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1. Automatic Dose Check dose control for proper Control operation per Warnings and Caution All labels must be present and be Labels legible Line Cord Look for physical damage to the line cord and connector Mechanical Cone Make sure that the mechanical cone is properly installed and secured for a SSD of 30 cm Verify that the warning label is not defaced Wheels on Mobile C Make sure that wheel surfaces are clean to prevent static discharge 10 Monitor Cart Casters Make sure casters are not damaged and that they are clean CDRH Maintenance For information on requirements imposed by the FDA please refer to the CDRH Maintenance Report included with the ZIEHM 7000 Service Manual MAN 06 0004 Chapter Rev B Page 37 W ZIEHM 7000 MANUAL C Arm Operation Preventative The System User 1s responsible for scheduling preventative maintenance and Maintenance for ensuring that such maintenance 1s performed only by gualified Service Engineers The following list of preventative maintenance activities should be performed at six month intervals or whenever the equipment has been subjected to any use or conditions that may compromise the safe operation of the system Il kV calibration 2 mA calibration 3 Electrical functions automatic dose rate control mA display at default low and normal fluoroscopy radiography time control fluoroscopy terminates after releasing button collimator controls display functio
2. Chapter 4 Installation Procedure This manual is written to Service Engineers It does not contain any procedures Audience that can be performed by the System Users Do NOT allow System Users to perform any of the service tasks described in this manual or any tasks that are not described in the User Manual In order to be qualified to perform the Installation procedures described in this manual Service Engineers must attend formal training provided by Instrumen tarium Imaging Ziehm Inc hereafter referred to as the manufacturer Shipping Container Unpacking the The system is shipped on a single pallet and contains a mobile stand monitor C Arm cart case assembly unmounted and the items listed in the table below GN r Technical Manual C arm Technical Data Approval Certificate Connection Cable Carefully inspect the equipment for damage If you find any damage immedi ately report it to the shipping carrier in the form of a damage claim Unpacking Unpacking of the x ray system is to be carried out by authorized qualified per sonnel 1 To avoid damage being caused to the equipment by condensation resulting from temperature differences make sure that all parts of the eguipment have reached room temperature before turning the eguipment on Remove the outside of the shipping container and inspect for damage Lower the unloading ramp into position Loosen all four bolts and remove the monitor cart Care
3. I FWD IMAGE REV CINE STORE CINE RECALL gt CINE EDIT Image Step During CINE replay image playback can be stopped and individuals images can be reviewed and stored to the patient file 1 Press one of the Contrast buttons on the Mobile Stand Control Panel Figure 6 7 number 34 or the Image RWD REV button on the Monitor Cart Control Panel Figure 6 8 number 22 This places the system into a playback mode that steps through images one at a time 2 The message F R OFF will display in the upper right corner of the moni tor indicating that the image loop has stopped and that the operator can now step through the images 3 Press either button to step through the images Hold down either button to step through the images at nearly the selected frame rate 4 When image playback has stopped select the image to transfer to the patient file and press either of the Image Store buttons see Storing Images on 70 5 The message Stored to XX XX is displayed on the left monitor which indicates that the image has been copied to the patient file as image number 18 as shown in figure 6 16 on page 71 CINE Store Figure 6 8 number 32 The CINE store function protects CINE runs that have been stored on the hard drive The system allows storage of nine CINE runs for each patient Each CINE runs may contain the maximum number of images Press the CINE Store button to protect the last CINE run stored on
4. 1 Press the Shift button 2 Press the Print Hard Copy button PRINT Compact Systems This function is only available in compact systems that are connected to a monitor cart eguipped with a hard copy camera MAN 06 0004 Chapter Rev B Page 59 ZIEHM 7000 MANUAL Mobile Stand Displays Monitor Cart Power ON Off Functions Figure 6 8 number 1 The ON button is green and is located in the lower right side of the Monitor Cart Control Panel as shown in figure 6 8 on page 47 Pressing the ON button to turn on power to the system The imaging system will perform self tests beep a few times and display READY FOR FLUORO on the left monitor The system is then ready to acquire images The OFF button is red and is located just below the ON button as shown in fig ure 6 8 on page 47 Pressing the OFF button turns of power to both the C Arm and the Monitor Cart Shift Key SHIFT Figure 6 8 number 8 KEY The Shift Key button 1s used with functions keys to activate functions Holding this button down while pressing a function key activates the function Note Some functions are special options that must be purchased Image Crop Function Increases the rate at which the shutters open and close by two times To Activate Press Image Crop button Hold down the Shift key and press either the Up Down or Left Right arrow buttons WNDW LEVEL Function Changes WNDW LEVEL values at two times the normal rate To Activate
5. BEE BEE MODIFICATIONS ENDANGER SAFETY H We Page 32 MAN 06 0004 Chapter Rev A Chapter 5 Technical Data Statement of Compliance ME 5 6 Program 0 Extremities kV mA Curve 5 kV m amp characteristics Ei T ableselecton C2 Ca 04 CH 3 mh JT SI EEEERRRR DO pw Di HI wm D BA H Lpi A MA ML A NN NENNEN An nL n n LL Ln hL n n n n n m n n_n nn Help MODIFICATIONS ENDANGER SAFETY UV MAN 06 0004 Chapter Rev A Page 33 ZIEHM 7000 MANUAL Statement of Compliance X Ray Generator X ray generator Housing and Tube with Beam Limiting Device Manufacturer Ziehm GmbH ZIEHM Maxipuls 3 110 Total filtration gt 4mm AL Focal spot 06 1 5 mm Tube type EP F 181 0 6 1 5 125 60 Registration no BY 287 84 RO Target material Tungsten Target angle 12 Radiation leakage lt 1m Sv h at 110 kV 7200 mAs h Maximum admissible high 110 kV voltage Dose Rate Control kV mA are constant pairs and are directly indicated at the mobile stand DIN 6811 of January 1975 point 33 1 2 Page 34 MAN 06 0004 Chapter Rev A Chapter 6 User Manual Audience Chapter 6 User Manual This manual provides information for the System User and Service Engineer Audience System Users must read this manual in its entirety with the exception of those chapters designated for Service Engineers only before being allowed to use an ZIEHM 7000 C Arm system X ray equipment operat
6. MAN 06 0004 Chapter Rev B Page 3 mi ZIEHM 7000 MANUAL Problems Symbols Page 4 Many symbols are used throughout the chapters of this book to represent sys tem functions This section displays these symbols and explains their meanings B m Potentiometer Brightness 2 gt nee GB TT 6 oo Fluoroscopy Iris Closed Radiography db Closed Slot MAN 06 0004 Chapter Rev B Chapter 1 Introduction Problems AL em 1 Radiation On Rotate Right Fault Temperature an Snap Shot SL Ea y Foot Switch 6 mA Fluoroscopy Open Slot Rotate Left Cable Connector Hand Switch Transfer A to B Voltage Peak To Peak nr Pulsed Fluoroscopy MAN 06 0004 Chapter Rev B Page 5 ZIEHM 7000 MANUAL Notified Body Notified Body Our Notified Body is TU V Rheinland of North America Inc number 0197 RW Page 6 MAN 06 0004 Chapter Rev B Chapter 2 Safety Audience EE Chapter 2 Safety This chapter must be read by Service Engineers System Users Eguipment Audience Owners Hospital Administrator and all other individuals responsible for the safe operation of x ray eguipment Disconnect eguipment from the power supply before opening and or removing safety covers Warranty Voided Warranty will not be given for eguipment that has been repaired by non autho rized persons or that has been damaged through misuse Electromechanical Compatibility The equipment is EMC tested acco
7. ell ler pen I I I I t i e kb D I I I I 1 4 nists La I i i I ee EE er WYR E I I i 1 9 1 I a A ee ee I I i A WN r I I e zc bs sje op db i I I Ee ee oe e T i i I I 17 r d t i i I o o o o o O ud lt r m N 30GVHOLLN39 S43HD3GO 081 SLI OZ S94 091 SSE ost Sl TI SEL og I Sel j D I F SLL OLL SOL 00 L S6 06 F S8 08 GZ OZ 09 TIME Min MAN 06 0004 Chapter Rev A Page 30 Chapter 5 Technical Data Statement of Compliance E 5 2 Program l Pelvic KV mA Curve 1 kV m characteristics E4 T ableselection Co 1 C2 C3 604 cC Cancel M mm Ge D Pw RRRRRERRZ BEEEEEEES MODIFICATIONS ENDANGER SAFETY II 5 3 Program 2 Thorax kV mA Curve 2 KV m i characteristics E T ableselection C 1 fo 03 04 C5 HIE Cancel DO re mm h Tel SI BEE BEE MODIFICATIONS ENDANGER SAFETY H MAN 06 0004 Chapter Rev A Page 31 W ZIEHM 7000 MANUAL Statement of Compliance 5 4 Program 3 DSA kV mA Curve 3 k mA characteristics NI Tableselection 7 Ce 3 C4 C5 _J Cancel rel Di LI d D WM rh KKRKRRERKRk BEREN MODIFICATIONS ENDANGER SAFETY H 5 5 Program 4 Soft kV mA Curve 4 KV m i characteristics F T ableselection C C2 03 fe OG Cancel Tel SI
8. the dynamic disk Shift Mask Press to re align the mask Special Function The system 1s eguipped to perform various special functions These functions Buttons are activated by pressing the buttons shown below Metal A Figure 6 7 number 32 METAL Note This function is to be used at kV levels of 50 kV or more and can be used with any other anatomical programming mode If any metal is in the path of the x ray the displayed image will be too bright and patient detail will be lost To compensate press the Metal button on the Mobile Stand Control Panel to add contrast to the image W Page 52 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Special Function Buttons Soft LPD Figure 6 8 number 33 o SOFT Use this function when you need to take images that require very little penetra tion such as revealing skin shapes at an injection site Press the Soft button on the Mobile Stand Control Panel to enter the Soft mode from any fluoroscopy program Press the Soft button again to return to the fluoroscopy program that you were using before pressing the Soft button Note On x ray systems with serial numbers greater than 2200 the Soft func tion was replaced by the Large Patient Diameter LPD function The button is still labeled Soft however the function has been changed When the x ray system is used on a large patient for example a patient who weighs more than 300 pounds kV may run to the maximum settin
9. WARNING Do NOT operate system until equipment has reached room temperature Severe damage may occur We Page 28 MAN 06 0004 Chapter Rev A Chapter 5 Technical Data Statement of Compliance Mechanism Focal spot to image intensifier input screen 97 cm C Arm width image intensifier to x ray tube 75 cm C Arm depth 68 cm Orbital movement 115 Rotation 225 Side to side wig wag EI Horizontal 22 cm Vertical 13 cm Weight C Arm 260 kg Monitor cart 125 kg Device ZIEHM 7000 C Arm with x ray source assembly Maxipuls 3 110 Statement of Compliance IEC STANDARDS e IEC 601 1 1990 e IEC 601 2 7 1987 e IEC601 2 8 1993 e IEC 601 2 32 1994 DHHS Complies with DHHS radiation performance standards 21 CFR Subchapter J as of the date of manufacture Instrumentarium Imaging Ziehm Inc reserves the right to make changes in specifications at anytime without prior notification MAN 06 0004 Chapter Rev A Page 29 W o o o E o o K o Fw o o fed Sed Al zal et Z et o o o fre L LLI N Charts THERMAL CURVE Thermal Capacity 400 000 J Continuous Thermal Emission 50W D T l i L i I I o o o KI m Al 40dVHOILN39 S33HO30 0 vw TIME Min COOLING CURVE e TEMP I I I 1 9 I r 4 i I i 19 pill f I i I I a Get se E bh A ictal UY een ES EWEG I I deeg yb EE i I 1
10. camera from being over driven by high light levels do not perform fluoroscopy in the KV manual mode at a kV level higher than needed e Use the hand switch to initiate the radiography mode e Adjust radiography time from 0 1 second to 4 0 seconds Verify that the following results occur e During fluoroscopy the live image appears on the left monitor e After fluoroscopy is completed the last image is held e 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 control panel lights up e When the film cassette is fully inserted in the documentation camera the cassette indicator light on the monitor cart control panel lights up Re Page 36 MAN 06 0004 Chapter Rev B Chapter 6 User Manual C Arm Operation Every month the System User is responsible for performing the inspections System Inspection listed in the table below pm isiracitons Radiation Leakage Inspect for physical damage that could affect radiation shielding such as the high voltage generator and shutters Radiation Switches Radiation must only release when the exposure switch is pressed it must immediately stop when not pressed Exposure Indicator The warning light on top of the monitor only lights when radiation is emitted Audible Exposure The audible alarm sounds during Indicator radiographic exposure and after five minutes of fluoroscopy
11. new kV values are entered or until a new operating mode is selected MAN 06 0004 Chapter Rev B Page 57 W ZIEHM 7000 MANUAL Mobile Stand Displays Exposure Time S In Radiographic mode the system sets the current to 20 mA and an exposure AN time from 0 1 to 4 0 seconds can be selected using the Up Down Arrow button This exposure time is then stored and displayed Generator Overheating If the generator overheats the system will automatically 1 flash the overheating indicator 2 revert to fluoroscopy mode and 3 limit tube voltage 0 5 mA If the indicator does not stop flashing turn off the ZIEHM 7000 and let the generator cool Note Systems with serial numbers greater than 2300 can be programmed to continue operating fluoroscopy until the maximum heat overload is reached and then turn off fluoroscopy The indicator will flash as the generator begins to overheat but when the generator reaches the maximum heat limit it will auto matically turn off fluoroscopy Dose spe The Dose indicator displays error messages and when the optional dose meter min is installed displays dose value in cGY cm To reset the Fluoroscopy Time and cGY cm displays press the Min button To reset dose display press the Min button and the 1 2 Dose button together Yo and hold for at least two seconds DOSE Fluoroscopy Time Fluoroscopy and radiography time are displayed in minutes and seconds Radiation Exposure Indicator When rad
12. saved while the Marker 1s displayed the Marker 1s saved with the image Fluoroscopy Fluoroscopic Figure 6 7 number 9 Procedures The Fluoroscopy button is located on the Mobile Stand Control Panel z Fluoroscopy is the first function that is available after the system is turned on When the C Arm is turned on it performs a self test of the imaging system and displays the message RDY FLUORO in the lower left corner of the monitor When this message displays the system 1s ready to release radiation by pressing either the foot switch or the hand switch When the pressed switch 1s released the image remains on the left monitor The radiation alert sound can be set to produce an audible sound once every second Note The radiation alert sound can be enabled or disabled by the Service Engineer MAN 06 0004 Chapter Rev B Page 65 ZIEHM 7000 MANUAL Fluoroscopic Procedures MSA CR Max Op Pulsed Fluoroscopy Figure 6 7 numberll1 The Pulsed Fluoroscopy button is located on the Mobile Stand Control Panel Pulse fluoroscopy 1s used to reduce patient radiation dose Pulsed fluoroscopy turns radiation on and off from one to two times per second while displaying the last exposure If the radiation alert is activated an audible sound will be produced with each pulse of radiation To automatically store the last image press the Auto Store button while pulsed fluoroscopy is activated The Auto Store button is l
