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Ziehm Imaging, Inc. QUANTUM User Manual Download Page 200

 

Section 13.0

 

MAN 06–0017H 

ZIEHM QUANTUM

 User’s Manual    

Page 200 of 220 

•

 

cables condition  

•

 

mechanical movements and limits  

•

 

laser power supply voltage tests (as applicable)  

•

 

laser alignment (as applicable)  

 

13.7

 

CDRH MAINTENANCE 

For information on requirements imposed by the FDA, please refer to the CDRH Maintenance 
Manual & Report. 

 

Summary of Contents for QUANTUM

Page 1: ...ZIEHM QUANTUM USER S MANUAL...

Page 2: ...Table of Contents MAN 06 0017H ZIEHM QUANTUM User s Manual Page 2 of 220...

Page 3: ...IATION REDUCTION 17 2 2 4 IMAGE QUALITY 17 2 2 5 IMAGE ADJUSTMENT 17 2 2 6 IMAGE MANAGEMENT 18 2 2 7 DOCUMENTATION AND OUTPUT 18 2 2 8 NETWORKABILITY 18 2 3 OPTIONS 18 2 4 OPTIONAL ACCESSORIES 19 2 5...

Page 4: ...5 3 7 ENVIRONMENTAL COMPATIBILITY 36 4 0 UNPACKING INSTALLATION 37 4 1 INSTALLATION PROCEDURE 37 4 1 1 AUDIENCE 37 4 1 2 DETAILED INFORMATION 37 4 1 3 ROOM TEMPERATURE 37 4 1 4 SHIPPING CONTAINER UNPA...

Page 5: ...CIAL CHARACTERS 73 6 7 MOBILE STAND CONTROL KEYBOARD 74 6 7 1 MAIN KEYBOARD ELEMENT GROUPS 74 6 8 MOBILE STAND CONTROL KEYBOARD TABLE 75 6 9 SWITCHING ON THE ZIEHM QUANTUM 81 6 10 SWITCHING OFF THE ZI...

Page 6: ...NG SAVING 101 8 13 STORE USB IMAGE 102 8 14 MOBILE STAND AND TOUCH INFORMATION DISPLAYS 103 8 14 1 KV DISPLAY 104 8 14 2 MA DISPLAY 104 8 14 3 EXPOSURE TIME S 104 8 14 4 CGYCM2 ERROR 104 8 14 5 MIN FL...

Page 7: ...GE DISPLAYS 121 8 23 DIRECT RADIOGRAPHY OPTION 122 8 23 1 OVERVIEW 122 8 23 2 FITTING THE FILM CASSETTE HOLDER 122 8 23 3 MANUAL SETTINGS 122 8 24 MAKING A DIRECT RADIOGRAPHIC EXPOSURE OPTIONAL 122 8...

Page 8: ...VICE KEY AND SERVICE LOG IN 167 10 13 4 SETUP SERVICE KEY AND SERVICE LOG IN 168 11 0 ZIEHM QUANTUM OPTIONAL TRANSPORT BRACKETS 169 11 1 FLOOR MOUNTED INSTALLATION 169 11 2 SHIPPING LOCKS INSTALLATION...

Page 9: ...BE 199 13 5 1 1 TO GETTER THE IMAGE INTENSIFIER TUBE DO THE FOLLOWING 199 13 6 PREVENTATIVE MAINTENANCE 199 13 7 CDRH MAINTENANCE 200 14 0 CLEANING DISINFECTION STERILIZATION 201 14 1 PREPARATION 201...

Page 10: ...About this Manual MAN 06 0017H ZIEHM QUANTUM User s Manual Page 10 of 220...

Page 11: ...stem 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 referen...

Page 12: ...About this Manual MAN 06 0017H ZIEHM QUANTUM User s Manual Page 12 of 220...

Page 13: ...ovided 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...

Page 14: ...atutory 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 Zi...

Page 15: ...ed 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...

Page 16: ...o 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...

Page 17: ...essing 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 QUANT...

Page 18: ...ter 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...

Page 19: ...e 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 powe...

Page 20: ...l 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 O...

Page 21: ...same time Fig 2 2 Power Switch On Flat Panel Monitors 2 5 3 MONITOR POSITION Movement of the Flat Screen Monitors The flat screen Monitors are mounted on a pivot and can be swiveled by approximately...

Page 22: ...tor Pivot CAUTION The Optional Quick Release mounting of the Flat screen Monitors are on a pivot and can be swiveled approximately 320 degrees please use caution when moving the monitors as collision...

Page 23: ...n the screens Live monitor Live images and transferred images Cine DSA loops as full screen image Reference monitor The reference images are full screen size with a Thumbnail mosaic on the lower part...

Page 24: ...actory settings The factory set menu language is English The following monitor settings cannot be changed by the user Video input Inputs Gamma Picture settings Picture e g vertical position horizontal...

Page 25: ...rast of the monitor do the following Press the Brightness Contrast button twice The Contrast menu appears on the screen Set the value to 69 for Contrast Contrast Press the Plus or Minus button to incr...

Page 26: ...appears automatically NOTE Lowering the backlight level will increase the backlight lifetime 2 5 6 4 SETTING THE MENU LANGUAGE The factory set menu language is English You can choose one of the follow...

