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Ziehm 8000 - Frank`s Hospital Workshop

1. Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 2 Safety Instructions WARNING 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 intensifier installed and has the following radius 15 cm image intensifier 3 m 23 cm image intensifier 4 m To minimize the radiation burden of the patient you must keep the source skin distance as large as possible The generator design guarantees a minimum source skin distance of 20 cm WARNE WARNING Additional material located in the beam path e g an operating 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 Protection of staff Protection of the patient Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 2 3 2 Safety Instructions 2 3 Electromagnetic compatibility Medical electrical equipment requires special
2. 6 6 6 3 Basic SettingS nae lie tie aa e head eee 6 7 6 3 1 Setting the system time and system date u seen 6 7 6 3 2 Selecting the live screen uurs22s444nnnnnennnnnnnennnnnnnnnennnnnnnnn nenn 6 7 6 3 3 Entering the hospital data u4snnennnennnnnnnnnennnnnnnnnnnnnnnnn en 6 8 6 3 4 Clearing storage media 4444444444Hnnn ne nnnnnnnennnnnnennen nennen 6 8 6 4 Sereen setings ii peiiini k r E E ss 6 9 6 4 1 Ziehm 8000 with flat screen monitor 24444444 44H nennen 6 9 6 4 2 Setting flat screen monitors of type 1 uunsssnnnnenneeennnnennennnnnnen 6 10 6 4 2 1 Built in keypad snunssnnnnnnennnnnnennennnnnnennennnnnnnnn nenn 6 11 6 4 2 2 Setting the brightness contrast and backlight 6 11 6 4 2 3 Setting the menu language uunssssnnnnenneesnnnnnnnnen nennen 6 13 6 4 2 4 Setting the video source uueeeneennennnnesnnnnnnnneennnnnnn nennen 6 14 6 4 2 5 Setting the gamma value 2220usnssnnnnnnnneennnnnnnennnnn nen 6 16 6 4 2 6 Setting up the display uunnsssnnnnnnnneennnnnnennnnnnnnennnnn 6 17 6 4 2 7 Setting up the menu neessssnnnnenneennnnnnnnennnnnnnnennnnn an 6 18 6 4 2 8 Locking the menu uueressssnneennnssnnnnnnnennnnnnnnnennnnnnn ern 6 19 6 4 2 9 Restoring the factory settings 22244400 sense 6 20 6 4 3 Setting flat screen monitors of type 2 nuun
3. Appendix A Recommended separation distances between portable and mobile RF communications equipment and the Ziehm 8000 Ziehm Compact or Ziehm Compact Litho The Ziehm 8000 Ziehm Compact and Ziehm Compact Litho are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Ziehm 8000 Ziehm Compact or Ziehm Compact Litho can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Ziehm 8000 Ziehm Compact or Ziehm Compact Litho as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to frequency of transmitter maximum m output power 150 kHz to 80 MHz 80MHzto 800 MHz 800 MHz to 2 5 GHz Ww d 1 2 x SQRT P d 1 2 x SQRT P d 2 3 x SQRT P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed in the above table the distance can be determined using the equation in the respective column header where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the frequency range 80 MHz to 2 5 GHz to d
4. 17 o gt Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 15 6 Configuration 6 4 2 5 Setting the gamma value The gamma value determines the contrast between the lightest and the darkest point of the screen display The Gamma tab furthermore shows the backlight operating hours clocked up so far and the BIOS version of the monitor 18 or 23 flat To set the gamma value on the 18 or 23 flat screen monitor do the screen monitor following e Press the MENU key The on screen menu appears MENU e Select the Gamma tab with the help of the or arrow keys On the Gamma tab the following gamma value options are available 1 5 1 7 2 2 2 6 3 0 e Press the SCROLL key until the desired value is highlighted in white SCROLL e Press the or arrow key The desired value is set e Press the MENU key The on screen menu disappears OO MENU 24 flat screen To set the gamma value on the 24 flat screen monitor do the monitor following e Press the MENU key The on screen menu appears m O 16 Ziehm 8000 i P_26471_CD_28218 EN 11 05 2009 6 Configuration Select the Defaults tab with the help of the or arrow keys Press the SCROLL key until the Gamma item is highlighted Press the or arrow key until the desired parameter value is selected On the Gamma tab the following gamma value options are avail
5. e Specify the print configuration parameters e Press key F1 Save To configure print server 2 do the following e Press the MENU key The Configuration Menu appears e Select the Service settings menu item e Type the password and press the Enter key rep A Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration e Select the DICOM settings menu item e Type the password and press the Enter key e Select the Print server menu item The DICOM Settings Print Server 1 menu appears DICOM Settings Print server 1 IP addr DICOM server IP subnet mask Host mame DICOM server AE title DICOM server Port addr DICOM server IP address gateway IP address ZiehmNetPort 192 168 127 081 255 255 255 908 ZI DICOM RADIN_DICOM_SCP 02010 192 168 127 254 192 168 127 811 Fa Save AE title ZiehmNetPort MODALITY 1 Number of copies 4 Print priority HIGH Media type PAPER Film destination MAGAZINE Film session label VISTA Film size ID BINK1GIN Number Page 9 Min Density Max Density User configuration On Function Print F2 F4 FS FB Cancel lt gt Verify Fig 6 35 e Place the cursor on the IP addr DICOM server menu item e Press key F5 gt The DICOM Settings Print Server 2 menu appears DICOM Settings Print Server 1 menu lt gt sal ia T lt gt al 2 gt ES Zie
6. Resolution 1920 x 1200 Mode Local Fig 6 13 The Configuration control on a 24 flat screen monitor SCROLL MENU 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 6 4 2 4 Setting the video source 18 or 23 flat To set the video source on the 18 or 23 flat screen monitor do the screen monitor following INPUT SCROLL FO te Press the Input key The Inputs on screen menu with the following options appears DVI analog BNC DVI digital Press the SCROLL key until the desired item is highlighted Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration Press the arrow key The highlighted item is marked as selected Press the Input key The Inputs on screen menu disappears To set the video source on the 24 flat screen monitor do the following Press the Input key The Inputs on screen menu with the following options appears DVI graphic input SOG video input Press the SCROLL key until the desired item is highlighted Press the Minus button The highlighted item is marked as selected Press the Input key The Inputs on screen menu disappears el e m 24 flat screen z peN 22 3 3
7. Ziehm 8000 7 9 P_26471_CD_28218 EN 11 05 2009 7 Technical Data Tolerances of C arm movements Fig 7 6 Tolerances of C arm movements on systems with 23 cm i i C arm stand with lower C arm position Fig 7 7 Dimensions of C arm stand with lower C arm position 7 10 ehm 8000 Zi P_26471_CD_28218 EN 11 05 2009 7 Technical Data Monitor cart with 24 flat screen monitor Fig 7 8 Dimensions of a monitor cart with 24 flat screen monitor Monitor cart with 23 flat screen monitor Fig 7 9 Dimensions of a monitor cart with 23 flat screen monitor Ziehm 8000 7 11 P_26471_CD_28218 EN 11 05 2009 7 Technical Data Monitor cart with 18 1 flat screen 710 ie gt p monitors l 1145 F A 2125 500 Fig 7 10 Dimensions of a monitor cart with 18 1 flat screen monitors 7 7 2 Ziehm Compact Ziehm Compact with flat screen monitor and 23 cm i i 455 675 267 1600 1820 2060 2280 Fig 7 11 Dimensions of a Ziehm Compact with flat screen monitor and 23 cm i i 7 12 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 7 Technical Data 7 7 3 Ziehm Compact Litho Ziehm Compact Litho with 23 cm i i Fig 7 12 Dimensions of Ziehm Compact Litho with 23 cm i i Zieh
8. 0xC000 0xC001 Ziehm NetPort is not properly connected to the server wrong DICOM settings or image data is not stored on the query server Table 6 7 DICOM Retrieve error messages 6 5 4 9 Hardware with DICOM option There are two hardware versions an RJ45 connection Twisted Pair 100 Mbit s Fiber optic connection FOC ST coupling 10base FL or 100base FX RJ45 connection On systems with an RJ45 connection a network cable runs directly from the network interface card of the image memory module out through the rear cover of the monitor cart and terminates in an RJ45 socket The system must be connected to the hospital network via this socket 6 52 Ziehm 8000 i P_26471_CD_28218 EN 11 05 2009 6 Configuration On systems with a fiber optic connection a network cable runs to a fiber optic converter built into the monitor cart From there two fiber optic cables run to the TX and RX sockets The sockets are located at the rear side of the monitor cart above the power supply connection Via these two sockets the two fiber optic links are connected to the hospital network Error Remedy Image memory module fault Replace image memory module Defective cables Visible damage kinks pinches abrasion cuts No connection between two correctly functioning components e g hub hub simple continuity test can be performed with a multimeter Replace cables Defective socket
9. 11 4 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 11 Disassembling the System e Undo the 4 screws M6x16 that attach the flat screen monitors to the monitor cart base NOTE Since the flat screen monitors will be mounted onto a transport rack you do not need the screws M6 x 16 that held the monitor head to the monitor cart base at this point Put these screws in the accessories box gt Ch 12 5 p 12 5 e With the help of a second person lift the flat screen monitors off the monitor cart base WARRING WARNING The flat screen monitors cannot be lifted by one person alone Therefore always ask a second person to assist you in lifting the monitors off the monitor cart base NO Never place the flat screen monitors directly on some surface always place them on the transport rack e Reattach the rear cover of the monitor cart base Ziehm 8000 11 5 P_26471_CD_28218 EN 11 05 2009 11 Disassembling the System 11 6 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 gt IND Mounting the System ona Pallet 2 1 Safety instructions and information 12 1 1 Safety instructions WARNING WARNING Only authorized personnel is allowed to pack and unpack the system Authorized personnel are persons who have attended an appropriate training course provided by the manufacturer WARNING Always observe the general occupational safety and accident prevention regulations
