Ziehm Imaging, Inc. QUANTUM User manual
ZIEHM QUANTUM
USER’S MANUAL
Table of Contents
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Table of Contents
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TABLE OF CONTENTS
ABOUTTHISMANUAL.......................................................................................................................................11
1.0SAFETY&RESPONSIBILITIES.....................................................................................................................13
1.1INTENDEDUSE...............................................................................................................................................13
1.2OPERATION(U.S.A.)......................................................................................................................................13
1.3AUTHORIZEDPERSONNEL.............................................................................................................................13
1.4EQUIPMENTOWNERRESPONSIBILITIES........................................................................................................14
1.5HOSPITALADMINISTRATION.........................................................................................................................14
1.6MANUFACTURER...........................................................................................................................................14
1.7EXCLUSIONOFLIABILITY...............................................................................................................................14
1.8USAREGULATORYRESPONSIBILITIES............................................................................................................15
1.8.1SERVICEENGINEERS/TECHNICIAN............................................................................................................15
1.8.2SYSTEMUSERS..........................................................................................................................................15
1.9CDRHREPORT................................................................................................................................................15
1.10PROBLEMS................................................................................................................................................15
1.11REGULATORY/NOTIFIEDBODY................................................................................................................15
1.12RECORDKEEPINGUSA..............................................................................................................................15
2.0SYSTEMOVERVIEWSECTION....................................................................................................................17
2.1FIELDSOFAPPLICATION................................................................................................................................17
2.2FEATURES......................................................................................................................................................17
2.2.1MOBILITY..................................................................................................................................................17
2.2.2ORGANPROGRAMS..................................................................................................................................17
2.2.3RADIATIONREDUCTION...........................................................................................................................17
2.2.4IMAGEQUALITY........................................................................................................................................17
2.2.5IMAGEADJUSTMENT................................................................................................................................17
2.2.6IMAGEMANAGEMENT.............................................................................................................................18
2.2.7DOCUMENTATIONANDOUTPUT.............................................................................................................18
2.2.8NETWORKABILITY.....................................................................................................................................18
2.3OPTIONS........................................................................................................................................................18
2.4OPTIONALACCESSORIES...............................................................................................................................19
2.5PARTSOFTHESYSTEM..................................................................................................................................20
2.5.1C‐ARMSTAND...........................................................................................................................................20
2.5.2TWINFLATPANELMONITORS..................................................................................................................20
2.5.3MONITORPOSITION.................................................................................................................................21
2.5.4DUALFLATPANELLCDMONITORS...........................................................................................................23
2.5.5CHANGINGTHEMONITORSETTINGS.......................................................................................................24
2.5.6ZIEHMQUANTUMFPMONITORSADJUSTMENTS....................................................................................24
2.5.6.1.MONITORSETTINGS............................................................................................................................24
2.5.6.2.INTEGRATEDBUTTONPANEL..............................................................................................................24
2.5.6.3.SETTINGTHEBRIGHTNESS,CONTRASTANDBACKLIGHTBRIGHTNESS...............................................24
2.5.6.4.SETTINGTHEMENULANGUAGE..........................................................................................................26
2.5.6.5.RESTORINGTHEFACTORYSETTINGS...................................................................................................27
2.5.7BNCSOCKETVIDEOOUTPUT....................................................................................................................28
3.0SAFETYINSTRUCTIONS.............................................................................................................................29
3.1GENERALSAFETYINSTRUCTIONS..................................................................................................................29
3.1.1OPERATION...............................................................................................................................................29
3.1.2OPERATION(U.S.A.)ASSEMBLYANDSERVICE.........................................................................................29
3.1.3WARRANTYVOIDED.................................................................................................................................29
3.2X‐RAYANDELECTRICALSAFETY....................................................................................................................29
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3.2.1GENERALRADIATIONSAFETY...................................................................................................................29
3.2.2HAZARDS...................................................................................................................................................30
3.2.2.1.X‐RAYTUBEHOUSING..........................................................................................................................30
3.2.2.2.X‐RAYTUBE..........................................................................................................................................30
3.2.2.3.RADIATIONWARNING.........................................................................................................................30
3.2.2.4.PROTECTION‐OFSTAFF........................................................................................................................30
3.2.2.5.FLAMMABLEGAS.................................................................................................................................31
3.3MECHANICALANDELECTRICALWARNINGS..................................................................................................31
3.3.1ELECTRICALSAFETY..................................................................................................................................31
3.3.2GROUNDING.............................................................................................................................................31
3.3.3HIGHVOLTAGECOMPONENTS.................................................................................................................31
3.3.4PERFORMINGINTERNALSERVICE.............................................................................................................32
3.4GENERALSAFETY...........................................................................................................................................32
3.4.1GETTERING...............................................................................................................................................33
3.4.2BONDING..................................................................................................................................................33
3.5PROTECTIONOFTHEPATIENT.......................................................................................................................33
