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Ziehm 8000

1. 6000 Fig A 6 Labels on the Ziehm Compact Fig A 7 Labels on the two pedal foot switch The labels shown in the following table are merely reproductions Their sizes and colors may differ from reality and serve illustrative purposes only A 16 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A No Label Comments P Values for 1 2 amp ziehm imaging MOBILE C ARM SERIAL NO Ziehm 8000 MOBILE C ARM MOBILE STAND A A MANUFACTURER DEGREE OF 1275 for Europe only ZIEHM IMAGING GMBH PROTECTION 90451 N RNBERG Germany a Rating label no DATE OF MANUFACTURE TS04_038 TS04_033 China O Values for 1 D ziehm imaging i MOBILE C ARM SERIAL NO Ziehm 8000 MOBILE C ARM Ziehm Compact X RAY GENERATOR A ne TOTAL FILTRATION CE 1275 for Europe only FOCAL SPOT i TUBE HOUSING SR NO MAX KVP TUBE SR NO 110 KV COMPLIES WITH IEC 60601 2 7 1998 TOTAL FILTRATION MANUFACTURER gt 3 9 mm AL ZIEHM IMAGING GMBH 90451 N RNBERG Germany FOCAL SPOT DATE OF MANUFACTURE 0 5 J 1 5 TUBE HOUSING MAXIPULSE 3 110 TUBE TYPE DF 151R 0 5 1 5 110 40 GF 181R 0 5 1 5 125 60 Rating label no TS04_040 TS04_037 China 7 Values for 1 S ziehm imagin 8 5 MOBILE C A
2. 23 cm image intensifier a front Fig A 9 Labels on the generator USA Ziehm 8000 A 23 P_26376 CD_28210 EN 01 07 2010 Appendix A Fig A 10 Fig A 11 b front rear Labels on the image intensifier USA A If 24 ED y Ces vv 7 43 of c 3 O AR Q ww 8 Labels on a monitor cart with 24 flat screen monitor USA A 24 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A 9 8 c Q Th I ISIS Fig A 12 Labels on a monitor cart with 18 1 flat screen monitors USA gt o b Sa o Ey v o 7 D gt gt a 7 VN li ll Fig A 13 Labels on the Ziehm Compact USA Ziehm 8000 A 25 P_26376 CD_28210 EN 01 07 2010 Appendix A Fig A 14 Label on the two pedal foot switch USA The labels shown in the following table are merely reproductions Their sizes and colors may differ from reality and serve illustrative purposes only No Label Comments 7 Values for 1 ziehm imaging weber
3. F1 Save Cancel Fig 16 12 Step Windowing menu The available parameter range 0 255 is displayed as soon as the menu item is selected with the Down Arrow or Up Arrow key The desired values must be entered with the alphanumeric keys The Windowing menu item is used for setting either standard windowing mode or step windowing mode for the contrast keys on the C arm stand Windowing Off The Contrast keys on the C arm stand work in standard windowing mode Windowing On The Contrast keys on the C arm stand work in step windowing mode The default windowing steps which are activated after power up can be programmed for each individual anatomical program under Configu ration Menu Service Settings Filter Factors Organ 0 Organ 1 Organ 2 Soft gt Ch 16 6 2 1 p 16 25 Ziehm 8000 16 23 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 6 2 Filter factors Function The Filter Factors submenu is used for setting different filter factors for each anatomical program and each subtraction mode in separate sub menus Filter Factors Organ 8 Organ 1 Organ 2 Soft Fig 16 13 Filter Factors menu Menu item Anatomical program Organ 0 extremities amp children Organ 1 head spine amp pelvis Organ 2 thorax amp abdomen E Table 16 1 Anatomical programs 16 24 Ziehm 8000 P_26376 CD_2
4. Optional foot switch pedal assignment Function Initiate radiation Save Background color transparent ZIR Art No 10 2986 ZIN Art No 58372 a Fluoro Mag Ca Optional foot switch pedal assignment Function Initiate radiation Magnify Background color white ZIR Art No 10 2989 ZIN Art No 58413 Table A 5 Labels USA cont Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 A 31 Appendix A No b Label Fluoro Mag Ca Comments Optional foot switch pedal assignment Function Initiate radiation Magnify Background color transparent ZIR Art No 10 2990 ZIN Art No 58414 Fluoro Snap Optional foot switch pedal assignment Function Initiate radiation Snapshot Background color white ZIR Art No 10 2991 ZIN Art No 58417 Fluoro Snap IL Optional foot switch pedal assignment Function Initiate radiation Snapshot Background color transparent ZIR Art No 10 2992 ZIN Art No 58418 Fluoro Swap gt Optional foot switch pedal assignment Function Initiate radiation Image swapping Background color white ZIR Art No 10 3031 ZIN Art No 58427 Fluoro Swap Optional foot switch pedal assignment Function Initiate radiation Image swapping Background color transparent ZIR Art No 10 3032 ZIN Art No 58428 E 2x 20AT
5. matic exposure rate control In exceptional cases you may set the AN exposure rate also manually N Do the following Select the appropriate anatomical program on the C arm stand AN Extremities amp children or Head spine amp pelvis or a Thorax amp abdomen or VY Soft tissues SOFT gt Ch 7 4 2 p 7 6 Screen the object briefly choosing one of the fluoroscopy modes with automatic exposure rate control on the C arm stand Continuous fluoroscopy or Continuous pulse fluoroscopy or Single pulse fluoroscopy gt Ch 7 2 p 7 2 Press the manual mode key on the C arm stand to freeze the auto matically determined kV value and to switch to the manual mode Select the desired kV value with the voltage setting key on the C arm stand With each keystroke the value is increased decreased by 1 kV Screen the patient uae VARNING To protect patients and staff from excessive radiation exposure you should use manual exposure rate setting only in exceptional circumstances Always select one of the modes with automatic exposure rate control when screening a new patient or body region for the first time Ziehm 8000 7 5 P_26376 CD_28210 EN 01 07 2010 7 Standard Fluoroscopic Operations 7 4 Fluoroscopy programs 7 4 1 Y DOSE function key To activate LED is lit and deactivate LED goes out the half dose Vp function press the DOSE key on the C arm stand DOSE When
6. Ziehm 8000 MODEL SERIAL NO MOBLE STAND Rating label no TS04_044 COMPLIES WITH CDRH RADIATION PERFORMANCE STANDARDS 21 CFR SUBCHAPTER J AS OF DATE OF MANUFACTURE DEGREE OF PROTECTION IP 20 MANUFACTURER ZIEHM IMAGING GMBH DONAUSTRASSE 31 90451 NURNBERG Germany MANUFACTURED NING ZIR Art No 10 2936 1 THIS X RAY UNIT MAY BE DANGEROUS TO ZIN Art No 58450 PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS OPERATING INSTRUCTIONS AND MAINTENANCE SCHEDULES ARE OBSERVED ZIR Art No 10 2938 1 DANGER ZIN Art No 58452 EXPLOSION HAZARD DO NOT USE IN PRESENCE OF FLAMMABLE ANESTHETICS Table A 5 Labels USA A 26 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A No Label Comments O i Values for 1 ziehm imaging A ER MOBILE C ARM Ziehm 8000 Ziehm Compact X RAY GENERATOR Fee MAX KVP TOTAL FILTRATION 110 kV FOCAL SPOT TUBE HOUSING TUBE HOUSING SR NO TOTAL FILTRATION TUBE INSERT TYPE TUBE SR NO gt 3 9 mm AL DET re eerste FOCAL SPOT OF MANUFACTURE MANUFACTURER 0 5 1 5 ZIEHM IMAGING GMBH 90451 N RNBERG Germany TUBE HOUSING MANUFACTURED MAXIPULSE 3 1 10 TUBE TYPE DF 151R 0 5 1 5 110 40 GF 181R 0 5 1 5 125 60 Rating label no TSO4_045 7 F Values for 1 ziehm imaging Re MOBILE C ARM Ziehm 8000 MOBILE C AR
7. 2 DOSE is activated the exposure rate is reduced by 50 thus minimizing the radiation exposure of patient and staff WARNING 4 WARNING You should deactivate the DOSE key only in excep tional cases Especially when screening a patient of heavy build you should never deactivate the DOSE key N e N Anatomical programs When you press one of the anatomical program keys on the C arm stand the system automatically selects a combination of tube voltage and tube current AERC characteristic which during fluoroscopy generates an optimized image of the corresponding body regions The following anatomical programs are available e Extremities amp children e Head spine amp pelvis e Thorax amp abdomen e Soft tissues SOFT You can use this anatomical program e g for foreign body localization or for visualization of syringe needles and skin contours 3 gO Q 2 9 EBp e Q To switch to another anatomical program press the desired anatomical program key You can also reactivate the previously active anatomical program simply by pressing the SOFT key once again Filter factors For each of these anatomical programs certain filter factors can be preset This is done under Configuration Menu Service Settings Filter Factors Organ 0 Organ 1 Organ 2 Soft gt Ch 16 6 2 1 p 16 25 N fon Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 7 Standard Fluoroscopic
8. 4s444244 44er nennen 7 13 7 10 2 Interval warning during radiation ceeceeeeeeeeeeeeeeeeneeeeeeeteeeeeeees 7 13 7 10 3 Temperature monitoring nennen snnnnnnnnnnnnnnnnnnnnnnnnnnnn nn 7 14 7 10 4 Error and alert messages u444224444Hennnsnnnnnnnnnnnnnnnnnnnnnnnnnnn ann 7 14 8 Adjusting Live Images 8 1 Bel OVERVIEW een 2er under sat ttensantd fendaccane A E de Tresen Beeren 8 1 8 25 Gollimation ers ern rin eile 8 1 8 2 1 Iris COMM ALOR sea aa en aR ee tee AE 8 1 8 2 2 Slot collimator 22228 aesecche hid tbec ceding kette a E 8 2 8 2 3 Slot collimator rotation 8 2 8 2 4 Virtual collimator n a for Ziehm Compact Ziehm Compact with adapter for lithotripter procedures ssnnneneennn 8 2 8 3 Electronic image magnification eessensnnnennennnnnnnnnennnnnnnnnennnnnnnnnnnn nn 8 3 8 4 Contrast and brightness adjustment Windowing nsnnneeenneeen 8 4 8 4 1 Control from the C arm Stand ceccceeeeceeeeeeeeeeteeeeeeeeeeeeeeeeseeeeeeeeaas 8 4 8 4 1 1 Standard windowing cccccceeeeeeceeeeeeeeeceeeeeeeestaeeeeeeenaaes 8 5 8 4 1 2 Step windowing uersesssnnnennnessnnnnnnennnnnnnnennnnnnnnn nn 8 5 8 4 2 Control from the monitor Cart cc eeceeeeeeeeeceeeeeeeeeeeeeeeenaeeeeeeeeaas 8 6 8 5 Image reversal and image rotation usrssnsesnnnnnnnnnnnennennnnnnnnnnnnnnnnnn nn 8 8 II Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Contents 8 5 1 Hori
9. 7 Standard Fluoroscopic Operations 7 10 3 Temperature monitoring The thermal conditions in the generator are indicated by the temperature symbol on the C arm stand Thermal behavior On your Ziehm 8000 the following thermal behavior may occur Overtemperature When the oil temperature reaches the overtemperature threshold the temperature symbol starts flashing and the single pulse fluoroscopy and direct radiography modes are inhibited If the system happens to be in one of these modes it will return automatically to continuous flu oroscopy In this mode you can continue to work for a few more minutes Overheating When the oil temperature reaches the overheating threshold radi ation is terminated immediately and remains blocked The temper ature symbol is illuminated permanently and the alert messages E 26 and E 29 appear alternately on the dose display of the C arm stand You can no longer release any radiation until the generator temperature drops below the overheating threshold and the indicators go out Switch off the system in order to shorten the cool down time 7 10 4 Error and alert messages oO na In case of malfunctions the corresponding error and alert messages E f E appear alternately with the dose area product on the dose display of the cGy cm C arm stand Error and alert messages always start with an E At the same time an audible alarm sounds For a detailed explanation of the messages
10. In 2 20 A lan 30 mA In 20 A lAN 30 mA In 16A lan 30 mA Typical current consumption 14 A continuous 22 A momentary 14 A continuous 22 A momentary 10 A continuous 16 A momentary Power supply in sta ndby mode 410 VA 4 3 A 460 VA 3 8 A 460 VA 2 3 A E 2 The values depend on the integrated documentation systems gt N Power input fuse 20 A slow 20 A slow 15 A slow Maximum line lt 0 30 lt 0 30 lt 0 60 impedance Equipment Protection Class I Type B ordinary equipment continuous protection operation classification Radiation controlled area with generator in lowermost position and C arm vertical 15 cm image intensifier 3 m 23 cm image intensifier 4 m Table A 7 Systems with a voltage rating of 100 V 120 V 200 V A 42 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A frequency rating of Systems with a voltage 100 Vac 10 120 Vac 10 200 Vac 10 50 60 Hz 50 60 Hz 50 60 Hz Power Direct radiography 40 110 kV 20 mA min 0 1 4s 5 Continuous fluoroscopy E 40 110 kV f 0 1 6 mA v 9 Single pulse fluoroscopy snapshot 40 110 kV 8 mA 1s Operating 20 kHz frequency Table A 7 Systems with a voltage rating of 100 V 120 V 200 V cont Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 A 43 Appendix A Generator Systems with a voltage 100 Vac 10 120 Vac 10
11. W 255 L 127 Bi Home Windowing Settings BLACK WHITE a Bi Home Fig 8 1 Windowing Settings menu default setting above and custom setting below Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 8 7 8 Adjusting Live Images 8 5 Image reversal and image rotation Function Sem The image reversal and image rotation keys allow individual adjustment of the image orientation on the live screen In most cases these functions are used to align the image orientation with the patient s orientation To make orientation easier for the operator a label is attached to both the image intensifier and the generator housing showing a patient in supine position If the patient is positioned as illustrated by the label then the image orientation on the live screen corresponds to the patient s orientation Both image reversal and image rotation are produced digitally and without the need to initiate any further radiation 8 5 1 Horizontal and vertical image reversal To mirror the fluoroscopic image vertically about the horizontal axis press the Reverse Up Down key on the C arm stand To mirror the fluoroscopic image horizontally about the vertical axis press the Reverse Left Right key on the C arm stand 8 5 2 Image rotation Ziehm 8000 O GUO Ziehm Compact Image rotation comprises two steps First you must determine whether you want to ro
12. 13 2 Printing on video printer The PRINT key on the C arm stand or on the monitor cart allows you to print the live screen image on the video printer During the print oper ation the key s LED is illuminated PRINT Text information appears as a text block with a gray background to the left of the image on the hard copy NOTE When you launch the print job directly from the video printer the resulting hard copy will be an exact repro duction of the live screen CAUTION Misinterpretation of printer images Due to less resolution printer images may contain less information than the corresponding digital images Store digital images on a storage medium For evalu ation purposes always use the digital images too Ziehm 8000 13 1 P_26376 CD_28210 EN 01 07 2010 13 Image Documentation Meran CAUTION When printing on the Sony UP 990 video printer always use the CUT button on the printer for cutting offthe printer paper Tearing off the printer paper may damage the video printer As opposed to that on the Sony UP 970 and UP 897 video printers you must tear off the printer paper For further information please refer to the video printer s separate oper ating instructions provided with this system 13 2 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 14 Laser Positioning Device 14 1 Overview As an option the system may be equipped with a laser positioning device a
13. BLACK WHITE 8 255 W 255 L 127 Home Post Windowing BLACK WHITE Home Fig 11 3 Post Windowing menu default setting above and custom setting below Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images 11 8 Measurements Submenu When you select the Measurements menu item and confirm with the Enter key the Post Measurements submenu opens It is used for mea suring different lengths and angles on the saved fluoroscopic image Post Measurements Cal length 39 8 mm F2 F3 Angle 3P_ Angle 4P Fig 11 4 Post Processing menu Post Measurements submenu If a reference length has been determined and saved before it will appear as a menu item gt Ch 11 8 1 p 11 7 maon CAUTION If you change the zoom factor after making a measurement the measured values will no longer be correct A corresponding alert message is displayed on the reference screen in this case However setting a zoom factor before making a mea surement will provide correct measured values F4 Function key F1 Length activates the function for measuring a length Length or a distance gt Ch 11 8 2 p 11 9 Function key F2 Angle 3P activates the function for measuring the Angle 3P lengths of two contiguous lines and the angle between them gt Ch 11 8 3 p 11 11 T n
14. EN 01 07 2010 14 Laser Positioning Device On a Ziehm Compact or a Ziehm Compact with adapter for lithotripter procedures you always use the F key to activate the crosshair However the crosshair does not appear on the screen until you have pressed the F key and initiated radiation e Initiate radiation with the hand or foot switch to visualize the foreign body on the screen e Position the C arm in such a way that the center of the crosshair on the screen lies exactly over the foreign body e Switch on the laser positioning device with the LASER key The laser positioning device s laser beam crosshair now marks the patient s skin exactly above the point where the foreign body lies so deter mining the precise point of surgical incision Ziehm 8000 14 3 P_26376 CD_28210 EN 01 07 2010 14 Laser Positioning Device 14 4 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 15 Direct Radiography 15 1 Overview The Ziehm 8000 can also be used for making direct radiographic film exposures NOTE This function is only enabled if a film cassette holder has been ordered as optional accessory for your system 15 2 Fitting the film cassette holder The film cassette holder for direct radiography must be fitted onto the image intensifier before use Do the following e Pull the spring loaded securing lever on the film cassette holder out wards e Slide the film cassette holder over the supporting ridge
15. Foreign body local ization The laser positioning device can be used for the following tasks As alignment aid for positioning the C arm For foreign body localization As a navigational aid for nail fixations AUTION era CAUTIO Use of controls or adjustments or performance of proce dures other than those specified herein may result in haz ardous radiation exposure The laser positioning device allows exact positioning of the C arm without radiation Do the following e Switch on the laser positioning device with the LASER key A laser beam crosshair is generated the central point of which corresponds to the position of the central X ray beam e Position the C arm in such a way that the central point of the laser beam crosshair is exactly in the center of the region of interest to be screened e Initiate radiation with the hand or foot switch The laser positioning device may also be used for foreign body local ization and extraction Do the following e Make sure that the on screen crosshair is activated On a Ziehm 8000 this can be done in two ways By presetting Crosshair On under Configuration Menu gt User Settings gt Ch 16 2 2 p 16 3 the crosshair is permanently dis played on the screen then By pressing the F key if it has been assigned the Crosshair function under Configuration Menu gt User Settings gt Ch 16 2 3 p 16 3 14 2 Ziehm 8000 P_26376 CD_28210
16. Labeling for fuses ZIN Art No 58474 Table A 5 Labels USA cont A 32 Zi P_26376 CD_28210 EN 0 ehm 8000 h 1 07 2010 Appendix A A 6 Focal spot position 22 745 215 E fot g ic mens 12 400 620 Fig A 15 Focal spot position on Ziehm 8000 with 23 cm i i Ziehm 8000 A 33 P_26376 CD_28210 EN 01 07 2010 Appendix A AN 800 Reference axis 215 ESS AA D a I 400 620 Focal spot red 680 t got gt 123 Anode angle Fig A 16 Focal spot position on Ziehm Compact with 15 cm i i A 34 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A A 7 Heat capacity Heating Heating characteristic at 110 kV 3 2 mA characteristic 800 000 J heat capacity 50 W continuous heat dissipation 70 60 2 a 5 F 40 30 20 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 Time min Fig A 1417 Heating characteristic Cooling Cooling characteristic ch
17. The respective patient data must be stored on the DICOM server already You must have the patient number or the patient ID label of the respective patient at hand 10 2 1 Query The Query DICOM function enables you to download a patient s data Function e g first name last name from the DICOM server CAUTION amp CAUTION If you use the patient ID to search for a patient folder please verify the search result by checking the patient name It may happen occasionally that a patient ID is assigned more than once on a DICOM network Ziehm 8000 10 1 P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions 10 2 2 Contents of the Worklist Time span of the Worklist Patient specific Worklist Opening the Worklist offline To retrieve patient data from a DICOM server do the following e Press the NEW PAT key The Patient Data Input menu appears on the reference screen e Enter the patient number under the Patient no menu item e Press function key F3 Query The patient data record is down loaded from the server and automatically entered into the patient data input menu e f necessary complete any missing data using the alphanumeric keys The data is displayed by default in upper case letters To enter lower case letters press function key F6 abc prior to each letter e Save the changes with function key F1 Save Retrieving a W
18. The system is not suitable for interventional procedures acc to IEC 60601 2 43 The system may only be operated by personnel who has undergone radiological training In the USA Federal law restricts use of this device to trained personnel on the order of a physician Only authorized personnel are allowed to assemble and repair the medical equipment described in this document Authorized personnel are persons who have attended an appropriate training course provided by the manufacturer The exposure of humans to ionizing radiation must always be medically justified Especially when used on pregnant women adolescents children and pediatric patients all procedures using ionizing radiation should be used with caution or be avoided altogether However the final decision lies with the attending physician or attending surgeon The manufacturer accepts responsibility for the safety reliability and performance of the system only if any installation modification or repair work is carried out exclusively by persons authorized by the manufacturer the electrical installation of the site where the system is operated complies with the requirements of VDE 0107 or the corresponding national regulations of the country of installation only original spare parts or components that comply with Ziehm Imaging s specifications are used the system is used in accordance with the Operating Instructions The warranty becomes invalid in c
19. cedure Please keep an emergency plan ready for this case GCAUTION CAUTION The system can fail due to mechanical defects This may cause obstructions to the operational pro cedure Please keep an emergency plan ready for this case 3 8 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 4 Mechanical Handling 4 1 Transport position For safety reasons you must return both the C arm stand and the General monitor cart to their respective transport position before transporting them 4 1 1 C arm stand transport position To return the C arm stand to its transport position do the following How to proceed e Wind the foot switch cable onto the foot switch support and hang up the foot switch there e Rotate the C arm orbitally until the image intensifier is positioned directly above the generator and secure it with the relevant blue brake gt Fig 4 1 p 4 2 and gt Fig 4 3 p 4 7 e Put the swivel arm of the C arm into an upright position and secure it with the relevant red brake gt Fig 4 1 p 4 2 and gt Fig 4 4 p 4 8 e Swivel the horizontal carriage into a central position and secure it with the relevant green brake gt Fig 4 1 p 4 2 and gt Fig 4 5 p 4 9 e Retract the horizontal carriage completely and secure it with the rel evant yellow brake gt Fig 4 1 p 4 2 and gt Fig 4 6 p 4 10 e Lower the lifting column completely gt Fig 4 1 p 4 2 and g
20. A 6 A 7 Reset 5 7 5 5 6 3 7 13 Dose meter VacuDAP C technical data A 47 VacuDAP duo technical data A 49 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Index E Edge enhancement 11 2 Edge filter 11 2 16 26 Emergencies Switching off 6 4 EMERGENCY STOP button 6 4 Enhancement Edges 11 2 Enter key 5 6 12 3 Equipotential grounding cable 4 2 Error During operation A 7 During power up A 6 Error messages 7 14 ESC key 5 6 Exposure guide 15 4 Exposure rate control Automatic 7 2 7 5 Manual 7 5 Exposure time display 5 5 15 3 Exposure Time Setting key 5 3 15 3 Extremities and Children key 5 3 F F key 5 4 14 2 14 3 16 3 F2 key 8 9 F3 key 8 9 Film cassette holder 15 1 A 5 Film size 15 2 Film size keys 5 3 Filter settings Edge filter 16 26 Recursive filter 8 9 16 25 16 26 Stack filter 16 25 16 26 Stack filter for continuous pulse 16 27 Stack filter for snapshot 16 27 Windowing step 16 26 16 27 Flatscreen monitors A 38 Built in keypad 16 7 Built in keypad for 24 flat screen monitor 16 17 Dimensions of monitor cart A 38 Fluoroscopy Fluoroscopy programs 7 6 Starting 7 8 Total radiation time 5 5 Fluoroscopy modes Continuous fluoroscopy 5 2 7 2 7 3 Continuous pulse fluoroscopy 5 2 7 2 7 3 Single pulse fluoroscopy 5 2 7 2 7 4 Snapshot 5 2 7 2 7 4 Fluoroscopy parameters Information on the screen 12 3 Fluoroscopy programs 1 2 DOSE 7 6 Anatomical programs 7 6
21. Save Ziehm 8000 11 11 P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images All values except the angle difference to a full circle appear below the image on the live screen Fig 11 9 ZIEHM ALFRED 25 12 89 1924 IHRE KLINIK PROF FORTSCHRITT ENDOSKOPIE 3 point measurement Post Measurements Cal length Length 1 Length 2 Angle 360 angle Fig 11 10 Post Processing gt Post Measurements 3 point mea surement 11 12 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images 11 8 4 4 point measurement To perform a 4 point measurement do the following Angle 4P e Press function key F3 Angle AP in the Post Measurements menu In addition to the reference length four menu items called Length 1 Length 2 Angle and 180 angle still without any values are dis played in the menu e Generate 4 measuring points as described under gt Ch 11 8 2 p 11 9 e The values for Length 1 distance between measuring point 1 and 2 Length 2 distance between measuring point 3 and 4 Angle interior angle between length 1 and 2 and 180 angle angle difference to a full circle are automatically entered into the Post Measurements menu e Save the measured values with function key F1 Save All values except the exterior angle appear below the image on the live screen ZIEHM ALFRED 25 IHRE KLINIK PROF FORTSCHRITT
22. Service Settings Filter Factors Organ 0 Organ 1 Organ 2 Soft gt Ch 16 6 2 1 p 16 25 7 2 2 Continuous pulse fluoroscopy To activate the continuous pulse fluoroscopy mode LED is lit press the continuous pulse fluoroscopy key on the C arm stand To deactivate the continuous pulse fluoroscopy mode LED goes out press the same key once again When you deactivate this mode the system automati cally returns to the continuous fluoroscopy mode Alternatively you can deactivate the continuous pulse fluoroscopy mode by simply selecting another mode In continuous pulse fluoroscopy mode radiation is turned on and off at intervals of approx 1 s as long as you press the hand or foot switch This method reduces the exposure rate by approx 50 Continuous pulse fluoroscopy is suitable for examinations where no or only slight dynamic movements need to be seen e g in traumatic surgery when repositioning fractures or localizing foreign bodies Depending on the selected anatomical program gt Ch 7 4 2 p 7 6 certain filter factors can be preset for continuous pulse fluoroscopy This is done under Configuration Menu Service Settings Filter Factors Organ 0 Organ 1 Organ 2 Soft gt Ch 16 6 2 1 p 16 25 Exposure time Filter factors Exposure time Fields of appli cation Filter factors Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 7 3 7 Standard Fluoroscopic Operations 7
23. Switches off the power supply of both system components ON Switches on the power supply of both system components 0 0 Arrow keys A v Are used for screen navigation HOME Moves the cursor to the beginning of a list HOME BJ Restores default settings Fr Scroll gt zZ Scroll 16 patient folders images backward or forward in the Mosaic menu ESC Cancels all functions In a submenu Returns you to the parent menu Enter or Return 8 Confirms the previously made inputs Table 5 2 Controls on the monitor cart control panel 5 6 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 5 Controls Symbol s Function Image swapping Swaps the images between the live and reference screens O Z o WNDW Opens and closes the menu for contrast and brightness adjustment windowing DEL Deletes all text inputs TEXT TEXT Activates and deactivates the text annotation mode MENU NEW PAT Opens and closes the menu for creating a new patient folder MENU Opens and closes the configuration menu MOSAIC Opens and closes the menu for image data management Function keys F1 F6 Keys with varying functions depending on the menu CINE This key is disabled 4 POST PROCESS Opens and closes the menu for image post processing PRINT Prints the image on the live screen to the video printer BO
24. USB pa CD F4 Net Store BES 13444 To display an image at full size on the reference screen and to compare images gt Ch 9 3 7 p 9 22 F2 Mark To mark one or more images F3 Protect To protect one or more images against being deleted F4 Delete To delete one or more images F6 Output To open the menu for saving and printing images This menu contains the keys for selecting a storage medium or printer Hospital PROTI ST FRANCIS Physician DR WONDER Department ENDOSCOPY Patient name ZIEHM DEMO 24 r N E N First name d ate irth r 12 09 1924 4 Sex Patient number Keywords ERCP Note 25 09 04 kV 57 kV 10 33 14 mA 2 7 mA 1 4 cGycm2 15 F4 F5 Net Store NetOutput Fig 9 8 Mosaic menu image level Output submenu F1 Print To print marked images on the video printer F2 USB To save marked images to a USB stick F3 CD To write marked images to CD F4 Net Store To save marked images to the connected DICOM server Ch 10 6 1 p 10 14 F5 NetOutput To print marked images on a connected DICOM network printer gt Ch 10 6 3 p 10 18 or co 16 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 Data Management To save marked images to a second DICOM storage server gt Ch 10 6 1 p 10 14 F6 Back To return
25. You can control the contrast and brightness adjustment in two ways Using the Contrast keys on the C arm stand Using the WNDW key on the monitor cart 8 4 1 Control from the C arm stand Ib To control the contrast and or brightness adjustment from the C arm stand you use the Contrast keys Two different windowing modes are available Standard windowing Step windowing Under Configuration Menu gt Service Settings gt Step Windowing gt Ch 16 6 1 p 16 23 you can preset which of the two modes shall be active 8 4 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 8 Adjusting Live Images 8 4 1 1 Standard windowing By pressing one of both Contrast keys in the anatomic programs the brightness of the image position of the contrast window on the live screen changes The brightness and or contrast adjustment becomes immediately visible in the live screen image Simultaneously the current contrast window level L and width W values are displayed there By pressing both Contrast keys simultaneously you can toggle between the default setting i e 256 evenly distributed gray levels and your custom setting You can correct your custom setting as often as desired We rec ommend though that you always reset the system to the default setting between any corrections by pressing both Contrast keys simulta neously Your last custom setting remains stored until you switch off the system CAUTION M
26. frequency rating of 50 60 Hz 50 60 Hz Max operating data Fluoroscopy 110 kV 6 mA Direct radiography 110 kV 20 mA Digital radiography 110 kV 8 mA 200 Vac 10 50 60 Hz Max power output Fluoroscopy 660 W 110 KV 6 mA Direct radiography 2200 W 110 KV 20 mA Digital radiography 880 W 110 KV 8 mA Nominal electric power 2000 W at 100 kV 20 mA 0 1s X ray tube Dual focus stationary anode tube Focal spot nominal size in relation to reference axis Fluoroscopy 0 5 acc to IEC 336 Direct radiography 1 5 acc to IEC 336 Anode angle in relation to reference axis 12 Anode material Tungsten Total filtration gt 3 9 mm Al equivalent Cu gt 0 1 mm Maximum X ray tube loading factors for 1h 3 mA at 110 kV 10800 mAs h Table A 7 Systems with a voltage rating of 100 V 120 V 200 V cont A 44 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A A 10 1 2 Systems with a voltage rating of 220 V 230 V 240 V Systems with avoltage 220 Vac 10 230 Vac 10 240 Vac 10 frequency rating of 50 60 Hz 50 60 Hz 50 60 Hz Power supply fuse C 16 A tripping characteristic C acc to VDE 0641 Part 11 DIN rating EN 60898 IEC 898 Required residual Iy gt 16 A Ian 30 mA current circuit breaker RCD Typical current 10 A continuous consumption 16 A mome
27. gt Ch 8 5 2 p 8 8 and can be adjusted later in the Post Processing menu gt Ch 11 4 p 11 3 Next to the letters W and L the contrast window width W and level L values are indicated 12 2 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 12 Displayed Texts and Text Functions The windowing values are selected with the Contrast keys on the C arm stand gt Ch 8 4 1 p 8 4 or via the WNDW key on the monitor cart gt Ch 8 4 2 p 8 6 and can be adjusted later in the Post Processing Windowing menu gt Ch 11 7 p 11 4 The time and date when the image was saved to the hard disk are auto Time and date of matically assigned by the system and cannot be edited saving 12 2 4 Lower right corner of the live screen The following fluoroscopy parameters are displayed here Fluoroscopy Tube voltage in kV parameters Tube current in mA Dose area product provided that your system is equipped with a dose meter and the display function for the dose area product has been enabled The values are automatically assigned by the system and cannot be edited 12 3 Manual text annotation and editing The text annotation or text editing mode is activated LED is lit and deac tivated with the TEXT key on the monitor cart When the text annotation mode is active a rectangular text annotation area appears overlaid on TEXT the live screen image With the arrow keys you can move to any desired po