10. Department and Physician menu items allow you to define which data appears automatically in the corresponding fields in the Patient Data Input menu 6 3 4 Clearing storage media When you select one ofthe 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 6 8 Ziehm 8000 i P_26471_CD_28218 EN 11 05 2009 6 Configuration 6 4 Screen settings 6 4 1 Ziehm 8000 with flat screen monitor The Ziehm 8000 is equipped with 18 23 or 24 flat screen monitors The 18 flat screen monitors are delivered as type1 and type 2 The Monitor Settings menu is used for adjusting the resolution mode of Setting the the 23 or 24 flat screen monitor resolution Further screen settings can be made directly atthe displays using a built in keypad gt Ch 6 4 2 p 6 10 er ccc Fig 6 4 Monitor Settings menu on a Ziehm 8000 with 23 or 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
11. E 28 Error Internal fault Please contact after sales service E 29 Alert Ziehm 8000 without Active E 26 Cooling alternat General generator fault Please contact after sales service ely or Generator overheated or temperature symbol on the Allow generator to cool down C arm stand illuminated Ziehm 8000 with Active Please contact after sales service Cooling General generator fault 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 E 37 Alert Internal fault Please contact after sales service E 38 Alert Internal fault Please contact after sales service E 39 Alert Internal fault Please contact after sales service E 40 Alert Internal fault Please contact after sales service E 41 Alert Internal fault Please contact after sales service E 42 Alert Internal fault Please contact after sales service E 43 Error Dose meter check VacuDAP Repeat dose meter check VacuDAP C Value measured If the error message appears again is outside the tolerance range contact after sales service E 44 Error Control connection to monitor Please contact after sales service cart i
12. E17 Alert Foot switch 1 pressed during Release foot switch and power up acknowledge alert message by briefly pressing hand or foot switch Caution On systems with four pedal foot switch foot switch 1 foot switch 3 left to right E 18 Alert Hand switch 2 pressed during Release hand switch and power up acknowledge alert message by briefly pressing hand or foot switch Caution On systems with four pedal foot switch hand switch 2 foot switch 2 left to right E 19 Alert Foot switch 2 pressed during Release foot switch and power up acknowledge alert message by briefly pressing hand or foot switch Caution On systems with four pedal foot switch foot switch 2 foot switch 4 left to right E 20 Error Short circuit in hand or foot Please contact after sales service switch cable E21 Alert Radiation warning lamp Please contact after sales service defective E 22 Alert Internal fault Please contact after sales service E 23 Alert Internal fault Please contact after sales service E 24 Alert Internal fault Please contact after sales service Table 10 1 List of error and alert messages Ziehm 8000 10 1 P_26471_CD_28218 EN 11 05 2009 10 Problem Report Code Type Description Measures E 25 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
13. IP addr DICOM server 908 008 000 908 IP subnet mask 255 255 255 008 Host mame DICOM server AE title DICOM server Port addr DICOM server IP address gateway 900 000 000 908 IP address ZiehmNetPort 908 900 000 908 AE title ZiehmNetPort ZIEHMNP Fxxxx Query model PATIENT ROOT Fa F2 F4 F5 F6 Save Cancel lt gt Verify Fig 6 30 DICOM Settings Retrieve Server menu here Retrieve Server 1 e Enter the network parameters The Gateway IP address Ziehm NetPort and AE title Ziehm NetPort settings must be identical to the corresponding query server settings When the cursor is in certain lines of the input screen additional function keys for entering lower case letters and special characters are displayed e To enter lower case letters press key F3 abc e To enter a special character press and hold down key FA lt or Es F5 gt until the desired special character appears e Press key F6 Verify FG The system checks the network connection between SCU and SCP Verify by means of a ping the DICOM settings e g AE title and common SOP classes association negotiation It sends an ECHO request to the SCP and waits for an ECHO response If all network parameters have been entered correctly the message Verification successful is displayed error messages Ch 6 5 4 7 p 6 57 Ziehm 8000 6 41 P_26471_CD_28218 EN 11 05 200
14. IP addr DICOM server IP Internet Protocol Each host on the network is assigned an IP address consisting of a 32 bit number e g 192 168 127 080 192 168 127 group address 080 individual host IP address ranges examples other configurations are possible Class A network 10 0 0 0 to 10 255 255 255 Class B network 128 16 0 0 to 172 31 255 255 Class C network 192 168 0 0 to 192 168 255 255 IP subnet mask 255 255 255 0 subnet mask combined with IP address yields group address see above IP address ranges examples other configurations are possible Class A network 255 0 0 0 Class B network 255 255 0 0 Class C network 255 255 255 0 Host name DICOM server Name of the network host e g sun server with unique IP address assignment AE title DICOM server Application Entity name of the application Name of the DICOM application on the server e g INOARCHIVE for DICOM Storage Ziehm 8000 6 33 P_26471_CD_28218 EN 11 05 2009 6 Configuration Entering special characters Port addr DICOM server At this address the server listens for requests from Ziehm NetPort IP address gateway If the server and Ziehm NetPort belong to different groups a gateway must be specified e g 192 168 127 254 IP address ZiehmNetPort IP address of Ziehm 8000 AE title ZiehmNetPort AE title of Ziehm NetPort freely configurable The DICOM Verification fun
15. RSA image DSA nativeimg On When you initiate radiation after injecting the contrast medium the native image is displayed on the reference screen DSA nativeimg Off When you initiate radiation after injecting the contrast medium no native image is displayed on the reference screen In this case you may open a reference image on the reference screen before generating the DSA MSA RSA image this reference image remains displayed there during the entire subtraction procedure 6 2 9 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 storage medium is used by the system for DICOM image retrieval 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 the CD inserted in the CD writer 6 2 10 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 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
16. 11 3 23 or 24 flat screen monitor on the transport rack e Mount the monitor head to the transport rack using four screws e Reattach the rear cover of the monitor neck using four screws e Reattach the rear cover of the monitor cart base e Inside the monitor cart tape the power plug to the side panel Ziehm 8000 11 3 P_26471_CD_28218 EN 11 05 2009 11 Disassembling the System 11 2 Dismounting the 18 1 flat screen monitors NOTICE Always wear cotton gloves when installing testing or making settings on displays or screens To dismount the flat screen monitors from the monitor cart base do the following e Remove the rear cover of the monitor cart base e Remove the rear cover of the flat screen monitors e To disconnect the ground wire from the monitor cart base remove the nut withdraw the ground wire from the screw and retighten the nut e Unplug the video cables and the radiation warning lamp cable from the image memory module e Disconnect the power supply units of the flat screen monitors from the corresponding connectors for non heating devices Video signal of left monitor Video signal of Radiation Ground wire right monitor warning lamp connection Fig 11 4 Connections on the flat screen monitors e Pull the following cables from the monitor cart base up into the monitor housing gt Fig 11 4 p 11 4 2 video cables golden Radiation warning lamp cable Ground wire
17. 8000 Ziehm Compact and Ziehm Compact Litho 7 1 7 2 Power plug specification cc cccccccccecceeeeeeeeeeeeeecceaeeeceeeeeeeeeeseeeeeeinsaneeeees 7 5 7 2 1 Systems with a voltage rating of 200V 220V 230V and 240V 7 5 7 3 Laser positioning device 2220004 s rr Ea RE EER EAEE 7 5 Tk Dose MEE a a U S TE 7 6 1 9 AKONI e e E E E AE E dee aaileeiad ealteee ates 7 7 4 6 Focal SpOt POSO 2 2 2 2 He ee sehen donee 7 8 7 1 DIMGMSIONS aE EAE EEEE EA ESEE 7 9 7 7 4 Zieh 8000 nee erent rr etrretcr reererrecrtrrrcet treet tin 7 9 7 7 2 Ziehm COM Pate eins E a oe 7 12 7 7 3 Ziehm Compact Litho cccececcecceeeeeeeeeeeceecceceeeeeeeeeeeeeeeteeeeessenaeees 7 13 II Ziehm 8000 i P_26471_CD_28218 EN 11 05 2009 Contents 8 Maintenance 8 1 8 1 General requirements 44424444444440aHnnnnnnnnnnnnnnnnnnnnnnnnnnnannnnnnnn nennen 8 1 8 2 ElECffics unn a a a a nee S 8 2 9 3 Meghani S nn a ete eee ete 8 4 9 Replacing Components 9 1 9 1 Hand switch and foot switch usressnnneeenessnnnnnnnnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn 9 1 9 25 GOUplINg CADIS 2 jis secede ate eich E HE rn ann 9 2 93 HEUSESH n EE ia evaieanet neieden tie deths e a a tay 9 3 10 Problem Report 10 1 10 1 List of error and alert messages urssnnsesnnennnnnnnnnnnnnnnnnnnnnennnnnnnnnn nenn 10 1 FO 2 Whatto dot ix estes ee ected ate lta ee ee e
18. Contents 1 General Information tt Typographical conventions sseennnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennn nn 1 2 Conventions for safety instructions u 22224444Hn ee nnnnnnnnennnnnnnnennnnnnne nenn 1 3 ACCESSOTIES ie naar lnueenenhuslenisketi 2 Safety Instructions 2 1 General safety instructions usserssnnneneensnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 2 2 KAAS A Eee Me ete eet 2 3 Electromagnetic compatibility ce eeeceeeceeeeeeeeeneeeeeeeeeeeeeeseeeeeeeeseeeaeeees 2 4 Protectiveigrounding ee testen el 2 5 Equipotential grounding seerias nnna a ETRE ATAS 2 6 gt Laserradiatioh eda na a a aa a a a a PAT AREN A ETE EE EEE A E TEE E A AA 28 MECHANICS aaae a ie aiaa aa a aa sbddeen aalads 29 VOYVSTSM TAI a a a TAN 3 Unpacking the System 3 1 Unpacking the system on the pallet 424444440s0nnennonnnnnenneennene en 3 1 1 Unpacking the pallet on delivery to distributors 3 1 2 Unpacking the pallet on drop shipments en 3 1 3 Unpacking the monitors 00 0 2 cceeeeeeeeeeeeeceeecaeceeeeeeeeeeeteeseeeseceeaeees 3 1 3 1 Flat Scre n monitors iisi iaa aae a aaa 3 1 4 Unpacking the C arm stand 4444sssssnnnnnnnnnnnnnnnnnsnnnnnnnnnnnnnn 3 1 5 Unpacking the monitor cart usru 244444eeennnnnnnnnnnnnnnnnnnnnnnnnnnn nn 4 Assembling the System 4 1 Assembly re ken 4 1 1 Mounting