Page 27: ...items are displayed immediately in the chosen language Press the Menu button The menu selection window disappears 2 5 6 5 RESTORING THE FACTORY SETTINGS After having changed the monitor settings you m...

Page 28: ...ft monitor image The image live Left monitor image is available for use with Video Printers Sony 980 or 960 WARNING Any supplementary third party devices and or components used in combination with the...

Page 29: ...ed personnel are allowed to assemble the system and to provide technical service The necessary qualifications can only be obtained by attending a training course provided by the manufacturer 3 1 3 WAR...

Page 30: ...leakage from the generator housing Only authorized personnel should operate or direct the operation of this equipment Persons become authorized in part by becoming completely familiar with and adherin...

Page 31: ...esult in death or serious injury to the operator and or patients 3 3 1 ELECTRICAL SAFETY Only allow properly trained and qualified service personnel to access any internal parts Live electrical termin...

Page 32: ...per or disable safety interlocks Before cleaning the equipment ALWAYS unplug the AC power cable from the wall If liquid drips into system equipment it will cause electrical short circuits that may res...

Page 33: ...e Stands and its integrated components such as monitor touch screen USB image storage devices are not AP version They may not be used in the presence of flammable gasses WARNING Any Supplementary thir...

Page 34: ...mful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installation If this equipment causes harmful interference to other de...

Page 35: ...s maintenance free Any adjustment or repair which might become necessary must be carried out be the manuafacturer or a person who has been authorized to do so by the manuafacturer Figure 3 1 Laser Bea...

Page 36: ...t or repair work becomes necessary it must be performed by the manufacturer or other authorized persons Figure 3 2 Position of Visible Laser Light Window and Labels 3 7 ENVIRONMENTAL COMPATIBILITY The...

Page 37: ...put into service in order to avoid damage to the system as a result of condensation WARNING Do not operate the system until the equipment has reached a safe operating temperature of 15 C to 35 C with...

Page 38: ...the unloading ramp into position 4 Remove the metal brackets that hold the C Arm mobile stand to the pallet Take care not to scratch the mobile stand 5 Remove the two straps that hold the monitors an...

Page 39: ...Section 4 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 39 of 220 4 2 MOUNTING MONITORS Fig 4 1 C Arm in the Transport Position...

Page 40: ...Video BNC Connectors to their respective monitor 7 Attach the Safety ground wires to the rear panel of the monitors 4 2 2 MOUNTING QUICK RELEASE MONITORS The monitors are the only components that need...

Page 41: ...mly grasp the outside out of each monitor Step 2 Place monitor over bayonet mounting Step 3 Wiggle monitor a little bit to seat the connector Step 4a Now lock the monitor to the pivot arm assembly Ste...

Page 42: ...n damage to the system s electronic components Wired for 120VAC 20 amps 4 4 PREPARING THE SYSTEM Before switching on the system e g during initial installation or after transport you must connect the...

Page 43: ...the two switches Buttons numbered 3 and 4 Fig 4 2 C Arm Mobile stand control keyboard Make sure that the inclination of the system does not exceed 5 from the level in operating position Ensure that a...

Page 44: ...r leakage current using a calibrated leakage meter in the following manner 1 Inspect ground leads to ensure that ground connections are solid 2 Insert the meter with 100 ohm input impedance in series...

Page 45: ...live image appears on the left monitor 2 When exposure occurs either during fluoroscopy or radiography the amber light on top of the left monitor lights up and the radiation indicator on the C Arm con...

Page 46: ...for the U S A 0 Power cable 7 5 m 1 Equipotential bonding conductor 6 m 1 Options USB DVD writer Option DVD CD DVD 4 7 GB actual memory size may vary CD 74GB actual memory size may vary 1 DICOM Option...

Page 47: ...g 5 1 and Fig 5 2 Swivel the horizontal carriage into a central position and secure it with the relevant brake See Fig 5 1 and Fig 5 2 Retract the horizontal carriage completely and secure it with the...

Page 48: ...onitor support arm pivot locks as show in Fig 5 2 may result in serious injury to patient or operator CAUTION System should never be operated on floors with an inclination greater than 5 from level Th...

Page 49: ...using damage to the equipment Exercise extreme caution when moving the ZIEHM QUANTUM mobile C arm stand over rough surfaces such as asphalt paving as this will cause damage to the wheels WARNING Opera...

Page 50: ...LABELS Labels are mounted and visible on the monitor arm and pivot lock areas NOTE Make sure all monitor pivot locks are correctly set for operation of the mobile stand Placement of the monitors on t...

Page 51: ...Section 5 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 51 of 220 5 1 2 TRANSPORT POSITION FOR ZIEHM QUANTUM...

Page 52: ...o maneuver the C arm stand freely ensure that the steering braking lever has engaged in its central position pointing directly backwards from the unit See Fig 5 3 To move the C arm stand in an exactly...

Page 53: ...separate brake is available allowing you to secure the C Arm in any position To release the corresponding brake turn it counter clockwise The limit stop of the brake handles can be adjusted individual...