28. gt Ch 9 3 1 p 9 9 F1 Backup To back up selected patient folders to CD gt Ch 9 3 2 p 9 10 F2 Search To search for patient folders using certain search criteria gt Ch 9 3 3 p 9 12 F3 Inv Docu To invert the grayscale of all images on the hard disk gt Ch 9 3 5 p 9 14 F4 Delete To delete a marked patient folder gt Ch 9 3 4 p 9 13 co Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 Data Management 9 3 1 Activating a patient folder To be able to save images to a patient folder you must activate it first The patient folder must be active also if you want to process any of the images stored there gt Ch 9 3 6 p 9 15 To activate a patient folder do the following e Press the MOSAIC key MOSAIC e Select the desired patient folder using the arrow keys or A V A e Search for the desired patient folder gt Ch 9 3 3 p 9 12 Q e Press the Enter key The message Please wait Creating thumbnails appears on the lt 2 screen Then all images contained in the patient folder are displayed as a thumbnail mosaic The image that was last saved is highlighted by a white frame e Press the Enter key Now you can generate new fluoroscopic images and save them to the active patient folder gt Ch 7 8 p 7 10 Hospital ST FRANCIS Physician DR WONDER Department ENDOSCOPY Patient name ZIEHM DEMO 18 First name TAMMY Date of bi
29. please refer to Appendix A 3 2 p A 8 NOTE In case of faults please communicate the fault code number as well as the serial number of the system to your after sales service center 7 14 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 8 Adjusting Live Images 8 1 Overview The Ziehm 8000 offers a comprehensive range of options for adjusting the appearance of the live image according to the individual preferences of the user The following functions are available Different collimation functions Electronic image magnification Contrast and brightness adjustment windowing Correction of the image orientation using image reversal and rotation Image comparison with the help of the image swapping function 8 2 Collimation The system is equipped with an iris and a slot collimator They allow you to limit the area of exposure of the patient just to the region of interest This offers the following advantages Reduction of the radiation exposure Less chance of flaring Better detail rendition and higher contrast 8 2 1 lris collimator With the open iris collimator key on the C arm stand you can open the iris collimator When you press the key repeatedly the collimator opens in steps When you press and hold down the key the collimator opens steplessly With the close iris collimator key on the C arm stand you can close the iris collimator When you press the key repeatedl
30. 1 SYSTEM COMPONEMIS si sie ur 502 ea ine ent 2 6 2 5 1 G amm stand 1 22 eier e a a at 2 6 2 5 2 Monitor Carte EE EAEE Da ae NOA 2 7 2 5 2 1 Integrated Wireless LAN on the monitor cart 2 8 2 5 3 Zieh Compact Sates tac aus ted eadaas pela EE AT 2 8 2 5 4 Monitors 2er ei einen Seal ut aden ts 2 10 2 5 5 Video eUh Nal i AEA E A EEE een dns eptibe EAA 2 11 3 Safety Instructions 3 1 3 1 General safety instructions seesssseeessrreeetrrrrssssrnnesstennnesttnnnnasttnnnatennneeenennne 3 1 Bile ATN e EEA A E T A AA asa A AT 3 2 3 3 Electromagnetic compatibility iesiisaenrecniss inniinn iani 3 4 3 4 Protective Grounding cccccsceeseeeessecceeeentenneceneesdeneeeeenteeaecenenedeneeqeentennenenenees 3 4 3 5 Equipotential grounding ocres aa E AN 3 4 3 6 Laser E 1 E ET a EEE een E A E A 3 5 Sif a 1AE EE keine E EA A E 3 6 3 8 Mocha S a T A T aa a 3 7 99 System TUE e e E E A AE E EE ance ale 3 7 4 Mechanical Handling 4 1 4 1 Transport position ee een nn e iaaa EN aaaea aeaa iai 4 1 4 1 1 C arm stand transport position erserseneeseeennnnnennnnnnennennnnn 4 1 4 1 2 Monitor cart transport position uurersesseenennnennennnnnennennnnn 4 2 4 2 Braking and steering the monitor cart ussensnneeeeennnnnennnennnnnnnnennnne nn 4 3 4 3 Braking and steering the C arm stand 4eeeennnnnnnnnennnnnnnnnennnnnnnn nennen 4 4
31. 1 General Information 1 4 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 2 System Overview 2 1 Fields of application and features 2 1 1 Fields of application The Ziehm 8000 can be used for all medical indications where fluo roscopy is required The Ziehm Compact lends itself to rapid casualty X ray diagnostics in the emergency ward The Ziehm Compact is designed to support lithotripter procedures The lithotripter is mounted onto the Ziehm Compact with adapter for this purpose 2 1 2 Features With its compact design and combined steering amp braking system the Ziehm 8000 offers unrestricted mobility at the operating table even if space is scarce The easy adjustability of the ample C arm and the excellent counterbal ancing of the C arm stand make it possible to access even the most dif ficult positions Computer controlled anatomical programs ensure optimum exposure rate and image quality control as well as high operating comfort A Soft program for soft tissue visualization during foreign body localization and a Metal program for suppressing image flare resulting from the use of metal implants and surgical instruments complete the automatic func tions The superior penetration capabilities of the high frequency generator enable a significant reduction in the patient skin dose The DOSE function considerably reduces the dose both for patient and operating staff thus contributing substantially
32. 16 2 2 Displaying a crosshair The Crosshair menu item allows you to control whether a crosshair is Positioning aid displayed as positioning aid e g for foreign body localization Ch 14 2 p 14 2 in the center of the live screen image during fluo roscopy The central point ofthe crosshair corresponds to the position of the central X ray beam e Crosshair On A crosshair appears on the live screen during fluoroscopy e Crosshair Off No crosshair is displayed on the live screen during fluoroscopy NOTE The Crosshair On Off function can also be assigned to the F key on the C arm stand gt Ch 16 2 3 p 16 3 16 2 3 Function of the F key The F key menu item allows you to control which function is assigned to Variable the F key on the C arm stand This enables you to activate the corre assignment sponding function directly from the C arm stand using the F key The following assignment options are available Crosshair If you have activated this option you can show or hide a crosshair as positioning aid in the center of the live screen image with the F key gt Ch 16 2 2 p 16 3 The central point of the crosshair corre sponds to the position of the central X ray beam Filters If you have activated this option you can reset the recursive filter to level 1 2 images during fluoroscopy by pressing the F key This will minimize motion blurring gt Ch 16 6 2 p 16 24 As long as the recursiv
33. 2 3 Single pulse fluoroscopy snapshot To activate the single pulse fluoroscopy mode LED is lit press the snapshot key on the C arm stand To deactivate the single pulse fluo TL roscopy mode LED goes out press the same key once again When you deactivate this mode the system automatically returns to the continuous fluoroscopy mode Alternatively you can deactivate the single pulse fluoroscopy mode by simply selecting another mode Exposure time In snapshot mode a single radiation pulse with a constant tube current of 8 mA and a predefined length of approx 1 s is triggered independently of how long you press the hand or foot switch Fields of appli The snapshot mode is suitable for examinations involving no patient cation movement The aim of snapshot mode is to generate high quality static images e g for printing documentation purposes Initiation Snapshot exposures can be initiated usually with the hand switch only Filter factors Depending on the selected anatomical program gt Ch 7 4 2 p 7 6 certain filter factors can be preset for single pulse fluoroscopy This is done under Configuration Menu gt Service Settings Filter Factors Organ 0 Organ 1 Organ 2 Soft gt Ch 16 6 2 1 p 16 25 7 4 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 7 Standard Fluoroscopic Operations 7 3 Manual exposure rate setting The tube voltage is usually adjusted automatically by the system s auto
34. 20 2 88 mn 9 zzo Oo mm Z aa gt Ss rm a ia This key is disabled P 7 F oc en Alphanumeric keys Allow text input DE Shift Shift alphanumeric key generates the upper character indicated on the key Table 5 2 Controls on the monitor cart control panel cont Ziehm 8000 5 7 P_26376 CD_28210 EN 01 07 2010 5 Controls Symbol s Function Space j gt Generates a blank space at the cursor position Shift Space deletes the character left of the cursor position Table 5 2 Controls on the monitor cart control panel cont 5 8 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 5 Controls 5 3 How to use menus The menus are controlled from the control panel on the monitor cart They always appear on the reference screen To select individual menu items within a menu you use the Down Arrow and U p Arrow keys When you place the cursor on a menu item where a submenu is available the word Enter appears Press the Enter key to open the submenu When you place the cursor on a menu item where several values may be selected the word Cursor lt gt appears behind the menu item Use the right arrow and left arrow keys to select the desired option A few menu items require an alphanumeric input You can save all changes you have made with function key F1 Save or discard them with function key F2 Cancel In both cases the program will
35. ENDOSKOPIE 12 89 1924 Fig 11 11 4 point measurement Ziehm 8000 11 13 P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images Post Measurements Cal length Length 1 Length 2 Angle 188 angle F2 Cancel Fig 11 12 Post Processing Post Measurements 4 point mea surement 11 14 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 12 Displayed Texts and Text Func tions 12 1 Overview Various text information blocks are always displayed automatically onthe General live screen of the Ziehm 8000 They are positioned around the fluoro scopic image so as not to interfere with it In addition you may manually enter an individual text or markers if desired in a defined text annotation area in the center of the image dis played on the live screen Pata a Eee ee data Image num ber Text annota tion area Reverse Up Down Revere EN Ig Edge ee Angle of rotation Windowing val ues a Recursive filter Time amp date saving Fluoroscopy parameters Fig 12 1 Text information blocks on the live screen Ziehm 8000 12 1 P_26376 CD_28210 EN 01 07 2010 12 Displayed Texts and Text Functions 12 2 Automatically displayed text information 12 2 1 Upper left corner of the live screen Patient data In this area the patient s last name and first name patient number and date of birth are displayed This patient da
36. IB IE z e Modify the data using the alphanumeric keys R IE le le ls The data is displayed by default in upper case letters EBRE To enter lower case letters press function key F6 abc prior to FE each letter abc F4 e Save your input by pressing function key F1 Save Save The patient folder is automatically activated in the Mosaic menu A blank fluoroscopy mask with the modified data appears on the live screen 9 6 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 Data Management 9 3 Managing image data Image data is managed in the Mosaic menu To activate the Mosaic menu do the following e Press the MOSAIC key A thumbnail image mosaic appears on the reference screen The MOSAIC mosaic shows all existing patient folders each one being symbolized by its most recent image In addition the function keys for the func tions that are available at this point are displayed ZIEHM DEMO 2 ZIEHM DEMO 3 ZIEHM DEMO 4 ZIEHM DEMO 5 ZIEHM DEMO 6 ZIEHM DEMO 7 ZIEHM DEMO 8 ZIEHM DEMO 9 ZIEHM DEMO 18 ZIEHM DEMO 11 ZIEHM DEMO 12 ZIEHM DEMO 13 ZIEHM DEMO 14 N ZIEHM DEMO 15 ZIEHM DEMO 16 ZIEHM DEMO 17 Patient ZIEHM DEMO 15 Date 14 07 98 First name ADAM Time 12 43 31 D of birth 18 12 1938 Images 2 Patient no 16 HD 19 Keywords PANCREAS F1 F2 F3 F4 Backup Search Inv Docu Delete Fig 9 3 Mosaic menu patient folder level A list at the l
37. Metal artifact correction 7 7 Foot switch 5 10 7 8 Format selection on image intensifier 5 7 8 3 Full size image 9 17 G Generator Overheating 7 14 Overtemperature 7 14 Gettering A 3 Grayscale Inversion Entire image archive 9 14 Single image 11 4 H Hand switch 5 10 7 4 7 8 15 3 Head Spine and Pelvis key 5 3 HOME key 5 6 8 6 9 8 10 3 11 5 Horizontal image reversal 5 3 Hospital data Department 16 6 Hospital name 16 6 Physician 16 6 I Illustrations C arm stand 2 6 Monitor cart 2 7 Monitor cart closed version A 13 Monitor cart semi open version A 13 Image Autostore function 7 11 Deleting 9 19 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Index Documenting 5 1 5 7 13 1 Importing from DICOM server 10 6 Marking 9 17 Outputting 9 19 Post processing 11 2 Printing on DICOM network printer 10 18 Printing on video printer 7 12 9 21 13 1 Protecting 9 18 Saving to DICOM server 10 14 Saving to hard disk 7 10 Saving to USB stick 9 19 Unmarking 9 18 Unprotecting 9 18 Writing to CD 9 20 Image archive Grayscale Inversion 9 14 Image comparison 8 10 Image data Managing 9 7 Image magnification level 5 11 Image magnification electronic 5 1 8 3 Image number 7 10 Image reversal 8 8 Image Rotation 5 3 8 8 11 3 Image Rotation keys 5 3 8 8 Image swapping Automatic 16 2 Manual 8 10 Ziehm Compact 8 10 Iris Collimator 5 2 8 1 K Key 1 2 DOSE 5 2 7 6 Key Clo
38. Mg ee 19 mn DER N z 680 A 35 gt 970 345 lS 1 x P 925 a 10 10 BR 450 E 760 1710 2130 oO i 3 19 Ann am o 8 o IO b am D 3 Il ill Il 400 620 1600 1820 700 2060 2280 il AN nn 2 t 7 AF g NY Ser Fig A 20 43 2 5 63 2 5 A 21 Fig Dimensions of C arm stand on systems with 23 cm i i Tolerances of C arm movements on systems with 23 cm i i C arm stand with 23 cm i i Tolerances of C arm movements Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 A 37 Appendix A Monitor cart with 24 flat screen monitor a Z E I Pr la Ziehm 8000 z TE 4 U K N N 125 500 500
39. NAME folder AUTION menoon CAUTIO Once you have saved a fluoroscopic image in the NO NAME folder you cannot move it to a specific patient folder later 9 1 1 Patient folders In order to be able to relate the fluoroscopic images to a certain patient Function you must always create a new patient folder or activate an existing one before acquiring an image You can create as many patient folders as desired on the hard disk In Storage capacity each patient folder you can store as many images as you wish The total number of images is limited only by the hard disk size image memory The size of the image memory depends on the chosen system configu ration When you save an image for which there would be no more space onthe Auto delete hard disk otherwise the oldest patient folder on the hard disk is automat function ically overwritten gt p 7 11 If the oldest patient folder contains one or more protected images p 9 18 only the unprotected images are deleted though The folder itself as well as the protected images remain on the hard disk The NO NAME folder gt Ch 9 1 2 p 9 2 is never deleted Ziehm 8000 9 1 P_26376 CD_28210 EN 01 07 2010 9 Data Management 9 1 2 NO NAME folder Function If you have not activated a patient folder prior to saving an image the image is automatically saved to the NO NAME folder In this case the image is not assigned to any sp
40. Picture Color Setup a User Defaults 2 KKKEMPTYKKK User Defaults 3 KRKEMPTYKKK d e Press the SCROLL key The Factory Defaults item is selected H SCROLL e Press the arrow key The on screen menu disappears All settings are reset to the factory values Ziehm 8000 16 21 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 6 Service settings Function The Service Settings menu is used for modifying different system parameters which affect both the quality of the fluoroscopic image and the user interface NOTE Most settings in this menu must not be modified by any person other than a trained service engineer The menu is therefore password protected Service Settings Step windowing Filter factors System settings Monitor calibration HEDIS data Software update Fig 16 11 Service Settings menu 16 22 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 6 1 Step windowing Function Parameter range Activating the step windowing mode Default setting The Step Windowing menu is used for presetting 4 fixed steps for the contrast window level L and width W During fluoroscopy you can select these steps with the Contrast keys on the C arm stand Step Windowing SIEHE 190 a 255 Step 2 L 145 Step 4 W 200 Step 4 L 145 Step 1 W 208 Step 1 L 118 Step 2 W 158 Step 2 L 188 Windowing On
41. after sales defective Ziehm Compact service or Ziehm Compact with adapter for lithotripter procedures only E22 Alert Internal fault Please contact after sales service E23 Alert Internal fault Please contact after sales service E 24 Alert Internal fault Please contact after sales service E25 Error Internal fault Please contact after sales service E 26 Error Internal fault Please contact after sales service E27 Error Internal fault Please contact after sales service E 28 Error Internal fault Please contact after sales service Table A 3 List of error and alert messages A 8 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A Code Type Description Measures E 29 E 26 Alert General generator fault Please contact after sales alternately service or Generator overheated or temperature symbol on the C arm stand Allow generator to cool down illuminated E 30 Error Internal fault Please contact after sales service E 31 Alert Internal fault Please contact after sales service E 32 Alert Internal fault Please contact after sales service E 33 Error Internal fault Please contact after sales service E 34 Alert Internal fault Please contact after sales service E 35 Alert Internal fault Please contact after sales service E 36 Alert Internal fault Please contact after sales service E37 Alert Internal fault Please contact after sales service E 38 Ale
42. automatically in the Length 1 field of the menu on the reference screen Corrections may be repeated as often as desired e Save the measured values with function key F1 Save The value appears below the image on the live screen Fig 11 7 ZIEHM ALFRED IHRE KLINIK PROF FORTSCHRITT ENDOSKOPIE 25 12 89 1924 09 11 29 amp 18 11 98 gt Length or distance measurement 11 10 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images This will return you to the Post Measurements menu Cal length 39 8 mm Length 1 32 3 m Fa F2 Save Cancel Fig 11 8 Post Processing gt Post Measurements length or dis tance measurement 11 8 3 3 point measurement To perform a 3 point measurement do the following F2 Angle 3P e Press function key F2 Angle 3P in the Post Measurements menu In addition to the reference length four menu items called Length 1 Length 2 Angle and 360 angle still without any values are dis played in the menu e Generate 3 measuring points as described under gt Ch 11 8 2 p 11 9 e The values for Length 1 distance between measuring point 1 and 2 Length 2 distance between measuring point 3 and 4 Angle interior angle between length 1 and 2 and 360 angle angle difference to a full circle are automatically entered into the Post Measurements menu e Save the measured values with function key F1
43. cable Monthly Must not show any signs of physical damage C arm stand Wheneve Clean when dirty wheels r necessar y Table A 1 Regular checks Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A NOTE For a detailed maintenance schedule please refer to the Ziehm 8000 Technical Manual A 1 2 Consistency test according to national regulations At regular intervals depending on your national radiation protection regulations you must check whether the system shows any deviations from the reference values stated in the acceptance test by performing a consistency test The acceptance test can be found in the Specifications and Certificates folder which is included in the scope of delivery CAUTION The relevant radiation protection regulations of the country of installation must be observed A 1 3 Checking the useful beam Inspection interval Centering Collimator diameter accuracy Together with the consistency test it is necessary to check the size and centering of the useful X ray beam To determine the correct alignment of the X ray beam to the center of the image intensifier and any possible deviation do the following e Angulate the C arm by 180 so that the X ray generator is above and the image intensifier is below e Place a reference or test object e g measuring board graduated collimator test tool exactly in the center of the image int
44. e Press the or arrow key to increase or decrease the contrast The settings become immediately active on the screen After a few seconds the Contrast control disappears automatically Backlight To set the screen backlight brightness do the following brightness e Press the Brightness Contrast key three times The Backlight Brightness control appears on the screen e Press the or arrow key to increase or decrease the backlight brightness The settings become immediately active on the screen After a few seconds the Brightness control disappears automatically NOTE Lowering the backlight level will increase the backlight lifetime 16 10 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 System Configuration The factory set menu language is English You can choose one ofthefol Setting the menu lowing languages as menu language German French Italian Swedish Spanish Dutch To define the menu language do the following e Press the MENU key The on screen menu appears e Select the Setup tab with the help of the or arrow keys Picture Gamma Setup Menu Position HOSGHREHOI Menu Orientation Language English DPMS Enable off Auto Source Select off Menu Lock e Move to the Language item with the help of the SCROLL key e Press the arrow key until the desired language is displayed All on screen menu element
45. gt Ch 12 2 4 p 12 3 If your system does not include the air kerma and air kerma rate measurement option gt Ch 7 7 p 7 10 the dose area product is also shown on the dose area product display on the control panel Fluoroscopic image Fluoroscopy parameters Visual alarms Display on the screen and the control panel Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 7 9 7 Standard Fluoroscopic Operations 7 7 Air kerma Air kerma display on the control panel Air kerma rate display on the control panel 7 8 Save Image number or The air kerma is saved for each patient folder and updated with each new exposure The total dose in mGy received by a patient so far is shown on the air kerma display on the control panel During the exposure the air kerma rate display showing the current air kerma rate in mGy min appears on the control panel You can save the last fluoroscopic image on the live screen to the active patient folder on the hard disk When you trigger the save function while no patient folder is active the image is automatically saved to the NO NAME folder AUTION mcan CAUTIO When the hard disk is full the oldest patient folder is over written without warning Before saving an image make sure that there is enough free hard disk space and regularly back up the patient folders which are still needed to external storage media or to a DICOM server Each saved image is automa
46. in which an item is highlighted by the cursor is downloaded to the Ziehm 8000 file system even if other series are marked or or 10 12 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions e To import single images or cine loops press key F5 Retrieve All marked single images are imported into the Ziehm 8000 file system A submenu with check marks next to the series and single images which have been downloaded into the Ziehm 8000 file system appears on the screen Hospital study date 87 Oct 1998 ST FRANCIS study time 10 05 48 Physician study id 1000 1201608 199 DR WONDER study accession Department ENDOSCOPY Modality Series No Image No Patient name 4 RA 4201608 8 z ZIEHM DEMO 18 2 KA 1201608 8 First name TAMMY Date of birth 24 10 1968 Sex F Patient number 11 Keywords ERCP Note image comment image date 87 Oct 1998 image time 10 05 48 image converted ZIEHM F2 F3 F5 F6 Mark Series Retrieve Back Fig 10 10 Mosaic menu series and image level query retrieve with status flag On the live screen the previously selected image is displayed From this submenu you can import further series and single images from the storage medium into the Ziehm 8000 file system Repeat the above steps to do so All series and single images which have been downloaded additionally to the Ziehm 8000 file syst
47. into the Ziehm 8000 file system DICOM Dir When you import images from external storage media into the Ziehm 8000 file system a new patient folder is always created even ifthe patient name already exists The maximum number ofimages which can be imported from the storage medium into a single patient folder of the Ziehm 8000 file system is only limited by the overall storage capacity of the Ziehm 8000 Selecting the You preset the storage medium from which you want to import the storage medium DICOM images under Configuration Menu gt User Settings gt Ch 16 2 5 p 16 4 To import DICOM images from a storage medium do the following e Make sure that the desired storage medium CD or USB stick has been preset under Configuration Menu User Settings e Insert the CD into the CD writer or plug the USB stick into the USB port e Press the NEW PAT key Be The Patient Data Input menu is displayed on the reference screen Patient Data Input Hospital ST FRANCIS Department ORTHOPAEDICS Physician Wonder Patient name Smith First name Sally D of birth 27 02 1913 Sex F Patient no 213467 Accession no NP 123 Keywords gonarthrotomy Note goneitis F1 F2 F3 F4 F5 FG Save Cancel Query Worklist DICOM Dir abc Fig 10 6 Patient Data Input menu ES e Press key F5 DICOM Dir DICOM Dir The message Searching patient data appears on the refe
48. is assigned more than once on a DICOM network To retrieve a Worklist from a DICOM server do the following e Press the NEW PAT key The Patient Data Input menu appears on the reference screen e Leave all the fields empty If the Hospital Department and or Phy sician fields contain default data you may leave this data as is or e To limit the Worklist to a single patient enter the patient number under the Patient no menu item e Press function key F4 Worklist The Worklist appears on the screen 1 Smith Sally 27 02 1998 213467 2 Miller Tom 11 11 1951 1202 3 Cannon Edna 44 14 1974 14021 4 Carter John 44 44 4974 1902 Requested ID 2345 Start date 24 04 2001 Step ID 23451 Start time 21 30 00 Doctor Wonder sion no 1 5 Description goneitis AE title EXP8B80 F 2623 Step description gonarthrotomy Fa F2 Select Cancel Fig 10 1 Worklist from the DICOM server e Using the Down Arrow and Up Arrow keys move the cursor to the desired examination of the patient With the HOME key you can jump to the beginning of the list With the key combination Shift HOME you can jump to the end of the list x 7 If i e e AR F4 Worklist gt HOME Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 3 10 DICOM Functions F4 F1 Save e Confirm your selection by pressing the Enter key or function key F1 Select The p
49. on the image intensifier e Release the spring loaded securing lever It will engage above the supporting ridge so securing the cassette holder safely in place e Insert a loaded film cassette fully into the film cassette holder from the side Image intensifier Securing lever Film cassette holder Film cassette lt _ Fig 15 1 Fitting the film cassette holder and inserting the film cas sette Ziehm 8000 15 1 P_26376 CD_28210 EN 01 07 2010 15 Direct Radiography WARNE VARNING Make sure that the film cassette holder is properly attached to the image intensifier so that the cassette cannot fall down onto the patient un 5 3 Activating the direct radiography mode The direct radiography mode is activated with the Radiography key When you press the radiography key again the system returns to the customer specific standard fluoroscopy mode an A Film size For direct radiography the collimator aperture on the 23 cm image inten sifier is automatically set to 24 cm after pressing the Radiography key AN G NOTE EX 7 30 40 Film size keys 30 and 40 are disabled 15 5 Selecting the radiography parameters The system always uses a constant tube current of 20 mA for direct radi ography For tube voltage use the same value that the system selected during any kV previous automatic fluoroscopy of the same body region If necessary you can correct the
50. port FO Monitor cart with 24 flat screen monitor Monitor cart with A 18 1 flat screen monitors Coupling cable support DICOM con nection aa SS RJ45 Video printer 1 USB port eS J Power cable CD writer Suppor Power supply connection Coupling cable connec tion Ziehm 8000 VIDEO OUT Equipoten tial ground Brakes 2 Spare GND ZN 7 N connection NZ ne DICOM port FO Fig 2 3 Monitor cart with 18 1 flat screen monitors Ziehm 8000 act P_26376 CD_28210 EN 01 07 2010 2 System Overview 2 5 2 1 2 5 3 Ziehm Compact Integrated Wireless LAN on the monitor cart If your system is equipped with Wireless LAN a transceiver is located at Ziehm Compact Image intensifier with integrated CCD camera Radiation indication pn lamp a Compact monitor Video printer Horizontal carriage Lifting col umn the back of the monitor cart A second transceiver comes with your accessories and must be connected to the DICOM network Cassette holder C arm handle Steering amp braking a lever Handle Hand switch Connection for power cable or cou pling cable IN l optional Monitor support arm Swivel arm WE Video output TH Cable guards gt Generator Fig 2 4 Zie
51. screen side 2 10 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 2 System Overview 2 5 5 Video output A BNC socket which is used for video connection VIDEO OUT is BNC socket located on the back of the monitor cart The VIDEO OUT socket supplies a CCIR video signal with 50 Hz ofthe VIDEO OUT live screen image The following image is available for further processing by a video cassette recorder an external monitor a video printer etc Fluoroscopic image live or saved Ziehm 8000 2 11 P_26376 CD_28210 EN 01 07 2010 2 System Overview 2 12 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 3 Safety Instructions 3 1 General safety instructions WARNE WARNING You must be familiar with the contents of the present Operating Instructions in order to be able to operate the system as intended Read and understand the present Operating Instructions before operating the system Itis important to observe all directions safety instructions and warnings The responsibility for any C arm assisted intervention lies with the physician in charge KONGE Supplementary equipment used in combination with the Ziehm 8000 must comply with the safety requirements according to IEC 60601 1 and or IEC 60601 1 1 or furnish proof of an equivalent degree of safety To ensure CE conformity these components must have a CE approval in accordance with Council Directive 93 42 EEC In addition a declarat
52. unexpected malfunctions WARNING Before opening any part of the equipment or removing the protective covers you must disconnect the system from the power supply The system produces X rays If you do not observe the safety measures and precautions required by your local radiation protection regulatory body or other national radiation protection measures and precautions these X rays can be hazardous both to operating staff and other persons within the radiation zone of occupancy WARNING WARNING The system may only be operated by personnel who has undergone radiological training Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 3 Safety Instructions EIERN WARNING USA The system may only be operated by properly trained per sonnel under the direction of a physician WARNING The relevant radiation protection regulations of the country of installation must be observed WARNING In order to avoid unintentional radiation the foot switch must be hung up on the foot switch support when the system is switched on but not in use Staff members who stay within the radiation controlled area must wear X ray protective clothing The radiation controlled area depends upon the size of the image inten sifier installed and has the following radius 15 cm image intensifier 3 m 15 cm image intensifier 4 m gt Fig A 19 p A 36 To minimize the radiation burden of t
53. with adapter for lithotripter procedures the windowing function is not available The Contrast keys are disabled Control from the monitor cart The Windowing Settings menu on the monitor cart provides a more accurate way of adjusting contrast and brightness To open the menu press the WNDW key The menu shows a graphical representation of the image grayscale stating also the current values for the contrast window width W and level L gt Fig 8 1 p 8 7 With the Up Arrow and Down Arrow keys you can modify the width of the contrast window number of gray levels visualized With the Left Arrow and Right Arrow keys you can modify the level of the contrast window more toward white or more toward black The brightness and or contrast adjustment becomes immediately visible in the live screen image Simultaneously the current contrast window level L and width W values are indicated there Using the HOME key or function key F1 Home you can toggle between the default setting i e 256 evenly distributed gray levels and your custom setting You can correct your custom setting as often as desired Your last custom setting remains stored until you switch off the system NOTE You can achieve the same effect by simultaneously pressing the two Contrast keys on the C arm stand 8 6 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 8 Adjusting Live Images Windowing Settings BLACK WHITE
54. 0 EN 01 07 2010 Appendix A A 2 Cleaning disinfection sterilization Preparation Always switch off the system and disconnect it from the power supply before cleaning or disinfecting it A 2 1 Cleaning Recommended For cleaning the system use only water with mild detergents applied with detergents a slightly damp cloth Never use abrasive cleansing agents organic solvents or detergents which contain solvents e g alcohol petroleum ether liquid stain remover NOTE If the unit presents dirt stains that cannot be removed with the method described above please contact your in house service engineer NOTICE Take care that no liquids penetrate into the unit through sockets plugs ventilation holes or gaps integrated external devices Never apply spray cleaners directly onto the unit Cleaning the For cleaning the display screens use only pure alcohol or a mixture monitor screens consisting of 1 3 alcohol and 2 3 distilled water Wipe the screens and surrounding painted surfaces dry with a soft cotton cloth immediately after cleaning A 2 2 Disinfection You must use one disinfectant that is suitable for disinfecting the system for details refer to the operating instructions of the disinfectant provided by its manufacturer e Dilute the disinfectant according to the manufacturer s instructions e Dampen a cloth with the solution and thoroughly wipe the entire outside of the unit with t