19. Level 1 2 0 3 4 continuous pulse fluoroscopy Snapshot Table 6 4 Filters for subtraction modes 6 5 2 3 Filters for subtraction modes with CO If the system is equipped with the CO option the values for the following filters can be selected for each of the subtraction modes DSA RSA and MSA in combination with CO2 negative contrast medium Recursive filter independent settings for normal view magnification 1 and magnification 2 Stack filter Edge filter Fig 6 24 Filter Factors for CO2 DSA Recursive filter 3 Recursive magn 1 3 Recursive magn 2 3 Stack filter 16 Edge filter z Fa F2 Save Cancel Filter Factors for CO2 DSA menu Parameter values Filter types Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration Parameter values The following parameter values can be set Filter type Fluoroscopy mode Available parameters Recursive Continuous fluoroscopy Level 0 1 2 3 filter 1 2 4 8 images Stack filter Continuous fluoroscopy 1 2 4 8 16 images Edge filter Continuous fluoroscopy Level 1 2 0 3 4 continuous pulse fluoroscopy Snapshot Table 6 5 Filters for subtraction modes with CO 6 5 3 Windowing settings for subtraction modes Function Parameter range F3 c02 This menu is used for setting default values for the width W and level L of the contrast window This is done separately f
20. Options Printer transparent film depending on printer model 1 roll DICOM RJ45 interface with Cat 5 patch cable 10 m Art No 24452 Wireless LAN transceiver Fiber optic connection FOC ST coupling 10base FL or 100base FX Table 1 2 Accessories 1 4 i P_26471_CD_28218 EN 1 Ziehm 8000 1 05 2009 1 General Information Accessories USA Qty Operating Instructions CD Operating Instructions Technical Manual CD Technical Manual CD Service Manual CDRH Maintenance Report Specifications and Certificates All systems Coupling cable with UL marking 7 5 m Art No 24815 a a ak Equipotential grounding cable 6 m Art No 24054 Mounting material Art No 88711 Skin cone with safety label Art No 89694 Touch up paint RAL 9001 Art No 89655 Touch up paint RAL 6027 Art No 89615 a a oa Options CD writer CD RW 640 MB Video printer Operating instructions for video printer Printer paper 1 roll Printer transparent film depending on printer model 1 roll DICOM RJ45 interface with Cat 5 patch cable 10 m Art No 24452 Table 1 3 Accessories USA Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 1 General Information 1 6 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 2 2 1 Safety Instr
21. System on a Pallet 12 9 Packing the ramp Prerequisites Before packing the ramp do the following Fold the wrap foil on the pallet around the system components and heat seal them but leave a small opening Remove the air from the wrap foil through the opening using vacuum suction Heat seal the small opening Tape the wrap foil with shipping tape To mount the ramp on the pallet do the following Position the ramp on the pallet as illustrated in Fig 12 22 Fig 12 22 Position of the ramp on the pallet Position board 1 on the side of the ramp and attach it using two screws 5 x 60 mm gt Fig 12 23 Put the big cardboard box over the pallet Attach the cardboard box to the pallet using clout nails Position board 2 between cardboard box and board 1 already attached to the ramp Ziehm 8000 12 17 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet Board 3 Board 4 Board 2 Board 1 Ramp Fig 12 23 Packing of the ramp e Attach board 2 to the outside of the cardboard box using three screws 5 x 40 mm gt Fig 12 24 Screws attaching the lateral boards boards 2 and 3 Fig 12 24 Attachment of the lateral boards e Position 3 on the opposite inside of the cardboard box and attach board 3 using three screws 5 x 40 mm from the outside of the cardboard box e Attach board 4 to the boards 2 and 3 using two screws 4 x 40 mm e Now continue with the
22. Video cable labeled LM Radiation warning lamp cable labeled Xray Ind Disassembling the System Dismounting the 23 or 24 flat screen monitors Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 11 Disassembling the System e Pull the ground wire from the monitor neck down into the monitor cart base Radiation warning lamp cable labeled Xray Ind Video cable labeled LM Power plug of the P flat screen monitor Ground wire Fig 11 1 Cables inside monitor neck and monitor cart base e Undo the 4 screws M6x16 that attach the flat screen monitor to the monitor cart base NOTE Since the flat screen monitor will be mounted onto a transport rack you do not need the screws M6x16 that held the monitor head to the monitor cart base at this point Put these screws in the accessories box gt Ch 12 5 p 12 5 e With the help of a second person lift the flat screen monitor off the monitor cart base WARNING WARNING The flat screen monitor cannot be lifted by one person alone Therefore always ask a second person to assist you in lifting the flat screen monitor off the monitor cart base NOTICE Never place the flat screen monitor directly on some surface always place them on the transport rack e Carefully place the monitor head on the transport rack Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 11 Disassembling the System Transport rack Fig
23. WARNING When handling detergents and solvents strictly observe the safety instructions provided by the respective manufacturer Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 12 1 12 Mounting the System on a Pallet 12 2 Scope of validity Information These instructions apply to the shipment of Ziehm 8000 X ray systems on pallets Please pay special attention to the additional information referring to sea transport 12 3 Environmental conditions The system must not be exposed to extreme ambient conditions The following minimum maximum values must not be exceeded during storage or operation Storage transport Temperature 5 C to 55 C Relative air humidity 20 70 Operation Temperature 15 C to 35 C Relative air humidity 70 max ISWARING WARNING Do not put the system into service at temperatures below 15 C NOTICE Temperatures above 40 C and relative air humidity above 60 may cause stains on the printer s heat sensitive paper 12 2 ehm 8000 Zi P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet 12 4 Packing material and contents 12 4 1 Material Article Art No en Pallet 26374 Transport rack with 66245 4 screws M10x25 with washers and 56172 57032 4 wood screws 10x40 56285 Steel retaining brackets Retaining bracket 1 with 65827 2 wood screws 10x40 56285 2 retaini
24. a padding on the pallet and with the assistance of a second person lay the monitor cart down on its side on the pallet WARNING WARNING Due to the heavy weight of the monitor cart there is a risk that it will tilt over if not blocked Therefore never move the cart alone into a lateral position always ask a second person to assist you e Remove the bubble wrap from the monitor cart wheels e Undo the screws holding the transport rack to the monitor cart and remove the transport rack e Putthe monitor cart back into an upright position with the help of a second person and remove the padding from the pallet e Carefully push the monitor cart down from the pallet using a ramp e Remove the wrap foil from the pallet You may now proceed to mounting the flat screen monitors to the monitor head Ch 4 1 2 p 4 5 3 8 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 4 Assembling the System BEAUTION CAUTION Only authorized personnel gt p 1 2 are allowed to unpack and assemble the system 4 1 Assembly For international shipments on a pallet the monitor head 23 or 24 flat screen monitor 18 flat screen monitors of the Ziehm 8000 has been dismounted Consequently you must reattach the monitor head to the monitor cart base In addition you must establish all cable connections gt Ch 4 2 p 4 8 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 4 Assembling the System 4 1 1 Mounting t
25. and those directly connected to acc to IEC 61000 3 2 the public low voltage power supply network Voltage fluctuations Complies that supplies buildings used for domestic purposes Table A 1 Guidance and Manufacturer s Declaration electromagnetic emissions Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 A 1 Appendix A Guidance and Manufacturer s Declaration electromagnetic immunity The Ziehm 8000 Ziehm Compact and Ziehm Compact Litho are intended for use in the electromagnetic environment specified below The customer or the user of the Ziehm 8000 Ziehm Compact or Ziehm Compact Litho should assure that the systems are used in such an environment Immunity tests IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD acc to IEC 61000 4 2 6 kV contact discharge 8 kV air discharge 6 kV contact discharge 8 kV air discharge Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst acc to IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge acc to IEC 61000 4 5 1 kV differential mo
26. during each DSA NONE You must always set the Always option under DSA mask Under Bri sensor gain you define to which extent the system adjusts the screen backlight brightness to the ambient light conditions You can select a value between 1 weak gain and 20 strong gain 6 54 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration Under Bri sensor limit you specify a maximum value for the screen backlight brightness You can select a value between 0 and 32 Under Bri sensor speed you define how long it takes to adjust the screen backlight brightness to changes in ambient light conditions You can select a value between 10 s and 60 s Here you define whether the histogram is displayed or not Here you define whether the dose area product is displayed on the live screen or not Here you define whether the system checks the internal image data list for corrupt files during power up Always set the option On here To match the virtual collimator to the iris collimator do the following e Press the up arrow or down arrow key until the cursor is on the Collimator offset menu item e Press the close iris collimator key until the collimator is closed as far as possible e Initiate radiation and terminate it again e Press the close iris collimator key The virtual collimator appears on the screen e Press the left arrow or right arrow key until the actual and the virtual collimator coincide e