3.5.1ELECTROMAGNETICCOMPATIBILITY........................................................................................................34
3.5.2PROTECTIVEEARTHING(PE).....................................................................................................................34
3.5.3EQUIPOTENTIALEARTHINGHEARTANDBRAINEXAMINATIONS.............................................................34
3.6LASERRADIATION..........................................................................................................................................34
3.6.1LASERTARGETINGDEVICE........................................................................................................................34
3.6.2MAINTENANCE.........................................................................................................................................35
3.6.3LASERRADIATION.....................................................................................................................................35
3.7ENVIRONMENTALCOMPATIBILITY................................................................................................................36
4.0UNPACKINGINSTALLATION......................................................................................................................37
4.1INSTALLATIONPROCEDURE...........................................................................................................................37
4.1.1AUDIENCE.................................................................................................................................................37
4.1.2DETAILEDINFORMATION.........................................................................................................................37
4.1.3ROOMTEMPERATURE..............................................................................................................................37
4.1.4SHIPPINGCONTAINERUNPACKING..........................................................................................................37
4.1.5UNPACKING..............................................................................................................................................37
4.2MOUNTINGMONITORS.................................................................................................................................39
4.2.1MOUNTINGSTANDARDMONITORS.........................................................................................................40
4.2.2MOUNTINGQUICKRELEASEMONITORS..................................................................................................40
4.3POWERCABLECONNECTIONS.......................................................................................................................42
4.4PREPARINGTHESYSTEM...............................................................................................................................42
4.4.1TOPREPARETHEUNIT,DOTHEFOLLOWING:..........................................................................................42
4.5SWITCHINGONTHESYSTEM.........................................................................................................................43
4.5.1CUSTOMER‐SPECIFICINITIALSETTINGS....................................................................................................43
4.5.2CONFIGURATION......................................................................................................................................44
4.5.3ENTERINGTHEHOSPITALDATA...............................................................................................................44
4.6TESTOPERATION...........................................................................................................................................44
4.6.1CHECKLEAKAGECURRENT.......................................................................................................................44
4.6.2C‐ARMOPERATION...................................................................................................................................44
4.6.3FLUOROSCOPYISSELECTED;....................................................................................................................44
4.6.4PERFORMTHEFOLLOWINGOPERATIONALTESTS&VERIFYTHATTHEFOLLOWINGRESULTSOCCUR:..45
4.7ACCESSORIES.................................................................................................................................................46
5.0MECHANICALHANDLING..........................................................................................................................47
5.1TRANSPORTPOSITION...................................................................................................................................47
5.1.1TRANSPORTPOSITIONOFTHEC‐ARMMOBILESTAND............................................................................47
5.1.2TRANSPORTPOSITIONFORZIEHMQUANTUM........................................................................................51
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5.2BRAKINGANDSTEERINGTHEC‐ARMSTAND.................................................................................................52
5.2.1STEERING&BRAKING...............................................................................................................................52
5.2.1.1.PARKINGBRAKE...................................................................................................................................52
5.2.1.2.STEERING.............................................................................................................................................52
5.3MOVEMENTOFTHEC‐ARM,MECHANICALBRAKES......................................................................................53
5.3.1ORBITALROTATION..................................................................................................................................54
5.3.2ANGULATION............................................................................................................................................55
5.3.3SWIVELING(PANNING).............................................................................................................................55
5.3.4HORIZONTALMOVEMENT........................................................................................................................56
5.3.5VERTICALMOVEMENT..............................................................................................................................57
5.3.5.1.VERTICALOVERRIDE:...........................................................................................................................57
6.0USERTOUCHANDCONSOLEKEYBOARDS.................................................................................................59
6.1DESKVIEWTMCONTROLPANEL......................................................................................................................59
6.2DESKVIEWCONTROLPANEL..........................................................................................................................59
6.2.1ELEMENTSOFTHECONTROLPANEL........................................................................................................59
6.3DESKVIEWMAINSCREENBUTTONS..............................................................................................................60
6.4MAINSCREENBUTTONIDENTIFICATIONTABLE:..........................................................................................61
6.5CONTROLSINFLUOROSCOPICOPERATIONMAINSCREEN...........................................................................72
6.6TOUCHCONTROLKEYBOARD........................................................................................................................72
6.6.1ALPHANUMERICKEYPAD..........................................................................................................................73
6.6.2UPPERCASELETTERSANDSPECIALCHARACTERS.....................................................................................73
6.7MOBILESTANDCONTROLKEYBOARD...........................................................................................................74
6.7.1MAINKEYBOARDELEMENTGROUPS.......................................................................................................74
6.8MOBILESTANDCONTROLKEYBOARDTABLE................................................................................................75
6.9SWITCHINGONTHEZIEHMQUANTUM........................................................................................................81
6.10SWITCHINGOFFTHEZIEHMQUANTUM..................................................................................................82
6.11VERTICALLIFT...........................................................................................................................................83
6.11.1VERTICALOVERRIDE:...........................................................................................................................83
6.12HANDSWITCHANDFOOTSWITCH..........................................................................................................83
7.0STANDARDFLUOROSCOPICOPERATIONS.................................................................................................85
7.1GENERALDESCRIPTION.................................................................................................................................85
7.2SPECIALFEATURES.........................................................................................................................................85
