X ray Tube Stand Operator s Manual Quantum Medical Imaging NOTE This device is designed to support the loads imposed by the specific X ray Tube and Collimator combinations referenced in Service Manuals DC30 005 and DC30 009 The application of components not shown therein is not authorized REGULATORY COMPLIANCE The Floor to Ceiling Tubestand Model QS 500 or Free Standing Tubestand Model TQS 550 hereinafter referred to as the Tubestand is not a CDRH certifiable product However the Tubestand must be compatible and operate in conjunction with other components in the X ray System so that the X ray System performs in compliance with H E W Performance Standards This product has been factory tested to assure its required performance in an X ray System Those responsible for the planning of x ray equipment installations must be thor oughly 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 par t
3. 3 USER MAINTENANCE 442 2 21 44 441 4 nennen nennen nnne nnn 4 3 P ak 4 3 X ray Tube Stand Operator s Manual Revision F Quantum Medical Imaging rer Revision F iv CHAPTER 5 WARRANTY INFORMATION WARRANTY STATEMENT WARRANTY EXCLUSIONS BUYER S REMEDIES WARRANTY RETURN PROCEDURE EQUIPMENT IN TRANSIT VOIDING WARRANTY 00000 0000000066 X ray Tube Stand Operator s Manual Quantum Medical Imaging Chapter SAFETY NOTICES 9 9 999999999999999 99 999 999 99999999999999999 999 999 999 999 9999999 99999 9 9 1 1 GENERAL SAFETY INFORMATION Quantum products are designed to meet stringent safety standards All medical elec trical 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 precau tions must be observed at all times WARNINGS CAUTIONS NOTES The following samples show how warnings cautions and notes appear in this docu ment The text explain
4. 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 A X RAY PROTECTION X rays are hazardous to both patient and operator unless established safe exposure factors and operating instructions are observed Only 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 I nternational Commission on Radiological Protection www icrp org and take adequate steps to protect against injury A WARNI NG X ray equipment may cause injury if used improperly The instructions con
5. the factory in accordance with QMI s Returned Materials Procedure refer to Dealer Price Book or contact QMI customer service WARRANTY EXCLUSIONS The foregoing warranties are exclusive and in lieu of all other warranties whether written oral express implied or statutory NO IMPLIED WARRANTY OF MERCHANT ABILITY OR FITNESS FOR PARTICULAR PURPOSE SHALL APPLY Quantum Medical Imaging QMI Warranty is exclusive of 1 Failure of Buyer Dealer to prepare the site or provide power requirements or operating environmental conditions in compliance with any applicable instructions or recommendations of QMI 2 Failure of Buyer Dealer to provide the proper incoming power required to support the equipment in accordance with the recommendation of QMI 3 Any modification of product performed by a party other than QMI 4 Combining products deemed by QMI to be incompatible 5 Improper or extraordinary use of the Product improper maintenance of the Prod uct or failure to comply with any applicable instructions or recommendations of Quantum Medical Imaging 6 Misuse tampering or negligent storage handling of the Product by Buyer its employees agents or contractors 7 Fuses glassware high voltage cables and other items deemed by QMI to be expendable 8 Acts of God acts of civil or military authority fires floods power failure or electri Cal power surges strikes or other labor disturbances war riots or other causes beyond the reaso
6. 601 1 Medical electrical equipment Part 1 General requirements for safety IEC 60601 1 2 2007 ENVIRONMENTAL PROTECTION This equipment contains certain materials and chemical compounds incidental to the manufacture of electrical and electronic equipment and improper end of life dis posal of such equipment can result 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 cen ter For further information on disposing of electrical and electronic waste contact the cognizant authority within the jurisdiction OO Oooo 4 0000040000 HEHEHE 1 HEHEHE HOE HEHEHE HEH OOH 200020 OOH HOF OHH HEF HHH EHH HHH EHH HHH HHH HOE X ray Tube Stand Operator s Manual Revision F Quantum Medical Imaging 1 7 ELECTROMAGNETIC COMPATIBILITY EN 60601 1 2 2007 60601 1 2 2007 The tubestand is intended for use in the electromagnetic environment specified below As such it must be installed and put into service according to the information provided in the accompanying Service Manual 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 m
