Chapter 1 Safety Notices - Spectrum Medical X
Contents
1. HEH HOH Revision H Wall Stand Frame Operator s Manual ii Quantum Medical Imaging LLC 1 5 5 GENERAL SAFETY INFORMATION WARNINGS CAUTIONS NOTES REGULATORY COMPLIANCE CLASSIFICATION COMPATIBILITY INTENDED OPERATOR TRAINING ACCOMPANYING DOCUMENTATION APPLICABLE STANDARDS ENVIRONMENTAL PROTECTION ELECTROMAGNETIC COMPATIBILITY EN 60601 1 2 2007 IEC 60601 1 2 2007 ABBREVIATION DEFINITION CHAPTER 2 GENERAL I NFORMATION OVERVIEW KEY FEATURES INTENDED USE RECEPTOR OPTIONS MAIN COMPONENTS MODEL QW 420 MAIN COMPONENTS MODEL QW 420 S MAIN COMPONENTS MODEL QW 420 D MAIN COMPONENTS MODEL QW 400 CHAPTER 3 OPERATION OVERVIEW OPERATION INSTRUCTIONS RECEPTOR CONTROL HANDLE OPTIONAL PATIENT OVERHEAD HANDGRIP OPERATION MODELS QW 400 QW 420 AND QW 420 S CASSETTE TRAY OPERATION Loading Cassette Tray Quantum Type Loading Cassette Tray Poersch Type PORTABLE DIGITAL RECEPTOR TRAY OPERATION MODEL QW 420 D WITH FIXED DIGITAL RECEPTOR OPERATION Wall Stand Frame Operator s Manual Quantum Medical Imaging LLC ee er E ii CHAPTER 4 USER MAI NTENANCE idum 4 3 USER MAINTENANCE 4 3 4 4 CHAPTER 5 WARRANTY INFORMATION WARRANTY STATEMENT r 5 3 WARRANTY EXCLUSIONS ENNEN 5 5 BUYER S REMEDIES au2. een 5 6 WARRANTY RETURN PROCEDURE 5 6 EQUIPMENT IN TRANSIT a 5 6 VOIDING WARRANTY l n 5 7 Revision H Wall Stand Frame Operator s Manual iv Quantum Medical Imaging LLC Chapter SAFETY NOTICES 999999999999999999999999999999999999999999999999999999999 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 explains their intended use tions are not obeyed Instructs users to refer to WARNING Indicates injury or death is possible if the instruc documentation if displayed without warning text Indicates that damage to equipment is possible if CAUTIO
3. Returned Material Evaluation Form must be returned with any defective product or any returned item All returns must include the Serial Number of the Equipment and the Specific Part Number written on the Field Returned Material Evaluation Form All freight charges resulting from Warranty Returns are the respon sibility of the Buyer Dealer EQUIPMENT IN TRANSIT QMI assumes no responsibility for equipment damaged in transit to or from QMI To protect the Buyer Dealer the receiver of any equipment should examine all cartons and crates carefully at the 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 an appropriate carrier claim Should concealed damage be detected immediately notify the carrier and request an inspection The purchaser Buyer Dealer Customer is fully responsible for the filing of freight damage claims to the freight carrier QMI assumes no responsibility for any loss or damage to products once they have been shipped from our factory As such the Buyer Dealer and Customer remain fully responsible for payment to QMI for all invoices according to our standard payment terms regardless of freight damage or processing of an insurance claim by the dealer or customer 444 HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HEHEHE M1 Me Wall Stand Frame Operator s M
4. S hereinafter referred to as the vertical wall stand 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 This manual provides information for operating and maintaining the vertical wall stand 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 KEY FEATURES The key features of the vertical wall stand are as follows e Accommodates all upright exams e Easy installation Fail safe electromagnetic locks for image receptor vertical motion e Model QW 400 receptor travel 1155 7 mm 45 5 in with 356 mm x 432 mm 14 in x 17 in image receptor and 546 1 mm 21 5 in with 356 mm x 914 mm 14 in x 36 in image receptor e Model QW 420 receptor travel 1524 mm 60 0 in with 356 mm x 432 mm 14 in x 17 in film receptor cabinet and 1041 4 mm 41 0 in with 356 mm x 914 mm 14 in x 36 in film receptor cabinet Model QW 420 S receptor travel 1511 3 mm 59 5 in with 14 in x 17 in fixed grid image receptor and 1537 mm 60 5 in with 356 mm x 432 mm 14 in x 17 in moving grid image receptor e Model QW 420 D receptor travel 1537 mm 60 5 in typical when installed with Q DRT CR Q DRT CL Q DRT CR R Q DRT CL R Q DRT DRXR R Q DRT DRXL R detector trays e Model QW 420 with Canon CXDI 50G port
5. 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 International Commission on Radiological Protection www icrp org and take adequate steps to protect against injury 4949494 9409949 SE HHH HEHEHE EEE HHH EHH 9 RRE EE EEE EHH EEE HOHE Eat Revision H Wall Stand Frame Operator s Manual 1 4 Quantum Medical Imaging LLC N 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 expo