7.3IMAGESYSTEMDESIGN.................................................................................................................................85
7.4IMAGINGPROCESSING..................................................................................................................................85
7.5THUMBNAILIMAGEDISPLAY........................................................................................................................86
7.6LIVEIMAGES..................................................................................................................................................86
7.7FLUOROSCOPY...............................................................................................................................................86
7.8BASICOPERATION.........................................................................................................................................87
7.8.1STEPSANDSETTINGS................................................................................................................................87
7.8.2ADJUSTMENTSTHATCANBEMADE:........................................................................................................87
7.9FLUOROSCOPYMODES..................................................................................................................................88
7.9.1CONTINUOUSANDPULSEFLUOROSCOPY................................................................................................88
7.9.1.1.CONTINUOUSFLUOROSCOPY..............................................................................................................89
7.9.1.2.PULSEFLUOROSCOPY..........................................................................................................................89
7.9.2SNAPSHOT................................................................................................................................................90
7.10FLUOROSCOPYANATOMICALPROGRAMS...............................................................................................90
7.10.1ACTIVATINGANATOMICAL/ORGANPROGRAM..................................................................................90
7.10.2BONE/EXTREMITY................................................................................................................................91
7.10.3PELVIS/ABDOMEN...............................................................................................................................91
7.10.4HEART/THORAX...................................................................................................................................91
7.10.5LPDLARGEPATIENTADIPOSEPATIENTFUNCTION.............................................................................91
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7.11DIGITALNOISEFILTERS.............................................................................................................................92
7.11.1NOISEFILTERFACTORS........................................................................................................................92
7.12LASTIMAGEHOLDNOISEFILTER..............................................................................................................92
7.13METALARTIFACTCORRECTION................................................................................................................92
7.14MANUALEXPOSURERATESETTING.........................................................................................................92
7.15SCREENDISPLAYDURINGRADIATION......................................................................................................94
7.15.1FLUOROSCOPIC....................................................................................................................................94
7.15.2FLUOROSCOPYFACTORS.....................................................................................................................94
8.0USERFUNCTIONALITY..............................................................................................................................97
8.1SPECIALFUNCTIONALITY...............................................................................................................................97
8.1.1METAL.......................................................................................................................................................97
8.1.21/2DOSE...................................................................................................................................................97
8.2MAGNIFICATIONELECTRO‐OPTICALIMAGEINTENSIFIER.............................................................................97
8.1.3MOBILESTANDCONTROLPANEL:............................................................................................................97
8.1.4DESKVIEWTOUCHPANEL:........................................................................................................................97
8.3IMAGEROTATION.........................................................................................................................................98
8.4IMAGEREVERSAL/IMAGEMIRROR..............................................................................................................98
8.5IRISCOLLIMATOR..........................................................................................................................................98
8.6SLOTCOLLIMATOR........................................................................................................................................98
8.7MARKIMAGE.................................................................................................................................................99
8.8LIVESWAP.....................................................................................................................................................99
8.9MONITORLTOR.........................................................................................................................................100
8.10MONITORRTOL.....................................................................................................................................100
8.11INVVIDEO...............................................................................................................................................100
8.12STORING/SAVING...................................................................................................................................101
8.13STOREUSBIMAGE..................................................................................................................................102
8.14MOBILESTANDANDTOUCHINFORMATIONDISPLAYS..........................................................................103
8.14.1.KVDISPLAY.........................................................................................................................................104
8.14.2.MADISPLAY.......................................................................................................................................104
8.14.3.EXPOSURETIME(S).............................................................................................................................104
8.14.4.CGYCM2/ERROR...............................................................................................................................104
8.14.5.MINFLUOROSCOPYTIMEDISPLAY....................................................................................................104
8.14.5.1.AUDIBLEALARM................................................................................................................................104
8.14.6.GENERATOROVERHEATING..............................................................................................................105
8.14.7.RADIATIONEXPOSUREINDICATOR....................................................................................................105
8.15DESKVIEWDISPLAYSFORKV/MA,TIMEANDDOSE...............................................................................106
8.15.1.KV:......................................................................................................................................................106
8.15.2.MA:.....................................................................................................................................................106
8.15.3.SORSECONDS:......................................................................................................................................106
8.15.4.MIN:....................................................................................................................................................106
8.15.5.MGY/MGY/MIN:(ACTIVEONLYONSYSTEMMANUFACTUREDAFTERJUNE10,2006)........................................107
8.16LASERAIMINGDEVICE............................................................................................................................107
8.16.1.RANGEOFAPPLICATIONS..................................................................................................................107
8.16.2.POSITIONINGAID...............................................................................................................................108
8.17DOSEDISPLAYFORAKRANDACCUMULATEDAIRKERMA.....................................................................108
8.17.1.AKR/CUMULATIVEAIRKERMADOSEDISPLAY(ACTIVEONLYONSYSTEMMANUFACTUREDAFTERJUNE10,2006)..108
8.17.2.DISPLAYFUNCTIONS:.........................................................................................................................108
8.17.3.DOSEDISPLAYUSER/OPERATOR........................................................................................................108