7. Carestream D MEI n Model 05 500 Division of Carestream Floor to Ceiling Wall Tubestand Model QS 550 Free Standing Tubestand OPERATOR MANUAL 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 QMI Copyright 2012 QMI Quantum Medical Imaging Division of Carestream Made in U S A 2002 B Orville Drive North Ronkonkoma New York 11779 USA Phone 631 567 5800 Fax 631 567 5074 E mail info qmiteam com www quantummedical net 0473 REVISION DATE TYPE OF MODIFICATION A 2004 03 01 Initial Release Incorporated ECOs 1717 1719 and1721 Combined Models QS 500 and QS 550 B 2007 03 23 Incorporated ECO 1811 C 2010 10 09 Incorporated ECO 2199 D 2010 09 17 Safety Notices enhancements E 2012 01 17 Added EU Representative F 2012 05 04 IEC 60601 1 2005 i thru iv 1 1 thru 1 12 2 1 thru 2 8 3 1 thru 3 10 4 1 thru 4 4 5 1 thru 5 6 n m n Tl X ray Tube Stand Operator s Manual Quantum Medical Imaging Revision F THIS PAGE INTENTIONALLY LEFT BLANK 49 9494909444999 2004 HEE EHH HEF HHH HEH HEHE or rr rra Revision F X ray Tube Stand Operator s Manual ii Quantum Medical Imaging CHAPTER 1 SAFETY NOT
8. I CES GENERAL SAFETY INFORMATION 1 3 WARNINGS CAUTIONS NOTES I 1 3 REGULATORY COMPLIANCE nen 1 5 CLASSIFICATION e m 1 5 COMPATIBILITY ua uu E 1 6 INTENDED OPERATOR u a 1 6 peu cae mL 1 6 ACCOMPANYING DOCUMENTATION eeennnmmH 1 7 APPLICABLE STANDARDS 4 1202 2 444 41 4 nnn nnn nnn nnn nn 1 7 ENVIRONMENTAL PROTECTION eene 1 7 ELECTROMAGNETIC COMPATIBILITY EN 60601 1 2 2007 IEC 60601 1 2 2007 1 8 ABBREVIATION 4 2 422 1 1 6 nnn nnn nnn 1 12 CHAPTER 2 GENERAL I NFORMATI ON OVERVIEW ai e 2 3 KEY EEAT qe 2 3 INTENDED USE usa ana en 2 4 COMPATABILITY STATEMENT 2 4 MAIN COMPONENTS MODEL QS 500 2 5 LABELING MODEL QS 500 nennen nennen ennnn nennen 2 6 MAIN COMPONENTS MODEL QS 550 2 7 LABELING MODEL QS 550 4 2 8 CHAPTER 3 OPERATI ON OVERVIEW z E 3 3 MANUAL MOTIONS AND DETENTS MODEL QS 500 3 3 MANUAL MOTIONS AND DETENTS MODEL QS 550 3 4 HANDGRIP CONTROLS AND INDICATORS 3 5 CHAPTER 4 USER MAI NTENANCE OVERVIEW 4
9. The purchaser dealer customer is fully responsi ble for the filing of freight damage claims to the freight carrier Quantum Medical Imaging is not responsible for any loss or damage to products once they have been shipped from our factory The dealer or customer is responsible for full payment to Quantum Medical Imaging for all invoices as per our standard pay ment terms regardless of freight damage or processing of an insurance claim by the dealer or customer 000006 Revision F 5 5 VOIDING WARRANTY Any installation maintenance repair service relocation or alteration to or of or any other tampering with the product performed by any person or entity other than Quantum Medical Imaging or a certified Quantum Medical Imaging dealer without the written approval of an authorized person at Quantum Medical Imaging shall immedi ately void and cancel all warranties with respect to the affected product AAA AAA 4 EHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH EHH HHH EHH HEE HOH v Revision F X ray Tube Stand Operator s Manual 5 6 Quantum Medical Imaging
10. V m 3 V m 61000 4 3 80 MHz to 2 5 GHz d L2NP 80 MHz to 800 MHz 4 23VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation dis tance 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 Revision F 1 10 HHH 0660906600066 X ray Tube Stand Operator s Manual Quantum Medical Imaging Guidance and manufacturer s declaration electromagnetic immunity 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 telephones 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 location in which the Tubestand is used exceeds the applicable RF complia
11. 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 ABBREVIATION DEFINITION The following abbreviations and acronyms may be found in this document Their definition is explained below cm Centimeters CCW Counterclockwise CW Clockwise in Inches GHz Gigahertz mm Millimeters MHz Megahertz SAE Society of Automotive Engineers SID Source to image distance W Watts Revision F X ray Tube Stand Operator s Manual 1 12 Quantum Medical Imaging Chapter 2 GENERAL INFORMATION 9 9 999999999999999999999 999999999 9999999 99999 999 99999 999 999 9999 99 9 99 2 2 OVERVIEW NOTE The user should read this manual in its entirety prior to using this equip ment It should be kept in a location near the equipment and be readily accessible to those who operate it This document is intended to assist users in the safe and effective operation of the equipment described herein Pay special attention to all the information described