6. 20 S See Figure 2 4 The Vertical Non Tilting Side Mount Wall Stand Model QW 420 S contains 1 Chin Rest 2 Cassette Tray Handle 3 Control Handle 4 Front Cover phenolic 5 Vertical Column 6 Compliance Label c WALL STAND REGULATORY N MARKINGS LABEL REFER TO Intertek anc asema CHAPTER 1 FOR MEANINGS OF gert degen SYMBOLS WALL STAND COMPLIANCE LABEL 0473 a 3 a Main Components cdr Figure 2 4 Model QW 420 S Vertical Wall Stand Side Mount Wall Stand Frame Operator s Manual Revision H Quantum Medical Imaging LLC 2 9 MAIN COMPONENTS MODEL QW 420 D See Figure 2 5 The Vertical Non Tilting Digital Image Receptor Holder Model QW 420 D contains 1 Control Handle 2 Digital Receptor Mounting Bracket when applicable 3 Vertical Column 4 Serialization Label WALL STAND REGULATORY MARKINGS LABEL REFER TO asa enen CHAPTER 1 FOR MEANINGS OF Pe SYMBOLS WALL STAND 0473 SERIAL LABEL 1420 200 REV pees el 2002 8 Orville Drive Hiorth Ronkonkoma HY 11779 USA Main Components cdr Figure 2 5 Model QW 420 D Digital Receptor Holder 4999990 9999999 4999999 9999994 HHH HOH HOOD Revision Wall Stand Frame Operator s Manual 2 10 Quantum Medical Imaging LLC MAIN COMPONENTS MODEL 400 See Figure 2 6 The Vertical Wall Frame Model QW 400 contains 1 Front Cover phenolic Control Handle Cassette Tray Handle Recept
7. 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 vertical wall stand This product has been factory tested to assure its required performance in an x ray system service personnel s recommendations may result D WARNI NG Failure to follow manufacturer s or in serious injury on this equipment In this context qualified means those legally permitted to work on the equipment and authorized means those specifi cally authorized by local management Only qualified and authorized persons shall work 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 graphic Table contains no user serviceable com ponents Do not attempt to disable these components or remove any trim covers Refer service to qualified service personnel WARNING Electric shock hazard Radio The user is responsible for performing certain routine maintenance and inspection procedures 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 qu
8. Carestream 2 Quan m Model QW 400 MEDICALIMAGING Vertical Wall Frame Models QW 420 QW 420 S and QW 420 D Vertical Wall Stand Operator s 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 LLC QMI Copyright 2012 QMI Quantum Medical I maging LLC Made in U S A Division of Carestream 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 Combined Models QW 400 QW 420 QW 420 D and QW 420 S Added CE mark B 2009 09 11 Incorporated ECOs 2123 2173 amp 2199 and updated CE mark 2009 10 30 Incorporated ECOs 1824 2015 2167 2010 05 21 Incorporated ECOs 2231 2266 2285 2286 2309 E 2010 12 23 Incorporated ECOs 2399 2432 F 2011 09 16 Revised safety mark to ETL incorporated ECO 2482 2011 12 29 Added EU Representative Information H 2012 05 22 Added IEC 60601 1 2005 H 3 1 thru 3 8 H 1 1 thru 1 14 H 4 1 thru 4 4 H 2 1 thru 2 12 H 5 1 thru 5 8 H Wall Stand Frame Operator s Manual Revision H Quantum Medical Imaging LLC I THIS PAGE INTENTIONALLY LEFT BLANK 4999990 4999994 9994
9. EOE EHH HHH HOH HOF OHH HIF EHH HHH OHH HHH HHH HOOD Wall Stand Frame Operator s Manual Quantum Medical Imaging LLC X Am Intertek MEDICAL ELECTRICAL EQUIPMENT 3100008 CONFORMS TO UL STD 0011 CERTIFIED TO CANICSA STD C222 NO 6011 0473 LA20 200 REV A with FDA radaticn performance standards set forth in CFR 21 Subchapter J applicable at date of manufacture 24V 10A EG El Quantum Medical imaging 2002 B Orville Drive North Ronkonkoma NY 11779 USA LA20 006 REV n YIM Main Components cdr Figure 2 2 Model QW 420 Vertical Wall Stand with 14 x 17 Cabinet Revision H X Aum WALL STAND REGULATORY MARKINGS LABEL REFER TO DEEN unterm CHAPTER 1 FOR MEANINGS OF CERTIFIED TO CANICSA STD 0222110 601 SYMBOLS C WALL STAND COMPLIANCE LABEL 0473 LA2O200 REV A Comples with FDA radiation performance standards set forth in CFR 21 Subchapter J applicable at date of manufacture 24V 10A ES EEE Quantum Medical Imaging LLC 2002 8 Orville Drive North Ronkonkoma NY 11779 USA tA20 005 n Main Components cdr Figure 2 3 Model QW 420 Vertical Wall Stand with 14 x 36 Cabinet 4999990 4999999 9999999 HEH HHH HHH HHH HHH HHH III III III III Revision H Wall Stand Frame Operator s Manual 2 8 Quantum Medical Imaging LLC MAIN COMPONENTS MODEL QW 4