8.17.4.RESETDOSEDISPLAY..........................................................................................................................109
8.18IMAGEFILTERS:......................................................................................................................................110
8.18.1.RTE(REAL‐TIMEEDGEENHANCEMENT)............................................................................................110
8.18.2.NOISEREDUCTION.............................................................................................................................110
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8.18.3.LIHNOISE(LASTIMAGEHOLDNOISE)...............................................................................................111
8.19AUTOFUNCTIONS...................................................................................................................................111
8.19.1.SETTINGAUTOSTORE:.......................................................................................................................111
8.19.2.AUTOOFF...........................................................................................................................................112
8.19.3.AUTOSTORE......................................................................................................................................112
8.19.4.AUTOTRANSFER................................................................................................................................112
8.19.5.EXITAUTO..........................................................................................................................................112
8.20POSTPROCESSINGFUNCTIONS..............................................................................................................112
8.20.1.W/L(WINDOWLEVEL).......................................................................................................................113
8.20.1.1.ADJUSTINGWINDOW........................................................................................................................113
8.20.1.2.ADJUSTINGLEVEL..............................................................................................................................113
8.20.1.3.USINGTHEWINDOW/LEVELFUNCTION............................................................................................113
8.20.2.INVERT...............................................................................................................................................114
8.20.3.IMAGECROP......................................................................................................................................115
8.20.4.ZOOM(DIGITALMAGNIFICATION)....................................................................................................116
8.21SELECTINGTHUMBNAILIMAGES............................................................................................................118
8.21.1.THUMBNAILS.....................................................................................................................................118
8.21.2.TOVIEWORSELECTASPECIFICIMAGES...........................................................................................118
8.21.3.DELETEIMAGE(ACTIVEONLYWITHSYSTEMSHAVINGSOFTWAREVERSION2.5.0ORABOVE)......119
8.21.4.STORETOORMAKEACOPYOFANIMAGE.......................................................................................119
8.22MONITORIMAGEDISPLAYS....................................................................................................................121
8.23DIRECTRADIOGRAPHYOPTION..............................................................................................................122
8.23.1.OVERVIEW:........................................................................................................................................122
8.23.2.FITTINGTHEFILMCASSETTEHOLDER...............................................................................................122
8.23.3.MANUALSETTINGS............................................................................................................................122
8.24MAKINGADIRECTRADIOGRAPHICEXPOSURE(OPTIONAL)..................................................................122
8.24.1.SETTECHNIQUEFACTORS:.................................................................................................................124
9.0CINE&DIGITALSUBTRACTIONMODE....................................................................................................125
9.1DSA/CINEFUNCTIONS.................................................................................................................................125
9.2CINEANDDSANAVIGATIONBUTTONS.......................................................................................................127
9.3PERFORMINGDSA.......................................................................................................................................127
9.4STORINGOFDSA/CINEIMAGES..................................................................................................................128
9.5STORINGINDIVIDUALIMAGESTOTHEPATIENTFILEDIRECTORY..............................................................129
9.6CINEFUNCTIONS.........................................................................................................................................129
9.6.1.CINEMESSAGES......................................................................................................................................129
9.6.2.IMAGESTOP/PLAYANDSTEP.................................................................................................................130
9.7PERFORMINGCINEACQUISITION...............................................................................................................130
9.7.1.ACQUIRINGANEWCINERUN................................................................................................................131
9.7.2.IMAGESTEP............................................................................................................................................131
10.0PATIENTFILEOPERATIONS.................................................................................................................133
10.1PATIENTFILEOVERVIEW........................................................................................................................133
10.2NEWPAT(NEWPATIENT).......................................................................................................................135
10.3NEWPATIENTENTRY..............................................................................................................................135
10.3.1.PATIENTNAME..................................................................................................................................135
10.3.2.FACILITYNAME..................................................................................................................................136
10.3.3.ESCAPE(ESC).....................................................................................................................................136
10.4NONAMEFOLDER..................................................................................................................................136
10.4.1.FUNCTION..........................................................................................................................................136
10.4.2.STORAGECAPACITY...........................................................................................................................136
10.5EDITPATIENTRECORDS..........................................................................................................................137
10.6DELETINGPATIENTRECORDS.................................................................................................................139
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10.7DELETINGPATIENTSTOFREEUPSPACE.................................................................................................140
10.8PROTECTINGAPATIENTFILE..................................................................................................................141
10.9LOGINSECURITYPERMISSION...............................................................................................................142
10.10IMAGEEXPORT.......................................................................................................................................143
10.10.1.OVERVIEWOFTHEUSBANDDVDEXPORTFUNCTIONS:...................................................................144
10.10.2.ENTERARCHIVE.................................................................................................................................146
10.10.3.IMAGEARCHIVESCREENBUTTONDESCRIPTION:.............................................................................147
10.10.4.SELECTINGIMAGEFORMAT:.............................................................................................................151
10.10.5.SELECTPATIENTIMAGESFOREXPORT:.............................................................................................152
10.10.6.USBMEMORYDEVICEPROBLEMS(THUMBDRIVE)...........................................................................153
10.10.7.OPTIONAL:SENDDICOMIMAGESTOTHEPAC’SSERVER.................................................................154
10.11PATIENTFOLDERS:..................................................................................................................................155