55. 0451 NURNBERG Germany MANUFACTURED i 7 Values for 1 ziehm imaging MOBILE C ARM SERIAL NO Ziehm 8000 MOBILE C ARM MONITORS A A MANUFACTURER 5 ZIEHM IMAGING GMBH BOIS INUENEERG ee Rating label no DATE OF MANUFACTURE TS04_042 TS04_036 China Table A 5 Labels USA cont A 30 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A No Label WARNING REMOVAL OF SKIN DISTANCE CONE IS AGAINST THE RULES AND REGULATIONS 21 CFR SUBCHAPTER J SECTION 1020 32 REMOVAL ONLY FOR SPECIAL SURGICAL PROCEDURES Comments ZIR Art No 10 2977 ZIN Art No 58460 WARNING DO NOT USE CASSETTE LESS THAN 24 X 24 cm IN CONJUNCTION WITH 23 cm IMAGE INTENSIFIER Systems with film cassette holder only ZIR Art No 10 2981 ZIN Art No 58462 SER c us MEDICAL ELECTRICAL EQUIPMENT UL 60601 1 and CAN CAS C22 2 No 60601 1 Reg Nr 3R65 CLASSIFIED BY UNDERWRITERS LABORATORY INC WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARD ONLY IN ACCORDANCE WITH L 60601 1 NOTE This label may only be applied to the system after the Notice of Application for the system was issued by the Underwriters Laboratory Inc UL ZIR Art No 10 2984 ZIN Art No 58464 Qa Fluoro Store Optional foot switch pedal assignment Function Initiate radiation Save Background color white ZIR Art No 10 2985 ZIN Art No 58371 b Fluoro Store
56. 1 6 Grayscale inversion Under the Invert menu item you can select whether you want to display the image with a positive or negative grayscale This is done with the Left Arrow and Right Arrow keys Invert Off default setting The image is displayed as a positive Invert On The image is displayed as a negative 11 7 Contrast and brightness adjustment Windowing Submenu When you select the Windowing menu item and confirm with the Enter key the Post Windowing submenu opens This submenu allows you to modify the contrast window width W and level L of the saved image A With the Up Arrow and Down Arrow keys you can modify the width of l gt the contrast window number of gray levels visualized v With the Left Arrow and Right Arrow keys you can modify the level of the contrast window more toward white or more toward black The brightness and or contrast adjustment becomes immediately visible in the live screen image Simultaneously the current contrast window level L and width W values are indicated there iehm 8000 11 4 Zieh P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images Using the HOME key or function key F1 Home you can toggle between the default setting i e 256 evenly distributed gray levels and your custom setting As opposed to real time windowing mode gt Ch 8 4 2 HOME p 8 6 your custom setting only applies to the currently active image Post Window ing
57. 10 9 Data Management 9 2 2 Editing patient data You may modify the patient data in an existing patient folder at any time General Depending on which data you change the modification will affectexisting Effects images the active image and or future images Existing Active Future images image Images Hospital e Department Physician Patient First name D of birth Sex Patient no e Subject Note e Table 9 1 Effects of patient data modifications The alphanumeric keypad allows you to enter data in upper or lower Upper and lower case case To modify data in an existing patient folder do the following e Press the MOSAIC key The Mosaic menu appears on the screen MOSAIC e Select the desired patient folder using the arrow keys A Vv e Press the Enter key twice The patient folder is activated lt 2x Ziehm 8000 9 5 P_26376 CD_28210 EN 01 07 2010 9 Data Management e Press the NEW PAT key NEW The Patient Data Modification menu appears on the reference PAT screen Its fields are prefilled with the current patient data D of birth 27 82 1913 Save Cancel EB 5 Fig 9 2 Patient Data Modification menu A e Use the Up Arrow and Down Arrow keys to move the cursor to the desired menu item 2 E k f
58. 4 4 C arm movementS nessssessennnennnnnnnnnennnnnnnnnnnnnennnennnnnennennnnnnne nennen nennen 4 6 4 4 1 Orbital rotation 4 444usnssnennnennnennnnnnnnnnennennnnnnnnnennnnne nennen 4 7 4 4 2 Angulation ee arena chee idee R EAR 4 8 4 4 3 Swiveling panning 44444eenennnnnnennennnnnnnnnnnnnnnnnnnnnnnn nennen 4 9 4 4 4 Horizontal movement 444444444440Hsnnnennnnnnnnennnnnennennnennen nen 4 10 4 4 5 Vertical movement 24444444444444HHanannnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnn en 4 11 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Contents 5 Controls 5 1 5 1 C arm stand control panel uu4444224444nnennnnnnnennnnnnnnnnnennnnnennnneannn nen 5 1 5 2 Monitor cart control panel nursnsssrnnennnnnnnnnnnnenennnnnnnnennnennenn nennen 5 6 5 3 HOW tO use menus enseesnnennennnnnnnnnnnennnnnnnnnennnnnnnsnnnnennnnnnnnnn nn aaa 5 9 5 4 Hand switch and foot switch 4esnnennnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn 5 10 6 Switching the System On and Off 6 1 6 1 Preparing the System aoran aA T T 6 1 6 2 Switching the System On and Off ussnsesnnennennnnnnnnnnnnnnnnnnnnnnnnnnn nenn 6 2 6 2 1 SWILCHING ONE res nee rare na arena sansa hha bare 6 2 6 2 2 SWILCHING Off ioeie arara ke E AAA een 6 3 6 3 EMERGENCY STOP button eersssessnennnnnnnnennnnnnnnnennnnnnnnnnnnnnnnnnennnnnnnnann 6 4 6 4 RE
59. 5 Selecting the radiography paramMeters ccccccceeeeeseeeeeeeeetteeeeeeteeseeeeseeenaees 15 2 15 6 Making the radiographic exposure 22ussssssnnnnnnnnsnnnnnnnnnnnnnnnnnnnnnnnnnn nn 15 3 15 7 Completing the radiographic procedure 4444444444snannennennnnennnennnnnnen 15 3 19 8 EXPOSUTE QUIde a El Rene anne deren 15 4 16 System Configuration 16 1 16 1 Overview ci eee eh a ne ee 16 1 16 2 User Settings annasa einander deweecetedieniah ca edad 16 2 16 2 1 Activating automatic image Swapping ceeeeeeeeeteeeeeeetteeteeeeeaee 16 2 16 2 2 Displaying a crosshair uusennnnnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnnenn 16 3 16 2 3 Function of the F KOy eierniie eae ae ena 16 3 16 2 4 Storage medium for image retrieval uunnsennnennennnnnnnnnnnnnnn 16 4 16 2 5 Selecting the storage medium for data retrieval with DICOM Dir 16 4 16 2 6 Defining the storage format for removable storage media 16 4 16 3 Basic Settings ti ta an a eet ea 16 5 16 3 1 Setting the system time and system date nennen 16 5 16 3 2 Selecting the live screen uuusnssessennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn 16 5 16 3 3 Entering the hospital data uussnnennnnnnnnnnnnnnnnnnnnnnnnnnnn nn 16 6 16 3 4 Clearing storage media rn4ensnnennnnnnnnnennnnnnnnnennen nennen mann 16 6 16 4 Monitor settings for 18 flat screen M
60. 8210 EN 01 07 2010 16 System Configuration 16 6 2 1 Filters for anatomical programs Filter types For each of the anatomical programs Organ 0 Organ 1 Organ 2 and Soft the values for the following filters can be programmed Recursive filter for continuous fluoroscopy independent settings for normal view magnification 1 and magnifi cation 2 Stack filter for continuous fluoroscopy Edge filter Default windowing step after power up Stack filter for continuous pulse fluoroscopy Stack filter for snapshot Filter Factors for Organ Key Recursive filter 1 Recursive magn 1 2 Recursive magn 2 2 Stack filter Edge filter Windowing step Continuous pulse 1 o NN os Snapshot F1 Save Cancel Fig 16 14 Filter Factors for Organ Key 0 menu Parameter values The following parameter values can be set Filter type Fluoroscopy mode Available param eters Recursive Continuous fluoroscopy Level 0 1 2 3 alier 1 2 4 8 images Stack filter Continuous fluoroscopy 1 2 4 8 16 images Table 16 2 Filters for anatomical programs Ziehm 8000 16 25 P_26376 CD_28210 EN 01 07 2010 16 System Configuration Recursive filter Stack filter Edge filter Filter type Fluoroscopy mode Available param eters Edge filter Continuous fluoroscopy Level 0 1 2 3 4 continuous pulse fluo roscopy Snapshot Windowing Continuou
61. AMPE X100 EXTERNAL RADIATION WARNING LAMP X100 Fig A 29 Wiring diagram The safety relay is able to isolate up to 250 Vac max The maximum admissible switching voltage is 24 Vac pc with a maximum current of 2 A meannan CAUTION Exceeding the maximum voltage and current values indicated above may lead to damage or failure of the unit A 50 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix B B 1 Attaching sterile disposable covers to the C arm For detailed information please refer to the operating instructions supplied with the sterile disposable covers STERINORM UNIVERSAL C ARM SET C ARM SET for quick C arm covering ce 1275 O Collapsible folded hose facilitates placement over the spring clasp The sterile person opens the hose by means of the fold over sleeve at Label 1 The circulating person inserts the non sterile spring clasp into the open hose The sterile person opens the hose and pulls it little by little over the spring bracket Simply fold over excess hose end Q Hook the spring clasp into the C arm O Put the hoods or bags contained in the SET over the X ray tube assembly and image intensifier by sliding your hands under the elastic rim STERINORM UNIVERSAL Ziehm C SET Hose cover B for image intensifier R for X ray tube assembly REF 341 B R 34100 3 30077 2 30054 7 30094 0 without pl
62. Additional absorption 2 8 mm Al Sensitivity 70 kV 2 7 mm Al HVL gt 1350 pC mGy cm Measuring range of DAP power 0 75 10 0 3 104 mG cm2 s Voltage range 40 110 kV Voltage correction Fig A 27 p A 49 Aluminum equivalent 0 5 mm Table A 11 Technical data of VacuDAP duo dose meter Voltage correction Additional absorption 2 8 mm Al filtration Additional absorption 2 8 mm 1 mm Al filtration 1 20 1 15 1 10 1 05 1 00 Correction factor 0 95 0 90 0 85 0 80 40 50 60 70 80 90 100 110 X ray tube voltage U kV Fig A 27 Voltage correction of VacuDAP duo dose meter Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 A 49 Appendix A A 11 Connections for additional monitors and external radiation indication lamp Connections Wiring diagram detail from U449 75 Hz non interlaced video output left monitor 75 Hz non interlaced video output right monitor 50 Hz CCIR video output Connection for external radiation indication lamp Fig A 28 Additional connections on the monitor cart 1 x4 Aen gt F1 1 2AT i ee ea lak 1704 S 02 l4 f MLAS1 06 64 TELAN ar kee o 1 BLAU BLUE 2 VIOLETT VIOLET 3 GRAUGREY 4 WEISS WHITE EXTERNE STRAHLUNGSL
63. Ber u 0 0 birth 26 01 196 Images 2 ee ORE Ke Fig 9 6 Mosaic menu patient folder level Search submenu with input field for patient number as search criterion e Enter the desired search string 1 B E IR s E j As soon as you enter the first character the list of patient folders is k E H f EJ resorted alphabetically in ascending order The cursor jumps to the E F I I z first matching folder and gradually homes in on the folder that you are ZJ e Y E N searching for as you continue to enter more characters e When the cursor is on the patient folder you are looking for in the list press the Enter key j The patient folder opens 9 3 4 Deleting patient folders You can delete a patient folder with all the images contained in it from the hard disk When you try to delete a folder which contains protected images the folder itself as well as the protected images remain on the hard disk Only the unprotected images are deleted To completely remove a patient folder containing protected images you must unprotect all images in the folder first gt p 9 18 Ziehm 8000 9 13 P_26376 CD_28210 EN 01 07 2010 9 Data Management To delete one or more patient folders do the following manon CAUTION Deleted patient folders are irretrievably lost Back up the patient folders you want to keep before deleting them or make sure that they are really no longer needed O e Press the MOSAIC key MOSAIC e Select the de
64. Br Fig A 25 Dimensions Ziehm Compact with adapter for lithotripter procedures and 23 cm BV Ziehm 8000 A 39 P_26376 CD_28210 EN 01 07 2010 Appendix A A 10 Technical data A 10 1 General technical data 5 Tube rn Scintillator Cesium iodide Nominal sizes 23 15 10cm 2 Anti scatter grid Pb 8 40 24 flat screen monitors Display measurements 520 mm x 325 mm 20 4 x 12 8 Refresh rate Resolution in pixels Screen size diagonal 610 mm 24 5 Luminance max 400 Cd m S Refresh rate 85 Hz S Resolution in pixels 1920 x 1200 5 18 1 flat screen monitors g Display measurements 300 mm x 360 mm 11 45 x 14 28 5 Screen size diagonal 460 mm 18 1 Luminance max 600 Cd m Refresh rate 75Hz Resolution in pixels 1280 x 1024 Flat screen monitor Display measurements 300 mm x 360 mm 11 45 x 14 28 85 Screen size diagonal 460 mm 18 1 5 S Luminance max 600 Cd m 75 Hz 1280 x 1024 Video standard output CCIR 50 Hz refresh rate like PAL no color EIA 343 60 Hz refresh rate like NTSC no color Table A 6 lithotripter procedures General technical data of Ziehm 8000 Ziehm Compact and Ziehm Compact with adapter for A 40 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A During storageltransport E Temperature 5 C to 55 C E Relative air humidity 20 70 E 2 During operation F Temperature 13
65. C to 35 C Relative air humidity 20 70 C arm Source image receptor distance 970 mm Vertical free space generator i i 760 mm C arm depth 680 mm 5 Orbital rotation Ziehm 8000 23 cm image intensifier 135 45 90 Ziehm Compact 23 cm image intensifier 115 25 90 Ziehm Compact with adapter for 23 cm image intensifier 115 25 90 lithotripter procedures Angulation 225 Swiveling panning 10 Horizontal movement 220 mm Vertical movement 420 mm C arm stand Ziehm 8000 23 cm image intensifier approx 264 kg Ziehm Compact 23 cm image intensifier approx 270 kg je Ziehm Compact with adapter for 23 cm image intensifier approx 280 kg 5 lithotripter procedures 2 Monitor cart Ziehm 8000 with 24 flat screen approx 150 kg monitor Ziehm 8000 with 18 1 flat screen approx 153 kg monitor Table A 6 General technical data of Ziehm 8000 Ziehm Compact and Ziehm Compact with adapter for lithotripter procedures cont Ziehm 8000 A 41 P_26376 CD_28210 EN 01 07 2010 Appendix A A 10 1 1 Systems with a voltage rating of 100 V 120 V 200 V Systems with a voltage frequency rating of 100 Vac 10 50 60 Hz 120 Vac 10 50 60 Hz 200 Vac 10 50 60 Hz Power supply fuse rating C20AorC32A tripping characteristic C acc to VDE 0641 Part 11 DIN EN 60898 IEC 898 C20A C20AorC32A Required residual current circuit breaker RCD
66. COM format The system documents not only patient related data but also image related data e g the fluoroscopy parameters In addition all systems have a CCIR video output 50 Hz The optional DICOM 3 0 interface enables integration into any network supporting DICOM e g PACS Thanks to Primary Capture support the original fluoroscopic images can be archived without the changes which may have been applied to them later The following DICOM classes are supported Print Storage including multiframe capability Storage Com mitment Media Worklist MPPS Query Retrieve and Verification It is possible to connect the Ziehm 8000 to a second DICOM storage server to act for example as standby server and to configure the system in such a way that data can be saved to that second DICOM storage server if necessary Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 2 System Overview 2 2 Model range NOTE These Operating Instructions describe all models in their corresponding maximum configuration The system configuration chosen by you may not contain all options and functions described here 2 2 1 Ziehm 8000 With 23 cm image intensifier storage capacity optionally for max 150 or Features 1 000 images separate monitor cart with single 24 flat screen monitor with split screen optionally with twin 18 flat screen monitors 2 2 2 Ziehm Compact With 23 cm or 15 cm image intensifier storage capacity for ma
67. Declaration concerning Electro magnetic Compatibility according to IEC 60601 1 2 in the Technical Manual 3 4 Protective grounding The system must be connected only to power systems having a separate ground connection 3 5 Equipotential grounding Heart and brain If you use the system in combination with other equipment for examina examinations tions of the heart or brain or the surrounding anatomical regions equipo tential grounding is required for patient and operating staff safety IEC 60601 1 1 3 4 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 3 Safety Instructions 3 6 Laser radiation As an option the system may be equipped with a laser positioning device Laser Positioning at the image intensifier and or generator Device The laser positioning device uses 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 the naked eye or with optical instruments The laser positioning device is a Class 2M laser product according to IEC 60825 1 Make sure to comply with all operating safety precautions when using the laser positioning device The maximum power output of continuous laser radiation measured at the laser beam apertures is lt 1 mW The wavelength of the emitted radi ation is 635 nm WARNING WARNING Laser radiation Do not stare into beam or view directly with optical instruments Laser Cla
68. Fig A 22 Dimensions of a monitor cart with 24 flat screen monitor Monitor cart with 18 1 flat screen o oa monitors 4 F 1690 1145 2125 500 Fig A 23 Dimensions of a monitor cart with 18 1 flat screen monitors A 38 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A A 9 2 Ziehm Compact Ziehm Compact en ee with 23 cm i i N va I 450 1710 2130 345 _ 305 H 520 940 3 Y x en IS 400 620 1600 1820 2060 2280 700 Fig A 24 Dimensions of Ziehm Compact with 23 cm i i A 9 3 Ziehm Compact with adapter for lithotripter procedures Ziehm Compact san with adapter for lithotripter procedures and 5 23 cm BV T HLA il 1
69. Initiate radiation Magnify Background color white ZIN Art No 58413 Ue b Optional foot switch pedal assignment 1 Fluoro Mag Function Initiate radiation Magnify Background color transparent i i ZIN Art No 58414 Optional foot switch pedal assignment 1 Function Initiate radiation Snapshot Background color white ZIN Art No 58417 Optional foot switch pedal assignment 1 Function Initiate radiation Snapshot Background color transparent ZIN Art No 58418 Table A 4 Labels n a for USA cont Ziehm 8000 A 21 P_26376 CD_28210 EN 01 07 2010 Append x A No Label Comments Oa Optional foot switch pedal assignment 1 Fluoro Swap Function Initiate radiation Image swapping Background color white ZIN Art No 58427 b Optional foot switch pedal assignment 1 Fluoro Swap Function Initiate radiation Image swapping Background color transparent ZIN Art No 58428 EU countries only 1 ZIN Art No 58408 er Labeling for fuses 1 axasar 9 ZIN Art No 58473 Table A 4 Labels n a for USA cont A 22 iehm 8000 Z P_26376 CD_28210 EN 0 h 1 07 2010 Appendix A A 5 Labels USA Fig A 8 Labels on the C arm stand of the Ziehm 8000 USA oa
70. M Ziehm Compact IMAGE INTENSIFIER Ie A examples a TH 9428 HP2 H707RF 23 15 10 cm COMPLIES WITH CDRH RADIATION PERFORMANCE STANDARDS 21 CFR SUBCHAPTER J AS OF DATE TH 9428 HP2 H552 23 15 10 cm OF MANUFACTURE A TUBER TH 9432 HX H314 31 23 15 cm DONAUSTRASSE at E 5830 SD H5 23 15 10 cm 90451 N RNBERG Germany MANUFACTURED Rating label no TS04_046 O ZIR Art No 10 2946 1 A ZIN Art No 58302 ZIR Art No 10 2947 1 A ZIN Art No 58440 Please observe accompanying 1 documents ZIR Art No 10 2948 ZIN Art No 58361 Table A 5 Labels USA cont Ziehm 8000 A 27 P_26376 CD_28210 EN 01 07 2010 Appendix A No Label MN DRIVE SYSTEM ONLY WHEN SECURED FOR TRANSPORTATION Comments ZIR Art No 10 2949 ZIN Art No 58441 ZIR Art No 10 2951 ZIN Art No 58490 Make sure that the face of the person shown is facing upwards when you attach the label ZIR Art No 10 2952 ZIN Art No 58443 Make sure that the face of the person shown is facing downwards when you attach the label Systems with laser positioning device only ZIR Art No 10 2953 ZIN Art No 58391 Systems with laser positioning device only ZIR Art No 10 2954 ZIN Art No 58444 Systems with laser positioning device only ZIR Art No 10 2955 ZIN Art No 58445 Systems with laser positioning device only ZIR Art No 10 2956 ZIN Art No 58446 Ob Systems with lase
71. N 3 Function key F3 Angle AP activates the function for measuring the Angle 4P lengths of two noncontiguous lines and the angle between them gt Ch 11 8 4 p 11 13 F4 With function key F4 Delete you can delete all measured values which Delete have been saved for an image The image itself remains unaltered on the hard disk 11 6 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images CAUTION The values are irretrievably deleted Function key F6 Calibrate activates the function for measuring a ref erence length on an image gt Ch 11 8 1 p 11 7 The results of all measurements appear in the corresponding fields on the reference screen If they are saved with F1 Save they are also dis played below the image on the live screen 11 8 1 Calibration The purpose of calibration is to determine an absolute scale for measure ments that you wish to perform on images resulting from subsequent flu oroscopy For that purpose you screen a reference object featuring a known length or distance e g a ruler or a balloon catheter with radio paque markers and enter the known length or distance manually in the menu CAUTION 4 CAUTION Measurements on a fluoroscopic image will only provide accurate results if during the acquisition of the relevant calibration image the reference object has been placed in exactly the same plane as the subject you want to measure later It i
72. Operations 7 4 3 METAL correction key The METAL key on the C arm stand corrects a possible flaring of the flu oroscopic image on the screen resulting from metal objects in the beam METAL path and increases contrast at tube voltages above 50 kV The METAL key can be combined with any anatomical program To deactivate metal artifact correction press the METAL key once again Ziehm 8000 7 7 P_26376 CD_28210 EN 01 07 2010 7 Standard Fluoroscopic Operations 75 Generating a fluoroscopic image 7 5 1 Starting fluoroscopy General You can initiate radiation either with the hand switch or the foot switch flu oroscopy pedal Hand switch Fig 7 2 Hand switch Two pedal foot The Ziehm 8000 is equipped with a two pedal foot switch The default switch pedal assignment is listed in gt Table 7 1 p 7 8 Fig 7 3 Two pedal foot switch Pedal Two pedal foot switch Two pedal foot switch Ziehm 8000 Ziehm Compact Ziehm Compact with adapter for lithotripter procedures left Fluoroscopy Fluoroscopy right Save image Swap image or save image gt Ch 7 8 p 7 10 gt Ch 8 7 p 8 10 Table 7 1 Default foot switch assignment 7 8 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 7 Standard Fluoroscopic Operations NOTE The foot switch pedals can be assigned with customer specific functions If this is the case the respective func tions are indicated on labels on the foot switch itse
73. RM SERIAL NO Ziehm 8000 MOBILE C ARM Ziehm Compact IMAGE INTENSIFIER A B A MANUFACTURER 1275 for Europe only DONAUSTRASSE 31 B jes 90451 N RNBERG Germany examp es DATE OF MANUFACTURE TH 9428 HP2 H707RF 23 15 10 cm TH 9428 HP2 H552 23 15 10 cm TH 9432 HX H314 31 23 15 cm E 5830 SD H5 23 15 10 cm Rating label no TS04_041 Table A 4 Labels n a for USA Ziehm 8000 A 17 P_26376 CD_28210 EN 01 07 2010 Appendix A No Label Comments Oa ZIR Art No 10 2946 1 ZIN Art No 58302 Ob China only 1 ZIN Art No 584925 ZIR Art No 10 2947 1 ZIN Art No 58440 all countries except Germany Austria Switzerland German speaking countries 1 ZIN Art No 58390 for Germany Austria Switzerland only Please observe accompanying 1 documents ZIR Art No 10 2948 ZIN Art No 58361 ZIN Art No 58340 1 a Ob Ban China onl 1 AN ERIA R AN EHRE ZIN Art Se 584926 Before transportation block the lock handle with brake ZIR Art No 10 2951 1 ol ZIN Art No 58490 Make sure that the face of the person shown is facing upwards when you attach the label 14 Systems with laser positioning device 1 only ZIR Art No 10 2953 ZIN Art No 58391 15 Systems with laser positioning device 1 only German speaking countries ZIN Art No 58405 Table A 4 Labels n a for USA cont A 18
74. WONDER Department ENDOSCOPY Patient name ZIEHM DEMO 24 mn N F N First name ALFRED N Date of birth 12 09 1924 A Sex M Patient number 25 Keywords ERCP Note Date 25 09 04 kV 57 kV Time 10 33 14 mA 2 7 mA Img no 1 41 cGycm2 HD 15 FA F2 F3 Print USB cD Fe Back F4 ts Net Store NetOutput Fig 10 12 Mosaic menu image level Output submenu e Press key F5 NetOutput The marked images are transferred to the second DICOM storage server Images which have been transmitted successfully are flagged with a D or If the User Configuration function has been enabled the Printer configuration menu is displayed RR Printer configuration Server Number 1 Storage lt gt Fa F5 Cancel NetOutput Fig 10 13 Printer configuration submenu e Press key F5 NetOutput Bs NetOutput FS NetOutput Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 17 10 DICOM Functions The marked images are transferred to the second DICOM server Images which have been transmitted successfully are flagged with a D 10 6 3 Printing images Printer configu If the User Configuration function has been enabled on the default print ration server you may select the desired print server In addition you can make the following print settings Number of copies Here you
75. X Ray On Off 6 5 Keyboard C arm stand 5 7 Monitor cart 5 6 kV value 5 4 L Labels C arm stand USA A 23 Generator USA A 23 Image intensifier for USA A 24 Monitor cart for USA A 25 Two pedal foot switch A 16 Two pedal foot switch for USA A 26 Laser Laser Class 3 5 14 1 Laser Positioning Device 3 6 5 4 14 1 Laser radiation A 47 Technical Data A 47 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Index LASER key 5 4 14 1 Length or distance Measurement 11 9 Lithotripsy 2 1 Lithotripter 2 1 Live screen 2 10 16 5 MOSAIC key 5 7 9 5 11 1 Mosaic menu 5 7 9 5 11 1 Motion blurring 8 9 16 3 16 26 Move Up Down keys 4 1 4 11 5 7 Movements of the C arm Angulation 4 8 Locking Horizontal 4 10 Entire system 6 5 Orbital 4 7 X rays 6 5 Swiveling panning 4 9 Lower case letters Vertical 4 11 Entering 9 4 MPPS 10 4 M N mA value 5 5 Navigation Magnification key 5 1 8 3 Magnify button 5 11 Maintenance Checking the useful beam A 2 Consistency test A 2 Regular checks A 7 Malfunction messages 7 11 7 14 A 6 A 7 Manual mode 5 2 7 5 Manual Mode key 5 2 Marking 9 17 Measurement 11 6 Angle with 3 points 11 11 Angle with 4 points 11 13 Calibrating 11 7 Deleting measured values 11 6 Length or distance 11 9 Measurements 11 6 Mechanical brakes on the C arm 4 6 Mechanical handling 4 1 MENU key 5 7 16 1 Menus Configuration Menu 16 1 Mosaic 5 7 9 5 11 1 Operation 5 9 Patient Dat
76. Y SWITCH za chic shaders sr Ques E Madi ceenaun tease 6 5 7 Standard Fluoroscopic Operations 7 1 121 OVERVIEW ae coh ates Be at eal atin A ree ate E ott bes at sa ak aaa 7 1 7 2 Eluor scopy modes en 22 en E EN 7 2 7 2 1 Continuous fluOrOSCOPY uuenessnnnnnnnnssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn 7 3 7 2 2 Continuous pulse flUOrOSCOPY cccecceeceeeeeeeeeeeeceecaeeeeeeeeeeeeettees 7 3 7 2 3 Single pulse fluoroscopy SNaPShOl eeeeeeeeeeeeeeeeeetteeeeeeeaes 7 4 7 3 Manual exposure rate setting uuersnnnesnennnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn 7 5 TA FIU OrOSCOPY PFOgFAMS ni ie 7 6 7 4 1 v DOSE TUnctlon Koy eeii aasidecnnadarcceausiaucee el in 7 6 7 4 2 Anatomical programs Ss seres aeaa E R O a 7 6 7 4 3 METAL correction Key caco E a E a 7 7 7 5 Generating a fluoroscopic image 2uennnnnennennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn 7 8 7 5 1 starting flUOTOSCHPY tree letlnpessenheenl 7 8 7 5 2 Saen display secs lice evesishectansssaun eda AT 7 9 1 6 Doseareaproduct che x rolecist titel cts lead eva atts tulad tines ee avila 7 9 Mal MAIKO MA Gr hie races ase crac ce A ee hc ia eee TT AA 7 10 T8 SAVE a iaaa e acta ikl hadi ldas teed ieecbncl a aaae a bebeell dete dukes 7 10 AQ PUNT a iva het cen A A A cased Seasons 7 12 7 10 Warning signals and malfunctions eee center eee eeeetaeeeeeeeaeeeeeeeaaeeeeeseeaas 7 13 7 10 1 Permanent warning during radiation
77. a Input 9 4 Post Processing 5 7 11 2 Text 12 3 Windowing Settings 8 6 METAL key 5 4 7 7 Metal artifact correction program 5 4 7 7 min key 5 1 5 5 6 3 7 13 Monitor cart Dimensions flat screen monitors A 38 Illustration 2 7 Illustration of closed version A 13 Illustration of semi open version A 13 Arrow keys 5 6 5 9 9 8 12 3 HOME key 10 3 Key HOME 9 8 Scroll keys 5 6 9 8 NEW PAT key 5 7 9 4 9 6 10 2 10 3 10 4 Noise in the image 16 27 Noise suppression 8 9 16 26 O OFF key 5 1 5 6 ON key 5 1 5 6 Open Iris Collimator key 5 2 Open Slot Collimator key 5 2 Operation settings Activating automatic image swapping 16 2 Defining the storage format for removable storage media 16 4 Defining the USB stick storage format 16 4 Displaying a crosshair 16 3 Function of the F key 16 3 Selecting the storage medium for data re trieval 16 4 Operator s log A 3 Optional accessories 2 5 Options 2 4 Output CD 9 21 USB stick 9 20 Video printer 9 22 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Index Overheating 7 14 Overtemperature 7 14 P Parking brake C arm stand 4 4 Monitor cart 4 3 Patient data Entering 9 4 Length of the patient number 9 2 Managing 9 2 Modifying 9 5 9 6 Retrieving from DICOM server 10 1 Patient folders Activating 9 9 Backup to CD 9 10 Creating 9 2 9 4 Deleting 9 13 9 14 Editing data 9 5 Mandatory data 9 3 Navigation 9 8 NO NAME folder 9 2 Ope
78. a gray overlay The collimator boundaries are represented by white edges e Screen the patient as usual 8 3 Electronic image magnification The image intensifier format selection function magnification mag Function nifies the fluoroscopic image electronically increasing image resolution proportionally to the magnification factor For 15 cm i i systems one magnification level is always available For 23 cm i i systems one or two magnification levels are available optionally To activate the magnification function you use the Magnification key on the C arm stand With each keystroke magnification is incremented by one level and then finally deactivated again The selected magnification level L 0 L I or L Il shows up briefly on the live screen Ziehm 8000 8 3 P_26376 CD_28210 EN 01 07 2010 8 Adjusting Live Images Image magnifi cation levels l l size Key Magnification LED stroke 15 cm 0x Normal view 15 cm Off 1x Magnification level 1 10 cm ON 2x Normal view 15 cm Off 23 cm 0x Normal view 23 cm Off 1x Magnification level 1 15 cm ON 2x Magnification level 2 10 cm Flashes option 3x Normal view 23 cm Off Table 8 1 Image magnification levels 8 4 Contrast and brightness adjustment Windowing Function In order to enhance image details the system provides an electronic con trast and brightness adjustment of the live image real time windowing
79. abled e To unlock the EMERGENCY STOP button press the red knob with a slight twist in clockwise direction The unit remains switched off You can switch the unit back on with the ON switch NOTE If the system cannot be switched on the EMERGENCY STOP button may have been actuated inadvertently e g during a transport Check whether the EMERGENCY STOP button is locked and unlock it if applicable 6 4 iehm 8000 Zieh P_26376 CD_28210 EN 01 07 2010 6 Switching the System On and Off 6 4 Key switch The Ziehm 8000 monitor cart is equipped with a key switch Depending on your chosen configuration it is used for locking either the entire system Power on or only the radiation function X Ray ofthe unit This allows you to prevent unauthorized persons from switching on the unit or initiating radiation Power on X Ray Unlock On Lock Off Fig 6 1 Key switch for locking the entire system left or the radi ation function right Lock or Off position With the Power on key switch you can completely switch off the unit Power on equivalent to OFF switch and lock it When you remove the key while it is in the Lock position the Ziehm 8000 can no longer be switched on with the ON switch To be able to switch on and operate the Ziehm 8000 you must first insert the key and turn it to the Unlock position While in the Unlock position the key cannot be removed With the X Ray key swit
80. act with adapter for lithotripter procedures The Save key is dis abled You may however transfer the image displayed on the screen tempo rarily to the random access memory and retrieve it from there after another fluoroscopy gt Ch 8 7 2 p 8 10 To transfer the fluoroscopic image displayed on the screen to the random access memory do the following e Press the image swapping key or e Press the right pedal of the foot switch gt Ch 7 5 1 p 7 8 Using this method you can always redisplay the last two fluoroscopic images alternately on the screen 7 9 Printing If your system is equipped with a video printer you can print the live screen image on the video printer e Press the PRINT key on the C arm stand or e Press the PRINT key on the monitor cart maon CAUTION When printing on the Sony UP 990 video printer always use the CUT button on the printer for cutting off the printer paper Tearing off the printer paper may damage the video printer As opposed to that on the Sony UP 970 and UP 897 video printers you must tear off the printer paper 7 12 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 7 Standard Fluoroscopic Operations On a Ziehm Compact or Ziehm Compact with adapter for lithotripter pro Ziehm Compact cedures you can print the currently displayed fluoroscopic image onthe Ziehm Compact small video printer integrated into the compact monitor with adapter for lith