12. able top in either metric or SAE units 13 QS 500 Indicator SID at 100 cm or 40 in and 180 cm or 72 in QS 550 Label markers Indicates SID is at 100 cm or 40 in wall stand or table receptor or at 180 cm or 72 in wall stand receptor only 14 QS 550 Indicator Trunnion Rotation Scale Indicates rotation angle Label of tube when system is equipped with optional trunnion mounted x ray tube SID INDICATORS Figure 3 7 Model QS 500 Tubestand Controls and Indicators Ceiling Track Floor Track X ray Tube Stand Operator s Manual Revision F Quantum Medical Imaging 3 9 SID INDICATORS LI 72 40 Figure 3 8 Model 05 550 Tubestand Controls and Indicators Vertical Column Floor Track Figure 3 9 Model QS 550 Tubestand Controls and Indicators Trunnion Assembly vo 000066 HARE HHH 4944994944999 99 t v Revision F X ray Tube Stand Operator s Manual 3 10 Quantum Medical Imaging Chapter 4 USER MAINTENANCE 9 9 999999999999999999999 9999999 999 9999999 99999 999 99999 999 999 999 999 9 999 OVERVIEW This chapter is designed to assist the system user in maintaining the smooth opera tion of the Tubestand This product has been factory tested to assure its required per formance in an X ray System The user is responsible for per
13. 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 require ments 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 9 9 999 89 9999 999989999 89999989999 9 6666 HOH HHH HHH rra hit III III Revision F X ray Tube Stand Operator s Manual 1 6 Quantum Medical Imaging ACCOMPANYING DOCUMENTATION The documentation consists of a User manual this document and related docu mentation Tube Stand Model QS 500 Service Manual P N DC30 005 or Tube Stand Model QS 550 Service Manual P N DC30 009 Contains technical and service documentation for this product including installation and configuration instructions to be performed by qualified persons The documentation shall be kept with the system for easy reference APPLICABLE STANDARDS This equipment complies with the following regulatory standards EN 60601 1 1990 A1 1993 A2 1995 A13 1996 IEC 60601 2 32 1994 CAN CSA C22 2 No 601 1 M90 2005 Medical Electrical Equipment part 1 General Requirements for Safety UL 60601 1 1st Edition 2006 04 26 Medical Electrical Equipment part 1 General Requirements for Safety IEC 60
14. al 2 4 Quantum Medical Imaging MAIN COMPONENTS MODEL QS 500 See Figure 2 1 The Model QS 500 Tubestand contains 1 X Ray Tube Handgrips Collimator Floor Track Base Assembly QS 50R option permits 90 Vertical Column Rotation Serialization Label Vertical Column Transverse Arm Vertical Trolley Wall Ceiling Track AN N 000000000 00000066 X ray Tube Stand Operator s Manual Revision F Quantum Medical Imaging 2 5 LABELING MODEL QS 500 Figure 2 2 below shows the locations of the serial and regulatory labels on the Model QS 500 Tubestand Power 05 500 5500 018 0012_ Date Manfaduedby Quantum Medical Imaging LLC 2002 Orville Drive North A Ronkonkoma NY 11779 USA TUBESTAND SERIAL LABEL LA20 008 REV L jenen gt Sen QS 500 outline drawing wmf cdr Figure 2 2 Floor to Ceiling Wall Model QS 500 Series Label Locations THEE HOE HHH AA RARA RARE 4 HOH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HEH 994449994 HHH EHH HHH HOH HOOD Revision F X ray Tube Stand Operator s Manual 2 6 Quantum Medical Imaging MAIN COMPONENTS MODEL QS 550 See Figure 2 3 The Model QS 550 tubestand contains 1 X Ray Tube Handgrips Collimator Floor Track Base Assembly Serialization Label Vertical Column N O Ui BW N Transverse Arm V