13. the hard drive CINE Auto Store When CINE 1s selected and the service option of CINE Auto Store has been activated CINE runs can be stored automatically by pressing the Auto Store button before starting acquisition Note When CINE Auto Store is active the message AUTO STORE is dis played on the left monitor CINE Edit and CINE Recall Figure 6 8 number 29 Figure 6 8 number 27 At one time CINE Edit and CINE Recall were separate functions However with the present software version pressing either buttons displays the CINE Run Edit Recall menu and performs the same function The menu lists patient and numbered CINE runs Use the Up Down Arrow buttons to select the desired patient Use the Left Right Arrow buttons located at the top of the screen to select from one of these four functions Patient Runs Accept and Delete WW Page 78 MAN 06 0004 Chapter Rev B Chapter 6 User Manual VCR Operation To Select a CINE run do the following 1 select a patient 2 select Runs and 3 enter the number of the CINE run The CINE run will begin to play back To Delete a CINE run do the following 1 select a patient 2 select Delete 3 press the number of the CINE run that you wish to delete and 4 press Y to confirm deletion The run will be deleted Recording VCR Operation Figure 6 8 number 16 The VCR function records images and plays them back on the monitors I Turn on power to the
14. 000 MANUAL Hazards Mechanical Movement Take care to prevent collision with any person or object when using the motor 1Zed vertical tube arm assembly or when manually rotating the C Arm To move the unit perform the following steps 1 Bring the C arm into transport position as shown in figure 2 1 on page 10 2 Roll up the power cable and connection cable on the back of the monitor cart 2 1 C Arm and Monitor Cart C Arm Swivel arm Carriage C stand column Connection cable Power cable Position the swivel arm vertically and lock with brake Swivel the carriage to the center position and lock with brake Retract the carriage and lock with brake na 2 Retract the C stand column Caution The floor should not be slanted more than 10 to horizon tal Page 10 MAN 06 0004 Chapter Rev A Chapter 2 Safety General Safety There is always high voltage in certain components of the system s equipment Electrical Safety even when the system is disconnected from a power source Touching these components can cause serious injury or even death High Voltage Components e High voltage transformer and x ray tube assemblies 110 000 volts e Power transformers 220 VAC and 120 VAC e Image power supply control assemblies 220 VAC and 120 VAC e Generator inverter control 300 Vdc at 20 Khz Performing Internal Service Two Service Engineer
15. 0715 000Z dlA gir 91018 OX IDA ZH09 oopiA Z2HO09 OBPlA D Wi GH H ul YMS no Kesi jood doo u 3LOW3 jno 110 doo uA 00L LN WOOId Jana WOOIO J0p4020400pIA i N W ao lt ADEZ LNO 068 df Jayong ZHO9 001 LN 0068 dN OU pieog ay pa eupapu aul OOOL WN SL JN ISEL 0d ex Lon EX LX ED NIG NIO paoeuaju oa COOOL AT PLA NY Od O I SvOIQ SNOW 44JO NO J19M0d BONES spedseg ale ORG VK NAM DLODION DECH I NaN JEMOd Jd loss9o01 afew 0002dlA y4evyne7 Addoj 4 OSPIA i Bh Od D I ACL Ce Ge SQUJBJXJF leuiepxj ajoway yowns oo4 068 dN OOLLN Nd VEN 40 9auuo95 Dds Og HOI OF 6X 92 8POIG br am bx ae 1 Doan oIp SIONUOW EE i WA pue 92 pi8og asepayuj pieog ayl p4e20gA9y MIN posn jou si sng 2 1 au AW UM 3 LON EX ION o aie du Ma LX se j y pue jsenbay UONEIPEN OSPIA Lon Bunsanajssbunyeins fen jno oapiA av opt W4 9 1078 NIE 068 an CR 20vn O gt 91078 1075 Jayoniq 9 1 1018 LX LEN paeau 4 pasepazui NVO SUNNOOL CEPIA SUIQOOL CEPIA X p 44O NO lt Z N H sne ui3 sne ui3 3LOW3MN 6X ON oA a CS wen mined ican A 6un6ios4e sbunuueds y91 010 SINPON 016 S ZHO9 OD D o lt RB N N lt X ADEZ ADEZ D 8 lt Sy adwejsbunjyeng XS min Buebsny nano A Chapter Rev MAN 06 0004 Page 20 Chapter 4 Installation Procedure Audience
16. B One floppy disk will hold four images WARNING Do NOT remove the disk until file transfer is complete Oth erwise the system will hang up and will have to be re booted MAN 06 0004 Chapter Rev B Page 83 ZIEHM 7000 MANUAL Review Buttons MON L zB MON LAR CINE CINE RECALL EDIT INV VIDEO 12 PRINT Monitor L To R Figure 6 20 on page 80 Press the MON L R button to transfer images from the left monitor to the right monitor Monitor R To L Figure 6 20 on page 80 Press the MON R L button to transfer images from the right monitor to the left monitor CINE Edit and CINE Recall Figure 6 8 number 29 Figure 6 8 number 27 At one time these two buttons had separate functions However with the present software version they both bring up the CINE Run Edit Recall menu and perform the same function The menu lists patient and numbered CINE runs Use the Up Down Arrow buttons to select the desired patient Use the Left Right Arrow buttons located at the top of the screen to select from one of these four functions Patient Runs Accept and Delete INV Video Figure 6 20 on page 80 The INV Video function can be used with both stored images and real time flu Oroscopy Press the INV Video button to reverse the light and dark areas of the image and create an image that resembles a film negative Print Figure 6 20 on page 80 The Print function transfers images from the monitor to the printe
17. Press the WNDW LEVEL button Hold down the Shift key and press either the Up Down or Left Right arrow buttons MAG Window Function Increases MAG Window movement to two times the normal scroll and pan rate To Activate Press the MAG WNDW button Hold down the Shift Key and press either the Up Down or Left Right arrow buttons Text Insert Function Increases the text insert movement of the arrow or text string by more than two times the normal scroll and pan rate Alpha Keys Functions Some of the keys have secondary functions such as period colon less than greater than etc To Activate Hold down the Shift key and press the key that has the desired symbol For example is the result of holding the Shift key and then pressing the A key We Page 60 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Mobile Stand Displays Alpha Keys The Alpha keys are arranged in a standard QWERTY arrangement Most of the keys perform secondary functions such as period colon less than greater than back slash and so on Number Keys The number keys are used to enter numeric information such as patient identi fication number date time and service values Delete Space Key DELETE Figure 6 8 number 5 SPACE To delete one character hold down the Shift Key button and press the Delete RAA Space button one time To insert a blank space just press the Delete Space but ton Enter Figure 6 8 number 4 After
18. THAM STREET RIVERSIDE CA 92501 MANUFACTURED MONTH ____ _ YEAR MAN 06 0004 Chapter Rev A Chapter 2 Safety General Safety 2 3 Position of Laser Warning Labels on Monitor Cart Mount Laser Caution Label 40 512 L10 Above Laser ON Button MAN 06 0004 Chapter Rev A Page 13 W ZIEHM 7000 MANUAL General Safety This page is intentionally blank Re Page 14 MAN 06 0004 Chapter Rev A Chapter 3 General Description Special Features Chapter 3 General Description The ZIEHM 7000 family of x ray systems have digital processing systems that are designed to extend the advantages of digital image technology to C Arm Fluoroscopy Their image enhancement capabilities answer the specific needs of a variety to clinical fluoroscopic applications The ZIEHM 7000 is a mobile x ray system developed for surgical and diag nostic applications such as fluoroscopy and spot film radiography It is not to be used in the presence of flammable anesthetics or other explosive gases The ZIEHM 7000 has been engineered to provide superior quality and perfor Special Features mance Here are some of its outstanding features e High frequency generator that produces a precise spectrum of radiation capable of superior penetration e Efficient generator design that allows the ZIEHM 7000 to perform fluo roscopy at maximum kV for up to 20 minutes e A 1 2 Dose function that reduces the working dose rate by half e Optimum a
19. Table of Contents re Chapter I Introduction MUNN 1 Responsibilities AAA 1 PARTS sorene AU ee UAN 2 CARR ve 2 PO he 2 Record ROEN E 3 Soo FUR UN EN Y FAN 4 Chapter 2 Safety PR NCTC FR RF FF NF NT HF FT WN NF HE NWR HF ees T EE EE EE T 9 See ER 11 General ale EEE EEE 11 ee ME 12 Chapter 3 General Description Special Features 15 MAING Processing ET 16 Optional Software YY YL LLY LLE LLGC LL LLC LEL LL LL L LLY LLFd noun 17 Technical Specs ui Gei WRAN dd RYN GU IR 18 Chapter 4 Installation Procedure PON En Le 21 Unpacking the Ce 21 Mounting Ode ui te au CORN RWAN WU gd SAR SR 22 System Inierconnect ENEE 24 AC Power ne 24 Mechanical le AE 24 Chapter 5 Technical Data Mod 27 FE TUDE sn 28 Statement of Compliance A 29 OE EEE EE EEE EN 30 X Ray GANG AO He ee 34 Chapter 6 User Manual MIT 35 C Arm Operation esu GW dn uu Globe glws Gy AO GST Syn nn PO 35 Systemi 1 DS CUO Mi EEE EN 37 Preventative Maintenance arrnnnnnnnnnnanennnnnnnnnnnnnennnennnnnnnsennnennnnnnnne 38 Description of Symbols s nneenneensnennennenrrerrrenrresrrrrrrerrrnrrreeresrrre rrene 39 Mechanical OperaU0ll uii Ru GW Y Yd SN GU MO 40 MAN 06 0004 Chapter Rev A Page 1 Ei E Table of Contents FLUOS CODY DEFFRO RF RYN REF ARFRYN FR RF RE 45 ETP EE TN NWN NN 46 Operating Modes A 48 PON COD UL ei anu an Ce a EEE 49 SUDI C ION Modes sevens NND 49 CINE Func ONS Lae 51 Special Fun
20. VCR 2 Press the VCR button located on the Monitor Cart Control Panel The mes sage VCR will display on the left monitor and the VCR will be placed VCR into Record Pause mode 3 Press the hand switch or the foot switch to start and stop recording Note It takes the VCR one to three seconds to come up to full speed There fore be sure to hold down the exposure switch long enough to capture the desired images Auto Record Start When the VCR is in Record Pause mode the VCR starts to record each time the hand switch or foot switch 1s pressed After replaying the tape be sure to for ward the tape to the desired recording position to avoid erasing important video Playback Fluoroscopy Is not possible while the VCR is in playback mode However it 1s possible when the VCR 1s placed in the following modes Stop Rewind and Fast Forward During Playback Still and Search modes of operation the system displays video on the left monitor In between recordings there will be brief blank sections because the VCR takes one to three seconds to come up to operational speed These blank sections cause the monitor to display noise bars and images that jump To minimize this make recordings of at least 20 seconds duration MAN 06 0004 Chapter Rev B Page 79 ia ZIEHM 7000 MANUAL DICOM DICOM a PRINT I PRINT Review Buttons Page 80 Turning off VCR Operation Press the VCR button on the Monitor Cart Contro
21. X INE IMAGE aano ymad Ai 11 30 33 Ae e Table 2 Monitor Cart Buttons To use this table refer to the circled numbers in Figure 6 8 No Page Power ON and OFF od 27 mage Forward Reverse 7830 z a 2 S Di Image Transfer Left to Right 84 a s T Image Transfer Right to Left 84 lan 2 eea IS MW fa omei mrsa so WELE CH iT DSA asee an p s 3 Noise 13 i image Cron S Arrow Button a is WNDW Hi 36 8 ONT S 6 VCR 0 7 S fame mala TI 9 Shit Mask ug 20 CINE RES AL She E meme fam o MAN 06 0004 Chapter Rev B Page 47 ZIEHM 7000 MANUAL Description of Symbols Operating Modes The Mobile Stand Control Panel has several buttons that control fluoroscopy Each button has an indicator light in the upper right hand corner that lights when the button 1s pressed and the function is on These fluoroscopic buttons are listed below and are shown 1n figure 6 7 on page 40 Name of Fluoroscopy Button TT 8 Fuoroseop III ap ose OO O SE SSC ROSE 13 Organ mode Thorax Filter Metal Filter Soft Note The tube current is automatically controlled at any given KV value when the Fluoro modes described below are selected For appropriate kV mA curves see Chapter 5 Fluoroscopy o Figure 6 7 number 9 Fluoroscopy is the standard mode It is automatically selected when the ZIEHM 7000 is turned on Pulsed Fluoroscopy coy Figure 6 7 number 11 FIL Pulsed fluoroscopy r
22. al power fuse 2 fuses 15 A at 220 V 2 fuses 20 A at 110 V Line resistance lt 0 6 ohms Safety Classification The ZIEHM 7000 1s classified as Class I continuous use type B equipment It is not suitable for use in a flammable atmosphere Generator output Fluoroscopy 40 kV to 110 kV 0 2 6 0 mA Radiography 40 kV to 110 kV 20 mA Operating frequency 20 kHz Operating values Fluoroscopy 110 kV 0 2 to 6 0 mA Radiography 110 kV 20 mA Exposure time 0 1 4 0 seconds radiographic Output values Fluoroscopy 550 watts Single pulse 880 watts Exposure 2200 watts Nominal electrical output max 220 watts at 110 kV 20 mA Current time reference 20 mA at 0 1 seconds Radiation safety area 2 5 m 7 I 1 3 5 m 9 LI MAN 06 0004 Chapter Rev A Page 27 ZIEHM 7000 MANUAL Introduction X Ray Tube 5 1 Focal Spot and Reference Axis 783 a i 164 Note More x ray tube specifications can be found in the X Ray Tube Data Sheet X ray tube Double focus stationary anode Nominal focal spot Fluoroscopic 0 6 Radiographic 1 5 Inherent filtration gt A mm AL Image intensifier 9 in 23 15 cm 7 in 17 10 cm Cesium iodide Magnification 1 5 x Fluoro grid Pb 8 1 40 Monitors Picture tube 17 in 44 cm Band width 20 mHz Resolution 32 kHz 60 120 Hz Storage temperature 10 C to 70 C 95 rel humidity Working temperature 10 C to 35 C 85 rel humidity
23. ale This function provides six levels of adjustment It is not a post processing function and cannot be used to change a previously stored image Text On Off Figure 6 8 number 17 The Text On Off function turns the text display on the left monitor on or off Turning the text display off removes the following text from the monitor Patient Name and ID Dr Name Facility Name Procedure Title Date Time and the Instrumentarium Logo When text is turned off the system stores the information for each image in the patient record An example of the monitor display with text turned off is shown in figure 6 19 on page 75 Frame Rate Figure 6 8 number 18 Press the Frame Rate button to set frame acquisition rate before acquiring 1mages The left monitor displays the selected frame rate The Frame Rate function sets the frame acguisition rate for CINE runs and play back frame rates With optional packages the frame rate can be set at 1 2 1 2 4 8 15 and 30 fps The system can acquire images at one rate and replay images at a different rate at rates below 8 fps Acquisitions of 1 2 to 4 fps can not be replayed at 8 to 30 fps Frame Rate can be used with stored image loops Re Page 4 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Look Up Tables E 6 19 An Example of Text Off RDV LUORO NR LOW LIH MED win 1 AUTO STORE Mask Selection in DSA Mode Figure 6 8 number 19 MASK The Mask function