81. ad the corresponding on screen menu appears MENU SCROLL To lock the menu do the following Locking the menu e Press the MENU key The on screen menu appears m e Select the Setup tab with the help of the or arrow keys e Press the SCROLL key until the Menu Lock item is highlighted Sio SCROLL e Press the arrow key The menu disappears A message saying that the menu is locked is displayed As long as the menu is disabled the message MENU LOCKED is dis played whenever you press one of the keys on the keypad Each flatscreen monitor has a built in keypad with six keys which are Built in keypad used for accessing the screen setting menus 88090 INPUT MENU SCROLL Fig 16 5 Built in keypad of the flatscreen monitor To set the screen brightness do the following Brightness e Press the Brightness Contrast key Ziehm 8000 16 9 P_26376 CD_28210 EN 01 07 2010 16 System Configuration The Brightness control appears on the screen e Press the or arrow key to increase or decrease the screen brightness The settings become immediately active on the screen After a few ar seconds the Brightness control disappears automatically Contrast To set the screen contrast do the following e Press the Brightness Contrast key twice The Contrast control appears on the screen
82. ages A Vv Select Save F2 Mark Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 5 10 DICOM Functions F4 e Press key F4 Net Store Net Store The marked images are transferred to the DICOM server The message Sending MPPS COMPLETED appears on the screen The procedure step is reported as being completed to the MPPS server A list of the images that have been transferred to the DICOM server is sent to the MPPS server 10 4 Importing images from a DICOM server Function When a patient folder is open or activated you can download images and cine loops image level query retrieve or entire series of images and cine loops series level query retrieve from the connected DICOM server and save them to this patient folder If you have not activated the patient folder yet it will be activated automatically for image download It is possible to download images with a size of up to 27 MB from the DICOM server The maximum number of images in each patient folder is not limited as long as the overall storage capacity of the system is not exceeded e Press the MOSAIC key MOSAIC A e Select the desired patient folder using the arrow keys Vv e Press the Enter key 10 6 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions e Press key F5 Retrieve The studies which are available on the DICOM server for this patient are displayed as a list A study can contain several series consisting of si
83. ake sure to always reset the contrast adjustment to the default setting by pressing both Contrast keys simulta neously if you change patients without switching off the system Otherwise a false contrast impression may be displayed 8 4 1 2 Step windowing In step windowing mode 4 different windowing steps with a predefined combination for the contrast window width W and level L are available in addition to the default setting Windowing step 0 corresponds to the default setting i e 256 evenly dis tributed gray levels Starting from windowing step 0 you can select the two predefined windowing steps 1 and 2 with the Left Contrast key and the two predefined windowing steps 1 and 2 with the Right Con trast key When you press both Contrast keys simultaneously the system is reset to windowing step 0 The custom settings for the individual windowing steps are made under Configuration Menu gt Service Settings gt Step Windowing gt Ch 16 6 7 p 16 23 Functioning Toggling Functioning Reset Configuration Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 8 5 8 Adjusting Live Images 8 4 2 WNDW HOME In addition the default windowing step for each anatomical program after power up can be set under Configuration Menu gt Service Settings gt Filter Factors gt Organ 0 Organ 1 Organ 2 Soft gt Ch 16 6 2 1 p 16 25 NOTE On a Ziehm Compact or Ziehm Compact
84. ant to print e Press key F1 Print The marked images are printed on the video printer mounted in the monitor cart Once they have been printed the images become unmarked manon CAUTION When printing on the Sony UP 990 video printer always use the CUT button on the printer for cutting off the printer paper Tearing off the printer paper may damage the video printer As opposed to that on the Sony UP 970 and UP 897 video printers you must tear off the printer paper 9 3 7 Comparing saved images MOSAIC N N gt gt v v A gt v You can display saved images either from one patient folder or from several different patient folders at full size on the live and reference screen in order to compare them to each other To compare two images from the same patient folder do the fol lowing e Press the MOSAIC key e Select the desired patient folder using the arrow keys e Press the Enter key e Select the desired image using the arrow keys e Press the Enter key The image is displayed at full size on the live screen e Select the desired second image using the arrow keys 9 22 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 Data Management e Press key F1 Enlarge The second image is displayed at full size on the reference screen You may compare the two images now To compare two images from different patient folders do the fol lowing e Press the MOSAIC
85. aracteristic 80 10 2 A 60 50 40 30 20 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 260 Time min Fig A 18 Cooling characteristic Ziehm 8000 A 35 P_26376 CD_28210 EN 01 07 2010 Appendix A A 8 Scattered radiation in the significant zone of occupancy Distribution of scattered radiation in the significant zone of occupancy of the C arm stand Measurement conditions in accordance with EN 60601 1 3 1994 Exposure conditions 84 kV 3 90 mA 327 W Rectangular water phantom 25 cm x 25 cm x 15 cm 1 5 mm Cu Distance phantom image intensifier 50 cm Measuring instrument Radcal 1515 S N 15 1427 Height above floor in cm 200 rE l i ee 9 100 1 2 3 4 5 p 50 Uo 30 cm 4 60 cm gt Distance to focus central ray beam Number Level in mGy h 1 lt 10 2 lt 5 3 lt 2 4 lt 1 5 lt 0 5 Patient positioning 80 cm 60 cm gt Fig A 19 Scattered radiation A 36 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A A 9 Dimensions A 9 1 Ziehm 8000 220 Kx IN ee S
86. ase that any repair modification or installation work is carried out by unauthorized personnel or any seals on components are broken No consequential damages will be accepted either The equipment conforms to Class Ilb according to Council Directive 93 42 EEC This document has been written and reviewed originally in German and translated Preface Normal use Operation Operation USA Authorized personnel Contraindications to the use of X rays Exclusion of liability CE1275 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Contents Contents 1 General Information 1 1 tI Typographical conventions neeese n EEEE EERE 1 2 1 2 Conventions for safety instructions eeeseseseeeeseeereesserresstterrnstttrnssrrtnnnssent 1 3 2 System Overview 2 1 2 1 Fields of application and features 44s0senennnnnennnnnnennennnnennnnnnnne 2 1 2 1 1 Fields of application 4444444444444nHnnennnnnnnnnnnennnnnnennnnnennennn 2 1 2 1 2 Features item dei net ehe tat all 2 1 2 2 M delrange u ua Ae a 2 3 2 2 1 ZiehM 8000 ii ee AA EAAS 2 3 2 2 2 Zieh COM Pacha ick E en aaa E han mepE oe 2 3 2 2 3 Ziehm Compact with adapter for lithotripter procedures 2 3 2 3 COPUONS Feen Ae tee een ee ee athe ae see oat nee 2 4 2 4 Optional accessories v sccteeiasheccees a tedden cacete abe a a a aaa 2 5 2 9
87. ateral 57 kV 0 5s Elbow a p 57 kV 0 4s Elbow lateral 57 kV 0 5s Forearm a p 52 kV 0 5s Forearm lateral 55 kV 0 6s Wrist joint d v 48 kV 0 35 Wrist joint lateral 52 kV 0 4s Hand d v 48 kV 0 2s Fingers 48 kV 0 1s Upper femur 70 kV 1 2s Lower femur 66 kV 0 8s Knee joint a p 60 kV 0 5s Knee joint lateral 60 kV 0 5s Knee joint space 60 kV 0 5s Patella axial 60 kV 0 5s Lower leg a p 60 kV 0 5s Lower leg lateral 60 kV 0 4s Ankle joint a p 60 kV 0 7 s Ankle joint lateral 60 kV 0 3s Calcaneus lateral 60 kV 0 4s Calcaneus axial 60 kV 0 75 Metatarsus 60 kV 0 2s Foot lateral 60 kV 0 2s Toes 60 kV 0 1s Table 15 1 Exposure guide cont Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 15 5 15 Direct Radiography 15 6 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 1 Overview A large number of parameters can be preset for the Ziehm 8000 This is done in a configuration menu To open the Configuration Menu you use the MENU key on the monitor cart The Configuration Menu is divided into four submenus Operation settings gt Ch 16 2 p 16 2 Basic settings gt Ch 16 3 p 16 5 Screen settings Ziehm 8000 with 18 flat screen monitor gt Ch 16 4 p 16 7 Ziehm 8000 with 24 flat screen monitor gt Ch 16 5 p 16 17 Service settings gt Ch 16 6 p 16 22 Configuration Menu User settings Enter Basic settings Monitor settings Serv
88. atient data record is downloaded from the server and automati cally entered into the patient data input menu If the patient number has more than 29 digits it will show up as 123456789 in the Patient no field e Save with function key F1 Save 10 3 Processing scheduled procedure steps of a Worklist MPPS Function F4 Worklist The DICOM function MPPS Modality Performed Procedure Step allows you to open a procedure step job scheduled in a Worklist gt Ch 10 2 2 p 10 2 process it and then report it as being completed to the MPPS server The corresponding function must be enabled in the DICOM settings for that purpose e Please contact your in house service engineer if you wish to enable the MPPS function NOTE You can use the MPPS function also when you create a patient folder manually gt Ch 9 2 1 p 9 2 In this case a procedure step is automatically generated and started when you save the patient data provided that the MPPS function is enabled To process a procedure step scheduled in a Worklist do the fol lowing e Make sure that the MPPS function is enabled e Press the NEW PAT key The Patient Data Input menu appears on the reference screen e Leave all the fields empty If the Hospital Department and or Phy sician fields contain default data you may leave this data as is or e To limit the Worklist to a single patient enter the patient number under t
89. atient folder Patient name function key F1 Pat Name Patient number function key F2 Pat No Keywords function key F3 Keywords maon CAUTION If you use the patient ID to search for a patient folder please verify the search result by checking the patient name It may happen occasionally that a patient ID is assigned more than once on a DICOM network To find a patient folder do the following e Press the MOSAIC key MOSAIC F2 e Press key F2 Search The search menu appears ZIEHM DEMO 5 ZIEHM DEMO 6 ZIEHM DEMO 7 ZIEHM DEMO 8 ZIEHM DEMO 9 ZIEHM DEMO 18 ZIEHM DEMO 11 ZIEHM DEMO 12 ZIEHM DEMO 13 ZIEHM DEMO 14 ZIEHM DEMO 15 ZIEHM DEMO 16 ZIEHM DEMO 17 ZIEHM DEMO 18 ZIEHM DEMO 19 INE Patient ZIEHM DEMO 13 13 10 98 First name ERIC Time 13 17 41 D of birth 28 01 1961 Images 2 Patient no 14 HD 19 Keywords FOOT Keywords Fig 9 5 Mosaic menu patient folder level Search submenu F4 e Press key F1 Pat Name Pat Name or or F2 e Press key F2 Pat No Pat No 9 12 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 Data Management or or e Press key F3 Keywords F3 An input field indicating the chosen search criterion appears on the screen 0000 Patient number Ban ae DEMO 13 pate
90. ay gt Fig 16 8 p 16 15 appears on the screen MENU SCROLL e Press the SCROLL key six times The Utilities submenu is highlighted in white SCROLL Ziehm 8000 16 15 P_26376 CD_28210 EN 01 07 2010 16 System Configuration MENU SCROLL Restoring the fac tory settings SCROLL Press the MENU key The first function in the utilities submenu is selected Press the SCROLL key until the desired language is displayed All on screen menu elements and controls are displayed immediately in the chosen language After a few seconds the control disappears automatically After having changed the screen settings you may restore the factory set values at any time To restore the factory settings do the following Press the key sequence MENU SCROLL MENU The OSD Onscreen Display gt Fig 16 8 p 16 15 appears on the screen Press the SCROLL key six times The Utilities submenu is highlighted in white Press the MENU key The first function in the utilities submenu is selected Press the SCROLL key three times The Factory reset function is selected Press the arrow key All settings are reset to the factory values 16 16 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 5 Monitor settings for 24 flat screen monitors 16 5 1 Overview The Monitor Settings menu is used for adjusting the
91. ays Ziehm Imaging GmbH authorizes only trained and skilled personnel to operate this medical device The system is intended for use by health care professionals such as physicians orthopedic surgeons surgeons radiologists and technologists in hospitals outpatient clinics and other clinical environments Ziehm Imaging GmbH anticipates the system will be used on a nearly daily basis Ziehm Imaging GmbH applications specialists and or qualified site personnel provide on site operator training in the proper use of the system The medical equipment is intended for fluoroscopies in the field of surgery e g in traumatology orthopedics neurosurgery urology cardiology Third party devices and components used in combination with this system must comply with the safety requirements according to IEC 60601 1 and or IEC 60601 1 1 or furnish proof of an equivalent degree of safety To ensure CE conformity these components must have a CE approval in accordance with Council Directive 93 42 EEC In addition a declaration in compliance with Article 12 of the said directive must be provided For components without CE approval a conformity assessment procedure is obligatory Proper and safe operation of the system requires adequate transportation storage assembly and installation as well as appropriate use and maintenance The limit values indicated in the present document must not be exceeded this applies also when putting the system into service
92. ch you can lock the radiation function of the unit X Ray When you remove the key while it is in the Off position it is possible to switch on the Ziehm 8000 and to use functions such as patient data man agement or image postprocessing However it is not possible to initiate radiation with the hand or foot switch To be able to initiate radiation you must first insert the key and turn it to the On position While in the On position the key cannot be removed Ziehm 8000 6 5 P_26376 CD_28210 EN 01 07 2010 6 Switching the System On and Off 6 6 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 7 Standard Fluoroscopic Opera tions 7 1 Overview Standard fluoroscopy comprises the following steps and settings Selecting the fluoroscopy mode Manual exposure rate setting only in exceptional cases Selecting the fluoroscopy program Acquiring the fluoroscopic image Saving the fluoroscopic image Printing the fluoroscopic image if desired Steps and settings Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 7 Standard Fluoroscopic Operations 7 2 Fluoroscopy modes Fluoroscopy The Ziehm 8000 provides three different fluoroscopy modes modes e Continuous fluoroscopy e Continuous pulse fluoroscopy e Single pulse fluoroscopy snapshot Continuous pulse fluoroscopy reduces the dose burden to approx 50 The following chart illustrates the difference between continuous fluo roscopy continuous
93. column Control panel SSS a Cassette holder Steering amp braking 7 lever ng Handle __ Hand switch A Generator Coupling cable connec tion Cable guards cee Fig 2 1 C arm stand Ziehm 8000 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 2 System Overview Monitor cart with 24 flat screen monitor ON OFF switchesfor flat screen monitors Coupling cable support 2 5 2 Monitor cart Radiation indication n Flat screen monitor ia Keypads for screen set tings Control panel lt A 4 _ Video printer 5 USB port CD writer T Ziehm 8000 Brakes Fig 2 2 Radiation indi m cation lamp _ gt A Flatscreen monitors H Keypads for screen set y tings a Control panel DICOM con c als nection RJ45 Power cable sup Power supply Coupling cable connec tion VIDEO OUT SM AM Equipotential 7 l 47 grounding N f 2 Spare GND I X connection DICOM
94. cont Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 5 Controls Symbol s Function Exposure time A For setting the exposure time for direct radiography S 7J Film size For setting the maximum collimator aperture for the film or cassette size used in direct radiography Reverse up down Mirrors the image vertically around the horizontal axis ge Reverse left right Mirrors the image horizontally around the vertical axis a Select left screen Selects the left screen for image rotation disabled on Ziehm Compact and Ziehm Compact with adapter for lithotripter procedures Select right screen Selects the right screen for image rotation disabled on Ziehm Compact and Ziehm Compact with adapter for lithotripter procedures Image Rotation Rotate the image on the selected screen This key is disabled DSA This key is disabled MSA This key is disabled RSA O O Extremities and children AN Activates and deactivates the anatomical program for the extremities body region or for children Head spine and pelvis Activates and deactivates the anatomical program for the head spine and pelvis body regions Table 5 1 Keys on the C arm stand control panel cont Ziehm 8000 5 3 P_26376 CD_28210 EN 01 07 2010 5 Controls Symbol s Function Thorax and abdomen Activates and deactivates the anatomical program for t
95. d Ziehm 8000 10 21 P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions 10 22 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images 11 1 Overview You may post process saved images at any time using the functions of General the Post Processing menu The following post processing functions are available Post processing functions Edge enhancement Image Rotation Setting a zoom factor Grayscale Inversion Contrast and brightness adjustment with windowing submenu Different measurement functions submenu Any modification becomes immediately visible in the live screen image The modifications can be saved and will be visible whenever you reopen the image later 11 2 Activating the post processing functions To be able to post process an image do the following How to proceed e Open the Mosaic menu by pressing the MOSAIC key on the monitor cart MOSAIC e Move to the desired patient folder gt Ch 9 3 1 p 9 9 and open it by pressing the Enter key A e Move to the desired image Ch 9 3 6 p 9 15 and open it by lt gt pressing the Enter key The image is displayed on the live screen Q e Press the POST PROCESS key on the monitor cart So PROCESS Ziehm 8000 11 1 P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images The Post Processing menu opens Edge filter 2 Rotation 78 1 8 Aus Windowing W 119 L 197 Mea
96. d you can switch it on again Circuit breaker 7 ia a oO 7 a a Ww Fig A 1 Monitor cart with mains fuse rear view To switch on the mains fuse do the following e Press rocker switch to ON position The circuit breaker is illuminated ON OFF circuit breaker with rocker switch 2x15A USA 2x 20 A Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 A 13 Appendix A A 4 Labels on the unit Fig A 2 Labels on the C arm stand of the Ziehm 8000 Al i Fig A 3 Labels on systems with integrated laser positioning device on the image intensifier left and on the generator right A 14 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A OO 26 24 aig vv a j o _ sg x O 5 8 Fig A 4 Labels on a monitor cart with 24 flat screen monitor 8 TT 8808080 A Fig A 5 Labels on a monitor cart with 18 1 flat screen monitors Ziehm 8000 A 15 P_26376 CD_28210 EN 01 07 2010 Appendix A
97. d system date 16 5 Brakes C arm stand 4 4 Monitor cart 4 3 Brightness adjustment 8 4 Button Magnify 5 17 Button Save 5 4 7 10 7 11 Buttons Alphanumeric keys 5 7 9 4 9 6 11 8 12 3 16 23 Anatomical program keys 7 6 Arrow keys 5 6 5 9 9 8 12 3 Contrast 5 4 8 4 8 5 Film size 5 3 Image Rotation 5 3 8 8 Move up down 4 1 4 11 5 1 Screen Selection 5 3 8 8 Scroll 5 6 9 8 C Cables Coupling cable 4 1 4 2 6 1 Equipotential grounding cable 4 2 Power cable 4 1 4 2 6 1 6 2 A 1 Calibrating 11 7 Reference object 11 7 C arm stand Dimensions A 37 Illustration 2 6 CD Writing images 9 20 CD recall 16 4 Checks Checking the useful beam A 2 Consistency test A 2 Gettering the i i tube A 3 Regular checks A 1 Cine loop Importing from DICOM server 10 6 Cleaning A 4 Recommended detergents A 4 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Index Screen A 4 Close iris collimator key 5 2 Close Slot Collimator key 5 2 Collimator apertures 15 2 Collimators Iris Collimator 5 2 8 1 Slot collimator 5 2 8 2 Virtual collimator 8 2 Comparing Images from different patient folders 9 23 Images from one patient folder 9 22 Configuration Menu 16 7 Consistency test A 2 Continuous fluoroscopy 5 2 7 2 7 3 Continuous fluoroscopy key 5 2 7 3 Continuous pulse fluoroscopy 5 2 7 2 7 3 Continuous Pulse Fluoroscopy key 5 2 7 3 Contrast keys 5 4 8 4 8 5 Contrast adjustment 8 4 Control pa
98. define the number of hard copies default setting 1 setting options 1 10 Film destination Here you may define a certain output tray for the printed film according to its intended use default setting none setting options MAGAZINE PROCESSOR BIN_1 BIN_2 BIN_9 BIN_9 Film session label Here you may enter any text for labeling the film default setting none Film size ID Here you may specify the film size default setting none setting options 8INX10IN 8_5INX11IN 10INX12IN 10INX14IN 11INX14IN 11INX17IN 14INX14IN 14INX17IN 24CMX24CM 24CMX30CM A4 A3 Number Page Here you may specify how many images you want to print on one page default setting 1 setting options 1 2 4 6 9 12 15 20 24 Server Number Here you may enter the desired print server setting options 1 or 2 Configuration of You cannot configure the DICOM Print DICOM Store and User Config the print servers uration functions yourself e Please contact your in house service engineer if you wish to enable functions on the print servers To print images on a DICOM network printer do the following e Press the MOSAIC key MOSAIC e Select the desired patient folder using the arrow keys N gt V e Press the Enter key iehm 8000 10 18 Zieh P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions e Select the desired image using the arrow keys A e Press key F2 Mark F2 e Repeat the
99. dge enhancement Table 16 3 Edge filter levels 16 26 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 System Configuration Windowing step Continuous pulse Snapshot Level Meaning 2 Medium edge enhancement 3 Strong edge enhancement 4 Extreme edge enhancement Table 16 3 Edge filter levels cont Increasing the level of edge enhancement will also cause any noise in the image to become more apparent though This value determines which windowing step is automatically set by the system for the corresponding anatomical program after power up pro vided that the step windowing mode has been activated gt Ch 16 6 1 p 16 23 You can adjust these default settings later during operation using the Contrast keys on the C arm stand This setting defines how many images are used for the stack filter in con tinuous pulse fluoroscopy mode overriding the value specified under Stack filter This setting defines how many images are used for the stack filter in snapshot mode overriding the value specified under Stack filter 16 6 3 DICOM settings NOTE The settings in this menu must not be modified by any person other than an authorized service engineer or a properly trained network administrator This menu is protected by an additional password 16 6 4 System settings NOTE The settings in this menu must not be modified by any person other than an authorized service e
100. ding 3 4 System failure 3 7 X rays 3 2 vi Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Index Save 7 8 7 10 Images to CD 9 20 Images to DICOM server 10 14 Images to USB stick 9 19 Shift F1 7 11 Save button 5 4 7 10 7 11 Scattered radiation A 36 Screen assignment 2 10 Modifying 2 10 Screen Selection keys 5 3 8 8 Screen selection for image rotation 5 3 8 8 Screen settings 18 16 7 24 16 17 Scroll keys 5 6 9 8 Security key switch 6 5 Select Left Screen key 5 3 Select Right Screen key 5 3 Service life 1 7 Service settings 16 22 DICOM settings 16 27 Filter factors 16 24 HEDIS data 16 28 Monitor calibration 16 28 Software update 16 28 Step windowing 16 23 System settings 16 27 Shift key 5 7 12 3 Significant zone of occupancy Scattered radiation A 36 Single pulse fluoroscopy 5 2 7 2 7 4 Slot collimator 5 2 8 2 Rotation 5 2 8 2 Snapshot 5 2 7 2 7 4 Snapshot key 5 2 7 4 SOFT key 5 4 7 6 Space key 5 8 12 4 Stack filter 16 25 16 26 For continuous pulse 16 27 For snapshot 16 27 Steering C arm stand 4 4 Monitor cart 4 3 Steering amp braking lever 4 2 4 4 Step windowing 8 4 Activating 16 23 Default windowing step after power up 16 27 Defining windowing steps 16 23 Sterilization A 5 Storage capacity 2 3 9 1 9 2 Storage Commitment 10 21 Storage formats DICOM 16 4 Selecting 16 4 TIFF 16 4 Swap image button 5 4 5 7 Switches Hand switch 5 10 Two pedal foot switch 5 10 Sw
101. e filter is reset the message Filter off is displayed on the live screen Ziehm 8000 16 3 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 2 4 Storage medium for image retrieval CD or hard disk The CD recall menu item allows you to control which storage medium is used by the system for data retrieval in the Mosaic menu Data retrieval from CD is subject to certain restrictions gt Ch 9 3 2 p 9 10 For systems with a CD writer the following applies CDrecall Off default setting The Mosaic menu retrieves the patient folders from the hard disk CD recall On The Mosaic menu retrieves the patient folders from a CD For that purpose you must insert a CD containing backed up patient folders into the CD writer which was written using the Backup function 16 2 5 Selecting the storage medium for data retrieval with DICOM Dir Storage medium for DICOM Dir The DICOM Dir from menu item allows you to control which external storage medium is used by the system for DICOM image retrieval gt Ch 10 5 p 10 10 DICOM Dir from USB The images are retrieved from the USB stick that is connected to the USB port DICOM Dir from CD The images are retrieved from a CD 16 2 6 Defining the storage format for removable storage media CD storage format USB stick storage format If the system is equipped with a CD writer the CD format menu item allows you to choose a storage format for
102. e menus from the reference screen to the live screen To compare two images do the following e Move the image on the live screen to the reference screen using the Image Swapping key e Initiate radiation to generate a new fluoroscopic image on the live screen e Now you can view the two images side by side and compare them 8 7 2 Ziehm Compact Ziehm Compact with adapter for lithotripter pro cedures Function On a Ziehm Compact or Ziehm Compact with adapter for lithotripter pro cedures the Image Swapping key transfers the image displayed on the screen to the memory After performing another fluoroscopy you can use the Image Swapping key to toggle between the last fluoroscopic image and the previously saved fluoroscopic image in order to compare them The right foot switch pedal gt Ch 7 5 1 p 7 8 has the same function ality as the image swapping key 8 10 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 Data Management 9 1 Organization of patient and image data Patient and image data is managed in the following menus onthe monitor General cart Patient Data Input gt Ch 9 2 1 p 9 2 Patient Data Modifi cation gt Ch 9 2 2 p 9 5 and Mosaic gt Ch 9 3 p 9 7 For each patient there is a patient folder on the hard disk where all data related to that patient is stored All image data is assigned to the corresponding folder There are two folder types Patient folders NO
103. e up of 1 to 16 individual images LIH Last Image Hold is displayed on the live screen The amount of images that are used for computing the LIH depends on the LIH filter setting gt Ch 16 6 2 p 16 24 The default values are preset in the anatomical programs You can modify these settings using the LIH filter controls On the Ziehm Compact and Ziehm Compact with adapter for lithot ripter procedures the number of images which is used for computing the LIH is predefined for each anatomical program You cannot modify the predefined number of images e Reference screen Menus or reference images You can swap the screen assignment in the Basic Settings menu gt Ch 16 3 p 16 5 NOTE To avoid confusion the neutral terms live screen and reference screen are used throughout this document regardless of your custom setting On systems with flat screen monitors you can adjust the screen contrast screen brightness and other screen settings with the built in keys on the monitors Ch 16 4 or Ch 16 5 The Ziehm Compact or Ziehm Compact with adapter for lithotripter pro cedures is equipped with one monitor only which is mounted on the hor izontal carriage of the C arm stand with an easily adjustable support arm On a Ziehm Compact with flat screen monitor or a Ziehm Compact with adapter for lithotripter procedures a small video printer is built into the left side of the monitor when looking onto the
104. ease order separately Rev 11 09 2005 P0142 01 STERINORM UNIVERSAL Ziehm C Arm Set Rev03 doc Udo Heisig GmbH The Disposables Company Hermann Oberth Stra e 17 D 85640 Putzbrunn CEO Udo Heisig AG M nchen HRB 82813 Z 49 0 89 4623920 Fax 49 0 89 46239228 Internet www heisig de e mail info heisig de Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 B 1 B 2 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Index Numerals 1 2 DOSE key 5 2 7 6 18 flat screen settings 16 7 24 flat screen settings 16 17 A Acquisition 15 1 AERC characteristics 7 6 Alert messages 7 14 Alerts During operation A 6 During power up A 6 Alphanumeric keys 5 7 9 4 9 6 11 8 12 3 16 23 Anatomical program keys 7 6 Extremities and children 5 3 Head spine and pelvis 5 3 SOFT 5 4 Thorax and abdomen 5 4 Anatomical programs 7 6 Extremities and children 7 6 Head spine and pelvis 7 6 Soft tissues 7 6 Thorax and abdomen 7 6 Angle Measurement 11 11 11 13 Applications of the system 2 1 Arrow keys 5 6 5 9 9 8 12 3 Audible alarm 7 11 7 13 7 14 15 3 A 1 A 6 A 7 Reset 5 1 7 13 Auto delete function 7 11 Autostore function 7 17 Autotransfer 16 2 B Backup to CD 9 10 Data retrieval from CD 9 11 16 4 Displaying images 9 11 Selecting patient folders 9 70 Basic settings 16 5 Entering the hospital data 16 6 Erasing storage media 16 6 Selecting the live screen 16 5 Setting system time an
105. ecific patient and cannot be moved to a patient folder later Storage capacity The NO NAME folder has a maximum storage capacity of 150 images When you save an image to the NO NAME folder and the folder happens to contain already 150 images the oldest image in the folder is automatically overwritten Delete functions The NO NAME folder is never deleted automatically You cannot delete the NO NAME folder nor any individual images stored there manually You may however delete all images from the NO NAME folder in one go under Configuration Menu Basic Settings gt Ch 16 3 4 p 16 6 9 2 Patient data management Length of the The length of the patient number is limited by the system patient ID When you enter a new patient number it must not have more than 30 digits When you import the data of a new patient from a DICOM Worklist gt Ch 10 2 2 p 10 2 the patient number may have up to 64 digits The system records all digits of the patient number internally but cannot display all of them If the patient number cannot be displayed completely it is represented in the form 1234567 The system displays 13 digits of the patient number in the fluoroscopic image gt Ch 12 2 1 p 12 2 and 29 digits in the Patient Data Input Fig 9 1 p 9 3 and Patient Data Modification gt Fig 9 2 p 9 6 menus 9 2 1 Creating a new patient folder on the Ziehm 8000 When you create a new patient fold
106. ed images are printed on the DICOM network printer 10 20 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions 10 7 Storage Commitment Function MOSAIC E5 NetCommit You can check whether the images that are flagged with a D gt Ch 10 6 1 p 10 14 have actually been stored on the DICOM server e g before you proceed to deleting them from the hard disk of the Ziehm 8000 The Storage Commitment function must be enabled in the DICOM settings for that purpose Please contact your in house service engineer if you wish to enable the Storage Commitment function To check whether the images are stored on the DICOM server do the following Make sure that the Storage Commitment function is enabled Press the MOSAIC key Press key F5 NetCommit The system searches the hard disk for images which have already been saved to the DICOM Storage server i e the ones flagged with aD Then the system verifies for each one of these images whether it is actually stored on the DICOM server If allimages are present on the DICOM server the message Storage commitment successfully completed is displayed on the screen All images which are present on the DICOM server are flagged with a C in the thumbnail mosaic If the system is unable to locate one or more of these images on the DICOM server a list of the missing images indicating the patient name first name patient number image number and date is dis playe
107. efly Means that stepping briefly on the foot switch pedal activates another function than holding it down for a while Press and hold down Means that holding the foot switch pedal down for a while activates another function than stepping briefly on it Magnify Activates the electronic image magnification ofthe image intensifier OFF Deactivates the respective function On Off Activates or deactivates the respective function Snapshot Acquires a snapshot gt 06 90778 Save Saves the active image to the hard disk Table 5 3 Optional labels on the foot switch gt Ch A 4 p A 14 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 5 Controls 5 12 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 6 Switching the System On and Off 6 1 Preparing the system Before switching on the system e g after a transport you must connect the two system components to each other and also connect the entire system to the power supply WARNING Never connect the monitor cart and C arm stand when the monitor cart is already connected to the power supply or switched on Damage to the electronics of the system cannot be excluded if this warning is ignored To prepare a Ziehm 8000 do the following Ziehm 8000 e Unwind the coupling cable from the upper cable support on the back of the monitor cart gt Fig 2 2 p 2 7 e Plug the coupling cable connector into the socket located at the