15. asonable care Manufacturer s equipment recommenda tions described in this manual must be observed MANUAL MOTIONS AND DETENTS MODEL 06 500 The Floor to Ceiling Tubestand Model QS 500 provides three standard man ual motions four when equipped with QS 50R option see Figure 3 1 Figure 3 1 Model QS 500 Tubestand Motions 1 Longitudinal left right travel of the Vertical Column is 102 cm 40 in and 183 cm 72 in and is marked by SID position detents and indicators 2 Vertical travel of the Transverse Arm is 102 cm 40 in marked by SID position detent and indicator 3 Angulation of the X Ray Tube Collimator mechanical detents at 0 90 CW and 90 CCW 4 Requires QS 50R Option Rotation of the Vertical Column detents at 0 90 clockwise and 90 counterclockwise X ray Tube Stand Operator s Manual Revision F Quantum Medical Imaging 3 3 MANUAL MOTIONS AND DETENTS MODEL 06 550 The Free Standing Tubestand Model QS 550 provides six manual motions with mechanical detents for each motion to aid in equipment positioning see Figure 3 2 FRONT VIEW SIDE VIEW Figure 3 2 Model QS 550 Tubestand Motions 1 Rotation of the Vertical Column detents at 0 90 clockwise and 90 counterclockwise 2 Angulation of the X Ray Tube Collimator detents at 0 90 clockwise and 90 counterclockwise Vertical travel of Transverse Arm is 102 cm 40 in with SID position detent 4 Lon
16. d with TechVision Handgrip option TechVision replaces the standard equipment hand grips to provide Tubestand position controls and indicators and serves as a Generator Remote Control Panel Refer to the TechVision Remote Control Panel Service and Operator s Manuals for complete installation and operation instructions This product is intended to be used and operated only in accordance with the safety procedures given within this manual for the purpose for which it was designed The intended use is given below Nothing stated in this manual reduces user s professional responsibilities for sound judgment and best prac tice INTENDED USE The Tubestand is intended for use as a support structure used to position a diagnostic x ray tube housing assembly for a medical radiographic procedure Use of the equipment for purposes other than those intended and expressly stated by the manufacturer as well as incorrect use or operation may relieve the manufacturer or his agent from all or some of the responsibility for resul tant non compliance damage or injury COMPATABILITY STATEMENT The Quantum Medical Imaging Tubestand is compatible with Quantum Medi cal Imaging manufactured tables and high voltage x ray generators and with other manufacturer s equipment having equivalent means for indication of SID and perpendicularity NOTE Electrical Ratings can be found in the Tubestand Service Manual Revision F X ray Tube Stand Operator s Manu
17. e of the product to meet any warranty whether the claim is on contract warranty Tort including negligence and strict liabil ity or otherwise and however instituted And upon the expiration of the applicable warranty period all such liability shall terminate In no event shall Quantum Medical Imaging be liable for special or consequential damages arising out of the use or ability to use its equipment whatsoever The warranties and remedies available to the buyer are conditioned upon all claims under this warranty being made in accordance with the aforementioned warranty statement WARRANTY RETURN PROCEDURE A fully completed Field Returned Material Evaluation Form must be returned with any defective product or any returned item All returns must have the Serial Number of the Equipment and or the Specific Part written on the Field Returned Material Evalu ation Form All freight charges resulting from Warranty Returns are the responsibility of the Buyer or Dealer EQUIPMENT IN TRANSIT QMI cannot assume responsibility for any equipment damaged in transit To protect the buyer dealer the receiver of any equipment should examine all cartons and crates carefully at time of delivery If damage is apparent make a notation on the delivery receipt request an inspection by the freight carrier and if applicable file appropriate carrier claim Should concealed damage be detected immediately notify the freight carrier and request an inspection
18. electromagnetic immunity Tubestand is intended for use the electromagnetic environment specified below The customer or the user of the Tubestand should assure that it is used in such an environment discharge ESD IEC 61000 4 2 8 kV air 8 kV air Immunity test IEC 60601 Compliance Electromagnetic environ test level level ment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are cov ered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruption and voltage variations on power supply input lines IEC 60601 4 11 lt 5 Ur gt 95 dip in Uy for 0 5 cycle 40 U 60 dip in Uy for 5 cycles 70 30 dip in Uy lt 5 Ur gt 95 dip in Uy for5s lt 5 Ur gt 95 dip in Uy for 0 5 cycle 40 Ur 60 dip in Uy for 5 cycles 70 Ur 30 dip in Ur lt 5 Ur gt 95 dip in Uy