10. HH EHH HEHEHE EHH HEHE HHH EHH HHH EHH HHO Se e Revision H Wall Stand Frame Operator s Manual 5 4 Quantum Medical Imaging LLC 00000004 POOH HEE HOHE HEHEHE HOE OEE HEF HEE EEE HEH EEE HEE OEE HED Wall Stand Frame Operator s Manual Quantum Medical Imaging LLC Promptly complete the warranty card and mail or fax it to Quantum Medical I maging LLC 2002 B Orville Drive North Ronkonkoma N Y 11779 USA 631 567 5074 fax 631 567 5800 voice Replacement components furnished by QMI to the Buyer Dealer during the warranty period shall be warranted for the remainder of the original product warranty or 90 days whichever is longer This warranty extends only to the original purchaser and is not transferable unless expressly authorized in writing by Quantum Medical Imaging LLC Products manufactured by parties other than QMI whereby QMI acts solely as distrib utor or reseller are warranted exclusively by their manufacturers according to each of their independent warranty terms and conditions Warranty consideration can only be given for defective QMI products properly returned to the factory in accordance with the QMI 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
11. N _ the instructions are not obeyed lt NOTE Notes provide advice and highlight unusual points A note is not intended as an instruction The purpose of safety icons such as those shown below is to indicate at a glance the type of caution warning or danger Ionizing radiation indicates the possibility of increased levels of radiation Dangerous voltage indicates the presence of high voltage Warning hot surface 000 4000 0040 0000000000 4944 4 4 6 e SE Wall Stand Frame Operator s Manual Revision H A Quantum Medical Imaging LLC 1 3 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 sale distribution and use by or on order of a licensed physician Quantum Medical I maging 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 WARNING X rays
12. ORS ARE IDENTIFIED BY REFERENCE wth A ee Bee PM EN 1201 C222 80 01 12 MANUFACTURED SEPTEMBER 2009 Quantum Medical Imaging LLC 4 2002 Orville Drive North 2008 09 Ronkonkoma NY 11779 USA ON REAR SIDE LA20 169 R Figure 2 1 Label on Receptor Cabinet Reference Number Location FEE HHH HHH HHH HEH HHH HHH HHH HEH 4 HHH HHH HHH HHH HHH HHH HEH HHH HHH HHH HHH 4 HHH HHH HHH 4 ZZ 4 ZZ HOOD ision H Wall Stand Frame Operator s Manual Revision Quantum Medical Imaging LLC 2 5 MAIN COMPONENTS MODEL QW 420 See Figures 2 2 and 2 3 The Model QW 420 Vertical Wall Stand contains 1 2 3 Receptor Cabinet Front Cover phenolic QW HG20 Patient Side Mounted Handgrips option item only used with 356 mm x 432 mm 14 in x 17 in cabinet QW HG30 Patient Overhead Handgrip option only used with 356 mm x 432 mm 14 in x 17 in cabinet Film Ejection Handle only used with 356 mm x 432 mm 14 in x 17 in cabinet Cassette Tray Handle Hand Control Compliance Label vr HOO OOD HARE RAR RRA ARRE RRA REE REIR RRA RRE RARE RX RRA RIIIE EHH HEHE Revision H 2 6 Wall Stand Frame Operator s Manual Quantum Medical Imaging LLC WALL STAND REGULATORY MARKINGS LABEL REFER TO CHAPTER 1 FOR MEANINGS OF SYMBOLS WALL STAND COMPLIANCE LABEL 02000 HHH HHH HEE HHH ZZ HHH OOH HHH OHH HOF EHH OOH EE
13. able receptor travel 1524 mm 60 in Wall Stand Frame Operator s Manual Revision H Quantum Medical Imaging LLC 2 3 This product is intended to be used operated only 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 practice INTENDED USE The vertical wall stand is intended for use as a support structure used to position a radiographic image receptor during a radiographic procedure Inasmuch as the Wallstand is designed with 1 2 mm AL beam attenuation charac teristics the operator when using accessories which present additional beam attenuation should consider their impact on imaging results 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 resultant non compliance damage or injury NOTE When the vertical wall stand is equipped with a digital receptor DR panel this manual is incomplete without the Installation amp Operation Manual shown in Table 2 1 which corresponds to the receptor option shipped with the system Prior to operating this product the user must become familiar with information provided therein RECEPTOR OPTIONS The followi