24. allows the operator to select a mask 1 Press the Mask button 2 Press the Image FWD REV button to select a mask number Figure 6 8 number 22 Variable Land Marking in DSA Replay The Mask function allows the operator to fade bony anatomy into the image to make it easier to determine the position of vascular anatomy 1 Press the Mask button during the replay of the subtraction procedure 2 Press the Up Arrow button to fade the mask away or press the Down Arrow button to fade the mask back in 3 When the desired mask level is obtained press the Frame Rate button to return to the medical procedure CINE Reset Figure 6 8 number 20 CINE By default images stored at 10 15 and 30 fps are protected from being over RESET written Press the CINE Reset button to remove this protection MAN 06 0004 Chapter Rev B Page 75 ie ZIEHM 7000 MANUAL CINE Functions CINE Functions CINE DSA CINE Without Subtraction Figure 6 8 number 21 The CINE function selects the dynamic acquisition mode for acquiring and replaying images in a sustained sequence Images can be acquired at a rate of 1 2 to 30 fps and can be replayed at either 4 or 30 fps depending on the optional equipment Images acquired at 4 fps are stored directly to the hard drive With the optional 30 fps package the images are transferred to the hard drive when the CINE Store button is pressed at a rate of 4 fps Transfer time is 37 5 seconds fo
25. at do not disable the system Briefly press the hand switch or foot switch to erase the caution message and de activate the alarm Errors at start up Errors at start up indicate faults that disable the system Write down the error code for possible future reference MAN 06 0004 Chapter Rev B Page 91 W ZIEHM 7000 MANUAL Error Codes Depending on the type of problem you may or may not be able to use the sys tem If the error will not clear by pressing the foot or hand switch then you must call Customer Service for equipment diagnosis and repair Errors during normal use immediately stop radiation and prevent any attempt to use radiation You cannot erase the message or de activate the alarm Table 4 List of Error Codes Code Type Message E16 Caution Hand switch I activated during start up E17 Caution Foot switch I activated during start up E18 Caution Hand switch 2 activated during start up E19 Caution Foot switch 2 activated during start up E20 Error Fault Cable defect hand or foot switch E21 Caution With compact unit yellow monitor light defective E22 Warning Call Customer Service E23 Warning Call Customer Service E24 Warning Call Customer Service E25 Error Fault Call Customer Service E26 Error Fault Call Customer Service E27 Error Fault Call Customer Service E28 Error Fault Call Customer Service E29 Warning Generator Fault Overheating allow to cool off E30 Error Fault Call Cus
26. ator in the normal position and the C Arm in the vertical position e Image intensifier size 7 inch 17 cm 8 feet 2 5 m e Image intensifier size 9 inch 23 cm 11 feet 3 5 m e Image intensifier size 12 inch 30 cm 11 feet 3 5 m MAN 06 0004 Chapter Rev A Page 7 W ZIEHM 7000 MANUAL Audience Take care to keep patient radiation exposure to a minimum and to use the low est possible dose rates Maintain the highest possible focus skin distance The stipulated minimum focus skin distance 1s 20 cm and is ensured by the design of the generator with the required special skin cone Additional objects in the path of the x ray e g operating table will lead to an increase in radiation dose X Ray Tube The x ray tube has a stationary anode with dual focus Here are some specific gualities of the x ray tube e Focal spot size for fluoroscopy 0 6 mm2 e Radiography 1 5 mm e Inherent filtration equivalent gt 4mm AL e Image intensifier electronic mag factor of 1 5 e 30 23 15 cm Cesium Iodide 23 15 cm Cesium Iodide e 17 20 cm Cesium Iodide WARNING Ambient temperature greater than 60 degrees centigrade may cause irreversible damage to the x ray tube Grounding The equipment may only be connected to power supplies with separate equip ment grounding Bonding If the equipment is used in combination with other equipment for the examina tion of the heart or brain or their proximity a potential bonding conductor i
27. ch The C Arm releases radia tion and after three or four seconds locks the kV mA and AGC functions of the CCD camera system to prevent the image from changing due to the injected bolus which might cause density fluctuations in AGC and DOSE 5 The system starts acquiring the image mask using high noise reduction 6 After the mask is acquired the system displays the real time image on the right monitor Note During acquisition image intensity and contrast looks different that dur ing fluoroscopy This is normal 7 The left monitor displays the message INJECT in the lower center of the screen to indicate that the system has captured a mask and is ready for injection MAN 06 0004 Chapter Rev B Page 69 W ZIEHM 7000 MANUAL Storing Images Storing Images CINE STORE 3 I Jo b gt FWD IMAGE REV 8 Press either the hand switch or the foot switch to begin image acquisition An audible alert activates when acquisition begins and the system subtracts the live images from the mask and displays the subtracted image on the left monitor at real time rates independent of the selected image acquisition rate Only the subtracted image will be displayed during capture and replay However during replay the subtracted image mask can be removed by pressing the DSA button on the Monitor Cart Control Panel 9 Release the switch when the desired vascular anatomy is visualized 10 To exit CINE DSA press the CINE butto
28. control unit or main power assembly until the main and auxiliary power supplies have been disconnected If you fail to follow these instructions you may be seriously injured or killed X Ray Tube Housing Hazards Tube housings have the following hazards 1 High voltage Normal operating voltages can be deadly 2 Hot oil Tube housings contain die electric oil which can reach high tem peratures If the tube housing ruptures due to overload the oil that leaks out can cause serious burns 3 X ray radiation X ray tubes produce x radiation that is dangerous and potentially fatal Flammable Gas Never use the system in the presence of flammable anesthetics or other flam mable gasses liquids or vapors Gasses and vapors can be ignited by electrical arcs that can occur during the normal operation of power contacts switches circuit breakers and other circuit components 1 Before the system is turned on If flammable liquids gasses or vapors are present before the system is turned on do not unplug the system and do not turn it on 2 After the system is turned on If flammable substances are detected after the system has been turned on do NOT turn the system off Do NOT touch any of the controls switches or knobs Do NOT unplug the system Remove all personnel immediately and then ventilate the room Remove any liquids that are producing flammable vapors to a safe storage area MAN 06 0004 Chapter Rev A Page 9 W ZIEHM 7
29. copied to the patient file as image number 18 as shown in Figure 6 16 RW Page 70 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Look Up Tables E 6 16 Example of Stored Image FIRST NAME THE FACILITY NAME LAST NAME iD CINE LOOP UNST RED Avail 45 PROCEDURE TITLE DSA Output Look Up Tables LUT Window and Level Look Up Tables Output LUT s can be used to adjust image contrast on CINE replay acquisitions 1 Select CINE run 1 9 and press the Enter button to accept the current CINE replay as the current CINE run 2 When the image sequence is either loaded or is replaying on the left moni tor press the WNDW Level button on the on the Monitor Cart Control Panel Figure 6 8 numbers 35 and 37 The image system will now allow changes to image contrast and bright ness Press the Right or Left Arrow buttons to adjust window size Press the Up and Down Arrow buttons to adjust window level Level Adjustment The Level of the Output LUT is adjusted to increase the available brightness range in order to meet a wider variety of image preferences See figure 6 17 on page 72 for more detailed information MAN 06 0004 Chapter Rev B Page 71 ZIEHM 7000 MANUAL Look Up Tables 6 17 Level Adjustment 1024 Decrease Increase 7 Increase 660 Brighter Image Decrease 200 Darker Image 0 1024 IN LEVEL adjust position of curve in OUTPUT LUT This will increase or decrease image bri
30. crolls the magnification window on the left monitor IMAGE CROP closes and opens the electronic collimation shutters WNDW LEVEL increases and decreases the Window level values TEXT INSERT places text and or arrows in the image circle 4 On 1 When the Image Page is displayed the Arrow buttons move the image selection box on the right monitor Deleting Patient Records 1 Press the PAT FILE button Figure 6 8 number 24 to open patient files PAT FILE 2 Use the Arrow buttons to select patient file 3 Select the Delete function from the activity menu at the top o the right mon itor The following message will be displayed on the right monitor Warning Be sure you are deleting the correct patient record file You cannot recover deleted patient records or images 4 Press the Enter button At the prompt press the Y key The system deletes all images and patient information for the selected patient file Image Crop Figure 6 8 number 34 IMAGE CROP The Image Crop function collimates the generator s electronic shutters to crop out unwanted parts of the image Press the Image Crop button The screen displays the message IMAGE CROP and removes all other text from the screen as shown in Figure 6 24 MAN 06 0004 Chapter Rev B Page 87 ZIEHM 7000 MANUAL Review Buttons 6 24 Positioning the Electronic Shutters The electronic shutters are located just outside the image circle The shutters are posi
31. ction Buttons 52 Mobile Stand Buttons 54 Mobile Stand Displays scsses ics eneed5s cnenvdawecatasenced ewcvoesenswmenetacansdiacadinnes 57 Monitor Cart Functions rrrnrnnnrerarernnrrnnnrnernnannnnnennernnnnnnanennsennnnnnnne 60 Fluoroscopic brocedures 65 Storing Mages Lanseres TN TA FEN 70 BOOK lee 71 More Monitor Cart Functions rrnrrrrarrrrnnrrrnnrrrnnnennnnenranenranennnnennnne 73 CINE le ee ee Gw NG UED y GYG YU oC ve Boi FU Glyn 76 VERN 79 Kee 80 Review BUIONS seemed 80 Seege 91 Cleaning and Dsmmtechng rrr Y LLY AEL LLA AY Y YLE RY YL FF Y Y FFY nnoo 93 Page 2 MAN 06 0004 Chapter Rev A Chapter 1 Introduction Audience E Chapter 1 Introduction This manual is written to Service Engineers System Users Equipment Owners Audience Hospital Administrators and all other individuals responsible for the safe oper ation of x ray eguipment All are responsible for carefully reading this manual paying special attention to Warnings Cautions and Notes Eguipment Owner Responsibilities The Equipment Owner is responsible for ensuring that the x ray system com plies 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 owner is responsible for ensuring that only properly trained and qualified Service Engineers perform CDRH
32. d numbers in Figure 6 7 Button Description Page No Button Description Page Verea Postion gt 22 Radiography Time Select 38 System power OFF S 24 fimase Reversal Miror System power ON det Left Monitor Radiation Time Reset Select Right Monitor Printer Paper Copy Image Rotation Magnification Zoom Subtraction Modes 3 1 2 Dose SS 58 Anatomical Programming 3 Fluoroscopy 48 65 Image Store System Disk KV Manual Mode of h Wwe Image Transfer Pulsed Fluoroscopy 48 66 Filter Metal al 33 Filter Son IEN Manual Adjustment Image Forward Reverse Contrast Slot Collimator Close kV Display Slot Collimator Open mA Display Slot Collimator Turn Left 35 37 Exposure Time Display Slot Collimator Turn Right ZS 38 Dose Error Message Display Iris Collimator EN Fluoroscopy Time Display mis Colimator 35a Temperate Fa Tier S 20 a Mode Radiation Indicator 58 YL Radiouraphy Field Sees Oo We Page 46 MAN 06 0004 Chapter Rev B Z OI O ool SI Cal G BI GB NI ka bech SO CO NY NGI BI UIN BB 18 YY 3 13 13 18 184 18 18 12 ieie Ki Chapter 6 User Manual Description of Symbols 6 8 Monitor Cart Control Panel DD DELETE space E 7 9 gt 23 26 28 31 34 38 40 dL EE LAR STORE CROP WNDW RSA a CINE CIN CINE IMAGE oe cpr recat STORE 35 35 13 16 19 35 E
33. dditional functions in systems that have the CINE DSA module 1 When in the CINE DSA mode press the Contrast button to stop image replay and step one image forward or backward per press of the button MAN 06 0004 Chapter Rev B Page 53 ZIEHM 7000 MANUAL Mobile Stand Buttons 2 When in the CINE DSA mode press both Contrast buttons to return to full frame rate press both buttons again to toggle through all of the available frame rates Mobile Stand Manual kV Adjustment Buttons Figure 6 7 numbers 10 and 13 By default kV levels are controlled automatically depending on the fluoro a scopic mode that you select You may however set kV levels manually in the following manner 1 Press the Hand button Make sure that the button s indicator light is illu minated 2 Press the KV button up or down arrow to raise or lower kV level one step per press If you need to make a kV adjustment guickly press and hold the up or down arrow for two seconds kV 3 To return to Auto Dose mode press the Hand button again 7 To lock in a kV level that has been established by the automatic dose control system press the Hand button Magnification Zoom Figure 6 7 number 7 9 The system s image intensifier can magnify images electronically Press the Zoom button on the Mobile Stand Control Panel to magnify the image 1 5 times The Zoom button s indicator light will illuminate to show that zoom is on Systems that have the o
34. djustment for various diagnostic requirements made possible by the system s multi processor e Reducing dose by approximately 70 for extended procedures through pulsed fluoroscopy e Digital memory featuring Last Image Hold e Noise filtering is available through Frame integration e Greater resolution is achieved through the image intensifier s electronic focus and magnification e Easier system positioning and maneuvering due to the compact design of the image intensifier e Easier cleaning due to the system s clean design and unique cable arrange ment e Quick access to fluoroscopy approximately 35 seconds from powering on Image System Design The 2760 image processing system is modular and allows for quick repair and upgrade Components were selected for their reliability to promote long service life Main components and interconnections are illustrated through block diagrams that are included in Chapter 12 MAN 06 0004 Chapter Rev A Page 15 ie ZIEHM 7000 MANUAL Special Features Imaging The imaging system is an integral part of the C Arm and is designed to work Processing hand in hand with the C Arm control The image processor is activated by the foot switch or hand switch and is controlled by the C Arm control panel or the monitor cart keyboard Video is acquired through the C Arm video camera Images are displayed on two high resolution black anti glare monitors Proprietary software improves imag
35. e quality by e reducing noise e acquiring images at a true 10 bit grayscale e digital acquisition of 1365 H x 525 V e digital display of 1287 H x 1049 V and e real time edge enhancement The image can be manipulated stored or displayed onto the monitors Images that have been saved to the hard drive can be edited zoom in zoom out enhance edges crop etc The imaging software includes these features e DSA RSA MSA e CINE runs at up to 30 frames per second fps e Remasking e Variable masking e Land marking e Multi subtracted masking e Subtracted image window and level and e Image page display Image Page Display Image page display places 16 images onto the right monitor for 1mage transfer during minification hard copy selection and other image post processing func tions Live Images Live images are displayed during CINE loop acquisition from 2 to 30 frames on the right monitor Acquired images are displayed on the left monitor We Page 16 MAN 06 0004 Chapter Rev A Chapter 3 General Description Special Features With the purchase of optional Real Time Edge Enhancement or Vascular Imag Optional Software ing software the imaging system can provide the following capabilities e Digital image rotation e Circular image masking e single image delete e CINE auto store e Pulse fluoro auto store e Cine default frame rate e DICOM 3 interface e Image Mirror Reversal with flu