19. ertical Trolley Figure 2 3 Free Standing Deluxe Tubestand Model QS 550 X ray Tube Stand Operator s Manual Revision F Quantum Medical Imaging 2 7 LABELING MODEL QS 550 Figure 2 4 below shows the locations of the serial and regulatory labels on the Model QS 550 Tubestand REGULATORY MARKINGS LABEL REFER TO CHAPTER 1 FOR MEANING OF SYMBOLS oils A MEDICAL ELEC TEIC AL EQUIPMENT UL 2601 1 CANESA 222 NO 60 1 1 IEC 60601232 sun C 0473 La20 110 REV B Power E24 voc 5 Sariai No Date Manufactured by Quantum Medical Imaging LLC 2002 Orville Drive North Ronkonkoma 11779 USA TUBESTAND SERIAL LABEL LA20 006 REV B 05 550 outline drawing cdr Figure 2 4 Free Standing Tubestand Model QS 550 Label Locations HOE HHH HEE FEE HEH HEH HHH HEH HEF HHH HEH HHH HHH HEH HOH HHH EHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH 994449994 HHH HEE HOH HOOD Revision F X ray Tube Stand Operator s Manual 2 8 Quantum Medical Imaging Chapter OPERATION 9 9 999999999999999999999 999999999 9999999 99999 999 99999 999 999 999 99 99 9 9 99 OVERVIEW This chapter explains howto operate Tubestand Models QS 500 and QS 550 Refer to Table 3 1 for descriptions and functions of the controls and indicators WARNING All movable assemblies and parts of this equipment must be operated with re
20. for 5 5 Mains power quality should that of a typical commercial or hospital environment If the user of the Tubestand requires continued operation during power mains interruptions it is recommended that the Tubes tand be powered from an unin terruptible power supply or battery Power frequency 50 60 Hz IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environ ment NOTE Ur is the A C mains voltage prior to application of the test level q 0440 0440 4044000010 X ray Tube Stand Operator s Manual Quantum Medical Imaging Revision F 1 9 Guidance and manufacturer s declaration electromagnetic immunity The Tubestand is intended for use the electromagnetic environment specified below The customer or the user of the Tubestand should assure that t is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment guid test level level ance Portable and mobile RF communications equipment should be used no closer to any part of the Tubestand including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms IEC 61000 4 6 150 kHz to 80MHz d 1 2VP Radiated RF 3
21. forming routine maintenance and inspection procedures to ensure proper equipment operation Aside from routine maintenance any abnormal noise vibration or unusual performance should be investigated by a qualified service representative Preventive maintenance or any repair service should be performed only by qualified service personnel WARNING Failure to follow manufacturer s or service personnel s recommendations may result in serious injury WARNING Only qualified and authorized persons shall work on this equipment In this context qualified means those legally permitted to work on the equipment and authorized means those specifically authorized by local management the equipment carried out by persons without appropriate qualifications and training and or using un approved spare parts may lead to serious risk of injury and damage to the equipment as well as making the warranty void WARNING Changes additions or maintenance to USER MAINTENANCE User maintenance consists of the following activities which should be performed on a daily basis e Visually inspect the Tubestand for wear and cleanliness e Clean the exterior painted surfaces of the Tubestand Cleaning The system user is responsible for the basic cleanliness of the equipment Painted metal surfaces should be cleaned using a clean cloth slightly moist ened in warm soapy water use mild soap Wipe with a clean wet cloth then dry Never use abrasive polish o