14. ali fied service personnel User maintenance consists of the following activities which should be performed on a daily basis e Visually inspect the wall stand frame for wear and cleanliness e Clean the exterior painted surfaces of the wall stand frame e Disinfect the front panel surface after each use in accordance with facility requirements Wall Stand Frame Operator s Manual Revision H Quantum Medical Imaging LLC 4 3 Cleaning WARNING Always disconnect the equipment from the main power supply prior to any 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 on this equipment 4999900 4999999 HEH EE HOH HHH HUH HHH HHH HHH HHH HHH HEH HEH HHH HHH HHH HHH HEH HHH OHH n Revision H Wall Stand Frame Operator s Manual 4 4 Quantum Medical Imaging LLC Chapter 5 WARRANTY INFORMATION 9 9 999999999999999999999999999 999 9999999 9999999 99999 999 999 999 99 99 9 9 99 WARRANTY STATEMENT Quantum Medical Imaging LLC herein after known as warrants to the buyer that any new product manufactured by QMI will be free from defects in material and workmanship and will substantially conform to the applicable specifications in effect on the date of shipment when subjected to normal pr
15. anual 5 6 Quantum Medical Imaging LLC VOIDING WARRANTY Tampering with or any attempt at installation maintenance repair service reloca tion or alteration of or to a QMI product when performed by any person or entity other than Quantum Medical Imaging LLC or its Certified Dealer without the written approval of an Authorized Person at Quantum Medical Imaging LLC shall immedi ately Void and Cancel all warranties with respect to the affected product 000000000000 OOH 000 EHH EEE AAA AAA AAA AAA AAA AAA ARA ARA RA AREA ARA Wall Stand Frame Operator s Manual Revision H Quantum Medical Imaging LLC 5 7 THIS PAGE INTENTIONALLY LEFT BLANK 444 HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HEHEHE HHH HEHE HHH HEHEH HHH EHH ZZ ZZ ZZ HEHE Se e Revision H Wall Stand Frame Operator s Manual 5 8 Quantum Medical Imaging LLC
16. ase Button locks the cabinet in its current position RECEPTOR CABINET LOCK RELEASE BUTTON Figure 3 1 Model QW 420 QW 420 D QW 420 S Receptor Cabinet Control Handle 4494009 OOH rr TH HR Wall Stand Frame Operator s Manual Revision H Quantum Medical Imaging LLC 3 3 RECEPTOR CABINET LOCK RELEASE BUTTON Figure 3 1a Model QW 400 Receptor Cabinet Control Handle 4999990 9499999 4999999 HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH EE HHH EHH HHH HOH HOOD Revision H Wall Stand Frame Operator s Manual 3 4 Quantum Medical Imaging LLC OPTIONAL PATIENT OVERHEAD HANDGRIP OPERATION The optional patient Overhead Handgrip assist the opera tor in keeping the patient s arms out of image area WARNING The QW 420 Vertical Wall Stand with Patient Overhead Handgrip option is designed only to support the patient s arms during lateral chest examinations It is not intended to support the full weight of the patient Never leave a patient unattended while using the Patient Over head Handgrip i INDEX PLUNGER OVERHEAD HANDGRIP Figure 3 2 Patient Overhead Handgrip Operation The optional Patient Overhead Handgrip QW HG30 shown in Figure 3 2 is operated by pulling out the Index Plunger and then rotating the Handgrip out away from column Release the Index Plunger and continue to swivel the Overhead Handgrip until it is perpendicular to the wall stand front panel When perp
17. center brass button to allow movement Insert cassette into tray back end first Lock cassette into tray Push front grip against cassette While pushing front grip against cassette turn cassette lock handle to lock position Push tray into Receptor Cabinet The cassette is now in exposure posi tion Wall Stand Frame Operator s Manual Quantum Medical Imaging LLC Loading Cassette Tray Poersch Figure 3 4 Poersch Cassette Film Tray 1 To load a film cassette into a Poersch type cassette tray proceed as fol lows 2 Pull cassette tray from Receptor Cabinet using tray handle see Figure 3 4 3 Remove shelf from retainer by rotating flange forward 4 Place shelf in holes required for size of film cassette 5 Place cassette on shelf back end first Lift handle of clamp 6 Slide clamp forward pushing clamp firmly against cassette 7 While pushing clamp against cassette press clamp handle down Wall Stand Frame Operator s Manual Revision H Quantum Medical Imaging LLC 3 7 PORTABLE DIGITAL RECEPTOR TRAY OPERATION In applications where a portable digital receptor is used e g Carestream DRX 1 there are several compatible digital receptor tray options available depending on the system ordered Refer to Table 2 1 in Chapter 2 GENERAL INFORMATION for a list of receptor tray options and associated Installation and Operation manual part numbers Detailed instructions for operation of thes