36. ease in image lag time in the video display It is not a post processing function and cannot be used to change a previously stored image When the Noise button is pressed the message NR LOW NR MED and NR HIGH is displayed in the left monitor LIH Noise Last Image Hold Noise Figure 6 8 number 14 LIH The LIH Noise reduction function reduces noise in the image when the radia NOISE tion switch is released It is used to reduce noise and distortions that arise from the movement of the C Arm or patient during a fluoroscopic procedure It is not a post processing function and cannot be used to change a previously stored image The system may be configured to apply low noise reduction for live images and a higher level of noise reduction when the foot switch is released There are four LIH setting available LOW MED HIGH and OFF If you do not wish to have the image displayed on the monitor after the foot switch is released press the LIH Noise button several times until the message LIH OFF is displayed on the right monitor Note The LIH function can be disabled in the Service Menu This must be per formed by certified Service personnel MAN 06 0004 Chapter Rev B Page 73 W ZIEHM 7000 MANUAL Look Up Tables WNDW TEXT ON OFF FRAME RATE WNDW Figure 6 8 number 15 The Window Level function changes the contrast and brightness of the video 1mage by changing the grayscale and brightness within the graysc
37. ecall mode with the Image Page displayed on the right moni tor the button moves the selection box within the 16 image page see fig ure 6 21 on page 81 e In Image Recall mode with the Patient File displayed on the right moni tor the button recall images from the hard drive Hold the button down to recall images at one to seven fps depending on system configuration e When the 4 ON 1 mode is selected and the patient file is closed and no other mode 1s active the button moves the selection box within the 16 image display on the right monitor to permit selecting images for the 4 ON I on the left monitor 6 21 Image Collage Page e y 6 o d q amp d Image Page Figure 6 20 on page 80 IMAGE PAGE The Image Page function displays 16 images on the right monitor with their corresponding image number as shown above in Figure 6 21 Use the Image FWD REV button or the Up Down Left Right Arrow buttons 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 16 images For example with images 1 16 displayed moving the selection box from image 16 to the right will cause the system to display images 17 32 When the 4 ON 1 function is selected and the patient file is not selected the system automatically displays the Image Page MAN 06 0004 Chapter Rev B Page 81 PAT FILE To exit the Image Page press the Ima
38. educes the effective dose rate Press the Pulsed Fluoros copy button on the mobile stand and then press the hand or foot switch Radia tion is released for an interval of approximately one second Press the Pulsed Fluoroscopy button to return to standard fluoroscopy When programmed by a service engineer pulsed fluoroscopy can take up to three pulses per second R Page 48 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Subtraction Modes Snapshot Figure 6 7 number 12 ce Press the Snapshot button on the C Arm control panel and then press the hand Fi switch Factory presets of 8 mA fluoroscopy and maximum image integration produce images of excellent quality Note Snapshot is only activated by the hand switch it is not activated by the foot switch Anatomical Programming Fluoroscopic C Figure 6 7 number 29 O The ZIEHM 7000 is equipped with fluoroscopy buttons for the following body regions ip eo Il Extremities pediatrics 2 Head spinal column and pelvis and 3 Thorax Generally the best results are achieved by using the appropriate fluoroscopy mode for the indicated body region Maximum Opacified Vascular Subtraction MSA Subtraction Modes Figure 6 7 number 28 Use MSA in conjunction with injected contrast solutions to obtain the best view of the patient s vascular anatomy To perform MSA follow these steps a 1 Press the MSA button on the Mobile Stand Control Panel or t
39. el is used to both steer and stop Push down the lever to engage the brake lift up on the lever to release the brake The lever is connected to the cart s two rear wheels Turn the handle in the opposite direction that you wish to travel e g turn the handle to the left to move the monitor cart right The single front wheel swings freely in the direc tion that you move the mobile stand see Figure 6 2 We Page 40 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Description of Symbols 6 2 Steering the Mobile Stand MAN 06 0004 Chapter Rev B Page 41 ia ZIEHM 7000 MANUAL Description of Symbols 6 3 Location of C Arm Major Components CCD Camera Intensifier lt Cassette Holder Orbital Brake Horizontal Brake Rotational Brake E Side to Side Brake a Brake Steering Lever Cr Hand Switch N X Ray Generator Nate Guards P O Cable Der MX 6 4 Rear View of Monitor Cart PO Cord and cable holder PO Cable attachment to monitor Potential Balance Ground Add Ground Hook Up BNC Video Out At the rear of the monitor cart is a BNC connector for Video Out The left mon itor image carries an RS 170 video signal for use with video recording equip ment external monitors printers and so on We Page 42 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Description of Symbols Accessory eguipment When selecting accessory egu
40. elect an image to be windowed and leveled 2 Transfer it to the left monitor 3 Press the WNDW LEVEL button The function adjusts the image contrast and brightness level to a normal range The image can then be stored to the hard drive transferred to the right monitor or printed by the hardcopy cam era 4 Press the WNDW LEVEL button again to return the image to it s original contrast and brightness levels 5 To exit the Window Level function press the WNDW LEVEL button or the ESC button MAG WNDW Figure 6 8 number 38 The MAG WNDW function magnifies the image by a factor of two or four The system displays the original image on the left or process monitor and the mag nified image on the right monitor 1 Select an image to the right monitor using PAT FILE IMAGE PAGE or the Image FWD REV buttons 2 Transfer the image to the left monitor using the MON LR button 3 Press the MAG WNDW button The text will be removed from the left monitor and a window the size of the magnified area will open on the right monitor displaying the image magnified two times 4 Move the window on the left monitor by pressing one of the Arrow buttons When the window has been moved the image on the right monitor will pan and scroll R Page 90 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Error Codes 5 To increase magnification four times press the MAG WNDW button The window on the left window will be smaller represent
41. esired vascular anatomy has been visualized The acquired images will begin to play back in a continuous loop from the hard drive or from memory depending on frame rate selected and the sys tem s optional equipment At frame rates of 4 fps and lower the images are stored on the hard drive At frame rates of 8 fps and higher the images are stored in RAM Protecting CINE Runs By default all images are unprotected To protect the images do one of the fol lowing AUTO 1 press the Auto Store button before or during the CINE procedure wie 2 press the CINE Store button after the procedure or 3 press the CINE Reset button after the procedure Figure 6 8 numbers 31 CINE 32 and 20 STORE Acquiring a new dynamic image acquisition With protection off press the foot switch CINE RESET With protection on either press one of the Contrast buttons on the Mobile Stand Control Panel Figure 6 7 number 34 or the Escape key on the Monitor Cart Control Panel Figure 6 8 number 39 If scout fluoroscopy 1s necessary between runs press the CINE button or the Exit button to return to normal fluoroscopy Note All images are stored in a raw format and can be reviewed in un sub tracted format as a dynamic image loop You can view the loop in subtracted mode on the left monitor by pressing the DSA button However image quality may not be acceptable MAN 06 0004 Chapter Rev B Page 77 W ZIEHM 7000 MANUAL CINE Functions
42. f the patient moves during a subtracted procedure use the Shift Mask function MASK to realign the mask to the patient s new position 1 Press the Shift Mask button 2 Use the Arrow buttons to realign the mask Note Press an Arrow button once to move the mask 1 4 pixel Hold down the Shift button and press the Arrow button to move the mask one pixel Press and hold down the Arrow button to move the mask repeatedly MAN 06 0004 Chapter Rev B Page 67 W ZIEHM 7000 MANUAL Fluoroscopic Procedures DSA DSA Digital Subtraction Figure 6 8 number 11 DSA is used to create a single subtracted image without dynamic image acqui sition It provides simple fluoroscopic subtracted imaging with last image hold DSA can be used during any fluoroscopic procedure When DSA is selected the imaging system optimizes the CCD camera s oper ating parameters for subtracted image acquisition and the imaging system selects values for LUT Window Level Noise Reduction and other parameters 1 Press the DSA button 2 Press either the hand switch or the foot switch 3 When the audible alert activates start the contrast injection 4 Release the switch when a fully opacified image is obtained Description of the DSA Operation 1 To set kV mA values for DSA acquisition perform a scout fluoroscopy of the anatomical region using the appropriate body region button 2 Press the DSA button on the Monitor Cart Control Panel F
43. ft Arrow button Image Store ae P Figure 6 7 number 30 Figure 6 8 number 33 IMAGE STORE Images can be copied to the systems hard drive When you press the Image Store button the left monitor will display an image number and the word Store the word Store will blink Use Image Store to e save a live image e save the last image held on the monitor e save a dynamic image run when CINE Acquire and Dynamic Image Replay are running and e save a single CINE image when the system is in CINE Step Mode Auto Store Figure 6 8 number 31 AUTO STORE The Auto Store function has four modes of operation Press the Auto Store but ton to toggle through these functions 1 Auto Store Auto Store automatically stores images on the left monitor to the hard drive when the exposure switch is released If there is no more space on the hard drive a warning 1s displayed when ever an attempt 1s made to store an image to the hard drive whether by using the Auto Store function or the Store function see figure 6 23 on page 86 To make more room on the hard drive press the Enter button When Auto Store is activated an image is stored every time the exposure switch is released To make room on the hard drive patient records must be deleted For instructions on how to delete patient records please read Deleting Patient Records on 87 MAN 06 0004 Chapter Rev B Page 85 W ZIEHM 7000 MANUAL Review Buttons 6 23 Aut
44. fully slide the cart towards the off ramp eS hy Remove the two straps that hold the monitors and take the monitors off the pallet 7 Remove all of the brackets from the pallet MAN 06 0004 Chapter Rev A Page 21 W ZIEHM 7000 MANUAL Mounting Monitors 8 Loosen the Wig Wag knob and straighten the C Arm as shown in figure 4 1 on page 22 This will keep the C Arm from tipping over as it is removed 9 Remove the metal brackets that hold the C Arm mobile stand to the pallet Take care not to scratch the mobile stand 10 Lift the lever located in the center of the control panel the hand brake and carefully move the mobile stand off the pallet and onto the floor 4 1 C Arm in the Transport Position Mounting Monitors ZIEHM 7000 The monitors are the only components that need to be mounted They are clearly marked Left and Right as viewed from the front of the monitor cart 1 Remove the monitor s rear panels 2 Have a qualified person help you place the monitor assembly onto the mobile cart s mounting surface 3 There are four screw holes located on the bottom of the monitor case Attach the monitor case to the cart with four allen screws 4 Route the mobile cart wiring through the hole in the bottom of the monitor case 5 Connect the AC power cords and video BNC connectors to their respective monitors left and right 6 Connect the yoke rotation cables to the X1 4 pin connectors on the U305 boards
45. g 110 kV and the resulting 1mage may be too dark If this happens press the Soft button to set camera gain to the maximum setting and fully open the camera iris Since the 1mage will be very noisy system noise reduction will automatically engage at the highest setting In most cases this will result in an image of diagnostic guality Noise reduction returns to the previously selected level when the Soft button is pressed again 1 2 Dose Figure 6 8 number 8 One half dose is the standard mode It is automatically selected when the o Yo ZIEHM 7000 is turned on DOSE One half dose reduces the amount of working dose used by 50 percent If you need access to full dose press the 1 2 Dose button again to turn it off Contrast Standard Systems Figure 6 8 number 34 The Contrast button performs several functions in the standard system d ha ob 1 When fluoroscopy is on press the Contrast button to adjust image con trast 2 Press the left arrow to decrease contrast the right arrow to increase con trast Contrast can be adjusted a total of six steps three to decrease contrast and three to add contrast 1 2 3 1 2 3 3 Press both arrows simultaneously to reset contrast to the factory default set ting 4 When fluoroscopy is off press the Contrast button to recall images step ping one image forward or backward per press of the button Contrast With Optional CINE DSA Module The Contrast button performs these a
46. ge Page button again or press the ESC key If escaping the Image Page when the 4 ON 1 function 1s selected a single image is displayed on the right monitor and the Image FWD REV button is used to recall images for 4 ON 1 PAT File Figure 6 20 on page 80 The Patient File function gives the operator control over patient files Press the PAT File button to displays a list of patient files on the screen as shown in Figure Refer to this figure when reading the remainder on this section 6 22 Example of the Patient File Display RCCEPPT ID DIE LLU DELETE DELETE COPY PATIENT IMAGE IMAGE PATIENT IMAGE PAT LAST NAME FIRST NAME DR DOCTOR I D IDF DATE 7 08 16 1995 TIME 15 26 04 PROCEDURE CINE RUN 3 Img Total 051 PAT LAST NAME FIRST NAME DR DOCTOR I D ID DATE 68 16 1995 TIME 14 26 04 PROCEDURE Img Total 611 PAT LAST NAME FIRST NAME BR gt BOETOR 1 0 ID DATE 08 22 1995 TIME 15 26 04 PROCEDURE img Total 0651 Press the Up Down Arrow buttons to browse patient files Files are arranged according to the date time created and not alphabetically on patient name When a file is selected the operator can make hard copies copy images to floppy disk and delete files Chapter 6 User Manual Review Buttons The Patient File function includes the following features e Patients File If a patient file is being used when the PAT File button is pressed other than the Non Spec
47. ge intensifier We also recommend that you keep a logbook of operating hours gettering times and maintenance details MAN 06 0004 Chapter Rev A Page 11 W ZIEHM 7000 MANUAL General Safety Laser Radiation Page 12 The laser alignment device incorporates the use of diode laser modules which emit laser radiation Do not under any circumstances look directly at the laser beam or any scattered laser radiation either with naked eyes or with opti cal instruments WARNING LASER RADIATION DO NOT LOOK INTO THE BEAM LASER CLASS II IN ACCORDANCE WITH FDA 21 CFR Subcategory J Section 1040 10 11 and EN60825 1 1994 You must comply with all operating safety precautions when operating the laser device The maximum output of continuous laser radiation measured at the laser beam exit is lt 1 mW The wavelength of the emitted radiation 1s 635 nm The laser device is maintenance free However if adjustment or repair work become necessary it must be performed by the manufacturer or other autho rized persons 2 2 Position of Visible Laser Light Window and Labels CAUTION Laser radiation when open DO NOT CAUTION STARE INTO BEAM LASER RADIATION DO NOT Located on rear of Generator cover LASER APERTURE CLASS I LASER PRODUCT MODEL SERIAL No LT 7000 COMPLIES WITH DHHS RADIATION PERFORMANCE STANDARDS 21 CFR SUBCHAPTER J AS OF DATE OF MANUFA MANUFACTURED BY RNATIONAL MEDICAL SYSTEMS INC INTE 4181 LA