Page 54: ...rol by holding on to and then slowly releasing the mechanical locks before moving any of the mechanical components of the ZIEHM QUANTUM mobile C arm Failure to observe this warning may result in serio...

Page 55: ...al carriage A scale with 10 divisions is provided at the pivot joint of the horizontal carriage to facilitate precise positioning Fig 5 5 Angulation of the C Arm NOTE Rotation Brake for angulations is...

Page 56: ...Panning function for the c arm you may need to reposition the monitors for a clear view of the image displays 5 3 4 HORIZONTAL MOVEMENT You can move the C arm forward and backward by 22 cm in the hori...

Page 57: ...The lower limit position for vertical travel uses a safety override switch located on and just forward of the UP and Down vertical travel buttons located on the mobile stand console Normal operation...

Page 58: ...ion 5 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 58 of 220 Fig 5 8 Vertical movement of C Arm CAUTION Before moving the C arm up or down make sure that it does not collide with any persons or obj...

Page 59: ...selected function different buttons display fields and input fields will appear on the screen NOTE The DeskView touch screen offers automatic display of relevant buttons and removes all but the button...

Page 60: ...Images Reset Button Patient Demographics Cine DSA modes Store Functions Manual KV Img Scroll Page Figure 6 1 Main Touch Panel Screen 6 3 DESKVIEW MAIN SCREEN BUTTONS The Main screen is displayed in t...

Page 61: ...ABLE Control No Symbol s Description Button 1 New Patient Activates the new patient entry screen Enter new patient information and set other parameters for patient demographics Button 2 Delete Image D...

Page 62: ...d without permission HIPAA Button 5 Live Swap Activates the Live monitor swap function This simply moves the live functions from the left to the right monitor The main use of this function is to allow...

Page 63: ...pper left corner of the image and is stored with image Press button several times to mark or un mark the image Button 11 Invert Image Displays the active image positive image in a negative inverted gr...

Page 64: ...age Transfer R to L Transfers image from the right monitor to the left monitor Press the image Icon on the right to select a Reference image it will then be displayed on the right monitor then the sec...

Page 65: ...hot Button 20 Image Rotation Rotate CW Rotates the Image in Clockwise direction Rotate CCW Rotates the image in a Counter Clock Wise direction The button informs the operator to the active live monito...

Page 66: ...icated on button Button 25 Metal Activates the metal artifact correction function This supplementary to the organ program image quality Button 26 Optional Cine Activates or deactivates the cine loop m...

Page 67: ...isplays them as Thumbnail images on touch screen and full size on the reference display monitor Button 32 Image Scroll Page image scroll button displays and selects the next four higher image numbers...

Page 68: ...c timer and if pressed more than 2 seconds resets both the fluoroscopic timer and the dose area product meter value Button 37 Tube kV value Shows the automatically determined or manually set tube volt...

Page 69: ...e active patient demographic information Name ID Accession number total Cine studies Total images study name and Dr Name Button 44 Live Image Display Operator display area for live and processed image...

Page 70: ...operator doe not use the buttons in 10 Seconds the collimator selection is automatically closed Button 49 Iris Collimator shutters Press the Iris collimator buttons to close or open the collimator Ir...

Page 71: ...Section 6 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 71 of 220...

Page 72: ...during radiation are removed from the screen to assist the operator in making and effecting easier control decisions NOTE In certain modes function buttons may not be active and therefore will be remo...

Page 73: ...h the Shift key first press and release the Shift key and then the desired key 6 6 2 UPPERCASE LETTERS AND SPECIAL CHARACTERS To generate uppercase letters and special characters first press and relea...

Page 74: ...of functions than the touch screen However the same buttons on the touch screen and the mobile stand control panel affect the same function and operations enabling the operator to use the touch or mo...

Page 75: ...r than normal operating height Button 2 Laser ON OFF Activates the laser s on the generator and the image intensifier Press the button once to activate and again to turn it off or wait for automatic t...

Page 76: ...ard auto dose rate Button 9 Radiation Modes Selects Fluoroscopic mode of operation Button 10 Manual Fluoroscopy Press the manual button to lock automatic dose regulation and allow setting of manual kV...

Page 77: ...e clockwise the radiation slot collimator Button 18 Close Iris Collimator Press and hold to close the iris collimator Button 19 Open Iris Collimator Press and hold to open the iris collimator Button 2...

Page 78: ...e Desk View touch screen image mirror button Button 24 Not Active Image Mirror The Image mirror buttons do not work on this keyboard to mirror image use the Desk View touch screen image mirror button...

Page 79: ...ate function NOT ACTIVE 3 MSA pressing this button will not activate function NOT ACTIVE Button 29 Anatomical Programs Activating the button will open all four buttons for selection 1 Bone or Extremit...

Page 80: ...ents and is called LPD on the Desk View touch screen See also Button 29 Button 34 Not Active Window Level Will not activate a function this button is blocked Button 35 Tube kV value Shows the automati...

Page 81: ...Button 41 Radiation indicator Lights when radiation is active This indicator is a representative of the radiation on and may lead and follow by a 0 5 seconds of actual radiation 6 9 SWITCHING ON THE...

Page 82: ...being fully functional NOTE Always set the ON OFF switches on the flat screen monitors to ON in the order to ensure that the monitors are switched on automatically during power up of the system 6 10...