10.12CONFIGURINGSYSTEM:(CONFIG)..........................................................................................................156
10.12.1.ERASINGDISKANDACTIVATINGDATABASEAFTERERASEDISKOPERATION...................................156
10.13SETTINGUSER/ADMINISTRATIVELOGINPERMISSIONS........................................................................161
10.13.1.RESTRICTIONS:...................................................................................................................................161
10.13.2.SETTINGUSERPERMISSIONS.............................................................................................................163
10.13.2.1.DELETESINGLELOGINPERMISSION:............................................................................................163
10.13.2.2.DELETEALLPERMISSIONS:............................................................................................................164
10.13.2.3.SAVEANDCLEAREXPORTLOGFILES:...........................................................................................164
10.13.2.4.SETTINGTIMEANDDATE:.............................................................................................................166
10.13.3.SETUPSERVICEKEYANDSERVICELOGIN.........................................................................................167
10.13.4.SETUPSERVICEKEYANDSERVICELOGIN.........................................................................................168
11.0ZIEHMQUANTUMOPTIONALTRANSPORTBRACKETS........................................................................169
11.1FLOORMOUNTEDINSTALLATION..........................................................................................................169
11.2SHIPPINGLOCKSINSTALLATION.............................................................................................................174
11.3SHIPPINGLOCKSREMOVAL....................................................................................................................178
11.4FLOORMOUNTEDREMOVAL.................................................................................................................178
11.5MONITORTRANSPORTCONTAINER.......................................................................................................179
12.0TECHNICALDATA...............................................................................................................................181
12.1SAFETYCLASSIFICATION.........................................................................................................................181
12.1.1STATEMENTOFCOMPLIANCEIECSTANDARDS:................................................................................181
12.1.2FDAPRODUCTCLASSIFICATIONNAME/CODE:................................................................................181
12.2TECHNICALSPECIFICATION.....................................................................................................................181
12.3X‐RAYGENERATORX‐RAYGENERATOR,HOUSINGANDTUBEWITHBEAM‐LIMITINGDEVICE.............183
12.4MECHANICS............................................................................................................................................184
12.5C‐ARMOVERALLDIMENSION.................................................................................................................186
12.5.1.CONVERSIONTABLEMMTOINCHES.................................................................................................186
12.6SCATTEREDRADIATIONINTHESIGNIFICANTZONEOFOCCUPANCY....................................................187
12.7LASERALIGNMENT.................................................................................................................................188
12.8DOSEAKRANDCUMULATIVEAIRKERMAMEASUREMENT...................................................................188
12.8.1.CALIBRATIONOFCALCULATEDDOSEMEASUREMENT21CFR1020.33(K)(4)(II)...............................................188
12.8.2.AKR/CUMULATIVEDOSEDISPLAYCALCULATION............................................................................188
12.8.3.TESTINTERVAL:..................................................................................................................................189
12.8.4.OPERATORMONTHLYTESTPROCEDURE:.........................................................................................189
12.8.5.TESTRESULTS:....................................................................................................................................190
12.8.6.DOSECALIBRATIONPOINT:...............................................................................................................190
12.9HEAT/COOLINGCAPACITY......................................................................................................................192
12.10ANATOMICALPROGRAMKV/MADOSECURVES....................................................................................192
13.0INSPECTION&MAINTENANCE...........................................................................................................197
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13.1ROUTINECHECKSTOBEPERFORMEDBYTHEUSER..............................................................................197
13.1.1SYSTEMINSPECTION..........................................................................................................................197
13.1.2TABLEOFREGULARCHECKS..............................................................................................................197
13.2TESTRECORDING....................................................................................................................................197
13.3VERIFYAUTOMATICDOSERATECONTROL............................................................................................198
13.4CHECKINGTHEUSEFULBEAM................................................................................................................198
13.4.1.INSPECTIONINTERVAL.......................................................................................................................198
13.4.2.CENTERING........................................................................................................................................198
13.5COLLIMATORDIAMETERACCURACY......................................................................................................198
13.5.1.GETTERINGTHEIMAGEINTENSIFIERTUBE.......................................................................................199
13.5.1.1.TOGETTERTHEIMAGEINTENSIFIERTUBE,DOTHEFOLLOWING:....................................................199
13.6PREVENTATIVEMAINTENANCE..............................................................................................................199
13.7CDRHMAINTENANCE.............................................................................................................................200
14.0CLEANING,DISINFECTION,STERILIZATION..........................................................................................201
14.1PREPARATION.........................................................................................................................................201
14.2CLEANING...............................................................................................................................................201
14.2.1.RECOMMENDEDDETERGENTS..........................................................................................................201
14.2.2.CLEANINGTHEMONITORSCREENS...................................................................................................201
14.3DISINFECTIONSTERILIZATION................................................................................................................201
14.3.1.RECOMMENDEDDISINFECTANTS......................................................................................................201
14.3.2.NOALCOHOLORSAGROTAN.............................................................................................................201
14.3.3.NODISINFECTINGSPRAYS.................................................................................................................201
15.0APPENDIXLABELS..............................................................................................................................203
16.0APPENDIXERRORCODES...................................................................................................................215
16.1ERRORANDALERTMESSAGES...............................................................................................................215
16.2ERRORSDURINGNORMALUSE..............................................................................................................215
16.3TABLE4:LISTOFC‐ARMSTANDERRORCODES.....................................................................................215
17.0GLOSSARY.........................................................................................................................................217
About this Manual
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About this Manual
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ABOUT THIS MANUAL
This manual is designed to enable owners and operators of a ZIEHM
QUANTUM c-arm to operate the systems described herein safely and
efficiently. This manual is written for Service Engineers, System Users,
Equipment Owners, and Hospital Administrators, and all other individuals
responsible for the safe operation of x-ray equipment. All are responsible for
carefully reading this manual, paying special attention to Warnings, Cautions,
and Notes. Operator must read and be familiar with this material before
operating this equipment.