108. eft or the right screen acts as live screen The live screen is the screen where the fluoroscopic image live or saved is displayed The other screen then automatically becomes the reference screen Ziehm 8000 16 5 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 3 3 Entering the hospital data The Hospital Department and Physician menu items allow you to define which data appears automatically in the corresponding fields in the Patient Data Input menu gt Ch 9 2 1 p 9 2 16 3 4 Clearing storage media When you select one of the menu items Clear hard disk or Clear USB device and then confirm the clear command with the Enter key all patient data are deleted from the corresponding storage medium after a confirmation prompt When you select the Clear NO NAME menu item and then confirm the clear command with the Enter key all images in the NO NAME folder are deleted gt Ch 9 1 2 p 9 2 16 6 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 4 Monitor settings for 18 flat screen monitors You can change the following screen settings yourself Screen settings Brightness Contrast Backlight brightness Menu language for screen settings In addition you can restore the factory settings The factory set menu language is English Therefore the English desig nations are used in this document If you want to change any of the following screen settings please con
109. eft side of the reference screen shows all existing patient folders sorted in chronological order The patient folder that was last active is highlighted by a gray bar The related thumbnail is highlighted by a white frame The information field below the thumbnail mosaic shows the following Patient and folder information about the highlighted folder data Patient data Last name first name date of birth patient number key words Date and time when the most recent image in the folder was saved Total number of images stored in the highlighted patient folder Used hard disk space in percent Ziehm 8000 9 7 P_26376 CD_28210 EN 01 07 2010 9 Data Management Available functions A Q D lt JANE in ao a wu mw n aol pa w nm c i o 4 D The following functions are available at patient folder level in the Mosaic menu With the Right Arrow and Left Arrow keys you can move to the next or previous patient folder in the thumbnail mosaic With the Up Arrow and Down Arrow keys you can scroll up or down one row in the thumbnail mosaic i e the cursor jumps 4 patient folders backward or forward With the Scroll keys you can scroll forward or backward 16 patient folders i e 1 complete page With the HOME key you can jump to the oldest patient folder With the key combination ShifttHOME you can jump to the most recent patient folder Enter To activate an open patient folder
110. em are equally identified by a check mark in the submenu on the screen e Press key F6 Back The study level query retrieve menu is displayed on the screen gt Fig 10 3 p 10 7 FS Retrieve F6 Back Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 13 10 DICOM Functions 10 6 Saving and printing images Function If the system is connected to a DICOM network you can save images from a patient folder to a DICOM server gt Ch 10 6 1 p 10 14 and send them to a DICOM network printer for printing gt Ch 10 6 3 p 10 18 Depending on your system configuration you can save images to a second print server which has been configured for DICOM storage and may act e g as standby server gt Ch 10 6 2 p 10 15 10 6 1 Saving images Transferring images MOSAIC N gt v If you send only images to the DICOM server which are not stored there already all images are actually transferred and saved Images that are already stored on the DICOM server are not saved there again Images which have been downloaded from the DICOM server with the Retrieve function will not be retransferred to the DICOM server Meran CAUTION Never modify any patient data in a patient folder after having transferred images from this patient folder to the DICOM server To save images to a DICOM server do the following e Press the MOSAIC key e Select the desired patient folder using the arrow keys e Press
111. ensifier e Close the iris collimator as far as possible and initiate radiation by pressing the hand or foot switch The object must appear exactly in the center of the fluoroscopic image The size of the collimator diameter in the image plane must not differ from the nominal image diameter by more than 2 of the source image receptor distance SID The SID and the nominal image diameter depend on the image intensifier size A 2 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A l l size SID Nominal image diameter 23 cm 97cm 20 1 cm 15 cm 102 cm 14 5 cm Table A 2 Nominal image diameter When the iris collimator is completely open the edges of the collimator must be just visible on the screen WARNING Contact your after sales service center in case of any non conformities A 1 4 Gettering the image intensifier tube To increase the useful life of the image intensifier it is recommended to getter the image intensifier tube after a period of 6 months of continuous non use or storage Do the following e Switch on the system e Leave the system switched on for at least 1 hour e Do not initiate radiation during this time We recommend keeping an operator s log where all operating times gettering times and maintenance events are recorded Maximum radiation field size Increasing the useful life How to proceed Operator s log Ziehm 8000 P_26376 CD_2821
112. er you may choose between the fol lowing ways of entering the patient data You enter the patient data in the Patient Data Input menu using the alphanumeric keypad on the control panel You download the patient data from a connected DICOM server using the DICOM functions Query gt Ch 10 2 1 p 10 1 or Worklist gt Ch 10 2 2 p 10 2 9 2 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 Data Management New patient folder data is entered in the Patient Data Input menu Patient Data Input Hospital ST FRANCIS Department ORTHOPAEDICS Physician Wonder Patient name mith First name Sally D of birth 27 02 1943 Sex F Patient no 213457 Accession no NP 123 Keywords gonarthrotomy Note goneitis F2 F3 Cancel Query F1 Save Fe F4 F5 Worklist DICOM Dir abc Fig 9 1 Patient Data Input menu To be able to create and save a patient folder you must enter atleast the Mandatory data patient s last name in the Patient name field If you save the patient folder without entering a number in the Patient no field the system auto matically generates and saves a patient number The Patient name field shows a generated name consisting of the time Prefilled fields of day and the date e g P_12_34_01_04_09 for a patient folder which was created on 01 04 2009 at 12 34 o clock You can overwrite this data The Hospital Department and Physicia
113. er up Errors during power up Alerts during operation Errors during operation Alerts during power up All displays on the C arm stand control panel are cleared The alert messages appear in an endless loop on the Dose display of the C arm stand An audible alarm sounds All alert messages can be cleared by briefly pressing the hand or foot switch no radiation is initiated However the system will not be fully operational afterwards Errors during power up All displays on the C arm stand control panel are cleared The error messages appear in an endless loop on the Dose display of the C arm stand An audible alarm sounds The error messages cannot be cleared with the hand or foot switch ne WARNING If an error message is displayed the system is not ready for operation The error must be corrected by your after sales service center Please communicate the error code number E and the serial number of the system to your after sales service center A 3 1 3 Alerts during operation The alert message appears alternately with the current operating values on the Dose display of the C arm stand An audible alarm sounds Although radiation is neither interrupted nor inhibited from then on the system is no longer fully operational Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A A 3 1 4 Errors during operation The error message appears alternately with the current operating values on t
114. evel will increase the backlight lifetime Ziehm 8000 16 19 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 5 3 Setting the menu language The factory set menu language is English You can choose one of the fol lowing languages as menu language German French Italian Spanish Dutch Swedish To define the menu language do the following SCROLL MENU Press the MENU key The on screen menu appears Select the Setup tab with the help of the or arrow keys r Menu Position Ho o g E EE EJ rei F DPMS Enable off On Auto Source Select off On off On Operating Hours 116 30 BIOS 5830001 Version A 00 Resolution 1920 x 1200 Mode Local Move to the Language item with the help of the SCROLL key Press the arrow key until the desired language is displayed All on screen menu elements and controls are displayed immediately in the chosen language Press the MENU key The on screen menu disappears 16 20 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 5 4 Restoring the factory settings After having changed the screen settings you may restore the factory set values at any time To restore the factory settings do the following e Press the MENU key The on screen menu appears MENU e Select the Defaults tab with the help of the or arrow keys gt
115. g keystroke PRINT Prints the image on the live screen to the video printer Magnification Activates and deactivates the image intensifier s electronic magnifi cation modes Table 5 1 Keys on the C arm stand control panel Ziehm 8000 5 1 P_26376 CD_28210 EN 01 07 2010 5 Controls Symbol s Function DOSE Reduces the exposure rate by 50 Continuous fluoroscopy Activates and deactivates the continuous fluoroscopy mode Continuous pulse fluoroscopy Activates and deactivates the continuous pulse fluoroscopy mode 6 z0 oJ 8 Snapshot Activates and deactivates the single pulse fluoroscopy mode snapshot mode a Manual mode Enables manual setting of the tube voltage Caution Use only in exceptional cases z b gt Voltage setting Manual tube voltage setting Caution Use only in exceptional cases Close slot collimator Closes the slot collimator Open slot collimator Opens the slot collimator Rotate slot collimator left Rotates the slot collimator in counter clockwise direction Rotate slot collimator right Rotates the slot collimator in clockwise direction Close iris collimator Closes the iris collimator AeL Open iris collimator Opens the iris collimator Direct radiography Activates and deactivates the direct radiography mode I 7 Keys on the C arm stand control panel
116. ge format under Configuration Menu User Settings gt Ch 16 2 6 p 16 4 Deleting A A Q F2 Mark F4 Delete Further processing Saving to USB stick Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 19 9 Data Management MOSAIC A HO Q A Q Be USB me a z 4 E iR N F O oO MOSAIC To save images to a USB stick do the following e Press the MOSAIC key e Select the desired patient folder using the arrow keys e Press the Enter key e Select the desired image using the arrow keys e Press key F2 Mark e Repeat these two steps for any further image you want to save e Plug the USB stick into the USB port on the monitor cart e Press key F2 USB The marked images are saved to the USB stick Once they have been saved the images become unmarked If your Ziehm 8000 is equipped with a CD writer you can write images to CD in the following formats TIF DICOM You can preset the storage format under Configuration Menu User Settings gt Ch 16 2 6 p 16 4 A CD 640 MB stores up to 1 000 images The images are stored in a compilation mirror file on the hard disk first You can then decide whether you want to write the images from the com pilation file to CD immediately or later When you switch off the Ziehm 8000 the images which have not been written to CD yet remain in the compilation file on the hard disk Thi
117. ges is undone 9 3 6 Processing and outputting images of a patient folder To process or output images of a patient folder you must activate gt Ch 9 3 1 p 9 9 or open the patient folder To open a patient folder do the following e Press the MOSAIC key MOSAIC e Select the desired patient folder using the arrow keys or A V A e Search for the desired patient folder gt Ch 9 3 3 p 9 12 D e Press the Enter key The message Please wait Creating thumbnails appears on the I screen Then all images contained in the patient folder are displayed as a thumbnail mosaic The image that was last saved is highlighted by a white frame Hospital ST FRANCIS Doctor DR WONDER Department ENDOSCOPY Patient name ZIEHM DEMO 18 First name TAMMY Date of birth 21 10 1968 Sex F Patient number 11 Keywords STENT Note Date 06 10 98 kV 45 kV Time 44 35 57 mA 1 8 mA Img no 2 HD 19 Fi F2 Fa F4 Fe Enlarge Mark Protect Delete Output Fig 9 7 Mosaic menu image level patient folder opened The following image processing and output functions are available in an open or activated patient folder F1 Enlarge F1 Ziehm 8000 9 15 P_26376 CD_28210 EN 01 07 2010 9 Data Management NetOutput Be Mark Protect Output Print ka F4 Delete F6 AGHA F1 F2
118. hat the inclination of the system does not exceed 5 from the level in operating position e Put on suitable protective clothing e DICOM Connect the DICOM port s on the back of the monitor cart to a DICOM network socket using the appropriate cable s 6 2 Switching the System On and Off 6 2 1 Switching on The keys for switching the system on and off are located on the control panels of the C arm stand gt Fig 5 1 p 5 1 and of the monitor cart gt Fig 5 2 p 5 6 Each of the two keys switches on or off both system components simultaneously CAUTION Do not plug any USB stick into the USB port until the system has fully completed its power up sequence NOTE Always set the ON OFF switches on the flat screen mon itors to ON in order to ensure that the monitors are switched on automatically during power up of the system 6 2 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 6 Switching the System On and Off During power up the system performs a self test The value 0 appears Power up on the operating value displays The radiation time display shows the global software version of the system The temperature symbol gt Fig 5 1 p 5 1 and the X ray symbol gt Fig 5 7 p 5 1 on the C arm stand control panel illuminate for a few seconds After power up a test image appears on the live screen The default set tings after power up vary from system to system according to the cus tome
119. he Patient no menu item e Press function key F4 Worklist 10 4 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions The Worklist appears on the screen Smith Sally 27 92 1980 213467 Miller Tom 11 11 1951 1202 Cannon Edna 11 11 1971 14921 Carter John 11 11 1971 1982 one Requested ID 2345 Start date 24 04 2801 Step ID 23451 Start time 21 30 08 Doctor Wonder Accession no 1 5 Description goneitis AE title EXP8B80 F 2623 Step description gonarthrotomy F1 F2 Select Cancel Fig 10 2 Worklist from the DICOM server Using the Down Arrow and Up Arrow keys move the cursor to the desired procedure step for the patient Confirm your selection by pressing the Enter key or function key F1 Select The patient data record is downloaded from the server and automati cally entered into the patient data input menu Save with function key F1 Save The message Sending MPPS CREATE appears on the screen The MPPS server is notified that the selected procedure step has been started If an error message is displayed please contact your in house service engineer Perform the required examination generating and saving as many flu oroscopic images as you like Mark all images you want to save to the DICOM server AUTION menoon CAUTIO The message and the image list can be sent only once to the MPPS server Therefore make sure that you have marked all relevant im
120. he automatically determined tube current in mA After fluoroscopy the last mA value remains stored Snapshot Tube current 8 0 mA constant Direct radiography Tube current 20 mA constant Ly Exposure time Shows the selected direct radiography exposure time in seconds 0 1 4 0 s Dose display Shows the dose dose area product air kerma air kerma rate An illuminated LED indicates which display is currently active Dose area product display cGy cm or Air kerma display mGy or Air kerma rate display mGy min during exposure only Reset Press min key for at least 3 s Also shows the alert and error messages Radiation Time Shows the accumulated radiation time of fluoroscopies and direct radiographies in minutes and seconds Reset Press min key for at least 3 s Temperature symbol Starts flashing when the generator reaches its overtemperature threshold Illuminates when the generator reaches its overheating threshold FTX X ray symbol Is lit during X ray exposure fluoroscopy and direct radiography Table 5 1 Keys on the C arm stand control panel cont Ziehm 8000 5 5 P_26376 CD_28210 EN 01 07 2010 5 Controls 5 2 Monitor cart control panel 5 6 MOSAIC F G H lt gt Com E POST PROCESS a ziehm imaging amp A lt B EF BEBBBB Ev Fig 5 2 Monitor cart control panel Symbol s Function Off
121. he dose display of the C arm stand An audible alarm sounds Radiation is interrupted it is not possible to initiate radiation again exception error E106 wane VARNING If an error message is displayed the system is not ready for operation The error must be corrected by your after sales service center Please communicate the error code number E and the serial number of the system to your after sales service center WARNING 4 WARNING Please contact your after sales service center also if a certain error occurs frequently Ziehm 8000 A 7 P_26376 CD_28210 EN 01 07 2010 Appendix A A 3 2 List of errors alerts and messages Code Type Description Measures E16 Alert Hand switch 1 pressed Release hand switch and during power up acknowledge alert message by briefly pressing hand or foot switch E17 Alert Foot switch 1 pressed Release foot switch and during power up acknowledge alert message by briefly pressing hand or foot switch E18 Alert Hand switch 2 pressed Release hand switch and during power up acknowledge alert message by briefly pressing hand or foot switch E19 Alert Foot switch 2 pressed Release foot switch and during power up acknowledge alert message by briefly pressing hand or foot switch E 20 Error Short circuit in hand or foot Please contact after sales switch cable service E21 Alert Radiation warning lamp Please contact
122. he patient you must keep the source skin distance as large as possible The generator design guar antees a minimum source skin distance of 20 cm WARNING WARNING Additional material located in the beam path e g an oper ating table not suitable for X raying may result in a dose increase when using a fluoroscopy mode with automatic exposure rate control WARNING When you initiate radiation and no live image is displayed although all necessary settings have definitely been made please contact your after sales service center gt Protection of staff Protection of the patient Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 3 3 3 Safety Instructions 3 3 Electromagnetic compatibility Medical electrical equipment requires special precautionary measures with respect to EMC and must be installed and put into service in accor dance with the EMC guidelines contained in the accompanying docu ments Portable and mobile RF communications equipment may interfere with medical electrical equipment All operating modes of the system have been considered in the EMC tests There are no exceptions to the rules Only conductors connecting cables and accessories that are specified by the manufacturer may be used AAE WARNING Using components other than those specified may result in increased electromagnetic emissions or reduced elec tromagnetic immunity Please observe also the Manufacturer s
123. he thorax and abdomen body regions we o 4 au gt gt SOFT Activates and deactivates the anatomical program for soft tissues METAL Activates and deactivates the correction program for image flaring resulting from metal objects in the beam path Save Saves the image on the live screen to hard disk disabled on Ziehm Compact and Ziehm Compact with adapter for lithotripter procedures Image swapping Swaps the images between the live and reference screens is used for saving on Ziehm Compact and Ziehm Compact with adapter for lithotripter procedures Ab Contrast Control electronic adjustment of the image contrast and or brightness disabled on Ziehm Compact and Ziehm Compact Litho F Customizable function key always programmed with crosshair function on Ziehm Compact and Ziehm Compact with adapter for lithotripter procedures F2 Reduces the noise suppression by one level F3 Increases the noise suppression by one level LASER LASER Activates and deactivates the laser positioning device s A a nq an e lt 0 Voltage Shows the automatically determined or manually set tube voltage in kV After fluoroscopy the last kV value remains stored Table 5 1 Keys on the C arm stand control panel cont Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 5 Controls Symbol s Function Current Shows t
124. his cloth NOTE We recommend users in Canada to use the following disinfectant Optim 33 TB Canadian DIN 02282488 A 4 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A WARNE WARNING Never use pure alcohol or Sagrotan for disinfection as these substances may corrode the surfaces Never use disinfecting sprays since the liquid droplets may penetrate inside the unit endangering safe system operation Electronic components may be damaged and explosive air solvent vapor mixtures may develop A 2 3 Sterilization The system is not sterile and cannot be sterilized The disposable covers optional accessories are sterile upon delivery Disposable covers maon CAUTION The disposable covers are not resterilizable Be sure to discard the disposable covers properly after use For attaching the sterile disposable covers to the C arm Appendix B p B 1 The detachable film cassette holder is non sterile upon delivery It is Film cassette sterilizable holder CAUTION Make sure to sterilize the detachable film cassette holder prior to first use Carefully clean and resterilize the detachable film cassette holder after each use Ziehm 8000 A 5 P_26376 CD_28210 EN 01 07 2010 Appendix A A 3 A 3 1 A 3 1 1 A 3 1 2 Malfunctions Types of malfunctions The following types of malfunctions are detected and indicated Alerts during pow
125. hm Compact Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 2 System Overview Image intensifier with integrated CCD cam Radiation indication gt A Compact monitor Video printer Horizontal car es Lifting col Ny C arm handle Mounting plate for aN lithotripter N c Control panel a A Monitor support arm Steering amp braking F N Swivel arm Handle Hand switch m n ___ optional Connection for power cable or Me a pling cable IN y Cable guards gt Win Generator Cassette holder Fig 2 5 Ziehm Compact with adapter for lithotripter procedures Ziehm Compact with adapter for lithotripter proce dures Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 2 System Overview 2 5 4 Monitors Screen assignment Ziehm 8000 LIH Screen settings Ziehm Compact Ziehm Compact with adapter for lithotripter proce dures On the Ziehm 8000 the live screen function has been factory assigned to the left screen and the reference screen function to the right screen During operation the following will be displayed on the screens e Live screen Fluoroscopic image While the radiation warning lamp is illuminated the native image is displayed When you terminate radiation a composite image mad
126. ice settings Fig 16 1 Configuration Menu General Opening the menu Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 1 16 System Configuration 16 2 User settings Function In the User Settings menu you can make a number of settings which determine the operation conditions during fluoroscopy User Settings AED Crosshair off F key Filter CD recall off Cine speed 8 img sec Cine length 50 DSA Cine On DSA nativeimg Off DICOM Dir from USB CD format TIF USB format DICOM F4 F2 Save Cancel Fig 16 2 User Settings menu 16 2 1 Activating automatic image swapping Moving the fluoro scopic image The Autotransfer menu item allows you to control whether the previous fluoroscopic image is moved automatically to the reference screen when you next initiate radiation e Autotransfer Off When you initiate radiation the previous fluoroscopic image on the live screen is replaced by the new image If it was unsaved it will be irretrievably lost e Autotransfer On When you initiate radiation the previous fluoroscopic image on the live screen is moved automatically to the reference screen As long as the Autotransfer function is active the LEDs on the Image Swapping keys on the monitor cart and on the C arm stand gt Ch 8 7 p 8 10 are illuminated Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 System Configuration
127. iehm 8000 Zieh P_26376 CD_28210 EN 01 07 2010 Appendix A No Label Comments Systems with laser positioning device 1 only ZIN Art No 58406 a Ob Emergency stop switch Pt Niere China only ZIN Art No 58384 China only ZIN Art No 58469 China only ZIN Art No 584927 ziehm imaging amp SERIAL NO MOBILE C ARM MONITOR CART A LINE VOLTAGE LINE IMPEDANCE CURRENT INPUT MAIN FUSE DEGREE OF PROTECTION IP 20 ZIEHM IMAGING GMBH DONAUSTRASSE 31 90451 N RNBERG Germany DATE OF MANUFACTURE Values for MOBILE C ARM Ziehm 8000 Ziehm Compact A CE 1275 for Europe only LINE VOLTAGE 100 V 10 50 60Hz 110 V 10 50 60Hz 115 V 10 50 60Hz 120 V 10 50 60Hz 200 V 10 50 60Hz 220 V 10 50 60Hz 230 V 10 50 60Hz 240 V 10 50 60Hz LINE IMPEDANCE lt 0 6 Ohm lt 0 3 Ohm 100 V 120 V CURRENT INPUT 14 A continuous 22 A momentary 100 V 120 V 10 A continuous 16 A momentary 200 V 240 V MAIN FUSE C 16A 250V Rating label no TS04_039 Table A 4 Labels n a for USA cont Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 A 19 Appendix A No Label Comments I Equipotential grounding 1 b ZIR Art No 10 2964 ZIN Art No 58331 Spare GND co
128. ing e Press the key combination Shift F2 The marked images are highlighted by a white frame To unmark an image do the following e Select the desired marked image in the thumbnail mosaic on the ref erence screen using the arrow keys e Press key F2 Mark You can protect one or more images against being deleted When you attempt to delete a patient folder that contains protected images neither the folder nor the protected images are deleted gt Ch 9 3 4 p 9 13 NOTE Patient folders containing protected images cannot be deleted automatically If many folders on the hard disk contain protected images the Auto Delete function will not delete them and you will be unable to save new images To avoid this situation regularly back up the patient folders which are still needed to external storage media or to a DICOM server You can then manually delete those patient folders or unprotect them and allow the Auto Delete function to free up space on your hard disk To protect one or more images do the following e Select the desired image in the thumbnail mosaic on the reference screen using the arrow keys e Press key F3 Protect e Repeat these two steps for any further images you want to protect Protected images are flagged with PROT To unprotect an image do the following e Select the desired protected image in the thumbnail mosaic on the ref erence screen using the arrow keys e Press key F3 Protec
129. initiate radiation E 48 Error Dose meter check Acknowledge error message by VacuDAP duo Error in briefly pressing hand or foot dose meter system switch to be able to continue working with the system Please contact after sales service E 51 Error Internal fault Please contact after sales service E 52 Error Internal fault Please contact after sales service E53 Error Internal fault Please contact after sales service E 54 Error Internal fault Please contact after sales service E 55 Error Internal fault Please contact after sales service Table A 3 List of error and alert messages cont A 10 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A Code Type Description Measures E 56 Error Internal fault Please contact after sales service E57 Error Internal fault Please contact after sales service E 58 Error Internal fault Please contact after sales service E 59 Error Internal fault Please contact after sales service E 60 Error Internal fault Please contact after sales service E 61 Error Internal fault Please contact after sales service E 62 Error Internal fault Please contact after sales service E 63 Error Internal fault Please contact after sales service E 64 Alert Internal fault Please contact after sales service E65 Error Internal fault Please contact after sales service E 90 Alert Internal fault Please contact afte
130. ion in compliance with Article 12 of the said directive must be provided For components without CE approval a conformity assessment procedure is obligatory If you combine the Ziehm 8000 with equipment which does not comply with these requirements the safety of the entire system is no longer given and the warranty will become invalid Please note that a combination with third party devices must be approved by Ziehm Imaging A combination must be possible in particular by the intended use of the two devices The system is not suitable for interventional procedures acc to IEC 60601 2 43 Only properly trained personnel are allowed to operate the system Operation Ziehm 8000 3 1 P_26376 CD_28210 EN 01 07 2010 3 Safety Instructions Operation USA Assembly and service 3 2 General X rays The system may only be operated by properly trained personnel under the direction of a physician Only authorized personnel are allowed to assemble the system and to provide technical service The necessary qualifications can only be obtained by attending a training course provided by the manufacturer BGAUTION CAUTION Always observe the relevant regulations of the country of installation for putting the system into service training of personnel and maintenance WARNING Never use the system if you suspect any electrical or radi ation generating components to be defective or if the system exhibits
131. isappears automatically 16 14 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 System Configuration To set the screen backlight brightness do the following Backlight brightness e Press the key sequence MENU SCROLL MENU The OSD Onscreen Display appears on the screen E MENU SCROLL picture X brightness 123 Emm Q contrast 123 En B h position 123 m options 1 v position 123 HE amp phase 123 SSD options 3 re ibn 2 gy frequency 1234 QED scaling one to one aIL adv scaling press lt gt to select Fig 16 8 Onscreen Display e Press the SCROLL key three times The options 1 submenu is highlighted in white SCROLL e Press the MENU key The first function in the options 1 submenu is selected MENU e Press the SCROLL key three times The Backlight cd m function is selected SCROLL e Press the or arrow key to increase or decrease the backlight brightness The settings become immediately active on the screen After a few seconds the control disappears automatically OC NOTE Lowering the backlight level will increase the backlight lifetime The factory set menu language is English Alternatively you can choose Setting the menu German as the menu language language To define the menu language do the following e Press the key sequence MENU SCROLL MENU The OSD Onscreen Displ
132. itching off in emergency situations 6 4 System date 16 5 System time 16 5 T Technical Data Laser A 47 VacuDAP C dose meter A 47 VacuDAP duo dose meter A 49 Temperature symbol 5 5 6 3 7 14 A 9 Text Automatically displayed 12 1 Editing 12 3 Entering 12 1 12 3 TEXT key 5 7 12 3 Thermal behavior 7 14 Thorax and Abdomen key 5 4 Total radiation time 5 5 7 13 Transport position C arm stand 4 7 Monitor cart 4 2 Tube current 5 5 7 2 7 4 15 2 Tube voltage 5 4 7 2 15 2 Two pedal foot switch 5 10 7 8 Assignment 5 10 Labels A 16 U USA Labels on the C arm stand A 23 Labels on the generator A 23 Labels on the image intensifier A 24 Labels on the monitor cart A 25 Labels on the two pedal foot switch A 26 USB stick Save image 9 19 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 vii Index V Vertical image reversal 5 3 Video Output 2 17 Signal 2 11 Socket 2 11 Video printer 5 1 5 7 7 12 Printing images 9 21 13 1 Virtual collimator 8 2 Voltage display 5 4 15 2 Voltage Setting key 5 2 7 5 15 2 W Windowing 5 7 8 4 Post windowing 11 4 Real time windowing 8 4 Step windowing 8 4 Windowing Settings 8 6 WNDW key 5 7 8 4 8 6 Worklist 10 2 Opening offline 10 2 Processing procedure steps 10 4 Time span 10 2 Writing Images to CD 9 20 X X ray symbol 5 5 6 3 7 9 7 13 A 1 X rays Initiating 7 8 Z Ziehm Compact Compact monitor 2 10 Dimensions A 39 Featu
133. key e Select the desired patient folder using the arrow keys e Press the Enter key e Select the desired image using the arrow keys e Press the Enter key The image is displayed at full size on the live screen e Press the ESC key The system returns to the patient folder level of the Mosaic menu e Select the desired second patient folder using the arrow keys e Press the Enter key e Select the desired second image using the arrow keys e Press key F1 Enlarge The second image is displayed at full size on the reference screen You may compare the two images now F4 Enlarge MOSAIC A A O DAN Q Q ZJ IS N gt V A gt ic lt Q Enlarge a Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 23 9 Data Management 9 24 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions 10 1 Prerequisites Depending on the DICOM classes integrated in the system gt Ch 2 3 p 2 4 you can use certain DICOM functions The system must be con nected to a DICOM network via cable or Wireless LAN for that purpose 10 2 Retrieving patient data from a DICOM server When creating a new patient folder gt Ch 9 2 1 p 9 2 you can retrieve the patient data from the DICOM server Query or Worklist To be able to retrieve patient data from a DICOM server the following Prerequisites prerequisites must be given The Ziehm 8000 must be connected to a DICOM server