Page 83: ...UP and Down vertical travel buttons of the mobile stand console Normal operation prevents the Image Intensifier from hitting the front foot of the mobile stand In certain procedures the operator can...

Page 84: ...d pedal assignment of the two pedal foot switch is as follows Left pedal Fluoroscopy Right pedal Save Store image OPT Laser and snapshot Optional two settings can be made o Laser on off o Snapshot mod...

Page 85: ...working dose rate by approximately half Optimum adjustment for various diagnostic requirements made possible by the system s Anatomical programming Reducing dose for extended procedures through pulsed...

Page 86: ...The Touch screen ICON Thumbnails are sued to control the transfer of the images so the user operator can perform post processing functions i e magnification hard copy selection invert zoom crop etc 7...

Page 87: ...rast 69 Backlight Brightness 69 7 8 1 STEPS AND SETTINGS To perform a standard fluoroscopy you must always make the following steps and settings Create a new patient folder in the Patient File mode or...

Page 88: ...s started again NOTE When you save an image it will be saved with all rotations reversals filter settings and markers etc All the modifications to the live image when stored are visible when the image...

Page 89: ...E FLUOROSCOPY In pulse fluoroscopy mode the system emits radiation pulses as long as you press the radiation hand or footswitch Rate 3 F sec The pulse rate is fixed The lower the pulse rate setting th...

Page 90: ...itch Factory presets of 8 mA fluoroscopy and maximum image integration produce images of excellent quality To deactivate the Snapshot mode press the Snapshot again to open the touch screen fluoroscopi...

Page 91: ...n on the control keyboard of the mobile stand to maximize the system image capture Since the image will be very noisy system noise reduction will automatically engage at the highest setting In most ca...

Page 92: ...dify the filter factors for one or more organ program 7 13 METAL ARTIFACT CORRECTION The metal artifact correction function corrects a possible flaring of the fluoroscopic image resulting from metal o...

Page 93: ...automatic exposure rate control Continuous Fluoroscopy Pulsed Fluoroscopy Snap Shot Initiate radiation for a brief moment Press the Manual Exposure Rate Setting button on the mobile stand and touch s...

Page 94: ...until it is replaced by a new fluoroscopic image or a reference image is transferred to the live monitor display See Fig 7 2 7 15 2 FLUOROSCOPY FACTORS During the exposure the tube voltage and the tu...

Page 95: ...Section 7 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 95 of 220 Fig 7 2 DeskView Radiation Lamp On Image Displayed In Center Store Radiation Indicator Active Live Image Dose Air Kerma...

Page 96: ...Section 7 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 96 of 220...

Page 97: ...anel 8 2 MAGNIFICATION ELECTRO OPTICAL IMAGE INTENSIFIER The system s image intensifier can magnify images electronically Press the Mag button on the DeskView or Mobile Stand Control Panel keyboard to...

Page 98: ...ve on the mobile stand control keyboard The Touch Panel Image Mirror button is active with the live monitor and is removed from the DeskView touch panel when certain modes and functions would not be a...

Page 99: ...ton 8 7 MARK IMAGE Mark Image function turns on the R for right or L for Left anatomical marker The display is located in the touch panel display on the upper left corner of the live image display On...

Page 100: ...all image to the right monitor then touch the image icon a second time after a 1 2 to 1 sec delay to transfer image from the reference or right monitor to the live or left monitor In certain condition...

Page 101: ...2 STORING SAVING CAUTION When the hard disk is full the system will give a message that you need to delete patient images to free space on the hard disk Before saving an image make sure that there is...

Page 102: ...tor NOTE When storing images during Radiation Live fluoroscopy the images will not be displayed on the touch or the reference monitors until the fluoroscopic hand or footswitch is released This will t...

Page 103: ...alog 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 com...

Page 104: ...lay window has two functions one to show dose area product value in Grays The other function provides the user with a way to see system error codes The dose display function is not operational on the...

Page 105: ...ystem will flash the thermometer symbol at which time the system will reduce the generator mA to 0 5 mA at which time the image may become dark and noise The generator will require cooling time to rec...

Page 106: ...can be a very short time period just before and after radiation is on this is normal and is a result of having three separate back up indicators for the system There can be some cases where the radiat...

Page 107: ...The laser is a class II laser product subject to 21 CFR Subchapter J 1040 Its peak power is 1 mW and operates at a wavelength of 635 nm You must comply with all operating safety precautions when usin...

Page 108: ...splay of Air Kerma AKR or the Cumulated Air Kerma values AKR x Fluoroscopic Time automatically sets the decimal point according to the dose rate and the accumulative values depending on weather radiat...

Page 109: ...To reset the Fluoroscopy Time and Dose display press and hold the Min or Reset Time Dose button for 2 sec on the DeskView or mobile stand CAUTION Not resetting the dose display just before starting a...

Page 110: ...function with the replay of the Cine DSA image sequence or a single recalled image Press the RTE button toggles between RTE Off Low Med and High edge sharpness 1 Off 2 10 3 20 4 30 Once pressed the mo...