48. ghtness Size Adjustment The size of the Output LUT 1s adjusted from linear to very steep to provide the operator with more control of contrast in the vascular anatomy Figure 6 18 provides more detailed information 6 18 Size Adjustment FIGURE 2 1024 Curve A OUT CURVE A 600S Lower Contrast CURVE B 20085 Higher Contrast 0 0 1024 IN SIZE Adjusts the Angle of curve in OUTPUT LUT This will increase or decrease subject Contrast We Page 72 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Look Up Tables K Edge Real Time Edge Enhancement More Monitor Cart Figure 6 8 number 12 Functions The optional Edge function sharpens the edges of 1maged anatomical structures It is not a post processing function and cannot be used to change a previously stored image EDGE Four levels of edge enhancement are available 1 20 2 35 3 5090 4 6590 The Edge button can only be pressed when fluoroscopy is not active Once pressed the monitor displays the message EDGE in the left monitor Best results are obtained when a noise level of at least Edge 1 1s used Noise Reduction Figure 6 8 number 13 w NOISE The amount of noise in fluoroscopic images can be reduced by three levels NR Low NR MED and NR HIGH The Noise button can be pressed before or dur ing fluoroscopy Noise reduction 1s accomplished by using weighted frame averaging of the cur rent and previous images which may cause an incr
49. he MSA MSA Max Op button on the Monitor Cart Control Panel 2 Press the hand switch or foot switch to start flouro The right monitor will display the live fluoroscopy image the mask will be automatically acquired and the left monitor will display the subtracted peak opacified image 3 When the INJECT message is displayed on the left monitor start the con trast injection 4 When the vascular anatomy is fully opacified release the foot switch or hand switch The left monitor will continue to display the regions of the vascular anatomy that had the greatest contrast during injection 5 Press the MSA button to exit the MSA program 1 An audible alert is optional MAN 06 0004 Chapter Rev B Page 49 W ZIEHM 7000 MANUAL Subtraction Modes RSA Road Map SHIFT MASK RSA Re registration of MSA mask MAX OP Figure 6 8 number 9 If the patient moves during the subtraction procedure you must realign the mask Press the Shift Mask button on the Monitor Cart Control Panel Figure 6 8 number 40 and then press the appropriate Arrow buttons to move the mask in the direction desired Mask Arrow Buttons Figure 6 8 number 35 To move the Mask use the Mask Arrow buttons located on the Monitor Cart Control Panel in the following manner e Press once to move the mask 0 25 pixels e Press and hold the Shift button and an Arrow button to move the mask 1 0 pixels e Hold an Arrow button down to
50. his manual includes forms for recording reguired tests Make several 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 4181 Latham Street Riverside CA 92501 Maintain original copies of completed forms for future reference If System Users have a eguipment related problem they must immediately stop using the system and notify a Service Engineer The system must not be oper ated until repairs have been made and the proper functioning of the system is verified a Page 2 MAN 06 0004 Chapter Rev B Chapter 1 Introduction Problems E Service Engineers are responsible for Record Keeping 1 completing the records listed below 2 filing the original and for 3 forwarding copies to the indicated recipient Service log Whenever any service is Original to performed on the system Service files FDA Form 2579 Whenever the system is Original to Report of assembly installed or when any of Service files diagnosis x ray the following certified system components are replaced Copies to or added e FDA X ray tube housing and e Manufacturer high voltage generator e State e Beam limiting assembly e Hospital e Image receptor X ray control unit FDA Eguipment When system installation Original to Locator Card is complete Service files Copy to manufacturer
51. iation is being released the Radiation Exposure indicator on the right control panel will illuminate Audible Alarm 3 After five minutes of radiation have accumulated an alarm is triggered and an k LED in the Min button begins to flash To turn off the alarm press the Min button The LED will continue to flash To turn off both the alarm and the LED press and hold the Min button Note Pressing and holding the Min button clears Radiation Time and cGY cm indicator displays W Page 58 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Mobile Stand Displays Laser Aiming Device The laser aiming device is an option that makes it easier to aim the radiation beam It produces a light cross that so that you can see where the radiation beam will fall Press the Laser button to turn the laser on and off The laser automatically turns E off after 60 seconds of use for your safety LASER The laser is a class II laser product subject to IEC 825 and 21 CFR Subchapter J 1040 Its peak power is I mW and operates at a wavelength of 635 nm WARNING Do NOT stare into the laser beam Eye damage may result The use of optical instruments with this product increases eye hazard Paper Printer The paper printer is an optional device that produces paper copies of captured images Press the Print button to print a copy of an image I For ZIEHM 7000 systems equipped with a hard copy camera and a printer PRINT follow these steps
52. ified Patient file then the system makes the patient file the Active Patient and places an activity box around the patient infor mation Accept Patient To accept a patient file for use use the Right Left Arrow buttons to high light the Accept Activity function a the top of the screen or place the activity box around the patient information and press the Enter button Note If the Image Crop or Window Level functions have been selected then the Arrow buttons cannot be used to select a patient file Escape both functions View Images Allows images in a patient file to be viewed without making the file active Move the activity box to the desired file and press the Image FWD REV button to view the file s images Delete Image Deletes a single image from the patient file Use the Right Left Arrow buttons to highlight the Delete Image box on the activity menu Press the Image FWD REV button to display the image Press the Enter button Delete Patient Deletes an entire patient flle Use the Up Down Arrow buttons to place the activity box around the patient information Use the Right Left Arrow buttons to highlight the Delete box Press the Enter button Copy Image Copies images from patient file to floppy disk or ZIP drive Place a formatted disk into the disk drive Select the image Use the Right Left Arrow buttons to select the Copy box from the activity menu on the right monitor Note Image size is approximately 306 K
53. igure 6 8 number 32 2 Select CINE Autostore if your system is so equipped Figure 6 8 num ber 31 3 Press the CINE Reset button on the Monitor Cart Control Panel Figure 6 8 number 20 to select CINE Protect 1 An audible alert is optional MAN 06 0004 Chapter Rev B Page 51 ie ZIEHM 7000 MANUAL Special Function Buttons Re registration of DSA mask SHIFT If the patient moves during the subtraction procedure you must realign the MASK mask Press the Shift Mask button on the Monitor Cart Control Panel Figure 6 8 number 40 and then press the appropriate Arrow buttons to move the mask in the direction desired To use the Arrow buttons refer to the Mask Arrow Buttons on page 50 6 9 Image Acguisition Buttons on the C Arm 12 15 18 23 26 28 31 34 38 40 Id ar gl had te la ks Kind lt gt RATE STORE CROP 37 y sar _ y Ey eve E 13 16 19 10 TEXT CINE 11 14 20 30 33 36 17 Table 3 CINE Buttons To use this table refer to the circled numbers in figure 6 9 on page 52 Button Button Function Description 18 Frame Rate Press to store dynamic 1mages at one to four frames per second 19 Mask The subtraction mask can be selected while running 22 Image FWD REV Press FWD or REV to display dynamically stored images 27 CINE Edit Press to select the CINE runs for editing CINE Recall Press to recall and display a CINE run 32 CINE Store Press to protect acguired images onto
54. igure 6 8 num ber 11 3 Press either the hand switch or the foot switch The C Arm releases radia tion and after three or four seconds locks the kV mA and AGC functions of the CCD camera system to prevent the image from changing due to the injected bolus which might cause density fluctuations in AGC and DOSE 4 The system starts acquiring the image mask using high noise reduction 5 After the mask is acquired the system displays the real time image on the right monitor Note During acquisition image intensity and contrast looks different that dur ing fluoroscopy This is normal 6 The left monitor displays the message INJECT in the lower center of the screen to indicate that the system has captured a mask and is ready for injection 7 Press either the hand switch or the foot switch to begin image acquisition An audible alert activates when acquisition begins and the system subtracts the live images from the mask and displays the subtracted image on the left monitor 8 Release the switch when the desired vascular anatomy is visualized We Page 68 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Fluoroscopic Procedures Re Registering the Mask During DSA Figure 6 8 number 40 SHIFT If the patient moves during a subtracted procedure use the Shift Mask function MASK to realign the mask to the patient s new position 1 Press the Shift Mask button 2 Use the Arrow buttons to realign the mask N
55. ing the area on the right monitor 6 Press the MAG WNDW button to turn off the MAG WNDW function and return the image on the right monitor back to normal size with text display The right monitor will continue to display the last magnified image Note The digitally magnified image may appear blotchy or pixilized To mini mize this effect press the Enter button Magnified images can be stored to the hard drive or copied to the paper printer or the file documentation camera Sharp Figure 6 8 number 41 SHARP The Sharp function increases the edge sharpness of anatomical structures in images This function provides two levels of adjustment number increases edge sharpness by 20 and number 2 by 35 The Sharp enhancement is a post processing function and cannot be used to enhance a live fluoroscopic image Press the Sharp button to toggle between Sharp Low Sharp High and No edge sharpness Escape Figure 6 8 number 41 Press the Escape button to exit from most system functions The ZIEHM 7000 displays error messages in the GY cm window and acti Error Codes vates an audible alarm Error codes consist of the letter E followed by a num ber such as E 16 If there are multiple errors the system displays them sequentially There are three types of error messages 1 cautions at start up 2 errors at start up and 3 errors during normal use Cautions at start up Cautions at start up indicate faults th
56. ipment you must consider e the proximity of the accessory to the patient and whether the accessory s safety certification has been performed in accor dance with the appropriate IEC 601 1 and or IEC 601 1 1 harmonized national standard Note Using accessory equipment with a safety rating that is not equivalent to the eguipment s may reduce the safety level of the entire system 6 5 Front View of Monitor Cart X Ray indicator light fi Monitors Floppy disk drive Control keyboard Video paper orinter a MAN 06 0004 Chapter Rev B Page 43 ZIEHM 7000 MANUAL Description of Symbols ZIEHM 7000 Compact System The Compact system provides all of the standard features of the 7000 but with out the need for the monitor cart The single monitor provides the Last Image Hold function The monitor can be positioned on either side of the C Arm The System User can view and position the mobile stand by referencing the small video monitor installed in the back of the 17 inch monitor 6 6 Optional Single C Mounted Monitor TT un e E Wm Re Page 44 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Description of Symbols Introduction Fluoroscopy Using the ZIEHM 7000 to perform fluoroscopy is easy turn the system on give the cathode filament around 30 45 seconds to warm up and press the hand switch or foot switch to view the first image The following optional features desc
57. ke on the mobile cart by pulling the handle up and check that the cart moves freely and can be steered by turning the brake handle 4 Turn on C Arm power at the monitor cart control panel Raise and lower the C Arm 4 2 ON OFF Keys OFF Caution The starting circuit is always powered even when power is switched off To completely disconnect from Mains Power remove the power cord from the wall power outlet Follow the instructions found in the CDRH report and record the results into the CDRH Report report MAN 06 0004 Chapter Rev A Page 25 W ZIEHM 7000 MANUAL CDRH Report This page is intentionally blank Re Page 26 MAN 06 0004 Chapter Rev A Chapter 5 Technical Data Introduction Chapter 5 Technical Data This chapter presents technical information for the ZIEHM 7000 C Arm and Introduction includes heating and cooling charts Caution Rapid changes to temperature can damage system compo nents Make sure that all components have reached room temperature before using Note Thermal paper can become discolored at temperatures greater than 409 C with a relative humidity greater than 60 At temperatures above 60 C image contrast can be permanently lost Line voltage 230 VAC 10 50 Hz 120 VAC 10 60 Hz Main fuse of power supply 15 A 220 V 20 A 110 V Leak current detection switch d 16 A Ian 30 mA specified for 230 V Nominal power draw 12 A at 120 V peak 30 A 6A at 220 v peak 15 A Intern
58. l Panel Note If the VCR button is pressed when the power to the VCR is off the left monitor will display the message VCR for a few seconds and then return to the main screen The VCR must be turned on before entering the VCR mode DICOM Video Capture Review VCR Images stored on the DICOM NT 100 system can be viewed on the right moni tor by pressing the VCR button Image Capture Figure 6 8 number 25 Figure 6 7 number 6 To store an 1mage to the DICOM NT 100 press the Print button on the Moni tor Cart Control Panel or the Print Button on the Mobile Stand Control Panel Note For detailed DICOM operating instructions read chapters 23 and 24 of MAN 06 0004 MON MON L REL R 6 20 Image Review Buttons PAT CINE CINE MASE FILE EDIT RECALL INV REV 4 2 PRINT VIDEO IMAGE FWD REV The function of the Image FWD REV button changes depending on the mode the system is in The button is used to perform the following functions If the CINE mode has been selected the button allows viewing of CINE run images one image at a time forward or reverse If Image Page Patient File and CINE modes have not been selected then images from the current patient record can be viewed one at a time Images are displayed on the right monitor Hold the button down to recall images from the hard drive at a minimum rate of 1 5 fps MAN 06 0004 Chapter Rev B Chapter 6 User Manual Review Buttons In Image R