134. lamp including software Video output for Ziehm Compact Ziehm Compact with adapter for lithotripter procedures Hand rail around the image intensifier handles at the bottom of the C arm Color coded brake handles Wireless LAN Software options DICOM 3 0 interface with support of Print Class Storage Class including multiframe capability Storage Commitment Class Media Class Worklist Class MPPS Class Query Retrieve Class and Verifi cation Class depending on the chosen system configuration Customer specific foot switch assignment 2 4 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 2 System Overview Measuring functions Radiography mode Memory capacity for 1 000 images Memory capacity for 5000 images Ziehm NaviPort 2D BrainLab 2 4 Optional accessories The following accessories are optionally available for the Ziehm 8000 Sterile disposable covers 3 part for generator C arm and image intensifier with spring clasp fastening Spring clasps for disposable covers Hand surgery table Universal film cassette holder Printer paper for Sony UP 990 and UP 970 Printer transparent film for Sony UP 990 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 2 System Overview 2 5 System components 2 5 1 C arm stand Ziehm 8000 Image intensifier with integrated CCD camera C arm handle C arm Swivel arm Horizontal car riage Lifting
135. lf and on the C arm stand 7 5 2 Screen display While radiation is active the current fluoroscopic image is displayed on the live screen When you terminate radiation by releasing the hand or foot switch the last fluoroscopic image remains displayed on the live screen Last Image Hold The image is marked by two small white rectangles in the upper part of the live screen This image remains displayed until it is replaced by a new fluoroscopic image When you terminate fluoroscopy the tube voltage and the tube current are stored and displayed on the C arm stand control panel During the exposure fluoroscopy or direct radiography the yellow radi ation indication lamp on the monitor cart and the X ray symbol on the C arm stand control panel gt Ch 7 10 1 p 7 13 are illuminated 7 6 Dose area product For each image that you generate and save to the active patient folder during a session the dose area product is measured and saved When you generate several images during a session and save them to the active patient folder the total dose area product for the active patient folder during the respective session is saved and displayed together with the image that was saved last The dose area product display is not updated for previously generated images Dose area product values from previous sessions are not taken into account in the current session either The dose area product is always displayed on the screen
136. n but also the greater motion blurring Independently of the filter presettings for certain anatomical programs gt Ch 16 6 2 p 16 24 you can decrease or increase the noise sup pression level with the F2 and F3 keys You can choose among the fol lowing noise suppression levels Level Screen display Meaning off N 0 no noise suppression low N 1 weak noise suppression medium N 2 medium noise suppression high N 3 strong noise suppression Table 8 2 Noise suppression levels To adjust the recursive filter level do the following e To decrease the noise suppression level press the F2 key When the low level has been reached the LED of the F2 key lights up F 2 e To increase the noise suppression level press the F3 key When the high level has been reached the LED of the F3 key lights up F 3 Ziehm 8000 8 9 P_26376 CD_28210 EN 01 07 2010 8 Adjusting Live Images 8 7 Image swapping 8 7 1 Ziehm 8000 Function How to proceed With the image swapping function you can move an image from the live screen to the reference screen and vice versa or ifthere are images on both screens swap them This allows you to view two different images side by side and to compare them Moving or swapping images is done with the Image Swapping key on the C arm stand or on the monitor cart NOTE The image swapping key only affects images or empty screens It is not possible to move th
137. n fields automatically show the data that has been entered under Configuration Menu Basic Set tings gt Ch 16 3 p 16 5 if applicable You can overwrite this data when you create a new patient folder Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 3 9 Data Management Upper and lower case The alphanumeric keypad allows you to enter data in upper or lower case To enter the data for a new patient folder do the following Press the NEW PAT key The Patient Data Input menu appears on the reference screen The cursor is in the Patient name field when the menu opens The Patient name field shows a generated name You can overwrite this data Move the cursor to the desired menu item or text position within a field using the arrow keys Enter the personal data of the patient using the alphanumeric keys The data is displayed by default in upper case letters To enter lower case letters press function key F6 abc prior to each letter The length of the patient number must not exceed 30 digits Save your input by pressing function key F1 Save If you do not enter a patient number in the Patient no field the system automatically generates and saves a patient number The newly created patient folder is automatically activated in the Mosaic menu A blank fluoroscopy mask with the new patient data appears on the live screen Ziehm 8000 P_26376 CD_28210 EN 01 07 20
138. n the back of the monitor cart gt Fig 2 2 p 2 7 or gt Fig 2 3 p 2 7 Wind the coupling cable onto the upper cable support on the back of the monitor cart gt Fig 2 2 p 2 7 or gt Fig 2 3 p 2 7 If applicable disconnect the equipotential grounding cable from the system ground Unlock the parking brake by raising the locking levers on the front wheels with your foot AUTION aeauTion CAUTIO Do not move the system over floors with an inclination of more than 10 from level during transport This applies to both the C arm stand and the monitor cart Exercise extreme caution when moving the C arm stand and the monitor cart over rough surfaces such as tile flooring pavement asphalt or carpet Take care that the cable guards do not drag and the wheels do not catch or tilt causing damage to the equipment Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 4 Mechanical Handling mcan AUTION When transporting a Ziehm Compact or Ziehm Compact with adapter for lithotripter procedures make sure that the monitor support arm is securely locked in position and does not move sideways in order to avoid injury to persons or damage to the equipment or to property 4 2 Braking and steering the monitor cart The monitor cart parking brakes are controlled by two foot operated Parking brake locking levers which are integrated into the front wheels The monitor cart parking brakes operate as follow
139. nels C arm stand 5 1 Monitor cart 5 6 Coupling cable 4 1 4 2 6 1 Crosshair 14 2 16 3 Current display 5 5 D DEL key 5 7 12 4 Delete key 12 4 Deleting Auto delete function 9 1 Hard disk 16 6 Image 9 19 Measured values 11 6 NO NAME folder 16 6 Patient folders 9 13 9 14 Text input 5 7 12 4 USB stick 16 6 DICOM DICOM classes 2 2 DICOM Dir 10 10 DICOM format 16 4 Importing images and cine loops 10 6 MPPS 10 4 Query 10 1 10 2 Retrieve 10 6 Second DICOM storage server 2 2 Settings 16 27 Storage Commitment 10 21 Worklist 10 2 10 3 10 4 DICOM network printer Printing images 10 18 DICOM server Save image 10 14 Dimensions C arm stand A 37 Monitor cart with flat screen monitors A 38 Tolerances of C arm movements A 37 Ziehm Compact A 39 Ziehm Compact with adapter for lithotript er procedures A 39 Direct radiography 15 7 Audible alarm 15 3 Exposure guide 15 4 Exposure time 5 5 15 3 Film cassette holder 15 7 Initiating 15 3 Interrupting 15 3 Total radiation time 5 5 Tube current 15 2 Tube voltage 15 2 Disinfection A 4 Displays Dose display 5 5 6 3 Exposure time 5 5 Malfunction messages 7 11 7 14 A 6 A 7 Radiation Time 5 5 7 13 Temperature symbol 5 5 6 3 7 14 A 9 Tube current 5 5 Tube voltage 5 4 15 2 X ray symbol 5 5 6 3 7 9 7 13 Disposable covers Attachment B 7 Sterile A 5 Documentation 13 1 Video printer 5 1 5 7 7 12 13 1 Dose display 5 5 6 3 7 14 Malfunction messages 7 11 7 14
140. new CD You can redisplay the images you have written to CD by means of the backup function on the Ziehm 8000 at a later moment This does not apply however to images you have saved using the menu command Mosaic gt Output gt CD gt Ch 9 3 6 p 9 15 You may also post process backed up images using the functions ofthe Post Processing menu gt Ch 11 p 11 1 but you cannot save the changes to the CD As long as you are viewing images that have been backed up to CD the fluoroscopy functions are inhibited When you attempt to initiate radi ation the alert message E101 appears on the dose display To view images that have been backed up to CD do the following e Insert the CD containing the backed up patient folders into the CD writer e Press the MENU key e Go to User Settings gt CD recall and activate the option On gt Ch 16 2 4 p 16 4 e Press key F1 Save e Press the MOSAIC key The patient folders which have been backed up to CD are displayed as a thumbnail mosaic on the reference screen You can search for patient folders activate them and display individual images gt Ch 9 3 p 9 7 MOSAIC F1 Backup Displaying backed up images MENU Hi Save MOSAIC Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 11 9 Data Management 9 3 3 Searching for patient folders Search criteria You can use the following criteria to locate a certain p
141. ngineer Ziehm 8000 16 27 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 6 5 Monitor calibration NOTE The settings in this menu must not be modified by any person other than an authorized service engineer 16 6 6 HEDIS data NOTE The settings in this menu must not be modified by any person other than an authorized service engineer 16 6 7 Software update NOTE The settings in this menu must not be modified by any person other than an authorized service engineer 16 28 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A A 1 Regular checks A 1 1 Routine checks to be performed by the user The following safety checks must be performed at regular intervals Check Interval Remarks Generator Monthly Inspect for physical damage Radiation switches Monthly Must initiate radiation only if pressed permanently Releasing them must terminate radiation after 1 s max depending on the LIH filter settings Radiation signals Monthly During exposure the yellow radiation indication lamp on top of the monitor housing and the X ray symbol on the C arm stand control panel must be lit Audible alarm Monthly Must sound in direct radiography mode during the whole exposure time and in fluoroscopy mode at 5 min intervals Information labels Monthly All warning and information labels must be properly attached and easily legible Power
142. ngle images or cine loops These series may have been gen erated by different types of imaging equipment Fig 10 3 Hospital ST FRANCIS Physician DR WONDER Department ENDOSCOPY Patient name ZIEHM DEMO 10 First name TAMMY Date of birth 21 10 1968 Sex F Patient number 11 Keywords ERCP Note Study date Study time Study id 4 7 Oct 1998 10 05 48 1000 1201608 199 2 10 Jun 1998 14 22 46 1808 1201608 199 study description PANCREATITIS referring physician accession number no referring physician F5 Retrieve F6 Back Mosaic menu study level query retrieve e Press key F6 Back The Patient Data Input menu is displayed on the screen or e Select a study using the arrow keys e Press key F5 Retrieve ES Retrieve A lt l gt Vv F5 Retrieve Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 7 10 DICOM Functions F6 Back gt F2 Mark sa 3 lt gt V res Series e 4 RS Retrieve The single images which are available on the DICOM server under the selected study are displayed as a list Images which belong to the same series have identical series numbers Hospital Study date 87 Oct 1998 ST FRANCIS study time 10 05 48 Physician study id 1000 1201608 199 DR WONDER study_accession Department ENDOSCOPY Modality Series No Image No Patie
143. ning 9 9 Prefilled fields 9 3 Searching 9 12 Patient number Length 9 2 POST PROCESS key 5 7 11 1 Post Processing menu 5 7 11 2 Post processing 5 7 11 2 Edge filter 11 2 Grayscale Inversion 11 4 Rotation 11 3 Windowing 11 4 Zoom 11 3 Power cable 4 1 4 2 6 1 6 2 A 1 PRINT key 5 1 5 7 7 12 13 1 Printer media Paper 2 4 3 6 Transparent film 2 4 Printing Images on DICOM network printer 10 18 Images on video printer 7 12 9 21 11 2 13 1 Protecting 9 18 Protective grounding 3 4 Q Query 10 1 10 2 R Radiation indication lamp 7 9 7 13 A 1 Radiation protection Laser radiation 3 5 14 1 X rays 3 2 Radiation Time display 5 5 7 13 Reset 5 1 5 5 7 13 Radiography key 5 2 15 2 Recursive filter 8 9 16 3 16 25 16 26 Reference length 11 6 Reference object 11 7 Reference screen 2 10 16 5 Reset Audible alarm 5 1 7 13 Display radiation time 5 1 5 5 7 13 Dose display 5 1 5 5 6 3 7 13 Retrieve 10 6 Image level 10 8 10 9 Series level 10 8 10 9 Study level 10 7 10 11 Return key 5 6 Reversal Horizontal 5 3 8 8 Reverse Left Right 5 3 8 8 Reverse Up Down 5 3 8 8 Vertical 5 3 8 8 Reverse left right button 5 3 Reverse Up Down key 5 3 Rotate Slot Collimator Left key 5 2 Rotate Slot Collimator Right key 5 2 S Safety Instructions Electromagnetic compatibility 3 4 Environmental compatibility 1 1 Equipotential grounding 3 4 General 3 1 Laser radiation 3 5 Protective groun
144. nloaded into the Ziehm 8000 file system appears on the screen Hospital Study_date 87 Oct 1998 ST FRANCIS study_time 10 05 48 Physician study id 1000 1201608 199 DR WONDER study accession Department ENDOSCOPY Modality Series No Image No Patient name 4 KA 1201608 a ZIEHM DEMO 18 2 KA 1201608 8 First name TAMMY Date of birth 24 10 1968 Sex F Patient number 44 Keywords ERCP Note image comment image date 87 Oct 1998 image time 10 05 48 image converted ZIEHM F2 F3 F5 F6 Mark Series Retrieve Back Fig 10 5 Mosaic menu series and image level query retrieve with status flag On the live screen the previously selected image is displayed From this submenu you can download further series and single images from the DICOM server into the Ziehm 8000 file system Repeat the above steps to do so All series and single images which have been downloaded additionally to the Ziehm 8000 file system are equally identified by a check mark in the submenu on the screen e Press key F6 Back The study level query retrieve menu is displayed on the screen gt Fig 10 3 p 10 7 F6 Back Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 9 10 DICOM Functions 10 5 Importing DICOM images from a storage medium DICOM Dir Function You can import images that have been saved to CD or USB stick in DICOM format
145. nnection 1 A 2 D ZIR Art No 10 2965 ZIN Art No 58338 24 Protection Class I Type B 1 A ZIR Art No 10 1881 ZIN Art No 58330 d IDES OUT ZIN Art No 58467 1 50Hz D Systems with DICOM option and RJ45 1 DICOM connection only connection optionally either in the upper or lower half of the monitor cart ZIR Art No 10 2969 ZIN Art No 58459 33 F Values for 1 ziehm imaging MOBILE C ARM Ba Ziehm 8000 MOBILE C ARM MONITORS A A MANUFACTURER CE 1275 for Europe only ZIEHM IMAGING GMBH DONAUSTRASSE 31 90451 N RNBERG Germany DATE OF MANUFACTURE Rating label no TS04_042 TS04_036 China D R F China only 1 ziehm imaging Values for MOBILE C ARM Bast cmr xn CE1275 Ziehm 8000 ER HUM 220V 10 50 60Hz 1Hz B mane ee 8A continuous 15A momentary lass E z C REGNO See L 16A WAGE T ZIEH IMAGING MBH Rating label no TS04_034 Bee MADE IN GERMANY BA al Table A 4 Labels n a for USA cont A 20 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A No Label Comments Qa Optional foot switch pedal assignment 1 Fluoro Store Function Initiate radiation Save 2 Background color white ZIN Art No 58371 b Optional foot switch pedal assignment 1 Fluoro Store Function Initiate radiation Save 2 Background color transparent ZIN Art No 58372 a Optional foot switch pedal assignment 1 Fluoro Function
146. nnnennnnnnnnnennenennnn nen 11 8 4 4 point measurement 444444snnsnennennnnnennnennnnne nennen nen Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Contents 12 Displayed Texts and Text Functions 12 1 12 1 SOVGIVIGW a didi kennen nde eee 12 1 12 2 Automatically displayed text information cccececesseeeee eee teeeeeeeettteeeeerens 12 2 12 2 1 Upper left corner of the live screen 00 0 cceeeeeeeeeeeeeeeceeeeeeeteeeeeeteees 12 2 12 2 2 Upper right corner of the live Screen eececeeeceeeeeeeeeeeeteteees 12 2 12 2 3 Lower left corner of the live screen ee eeeeeeeeeenteeeeeeeeneeeeeeenaaes 12 2 12 2 4 Lower right corner of the live screen uuussssssnnnnnesnnnnnnnnennnnen 12 3 12 3 Manual text annotation and editing rr444nennssnnnnnnnsnnnnnnnnnnnnnnnnnn nn 12 3 13 Image Documentation 13 1 13 1 Overview eiin einlesen 13 1 13 2 Printing on video PIME iranu a T A T 13 1 14 Laser Positioning Device 14 1 14 1 OVO EW aaie A E EEE E EE 14 1 14 2 VAPPIICATONS T 04H re r a aan en ferne T E keane A A 14 2 15 Direct Radiography 15 1 19 1 Overview nannten eek A ERAT 15 1 15 2 Fitting the film cassette holder 444444snnnnnnnnnnnnnnnnnsnnnnnnnnnnnnnnnnnn nn 15 1 15 3 Activating the direct radiography mode 0 ccecceeeeeeeeeeneeeeeeeeteteeeeeeetiaeeeeeees 15 2 19 4 MIM SIZ eck see Aas senkt erlernt tage N 15 2 15
147. node material Tungsten Total filtration gt 3 9 mm Al equivalent Cu gt 0 1 mm Maximum X ray tube loading factors for 1h 3 mA at 110 kV 10800 mAs h Table A 8 Systems with a voltage rating of 220 V 230 V 240 V cont A 46 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A A 10 2 Laser positioning device Laser Class Class 2M acc to IEC 60825 1 Max power output of lt 1mW continuous laser radiation measured at the laser beam apertures Wavelength of the radiation 635 nm Table A 9 Technical data of laser positioning device A 10 3 Dose meter A 10 3 1 VacuDAPC Additional absorption 3 mm Al Sensitivity gt 700 pC mGy cm 75 kV 2 7 mm Al HVL Measuring range of DAP power 0 1 10 mGy cm s Voltage range 40 150 kV Voltage correction Fig A 26 p A 48 Aluminum equivalent lt 0 4mm Table A 10 Technical data of VacuDAP C dose meter Ziehm 8000 A 47 P_26376 CD_28210 EN 01 07 2010 Appendix A Voltage correction Additional absorption 3 mm Al filtration Correction factor 0 5 40 50 60 70 80 90 100 110 120 130 140 150 U kV Fig A 26 Voltage correction of VacuDAP C dose meter A 48 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A A 10 3 2 VacuDAP duo
148. nputs Display settings Picture e g vertical position horizontal position sharpness scaling Gamma Menu setup Setup e g menu lock exception language setting 16 5 2 Setting the brightness contrast and backlight Brightness Contrast To set the screen brightness do the following e Press the Brightness Contrast key The Brightness control appears on the screen e Press the or arrow key to increase or decrease the screen brightness The settings become immediately active on the screen After a few seconds the Brightness control disappears automatically To set the screen contrast do the following e Press the Brightness Contrast key twice 16 18 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 System Configuration The Contrast control appears on the screen e Press the or arrow key to increase or decrease the contrast The settings become immediately active on the screen After a few seconds the Contrast control disappears automatically To set the screen backlight brightness do the following Backlight e Press the Brightness Contrast key three times The Backlight control appears on the screen e Press the or arrow key to increase or decrease the backlight The settings become immediately active on the screen After a few seconds the Backlight control disappears automatically NOTE Lowering the backlight l
149. nt fire or electric shock the system must not be exposed to rain or moisture The system must not be operated next to flammable anesthetic gas mixtures of air oxygen and nitrogen oxides Menu displa NOTE pay The menu display for setting the brightness and contrast is not locked Do not change the values in order to ensure optimum display settings Ziehm 8000 16 13 P_26376 CD_28210 EN 01 07 2010 16 System Configuration Built in keypad Each flatscreen monitor has a built in keypad with four keys which are used for accessing the screen setting menus e000 MENU SCROLL Fig 16 7 Built in keypad of the flatscreen monitor Brightness To set the screen brightness do the following e Press the SCROLL key The Brightness control appears on the screen SCROLL X brightness 123 n e Press the or arrow key to increase or decrease the screen gt brightness The settings become immediately active on the screen After a few seconds the Brightness control disappears automatically Contrast To set the screen contrast do the following e Press the SCROLL key twice The Contrast control appears on the screen SCROLL contrast 123 3 e Press the or arrow key to increase or decrease the contrast gt The settings become immediately active on the screen After a few Fr seconds the Contrast control d
150. nt name Mp4 RA 1201608 ZIEHM DEMO 18 2 HA 1201608 8 First name TAMMY Date of birth 21 19 1968 Sex F Patient number 1 Keywords ERCP Note series description PANCREATITIS image comment no image comments image SOP instance UID 2 16 848 1 113669 632 6 1 1808 1281688 19981897 1188548 58 status online F2 F3 F5 Fe Mark Series Retrieve Back Fig 10 4 Mosaic menu series and image level query retrieve e Press key F6 Back The study level query retrieve menu appears on the screen or e Toimporta series select an image or an image series using the arrow keys or Mark the single images and or cine loops you want to import with key F2 Mark e To import a series press key F3 Series The series in which an item is highlighted by the cursor is downloaded to the Ziehm 8000 file system even if other series are marked or e To import single images or cine loops press key F5 Retrieve All marked single images are imported into the Ziehm 8000 file sys tem AUTION meoo CAUTIO Do not switch off the system during image data transfer You can download images with a size of up to 27 MB from the archive The transfer time depends on the network interface card and the network load 0 8 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions A submenu with check marks next to the series and single images which have been dow
151. ntary Power supply in standby mode approx 370 VA approx 1 6 A E The values depend on the integrated documentation systems a Power input fuse 15 A slow N Maximum line lt 0 60 impedance Equipment Protection Class I Type B ordinary equipment continuous protection operation classification Radiation controlled area with generator in lowermost position and C arm vertical 15 cm image intensifier 3 m 23 cm image intensifier 4 m Power Direct radiography 40 110 kV 20 mA 0 1 4s 5 Fluoroscopy g 40 110 kV S 0 1 6 mA 9 Digital radiography snapshot 40 110 kV 8 mA 1s Operating 20 kHz frequency Table A 8 Systems with a voltage rating of 220 V 230 V 240 V Ziehm 8000 A 45 P_26376 CD_28210 EN 01 07 2010 Appendix A Max operating data Fluoroscopy 110 kV 6 mA Direct radiography 110 kV 20 mA Digital radiography 110 kV 8 mA Systems with a voltage 220 Vac 10 230 Vac 10 frequency rating of 50 60 Hz 50 60 Hz 240 Vac 10 50 60 Hz Max power output Fluoroscopy 660 W 110 kV 6 mA Direct radiography 2200 W 110 kV 20 mA Digital radiography 880 W 110 kV 8 mA Nominal electric power 2000 W at 100 kV 20 mA 0 1 s Generator X ray tube Dual focus stationary anode tube Focal spot nominal size in relation to reference axis Fluoroscopy 0 5 acc to IEC 336 Direct radiography 1 5 acc to IEC 336 Anode angle in relation to reference axis 12 A
152. onitors u 42 44444ensssnnnnnnnnnnnnnnnnns nn 16 7 16 4 1 Flat screen monitors of type 1 uunssnennnnnnnennnnnnnnnnnnnnnnnnnnnnn 16 8 16 4 2 Flat screen monitors of type 2 nnessennssennnnnnnennnnnnennnnnnnnn nenn 16 13 16 5 Monitor settings for 24 flat screen monitorS 2 0 0 2 eee eeeeeee sn nnnnnnnnnnnnnnnn nn 16 17 16 5 1 Overview aehneigenllingehlan 16 17 16 5 2 Setting the brightness contrast and backlight 16 18 16 5 3 Setting the menu language eee ceeeeeeeeeeeeeteeeeeeeetaeeeeeeetaeeeeeeeeaas 16 20 16 5 4 Restoring the factory settings snennnnnnnennnnnnnnnnnnnennnnnnnnn 16 21 16 6 Service settings a nnd 16 22 16 6 1 Step windowing isai sraa ean aa a A aeS 16 23 16 6 2 Filler factors ee es rn 16 24 16 6 2 1 Filters for anatomical programs u seen 16 25 IV Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Contents 16 6 3 DICOM Settings on rnei a A nia a 16 27 16 6 4 System Settings nsee iais raa etinis aA RT AE E iS ri 16 27 16 6 5 Monitor calibration cc ccccecceceeeeeeeeeeecnceeaeceeeeeeeeeeeeeeesensenniaeeees 16 28 16 6 6 HEDIS dataz w c nanan ee ee ae 16 28 16 6 7 Software update unuunssseeennennennennnnennnnnnnnennnnnnennnnennennnnn 16 28 Appendix A A 1 Ade Regular checks i un ian as a ates eee a A 1 A 1 1 Routine checks to be performed by the user s es A 1 A 1 2 Consistency
153. operating modes functions Cross references Italic preceded by an arrow Ch 16 p 16 1 Procedure steps Preceded by a e e Press the OK but ton Text input Courier bold Administrator Table 1 1 Notations and formats used in these Operating Instructions Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 1 General Information un 2 Conventions for safety instructions The present document does not constitute a complete catalog of all safety measures necessary for the operation of the respective medical equipment since special operating conditions may require further mea sures However it does contain instructions which must be observed in order to ensure the personal safety of operating staff and patients as well as to avoid damage to property These instructions are highlighted as follows na DANGER indicates a hazardous situation which if not avoided will result in death or serious injury WARNING WARNING indicates a hazardous situation which if not avoided may result in death or serious injury CAUTION CAUTION indicates a hazardous situation which if not avoided may result in minor or moderate injury Metis NOTICE NOTICE indicates a property damage message NOTE Notes are merely informative Additional useful infor mation and hints are provided for the operator here Pi Pi Ziehm 8000 1 3 P_26376 CD_28210 EN 01 07 2010
154. orklist You can retrieve a specific Worklist from the DICOM server The Worklist contains the patient data as well as the examinations which are scheduled for the patient By default the data and examinations of all patients who have been scheduled for the entire current day 0 00 to 24 00 o clock are retrieved This means that when you download a Worklist at 10 00 o clock it also shows the examinations which were scheduled for 9 00 o clock and which may have been postponed Basically you may have the time span adjusted to shorter intervals Please contact your your in house service engineer for that purpose In addition you may limit the Worklist contents to a certain patient pro vided that his her patient number is known to you Once you have downloaded the Worklist of the current day you can open it as often as you like even if the Ziehm 8000 is no longer connected to the DICOM server In this case the word OFFLINE appears in the Worklist on the screen When you try to open a Worklist in offline mode although no Worklist has been downloaded for the current day from the DICOM server yet the message No connection to server appears and no Worklist is dis played Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions maon CAUTION If you use the patient ID to search for a patient folder please verify the search result by checking the patient name It may happen occasionally that a patient ID
155. otripter proce dures e Press the PRINT key PRINT 7 10 Warning signals and malfunctions 7 10 1 Permanent warning during radiation Active radiation both during fluoroscopy and direct radiography is indi cated by two different visual alarms The yellow radiation indication lamp on the monitor cart is illuminated TIA The X ray symbol on the C arm stand control panel is lit 7 10 2 Interval warning during radiation During fluoroscopy the following occurs after each 5 minutes of elapsed total radiation time as indicated on the radiation time display on the Je C arm stand in An audible alarm sounds The red LED of the min key on the C arm stand starts flashing You now have two ways to proceed Switching off the warning signals e To switch off the audible alarm briefly press the min key on the C arm stand The LED of the min key continues flashing and after another 5 minutes of radiation time the audible alarm starts sounding again etc AUTION meam CAUTIO If you do not acknowledge the audible alarm at the latest after 30 s with the min key radiation will be terminated automatically e To start a completely new radiation cycle press and hold down the min key on the C arm stand for at least 3 s At the same time the radi ation time display and the dose area product display if enabled on the C arm stand are reset to zero Ziehm 8000 7 13 P_26376 CD_28210 EN 01 07 2010
156. pe of validity of these Operating Instructions For several system options separate operating instructions may be Separate operating available They are supplied with the system provided that the system instructions configuration includes the respective option You will find a corre sponding reference to those operating instructions in the relevant sec tions of this document The system does not produce any waste during operation Environmental When the system has reached the end of its useful service life the rel compatibility evant waste disposal regulations of the country of installation must be observed Ziehm Imaging GmbH takes back your devices and undertakes to dispose of them appropriately in accordance with national regulations If you want to return a device please contact the Ziehm Imaging Service department The useful service life defined for this medical device is seven years For this period Ziehm Imaging GmbH warrants that spare parts can be sup plied After this period Ziehm Imaging GmbH must check whether the technology used is appropriate Ziehm 8000 1 1 P_26376 CD_28210 EN 01 07 2010 1 General Information 1 1 Typographical conventions In these Operating Instructions the following notations and formats are used to highlight certain elements of the control panel or the documenta tion itself Element Format Example Control panel Bold Fluoro elements but tons tabs and boxes
157. pulse fluoroscopy and single pulse fluoroscopy Continuous fluoroscopy re PFS PFS FS Continuous pulse fluoroscopy Single pulse fluoroscopy ee ime of hand or foot switch actuation Fig 7 1 Continuous fluoroscopy continuous pulse fluoroscopy and single pulse fluoroscopy Anatomical pro All three fluoroscopy modes work with automatic exposure rate control grams AERC unless the user explicitly selects manual exposure rate setting gt Ch 7 3 p 7 5 The system automatically adjusts the tube voltage and the tube current taking into account the selected fluoroscopy program Ch 7 4 p 7 6 as well as the thickness and structure of the subject Automatic exposure rate control reduces the radiation burden of both patient and operating staff to a minimum and prevents overexposure of the screened body region 7 2 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 7 Standard Fluoroscopic Operations 7 2 1 Continuous fluoroscopy To activate the continuous fluoroscopy mode LED is lit press the con tinuous fluoroscopy key on the C arm stand To deactivate the con tinuous fluoroscopy mode simply select another mode LED goes out In continuous fluoroscopy mode radiation is active as long as you press the hand or foot switch Depending on the selected anatomical program gt Ch 7 4 2 p 7 6 certain filter factors can be preset for continuous fluoroscopy This is done under Configuration Menu
158. r positioning device only ZIR Art No 10 2957 ZIN Art No 58447 Table A 5 Labels USA cont A 28 P_26376 CD_28210 EN Ziehm 8000 h 01 07 2010 Appendix A No Label a ziehm imaging MODEL SERIAL NO LASER AIMING DEVICE COMPLIES WITH CDRH RADIATION PERFORMANCE STANDARDS 21 CFR SUBCHAPTER J AS OF DATE OF MANUFACTURE MANUFACTURER ZIEHM IMAGING GMBH DONAUSTRASSE 31 90451 N RNBERG Germany Comments Systems with laser positioning device only Values for MODEL Ziehm 8000 Ziehm Compact Rating label no TS04_053 MODEL SERIAL NO MONITOR CART LINE VOLTAGE LINE IMPEDANCE CURRENT INPUT MAIN FUSE DEGREE OF PROTECTION IP 20 MANUFACTURER ZIEHM IMAGING GMBH DONAUSTRASSE 31 90451 N RNBERG Germany MANUFACTURED MANUFACTURED b 7 R Systems with laser positioning device ziehm imaging only MODEL SERIAL NO Values for u MODEL INTEGRATED LASER COMPLIES WITH CDRH RADIATION PERFORMANCE Ziehm 8000 STANPARDS 21 CER SUBCHAPTER J AS OF DATE Zieh m Compact ZIENM IMAGING GMBH Rating label no TS04_054 DONAUSTRASSE 31 90451 N RNBERG Germany MANUFACTURED a Values for ziehm imaging MOBILE C ARM Ziehm 8000 Ziehm Compact LINE VOLTAGE 120 V 10 50 60Hz LINE IMPEDANCE lt 0 6 Ohm lt 0 3 Ohm CURRENT INPUT 14 A continuous 22 A momen
159. r sales service E 91 Alert Internal fault Please contact after sales service E 92 Alert Radiation warning lamp on Please contact after sales the monitor cart defective service E 93 Error Internal fault Please contact after sales service E100 Error Internal fault Please contact after sales service E101 Alert CD Recall is selected Deactivate CD recall under fluoroscopy inhibited Configuration Menu gt User Settings E102 Error Internal fault Please contact after sales service Table A 3 List of error and alert messages cont Ziehm 8000 A 11 P_26376 CD_28210 EN 01 07 2010 Appendix A Code Type Description Measures E105 Alert Not enough hard disk Delete a protected patient folder space available for after unprotecting it with the key operation combination Shift F4 Perform a backup gt Ch 9 3 2 p 9 10 of the hard disk as soon as possible and then delete the backed up patient folders E106 Error Hard disk access error Please contact after sales ice The system continues to operate in restricted mode radiation can be initiated but no images can be saved E151 Alert Internal fault Please contact after sales service Table A 3 List of error and alert messages cont A 12 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Appendix A A 3 3 Mains fuse If the mains fuse on the monitor cart has triggered rocker switch in OFF position circuit breaker is not illuminate