22. gitudinal left right travel of the vertical column 102 cm 40 in and 183 cm 72 in with SID position detents 5 Transverse cross table travel of the Tube Arm 5 in to 5 in relative to center position 6 Rotation of the tube collimator 40 20 vr AAA OOD 44 2204440442 HOH HEF HHH RR Revision F X ray Tube Stand Operator s Manual 3 4 Quantum Medical Imaging HANDGRIP CONTROLS AND INDICATORS The Tubestand is equipped with a Handgrip Control Module which provides the oper ator with the ability to easily move the Tubestand throughout its longitudinal vertical and transverse operating envelope The Handgrip also controls X ray Tube angulation positioning 90 CW and 90 CCW and Vertical Column rotation 90 on models equipped with the QS 50R option as shown in Figure 3 5 As shown in Figures 3 3 through 3 6 the Handgrip display features clearly marked push buttons using standard symbology and indicators which are described in Table 3 1 Figures 3 7 and 3 8 show the locations of the other SID indicators Figure 3 3 Model QS 500 Handgrips Controls and Indicators Standard Configuration X ray Tube Stand Operator s Manual Revision F Quantum Medical Imaging 3 5 M lantum IMAGING TRANSVERSE Figure 3 4 Model QS 500 Handgrips Controls and I
23. icipate in or supervise the operation of the equipment must be thoroughly familiar and comply completely with the currently established safe exposure factors and pro cedures described in publications such as Subchapter J of Title 21 of the Code of Fed eral Regulations Diagnostic X Ray Systems and Their Major Components and NCRP Report No 102 Medical X Ray Electron Beam and Gamma Ray Protection for Ener gies 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 perfor mance to the regulatory standard is incumbent upon the user s diligent conformance to recommended maintenance instructions Complies with EC Directive 93 42 EEC for Medical Devices Carestream Health France 1 rue Galil e 93192 NOISY LE GRAND CEDEX France CLASSIFICATION This product has been classified as Class I Type B by Underwriters Laboratories Inc Equipment not suitable for use in the presence of a flammable anesthetic mixture of air with oxygen or with nitrous oxide Protection against Harmful Ingress of Water Ordinary enclosed equipment without protection against ingress of liquids TERA
24. in the Safety section refer to Chapter 1 SAFETY NOTICES This manual is written for trained users of the Floor to Ceiling Tubestand Model QS 500 and Free Standing Tubestand Model QS 550 hereinafter referred to as the Tubestand and for authorized field service personnel Quantum Medical Imaging LLC assumes no liability for use of this document if any unauthorized changes to the content or format have been made KEY FEATURES It is imperative that all safety procedures described in this manual be strictly adhered to in order to ensure the safety of both patient and user The key features of the Model QS 500 and QS 550 Tubestand are as follows PEE 240022 200 02420 0020 00 OOH 000 HOH OOH OOD Vertical travel 1537 mm 60 5 in longitudinal travel 2438 4 mm 96 0 in using a 10 ft floor track Fail safe Electromagnetic Lock for vertical Tubestand motion Electromagnetic Locks for longitudinal and angulation Tubestand motions 40 in and 72 in SID indicators metric equivalents available on Handgrips and Vertical Column 40 in and Floor Track 72 in Tube Collimator positioning Handgrips provide Lock Release Buttons for quick Tube positioning As low as 330 2 mm 13 in focal spot to floor distance Model QS 500 Tubestands equipped with QS 50R option permits 90 Vertical Column Rotation X ray Tube Stand Operator s Manual Revision F Quantum Medical Imaging 2 3 e Models QS 500 and QS 550 Tubestands equippe
25. n this equipment Use only alcohol based liq uid disinfectants WARNING Always disconnect the equipment from the main power supply prior to any cleaning X ray Tube Stand Operator s Manual Revision F Quantum Medical Imaging 4 3 THIS PAGE INTENTIONALLY LEFT BLANK AAA AAA ARA RR ERRE EXE HOH HHH EHH HHH HHH HHH HHH HHH HHH HHH HHH EHH ttt HHH HHH HHH HHH HHH EHH HHH EHH HHH HOH HOOD Revision F X ray Tube Stand Operator s Manual 4 4 Quantum Medical Imaging Chapter 5 WARRANTY INFORMATION 9 9 99999999999999999999999999999 9999999 99999 999 99999 999 99999 99 99 9 9 99 WARRANTY STATEMENT Quantum Medical Imaging herein known as warrants to buyer that any new product manufactured by QMI will be free from defects in material and manufacturing and conform substantially to applicable specifications in effect on the date of ship ment when subjected to normal proper and intended usage by properly trained per sonnel QMI will act as the sole judge in determining whether equipment or part is defective by reason of manufacture All QMI products shall be warranted for a period of 12 months from the original instal lation the date of which will be determined by a completed returned warranty card which must be returned to QMI headquarters within 30 days of system installation In no case shall the warranty exceed 15 months from the date of shipment If the warranty card is not returned