59. layed in the middle of the image circle and the message TXT INSERT to display in the lower left corner as shown in figure 6 15 on page 65 2 Using the Arrow buttons position the arrow to the desired location Press Enter to store the arrow in that location You may then move the arrow to a new location for another arrow or start entering text 3 Press any alphanumeric key to enter a text string Each string can contain up to three lines of fifteen characters 4 To save the text overlay either press the Store button or transfer the image to the right monitor Note Text and arrow markers can be repositioned on the image circle by using the Arrow buttons but only before the Enter button is pressed Page 64 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Fluoroscopic Procedures 6 15 Text Insert THE TEXT CAN BE PLACED INSIDE CIRCLE THE TEXT CAN BE PLACED INSIDE CIRCLE THI INSERT Right or Left Anatomical Marker Anatomical Markers are used to indicate whether the view is left anatomical or right anatomical They can only be applied to images that are not saved to the hard drive Markers are displayed on the left monitor in the upper left corner of the screen Press the R key to select a Right Anatomical Marker or the L key to select a Left Anatomical Marker The R and L keys toggle the Markers on and off If the image is transferred to the right monitor the Marker remains visible If the 1mage is
60. lun WW Us 91018 fest G 1015 GN nn ae AG 3 ALA AS NZ Aen ACL AG Kar AZb Mn SR NIOZ inooez gt U e D ere mmen meene ama eee ee JOSSA a Bui OO AA 49UOE 4 UNY AG uey 6ul 00 Nr NEM OOF 9 OO 6un6JosJeA uioJ s Aiddng JeMOd Z Sd De pooo 19MOd 6d do AG Apr Ach 8d Ndd 0000dlA yXie yne7 Addo 4 jeuJ9 34 seuio xy 9a9ej49 u Addo 4 J8MOd Z Sd AG AcV IPA S G CL C Sd I IZ N JOMOd af 0000008 y co Cn co G 18YJON ZUW OO L IG ENN unnpued OFS uu is A Z 19 U Nd YEW 10 99uuo59 OG 4 AG A n AG AZL c Akt Ndo VEN 30 dd Nd VIEW 30 Id AG roe Hd Saal Q D J9MOd Z Sd 38MOd Z Sd 38MOd Z Sd 38MOd C Sd did EE ad LSH JCS jeuondg yeuondo jeuondo eA uO 4 i eA ug 3 BAU O Q H 30 OH 3al i Q H 3al OLX goeye U gen o o Bn gt o LL E o o o V c O o a o OU o o a o cc o o op Bn o Q o MAN 06 0004 Chapter Rev A Features la Speci et Z et gt o o o N le LLI N woad OOF LN Woy du 9p NOA WO4 Mdu GP OdX Gap Mdu pp sng ueg pX ESEN gt o T 18594 Ndd ZX EX OLX VX LX 9X ge SX IDA GJL JLISJU L9LN UU O9PIA SX OdX COLn aow y ZX GM 801 sng ueg WH W1 HOA eduejsbunjuye s OdX aseaay Asanbay uopeipey Bunsanayssbunyensg z 98ed ol 6X a 1 aseq OL n t ar 1
61. m the 16 1mage page using the Image FWD REV button or the Arrow buttons 3 Press the MON R L button to place a reduced copy of the image in position one on the left monitor as shown in figure 6 25 on page 89 4 Repeat step three for images two three and four Note You can print the 4 On 1 image but it cannot be stored 6 25 Example of 4 ON 1 4oni Next Image To Transfer And Minifv Will Be Placed At Position 2 Etc MAN 06 0004 Chapter Rev B Page 89 W ZIEHM 7000 MANUAL Review Buttons WNDW LEVEL MAG WNDW WNDW Window Level Figure 6 8 number 15 Pressing the WNDW button changes the contrast of the video image by chang ing the window of gray scale It modifies the brightness of the video by chang ing the level of brightness within the window of gray scale When the WNDW button is pressed the left monitor displays a text message and the W and L values in relative numbers to the level set Adjusting WNDW Press the Right Arrow button to decrease the image s relative contrast scale Press the Left Arrow button to increase the image s relative contrast scale Adjusting Level Press the Up Arrow button to increase the image s relative brightness Press the Down Arrow button to decrease the image s relative brightness Note WNDW and LEVEL are post processing functions post processing func tions and can only be used to change stored images Using the Window Level Function 1 S
62. manufacturer e the electrical installations in the room in which the ZIEHM is used corre spond to the power requirements listed in Appendix A and e the equipment is used in accordance with this manual MAN 06 0004 Chapter Rev B Page 1 We ZIEHM 7000 MANUAL CDRH Tests CDRH Tests CDRH Report Problems Service Engineers Service Engineers are responsible for installing calibrating and maintaining the C Arm system In order to be gualified to perform the procedures described in this manual Service Engineers must attend formal training provided by Instrumentarium Imaging Ziehm Inc hereafter referred to as the manufac turer System Users System Users are responsible for reading and following each section of this manual that applies to them which includes Safety System User Manual It does not contain any procedures that can be performed by the System Users Do NOT allow System Users to perform any of the service tasks described in this manual or any tasks that are not described in the User Manual This manual contains test procedures that the Center of Disease and Radiologi cal Health CDRH reguires to be performed as the system is installed and prior to customer acceptance A list of the eguipment reguired to conduct these tests is included Use only this equipment or approved substitutes If you have any guestions concerning testing call the manufacturer at 909 781 2020 and ask for the Service department T
63. mmon non abrasive cleaning liguid e To clean the monitors you need 100 alcohol or a mixture of 75 alcohol and 25 distilled water and two or more soft clean cloths Moisten a cloth with alcohol and wipe the monitor glass surfaces clean Immediately use a dry cloth to dry the monitors Disinfecting We guarantee that eguipment surfaces can be disinfected with any of the fol lowing solutions e 97 water and 3 Incidin e 80 water and 20 Ultrasol F 5 parts water to I part Ultrasol F e 65 water and 35 Formaldehyde Please observe the following e Never use pure alcohol or pure Sagrotan to disinfect equipment surfaces These chemicals can permanently destroy eguipment paint e Never spray disinfectants onto equipment surfaces The spray might get inside the equipment and damage electronic components Spray vapors inside the equipment can ignite Note The film cassette holder can be sterilized MAN 06 0004 Chapter Rev B Page 93 W ZIEHM 7000 MANUAL Cleaning and Disinfecting This page is intentionally blank W Page 94 MAN 06 0004 Chapter Rev B
64. n of Symbol Symbol Description Symbols AC Alternating Power ON Current 417 IEC 5007 ON 417 1EC 5032 Protective Earth Power OFF Terminal 417 IEC 5265 417 IEC 5019 Earth Type B 417 IEC 5017 Equipment fi IEC878 02 02 Potential Dangerous o Equalization Voltage 417 IEC 5021 Attention See accompanying documents IEC 348 MAN 06 0004 Chapter Rev B Page 39 ZIEHM 7000 MANUAL Description of Symbols Mechanical Operation The mechanical brakes for the C Arm should always be secured in the locked position especially when the equipment is in transport To adjust the locked position of the handles lift the handle and move it to the desired position and then gently release it Orbital movement The C Arm is capable of 115 of orbital movement 90 from horizontal to ver tical and 25 beyond vertical The brake can be released in any of these posi tions Rotation The C Arm can be rotated 225 if the horizontal arm 1s positioned correctly an locked with the brake Swivel The C Arm can be rotated side to side 12 and locked in any position Horizontal Movement When locked in any position the C Arm can still move approximately 22 cm horizontally Vertical Movement The mobile stand has a motor that can raise and lower the C Arm up to 43 cm by pressing the Up Down buttons located on the Mobile Stand Control Panel Braking and Steering The lever near the Monitor Cart Control Pan
65. n or the Exit button Storing Images Figure 6 8 number 32 and Figure 6 7 number 30 To store the entire dynamic image acquisition to the hard drive during play back press either the CINE Store button on the Monitor Cart Control Panel or the Image Store button on the Mobile Stand Control Panel Note The Image Store button on the Mobile Stand Control Panel will store the CINE run only when in the CINE mode When not in CINE mode it will work as a simple Image Store button When storing the acquisition at frame rates of 1 2 to 4 fps the system protects the acquisition and requires less than one second to store it to the hard drive When storing acquisition at frame rates of 8 15 and 30 fps the system transfers the images from the extended dynamic image memory to the hard drive and requires 37 5 seconds to store the images to the hard drive Storing Individual Images to the Patient Image File Directory 1 Press the Image RWD REV button on the Mobile Stand Control Panel Figure 6 7 number 34 or the Image RWD REV button on the Monitor Cart Control Panel Figure 6 8 number 22 This places the system into a playback mode that steps through images one at a time 2 When image playback has stopped select the image to transfer to the patient file and press either of the Image Store buttons see Storing Images on 70 3 The left monitor will display the message Stored to XX XX which indi cates that the image has been
66. n to move the cursor to the New Patient Information data entry field Date Press the Down Arrow button to move the cursor to the Date data entry field When the field is highlighted type in the desired information and press the Enter button date format is MM DD YY Use the Up Arrow button to move the cursor to the Patient Information data entry field Time Press the Down Arrow button to move the cursor to the Time data entry field When the field is highlighted type in the desired information and press the Enter button time format 1s HH MM SS Use the Up Arrow button to move the cursor to the Patient Information data entry field To exit the New Patient Information screen without saving the information added to the data entry fields press the ESC button To exit the New Patient Information screen and save the information added to the data entry fields press the Y key After the Y key 1s pressed the system closes the file and changes the display on the left monitor as shown in Figure 6 14 MAN 06 0004 Chapter Rev B Page 63 ZIEHM 7000 MANUAL Mobile Stand Displays 6 14 New Patient Information Displayed on Left Monitor Text Insert TEXT Figure 6 8 number 8 INSERT The Text Insert function adds an overlay of text to the left monitor In order for this text to be visible it must be located within the image circle To insert text follow these steps 1 Press the Text Insert button This will cause an arrow to be disp
67. nitor Note Live Image Transfer cannot be activated when the system is releasing radiation Compact Systems This function only works when the monitor cart is con nected to the mobile stand Image Store Figure 6 7 number 30 Figure 6 8 number 33 Images can be copied to the system hard drive When you press the Image Store button the left monitor will display an image number and the message Store will blink on the monitor Use Image Store to e save a live image e save the last image held on the monitor e save a dynamic image run when CINE Acquire and Dynamic Image Replay are running and e save a single CINE image when the system is in CINE Step Mode Radiography Figure 6 7 number 20 To select spot film radiography follow these steps 1 press the Radiography button and 2 press and hold the Hand switch The button s LED will illuminate and an alarm will trigger and remain on throughout the taking of the exposure Releasing the hand switch interrupts the exposure The spot film radiography function is available for re use ten seconds after an exposure is taken Exposure Techniques Radiography operates at a fixed tube current of 20 mA and kV is automatically set for optimum penetration Therefore the only remaining way to control dose is by adjusting exposure time Exposure time can be set from 0 1 to 4 0 seconds We Page 56 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Mobile S
68. ns line cord condition ground cables condition mechanical limits laser power supply voltage tests as applicable laser alignment as applicable Verify Automatic Dose Rate In accordance with CDRH regulations automatic dose rate must be checked monthly Power on the C Arm in default mode The control panel must display the following Fluoro program number one Extremities with patient equiva lent filter 25 mm aluminum plus mm copper The control panel will also display values that should resemble the following 1 2 Dose 67 2 kV 2 1 mA 0 4 mA 1 1 Dose 70 2 kV 2 7 mA 0 4 mA Check Beam Centering Centering refers to the deviation of the beam center to the image recep tor Check beam centering and size periodically especially if the system hasn t been used for a long time in the following manner 1 Place the primary beam shutters in the cone in position 2 Look at the fluoro 1mage on the monitor and check the amount of drift from the center position 3 Place an object at the center of the image intensifier like a measuring plate or a center cross hair 4 Set up the equipment as follows We Page 38 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Description of Symbols Focus Object Distance FOD 90 cm Maximum deviation from center lt 2 FOD e Field size shutters primary shutters must be visible in the monitor Note For more information refer to Chapter 6 Descriptio
69. o Store Warning FIRST NAME LAST NAME ID 041 22 95 THE FACILITY NAME DR NAME WARNING image D sk io full Delere another patient record to free space for this patient No further image storage is possible without deletting another patient record cee eee ROY Press Enter to continue FLUORO iia LIH MED RUIO SIORI HIIN 1 PROCEDURE TITLE NNN IMS 2 Auto Transfer Auto Transfer automatically transfers images from the left monitor to the right monitor The last image on the left or process monitor is transferred to the right or reference monitor the next time fluoroscopy 1s initiated 3 Auto Both Auto Both automatically performs both the functions of Auto Store and Auto Transfer 4 Auto Magnification available only on system with RTE or VIM installed Press and hold the Auto Store button until the left monitor displays the message AUTO MAG When the exposure switch 1s released the last image on the left monitor will be magnified and displayed on the right mon itor To exit Auto Store functions press the Auto Store button until the display 1s removed from the left monitor We Page 86 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Review Buttons Arrow Buttons Figure 6 8m number 35 The Arrow buttons are located on the Monitor Cart Control Panel in the lower right hand side They have several functions depending on the mode or func tion that is active MAG WNDW pans and s
70. ocated on the Monitor Cart Control Panel as shown 1n Figure 6 8 number 31 The imaging system stores the last image to the patient file when the foot switch or hand switch is released Snapshot Figure 6 7 number 12 The Snapshot button 1s located on the Mobile Stand Control Panel The Snap shot function can only be activated by the hand switch Press the Snapshot button to activate the function Press the hand switch to take an 8 mA exposure The exposure 1s automatically displayed on the monitor and remains until another snapshot is taken If the radiation alert is activated an audible sound will be produced with each pulse of radiation Note Default noise reduction setting is 16 image MSA The MSA button is located on the Mobile Stand Control Panel see figure 6 7 on page 46 number 28 The MSA Max Op button is located on the Monitor Cart Control Panel see figure 6 8 on page 47 number 9 MSA provides maximum image opacification of vascular injection regions 1 Press the MSA button on the Mobile Stand Control Panel or the MSA Max Op button on the Monitor Cart Control Panel to enable maximum opacification Use the standard fluoroscopy mode to position the patient Press either the hand switch or the foot switch When the audible alert activates start the contrast injection or WON Press the Auto Store button to store the image when the exposure switch is released 6 Release the exposure switch when a fully