18. e digital receptor tray options are provided in Model Q DRT Series Trays for Portable Digital Detectors Installation and Operation Manual DC30 092 shipped with the product Refer to the digital receptor manufacturer s docu mentation provided with the digital imaging system for specific instructions on use of the portable digital receptor MODEL QW 420 D WITH FIXED DIGITAL RECEPTOR OPERATION Operation of the QW 420 D Wall Stand when equipped with a permanently mounted fixed digital receptor is similar to that of non digital systems described previously in this chapter However because there is no film cas sette used the instructions pertaining to cassette tray operation does not apply Refer to Table 2 1 in Chapter 2 GENERAL INFORMATION for a list of fixed digital receptor housing options and associated Installation and Opera tion manual part numbers Detailed instructions for operation of these digital receptor housings are provided in Model Q FDR Series Housings for Digital Detectors Installation and Operation Manual DC30 110 shipped with the product Refer to the digital receptor manufacturer s documentation pro vided with the digital imaging system for specific instructions on use of the fixed digital receptor 4949999 OOH HOOD 666 06t6 HHH HOH 9999999 9494949 EH HHH HHH HOOD Revision H Wall Stand Frame Operator s Manual 3 8 Quantum Medical Imaging LLC Chapter 4 USER MAINTENANCE 9 9 999999999999999999999
19. e during shipment of the product following the freight carrier s pick up for transportation to the delivery point Revision H 5 5 BUYER S REMEDIES If QMI determines that a product fails to meet any specification during the applicable warranty period QMI shall correct any such failure as follows A By repairing adjusting or replacing any defective or non conforming component or product B By making available any necessary repair or replacement parts or assemblies for exchange Quantum Medical Imaging LLC shall have the option to furnish either new or rebuilt replacement parts or assemblies for exchange All returned parts shall become the property of Quantum Medical Imaging LLC upon exchange The preceding Paragraphs set forth the Buyer s sole remedies and QMI s sole liability for claims based upon failure of the product to meet any warranty whether the claim is on contract warranty tort including negligence and strict liability or otherwise and however instituted Upon the expiration of the applicable warranty period all such liability shall terminate In no event shall QMI be liable for special or consequential damages arising out of the use of or inability to use its equipment whatsoever The warranties and remedies available to the buyer are conditioned upon claims under this warranty being made in accordance with the aforementioned warranty statement WARRANTY RETURN PROCEDURE A fully completed Field
20. e in the electromagnetic environment specified below The cus tomer or the user of the vertical wall stand should assure that it is used in such an environment Immunity test I EC 60601 Compliance Electromagnetic environment guid test level level ance Portable and mobile RF communications equipment should be used no closer tp any part of the vertical wall stand including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmit ter Recommended separation distance Conducted RF 3 Vrms 3 Vrms JP IEC 61000 4 6 150 kHz to 80MHz d 124P Radiated RF 3 V 3V C 610 4 m 1 2VP IEC 61000 4 3 80 MHz to 2 5 GHz 80 MHz to 800 MHz vr HOO THOT HOH HHH HOH HEH HHH EEE HEH HEH HHH EH HHH EHH HHH HHH HHH HHH EHH HHH HHH HHH HHH HHH HHH ott EE HHH HHHHHH ERR ERR HEHE Revision H Wall Stand Frame Operator s Manual 1 10 Quantum Medical Imaging LLC Guidance and manufacturer s declaration electromagnetic immunity d 23VP 800 MHz to 2 5 GHz where 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 eq