27. precautionary measures with respect to EMC and must be installed and put into service in accordance with the EMC guidelines contained in the accompanying documents 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 WARNING WARNING Using components other than those specified may result in increased electromagnetic emissions or reduced electromagnetic immunity Please observe also the Manufacturer s Declaration concerning Electromagnetic Compatibility according to IEC 60601 1 2 in the Technical Manual 2 4 Protective grounding The system must be connected only to power systems having a separate ground connection 2 5 Equipotential grounding Heart and brain If you use the system in combination with other equipment for examinations examinations of the heart or brain or the surrounding anatomical regions equipotential grounding is required for patient and operating staff safety IEC 60601 1 1 2 4 ehm 8000 Zi P_26471_CD_28218 EN 11 05 2009 2 Safety Instructions 2 6 Laser radiation As an option the system may be equipped with a laser positioning device at the image intensifier and or generator The laser positioning device uses diode laser module
28. the 23 or 24 flat screen monitor 4ssesr sn 4 1 2 Mounting the 18 flat screen monitors uuu 4224444en nennen nennen 4 2 Gable c nnections aa nennen alikem 4 3 BIGCOM connection 2 RR II 5 Putting the System into Service 5 11 Eemperaluren rsme are a a deed othe it enti Aaah edna 5 2 First power up of the system 0 0 cccceeeeeeeceeeeeeeceeeeeeeeeeeseceeceacaaeaeseeeeeeeeeeeess 5 3 Setting up the system 22uusensnannnnesnnnnnanennnnannnnnnnnnnnnunnnnannnnnnnnnnan nennen 6 Configuration 6 1 Overview in a ne ee ne nur 6 2 sersettings Anni Irina 6 2 1 Activating automatic image SWAPPING urs2ss nn nnnnnnnnnennnnn nen 6 2 2 Displaying a crosshair 444ss44444nnnnnnnnnnnnennnnnnnnnnnnnnnnnnnnnnn ann 6 2 3 Function of the F key ucenennsnssnennnannsenennnnnnnennennsnnnennnnnnnnennnnnnn 6 2 4 Storage medium for image retrieval u4us nennen 6 2 5 Setting the cine loop SPCOd ee eee cece eee eeeeeeceeececeeeeeeeeeeeeteesennteaees 6 2 6 Setting the cine loop IENgth 0 ceeeecceeeeeeeeeeeeenneeeeteeeeeeeeteeaaeees 6 2 7 Combining DSA with a cine loop Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 Contents 6 2 8 Showing or hiding the native image 44ns nn 6 6 6 2 9 Selecting the storage medium for data retrieval with DICOM Dir 6 6 6 2 10 Defining the storage format for removable storage media
29. the wrap foil open and fold it back Fig 3 3 Unwrapped pallet 32 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 3 Unpacking the System 3 1 2 Unpacking the pallet on drop shipments In drop shipments the pallet is equipped with a ramp This ramp is required to move the C arm stand off the pallet To unpack the full pallet do the following Fig 3 4 Packed pallet e Cut the plastic straps and remove them e Check the two shock watch devices e Remove the shipping tape from the cardboard box and open it e Unfasten the screws that attaches board 4 to board 3 and 2 and remove board 4 gt Fig 3 5 Board 3 Board 4 Board 2 Board 1 Ramp Fig 3 5 Ramp packing in the cardboard box e Unfasten the screws on the outside of the box attaching board 3 on the inside of the cardboard box gt Fig 3 6 and remove board 3 Ziehm 8000 3 3 P_26471_CD_28218 EN 11 05 2009 3 Unpacking the System Screws attaching the lateral boards boards 2 and 3 Fig 3 6 Screws for attachment of the lateral boards e Unfasten the screws on the outside of the box attaching board 2 on the inside of the cardboard box gt Fig 3 6 and remove board 2 e Remove the clout nails holding the cardboard box to the pallet e Lift the cardboard box off the pallet mel e nn T Fig 3 7 Pallet and ramp with foil wrapping e Unfasten the two screws attaching board 1 on the ramp and remove boar
30. 09 6 29 6 Configuration Windowing step Continuous pulse Snapshot This value determines which windowing step is automatically set by the system for the corresponding anatomical program after power up provided thatthe step windowing mode has been activated gt Ch 6 5 1 p 6 26 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 continuous 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 6 5 2 2 Filters for subtraction modes Filter types For each of the subtraction modes DSA RSA and MSA the values for the following filters can be programmed Recursive filter independent settings for normal view magnification 1 and magnification 2 Stack filter Edge filter Recursive Fitter 2 Fig 6 23 Filter Factors for DSA Key menu 6 30 Ziehm 8000 i P_26471_CD_28218 EN 11 05 2009 6 Configuration The following parameter values can be set Filter type Fluoroscopy mode Available parameters Recursive Continuous fluoroscopy Level 0 1 2 3 filter 1 2 4 8 images Stack filter Continuous fluoroscopy 1 2 4 8 16 images Edge filter Continuous fluoroscopy
31. 09 6 Configuration 6 5 2 1 Filter types Filters for anatomical programs For each of the anatomical programs Organ 0 Organ 1 Organ 2 and Soft the values for the following filters can be programmed F Parameter values Recursive filter for continuous fluoroscopy independent settings for normal view magnification 1 and magnification 2 Stack filter for continuous fluoroscopy Edge filter Default windowing step after power up Stack filter for continuous pulse fluoroscopy Stack filter for snapshot ig 6 22 Filter Factors for Organ Key 8 Recursive filter Recursive magn 1 2 Recursive magn 2 2 Stack filter Edge filter Windowing step 2 Continuous pulse 2 Snapshot Filter Factors for Organ Key 0 menu The following parameter values can be set Filter type Fluoroscopy mode Available parameters Recursive Continuous fluoroscopy Level 0 1 2 3 filter 1 2 4 8 images Stack filter Continuous fluoroscopy 1 2 4 8 16 images Edge filter Continuous fluoroscopy Level 1 2 0 3 4 continuous pulse fluoroscopy Snapshot Table 6 2 Filters for anatomical programs 6 28 Ziehm 8000 i P_26471_CD_28218 EN 11 05 2009 6 Configuration stack filter Filter type Fluoroscopy mode Available parameters Windowing Continuous fluoroscopy Level 2 1 0 1 2 step continuous pulse fluoroscopy Snapshot Cont
32. 1_CD_28218 EN 11 05 2009 6 Configuration e Select the Query server menu item The DICOM Settings Query Server menu appears I IP H AE P I I Al Qu j T DECOM server PATIENT ROOT 8 HK 3 PINI _ C1 y Fi Save F2 Cancel F3 abc F4 F5 F6 Verify Fig 6 28 e Enter the network parameters When the cursor is in certain lines of the input screen additional function keys for entering lower case letters and special characters are displayed DICOM Settings Query Server menu e To enter lower case letters press key F3 abc e To enter a special character press and hold down key F4 lt or F5 gt until the desired special character appears e Press key F6 Verify The system checks the network connection between SCU and SCP by means of a ping the DICOM settings e g AE title and common SOP classes association negotiation It sends an ECHO request to the SCP and waits for an ECHO response If all network parameters have been entered correctly the message Verification successful is displayed error messages Ch 6 5 4 7 p 6 51 The retrieve server settings are entered in the DICOM Settings Retrieve Server X menu If any requested images cannot be found on the query server Ziehm NetPort will automatically select the appropriate retrieve server using the retrieve AE ti
33. 2009 7 Technical Data 7 5 Air kerma In compliance with the requirements of international standards e g 21 CFR 1020 32 d 1 IEC 60601 2 43 Ziehm fluoroscopy systems with automatic exposure rate control are not operable at any combination of tube voltage and tube current which will result in an exposure rate in excess of 88 mGy min at the point where the center of the useful beam enters the patient Image intensifier input plane blocker Dose probe Interventional reference point 97 0 cm Focal spot Fig 7 2 Interventional reference point Ziehm 8000 The air kerma that is displayed on the system s user interface refers to the interventional reference point according to IEC 60601 2 43 and 21 CFR 1020 32 d 10 00 Air kerma deviation 5 00 5 23 ea 0 00 90 50 60 70 80 90 100 110 x 3 53 5 00 gt 2 7 72 io SS 3 10 00 a 012 29 15 00 18 77 20 00 Voltage in kV Fig 7 3 Typical deviation of dose as compared to an external calibrated measurement system Ziehm 8000 7 7 P_26471_CD_28218 EN 11 05 2009 7 Technical Data 7 6 Focal spot position Fig 7 4 Focal spot position on systems with 23 cm i i 7 8 ehm 8000 Zi P_26471_CD_28218 EN 11 05 2009 7 Technical Data 7 7 Dimensions 7 7 1 Ziehm 8000 C arm stand with 23 cm i i Fig 7 5 Dimensions of C arm stand on systems with 23 cm i i
34. 334 F7 1A slow 5x20 mm 17019 F8 1A slow 5x20 mm 17019 F9 1A slow 5x20 mm 17019 Supply for monitor rotation Table 9 1 Transformer fuses Rating Art No Function F1 15 A fast 6 3x32mm 17076 230V power supply F4 15 A fast 6 3x32mm 17076 F5 1A slow 5x20 mm 17019 Load resistor RL for transformer 11079 F7 100 mA slow 17056 Input of transformer 5x20mm 11080 on U333 F8 250 mA slow 17001 Output of transformer 5x20mm 11080 on U333 Table 9 2 Fuses on U333 Rating Art No Function F2 20 A slow 6 3x32 mm 17044 120V power supply F3 20 A slow 6 3 x32 mm 17044 Table 9 3 Fuses on the transformer mounting plate Ziehm 8000 9 3 P_26471_CD_28218 EN 11 05 2009 9 Replacing Components Name Rating Function FIA 15 A slow Power fuse for 210 220 230 240 Vac 20 A slow Power fuse for 105 110 115 120 Vac F1B 15 A slow Power fuse for 210 220 230 240 Vac 20 A slow Power fuse for 105 110 115 120 Vac Table 9 4 External fuses on the monitor cart Ziehm 8000 9 4 i P_26471_CD_28218 EN 11 05 2009 10 Problem Report 10 1 List of error and alert messages Code Type Description Measures E 16 Alert Hand switch 1 pressed during Release hand switch and power up acknowledge alert message by briefly pressing hand or foot switch Caution On systems with four pedal foot switch hand switch 1 foot switch 1 left to right
35. 6 2 5 Setting the cine loop speed The Cine speed menu item allows you to control the number of frames per second that the system uses for acquisition and playback of a cine loop Depending on the system configuration you can choose between 1 2 4 8 12 5 or 25 frames per second 6 2 6 Setting the cine loop length The Cine length menu item allows you to control how many single images frames are saved automatically by the system during a cine acquisition run You can choose between 50 100 150 200 or 250 images 6 2 7 Combining DSA with a cine loop The DSA Cine menu item allows you to control whether the system automatically acquires a cine loop each time you activate the DSA mode DSA Cine On When you press the DSA key on the C arm stand and then initiate radiation the system automatically acquires a cine loop after having acquired the DSA mask image DSA Cine Off When you press the DSA key on the C arm stand and then initiate radiation the system automatically generates a single DSA image CD or hard disk Number of frames per second Total number of images Single image or cine loop with DSA Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 5 6 Configuration 6 2 8 Showing or hiding the native image Display native image or not The DSA nativeimg menu item allows you to control whether the native image is displayed or not on the reference screen during generation of a DSA MSA