Purpose of this
manual
ZIEHM QUANTUM Software Package
•Software and Optional modules
•Options: Image formats, laser alignment device
•External storage DICOM, USB and DVD
•Option: Sequential Imager Capture (CINE)
•Option: Digital Subtraction Angiography (DSA)
Scope of validity
of this manual
For several system options, separate operating instructions are available. They
are supplied with the system, provided that the system configuration includes
the respective option. You will find a corresponding reference in the relevant
sections of the manual.
Separate
operating
instructions
Copyright
Copyright © 2005 Ziehm Imaging, Inc. of All rights
reserved. Transmission or reproduction of this
manual, exploitation and disclosure of its contents
to third persons is not permitted without express
written consent of the manufacturer. Infringements
shall entitle to damage claims.
Quality Standards
This manual was produced in compliance with the
quality principles ISO 13485:2003, IEC 60601, and
UL:60601. The information provided in this manual
may be updated at regular intervals and is subject to
change without prior notice.
Registered Trademarks
This manual may contain the names of registered
trademarks or brands, the use of which by third
persons for their purposes may infringe the rights of
their respective owners.
Manufactured by:
In the U.S.A.: Ziehm Imaging, Inc.
4181 Latham Street
Riverside, CA 92501
About this Manual
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Section 1.0
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1.0SAFETY & RESPONSIBILITIES
This manual does not constitute a complete catalog of all safety and responsibility measures
necessary for the operation of the respective medical equipment, since special operating
conditions may require further measures. However, it does contain an overview of
responsibilities and instructions that must be observed in order to ensure the personal safety of
operating staff and patients as well as avoiding damage to property when operating the ZIEHM
QUANTUM Mobile C-Arm. These are highlighted as follows:
WARNING
This is the highest level of risk. Personal injury or damage to property may
occur if the operator does not observe the instructions provided here.
CAUTION
This means that a situation exists which may require a decision or action on
the part of the user for optimum equipment performance or to avoid a minor
hazard.
NOTE
Notes are informative. Additional useful information and hints are provided
for the operator here.
1.1 INTENDED USE
The ZIEHM QUANTUM Mobile C-arm, is a medical device intended for fluoroscopic imaging
in the field of surgical procedures, e.g. trauma, orthopedics, neurology, urology, pain
management, gastroenterology, ERCP, simple peripheral vascular and limited interventional
procedures such as pacemakers.
Third-party devices and components used in combination with the system must comply with the
safety requirements according to IEC 60601-1 and/or IEC60601-1-1 or furnish proof of an
equivalent degree of safety before use.
Proper and safe operation of the system requires adequate transportation, storage, assembly and
installation as well as appropriate use and maintenance. The limiting values indicated in this user
manual must not be exceeded; this applies also when putting the system into service.
1.2 OPERATION (U.S.A.)
In the U.S.A., Federal law restricts use of this device to trained personnel on the order of a
physician.
1.3 AUTHORIZED PERSONNEL
Only authorized personnel are allowed to assemble and/or repair the medical equipment described
in this manual. Authorized personnel are persons who have attended an appropriate training
course provided by the manufacturer.
Section 1.0
MAN 06–0017H ZIEHM QUANTUM User’s Manual Page 14 of 220
1.4 EQUIPMENT OWNER RESPONSIBILITIES
The Equipment Owner is responsible for ensuring that the x-ray system complies with the
applicable sections of CFR 21, Subchapter J - Radiological Health. Compliance is periodically
verified by subjecting the system to various test procedures defined by the Center for Disease and
Radiological Health (CDRH).
The Equipment Owner is responsible for ensuring that only persons who are trained and qualified
are allowed to operate the x-ray system.
When required, System Users must obtain credentials from local, state, and federal authorities
before operations of the device.
If the system fails to operate correctly, or fails to respond to system controls as outlined in this
manual, notify the local, authorized Ziehm Imaging, Inc. dealer representative.
1.5 HOSPITAL ADMINISTRATION
Hospital Administration is responsible for verifying that the equipment continues to operate
within the correct calibration of mA, kV, time/mAs, and alignment of the useful beam.