21. endicular to the front panel the Index Plunger will engage locking the Overhead Handgrip in position Never use Overhead Handgrip without the Index Plunger securely engaged The Patient Overhead Handgrip can support up to 22 7 kg 50 Ib A down ward force exceeding this load capacity could override the System s fail safe brake holding force allowing the film cabinet to move slowly downward This Wall Stand Frame Operator s Manual Revision H Quantum Medical Imaging LLC 3 5 Revision 3 6 will not damage the equipment but may unsteady the patient If the system begins to move slowly downward reduce load on handgrip MODELS QW 400 QW 420 AND QW 420 S CASSETTE TRAY OPERATION The Vertical Wall Stand Frame is equipped with either a Quantum or Poersch cassette tray depending on the system ordered The following paragraphs describe the operating instructions for each Additional information is con tained in the cassette tray manufacturer s documentation which is shipped with the cassette support system Loading Cassette Tray Quantum Type OND uw Figure 3 3 Quantum Cassette Film Tray To load a film cassette into a Quantum type cassette tray proceed as follows Pull cassette tray from Receptor Cabinet using tray handle see Figure 3 3 Pull back on front cassette grip opens both grips Position slide guides L brackets seated in channels to cassette size using indicators on cassette tray press
22. erformed 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 ist Edition 2006 04 26 Medical Electrical Equipment part 1 General Requirements for Safety IEC 60601 1 Medical electrical equipment Part 1 General requirements for safety IEC 60601 1 2 2007 EU Authorized Representative Carestream Health France 1 rue Galil e 93192 NOISY LE GRAND CEDEX France 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 000000000000 HEH HEHEHE HOE n 4949099 200 HHH EHH HHH EHH HOF EHH OEE HHH OOH HHH OHH HHH HOH OHH HHH OOD CHO HHHHOH HHH Wall Stand Frame Operator s Manual Revision H Quan
23. ferential 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 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip Ur lt 5 Ur gt 95 dip in Uy for 55 lt 5 Ur gt 95 dip in Uy for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 30 dip in Ur lt 5 Ur gt 95 dip in Ur for 55 Mains power quality should be that of a typical commercial or hospital environment If the user of the vertical wall stand requires continued operation during power mains interrup tions it is recommended that the vertical wall stand be pow ered from an uninterruptible 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 is the mains voltage prior to application of the test level 4 HHH HHH HHH 4 4 4 HHH 4 4 4 HHH 4 HHH 4 HHH HHH 4 MA 444 6 4 4 7 Wall Stand Frame Operator s Manual Quantum Medical Imaging LLC Revision H 1 9 Guidance and manufacturer s declaration electromagnetic immunity The vertical wall stand is intended for us
24. is intended for use in an electromagnetic environment in which radiated RF distur bances are controlled The customer or the user of the vertical wall stand can help prevent electromag netic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the vertical wall stand 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 1 2VP d 1 2VP d 234 P 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 73 100 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 SOHO 0020002020 022 02002 0202 02 0 FEF EES EHH SE HHH HEHEHE HEH HHH EHH ERR HEH RRE EE EEE EHH EEE HOHE Eat Revision H Wall Stand Fra
25. itable for CISPR 11 use in all establishments other than domestic and those directly con Harmonic emissions Class nected to the public low voltage IEC 61000 3 2 power supply network that supplies Voltage fluctuations Complies buildings used for domestic pur flicker emissions poses IEC 61000 3 3 4944949 4099494 HOE HEHEHE HHH 02 1 HOH HOH HEE HEHEHE EHH EEE HHH xxx Revision H Wall Stand Frame Operator s Manual 1 8 Quantum Medical Imaging LLC Guidance and manufacturer s declaration electromagnetic immunity The vertical wall stand is intended for use in the electromagnetic environment specified below The customer or the user of the vertical wall stand should assure that it is used in such an environment discharge ESD IEC 61000 4 2 8 kV air 8 kV air Immunity test 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 dif
26. me Operator s Manual 1 12 Quantum Medical Imaging LLC ABBREVIATION DEFINITION The following abbreviations and acronyms may be found in this document Their definition is explained below A Ampere DR Digital Receptor hPa Hecto Pascals kg Kilograms Ib Pound mm Millimeters Vdc Volts Direct Current Wall Stand Frame Operator s Manual Revision H Quantum Medical Imaging LLC 1 13 THIS PAGE INTENTIONALLY LEFT BLANK 4999099 4999999 9999999 III III III HHH HHH HHH HOH otii i ii i Revision H Wall Stand Frame Operator s Manual 1 14 Quantum Medical Imaging LLC 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 N entirety prior to using this equipment 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 in the Safety section refer to Chapter 1 SAFETY NOTICES This manual is written for trained users of Quantum Medical Imaging LLC s Vertical Wall Frame Model QW 400 Vertical Wall Frame Model QW 420 Vertical Non Tilting Digital Image Receptor Holder Model QW 420 D and Vertical Wall Stand with Side Mounted Receptor Cabinet Model QW 420