36. 9 6 Configuration 6 5 4 5 Configuration of Worklist and MPPS Search arguments for Worklist Server Operator s name I BRE a Danas S 3 u rd pape lt gt When configuring the worklist server you specify not only the general network parameters gt Ch 6 5 4 1 p 6 33 but also one or several search arguments Modality You can limit the Worklist to images of the XA or CR SOP class gt p 6 34 Station AE title You can limit the Worklist to jobs that are assigned to the AE title ZiehmNetPort specified YES NO no limitation Time span The default setting for the time span is 0 24 o clock of the current day You may set a shorter period of time full hours only Location You can limit the Worklist to jobs that are related to the location of the respective Ziehm NetPort e g OR 1 In addition you must enter the name of the radiological technologist under Operator s Name To configure the worklist server do the following Press the MENU key The Configuration Menu appears Select the Service settings menu item Type the password and press the Enter key Select the DICOM settings menu item Type the password and press the Enter key Select the Worklist server menu item The DICOM Settings Worklist Server menu appears 6 42 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration DICOM Settings Worklist Server AE title DI Port addr IP a
37. Allen key 2 mm e Foot switch Unscrew the strain relief using an Allen key 2 5 mm e Open the twist lock Ziehm 8000 9 1 P_26471_CD_28218 EN 11 05 2009 9 Replacing Components e Unplug the cable e Plug in the cable of the new switch e Close the twist lock e Foot switch Screw down the strain relief using an Allen key 2 5 mm e Screw down the safety sleeve of the twist lock using an Allen key 2 mm 9 2 Coupling cable Coupling cable connection VIDEO 501 Coupling cable plug Locking lever latching on both sides Fig 9 3 Coupling cable connection To replace the coupling cable do the following e Press the locking lever toward the unit The latches open e Unplug the coupling cable e Plug in the new coupling cable e Pull the locking lever away from the unit so that the latches lock 9 2 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 9 Replacing Components 9 3 Fuses Rating Art No Function Transformer TR1 11079 F2 10A slow 5x20 mm 17007 Supply of lifting motor F3 10A slow 5x20 mm 17007 Supply of U326 heating current Transformer TR2 11081 F1 2A slow 5x20 mm 17006 Line side fuse TR2 F4 4A slow 5x20 mm 17021 Supply for component 1 18V on U333 F5 4A slow 5x20 mm 17021 Supply for different 5V F6 1A slow 5x20 mm mog S kegssion 1
38. Here you may enter any text for labeling the film default setting none 6 46 ehm 8000 Zi P_26471_CD_28218 EN 11 05 2009 6 Configuration 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 Min Density or Max Density Here you define the desired minimum or maximum print density default setting none setting options 0 65535 User Configuration Here you define whether an additional dialog for making the print settings is displayed or not when the user selects the DICOM Print function default setting Off setting options Off On Function Here you define which function is assigned to function key F5 NetOutput in the Mosaic menu Output submenu default setting Print setting options Print DICOM Print Storage2 DICOM Store Navigation Navigation for Brainlab Print Server 2 Only the Print DICOM Print function is available To configure print server 1 do the following e Press the MENU key The Configuration Menu appears e Select the Service settings menu item e Type the password and press the Enter key e Select the DICOM settings menu item e Type the password an
39. NU 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 6 24 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration 6 5 Service settings The Service Settings menu is used for modifying different system Function parameters which affect both the quality of the fluoroscopic image and the user interface The Service Settings menu is password protected If you are an Password authorized person you can obtain the password from your local Ziehm dealer Service Settings Step windowing Enter Filter factors Subtr windowing DICOM settings System settings Monitor calibration HEDIS data Software update Fig 6 19 Service Settings menu Ziehm 8000 6 25 P_26471_CD_28218 EN 11 05 2009 6 Configuration 6 5 1 Step windowing Function 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 NOTE For the subtraction modes no step windowing is available Step Windowing Step 2 W Step 2 L Step 4 W 2 Step 1 L Step 41 W 2 Step L Step 2 W Step 2 L Windowing Fig 6 20 Step Windowing menu Parameter range The availabl
40. Press key F1 Save e Press the up arrow key The Collimator factor menu item is selected e Press the open iris collimator key until the collimator is completely open e Press the left arrow or right arrow key until the actual and the virtual collimator coincide Ambient light sensor limit value Ambient light sensor speed Histogram Dose area product File check Collimator factor and collimator offset 8 III IM a f z C4 8 gt o gt s A Q Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 55 6 Configuration F1 Save Language F1 Save F2 Cancel e Press key F1 Save e Repeat the collimator offset and collimator factor adjustment alternately until the deviations are minimal You can choose between the following languages for the user interface DEUTSCH ENGLISH FRANGAISE ITALIANO ESPANOL SVENSKA POLSKI CZECH To apply the settings do the following e Press key F1 Save e Switch off the system e Switch the system back on The new settings are valid now To discard system settings that have not been applied yet do the following e Press key F2 Cancel or e Quit the Service Settings menu without applying the settings 6 56 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration ez 0 6 HEDIS data To upload data from the system to a USB stick do the following e Inthe Service S
41. X ray symbol 5 1 Z Ziehm Compact Cable connections 4 9 Dimensions 7 12 Weight 7 4 Ziehm Compact Litho Dimensions 7 13 Ziehm 8000 i P_26471_CD_28218 EN 1 1 05 2009
42. a teiaa a eai ae a arara 12 19 A 1 A 1 Manufacturer s Declaration concerning Electromagnetic Compatibility acc to IEC 60601 1 2 Class B haa rr er EE EE TERE AIRE A ENS A 1 Index i Ziehm 8000 III P_26471_CD_28218 EN 11 05 2009 Contents IV Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 1 General Information This manual is designed to enable owners and operators of the system to operate the systems described herein safely and efficiently Ziehm 8000 with the options Ziehm Compact and Ziehm Compact Litho software version L2 04 or higher All illustrations in these Operating Instructions are exemplary only and may differ from the actual situation The present Operating Instructions describe a system with maximum configuration The system configuration chosen by you may not contain all options and functions described here For several system options separate operating instructions may be available They are supplied with the system provided that the system configuration includes the respective option You will find a corresponding reference to those operating instructions in the relevant sections of this document The system does not produce any waste during operation When the system has reached the end of its useful service life the relevant 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 acco
43. able 1 8 2 0 2 2 2 4 2 6 Press the MENU key The on screen menu disappears 6 4 2 6 Setting up the display To set up the display do the following Press the MENU key The on screen menu with the Picture tab displayed on top appears Depending on the set video source gt Ch 6 4 2 4 p 6 14 the Picture tab shows the following items as a maximum Horizontal Position Vertical Position Sharpness Phase Frequency Overscan 24 flat screen monitor only Scaling 23 flat screen monitor only 24 flat screen monitor only SmartSync SCROLL OO MENU MENU Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 17 6 Configuration SCROLL MENU Press the SCROLL key until the desired item is highlighted Press the or arrow key until the desired setting is displayed or marked as selected The desired value is set Repeat these two steps for any further parameter you want to set Press the MENU key The on screen menu disappears 6 4 2 7 Setting up the menu SCROLL On the Setup tab you can make different settings that affect the menu display In addition you may lock the menu gt Ch 6 4 2 8 p 6 19 and select the menu language gt Ch 6 4 2 3 p 6 13 The Configuration tab on the 24 flat screen monitor furthermore shows the backlight operating hours clocked up so far and th
44. allet and put the monitor cart into the position shown below gt Fig 12 6 with the help of a second person WARNING WARNING Due to the heavy weight of the monitor cart there is a risk that it will tilt over if not blocked Therefore never move the unit alone into the position illustrated gt Fig 12 6 always ask a second person to assist you Fig 12 6 Monitor cart lying flat on the pallet e Tape foam rubber to the cable support gt Fig 12 7 e Wrap the wheels in bubble wrap Ziehm 8000 12 7 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet e Fasten the transport rack at the bottom plate of the monitor cart using the four screws provided for that purpose Cable support Screws for the transport rack Fig 12 7 Monitor cart with transport rack attached e Putthe monitor cart back into an upright position with the help of a second person and remove the foam rubber block from the pallet e Position the monitor cart on the pallet as illustrated in Fig 12 8 at a distance of 180 mm 80 mm from the pallet edge Fig 12 8 Position of the monitor cart on the pallet e Attach the transport rack to the pallet using the corresponding wood screws 12 8 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet USA Drill three holes for the round head square neck bolts Fasten the transport rack with the corresponding wood screw fr