Hospital Administration is responsible for ensuring that the system complies with applicable
local, federal, statutory, and regulatory requirements. Hospital administration is responsible for
consulting with local, state, and federal agencies regarding requirements and regulations
applicable to the system’s use.
Ziehm Imaging, Inc. assumes no responsibility or liability for after-sale operating and safety
practices and is not responsible for personal injury or damage resulting from the misuse of its
systems.
If you have any safety-related questions, contact your authorized Ziehm Imaging, Inc. dealer
representative.
1.6 MANUFACTURER
The manufacturer is responsible for the safety, reliability and efficiency of the equipment only
when:
•Installation, alterations or repairs are carried out by persons authorized by the manufacturer.
•The electrical installation in the room in which the ZIEHM QUANTUM is used
corresponds to the power requirements listed in Appendix A.
•The equipment is used in accordance with this manual and the operator follows said manual.
1.7 EXCLUSION OF LIABILITY
The manufacturer accepts responsibility for the safety, reliability and performance of the system
only if;
•Any installation, modification or repair work is carried out exclusively by persons
authorized by the manufacturer;
•The electrical installation of the room where the system is operated complies with the
requirements of VDE 0107, or the corresponding national regulations of the respective
Section 1.0
MAN 06–0017H ZIEHM QUANTUM User’s Manual Page 15 of 220
country;
•The system is used in accordance with the User Manual.
The warranty becomes invalid when any repair, modification, or installation work is carried out
by unauthorized personnel. No consequential damages will be accepted either. The equipment
conforms to Class IIb according to the Council Directive 93/42/EEC. This User Manual has been
written and reviewed originally in German and translated.
1.8 USA REGULATORY RESPONSIBILITIES
1.8.1 SERVICE ENGINEERS/TECHNICIAN
Service Engineers/Technicians are responsible for installing, calibrating, and maintaining the C-
Arm system. In order to be qualified to perform the procedures described in the Service Manual,
Service Engineers must attend formal training provided by Ziehm Imaging, Inc. (hereafter
referred to as the manufacturer).
1.8.2 SYSTEM USERS
System Users are responsible for reading and following each section of this manual that applies to
them. The user should not attempt any procedures in this manual that are described as a service
task. USERS shall contact manufacturer to perform service related tasks described in this manual.
1.9 CDRH REPORT
The CDRH Maintenance Manual contains or may refer to test procedures that the Center of
Disease and Radiological Health (CDRH) requires to be performed as the system is installed and
prior to customer acceptance. A list of the equipment required to conduct these tests is included.
Use only this equipment, or approved substitutes. This manual includes reference to forms for
recording required tests. Make copies of these forms and safeguard the original. As tests are
conducted, record the results onto a blank copy of the form. Keep the original, and send a copy to
the manufacturer at the following address: Ziehm Imaging, Inc.; 4181 Latham Street; Riverside,
CA 92501. If you have any questions concerning testing, call the manufacturer at: 951-781-2020,
and ask for the Service department. Maintain original copies of completed forms for future
reference.
1.10 PROBLEMS
If System Users have an equipment-related problem, they must immediately stop using the
system and notify a Service Engineer. The system must not be operated until repairs have been
made and the proper functioning of the system is verified.
1.11 REGULATORY /NOTIFIED BODY
Ziehm Imaging, Inc. USA
1. The Food and Drug Administration (FDA) is our Regulatory Body.
1.12 RECORD KEEPING USA
Service Engineers are responsible for:
Section 1.0
MAN 06–0017H ZIEHM QUANTUM User’s Manual Page 16 of 220
1. Completing the records listed below,
2. Filing the original, and for
3. Forwarding copies to the indicated recipient.
Record When Required Recipient
Service log Whenever any service is
performed on the system
•
Original to Service files.
•Copy to Manufacturer for
DHR
FDA Form 2579,
Report Of Assembly
Diagnosis X-Ray
System
Whenever the system is
installed, or when any of the
following certified
components are replaced or
added:
• New system
• X-ray tube housing, high-
voltage generator
• Beam-limiting assembly
• Image receptor
• X-ray control unit
Original to Service files.
Copies to:
•FDA
• Manufacturer
• State
• Hospital
Must be filed within 15 days
Equipment
Locator Card When system installation is
complete
•
Original to Service files.
•Copy to Manufacturer for
DHR
Section 2.0
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2.0 SYSTEM OVERVIEW SECTION
2.1 FIELDS OF APPLICATION
The ZIEHM QUANTUM is a Mobile C-Arm X-Ray System with Image Intensifier which is
suitable for all surgical applications, pain management, traumatology, orthopedics, neurology,
urology, gastroenterology, ERCP, simple peripheral vascular and simple interventional
procedures such as pacemaker.
2.2 FEATURES
2.2.1 MOBILITY
With its compact design and combined steering & braking system, the ZIEHM QUANTUM
offers the operator unrestricted mobility in positioning at the operating table, even if space is
scarce.