27. ng table defines digital imaging receptor options available for the vertical wall stand including references to ancillary documentation which sup ports the installation and operation of each receptor listed The appropriate man ual is shipped with each vertical wall stand Table 2 1 Compatible Receptor Options Varian 4343R non portable DR QW 420 D Q FDR V R DC30 110 panel Q FDR V L Canon CXDI 40G COMPACT QW 420 D Q FDR C R DC30 110 non portable DR panel Q FDR C L Agfa DX D 4336R Portable DR QW 420 D Q DRT VR R DC30 092 panel rotating tray Q DRT VL R Canon CXDI 50G Portable DR QW 420 D Q DRT CR DC30 092 panel non rotating tray Q DRT CL Revision H Wall Stand Frame Operator s Manual 2 4 Quantum Medical Imaging LLC Table 2 1 Compatible Receptor Options Canon CXDI 50G Portable DR QW 420 D Q DRT CR R DC30 092 panel rotating tray Q DRT CL R Canon CXDI 55G Portable DR QW 420 D Q DRT 55CR R DC30 092 panel rotating tray Q DRT 55CL R Carestream DRX 1 Portable DR QW 420 D Q DRT DRXR R DC30 092 panel rotating tray Q DRT DRXL R Vatech Samsung Xmaru 1417 QW 420 D Q DRT SAMR R DC30 092 Q DT SAML R Figure 2 1 shows the location of serialization labeling which should be used for proper identification of the specific digital receptor installed in the vertical wall stand when equipped with this option The label is affixed to the rear panel of the cabinet RECEPT
28. oper and its intended use by properly trained personnel QMI shall be the sole judge in determining whether said equipment or component is defective by reason of manufacture All QMI products shall be so warranted for a period of 12 months from the date of original installation such date to be evidenced by means of a completed Warranty Card returned to QMI within 30 days of installation In no case shall the warranty extend beyond 15 months from the date of shipment If the attached warranty card is not so returned to QMI then the warranty period will be deemed to have com menced on the date of shipment the invoice date and extend for a period of twelve months The buyer should submit only one such card per system or major compo nent purchased WARRANTY CARD Cut along dashed line Sc 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 No Hi Freq Generator Table Collimator Hi Tension Cable Tube Tube Stand Wall Stand EEE ERRE ERA Wall Stand Frame Operator s Manual Revision H Quantum Medical Imaging LLC 5 3 Clip Copy Warranty Card on reverse side and submit to QMI See Reverse Side for Warranty Card 444 HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HEHEHE HHH HEHEHE HHH HEHEHE H
29. or Cabinet Compliance Label BW Legs Complies wm lation performance standards set forth in CFR 21 Sete Paga we et ee awa WALL STAND i SERIAL LABEL Metered EE onkonkoma NY 11779 USA _ ta20004nEV c A Main Components cdr Figure 2 6 Model QW 400 Vertical Wall Frame 00000 HHH HHH HEE HHH OEE HHH OOH HHH 900909006 HOE EE OSH HHH E HOF OHH HHH HOE HOOD Wall Stand Frame Operator s Manual Revision H 2 11 Quantum Medical Imaging LLC THIS PAGE INTENTIONALLY LEFT BLANK Revision H Wall Stand Frame Operator s Manual 2 12 Quantum Medical Imaging LLC Chapter OPERATION 9 9 999999999999999999999 999999999 9999999 99999 999 99999 999 999 999 99 99 9 9 99 OVERVIEW This chapter explains how to operate the vertical wall stand frame WARNING movable assemblies and parts of this equipment must be operated with reasonable care Manufacturer s equipment recommenda tions described in this manual must be observed OPERATION INSTRUCTIONS RECEPTOR CONTROL HANDLE Operation of the Vertical Wall Stand Frame involves moving the Receptor Cabinet vertically i e and down This isaccomplished by depressing the Receptor Cabinet Lock Release Button see Figures 3 1 and 3 1a located on the control handle attached to the Receptor Cabinet and then moving the cabinet to the desired vertical position Releasing the Receptor Cabinet Lock Rele