45. ards e g 21 CFR 1020 32 d IEC 60601 2 43 the system emits less than 88 mGy min in any operating condition Voltage frequency rating 230 Vac 10 50 60 Hz Power supply fuse rating Required residual current circuit breaker RCD C 16 A tripping characteristic C acc to VDE 0641 Part 11 DIN EN 60898 IEC 898 In 2 16 A Ian 30 mA Typical current consumption 8 A continuous 15 A momentary Power input fuse 15 A slow 2 pcs System Maximum line impedance Equipment protection classification lt 0 6 Q Protection Class Type B ordinary equipment continuous operation Radiation controlled area with generator in lowermost position and C arm vertical 15 cm i i 3m 23 cm i i 4m Table 7 1 Technical data Ziehm 8000 Ziehm Compact and Ziehm Compact Litho Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 7 Technical Data Voltage frequency rating 230 Vac 10 50 60 Hz Power Fluoroscopy 40 110 kV 0 2 6 mA Direct radiography 40 110 kV 20 mA Operating frequency 20 kHz Max operating data Fluoroscopy 110 kV 0 2 6 mA Direct radiography 110 kV 20 mA Exposure time 0 1 4 s Max power output Fluoroscopy 660 W z Single pulse 880 W 2 Direct radiography 2200 W Nominal electric power 2000 W at 100 kV 20 mA 0 1s X ray tube Dual focus stationary anode tube Focal spot nominal size Fluor
46. at the menu is unlocked is displayed When you press one of the keys on the keypad the corresponding on screen menu appears MENU MENU SCROLL MENU SCROLL Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 19 6 Configuration 6 4 2 9 Restoring the factory settings MENU SCROLL 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 e Select the Defaults tab with the help of the or arrow keys DYI analog 1024 x 768 60 Hz Factory Defaults Fig 6 14 The Defaults control on a 18 or 23 flat screen monitor Factory Defaults User Defaults 1 OOK EMPTY 0 User Defaults 2 JOCKEMPT Y User Defaults 3 RRKEMPTY KKK User Defaults 4 KKKEMPTYKRK User Defaults 5 KRKEMPTY KKK d Fig 6 15 The Configuration control on a 24 flat screen monitor e Press the Scroll key The Factory Defaults menu item is selected e Press the arrow key The on screen menu disappears All settings are reset to the factory values 6 20 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration 6 4 3 Setting flat screen monitors of type 2 NOTE The menu display for setting the brightness and contrast is not locked Do not change the values in order
47. ation 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 warning lamp may light up This is a system test and does not mean that radiation is released 5 3 Setting up the system After switching on the system for the first time you can make various Bs A ENU customer specific settings for the system if this has not already been M done at the factory Entering the As a minimum it is recommended that you enter the relevant hospital hospital data data under Configuration Menu Basic Settings This data will then be displayed automatically when you create new patient folders in the Patient Data Input menu eliminating the need to enter it for each new patient Further settings For a detailed description of all other setting options please refer to Ch 6 p 6 1 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration 6 1 Overview A large number of parameters can be preset for the Ziehm 8000 This is done in a configuration menu To switch between the different menu items do the following e Press the up arrow or down arrow key until the cursor is on the desired menu item To select a setting option do the following e Press the left arrow or right arrow key until the
48. ave reached room temperature before the system is put into service in order to avoid damage to the system as a result of condensation WARN WARNING Do not operate the system until the equipment has reached a safe operating temperature of 15 C to 35 C with no condensation present Otherwise severe equipment damage may result 5 2 First power up of the system e Make sure that the inclination of the system does not exceed 5 from the level in operating position e Ensure that all electrical connections are properly established gt Ch 4 2 p 4 8 e Put on suitable protective clothing e Switch on the system You can find an ON key and an OFF key on the control panels of both the C arm stand and the monitor cart Each of the two keys switches on or off both system components simultaneously During power up the system performs a self test The value 0 appears on the operating value displays The radiation time display shows the global software version of the system The temperature symbol and the X ray symbol on the C arm stand control panel light up for a few seconds After power up a test image appears on the live screen The default settings after power up vary from system to system according to the customer specific setup Room temperature Preparation OFF Power up ON Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 5 1 5 Putting the System into Service NOTE Due to background radi
49. ction enables you to check whether all parameters have been entered correctly error messages Ch 6 5 4 7 p 6 51 The default port address for DICOM is set to 104 and cannot be reconfigured In some lines of the network parameter input screen you may enter certain special characters Function keys F4 lt and F5 gt appear in this case A list of the available special characters is displayed above these two function keys As long as you hold down one of these two function keys the available special keys are displayed one after the other in the order of the list With F4 lt you can scroll forward in the list With F5 gt you can scroll backward in the list 6 5 4 2 Configuration of Storage and Storage Commitment Storage information model Image attributes MENU When configuring the storage server you specify not only the general network parameters gt Ch 6 5 4 1 p 6 33 but also the storage information model SOP class Service Object Pair You can choose between the following options XA X ray Angiography CR Computed Radiography SC Secondary Capture The original images furnished by Ziehm NetPort are of type XA Since some servers do not support the XA SOP class CR and SC are provided as alternatives Under Image attributes included you define which HEDIS filter algorithms are applied to the DICOM image prior to transfer By default all attributes are set to Off and the raw i
50. d 1 e Lift the ramp off the pallet and place it to the short front side of the pallet e Remove the fixing clamps from the drill holes on the pallet 3 4 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 3 Unpacking the System Fixing clamp Fig 3 8 Fixing clamp hooked up in the drill holes on the pallet e Attach the ramp to both sides of the pallet using the fixing clamps gt Fig 3 9 Fixing clamp Fig 3 9 Fixing clamps attaching the ramp e Cut the wrap foil open and fold it back en I nn Sy fi ay f Fig 3 10 Unwrapped pallet Ziehm 8000 3 5 P_26471_CD_28218 EN 11 05 2009 3 Unpacking the System 3 1 3 Unpacking the monitors 3 1 3 1 Flat screen monitors The monitors are on a transport rack that is mounted on the pallet To unpack the flat screen monitors do the following e Undo the wood screws holding the transport rack to the pallet e Remove the bubble wrap from the monitors e Lift the flat screen monitors off the pallet and carefully place them on a suitable surface e Undo the four screws M6x12 that attach the transport rack to the monitor neck The screws M6x16 needed for attaching the monitor head to the monitor cart base are contained in the cardboard box with the accessories gt Ch 1 3 p 1 4 3 1 4 Unpacking the C arm stand The C arm stand is attached to the pallet by means of retaining brackets Fig 3 11 Mobile C arm stand on the pallet To unpac
51. d press the Enter key e Select the Print server menu item The DICOM Settings Print Server 1 menu appears Configuring print server 1 lt gt Le JF Eu en Ser rae gt 5 let lt gt Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 47 6 Configuration DICOM Settings Print server 1 IP addr DICOM server IP subnet mask Host mame DICOM server AE title DICOM server Port addr DICOM server 192 168 127 081 255 255 255 808 ZI DICOM RADIN_DICOM_SCP 82918 F3 ADEs F4 F1 Save i Configuring print 7 Cc N z ai a 192 168 127 254 192 168 127 011 IP address gateway IP address ZiehmNetPort AE title ZiehmNetPort MODALITY4 Number of copies 4 Print priority HIGH Media type PAPER Film destination MAGAZINE Film session label VISTA Film size ID SINKABIN Number Page 3 Min Density Max Density User configuration On Function Print Fi F2 F4 ES F6 Save Cancel lt gt Verify Fig 6 34 DICOM Settings Print Server 1 menu e Enter the network parameters When the cursor is in certain lines of the input screen additional function keys for entering lower case letters and special characters are displayed e To enter lower case letters press key F3 abc e To enter a special character press and hold down key F4 lt or F5 gt until the desired special character appears
52. ddr Verification successful Do you want to activate MPPS PSOR K PIN Cl FA F2 F3 F4 F5 F6 Save Cancel abc lt gt Verify Fig 6 31 DICOM Settings Worklist Server menu e Enter the network parameters When the cursor is in certain lines of the input screen additional function keys for entering lower case letters and special characters are displayed e To enter lower case letters press key F3 abc F3 aber e To enter a special character press and hold down key FA lt or F4 F5 gt until the desired special character appears lt ES e Enter the desired search arguments gt e Enter the name of the radiological technologist under Operator s Name e Press key F6 Verify F6 The system checks the network connection between SCU and SCP by means of a ping the DICOM settings e g AE title and common SOP classes association negotiation It sends an ECHO request to the SCP and waits for an ECHO response If all network parameters have been entered correctly the message Verification successful is displayed error messages Ch 6 5 4 7 p 6 57 e Press key F1 Save F1 Save Ziehm 8000 6 43 P_26471_CD_28218 EN 11 05 2009 6 Configuration MPPS Server When configuring the MPPS server you specify only the general network parameters gt Ch 6 5 4 1 p 6 33 The search arguments are irrelevant for the MPPS serv