The easy adjustability and accurate counterbalancing of the ample C-Arm profile and stand
makes it possible to access even the most difficult positions.
2.2.2 ORGAN PROGRAMS
Computer-controlled anatomical programs ensure optimal exposure rate and image quality
control as well as high operating comfort. A “LP”’ program for visualization of larger adipose
patients and a ‘Metal’ program for suppressing image flare resulting from the use of metal
implants and surgical instruments complete the automatic functions.
2.2.3 RADIATION REDUCTION
The superior penetration capabilities of the ZIEHM QUANTUM High-Frequency Generator
enable a significant reduction in the patient skin dose.
Radiation-free digital image rotation is provided by the system’s state of the art image processing.
LPD operation allows larger adipose patient penetration without incorporating boost or high mA
modes of radiation.
2.2.4 IMAGE QUALITY
18" flat-panel LCD Monitors with anti-reflection coating guarantee clear flicker-free images. The
advanced LCD TFT Technology, CCD camera, 16 bit image processing, and 1K x 1K up-scan
image system matrix, provides the operator with higher resolution images.
2.2.5 IMAGE ADJUSTMENT
Comprehensive real-time image processing functions, customizable noise and area filtering,
electronic contrast and brightness adjustment, zooming, radiation-free horizontal and vertical
image reversal, digital image rotation ensure perfect adaptation of the image quality and
orientation on the screen to the surgeon’s needs.
Further image processing functions are available for saved images by means of Post-processing.
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2.2.6 IMAGE MANAGEMENT
A patient-based image management system providing an image Mosaic (thumbnails) view and
menu-controlled user guidance guaranties efficient image data handling.
2.2.7 DOCUMENTATION AND OUTPUT
For documentation purposes, optional USB image port is available, as well as an optional DVD
re-writer allowing film less archiving in PC compatible full resolution digital BMP image format.
You also have the option to save your images in DICOM format and/or other optional image
formats depending on system configurations. Patient-related data, data (e.g. the fluoroscopy
parameters) are included in the stored image. In addition, all systems have a video BNC output.
2.2.8 NETWORKABILITY
The optional DICOM 3.0 interface (Quantum FlexNet) enables integration into any network
supporting DICOM 3.0, e.g. PACS. Thanks to “Primary Capture” support, the original
fluoroscopic images can be archived without changes to the image that may have been applied to
them later. The following DICOM Classes are available:
-Storage
-Work list
-Print
WARNING
Do not touch the USB or DICOM ports and the patient at the same time. Failure to
observe this warning may result in serious injury to patient or operator.
WARNING
Accessory equipment connected to the analog and digital interfaces must be
certified to the respective IEC standards (i.e. IEC 60950 for data processing
equipment and IEC 60601-1 for medical equipment.) Furthermore, all
configurations shall comply with the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input part or signal
output part configures a medical system, and is therefore responsible that the system
complies with the requirements of IEC 60601-1-1. If in doubt, consult the technical
services department of your local representative.
2.3 OPTIONS
This manual describes a system with maximum configuration. The system configuration chosen
by you may not contain all options and functions described here.
The following options can be integrated into the system upon request:
-The DICOM 3.0 interface ZIEHM QUANTUM FlexNet (Primary Capture)
Depending on the system configuration chosen, the following functions, features and
DICOM Classes are supported:
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-DICOM
-Print Class
-Storage Class including multi-frame capability
-Media Class (images for DSA and Cine sequences)
-Worklist Class
-Laser targeting device on the generator and/or image intensifier
-USB DVD writer
-CINE with 5/10/15 frames per second (15 frames per second only with DSA option)
-DSA with final Max Opacification (MSA) image on reference monitor.
-Additional image storage: 1000/5,000/10,000/20,000 images (20,000 images only with
DSA option)
-USB Port using certified USB 2.0 USB Memory storage device
-Image export of AVI image format for motion studies (Cine)
-JEG, BMP and DIOCM 3.0 media image formats. (Available image formats vary
depending on system configurations)
WARNING
Do not touch the USB or DICOM ports and the patient at the same time. Failure to
observe this warning may result in serious injury to patient or operator.
WARNING
The Optional USB port does not support externally powered USB devices.
WARNING
Accessory equipment connected to the analog and digital interfaces must be certified
to the respective IEC standards (i.e. IEC 60950 for data processing equipment and
IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply
with the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input part or signal
output part configures a medical system, and is therefore responsible that the system
complies with the requirements of IEC 60601-1-1. If in doubt, consult the technical
services department of your local representative.
2.4 OPTIONAL ACCESSORIES
The following accessories are optionally available for the ZIEHM QUANTUM:
-Sterile disposable covers
-Radiographic Cassette holder
Section 2.0
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ZIEHM QUANTUM
User’s Manual Page 20 of 220
2.5 PARTS OF THE SYSTEM
2.5.1 C-ARM STAND
Fig 2.1: ZIEHM QUANTUM Mobile Stand
2.5.2 TWIN FLAT PANEL MONITORS
On the rear side of each flat-screen monitor, there is an ON/OFF
switch.
ON OFF
NOTE
Newer models may not have the Power Switch.
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