160. r specific setup NOTE Due to background radiation the dose display on the C arm stand if enabled may indicate some small value after power up of the system To reset the display to zero press and hold down the min key on the C arm stand control panel for a few seconds NOTE As part of the power up sequence the radiation indication lamp may light up This is a system test and does not mean that radiation is released To switch on the system do the following e Press the ON switch The system is switched on The LED of the ON key illuminates The default settings after power up vary from system to system according to the customer specific setup 6 2 2 Switching off To switch off the system do the following e Press the OFF key on the monitor cart or C arm stand control panel The system switches off Any unsaved patient data and or images are lost Ziehm 8000 6 3 P_26376 CD_28210 EN 01 07 2010 6 Switching the System On and Off 6 3 EMERGENCY STOP button There is an EMERGENCY STOP button on both the C arm stand and the monitor cart of the Ziehm 8000 enabling you to switch off all electrical functions of the unit in case of emergencies To switch off the system in an emergency situation do the fol lowing e Fully press down the EMERGENCY STOP button The EMERGENCY STOP button is locked in this position The system switches off immediately All electrical functions of the system are dis
161. r the remaining disk space is sufficient for the next folder to be backed up If the folder is too large to fit on the disk in the CD writer you are prompted by a message to insert another CD into the CD writer The entire folder is then backed up to the new CD NOTE You can write a maximum of 1 000 images to one CD Since the contents of a patient folder cannot be dis tributed to several CDs it is not possible to back up patient folders which contain more than 1000 images You can back up only entire patient folders with all images contained in them You use the image creation date to determine which folders are to be backed up When you enter e g a period between 01 01 YYYY and 01 31 YYYY all patient folders containing images that were created between January 1 YYYY and January 31 YYYY are backed up These folders are backed up in their entirety including the images that were not generated within the specified period of time 9 10 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 Data Management To back up selected patient folders to CD do the following e Press the MOSAIC key e Insert an empty CD into the CD writer e Press key F1 Backup e Enter the desired start and stop date e Press key F6 Back All folders containing images that were generated within the specified period of time are backed up in their entirety A progress message is shown If applicable you are prompted to insert a
162. re time must be multiplied by 1 5 With cassette with 8 40 grid and SE 4 screen Skull p a 73 kV 1 35 Skull lateral 66 kV 0 8 s Paranasal sinuses p a 73 kV 2 58 Mandible lateral 60 kV 0 4s Rib 1 7 63 kV 0 8s Rib 8 12 70 kV 2 0s Sternum p a 63 kV 1 6s Clavicle p a 63 kV 0 4s Scapula a p 66 kV 0 75 Lung p a 60 kV 0 25 Lung lateral 73 kV 0 5s Kidney gall bladder a p 75 kV 1 8 s Kidney gall bladder lateral 85 kV 2 08 Urinary bladder 73 kV 2 58 Cervical vertebrae C1 C3 open mouth 60 kV 1 0s Cervical vertebrae C4 C7 a p 60 kV 1 2s Cervical vertebrae C1 C7 lateral 66 kV 0 4s Upper thoracic vertebrae a p 63 kV 1 6s Lower thoracic vertebrae a p 73 kV 2 08 Thoracic vertebrae lateral 70 kV 2 58 Lumbar vertebrae L1 L4 a p 73 kV 1 38 Lumbar vertebrae L1 L4 lateral 81 kV 3 08 Lumbar vertebra L5 a p 81 kV 1 75 Lumbar vertebra L5 lateral 90 kV 3 28 Pelvis hip a p 73 kV 1 58 Sacrum coccyx a p 77 kV 1 58 Sacrum coccyx lateral 85 kV 1 58 Femoral neck lateral 85 kV 1 55 Upper femur 70 kV 1 08 Lower femur 66 kV 0 68 Table 15 1 Exposure guide 15 4 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 15 Direct Radiography With cassette without grid and with universal screen Shoulder joint a p 66 kV 0 5s Shoulder joint axial 66 kV 0 7 s Upper arm a p l
163. rence screen 10 10 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions Then a list of the patients for which there are images on the storage medium is displayed on the reference screen Patient First name Patient number 1 DOE JOHN 123 2 THATCHER MARGARET TM45 F2 F5 Cancel Retrieve Fig 10 7 DICOM Dir list e Select the desired patient name using the arrow keys A lt gt V e Press key F5 Retrieve FS A patient folder is created and activated for the selected patient Retrieve The studies which are available on the storage medium for this patient are displayed as a list A study can contain several series consisting of single images or cine loops These series may have been gen erated by different types of imaging equipment Hospital Study date Study time Study id ST FRANCIS Physician 4 87 Oct 1998 19 05 48 1000 1201608 199 DR WONDER 2 10 Jun 1998 14 22 46 1908 1201608 199 Department ENDOSCOPY Patient name ZIEHM DEMO 18 First name TAMMY Date of birth 21 10 1968 Sex F Patient number 11 Keywords ERCP Note study description PANCREATITIS referring physician no referring physician accession number F5 Fe Retrieve Back Fig 10 8 Mosaic menu study level query retrieve Ziehm 8000 10 11 P_26376 CD_28210 EN 01 07 2010 10 DICOM Function
164. res the image intensifier may collide with the compact monitor if the latter has been moved to its maximum lateral position 225 Angulation brake brake handle optionally red Fig 4 4 Angulation of the C arm 4 8 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 4 Mechanical Handling 4 4 3 Swiveling panning You can swivel the C arm 10 to the left or to the right around the vertical axis of the lifting column NOTE On a Ziehm Compact with adapter for lithotripter proce dures swiveling panning of the C arm is not possible Swivel brake brake handle optionally green Fig 4 5 Swiveling panning of the C arm view from above Ziehm 8000 4 9 P_26376 CD_28210 EN 01 07 2010 4 Mechanical Handling 4 4 4 Horizontal movement You can move the C arm forward and backward by 22 cm in the hori zontal plane by means of the horizontal carriage A scale with 1 cm divi sions facilitates precise positioning NOTE On a Ziehm Compact with adapter for lithotripter proce dures swiveling panning of the C arm is not possible Horizontal movement brake Ale carriage brake u brake handle optionally yellow 22 cm gt pen z gt S o I AN ID Fig 4 6 Horizontal movement of the C a
165. res 2 1 2 3 Features for lithotripter procedures 2 3 Image swapping 8 10 Printing 7 13 Screen Selection 8 8 Transferring an image to the memory 7 12 Transport position 4 3 Two pedal foot switch 7 8 with adapter for lithotripter procedures 2 1 Ziehm Compact with adapter for lithotripter procedures Dimensions A 39 Transport position 4 3 Zoom 11 3 viii Ziehm 8000 P_26376 CD_28210 EN 01 07 2010
166. resolution mode of Function the flat screen monitor Further screen settings can be made directly atthe displays using a built in keypad Ae Fig 16 9 Monitor Settings menu on a Ziehm 8000 with 24 flat screen monitor When you choose the option Scaled resolution the fluoroscopicimages Scaled resolution and menus are displayed in the original resolution of the system When you choose the option Full size the fluoroscopic images and Full size menus are displayed so as to completely fill the left or right half of the screen Each flat screen monitor gt Fig 2 3 p 2 7 has a built in keypad with Built in keypad six keys which are used for accessing the screen setting menus 000000 INPUT MENU SCROLL Fig 16 10 Built in keypad of the flatscreen monitor Ziehm 8000 16 17 P_26376 CD_28210 EN 01 07 2010 16 System Configuration Screen settings On systems with flat screen monitors the screen settings are made directly on the monitors using a built in keypad You can change the following screen settings yourself Brightness Contrast Backlight Menu language for screen settings In addition you can restore the factory settings The factory set menu language is English Therefore the English desig nations are used in this document Please contact your in house service engineer if you wish to change any of the following screen settings Video source I
167. return to the parent menu To close a submenu and return to the parent menu you can also press the ESC key Post Processing Edge filter Rotation 70 Zoom 1 0 Invert Aus Windowing W 119 Measurements FA F2 F3 Save Cancel Print Fig 5 3 Example of how to use the menus General Navigation Submenus Selecting options Confirming the selected options Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 5 9 5 Controls 5 4 Hand switch and foot switch General The Ziehm 8000 is equipped with a hand switch and a two pedal foot switch Hand switch Fig 5 4 Hand switch Two pedal foot switch Fig 5 5 Two pedal foot switch Radiation is initiated either with the hand switch or the fluoroscopy pedal of the foot switch The default pedal assignment of the two pedal foot switch is as follows Left pedal Fluoroscopy Right pedal Save image NOTE The foot switch pedals can be assigned with customer specific functions If this is the case the respective func tions are indicated on labels on the foot switch itself and on the C arm stand 5 10 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 5 Controls The following table lists the labels which may appear on the foot switch Symbol Meaning Initiate Radiation Initiates radiation Image swapping Swaps the images between the live and reference screens Press bri
168. rks the exact measuring point and a flashing arrow is seen pointing to it e Move the marker square with the arrow keys pixel by pixel until you reach the desired starting point for the measurement Holding down an arrow key will speed up movement in the corresponding direction e Confirm the measuring distance starting point with the Enter key The arrow symbol on the marker square disappears and instead a 1 is displayed in its upper right corner At the same time a second marker square appears on the screen The two marker squares are con nected by a flashing white line symbolizing the distance to be deter mined e Move the second marker square with the arrow keys until you reach the desired final point of the measuring distance Ziehm 8000 11 9 P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images e Confirm the measuring distance final point with the Enter key The arrow symbol jumps outside the marker square and instead a 2 is displayed in its upper right corner The length appears automatically in the Length 1 field of the menu on the reference screen e Now you may correct the measurement if necessary To do so move the arrow symbol with the arrow keys to the desired position and confirm with the Enter key The nearest marker square jumps to the arrow symbol snap function Move the marker square with the arrow keys to the desired measuring point and confirm with the Enter key The corrected length appears
169. rm 4 10 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 4 Mechanical Handling 4 4 5 Vertical movement You can move the C arm up and down by 43 cm This movement is motorized On a Ziehm Compact with adapter for lithotripter procedures you can move the C arm up and down by 23 cm The Move Up Down keys are located in the upper left and right corner of the C arm stand control panel gt Fig 5 1 p 5 7 Al A CAUTION Before moving the C arm up or down make sure that it does not collide with any persons or objects Fig 4 7 Vertical movement of the C arm Ziehm 8000 4 11 P_26376 CD_28210 EN 01 07 2010 4 Mechanical Handling 4 12 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 5 Controls 5 1 C arm stand control panel GA F user og abe ana B ods Foy CHE yen mGyimin mGy onr 0 00 OA gi e Q PAN O O aN O o RSA METAL SOFT 2 v0867v GOO dp dp Fig 5 1 C arm stand control panel Symbol s Function Off Switches off the power supply of both system components ON Switches on the power supply of both system components _ Move up down v G x Control the vertical travel ofthe C arm min e min Resets the audible alarm short keystroke Resets the radiation time and dose displays to zero lon
170. rt Internal fault Please contact after sales service E 39 Alert Internal fault Please contact after sales service E40 Alert Internal fault Please contact after sales service E41 Alert Internal fault Please contact after sales service E42 Alert Internal fault Please contact after sales service E43 Error Dose meter check Repeat dose meter check VacuDAP VacuDAP C If the error message appears Value measured is outside f again contact after sales service the tolerance range E 44 Error Control connection to Please contact after sales monitor cart interrupted service Table A 3 List of error and alert messages cont Ziehm 8000 A 9 P_26376 CD_28210 EN 01 07 2010 Appendix A Code Type Description Measures E45 Error Internal fault Acknowledge error message by VacuDAP duo briefly pressing hand or foot switch E 46 Error During power up Acknowledge error message by Error in VacuDAP duo dose bueny pressing hand er Bat switch meter system During operation Press min key long keystroke Error in VacuDAP duo dose meter system E47 Error Measuring value limit of Press min key long keystroke 9999 9 cGy cm or 999 99 mGy has been exceeded If the measuring value limit for the air kerma rate 999 99 mGy min is exceeded during an exposure radiation is not interrupted The error number appears after radiation has been terminated It is not possible to re
171. rth 21 19 1958 Sex F Patient number Date 06 10 98 KV 45 kV Time 11 39 57 mA 1 8 mA Img no 2 HD 19 F1 F2 F3 F4 F5 Enlarge Mark Protect Delete Retrieve Output Fig 9 4 Mosaic menu image level patient folder active Ziehm 8000 9 9 P_26376 CD_28210 EN 01 07 2010 9 Data Management Thumbnail display Patient and image data The thumbnails shown are the original fluoroscopic images native images They do not reflect any modifications which may have been applied to them after fluoroscopy such as contrast adjustment rotation zoom Such modifications will not show up until you display the post pro cessed image at full size gt p 9 17 At the left side of the screen the patient data of the active patient folder is displayed i e the data which was entered in the Patient Data Input menu before gt Ch 9 2 1 p 9 2 The following information about the image marked by the cursor is dis played in an information field below the thumbnail mosaic Date and time of saving Image number kV value and mA value The percentage of total hard disk space currently used is also indicated 9 3 2 Backup to CD Storage capacity Selecting patient folders If your system is equipped with a CD writer you can back up selected patient folders to CD During backup the system checks automatically whethe
172. s FG Back or A lt gt V F5 Retrieve FG Back e Press key F6 Back The Patient Data Input menu is displayed on the screen or e Select a study using the arrow keys e Press key F5 Retrieve The single images which are available on the storage medium under the selected study are displayed as a list Images which belong to the same series have identical series numbers Hospital Study_date 07 Oct 1998 ST FRANCIS study time 19 05 48 Physician study id 1988 1201608 199 DR WONDER study accession Department ENDOSCOPY Modality Series No Image No Patient name MO 4 RA 14204608 0 ZIEHM DEMO 18 2 RA 1201608 9 First name TAMMY Date of birth 21 10 1968 Sex F Patient number 11 Keywords ERCP Note series description PANCREATITIS image comment no image comments image SOP instance UID 2 16 840 1 113669 632 6 1 1000 1201608 19981907 1190548 50 status online F2 Fa F5 Fe Mark Series Retrieve Back Fig 10 9 Mosaic menu series and image level query retrieve e Press key F6 Back The study level query retrieve menu appears on the screen or or A e Toimporta series select an image or an image series using the arrow l gt keys V or or F2 e Mark the single images and or cine loops you want to import with key F3 e To import a series press key F3 Series Series The series
173. s Locking levers lowered Front wheels are locked Locking levers raised Front wheels can move freely To steer the monitor cart use the two lateral handles Steering Ziehm 8000 4 3 P_26376 CD_28210 EN 01 07 2010 4 Mechanical Handling 4 3 Braking and steering the C arm stand Steering amp braking The C arm stand has a combined steering amp braking lever It is located lever at the rear end of the C arm stand gt Fig 2 1 p 2 6 Parking brake The C arm stand parking brake operates as follows Steering amp braking lever lowered Rear wheels are locked Steering amp braking lever raised Rear wheels can move freely Steering The C arm stand steering operates as follows e Lift the steering amp braking lever and turn it until reaching the desired position The lever can be turned freely however detents are placed at 90 increments The rear wheels will always stay parallel to one another aligned exactly in parallel with the steering amp braking lever To maneuver the C arm stand freely ensure that the steering amp braking lever has engaged in its central position pointing directly backward from the unit gt Fig 4 2 p 4 5 left Tomove the C arm stand in an exactly defined direction rotate the steering amp braking lever until it points toward the desired direction gt Fig 4 2 p 4 5 right e Push the C arm stand in the desired or predefined direction using
174. s above 40 C and relative air humidity above 60 may cause stains on the printer s heat sensitive paper Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 3 Safety Instructions maman CAUTION Misinterpretation of printer images Due to less resolution printer images may contain less information than the corresponding digital images Store digital images on a storage medium For evalu ation purposes always use the digital images too 3 8 Mechanics WARNING WARNING Never pull at the power cable or coupling cable of the monitor cart in order to move the cart to another position Otherwise severe equipment damage may result thus leading to severe injuries CAUTION Risk of stumbling due to improper cable laying This may cause obstructions to the operational proce dure gt Avoid laying cables on walking areas from and to the sys tem Avoid tension when laying the cables 3 9 System failure BGAUTION CAUTION The system is a highly complex medical device that in rare cases can fail like any other electrical device in spite of comprehensive tests and maintenance This may cause obstructions to the operational pro cedure Please keep an emergency plan ready for this case Ziehm 8000 3 7 P_26376 CD_28210 EN 01 07 2010 3 Safety Instructions BGAUTION CAUTION Data transmission of the system can fail This may cause obstructions to the operational pro
175. s and controls are displayed immediately in the chosen language e Press the MENU key The on screen menu disappears After having changed the screen settings you may restore the factory set values at any time language SCROLL MENU Restoring the fac tory settings Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 11 16 System Configuration To restore the factory settings do the following e Press the MENU key The on screen menu appears e Select the Defaults tab with the help of the or arrow keys DVI analog 1024 x 768 60 Hz Picture 7 Gamma Setup Defaults Factory Defaults e Press the SCROLL key The Factory Defaults item is selected SCROLL e Press the arrow key The on screen menu disappears All settings are reset to the factory values KO 16 12 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 4 2 Flat screen monitors oftype 2 Fig 16 6 Flatscreen monitor oftype 2 Safety measures nr The system may only be set up and put into service by service engineers who are authorized by the manufac turer If service is needed the system may only be repaired by authorized service engineers WARNING When the system is opened there is a risk of electric shock The system may only be opened by qualified service personnel To preve
176. s enables you to gather images from different patient folders in the compilation file and to write them to CD later in one go To write images to CD do the following e Press the MOSAIC key 9 20 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 Data Management Select the desired patient folder using the arrow keys Press the Enter key Select the desired image using the arrow keys Press key F2 Mark Repeat these two steps for any further image you want to save Insert a CD into the CD writer mounted in the monitor cart Press key F3 CD The following message appears on the screen Write images to CD To leave the marked images in the compilation file on the hard disk for the time being press the N No key ES EA kG i w L E J 6 amp a iis D F G H P_26376 CD_28210 EN 01 07 2010 or Ifv leE fs tie x ley ARE e To write the marked images to CD right now confirm by pressing the Y Yes key The marked images are written to CD Once they have been written to CD the images become unmarked 9 3 6 2 Printing images on video printer e Press the MOSAIC key O MOSAIC e Select the desired patient folder using the arrow keys A V e Press the Enter key e Select the desired image using the arrow keys A V Ziehm 8000 9 21 9 Data Management F2 Mark F4 Print e Press key F2 Mark e Repeat these two steps for any further image you w
177. s fluoroscopy Level 2 1 0 1 step f 2 continuous pulse fluo roscopy Snapshot Continuous Continuous pulse fluo 1 2 4 8 16 images pulse roscopy stack filter Snapshot Snapshot 1 2 4 8 16 images stack filter Table 16 2 Filters for anatomical programs cont The recursive filter adds the preset number of images during fluo roscopy whereby each newly acquired image is superimposed by the result of the previous addition with a certain weighting factor The higher the preset number of images the greater the noise suppression but also the greater motion blurring The values can be set independently for normal view magnification 1 and magnification 2 The values are displayed in the lower left corner of the live screen in the following form N 0 N 1 N 2 N 3 You can adjust the preset values during operation with the F2 and F3 keys on the C arm stand control panel gt Ch 8 6 p 8 9 The stack filter generates and adds the preset number of images after radiation has been terminated The higher the preset number of images the greater the noise suppression but also the greater motion blurring if the patient moves during image generation The edge filter is used for setting a greater or lesser degree of enhancement sharpening of edges within the image 4 levels of edge enhancement are available Level Meaning 0 No edge enhancement original fluoroscopic image 1 Slight e
178. s imperative that any change in C arm and or patient position is followed by a new calibration before acquiring new fluoroscopic images on which you intend to perform measurements To perform a calibration do the following e Screen the reference object The reference object must be in the same plane as the subject that you wish to measure subsequently e Press function key F6 Calibrate in the Post Measurements menu A small white marker square appears in the fluoroscopic image on the live screen In the center of the square is a flashing point which marks the exact measuring point and a flashing arrow is seen pointing to it On the reference screen the request Please mark the reference object is displayed F6 Calibrate F6 Calibrate Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images Move the marker square with the arrow keys pixel by pixel until you reach the first measuring point on the reference object e g the first radiopaque marker on a balloon catheter Holding down an arrow key will speed up movement in the corresponding direction Confirm the measuring distance starting point with the Enter key The arrow symbol on the marker square disappears and instead a 1 is displayed in its upper right corner At the same time a second marker square appears on the screen The two marker squares are con nected by a flashing white line symbolizing the reference length to be determined Move
179. se Iris Collimator 5 2 Key Close Slot Collimator 5 2 Key Continuous Fluoroscopy 5 2 7 3 Key Continuous Pulse Fluoroscopy 5 2 7 3 Key DEL 5 7 12 4 Key Enter 5 6 12 3 Key ESC 5 6 Key Exposure Time Setting 5 3 15 3 Key Extremities and Children 5 3 Key F 5 4 14 2 14 3 16 3 Key F2 8 9 Key F3 8 9 Key Head Spine and Pelvis 5 3 Key HOME 5 6 8 6 9 8 10 3 11 5 Key Image Swapping 5 4 5 7 Key LASER 5 4 14 1 Key Magnification 5 1 8 3 Key Manual Mode 5 2 Key MENU 5 7 16 1 Key METAL 5 4 7 7 Key min 5 1 5 5 6 3 7 13 Key MOSAIC 5 7 9 5 11 1 Key NEW PAT 5 7 9 4 9 6 10 2 10 3 10 4 Key OFF 5 1 5 6 Key ON 5 7 5 6 Key Open Iris Collimator 5 2 Key Open Slot Collimator 5 2 Key POST PROCESS 5 7 11 1 Key PRINT 5 1 5 7 7 12 13 1 Key Radiography 5 2 15 2 Key Return 5 6 Key Reverse left right 5 3 Key Reverse Up Down 5 3 Key Rotate Slot Collimator Left 5 2 Key Rotate Slot Collimator Right 5 2 Key Select Left Screen 5 3 Key Select Right Screen 5 3 Key Shift 5 7 12 3 Key Snapshot 5 2 7 4 Key SOFT 5 4 7 6 Key Space 5 8 12 4 Key TEXT 5 7 12 3 Key Thorax and Abdomen 5 4 Key Voltage Setting 5 2 7 5 15 2 Key WNDW 5 7 8 4 8 6 Key switch 6 5 Power on 6 5
180. se two steps for any further image you want to print or or e To mark all images in the patient folder press the key combination F2 e Press key F6 Output F6 The function keys for selecting the output target appear on the screen Output Hospital ROTI ST FRANCIS Physician DR WONDER Department ENDOSCOPY Patient name ZIEHM DEMO 24 mn gt F N First name ALFRED N Date of birth b 4 12 89 1924 NN 4 Sex M Patient number 25 Keywords ERCP Note Date 25 09 04 kV 57 kV Time 18 33 14 mA 2 7 mA Img no 1 41 cGycm2 HD 15 Fa F2 F3 F4 F5 F6 Print USB cD Net Store NetOutput Back Fig 10 14 Mosaic menu image level Output submenu e Press key F5 NetOutput F5 The marked images are printed on the DICOM network printer NetOutput Ziehm 8000 10 19 P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions or If the User Configuration function has been enabled gt p 10 18 the Printer configuration menu is displayed MR Printer configuration Number of copies 4 Film destination PROCESSOR Film session label ZIEHM Film size ID Number Page 4 Server Number 2 Fa F5 Cancel NetOutput Fig 10 15 Printer configuration submenu 1 IF IF F f Ef e Make the desired settings or F5 e Press key F5 NetOutput NetOutput The mark
181. side of the C arm stand and lock the connector by pulling the locking lever upward gt Fig 2 1 p 2 6 e Make sure that a suitable supply voltage is available and that the socket outlet is properly grounded and fused e Check the power plug on the monitor cart power cable gt Fig 2 2 p 2 7 and the socket outlet for compatibility e Connect the system to the power supply e Make sure that the inclination of the system does not exceed 5 from the level in operating position e Put on suitable protective clothing e DICOM Connect the DICOM port s on the back of the monitor cart to a DICOM network socket using the appropriate cable s Ziehm 8000 6 1 P_26376 CD_28210 EN 01 07 2010 6 Switching the System On and Off Ziehm Compact To prepare a Ziehm Compact or Ziehm Compact with adapter for Ziehm Compact lithotripter procedures do the following with adapter for lithotripter proce dures e Unwind the power cable from the combined foot switch power cable support located at the side of the C arm stand gt Fig 2 4 p 2 8 e Plug the power cable connector into the socket located at the side of the C arm stand and lock the connector by pulling the locking lever upward e Make sure that a suitable supply voltage is available and that the socket outlet is properly grounded and fused e Check the power plug and the socket outlet for compatibility e Connect the system to the power supply e Make sure t
182. sired patient folder using the arrow keys N gt v F2 e Press key F2 Mark e Repeat these two steps for each patient folder you want to delete F4 e Press key F4 Delete The following confirmation prompt is displayed Really delete patient folder e Confirm by pressing the Y Yes key The marked patient folders are deleted from the hard disk If one of the patient folders contains protected images only the unprotected images will be deleted and the message Folder is delete protected appears on the screen 9 3 5 Inverting the grayscale of the entire image archive If you are used to viewing negative images for instance if you are a radi ologist you can invert the grayscale of all images on the hard disk in one step Images that have already been saved with a negative grayscale remain the way they are To invert the grayscale of all images or to undo the grayscale inversion do the following e Press the MOSAIC key MOSAIC F3 e Press key F3 Inv Docu Inv Docu The grayscale of all images on the hard disk is inverted In the mosaic view the images are always displayed with a positive grayscale The negative grayscale will not become visible until you display an image at full size Key F3 Norm Docu appears on the screen 9 14 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 Data Management e Exit the MOSAIC menu or e Press key F3 Norm Docu F3 The grayscale inversion of all ima
183. sition within the text A annotation area l gt With the key combination Shift tarrow keys you can move the entire v text block you have entered to any desired position With the alphanumeric keys you can enter any character at the position f of the flashing cursor Any existing character at this position will be over i IE IF E E written DE 7 T 1 JH Pressing the Shift key plus another key on the alphanumeric keyboard simultaneously generates the upper character on the respective key fi Pressing the Enter key moves the cursor to the beginning of the next line Ziehm 8000 12 3 P_26376 CD_28210 EN 01 07 2010 12 Displayed Texts and Text Functions n 5 DEL The Space key generates a blank space at the cursor position Any existing text will be overwritten when you enter a blank space at its position The Shift Space key combination deletes the character to the left of the cursor Pressing the DEL key deletes the entire text block you have entered even after saving and reopening the image 12 4 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 13 Image Documentation 13 1 Overview An image documentation system can be incorporated into the monitor cart A video printer can be accommodated in the mounting frame below the control panel On a Ziehm Compact or a Ziehm Compact with adapter for lithotripter procedures a small video printer is mounted at the side of the monitor
184. ss 2M according to IEC 60825 1 Please observe the provisions of IEC 60825 1 Section 3 User s Guide for operation of the laser positioning device Viewing the laser output with certain optical instruments e g eye loupes magnifiers and microscopes within a distance of 100 mm may pose an eye hazard CAUTION USA LASER RADIATION DO NOT STARE INTO BEAM CLASS IILASER PRODUCT in accordance with FDA 21 CFR Subchapter J Section 1040 10 11 Ziehm 8000 3 5 P_26376 CD_28210 EN 01 07 2010 3 Safety Instructions Maintenance The laser positioning device is maintenance free Any adjustment or repair which might become necessary must be carried out by the manu facturer or a suitable qualified service engineer who has received appro priate training from the manufacturer Laser beam apertures 4 Ve Laser beam apertures Fig 3 1 Laser beam apertures on an image intensifier with inte grated laser positioning device left and on the generator right 3 7 Printers NOTICE NOTICE When printing on the Sony UP 990 video printer always use the CUT button on the printer for cutting off the printer paper Tearing off the printer paper may damage the video printer As opposed to that on the Sony UP 970 and UP 897 video printers you must tear off the printer paper Please refer to the Operating Instructions of the corre sponding printer NOTICE NOTICE Temperature
185. surements Fig 11 1 Post Processing menu Fi Function key F1 Save saves the modified image parameters to a sep Save arate file The saved original fluoroscopic image remains unaltered F2 Function key F2 Cancel discards all changes made in this session Cancel F3 Function key F3 Print prints the post processed image on the video Print printer mounted in the monitor cart 11 3 Edge enhancement The Edge filter menu item allows you to adjust the edge sharpness of the saved image with one of 4 levels of edge filtering These are selected with the left arrow and right arrow keys Level Meaning 0 No edge enhancement original fluoroscopic image 1 Slight edge enhancement 2 Medium edge enhancement 3 Strong edge enhancement 4 Extreme edge enhancement Table 11 1 Edge filter levels 11 2 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images 11 4 Image rotation The Rotation menu item allows you to rotate the image limitlessly using the Left Arrow and Right Arrow keys 11 5 Zooming When you select the Zoom menu item and confirm with the Enter key Submenu the selected image is displayed at full size on the reference screen and the menu bar changes To control what is displayed on the live screen two different tools are available Using the function keys you can select the desired zoom level Using the arrow keys yo
186. t 9 18 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 Data Management To delete one or more images from a patient folder do the fol lowing AUTION meam CAUTIO Deleted images are irretrievably lost Back up the images you want to keep before deleting them or make sure that they are really no longer needed e Select the desired image in the thumbnail mosaic on the reference screen using the arrow keys e Press key F2 Mark e Repeat these two steps for any further images you want to delete e Press key F4 Delete The following confirmation prompt is displayed Really delete image e Confirm by pressing the Y Yes key The marked images are deleted from the patient folder If there are any protected images among the ones you have selected they will not be deleted 9 3 6 1 Saving images You can save marked images from a patient folder to a USB stick and write them to CD Images that have been saved to a USB stick or CD in TIF format cannot be reimported from the external storage medium into the Ziehm 8000 For opening and processing these images you need a separate PC which is equipped with the appropriate drives and software Images that have been saved to a USB stick or CD in DICOM format can be reimported into the Ziehm 8000 with the DICOM Dir function gt Ch 10 5 p 10 10 You can write images to a USB stick in the following formats TIF DICOM You can preset the stora