Page 111: ...d by certified Service personnel 8 19 AUTO FUNCTIONS The Auto function has two modes of operation You can configure the ZIEHM QUANTUM so that a new image will be stored or transferred automatically as...

Page 112: ...ted 8 19 5 EXIT AUTO To exit Auto Store functions presses the Auto Function button then select the Auto Off button 8 20 POST PROCESSING FUNCTIONS With all Post processing functions you can process or...

Page 113: ...ton changes the contrast of the video image by changing the window of gray scale It modifies the brightness of the video by changing the level of brightness within the window of gray scale When the W...

Page 114: ...and level values as the new defaults for image display press the Save W L button 6 To exit the Window Level function press the W L button again or one of the other post processing buttons to close W L...

Page 115: ...LEFT RIGHT Arrow buttons in the following manner Close Vertically press the DOWN Arrow button Open Vertically press the UP Arrow button Close Horizontally press the RIGHT Arrow button Open Horizontal...

Page 116: ...LEFT moves the Circle and the reference screen will display the area within the circle of the live monitor at the magnification factor To activate the ZOOM mode 1 Select Image or use the present image...

Page 117: ...reference monitor Press the ZOOM button or press ESC to exit the function The right monitor will continue to display the last magnified image Magnified images can be stored to the hard drive or USB st...

Page 118: ...s on the DeskView touch panel to move the selection box through the images When the selection box moves off the screen in either direction the system displays another set of images For example with im...

Page 119: ...x menu Once the image is highlighted by the selection box just press the Delete button to delete the selected image or run No message is given for a single image delete operation Confirmation Message...

Page 120: ...ference Thumbnail Images Image Scroll Arrow keys Selects the next four reference images from the patient file These keys are available only when more than 4 images are stored in the patient file Refer...

Page 121: ...LIVE SWAP button is active then the right and left monitors switches display functions and the live function display is on the right This mode of LIVE SWAP is used when the operator needs to view the...

Page 122: ...assette holder from the side Fig 8 7 Fitting The Film Cassette Holder And Inserting The Film Cassette Securing lever Film cassette Film cassette holder Image Intensifier 8 24 MAKING A DIRECT RADIOGRAP...

Page 123: ...buttons for controlling the direct radiography functions are displayed WARNING Make sure that the film cassette holder is properly attached to the image intensifier that the cassette cannot fall down...

Page 124: ...tion using the hand switch In the Radiography operating mode you cannot initiate radiation with the foot switch An audible alarm will sound throughout the entire exposure time Radiation is terminated...

Page 125: ...ate that is appropriate for the medical procedure During DSA the system will automatically display on the reference monitor a representative native image with some of the DSA special settings for CCD...

Page 126: ...Section 9 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 126 of 220 Fig 9 1 DSA touch Screen in Replay Stop Fig 9 2 DSA Flat Panel Display...

Page 127: ...Stand is not functional RSA The RSA button of the Mobile Stand is not functional 9 3 PERFORMING DSA 1 Perform a scout fluoroscopy of the anatomical region using the appropriate body region button Thi...

Page 128: ...age will be displayed during capture and replay The user cannot remove the mask from the DSA To change the capture or replay rate use the Frame Rate button to change from 1 to 15 f sec NOTE During acq...

Page 129: ...acquired at 1 to 15 fps are stored directly to the hard drive When the CINE function is selected the system does not change its image properties The C Arm stays in the fluoroscopic body region that w...

Page 130: ...cquisitions Cine Studies they are automatically stored to the Hard Drive for immediate review of the image sequences images DeskView Cine Operation Screen Fig 9 3 Touch Screen Cine Select And Replay B...

Page 131: ...luoroscopy Repeat the Cine procedure above To acquire another study cine run 9 7 2 IMAGE STEP During CINE replay image playback can be stopped and individual images can be reviewed and or stored to th...

Page 132: ...Section 9 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 132 of 220...

Page 133: ...y of the patients in the data base and perform the following operations 1 WORKLIST allows the user operator to select via a DICOM server connection the patient list and load the patient names into the...

Page 134: ...tient name and images on the display monitors To make this the active patient press the ENTER button on the right side of the text entry keyboard The system will then make this the active patient clos...

Page 135: ...ess the button next to the entry filed that you would like to enter information into After the last line has been completed you have the opportunity to review the entered data before it is added to th...

Page 136: ...entry fields press the ESC key 10 4 NO NAME FOLDER 10 4 1 FUNCTION If you have not activated a patient during power up cycle and prior to saving an image the image is automatically saved to the NO NA...

Page 137: ...he shaded area inside the bar in the center of the scroll bar to scroll through the patient files for the correct patient file To use the text entry boxes at the top of the screen press the Patient Se...

Page 138: ...t side of the keyboard to move to a patient file User must wait until the image system has displayed the patient images on the Right monitor Then user can proceed to with modifying the record Touch th...

Page 139: ...nt file to select a specific patient record Button 3 Press the Delete button from the activity menu bar on the DeskView The following message will be displayed WARNING Be sure you are deleting the cor...

Page 140: ...eleting older patient folders and or images on the hard disk Press the File button on the main touch screen to open the Patient File screen Once this screen is open the user can select a patient and d...