71. on the yoke assembly of each monitor 7 Connect the IC buss cables 6 pin connectors to their connectors in the middle of the chassis boards of their respective monitors We Page 22 MAN 06 0004 Chapter Rev A Chapter 4 Installation Procedure Mounting Monitors 8 Connect the cables to the floppy drive and or Zip drive as labeled mounted in the base of the monitor housing 9 Attach the ground wires to the rear panel and cart 10 Install the larger set of four pin connectors to X1 of the U355A board which 1s located behind the monitor chassis board 11 Apply power to the C Arm and Monitor Cart and verify that the system works properly Test All functions If the system 1s set up to be non fluoro scopic then confirm that it cannot produce radiation 12 Re attach the rear panels and access plates ZIEHM 7000 Single Monitor Option Compact System The monitor is the only item that needs to be mounted 1 Connect the monitor to the monitor cart before turning on the system s power 2 Plug the monitor cart power cord into a properly rated and grounded power outlet 3 Hold the monitor upright and securely attach it to the horizontal arm with the four bolts provided for this purpose Note To perform step 3 safely you will need another person to help you 4 Attach the cable connector end from the monitor assembly to the XP1 con nector on the mobile stand Make sure that the cable 1s draped in a manner that does no
72. opacified image is obtained We Page 66 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Fluoroscopic Procedures MSA Max Op Figure 6 8 number 40 SHIFT If the patient moves during a subtracted procedure use the Shift Mask function MASK to realign the mask to the patient s new position 1 Press the Shift Mask button 2 Use the Arrow buttons to realign the mask Note Press an Arrow button once to move the mask 1 4 pixel Hold down the Shift button and press the Arrow button to move the mask one pixel Press and hold down the Arrow button to move the mask repeatedly RSA Figure 6 7 number 28 and Figure 6 8 number 10 o RSA RSA Road RSA subtracts the vascular pathway during live fluoroscopy to aid in the posi Map tioning of a catheter or guide wire 1 Use the standard fluoroscopy mode to position the patient 2 Press either the RSA button on the Mobile Stand Control Panel or the RSA Road Map button on the Monitor Cart Control Panel Press either the hand switch or the foot switch When the audible alert activates start the contrast injection Release the switch when a fully opacified image is obtained a e a To continue the Road Map procedure repeat steps 3 through 5 The sub tracted Road Map will continue to be displayed on the left monitor while the right monitor will display an un subtracted live image Re Registering the Mask During Road Map Figure 6 8 number 40 SHIFT I
73. oroscopy off e Auto magnification mode e Image store alert e Subtracted image mask in DSA RSA MSA re registration e Patient view markers for Right and Left e CINE run indication in Patient View mode s LIH off function default setting e DSA default noise reduction setting MAN 06 0004 Chapter Rev A Page 17 W ZIEHM 7000 MANUAL Special Features Technical Specs VIDEO INPUT Video input compatibility Sampling rate of A D converter A D converter Acguisition frames per second VIDEO OUTPUT Video output compatibility Number of output images Special outputs Video bypass Image store format D A converters Image noise reduction Memory CPU DISK STORAGE Type Capacity CINE Image Loop RS170 1365 H x 525 V 2 21 5 mHz 10 BIT 30 RS170 1049 High Line Rate two 1278 H x 1049 V Documentation camera 4 X 525 V 1365 H Video RS170 output automatic a system power off only with software version 06B and earlier 1024 x 512 x 10 BIT Three 10 BIT D A 16 BITALU 2 16 frames real time 2 16 last image hold independently programmable Standard 12 MB Max 256 MB IDE ATA Digital disk 16 frames basic up to 7000 frames optional 1 2 to 2 fps with chali 4 to 30 fps with DSA Page 18 MAN 06 0004 Chapter Rev A induj oepiA ieuondo 9r nino oapia imuondo 94 indu 09piA euondo Sr OOPIA WN SIP Indul O6piA 20890204 Gew pp OGPIA WT PIT Page 19 bM nT Terry te D iy Cas c
74. ors must observe all safety rules Exposure to the x ray C Arm Operation beam must be strictly avoided Equipment operators and others in the area should protect themselves with such devices as lead aprons or shields When the x ray system is first turned on and warming up the control panel dis plays zeros the shutters open to maximum and the monitor yokes to the normal position The following default operating mode will be selected e Fluoroscopy with automatic dose rate control e Pelvic fluoroscopic mode the Full function e Live Image on the Left Monitor with Last Image Hold e normal picture size no magnification e 75 kV tube voltage and e one second radiographic exposure time The control panel keys on the monitor cart shown in Figure 6 1 will light up 6 1 Keys Activated in Default Mode _ eo 80 After 30 seconds of filament preheating approximately you may begin fluo roscopy by pressing either the hand switch or foot switch The kV mA will be automatically adjusted and displayed on the C Arm control panel display Perform the following operational tests e Open and close the slot and iris collimators e Rotate the slot collimator e Reverse the image e Rotate the image e Select manual kV mode MAN 06 0004 Chapter Rev B Page 35 W ZIEHM 7000 MANUAL C Arm Operation e Set kV setting manually e Rotate the monitor image using Mobile Stand Control Panel keys WARNING To prevent the
75. ote Press an Arrow button once to move the mask 1 4 pixel Hold down the Shift button and press the Arrow button to move the mask one pixel Press and hold down the Arrow button to move the mask repeatedly CINE with DSA Figure 6 8 number 21 and Figure 6 7 number 28 i CINE DSA CINE with DSA is used to acquire high quality dynamic subtracted images which is important when viewing peripheral injections leg run offs femoral arteries etc Note CINE must be selected before DSA is selected from the monitor cart If DSA is selected from the Mobile Stand both CINE and DSA will be activated When DSA is selected the imaging system optimizes the CCD camera s oper ating parameters for subtracted image acquisition and the imaging system selects values for LUT Window Level Noise Reduction and other parameters Frame rates of 1 2 to 30 frames per second fps can be selected depending on the options included with the system and on the rate that 1s appropriate for the medical procedure 1 To set kV mA values for DSA acquisition perform a scout fluoroscopy of the anatomical region using the appropriate body region button 2 Press the DSA button on the Monitor Cart Control Panel Figure 6 8 num ber 11 3 Ensure that the frame rate is appropriate If it is not press the Frame Rate button on the Monitor Cart Control Panel Figure 6 8 number 18 and set the rate 4 Press either the hand switch or the foot swit
76. ptional Triple Mode image intensifier can zoom 1 5 and 2 0 times Press the Zoom button once to select level one zoom 1 5 The Zoom button s indicator light will illuminate to show that level one zoom is on Press the Zoom button again to select level two zoom 2 0 The Zoom button s indicator light will flash to show that level two zoom is on Monitor Selection Figure 6 7 numbers 25 and 26 E O To select the left monitor press the Left Monitor button When selected the button s indicator light will be illuminated To select the right monitor press the Right Monitor button o E Compact Systems The select button for the right monitor is disabled Monitor Image Rotation Figure 6 7 number 27 The monitors image can be rotated clockwise and counter clockwise by press ing the appropriate Image Rotation button To return the image to its original upright position briefly press both buttons simultaneously RW Page 54 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Mobile Stand Buttons Image Reversal Figure 6 7 number 23 The monitors head to toe image can be flipped upside down and reversed to a mirror image To flip the image upside down press the Image Flip button cu Image Mirror Figure 6 7 number 24 To reverse the image right to left press the Image Mirror button EN Iris Collimator The Iris Collimator can be manually opened and closed To open the Iris Collimator pres
77. r Film Documentation Camera 1 Load a film cassette into the Documentation Camera The Number I light will illuminate 2 Press the Print button to begin exposing the film The Number 2 light will flash until the exposure is complete Note With two frame cameras the Number 2 light will illuminate until the Print button is pressed a second time to expose the second film 3 When all of the camera s light turn off close the shutter and remove the cassette Paper Printer If the system has both a Document Camera and a printer hold down the Shift button and the Print button If the system only has a printer press the Print button We Page 84 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Review Buttons Digital Document Rotation Figure 6 20 on page 80 Note The following only applies to systems that have installed the either the optional Real Time Edge RTE feature or the optional VIM module 1 Press the Print button The left monitor displays a message directing the operator to press the Right Left Arrow button to perform digital rotation before making a film exposure 2 Select an image from the PAT View screen and transfer it to the left moni tor or select a single image from the right monitor image collage 3 Use the Right or Left Arrow button to rotate the image into the desired position To bypass the Digital Document Rotation feature just press the Print button again without pressing the Right Le
78. r 150 images When the CINE function is selected the system does not change it s image properties as is the case in the DSA acquisition operation The C Arm stays in the fluoroscopic body region that was selected The CINE function allows the operator the ability to perform procedures such as Cholangiography Barium Swallows Urinary Studies ERCP or any procedure that requires a sequence of images to be acquired The images may be viewed as a subtracted image loop by pressing the DSA button on the Monitor Cart Control Panel Figure 6 8 number 11 during replay of the acquired image sequence Note The image quality of subtracted images will not be as good as with the special image properties of the dynamic DSA function selected from the Mobile Stand Control Panel CINE Messages All messages are displayed on the left monitor LOOP UNSTORED Indicates that the image loop currently being replayed has not been stored Press the CINE Store button to change the protected run number on the hard drive FRAME RATE DISPLAY 1 2 30 F SEC Indicates the selected frame rate To change the frame rate press the Frame Rate button before starting an acquisition or during replay of a captured loop AVAILABLE Indicates the number of images that can be stored When acquiring CINE loop images at a frame rate of 1 2 to 4 fps the displayed num ber of images available will decreased as more images are stored However when acquiring image
79. r Cart Control Panel and then MASK press the appropriate Arrow buttons to move the mask in the direction desired To use the Arrow buttons refer to Mask Arrow Buttons on page 50 Subtracted Dynamic Image Acquisition DSA CINE CINE Functions Figure 6 7 number 28 To perform DSA follow these steps 1 Push the fluoroscopy button that corresponds to the region of the patient that 1s to be examined Refer to Anatomical Programming on page 49 2 Press the DSA button on the on the Mobile Stand Control Panel The sub tracted image will be displayed on the left monitor DSA 3 Press the hand or foot switch The subtracted image will be displayed on the left monitor 4 When the INJECT message is displayed on the left monitor start the con trast injection 5 When you have obtained the desired vascular anatomy release the hand or foot switch The acquired images will automatically replay in a continuous loop until you either exit DSA or start a new acquisition 6 To exit DSA mode press either the CINE button or the ESCAPE button on CINE the Monitor Cart Control Panel Figure 6 8 numbers 32 and 39 Protecting Acquired Images Pressing the foot switch overrides all other activities Protect acquired images CINE before starting a new procedure by performing the following steps STORE 1 Press either the Store button on the on the Mobile Stand Control Panel or the CINE Store button on the Monitor Cart Control Panel F
80. rding to EN 60601 1 2 limit class A It may only be operated in residential areas under the supervision of qualified medical personnel Environmental Compatibility During operation the system does not produce waste When the system is decommissioned from use or sold attention should be paid to relevant disposal regulations Radiation Warning This equipment produces x rays which are dangerous to operators and others in the vicinity if relevant safety procedures are not strictly adhered to Useful and scattered beams can cause serious or fatal injuries to any persons in the sur rounding area if the equipment is used by unskilled operators Take appropriate precautions to avoid exposure to the radiation beam and radiation leakage from the generator housing Only authorized personnel should operate or direct the operation of this equip ment Persons become authorized in part by becoming completely familiar with and adhering to 21 CFR Subchapter J Radiological Health and National Council on Radiation Protection NCRP document 33 Medical X ray and Gamma Ray Protection for Energies up to 10 MEV Eguipment Design and Use Persons responsible for planning the installation of x ray eguipment must be completely familiar with and adhere to NCRP 49 Structural Shielding Design and Evaluation For Medical Use of X rays and Gamma rays of Ener gies Up To 10 MEV X Ray Control Area The following distances apply with the x ray gener
81. repeatedly move the mask 0 25 pixels RSA Road Map Figure 6 7 number 28 Figure 6 8 number 10 To perform RSA Road Map follow these steps 1 Perform standard fluoroscopy and position the patient as needed 2 Press the RSA Road Map button either on the Mobile Stand Control Panel or the Monitor Cart Control Panel to automatically enable peak opacification for the first part of the procedure 3 Press the hand or foot switch to start Fluoro The right monitor displays the live fluoroscopy image The mask 1s acquired and the left monitor displays the subtracted peak opacified image 4 When the INJECT message is displayed on the left monitor start the con trast injection 5 When the vascular anatomy is fully opacified release the foot switch or hand switch The left monitor will continue to display the regions of the vascular anatomy that had the greatest contrast during injection 6 Press the hand switch or foot switch to display the subtracted road map image live on the left monitor and the un subtracted live fluoro image on the right monitor 7 Press the RSA Road Map button to exit this mode of operation 1 An audible alert is optional We Page 50 MAN 06 0004 Chapter Rev B Chapter 6 User Manual CINE Functions D Re registration of RSA mask Figure 6 8 number 40 If the patient moves during the subtraction procedure you must realign the SHIFT mask Press the Shift Mask button on the Monito