30. oral express implied or statutory NO IMPLIED WARRANTY OF MERCHANT ABILITY OR FITNESS FOR A PARTICULAR PURPOSE SHALL APPLY Quantum Medical Imaging LLC Warranty is exclusive of 1 Failure of the Buyer Dealer to prepare the site and operating environment in accordance with applicable instructions and recommendations of QMI 2 Failure of Buyer Dealer to provide the proper incoming power required to support the equipment in accordance with the requirements of QMI 3 Modification of QMI products performed by a party other than QMI 4 Combining products deemed by QMI to be incompatible 5 Improper or extraordinary use of a product improper maintenance of the prod uct or failure to comply with any applicable instructions and recommendations of Quantum Medical Imaging LLC 6 Misuse abuse tampering or negligent storage or handling of a product by the Buyer its employees agents or contractors 7 Fuses glassware high voltage cables and other items deemed by QMI to be expendable Acts of God fires floods power failure or electrical power surges Strikes sabotage labor disturbances war riots acts of civil or militaryauthority or other causes beyond the reasonable control of QMI Installation routine troubleshooting and repair are also excluded from warranty Technical service and maintenance is the responsibility of the Dealership selling the equipment The Manufacturer is hereby relieved of all responsibility for damag
31. r 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 FDA Center for Devices and Radiological Health CDRH Title 21 CFR Subchapter J and EC Directive 93 42 EEC for Medical Devices SHH HHH HHH 4 HHH 4 HHH 4 4 HHH 4 HHH 4 4 4 4 4 MA 444 6 e SR Wall Stand Frame Operator s Manual Revision H A Quantum Medical Imaging LLC 1 5 CLASSIFICATION This product has been classified as Class I Type B 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 Ordi nary enclosed equipment without protection against ingress of liquids MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK FIRE MECHANICAL HAZARDS ONLY CONFORMS TO UL STD 60601 1 C us CERTIFIED TO CAN CSA STD C22 2 NO 601 1 LISTED Intertek The following symbols may be used for marking on this equipment or equipment doc umenta
32. sure 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 Diag nostic X ray System by the assembler i e the installer with the appropriate agen cies 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 Quan tum Medical Imaging LLC 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 ticipate 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 Ene
33. tion 6 Non ionizing Radiation D Protective Earth ground SP Earth ground Type B Equipment 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 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 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 Revision H Wall Stand Frame Operator s Manual 1 6 Quantum Medical Imaging LLC ACCOMPANYING DOCUMENTATION The documentation consists of a User manual this document and related docu mentation Service Manual P N DC30 040 Contains technical and service documentation for this product including installation and configuration instructions to be p
34. tum Medical Imaging LLC 1 7 ELECTROMAGNETIC COMPATIBILITY 60601 1 2 2007 1 60601 1 2 2007 The vertical wall stands are intended for use the electromagnetic environment specified below As such the vertical wall stands must be installed and put into ser vice 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 mobile 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 vertical wall stand is intended for use in the electromagnetic environment specitied below The customer or the user of the vertical wall stand should assure that it is used in such an envi ronment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The vertical wall stand uses RF CISPR 11 energy only for their internal func tions Therefore the RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A The vertical wall stand is su
35. uipment marked with the following sym bol Dei 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 vertical wall stand is used exceeds the applicable RF compliance level above the vertical wall stand should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the vertical wall stand b Over the frequency range 150 kHz to 80 kHz field strengths should be less than 3 V m 4999 HHH HHH HHH HHH HHH 4 HHH 9 4 HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH HHH OHH HOD 9 HHH 4 HHH HHH HOOD e Wall Stand Frame Operator s Manual Revision H A Quantum Medical Imaging LLC 1 11 Recommended separation distances between portable and mobile RF communications equipment and the vertical wall stand The vertical wall stand
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