26. nable control of Quantum Medical Imaging 9 Installation troubleshooting or repair service are not included in this warranty Technical service and maintenance is the responsibility of the dealer selling the equipment 10 The Manufacturer is relieved of any responsibility for damage during shipment after the freight carrier picks up and begins transport of the unit for delivery 9 99 9999 99999 89989 98899999 99999 99899 9989 9 9989 999889 9888 998 988 4444494444904 EHH rr Revision F X ray Tube Stand Operator s Manual 5 4 Quantum Medical Imaging X ray Tube Stand Operator s Manual Quantum Medical Imaging BUYER S REMEDIES If Quantum Medical Imaging determines that any Product fails to meet any warranty during the applicable warranty periods Quantum Medical Imaging shall correct any such failure as follows A By repairing adjusting or replacing any defective or non conforming Parts or Products B By making available any necessary repaired or replacement parts or assemblies Quantum Medical Imaging shall have the option to furnish either new or exchange replacement parts or assemblies All returned parts shall become the property of Quantum Medical Imaging if said parts have been determined by QMI to be defective by reason of manufacture The preceding Paragraphs set forth Buyer s Remedies and Quantum Medical Imag ing s sole liability for claims based upon failur
27. nce level above the Tubestands including Tech Vision option should be observed to verify normal operation If abnormal performance is observed addi tional measures may be necessary such as re orienting or relocating the Tubestand b Over the frequency range 150 kHz to 80 kHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the Tubestand including TechVision option The Tubestand is intended for use in an electromagnetic environment which radiated RF disturbances are controlled The customer or the user of the Libestand can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment trans mitters and the Tubestand as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 12 P d 12 P d 234P 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 X ray Tube Stand Operator s Manual B Revision F Quantum Medical Imaging 1 11 Recommended separation distances between portable and mobile RF communications equipment and the Tubestand including TechVision option For transmitters rated at
28. ndicators With QS 55V Transverse Option THIS BUTTON NOT OPERATIONAL Quantum UNITS WITH QS 50R OPTION TRANSVERSE ROTATIONAL LONGITUDINAL ALL LOCKS 40 100 cm Figure 3 5 Model 05 500 Handgrips Controls and Indicators Only used with QS 50R option 9 89 98 9 898999 EH HHH EHH HHH HHH HHH HHH HOH HHH HHH HHH HHH HHH HHH HHH HHH EHH HHH HHH ng Revision F X ray Tube Stand Operator s Manual 3 6 Quantum Medical Imaging LONGITUDINAL Figure 3 6 Controls and Indicators Model QS 550 Handgrips 9 906999906909990909099990909999009999009999099999090999909099900099090099990909990909990009990009909099990999900990900 09909000999909099909999009 X ray Tube Stand Operator s Manual Revision F Quantum Medical Imaging 3 7 Table 3 1 Tubestand Controls and Indicators 1 QS 500 Push button Longitudinal Lock Release Releases magnetic QS 550 Control lock to allow tube stand longitudinal motion along floor track 2 QS 500 Push button All Locks Release Releases all tube stand mag QS 550 Control netic locks to allow vertical transverse longitudi nal and tube angulation motions 3 QS 500 Indicator SID at 40 in 100 cm Indicates tube and wall QS 550 Blue or table receptor is at 40 inches 100 cm source to image distance SID 4 QS 500 Indicator Tube Anqulation Display Indicates a