Page 141: ...protect a patient or many patient files by first selecting the patient on the screen then pressing the PROTECT button The system will place a mark in the far right edge of the file screen P to alert t...

Page 142: ...nd if the owner operator does not set permissions then control has not been established to limit accesses to patient s images which are medical records NOTE The user must understand that until the sys...

Page 143: ...the system is left unattended In all cases the system will not keep the Log In active if the power is turn off You must reenter your password after each power on cycle Fig 10 6 10 10 IMAGE EXPORT The...

Page 144: ...ievable media for long term image storage This could be Archival CD and DVD s or by using Optional DICOM interface or by using USB memory devices to transfer the images to a PAC S image server or to o...

Page 145: ...USB archive 200MB of data approx 2 min 20sec This assumes all images were BMB file formats and a 2 0 USB device was used and images were single frames not DSA or Cine sequences DSA Cine runs take a l...

Page 146: ...elect the FILE button from the main touch screen Once the patient file screen is open the user must select a patient that has images attached to its file by pressing one of the patients listed on the...

Page 147: ...REEN BUTTON DESCRIPTION Control No Symbol s Description Button 1 Delete Image Allows user to delete a single image from the active patient file in the Archive Screen Button 2 Delete Patient Allows use...

Page 148: ...images to a DICOM printer System has separate AE address for the printer Button 6 Optional DICOM Store The DICOM store button allows the user to send images to the hospital PAC server for archiving Sy...

Page 149: ...Play Button Allows the user to play back and stop the play back of CINE DSA image sequences When the user selects a CINE or DSA run system will start replay of the image sequence the button will then...

Page 150: ...e images in a patient file with one button Select a patient that has already been marked the press the Mark All button again to remove all the image marks in the patient file Mark Image Press the Mark...

Page 151: ...P This is a full 1 k x 1k image This provides an image with no image data lost BMP image format provides the best possible image Image size is about 3 1Mega Bytes 2 JPG This is a 512 x 512 image By it...

Page 152: ...JPG all the images saved for this particular burn to CD DVD must all be the same image format If the user wishes to save in different formats they will need to copy to USB memory stick or CD DVD with...

Page 153: ...n now use the image scroll arrow keys to move the image selection box to the image to be selected view the images on the right monitor Once the user has moved the selection box to an image they want t...

Page 154: ...es a few minutes depending on the number of images selected WARNING If the user chooses to use non medical grade CD R or DVD disks they do so at their own risk The non medical grade DVD and CD disks h...

Page 155: ...ers for the images exported to the devices The Patient folders made by the archive export function on both the DVD and USB memory Peripheral are made in a file tree structure The actual folders stored...

Page 156: ...an only be set by the system Administrator User can not set these listed functions Erase Disc this function will erase all the patient data from the system hard drive DICOM 1 and DICOM 2 Settings Set...

Page 157: ...creen The right monitor will display the image and small icon on the bottom ACTIVATING DATABASE Go to the configuration screen and perform the Erase Disk operation a second time and then turn off powe...

Page 158: ...the DICOM settings for DICOM 1 and DICOM 2 to match their DICOM port and AE TITLE information Please see example of settings for DICOM 1 2 Screen Fig 10 9 and Fig 10 10 The following are the fields a...

Page 159: ...rklist_scp IP ADDRESS 192 168 1 64 192 168 1 66 PORT 107 108 Host Name 192 168 1 64 192 168 1 66 Modality XA CR OT RF ALL XA CR OT RF ALL Pacs Type Generic McKesson NOTE McKesson Removes asterisk from...

Page 160: ...l the actual values for each must be obtained from the Information Technologies department of the facility and then entered accordingly To enter and set up DICOM services please contact your Ziehm Ima...

Page 161: ...tion screen and activating the ERASE DISK function Select and export Log In file from system gives log of patient and images as well as permission used to copy images from the system 2 User level Allo...

Page 162: ...al Page 162 of 220 Fig 10 11 Main Configuration Screen The Administrator now presses the AUTH USERS Button on the configuration screen to enter the Authorization screen to setup up user permissions to...

Page 163: ...st be more than 4 alphanumerical characters long Next select the Permission level button twice to toggle through the selection for ADMIN or USER Once the name password and permission level is set pres...

Page 164: ...delete the log file CAUTION The log file should be copied once a week to keep it from getting too large The system will stop acquiring the log files when the file reaches it maximum capacity There is...

Page 165: ...Section 10 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 165 of 220 Fig 10 13 Configuration Screen...

Page 166: ...button VERSION on the configuration screen and a message box will open with the current software versions Press OK to clear the screen you may have to do this twice SAVE The User and Administrator mu...

Page 167: ...ons will have no effect if the owner operator did not purchase certain product options Such as CINE DSA DICOM etc 10 13 3 SETUP SERVICE KEY AND SERVICE LOG IN These are for service use only and are no...

Page 168: ...oftware Log In screen Service screen requires special rights and training to set the correct values and update of software Only qualified Service Engineers can access the service areas of the configur...

Page 169: ...nting brackets are all secured through the plate and into the floor or pallet The generator cradle is also secured to the floor or pallet and securely holds the generator in place during transport The...