187. t Fig 4 7 p 4 11 using the Move Up Down keys on the control panel gt Fig 5 1 p 5 1 e Ziehm Compact or Ziehm Compact with adapter for lithotripter proce dures Retract the monitor support arm so that the compact monitor is positioned directly over the horizontal carriage e Switch off the system and disconnect the power cable from the power supply e Unlock the coupling cable connector on the C arm stand by pushing the locking lever downward and unplug the connector Ziehm 8000 4 1 P_26376 CD_28210 EN 01 07 2010 4 Mechanical Handling Swivel arm brake brake handle optionally red Horizontal carriage brake EE brake handle optionally yellow Swivel brake brake handle optionally green Lifting col ss umn Ewy v Steering amp braking t gt gt lever green Release the parking brake by lifting the green steering amp braking lever gt Fig 4 1 p 4 2 When moving the C arm stand over very soft or uneven floors e g doorways raise the cable guards on the wheels C arm brake brake handle optionally blue F Cable guards Fig 4 1 C arm stand transport position 4 1 2 Monitor cart transport position How to proceed To return the monitor cart to its transport position do the following Wind the power cable onto the lower cable support o
188. t the generator and or image intensifier The laser positioning device is activated and deactivated by pressing the LASER key The laser positioning device generates a laser beam crosshair the central point of which marks the position of the central X ray beam on the patient The laser positioning device uses 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 the naked eye or with optical instruments Make sure to comply with all operating safety precautions when using the laser positioning device The maximum power output of continuous laser radiation measured at the laser beam apertures is lt 1 mW The wave length of the emitted radiation is 635 nm For safety the laser positioning device is switched off automatically after 1 minute uae VARNING Laser radiation Do not stare into beam or view directly with optical instruments Laser Class 2M according to IEC 60825 1 Please observe the provisions of IEC 60825 1 Section 3 User s Guide for operation of the laser positioning device Viewing the laser output with certain optical instruments e g eye loupes magnifiers and microscopes within a distance of 100 mm may pose an eye hazard LASER Safety Instructions Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 14 1 14 Laser Positioning Device 14 2 Applications Positioning aid
189. t zone of OCCUPANCY nneeeeennneneeenn A 36 ALOT DIMENSION Se 44 Y 2 a tae eet tae Reda ave Succ nee nano ieee hat tat sat at Nenn ore oe A 37 A 9 1 Ziehm OOO sas at en a a cea aaah uted ee ote A 37 A 9 2 Ziehm O70 08 0 1 P E EE E eee A 39 A 9 3 Ziehm Compact with adapter for lithotripter procedures A 39 A102 Techniealdatarsa r et ee a aa Pete a nk a AT ase A 40 A 10 1 General technical data 22444444444400nnennnnnnnen nennen A 40 A 10 1 1 Systems with a voltage rating of 100 V 120 V 200 V A 42 A 10 1 2 Systems with a voltage rating of 220 V 230 V 240 V A 45 A 10 2 Laser positioning device eect teeter cette ettteeeeeetiaeeeeeetnaeeeeeeeas A 47 A 10 3 Dose Meler 2 2 en ati ane en nannte A 47 ATST VacuDAP Cra aaa ois atin ee ees A 47 A 10 3 2 VacuDAP Aus riesen A 49 A 11 Connections for additional monitors and external radiation indication lamp A 50 Appendix B B 1 B 1 Attaching sterile disposable covers to the C arm u sssssenennesnnnnennnennnn nen B 1 Index i Ziehm 8000 V P_26376 CD_28210 EN 01 07 2010 Contents VI Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 1 General Information These Operating Instructions are designed to enable owners and oper ators of a Ziehm 8000 alternate trade name Exposcop 8000 to operate the respective system safely and efficiently Ziehm 8000 software version L2 05 or higher Sco
190. ta is that which was entered or corrected in the Patient Data Input menu gt Ch 9 2 1 p 9 2 If the patient number has more than 13 digits it will show up as 1234567891234 12 2 2 Upper right corner of the live screen Hospital data Image number In this area the name of the hospital the attending physician and department are displayed This data is initially entered under Configu ration Menu gt Basic Settings gt Ch 16 3 3 p 16 6 and may have been corrected later in the Patient Data Input menu gt Ch 9 2 2 p 9 5 Below the hospital data the image number is displayed gt p 7 10 12 2 3 Lower left corner of the live screen Image reversal Edge filter Angle of rotation Windowing values The symbols for vertical and horizontal image reversal appear only if these functions were active when the image was saved or when you press the Reverse Up Down and or Reverse Left Right keys on the C arm stand gt Ch 8 5 1 p 8 8 Next to the letter K the selected edge filter level is indicated The edge filter value is preset under Configuration Menu Service Settings Filter Factors Organ 0 Organ 1 Organ 2 Soft gt Ch 16 6 2 p 16 24 and can be adjusted later in the Post Pro cessing menu gt Ch 11 3 p 11 2 Next to the letter R the angle of image rotation applied is indicated The angle of image rotation is selected on the C arm stand with the Image Rotation keys
191. tact your in house service engineer Video source Inputs Gamma Display settings Picture e g horizontal and vertical position sharpness scaling Menu setup Setup e g menu lock exception language setting Ziehm 8000 16 7 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 4 1 Flat screen monitors of type 1 Fig 16 4 Flatscreen monitor of type 1 Safety measures ar The system may only be set up and put into service by service engineers who are authorized by the manufac turer If service is needed the system may only be repaired by authorized service engineers WARNING When the system is opened there is a risk of electric shock The system may only be opened by qualified service personnel To prevent fire or electric shock the system must not be exposed to rain or moisture The system must not be operated next to flammable anesthetic gas mixtures of air oxygen and nitrogen oxides Enabling the menu NOTE The menu display for setting the brightness and contrast is locked by default to ensure optimum display settings To display this menu again you must first enable it 16 8 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 System Configuration To re enable the menu display do the following e Simultaneously press the MENU and SCROLL keys until the message is displayed saying that the menu is unlocked When you press one ofthe keys on the keyp
192. tary 100 V 120 V MAIN FUSE C 16A 250V Rating label no TS04_043 ak Equipotential grounding ZIR Art No 10 2964 ZIN Art No 58331 A2 Spare GND connection ZIR Art No 10 2965 ZIN Art No 58338 Table A 5 Labels USA cont Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 A 29 Appendix A No Label Comments D A Protection Class I Type B 1 A ZIR Art No 10 1881 ZIN Art No 58330 D Cc VIDEO OUT 60 Hz video output 1 60Hz ZIR Art No 10 2968 J ZIN Art No 58458 D Systems with DICOM option and RJ45 1 DICOM connection only connection optionally either in the upper or lower half of the monitor cart ZIR Art No 10 2969 ZIN Art No 58459 b TE i Values for 1 Ga z enm 1magin Sills MODEL MODEL SERIAL NO Ziehm 8000 Ziehm Compact VIRTUAL COLLIMATOR S COMPLIES WITH CDRH RADIATION PERFORMANCE Rating label no TS04_061 STANDARDS 21 CFR SUBCHAPTER J AS OF DATE OF MANUFACTURE MANUFACTURER ZIEHM IMAGING GMBH DONAUSTRASSE 31 90451 N RNBERG Germany MANUFACTURED Values for 1 ziehm imaging MODEL SERIAL NO MODEL Ziehm 8000 CCD CAMERA Rating label no TS04_047 COMPLIES WITH CDRH RADIATION PERFORMANCE STANDARDS 21 CFR SUBCHAPTER J AS OF DATE OF MANUFACTURE MANUFACTURER ZIEHM IMAGING GMBH DONAUSTRASSE 31 9
193. tate the image on the left or on the right screen this is done by pressing one of the Screen Selection keys on the C arm stand By default the live screen is selected Then you can rotate the image on the selected screen limitlessly using the Image Rotation keys on the C arm stand When you briefly press both keys simultaneously the image automati cally rotates back into its initial position On a Ziehm Compact with flat screen monitor or on a Ziehm Compact with adapter for lithotripter procedures the Screen Selection keys are disabled since the system has only one monitor You can rotate the image in 90 steps with the Image Rotation keys on the C arm stand When you briefly press both keys simultaneously the image automati cally rotates back into its initial position 8 8 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 8 Adjusting Live Images NOTE When you press one of the Image Rotation keys any horizontally or vertically reversed image automatically returns to its initial position first The horizontal and vertical image reversal functions remain blocked as long as the image is in the 90 180 or 270 position 8 6 Recursive filter The recursive filter adds a preset number of images during fluoroscopy whereby each newly acquired image is superimposed by the result of the previous addition with a certain weighting factor The higher the preset number of images the greater the noise suppressio
194. test according to national regulations A 2 A 1 3 Checking the useful beam 4442440nnnnnnnneennnnnnnnnennnnnnnnn nn A 2 A 1 4 Gettering the image intensifier tube 4ssennnnneeeennnnnenneennnn A 3 A 2 Cleaning disinfection sterilization 44 0ssnnennnnnnnnnennennennnnennnnnnn A 4 A 2 1 Glean BRRSERRER RN SFLESE RUE RL CFRIESERTEFUESTERTAFFISSTRFFFFETERTERTEFTSPEIETFFFRSSSEFFRIPEN A 4 A 2 2 Disinfection 22 abate ht iets een ne ee ei A 4 A 2 3 stenlization 2 22 are nenne aetna A 5 AS MaN S e a a aae a a na a e a aaa Sheet by dete das Rlekkikdete A 6 A 3 1 Types of MalfUNCTIONS eenia n E A TN A 6 A 3 1 1 Alerts during power Up ssssssssssssrrsrrerrssnsseesrrrnrrnnrrnnsenne A 6 A 3 1 2 Errors during power UP ccccceeeeeeeeeeeeeeeeneettcaeeeeeeeees A 6 A 3 1 3 Alerts during Operation cccceeeeeeeeeeeeeenneeeeeeeetteeeeeeeenaaes A 6 A 3 1 4 Errors during operation u 222444nneennnnnnnnennnnnnnn nennen A 7 A 3 2 List of errors alerts and messages ccecceceeeeeeeeeeeeteeesettteaeeess A 8 A 3 3 MAINS TUSCi Aa heck Sn ae co he Sek cee oa A 13 AM Eabels nthetunit z ui re entleeren iad aa aa eaea A 14 AS Lapas TUSA eani teren men umannentsaleker A 23 A67 Focabspotiposition rue ee ea a ea a asin a A 33 AT Heat Capacity e cast ed cei caine deers tial ee ee A 35 A 8 Scattered radiation in the significan
195. tesza until E E E 10 2 Retrieving patient data from a DICOM server uuuseennnennennennnn 10 21 QUeIy see een 10 2 2 Retrieving a Worklist nssnsnennnnnnnnnnnnennnnnnnnnnnnn nenn 10 3 Processing scheduled procedure steps of a Worklist MPPS 10 4 Importing images from a DICOM server usnnesennnnnennnennnnnenn nn 10 5 Importing DICOM images from a storage medium DICOM Dir 10 6 Saving and printing images Ssenari anere anian RERA aii REAREA 10 6 1 Saving IMAGES snn a a A ARAN 10 6 2 Saving images to a second storage server 10 6 3 Printing imagas ease iara a Ea ETEEN 10 7 Storage CommMitment ioterest scenester aE EAEE EA 11 Post Processing Images 11 1 Overview ne a IR ren In Ile ai 11 2 Activating the post processing functions usersnnensensnnnnnnnnnnnnnennn nn 11 3 Edge enhancement srraus00ssrernnnenessnnannnsnnnnnnnnnnennnnanannnsnnnnnnnnnnnnn 11 4 Image rotation s 22 aiien einen 11 5 ZOOMING sateh ei ie kei te e lin nl 11 6 Grayscale inversion ssssrssnneeneennnnnnnnnennnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 11 7 Contrast and brightness adjustment Windowing 11 8 MEASUPEMONNS erson eaae aE TEA pea EA e a died 141 851 Calibration a nm Bee ni 11 8 2 Length or distance measurement uunsssnseneneennnnnnnnen nenn 11 8 3 3 point measurement 44444ssnnsnennenn
196. the lateral handles or use the hand rail around the image intensifier optional to pull the C arm stand CAUTION Keep in mind that the C arm stand may roll away on uneven floors Leave the C arm stand behind only on even floors and lock its brakes inclination lt 0 25 Release the parking brake only to move or position the C arm stand 4 4 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 4 Mechanical Handling Fig 4 2 C arm stand steering view from above Ziehm 8000 4 5 P_26376 CD_28210 EN 01 07 2010 4 Mechanical Handling 4 4 C arm movements Mechanical brakes The C arm can be moved in virtually any plane For each movement a separate brake is available allowing you to secure the C arm in any position To release the corresponding brake turn it counter clockwise The limit stop ofthe brake handles can be adjusted individually To do so lift the spring loaded brake handle turn it until reaching the desired limit stop position and release it to re engage it at the new position AUTION ers CAUTIO Before moving the C arm make sure that there is nobody within its range of movement WARNING Release the mechanical brakes only for positioning Take care to always seize the C arm at its handle during any movement in order to prevent the C arm from hitting the respective limit stop at full speed Take care not to place your hand in the C arm guide rails when adjus
197. the Enter key e Select the desired image using the arrow keys e Press key F2 Mark e Repeat these two steps for any further image you want to save or or F2 e To mark all images in the patient folder press the key combination 10 14 iehm 8000 Zieh P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions e Press key F6 Output The function keys for selecting the output target appear on the screen Hospital PROTI ST FRANCIS Physician DR WONDER Department ENDOSCOPY Patient name ZIEHM DEMO 24 r N F N First name ALFRED N amp Date of birth N 12 89 1924 A Sex Patient number 25 Keywords ERCP Note Date 25 09 04 kV 57 kV Time 10 33 14 mA 2 7 mA Img no 1 41 cGycm2 HD 15 FA F2 Fe F4 FS F6 Print USB cD Net Store NetOutput Back Fig 10 11 Mosaic menu image level Output submenu e Press key F4 Net Store The marked images are transferred to the DICOM server Images which have been transmitted successfully are flagged with a D 10 6 2 Saving images to a second storage server If Print Server 1 has been assigned the Storage2 function you can save images in DICOM format to this server using it e g as standby server You cannot configure the DICOM Print DICOM Store and User Config uration functions yourself e Please contact your in house service engineer if yo
198. the second marker square with the arrow keys until you reach the second measuring point on the reference object e g the second radiopaque marker on a balloon catheter Confirm the measuring distance final point with the Enter key The arrow symbol on the marker square disappears and instead a 2 is displayed in its upper right corner On the reference screen the request Please enter the length of this distance appears Enter the known length of the distance with the alphanumeric keys Save the reference length with function key F1 Save ZIEHM ALFRED 25 IHRE KLINIK PROF FORTSCHRITT ENDOSKOPIE 12 89 1924 09 11 23 OR 18 11 98 RY Fig 11 5 Calibrating Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images This will return you to the Post Measurements menu E 900 0 mm Please enter the length of this distance Fa F2 Save Cancel Fig 11 6 Post Processing Post Measurements calibration 11 8 2 Length or distance measurement To measure a length or distance do the following F1 Length e Press function key F1 Length in the Post Measurements menu gt Fig 11 4 p 11 6 In addition to the reference length a menu item called Length 1 still without any values is displayed in the menu e A small white marker square appears in the fluoroscopic image on the live screen In the center of the square is a flashing point which ma
199. tically assigned an image number which appears in the upper right part ofthe screen These image numbers are assigned and incremented consecutively for each separate patient folder Unsaved images those without a number will be replaced by a new flu oroscopic image during the next fluoroscopy and cannot be retrieved later To save the fluoroscopic image on the live screen to the hard disk do the following e Press the Save key on the C arm stand or 7 10 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 7 Standard Fluoroscopic Operations e Press pedal 2 of the two pedal foot switch gt Fig 7 3 p 7 8 or e Press the key combination Shift F1 on the monitor cart control panel The image is saved to the active patient folder or to the NO NAME folder fi F The image number appears in the upper part of the screen You can configure the Ziehm 8000 so that during each fluoroscopy anew Autostore function image is automatically saved as soon as you terminate radiation Autostore function To activate the Autostore function do the following e Press and hold down the Save key on the C arm stand for more than 4s 45 The Autostore function is activated The LED of the Save key is lit During each subsequent fluoroscopy a new image is automatically saved as soon as you terminate radiation To deactivate the Autostore function do the following e Briefly press the Save key on the C arm stand The Autos
200. ting the C arm Make sure that all mechanical brakes are locked when transporting the C arm stand 4 6 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 4 Mechanical Handling 4 4 1 Orbital rotation You can rotate the C arm orbitally by 135 on a Ziehm 8000 90 from vertical to horizontal position and 45 forward On a Ziehm Compact and Ziehm Compact with adapter for lithotripter procedures you can rotate the C arm orbitally by 115 90 from vertical to horizontal position and 25 forward A scale with 5 divisions on the outside of the C arm as well as a mechanical detent at the zero position are provided to facilitate precise positioning 5 l Orbital rotation brake 45 brake handle optionally blue Angulation brake brake handle optionally red N IF e Fig 4 3 Orbital rotation of the C arm Ziehm 8000 4 7 P_26376 CD_28210 EN 01 07 2010 4 Mechanical Handling 4 4 2 Angulation You can rotate the C arm by 225 in the vertical plane around the hor izontal axis i e the horizontal carriage A scale with 10 divisions at the pivot joint of the horizontal carriage facilitates precise positioning AUTION mcan CAUTIO When combining angulation and orbital rotation of the C arm on a Ziehm Compact or Ziehm Compact with adapter for lithotripter procedu
201. tion When you press the key repeatedly the collimator rotates in steps When you press and hold down the key the collimator rotates steplessly When you briefly press both keys simultaneously the slot collimator rotates to its default zero position 8 2 4 Virtual collimator n a for Ziehm Compact Ziehm Compact with adapter for lithotripter procedures Function How to proceed All systems which are equipped with a virtual collimator allow the operator to adjust the collimators without radiation Using this feature patient exposure can be reduced significantly Do the following e Open both the slot collimator and the iris collimator completely using the following keys on the C arm stand Open slot collimator and Open iris collimator Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 8 Adjusting Live Images e Select the appropriate anatomical program on the C arm stand Extremities amp children or Head spine amp pelvis or Thorax amp abdomen or Soft tissues SOFT e Screen the patient briefly e On the generated image adjust the collimator exactly to the object without radiation To do this use the following keys on the C arm stand Open iris collimator and close iris collimator and or Open Slot Collimator and Close Slot Collimator and Rotate Slot Collimator Left and Rotate Slot Collimator Right The areas of the image that will not be visible later are shown beneath
202. to radiation protection Furthermore the virtual collimator allows you to adjust the collimators without radiation Applications Casualty ward Lithotripsy Mobility Anatomical pro grams Radiation dose reduction Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 2 1 2 System Overview Image quality Image management Documentation and output Networkability Flatscreen monitors guarantee flicker free images The advanced Full Frame Technology which uses non interlacing throughout the entire image processing chain generates noise free images without motion artifacts even ifthe subject has moved Comprehensive real time image processing functions customizable noise and area filtering electronic contrast and brightness adjustment zooming radiation free horizontal and vertical image reversal digital image rotation ensure excellent adaptation of the image quality and ori entation on the screen to the surgeon s needs Further image processing functions are available for saved images post processing A patient based image management system providing a 16 image mosaic view and menu controlled user guidance allows efficient image data handling For documentation purposes a video printer is available With a Ziehm Compact the Sony UP 897 printer is included in the scope of delivery by default A CD writer as well as a USB port allow filmless archiving in PC compatible TIF format and optionally in DI
203. to the parent menu All actions are always applied to marked images only If you have not marked any image before the system will process or output the image that is currently highlighted by the cursor in the thumbnail mosaic on the reference screen The only exception is the protection function You can only protect the image where the cursor is To display an image at full size on the reference screen do the fol lowing e Select the desired image in the thumbnail mosaic on the reference screen using the arrow keys e Press key F1 Enlarge The image is displayed at full size on the reference screen All function keys disappear from the menu bar Key F2 Back appears enabling you to return to the mosaic view The Enlarge function allows you to compare saved images gt Ch 9 3 7 p 9 22 To mark one or more images do the following e Select the desired image in the thumbnail mosaic on the reference screen using the arrow keys e Press key F2 Mark e Repeat these two steps for any further images you want to mark FG Back Full size image A lt gt v Ha Enlarge Marking A lt gt v F2 Mark Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 9 Data Management Marking all images 7 Unmarking A lt gt v F2 Mark Protecting A lt gt v F3 Protect Unprotecting A lt gt v ES Protect To mark all images of a patient folder do the follow
204. tore function is deactivated The LED of the Save key goes gt out When you attempt to save an image and there is not enough hard disk Auto delete space left the patient folders and or images on the hard disk are deleted function automatically and without confirmation prompt in the following order First the oldest patient folder is overwritten If there is still not enough disk space forthe save operation then the second oldest third oldest etc patient folder are deleted However the active patient folder is never deleted If a patient folder contains one or more protected images only the unprotected images are deleted but not the protected images or the folder itself If it is not possible to free up enough space on the hard disk for the save operation due to the large number of protected images an audible alarm sounds and the alert message E 105 appears on the dose display ofthe C arm stand The save operation is aborted Ziehm 8000 7 11 P_26376 CD_28210 EN 01 07 2010 7 Standard Fluoroscopic Operations Ziehm Compact Ziehm Compact with adapter for lithotripter proce dures or NOTE If more than 75 of the hard disk is full the exact per centage of used hard disk space is displayed on the ref erence screen during power up of the system This gives you an approximate idea of the remaining hard disk space You cannot save any fluoroscopic images on a Ziehm Compact or Ziehm Comp
205. tube voltage manually with the voltage setting key 7 gt Ch 7 3 p 7 5 When doing so please refer to the suggested exposure values in the exposure guide gt Ch 15 8 p 15 4 The automatically determined or manually selected tube voltage is indi L cated on the voltage display kV 15 2 iehm 8000 Zieh P_26376 CD_28210 EN 01 07 2010 15 Direct Radiography Select the required exposure time with the Exposure Time Setting key The available parameter range is from 0 1 s to 4 s gt Ch 15 8 p 15 4 A Ss VY The selected exposure time is indicated on the Exposure Time display C CLE s 15 6 Making the radiographic exposure The radiographic exposure can only be initiated with the hand switch An Hand switch audible alarm is sounding throughout the exposure time When you ter minate radiation prematurely by releasing the hand switch the exposure is interrupted immediately 15 7 Completing the radiographic procedure After completing the radiographic exposure do the following e Withdraw the film cassette e Remove the film cassette holder from the image intensifier e Switch to the desired fluoroscopy mode Ziehm 8000 15 3 P_26376 CD_28210 EN 01 07 2010 15 Direct Radiography 15 8 Exposure guide In the following table you will find reference values for the exposure of different body regions The values refer to a patient of medium build If the patient has a plaster cast the exposu
206. u can pan around the image on the reference screen to select the image area you want to enlarge Fig 11 2 Zoom submenu reference screen Function key F2 Zoom In lets you magnify the image on the live screen F2 a step ata time In addition to the original image size a total of 6 zoom levels ranging from 1 5 to 4 in steps of 0 5 are available When you press function key F2 a boundary frame appears on the image defining the image area that will be displayed enlarged on the live screen You can adjust the position of the boundary frame and thus the image area that will be enlarged with the arrow keys Function key F2 Zoom In disappears from the menu bar as soon as you choose the maximum zoom factor Ziehm 8000 11 3 P_26376 CD_28210 EN 01 07 2010 11 Post Processing Images F1 Function key F1 Zoom Out lets you reduce the image on the live screen a step at a time again When you press function key F1 a boundary frame appears on the image defining the image area that will be displayed reduced on the live screen You can adjust the position of the boundary frame and thus the image area that will be reduced with the arrow keys Function key F1 Zoom Out disappears from the menu bar as soon as you choose the minimum zoom factor original size F3 Function key F3 1 1 restores the image on the live screen to its original 8 size To return to the Post Processing menu press the ESC key 1
207. u wish to enable functions on Print Server 1 If you send only images to the DICOM storage server which are not stored there already all images are actually transferred and saved Images that are already stored on the DICOM storage server are not saved there again Images which have been downloaded from the DICOM storage server with the Retrieve function will not be retransferred to the storage server FE Output F4 Net Store Second storage server Configuration of Print Server 1 Transferring images Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 15 10 DICOM Functions MOSAIC A V or F2 F6 Output Aero CAUTION Never modify any patient data in a patient folder after having transferred images from this patient folder to the DICOM storage server To save images to an additional DICOM storage server do the fol lowing e Press the MOSAIC key e Select the desired patient folder using the arrow keys e Press the Enter key e Select the desired image using the arrow keys e Press key F2 Mark e Repeat these two steps for any further image you want to save or e To mark all images in the patient folder press the key combination Shift F2 e Press key F6 Output 10 16 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 10 DICOM Functions The function keys for selecting the output target appear on the screen Hospital PROT ST FRANCIS Physician DR
208. writing images to CD The following options are available TIFF format for further use on a PC DICOM format for further use on a DICOM network or viewing with a DICOM viewer The USB format menu item allows you to control which storage format is used for saving images to a USB stick The following options are available TIFF format for further use on a PC DICOM format for further use on a DICOM network or viewing with a DICOM viewer 16 4 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 16 System Configuration 16 3 Basic settings The Basic Settings menu is used for making different settings which Function directly affect the user interface e g default data for certain menu fields In addition you can clear different storage media Usually the options in this menu are set by a service engineer during installation of the system Basic Settings Time 89 56 06 Date 29 08 06 Live image Left Hospital ST FRANCIS Department ENDOSCOPY Physician DR WONDER Clear hard disk Clear NO NAME Clear USB device FA Save Cancel Fig 16 3 Basic Settings menu 16 3 1 Setting the system time and system date Under the Time menu item the system time format hh mm ss must be set once Under the Date menu item the system date format dd mm yy must be set once 16 3 2 Selecting the live screen The Live image menu item allows you to choose whether the l
209. x 2 Features images 18 flat screen monitor mounted on the C arm stand with small video printer laterally 2 2 3 Ziehm Compact with adapter for lithotripter procedures With 23 cm image intensifier storage capacity for max 2 images 18 flat Features screen monitor mounted on the C arm stand with small video printer lat erally mounting plate for lithotripter on the C arm stand Ziehm 8000 2 3 P_26376 CD_28210 EN 01 07 2010 2 System Overview 2 3 Options The following options can be integrated into the system upon request Hardware options Ziehm Compact adapter for lithotripter procedures on Ziehm Compact Magnification function electronic image magnification Virtual collimator Laser positioning device on the generator Laser positioning device on the image intensifier integrated 23 cm i i or external 15 cm i i Integrated dose meter for measuring the dose area product Integrated dose meter for measuring the air kerma air kerma rate AKR copper filter Key switch Power On Off or X ray On Off EMERGENCY STOP button CDwriter Video printer for printout on paper Video printer for printout on paper or transparent film Twin screens 18 flat screen monitors Video socket for external single flat screen monitor External 18 single flat screen monitor External 24 single flat screen monitor Connection for external radiation indication
210. y the collimator closes in steps When you press and hold down the key the collimator closes steplessly When you briefly press both keys simultaneously the collimator opens to the maximum permissible size for the selected image intensifier format i e normal view magnification or magnification II gt Ch 8 3 p 8 3 Individual adjustment Function Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 8 1 8 Adjusting Live Images 8 2 2 Slot collimator ole With the open slot collimator key on the C arm stand you can open the slot collimator When you press the key repeatedly the collimator opens in steps When you press and hold down the key the collimator opens steplessly With the close slot collimator key on the C arm stand you can close the slot collimator When you press the key repeatedly the collimator closes in steps When you press and hold down the key the collimator closes steplessly When you briefly press both keys simultaneously the slot collimator opens completely 8 2 3 Slot collimator rotation al When you press the rotate slot collimator right key on the C arm stand the slot collimator rotates in clockwise direction When you press the key repeatedly the collimator rotates in steps When you press and hold down the key the collimator rotates steplessly When you press the rotate slot collimator left key on the C arm stand the slot collimator rotates in counter clockwise direc
211. ziehmimaging dedicated to clinical innovation Ziehm 8000 Operating Instructions Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 Copyright Copyright 2010 Ziehm Imaging GmbH All rights reserved Transmission or reproduction of this document exploitation and disclosure of its contents to third persons is not permitted without express written consent of the manufacturer Infringements shall entitle to damage claims Registered Trademarks This document may contain the names of registered trademarks or brands the use of which by third persons for their purposes may infringe the rights of their respective owners Quality Standards This document was produced in accordance with a certified QM system as per DIN EN ISO 13488 It conforms to the requirements of Council Directive 93 42 EEC Annex and other applicable norms The information provided in this document may be updated at regular intervals Subject to change without prior notice Manufactured by Ziehm Imaging GmbH Donaustr 31 90451 Nuremberg Germany e mail info ziehm eu com http www ziehm com Rev 06 2010 Ziehm 8000 P_26376 CD_28210 EN 01 07 2010 With the Ziehm 8000 Ziehm Imaging GmbH provides an active medical device connected to the mains power supply The above listed medical device is a non contact device It does not require any contact with the patient to perform its intended use It provides contactless energy in the form of X r
212. zontal and vertical image reversal 8 5 2 Image Tot tion 2 222 222 en ine ds 8 6 Rec rsiverfilter r ur nun in nee in lt 8 7 Image swapping unrin er E T e nn 8 7 1 Ziehnm 8000 une nenn 8 7 2 Ziehm Compact Ziehm Compact with adapter for lithotripter PFOCCOUES eetacosstertatad itesed niscehen ved anbenelaiana lected d aaceeesabhyeeie de tet nd 9 Data Management 9 1 Organization of patient and image data cc eeeseeeeeceeeeeeeeeeeeenteeeeeeeeaas 9 1 1 Patient Toldersznr n eek 9 1 2 NO NAME folder O 9 2 Patient data management 2444essennnnnnenennnnnnennnnnnnnneennnnnn ren 9 2 1 Creating a new patient folder on the Ziehm 8000 9 2 2 Editing patient data s eieren e AREA A AE EER 9 3 Managing image datas erosi rna aE Ea A T 9 3 1 Activating a patient folder 24440nnennnennnnnnnnnennnennnnen 9 3 2 Backup 10 ED ne en Eee ernaen 9 3 3 Searching for patient folders 44 44424444Hn nennen 9 3 4 Deleting patient folders u 44444444nnnnnnnnnennnnnnnnnnnnnnnnnn 9 3 5 Inverting the grayscale of the entire image archive 9 3 6 Processing and outputting images of a patient folder 9 3 6 1 Saving magos etiri Eea AARE san 9 3 6 2 Printing images on video printer ceeeeeeeeeeees 9 3 7 Comparing saved images 44444esssnnnnnnnnsnnnnnnnnnnnnnnnnn anne 10 DICOM Functions 10 1 WPrerequisi

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