82. ribed in detail later in this chapter are also available e Several fluoroscopy programs e Snapshot technique e Pulsed fluoroscopy e Manual control of kV e Image integration for noise reduction e Zoom magnification e Multi format image and data storage e Image reversal e Image rotation monitor e Iris collimation e Slot collimation with rotation e Real time edge enhancement e Documentation rotation digital e Imaging mirroring after image is acquired Basic Operation Turn on the C Arm as described in See C Arm Operation on page 35 e Fluoroscopy Is activated or radiation is released by pressing either the hand switch or the foot switch e When you stop pressing the hand or foot switch the generator stops releas ing radiation and the last image is displayed held by the left monitor This image will continue to be displayed until a new fluoroscopic image IS obtained e Contrast and brightness levels are set at the factory and are generally best left alone However to change contrast or brightness levels simply pull out the knob and rotate to obtain the desired effect MAN 06 0004 Chapter Rev B Page 45 W _ ZIEHM 7000 MANUAL Description of Symbols Control Panels This section describes the functions of the buttons found on the mobile stand and Monitor Cart Control Panels 6 7 Mobile Stand Control Panel EXPOS C OP Table 1 Mobile Stand Buttons To use this table refer to the circle
83. s required for the safety of patients and operators IEC and VDE regulations You must ensure that the x ray system meets the requirements of DIN IEC 601 part 1 37 ff see chap 1 6 through a program of regular maintenance and periodic inspection You can find a schedule for periodic inspection in the Technical Manual Mobile Stands and Monitor Carts with integrated components such as screens documentation camera and paper image printer are not AP version They may not be used in the presence of flammable gasses WARNING Any third party devices and components used in combina tion with the system must comply with the safety requirements accord ing to IEC 60601 1 and or IEC 60601 1 1 or furnish proof of an equivalent degree of safety Non compliance may result in a downgrade of the safety classification of the whole system and invalidation of war ranty We Page 8 MAN 06 0004 Chapter Rev A Chapter 2 Safety Hazards Mechanical and Electrical Warnings Operate moveable assemblies and parts with caution Inspect moveable assem blies and parts at the intervals stated in this manual Only allow properly trained and gualified service personnel to access any inter nal parts Live electrical terminals are deadly Be sure that line disconnect switches are open off and that precautions are taken before opening access doors removing enclosures and panels and attaching accessories Do not remove access covers from the generator
84. s are required to perform any internal service and one of the Service Engineers must be trained in the Emergency Power Removal proce dure Both Engineers must fully understand equipment circuits and voltages Here are some safety rules that must be followed e Before removing equipment covers disconnect the power cord from the power source e Never assume that a capacitor is discharged Use a ground shorting device when working on circuits with capacitors even when the equipment is dis connected from a power source e Make sure that equipment connections are made as described in the Instal lation section of the manual Do not under any circumstances remove by pass jumper or disable safety General 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 result in electrical shock or fire hazard Therefore NEVER allow bev erage or food containers to be placed on system equipment Never operate the system in a location where conductive fluids such as water or saline solution may come into contact with any part of the equipment unless the equipment is covered 1n protective waterproof draping Gettering If the system is stored for more than 6 uninterrupted months we recommend that you turn it on for at least one hour before using it Doing so will signifi cantly prolong the useful life of the ima
85. s at 10 to 30 fps the displayed number of available images does not decrease as images are stored it continues to show the maxi mum number of images that can be stored to the hard drive Press the Image FWD REV button to sequence through the images in the CINE run one at a time When the hard drive fills to the point that it cannot store at least 50 images the system will display a message that dynamic image acquisition cannot be started until more space is available To make room on the hard drive delete image runs or patient files To exit the CINE function press the CINE button We Page 76 MAN 06 0004 Chapter Rev B Chapter 6 User Manual CINE Functions CINE Procedure Image Loop Acquire 1 Position the C Arm over the selected anatomical region and select the appropriate body region button Use fluoroscopy to verify optimum C Arm positioning 2 Press the CINE button on the Monitor Cart Control Panel Figure 6 8 number 21 3 Select the frame rate for dynamic image acquisition the left monitor will display the message CINE the CINE button will light up and the selected frame rate will display on the left monitor 4 Press and hold either the hand switch or the foot switch The left monitor displays the message INJECT in the lower center of the screen to indicate that the system has captured a mask and is ready for injection 5 Start the injection 6 Continuing holding the exposure switch until the d
86. s the Iris Collimator Open button Figure 6 7 number 19 Each press opens the collimator one step To make a larger adjustment press and hold the button down to advance through several steps To close the Iris Collimator press the Iris Collimator Close button Figure 6 7 number 18 Each press closes the collimator one step To make a larger adjustment press and hold the button down to advance through several steps G To fully open the iris briefly press both buttons simultaneously Slot Collimator The Slot Collimator can be manually opened closed and rotated To open the Slot Collimator press the Slot Collimator Open button Figure 6 7 number 15 To close the Slot Collimator press the Slot Collimator Close button Figure 6 7 number 14 To rotate the Slot Collimator counter clockwise press the Slot Collimator Counter Clockwise Rotation button Figure 6 7 number 16 To rotate the Slot Collimator clockwise press the Slot Collimator Clockwise Rotation button Figure 6 7 number 17 O O MAN 06 0004 Chapter Rev B Page 55 W ZIEHM 7000 MANUAL Mobile Stand Buttons Eu Jl IMAGE STORE Live Image Transfer Figure 6 7 number 31 The images from the left and right monitor can be swapped Press the Live Image Transfer button to transfer the image and text from the left monitor to the right monitor and the image without the text from the right monitor to the left mo
87. t interfere with the movement of the mobile stand MAN 06 0004 Chapter Rev A Page 23 W ZIEHM 7000 MANUAL AC Power Check System Interconnect AC Power Check The monitor cart and mobile stand are connected with a single heavy duty cable which attaches at the rear of the monitor cart Connect the monitor to the monitor cart before turning on the system s power Plug the monitor cart power cord into a properly rated and grounded power outlet Compact Systems The Compact system does not require system connec tion Simply plug the monitor cart power cord into a properly rated and grounded power outlet Ensure that the system s AC power cord is compatible with the AC power receptacle The system must be grounded through the U shaped grounding prong of the line WARNING Do NOT use a 3 prong to 2 prong adapter unless properly installed by a licensed electrician Failure to comply may result in seri ous or fatal injuries to the System User and other persons in the sur rounding area Ensure that the AC line voltage is compatible with the power requirements of the system Line voltage must be set to match service For voltages above and below 110 VAC adjust module 10 line voltage Verify power input to the Monitor Cart and adjust Module 10 transformer input according to the wall outlet drop off For example if the wall outlet idles at 115 VAC and drops to 110 VAC when the x ray system produces fluoroscopy at 90 kV then tap
88. tand Displays Radiography Field Size Figure 6 7 number 21 Spot film radiography reguires the use of film held against the 1mage intensi fier To attach the film holder to the image intensifier pull back the holder s spring knob position the holder on the image intensifier and then release the e Ve knob 30 Eg The collimator can be set to three different sizes of film 24 30 and 40 cm However the 24 cm format is the only size used in the United States The Mobile Stand Control Panel has two display windows Mobile Stand Displays 1 The left window displays numeric kV and mA information and exposure time S Se The right window displays numeric and graphic information regarding dose fluoro time and temperature and includes fault and exposure indica tors 6 10 Left Display Window 6 11 Right Display Window FIN kV Display The default setting is 75 kV During fluoroscopy the ZIEHM 7000 adjusts kV levels automatically using dose rate control circuitry unless manually over ridden After fluoroscopy the last kV value used is stored in the system and is shown in the kV section of the display window mA Display The ZIEHM 7000 controls mA level in relation to kV level The mA value is displayed in the left window during live fluoroscopy The last value used by the system is stored and recalled when the system returns to fluoroscopic mode This value will continue to be used until either
89. tests 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 If the system fails to operate correctly or fails to respond to system controls as outlined in the this manual notify the local authorized Instrumentarium Imag ing Ziehm Inc dealer representative Hospital Administration Hospital administration is responsible for verifying that the equipment contin ues to operate within the correct calibration of mA kV time mAs and align ment 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 agen cies regarding requirements and regulations applicable to the system s use Instrumentarium Imaging Ziehm 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 dealer representative Manufacturer The manufacturer is responsible for the safety reliability and efficiency of the equipment only when e installation alterations or repairs are carried out by persons authorized by the
90. the Monitor Cart for 110 VAC Compact Systems Adjust line voltage at the appropriate terminal block inside the lower rear of the mobile stand WARNING Failure to properly set line voltage taps may result in dam age to the system s electronic components Check Leakage Current We recommend that you perform a check of 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 with the ZIEHM 7000 line cord per the meter manufacturer s instructions 3 Turn the meter on and verify that leakage current does not exceed 100 uA in either normal or reversed line polarity 4 Connect the black lead of the meter to an exposed metal surface on the ZIEHM 7000 5 Turn the meter on and verify that leakage current does not exceed 100 uA We Page 24 MAN 06 0004 Chapter Rev A Chapter 4 Installation Procedure Mechanical The C Arm is capable of moving in a 1159 arc 90 from horizontal to vertical Mechanical and 25 beyond the vertical plane rotating in the vertical plane around the hori Movement zontal cross arm 225 or swinging from side to side 12 Test C Arm movement and brakes in the following manner 1 Release one brake and verify full the full and unrestricted movement of the C Arm Secure the brake 2 Repeat step one for each brake 3 Release the hand bra
91. tioned with the Up Down Left Right Arrow buttons in the following man ner Close Vertically press the Down Arrow button Open Vertically press the Up Arrow button Close Horizontally press the Right Arrow button Open Horizontally press the Left Arrow button Store Image Crop Press the Image Store button to store the cropped image Transfer Image Crop When the shutters are positioned correctly press the MON L to R button to transfer the image to the right monitor Electronic Shutters Once the operator has positioned the electronic shutters this becomes the shut ters default position as long as the system is turned on Once the system is turned off shutter position returns to the original position of just outside the image circle We Page 88 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Review Buttons 4 ON 1 Figure 6 8 number 36 The 4 ON 1 function reduces the size of images so that four images will fit onto the film for documentation printing thereby eliminating the need for a multi format camera 1 Press the 4 ON 1 button and the following events occur the left monitor clears the message 4 ON 1 is displayed on the left monitor the numbers 1 2 3 4 are positioned on the left monitor to indicate where the images will be placed and the 16 1mage page is displayed on the right monitor with the selection box placed on the first image 2 Select the desired image fro
92. tomer Service E51 Error Fault Call Customer Service E52 Error Fault Call Customer Service E53 Error Fault Call Customer Service E54 Error Fault Call Customer Service 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 Error Fault Call Customer Service E6l Error Fault Call Customer Service E62 Error Fault Call Customer Service E63 Error Fault Call Customer Service E64 Warning Call Customer Service E65 Error Fault Call Customer Service Re Page 92 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Cleaning and Disinfecting Table 4 List of Error Codes E91 Error Fault Call Customer Service E9 Error Fault Call Customer Service E151 Error Fault Call Customer Service E90 Error Fault Call Customer Service 2 Caution Disconnect the ZIEHM 7000 from the wall power source Cleaning and before performing any cleaning or disinfection Disinfecting Cleaning To ensure that the system is not damaged during cleaning follow these rules e Only use common non abrasive cleaning liquids to clean exterior metal parts Never use abrasive cleaners or solvents e Never spray the cleaning solution onto the equipment To clean exterior metal parts of the eguipment use a soft towel that has been moistened with a co
93. you have typed in the desired information press the Enter button to accept the entry New PAT New Patient Figure 6 8 number 2 The New PAT button is green and 1s located in the upper right side of the Mon itor Cart Control Panel as shown in figure 6 8 on page 47 Press the New PAT button to enter the New Patient Information screen as shown in figure 6 12 on page 62 MAN 06 0004 Chapter Rev B Page 61 ZIEHM 7000 MANUAL Mobile Stand Displays 6 12 Patient Information Menu a carr r Esra gt WS gt FER Ar rr x gt bh IS kr fiki lp I j rial NE gt Se mS S i L bas UUs UL GI fe PRESS ESCAPE TO EXIT Enter information line by line and then press the Enter button to enter the information Note Pressing the Enter button on an empty field causes the cursor to move to the next field After the last line has been completed the screen displays a verification notice in the lower third of the screen to give you an opportunity to review the entered data before it is added to the data file Facility Name Note By default Facility Name Date and Time are entered by the system Press the Down Arrow button to move the cursor to the desired line We Page 62 MAN 06 0004 Chapter Rev B Chapter 6 User Manual Mobile Stand Displays 6 13 Arrow Buttons When the New Facility data entry field is highlighted type in the facility s name and either press the Enter button or use the Up Arrow butto

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