Page 170: ...of 220 Power up the C Arm and adjust the vertical height to 14cm Example Fig 11 2 Figure 11 2 Slowly but firmly push the front C Arm wheels up the base plate ramp while guiding the generator assembly...

Page 171: ...of 220 Adjust the steering lever to position the steering wheels at 90 degrees to the C Arm body Example Fig 11 4 Lower the vertical shaft while guiding the generator assembly into the generator cradl...

Page 172: ...017H ZIEHM QUANTUM User s Manual Page 172 of 220 Position the bracket with stencil 4 over the left wheel hub assembly Example Fig 11 6 Position the bracket with stencil 3 over the right wheel hub asse...

Page 173: ...Position the bracket with stencil 2 over the front wheel assembly Example Fig 11 8 Tighten the 2 bolts to secure the front wheel bracket to the floor mounting plate and the 3 bolts to secure the left...

Page 174: ...of 220 11 2 SHIPPING LOCKS INSTALLATION Push the shipping lock forward and while simultaneously pulling the curved portion of the bracket around the DeskView support shaft Example Fig 11 10 Tighten t...

Page 175: ...sembly into the home position and lift the lever to securely locate the DeskView to the transport position Tighten the two bolts to keep the lever in position Example Fig 11 12 Ensure the C Arm monito...

Page 176: ...AN 06 0017H ZIEHM QUANTUM User s Manual Page 176 of 220 Slip the Arm Support Shipping lock onto the horizontal arm assembly Example Fig 11 14 Flip up the lever and partially tighten into position Exam...

Page 177: ...rm into the top portion of the Arm Support Shipping lock Example Fig 11 16 Flip up the lever and secure into position and tighten bolt from step 7 above Example Fig 11 17 For removal instructions perf...

Page 178: ...y pulling the curved portion of the bracket around the DeskView support shaft Pull the shipping lock forward to remove Example Fig 11 11 11 4 FLOOR MOUNTED REMOVAL Loosen the 2 bolts that secure the f...

Page 179: ...bly from the c arm monitor arm and insert the monitor assembly into the transport container see section 4 2 2 for how to mount and un mount the monitor assembly Make sure the monitor seat fully into t...

Page 180: ...Section 11 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 180 of 220...

Page 181: ...radiation performance standards 21 CFR Subchapter J as of the date of manufacture System X Ray Fluoroscopic Image Intensifier Product Code JAA Regulation number 892 1650 WARNING The ZIEHM QUANTUM is...

Page 182: ...0 mA Line resistance 6 Ohms 6 Ohms Max operating data Fluoroscopy Generator 110 kV 6 mA 110 kV 6 mA 80 kV 6 mA 80 kV 6 mA Direct radiography 110 kV 8 mA 110 kV 8 mA 80 kV 8 mA 80 kV 8 mA Radiography 1...

Page 183: ...onditions Temperature 10 C to 60 C Relative air humidity 10 95 non Condensing max During operation Environmental Temperature 10 C to 35 C Relative air humidity 35 75 non Condensing max 12 3 X RAY GENE...

Page 184: ...ICS Weight Monitors Pair With 18 1 flat screen monitors approx 12 6 kg 18 1 flat screen monitors Screen size Resolution 460 mm 18 1 1280 1024 60 Hz During storage Conditions Temperature 10 C to 60 C R...

Page 185: ...Section 12 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 185 of 220 Fig 12 1 Focal Spot Reference...

Page 186: ...ig 12 2 12 5 1 CONVERSION TABLE MM TO INCHES MM Inches MM Inches 220 9 00 822 19 30 252 9 94 910 35 75 340 13 375 940 37 00 399 15 70 950 37 40 430 17 00 970 38 25 450 17 75 1669 66 90 490 19 30 1710...

Page 187: ...ion in the significant zone of occupancy of the C arm stand Measurement conditions in accordance with EN 60601 1 3 1994 Exposure conditions 84 kV 3 90 mA 327 W Rectangular water phantom 25 cm 25 cm 15...

Page 188: ...ctions of CFR 21 1020 30 h 6 i Compliance must be periodically verified by subjecting the system to various test procedures defined by the Center for Disease and Radiological Health CDRH including the...

Page 189: ...ivalent in the beam at approximately 30 cm from the image intensifier on top of a radiation translucent table Position the c arm image intensifier over the phantom with generator under the table makin...

Page 190: ...ical ISO point Therefore the measurement point has been determined by Ziehm Imaging Inc to be located 51 cm from the source focal spot toward the image receptor and represents the patient entry locati...

Page 191: ...Section 12 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 191 of 220 Dose Air Kerma Setup Diagram 21CFR 1020 33 k 4 ii Fig 12 4 AKR Dose Calibration Setup...

Page 192: ...ser s Manual Page 192 of 220 12 9 HEAT COOLING CAPACITY Fig 12 5 Heating curve with Active Cooling Fig 12 6 12 10 ANATOMICAL PROGRAM KV MA DOSE CURVES The Anatomical Program curve below is representat...

Page 193: ...and anatomical density Therefore we have only given this curve as an example for user to understand that KV and MA are match pairs Program 1 Pelvic kV mA Curve 1 EXAMPLE OF ANATOMICAL PROGRMA CURVE 40...