29. ngle of tube QS 550 rotation 5 QS 500 Indicator SID at 72 in 180 cm Indicates tube and wall QS 550 Blue receptor is at 72 inches 180 cm SID 6 QS 500 Push button Vertical Lock Release Releases magnetic lock QS 550 Control to allow vertical tube motion 7 QS 500 Push button Angulation Lock Release Releases magnetic QS 550 Control lock to allow tube angulation 8 QS 500 w QS Push button Transverse Lock Release Releases magnetic 55V option Control lock to allow transverse tube motion QS 550 9 QS 550 Push button Auto Stop When this button is pressed in combi Control nation with the Longitudinal Lock Release button longitudinal movement of the vertical column stops automatically when it reaches either the 40 in or 72 in SID detent on the floor track 10 QS 500 w QS Push button Rotational Lock Release Releases magnetic option Control lock to allow 90 Rotation of the Vertical Col umn 11 QS 500 Indicator Source to Table Receptor SID Scale Indicates QS 550 Label distance from tube focal spot to film plane image receptor in either metric or SAE units TAREA AAA AAA ARA ARA RE HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH EHH HHH HHH HHH HHH HOH HHH HHH Revision F X ray Tube Stand Operator s Manual 3 8 Quantum Medical Imaging A QS 500 Indicator Source to Table Top SID Scale Indicates dis QS 550 Label tance from tube focal spot to t
30. obile radio equipment be restricted from the vicinity of this device Use of accessories transducers and cables other than those specified in the accom panying documents may result in increased emissions or decreased immunity of the equipment Guidance and manufacturer s declaration electromagnetic emissions The Tubestand is intended for use in the electromagnetic environment specified below The customer or the user of the Tubestand should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The Tubestand uses RF energy only CISPR 11 for their internal functions There fore the RF emissions are very low and are not likely to cause any inter ference in nearby electronic equip ment RF emissions Class A The Tubestand is suitable for use in CISPR 11 all establishments other than domes ao tic and those directly connected to Harmonic emissions Class A the public low voltage power supply IEC 61000 3 2 network that supplies buildings used Voltage fluctuations Complies for domestic purposes flicker emissions IEC 61000 3 3 SOHO HEHE EEE FEE HEHEHE EEE EEE HEHEHE HHH EOE HEE HOH EEF HHH FEE HHH EHH EEE HHH EHH HEH 4444494444904 EHH EEE HHH EEE HESSD Revision F X ray Tube Stand Operator s Manual 1 8 Quantum Medical Imaging Guidance and manufacturer s declaration
31. s their intended use WARNING Indicates injury or death is possible if the instructions are not obeyed CAUTION Indicates that damage to equipment is possible if the instructions are not obeyed NOTE Indicates essential information that should be read to avoid incorrect operation P gt The purpose of safety icons such as those shown below is to indicate at a glance the type of caution warning or danger WARNING Ionizing radiation indicates the possibility of increased levels of radiation WARNING Indicates that damage to equipment is possible if the instructions are not obeyed WARNING Indicates essential information that should be read to avoid incorrect operation PP P ZZ ZI EEE ZZ ics X ray Tube Stand Operator s Manual Revision F Quantum Medical Imaging 1 3 000000000 000 0006004060606 Revision 1 4 WARNING Quantum Medical I maging 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 the United States Federal law restricts this device to
32. to QMI then the warranty period will begin immediately on the date of shipment invoice date and last for twelve months Buyers should complete only one 1 form per system or component WARRANTY CARD Cut along dashed line Q Name of Owner Name of Facility Address 1 Address 2 City State Country Zip Phone e mail Name of Distributor Installation Date Check Type of Equipment and Provide ID No s Model No Serial Hi Freq Generator Table Collimator Hi Tension Cable Tube Tube Stand Wall Stand Boo Oo O 0 Other X ray Tube Stand Operator s Manual Revision F Quantum Medical Imaging 5 3 Fill in and mail Warranty Card promptly to Quantum Medical Imaging 2002 B Orville Drive North Ronkonkoma N Y 11779 USA Any component furnished without charge to Buyer Dealer during the warranty period to correct a warranty failure shall be warranted only to the extent of the unexpired term of the warranty of the original product This warranty extends only to the origi nal purchase and is not transferable unless authorized in writing by Quantum Medical Imaging Products manufactured by parties other than QMI where QMI acts solely as distribu tor or reseller will carry their respective manufacturers warranties including each of their independent terms and conditions Warranty consideration will be given only for defective QMI products properly returned to
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