Page 194: ...Section 12 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 194 of 220 Fig 12 8 Program 2 Thorax kV mA Curve 2 Fig 12 9 Program 3 DSA kV mA Curve 3...

Page 195: ...Section 12 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 195 of 220 Fig 12 10 Program 4 Soft kV mA Curve 4 Fig 12 11 Program 0 Extremities kV mA Curve 5...

Page 196: ...Section 12 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 196 of 220...

Page 197: ...se display in rate mGy min and accumulative mGy must be within 10 of pervious monthly test values Audible alarm Monthly Must sound in direct radiography mode during the whole exposure time and in fluo...

Page 198: ...BEAM 13 4 1 INSPECTION INTERVAL Together with the consistency test it is necessary to check the size and centering of the useful X ray beam 13 4 2 CENTERING To determine the correct alignment of the r...

Page 199: ...st 1 hour Do not initiate radiation during this time We recommend keeping an operator s log where all operating times Operator s log gettering times and maintenance events are recorded 13 6 PREVENTATI...

Page 200: ...00 of 220 cables condition mechanical movements and limits laser power supply voltage tests as applicable laser alignment as applicable 13 7 CDRH MAINTENANCE For information on requirements imposed by...

Page 201: ...he unit 14 2 2 CLEANING THE MONITOR SCREENS For cleaning the monitor screens use only pure alcohol or a mixture consisting of 1 3 alcohol and 2 3 distilled water Wipe the screen and surrounding painte...

Page 202: ...Section 14 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 202 of 220...

Page 203: ...on 15 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 203 of 220 15 0 APPENDIX LABELS Fig 15 1 ZIEHM QUANTUM Label Location Label with the next to the number are only required if the system ships to C...

Page 204: ...Section 15 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 204 of 220 Fig 15 2 Generator Laser Alignment Labels...

Page 205: ...Section 15 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 205 of 220 Fig 15 3 Transport and Safety Labels Label with the next to the number are only required if the system ships to Canada...

Page 206: ...UFACTURE MAIN FUSE Used when system is connected to 120 VAC power Located left side below top cover under Label 4 1 1 MANUFACTURED MONTH ________ YEAR ______ LINE VOLTAGE 220 vac 60Hz 0 6 ohm CURRENT...

Page 207: ...this label must be attached Same location as Item 2 1 4 Located left side below top cover above label 1a or 1b 1 5 If sold in Canada this label must be attached Same location as Item 4 1 6 Location o...

Page 208: ...Located on Generator Background is Yellow in color 1 9 KEEP OUT RADIATION CONTROL AREA 1M CIRCLE DISTANCE 4M Top Desk Located on top of the Mobile stand 1 10 Please observe accompanying documents On s...

Page 209: ...stems with Laser device Background is Yellow in color Location see fig 15 2 3 15 Only on systems with Laser device Background is Yellow in color Location see fig 15 2 2 16 Only on systems with Laser d...

Page 210: ...G Location see fig 15 2 19 Laser Label for the image intensifier Only on systems with Laser device Qty 1 for Laser LC Image intensifier See Fig 15 1 20 Located on side of the Mobile Stand above XPO Co...

Page 211: ...aces Label 22 when this option is used See Fig 15 1 1 24 Protection Class 1 Type B Fig 15 1 1 25 60Hz VIDEO OUT 60Hz Video output Fig 15 1 1 26 Only on systems with DICOM option and RJ45 Connection Fi...

Page 212: ...Located on the back of the DeskView touch screen assembly Fig 15 2 1 30 Located on Generator top cover Fig 15 1 1 31 If sold in Canada this label must be attached next to item 30 Fig 15 1 1 32 Locate...

Page 213: ...35 If sold in Canada this label must be attached Located next to Item 34 Fig 15 1 1 36 Image System Label is located in side the Mobile Stand on the image system Fig 15 1 1 37 System Locks for operati...

Page 214: ...Section 15 0 MAN 06 0017H ZIEHM QUANTUM User s Manual Page 214 of 220 39 Safety Override Switch label Located on switch cover top desk Fig 15 3 2...

Page 215: ...error will not clear by pressing the foot or hand switch then you must call Customer Service for equipment diagnosis and repair 16 2 ERRORS DURING NORMAL USE Immediately stop radiation and prevent any...

Page 216: ...ce E55 Error Fault Call Customer Service E56 Error Fault Call Customer Service E57 Error Fault Call Customer Service E58 Error Fault Call Customer Service E59 Error Fault Call Customer Service E60 Err...

Page 217: ...collimates the radiation beam size DELETE A button that allows the operator to remove from memory images or patient data DeskView A touch control screen which allows the user to control the system fun...

Page 218: ...it to black and black to white in the video image Iris collimator A device that collimates radiation in to a circular beam and allows operator to limit radiation beam size to reduce exposure to the pa...

Page 219: ...nic enhancement of edge detail in the image during live Fluoroscopic exposures Recall Image Image that is recovered from the image system memory and is displayed on the reference monitor Receptor a de...

Page 220: ...e which is used as the Graphical User Interface for controlling the c arm functionality Also known as DESK VIEW Transfer Button i e transfer image form left to right or right to left monitor Tube Curr...

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