53. ddr DICOM server menu item e Press key F4 lt The DICOM Settings Print Server 1 menu appears 6 50 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration 6 5 4 7 DICOM Verification error messages The DICOM Verification function enables you to check whether all parameters have been entered correctly If the verification procedure is not successful one of the following error messages is displayed Error message Cause s No connection to server is displayed in the respective interface language Server is missing or not switched on or wrong IP address PC TCP resident module is not loaded aborting program up to SW 15 No connection to server Network interface card driver is not loaded PCTCP in autoexec bat is not set Failed to connect to remote host v5 up to SW 15 No connection to server Server is not switched on IP address of DICOM server is wrong IP subnet mask is wrong Unable to resolve host name to ip address v5 up to SW 15 No connection to server Host name of DICOM server is wrong Association negotiation failed v5 up to SW 15 SYSTEM ERROR 23 AE title of DICOM server is wrong Port address of DICOM server is wrong AE title of Ziehm NetPort is wrong when trying to connect to the server no common SOP classes mergecom app Connection aborted before association negotiation was completed v5 up to SW 15 No respon
54. de 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines acc to IEC 61000 4 11 lt 5 Ur for 0 5 cycle gt 95 dip 40 U7 for 5 cycles 60 dip 70 Ur for 25 cycles 30 dip lt 5 Urfor5s gt 95 dip lt 5 U for 0 5 cycle gt 95 dip 40 UT for 5 cycles 60 dip 70 Ur for 25 cycles 30 dip lt 5 Urfor5s gt 95 dip Mains power quality should be that of a typical commercial or hospital environment If the user of the Ziehm 8000 Ziehm Compact or Ziehm Compact Litho requires continued operation during power mains interruptions it is recommended that the Ziehm 8000 Ziehm Compact or Ziehm Compact Litho be powered from an uninterruptible power supply or battery Power frequency 50 60 Hz magneticfield acc to IEC 61000 4 8 3 V m 3 V m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Ur is the AC mains voltage prior to application of the test level Table A 2 Guidance and Manufacturer s Declaration electromagnetic immunity A 2 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 Appendix A Guidance and Manufacturer s Declaration electroma
55. desired option appears or e Enter the desired value using the alphanumeric keypad on the control panel General A Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 1 6 Configuration Opening the 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 Basic settings Monitor settings only Ziehm 8000 with 23 or 24 flat screen monitor Service settings Configuration Menu User settings Basic settings Monitor settings Service settings Fig 6 1 Configuration Menu Ziehm 8000 i P_26471_CD_28218 EN 1 1 05 2009 6 Configuration 6 2 User settings In the User Settings menu you can make a number of settings which determine the operation conditions during fluoroscopy User Settings Autotransfer Crosshair F key CD recall Cine speed Cine length DSA Cine CD format USB format DSA nativeimg DICOM Dir from DICOM F4 Save Cancel Fig 6 2 User Settings menu 6 2 1 Activating automatic image swapping 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 Autotransfer Off When you initiate radiation the previous fluoroscopic image on the live screen is rep
56. e Returning to the To return from the DICOM Settings MPPS Server menu to the Worklist server DICOM Settings Worklist Server menu do the following configuration A e Inthe DICOM Settings MPPS Server menu place the cursor on the IP addr DICOM server menu item F4 e Press key F4 lt lt The DICOM Settings Worklist Server menu appears 6 5 4 6 Configuration of the print servers Two print servers You can configure two print servers if you wish Print server 1 can be configured to perform one of the following functions Print DICOM Print Navigation Storage2 DICOM Store Print server 2 can only be configured for the Print function Additional When configuring the print server you specify not only the general parameters network parameters gt Ch 6 5 4 1 p 6 33 but also the following additional parameters Number of copies Here you define the number of hard copies default setting 1 setting options 1 10 Print priority Here you may define a certain priority for the print jobs default setting none setting options HIGH MED LOW Medium type Here you may define a certain printer medium default setting none setting options PAPER CLEAR FILM BLUE FILM 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 Film session label
57. e Phase single phase Strain relief required Voltage 250 Vac Dielectric strength gt 2000 V Current carrying capacity 16 A continuous min Flammability rating acc to UL 94 VO Temperature 40 C to 80 C Mark of conformity VDE or equivalent safety testing and national mark of conformity of country of installation if required Equipment protection classification IP 20 or higher Table 7 2 Power plug specification 7 3 Laser positioning device Laser Class Class 2M acc to IEC 60825 1 2001 11 Max power output of lt 1 mW continuous laser radiation measured at the laser beam apertures Wavelength of the radiation 635 nm Table 7 3 Technical data of laser positioning device Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 7 Technical Data 7 4 Dose meter Additional absorption 2 8 mm Al Sensitivity pC 75 kV 2 7 mm Al HVL gt 800 mGy cm Measuring range of DAP power 0 1 1 0 mGy cm s Voltage range 35 150 kV Voltage correction Fig 7 1 p 7 6 Aluminum equivalent lt 0 4mm Table 7 4 Technical data of dose meter Voltage correction Additional absorption 2 8 mm Al filtration Correction factor Fig 7 1 Voltage correction of dose meter 7 6 ehm 8000 Zi P_26471_CD_28218 EN 1 1 05
58. e BIOS version of the monitor To make the basic menu settings do the following Press the MENU key The on screen menu appears Select the Setup tab with the help of the or arrow keys On the Setup or Configuration tab the following controls are available Position menu Language gt Ch 6 4 2 3 p 6 13 DPMS Enable 23 flat screen monitor only DPMS Enable 24 flat screen monitor only Auto Source Select Lock menu gt Ch 6 4 2 8 p 6 19 Press the SCROLL key until the desired item is highlighted 6 18 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration Press the or arrow key until the desired parameter value is selected The desired parameter value is set Repeat these two steps for any further parameter you want to set Press the MENU key The on screen menu disappears 6 4 2 8 Locking the menu To disable access to the menu system do the following Press the MENU key The on screen menu appears Select the Setup tab with the help of the or arrow keys Press the SCROLL key until the Lock menu item is highlighted Press the arrow key The menu disappears The message MENU LOCKED is displayed As long as the menu is disabled the message MENU LOCKED is displayed whenever you press one of the keys on the keypad To re enable the menu display do the following Simultaneously press the MENU and Scroll keys A message saying th
59. e a 10 5 10 3 Failure of the power supply cceccecceeeeeeeeeeeeeceeeaeaeeceeeeeeeeseteeesennneaeees 10 6 11 Disassembling the System 11 1 11 1 Dismounting the 23 or 24 flat screen monitorS uuessssssnnennennnnnnnnnennnnn nn 11 1 11 2 Dismounting the 18 1 flat screen monitors 22244nnsnnennnnnnennnnnnnen nenn 11 4 12 Mounting the System on a Pallet 12 1 12 1 Safety instructions and information uurssnsennnnnnnnnnnnnnnnnnnnennnnnnnnn nme 12 1 12 1 1 Safety instructions raain i ea da 12 1 12 2 Oratio Nsa a da ede ax dag ties aa aa m Pac A a aaa R A E AEAEE AAE eee 12 2 12 3 Environmental conditions u nesnnnnnnnnnennnnnnnnnennnnnnnnnennnn nenn nnnn nn 12 2 12 4 Packing material and Contents 4444ennnnnnnnnnnnennnnnnnnnnnnnnnnnnn mann 12 3 12 41 Materials ueri anne Hall 12 3 12 4 2 Parts to be packed 2444444444444snnnnennnnnnnnnnennnennen nennen 12 4 12 5 How to pack the accessories uunsnennnesnnnnnennnnnnnnennennnnennnennnnne nn 12 5 12 6 Packing the monitor cart urssseesennnnnnnnnennnnnnnnnennnnnnnnnnnnnnnnnnnnn nennen ann 12 6 12 7 Packing the C arm stand u 4244444nnnennnnnnnenennnnnnennnnnnennenennnnnne nn 12 10 12 8 Packing the monitor head u 4sssnnnnnennennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn 12 15 12 9 Packing therramp nenne kr ne as 12 17 12 10 Packing the full pallet rorid
60. e 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 Activating the step The Windowing menu item is used for setting either standard windowing windowing mode 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 Default setting The default windowing steps which are activated after power up can be programmed for each individual anatomical program under Configuration Menu gt Service Settings Filter Factors gt Organ 0 Organ 1 Organ 2 Soft gt Ch 6 5 2 1 p 6 28 6 26 ehm 8000 Zi P_26471_CD_28218 EN 11 05 2009 6 Configuration 6 5 2 Filter factors The Filter Factors submenu is used for setting different filter factors for Function each anatomical program and each subtraction mode in separate submenus Filter Factors Organ Enter Organ 1 Organ 2 MSA co2 DSA C02 RSA C02 MSA Fig 6 21 Filter Factors menu Menu item Anatomical program Organ 0 extremities amp children O An Organ 1 head spine amp pelvis Organ 2 thorax amp abdomen Table 6 1 Anatomical programs Ziehm 8000 6 27 P_26471_CD_28218 EN 11 05 20
61. ean screens with a mild detergent mixed x with water Fluoroscopy modes Activate each mode the corresponding X z LED must light up 9 Coupling cable Inspect cable plug and socket 2 connections and anti kink sleeves for x physical damage c Swivel harness Inspect hose for physical damage X Table 8 1 Regular electrical checks without radiation release Checks involving radiation To be able to check the following functions you must initiate radiation Zi P_26471_CD_28218 EN 1 m 8000 1 05 2009 8 Maintenance WARNE WARNING Always observe the safety and precautionary measures required by the relevant national X ray and radiation protection regulations Object Action required gt Ss 5 9 gt S 2 5 gt n 5 1 a z gt Radiation warning Must be lit during radiation x lamp gt amp Hand switch Must function with fluoroscopy and direct X radiography N S Dead man s control for direct radiography X Foot switch Must not release radiation in direct X radiography mode Fluoroscopy The X ray symbol on the control panel is lit x The radiation time display is counting up X during radiation Unsaved marks on the live screen X disappear An audible alarm sounds after 5 minutes of X radiation time Press min key briefly The audible alarm is c S switched off 7 5 Press min key for more t
62. ecrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Table A 4 Recommended separation distances between portable and mobile RF communications equipment and the Ziehm 8000 Ziehm Compact or Ziehm Compact Litho Ziehm 8000 A 5 P_26471_CD_28218 EN 11 05 2009 Appendix A A 6 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 Index A Accessories 1 4 12 4 Alphanumeric keys 6 26 6 32 Authorized personnel 12 1 Autotransfer 6 3 B Backup to CD Data retrieval from CD 6 5 Basic settings 6 7 Entering the hospital data 6 8 Erasing storage media 6 8 Selecting the live screen 6 7 Setting system time and system date 6 7 C Cables Power cable 4 9 C arm stand Dimensions 7 9 Dimensions of C arm stand with lower C arm position 7 10 Illustration 4 8 Mounting on the pallet 12 10 Position on the pallet 12 10 Unpacking 3 6 Weight 7 4 CD recall 6 5 Cine loop Frame rate 6 5 Length 6 5 CO 6 4 6 32 Default windowing values 6 32 Filter settings 6 31 Configuration 6 2 Configuration Menu 6 2 Crosshair 6 4 D Deleting Hard disk 6 8 NO NAME folder 6 8 USB stick 6 8 DICOM DICOM format 6 6 Settings 6 33 Dimensions C arm stand 7 9 C arm stand with lower C ar
63. ecting the system to the hospital s DICOM network an RJ45 connection Twisted Pair 100 Mbit s a Wireless LAN connection On systems with an RJ45 connection a network cable runs directly from the network interface card of the image memory module out through the rear cover of the monitor cart and terminates in an RJ45 socket The system must be connected to the hospital s DICOM network via this socket To connect the system to the DICOM network do the following e Connect the RJ45 socket on the back of the monitor cart to a DICOM network socket using the appropriate cable On systems with Wireless LAN a transceiver is located at the back of the monitor cart A second transceiver comes with your accessories and must be connected to the hospital s DICOM network To connect the system to the DICOM network do the following e Connect the transceiver included in the accessories to a DICOM network socket e Connect the DICOM port of the PC Workstation on the back of the monitor cart to another DICOM network socket using the appropriate cable Ziehm Compact Ziehm Compact Litho General RJ45 connection Wireless LAN Ziehm 8000 Workstation Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 4 9 4 Assembling the System 4 10 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 5 Putting the System into Service 5 1 Temperature In case of major differences in temperature all parts of the system must h
64. ee oe Ziehm 8000 6 37 P_26471_CD_28218 EN 11 05 2009 6 Configuration F4 lt Pal gt F1 Save 6 5 4 4 Query model Network parameters for Retrieve paa A Ge ind gt x an PE el Eu gt NX e To enter a special character press and hold down key F4 lt or F5 gt until the desired special character appears e Activate or deactivate the desired image attributes e Press key F1 Save Configuration of DICOM Query Retrieve When configuring the query retrieve server you specify not only the general network parameters gt Ch 6 5 4 1 p 6 33 but also the query model PATIENT ROOT Patient level data STUDY ROOT Study level data NOTE If several patients with the same patient ID are stored in the PACS you will get the patient with the respective ID who is sent by the PACS first To enable Ziehm NetPort to connect to the Query server for the Retrieve function you must enter its AE title IP address as well as port 104 Use the same IP address and AE title as in the DICOM Settings Query Server menu Fig 6 28 p 6 39 To configure the query server do the following e Press the MENU key The Configuration Menu appears e Select the Service settings menu item e Type the password and press the Enter key e Select the DICOM settings menu item e Type the password and press the Enter key Ziehm 8000 P_2647
65. er To configure the MPPS server do the following e Press the MENU key The Configuration Menu appears Select the Service settings menu item fe e Type the password and press the Enter key e e Select the DICOM settings menu item fe e Type the password and press the Enter key e Select the Worklist server menu item lt The DICOM Settings Worklist Server menu appears DICOM Settings Worklist Server lt gt 3 8 ae S A Fer sles Fae rad gt Verification successful Do you want to activate MPPS ASER PESILO F4 F5 F6 gt Verify F2 Cancel Ge lt Fig 6 32 DICOM Settings Worklist Server menu e Place the cursor on the IP addr DICOM server menu item gt 6 44 ehm 8000 Zi P_26471_CD_28218 EN 11 05 2009 6 Configuration Press key F5 gt The DICOM Settings MPPS Server menu appears DICOM Settings MPPS Server IP addr DICOM server 192 188 127 042 IP subnet mask 255 255 255 008 Host name DICOM server ROTERMUND AE title DICOM server MESA_IMG_MGR Port addr DICOM server 2350 IP address gatew 192 168 127 254 IP address ZiehmNetPort 192 168 127 011 AE title ZiehmNetPort MODALITY4 Modality Station AE title NO Time span Ba 24 Location Operator s Name Miller b RK PESILO Fa F2 F3 F4 F5 F6 Save Cancel abc gt Verify Fig 6 33 DICOM Sett
66. ettings menu press the up arrow or down arrow key until the cursor is on the HEDIS data menu item e Press the Enter key The keys F1 Export and F2 Import appear on the screen fe lt gt Service Settings Step windowing Filter factors Subtr windowing DICOM settings System settings Monitor calibration HEDIS data Escape Software update F1 F2 Export Import Fig 6 38 Service Settings menu HEDIS data menu item e Plug the USB stick to which you want to upload the HEDIS data into the USB port F4 e Press key F1 Export The HEDIS data is uploaded to the USB stick and saved there e Press the ESC key ESC To download data from a USB stick to the system do the following e Inthe Service Settings menu press the up arrow or down arrow key until the cursor is on the HEDIS data menu item Press the Enter key The keys F1 Export and F2 Import appear on the screen ae lt gt Ziehm 8000 6 57 P_26471_CD_28218 EN 11 05 2009 6 Configuration Service Settings Step windowing Filter factors Subtr windowing DICOM settings System settings Monitor calibration HEDIS data Software update Fig 6 39 Service Settings menu HEDIS data menu item e Plug the USB stick with the HEDIS data you want to download to the system into the USB port Press key F2 Import Import The HEDIS data is downloaded fro
67. ey F4 lt or F4 F5 gt until the desired special character appears lt er BES e Activate or deactivate the desired image attributes gt Ziehm 8000 6 35 P_26471_CD_28218 EN 11 05 2009 6 Configuration F6 Verify 6 5 4 3 Storage information model Image attributes e Press key F6 Verify The system checks the network connection between SCU Service Class User Ziehm NetPort and SCP Service Class Provider server by means of a ping the DICOM settings e g AE title and common SOP classes association negotiation It sends an ECHO request to the SCP and waits for an ECHO response If all network parameters have been entered correctly the message Verification successful is displayed error messages gt Ch 6 5 4 7 p 6 57 If your system includes the Storage Commitment function the following message is displayed Do you want to activate NetCommit Y N e Press the Y key if you want to activate the Storage Commitment function or e Press the N key if you do not want to activate the Storage Commitment function e Press key F1 Save Configuration of Media Storage When configuring the storage server you specify not only the general network parameters gt Ch 6 5 4 1 p 6 33 but also the storage information model SOP class Service Object Pair You can choose between the following options XA X ray Angiography CR Computed Radio
68. ey twice The Contrast control appears on the screen SCROLL P 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 ze seconds the Contrast control disappears automatically 6 22 ehm 8000 Zi P_26471_CD_28218 EN 11 05 2009 6 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 Je picture X brightness 123 TD D advanced contrast 123 Sees pip B h position 123 H amp v position 123 sD gt en amp phase 123 m utilities frequency 1234 GHE scaling one to one infos LZ adv scaling press lt gt to select Fig 6 18 Onscreen Display flat screen monitor 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 disap
69. eypad with six keys which are used for accessing the screen setting menus 00000 INPUT MENU SCROLL Fig 6 5 Built in keypad of the flat screen monitor 6 4 2 2 Setting the brightness contrast and backlight To set the screen brightness do the following Brightness e Press the Brightness Contrast key The Brightness control appears on the screen A Fig 6 6 The Brightness control on a 18 or 23 flat screen monitor E J Fig 6 7 The Brightness control on a 24 flat screen monitor 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 Backlight Brightness control disappears automatically Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration Contrast Backlight To set the screen contrast do the following e Press the Brightness Contrast key twice The Contrast control appears on the screen Fig 6 8 The Contrast control on a 18 or 23 flat screen monitor A Fig 6 9 The Contrast control on a 24 flat screen monitor 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 e Press the Brightness Contrast key three times The Brightness or Backlight Brigh
70. f lifting column X travel C arm stand and Inspect foil for damage monitor cart control x panels Labels on the unit Check whether all warning and information X labels are legible Table 8 3 Regular mechanical checks 8 4 ehm 8000 Zi P_26471_CD_28218 EN 1 1 05 2009 8 Maintenance Object Action required gt 7 D g 5 gt 215 3 z gt C arm stand wheels Readjust or replace brake blocks X d Check firm seat of wheel brackets d Monitor cart wheels Check firm seat of wheel brackets X g Steering Check mechanical play between steering X gt lever and wheels 9 Clamping levers of Grease thread with Varilub extreme Oo 3 x D mechanical brakes pressure lubricant E Motorized vertical Grease lifting spindle with Varilub extreme X travel pressure lubricant lt Inspect bearings for damage X Table 8 3 Regular mechanical checks cont Ziehm 8000 8 5 P_26471_CD_28218 EN 11 05 2009 8 Maintenance 8 6 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 9 Replacing Components 9 1 Hand switch and foot switch Hand switch Twist lock Safety sleeve of twist lock Fig 9 1 Connection of hand switch cable Twist lock Safety sleeve of twist lock Strain relief Fig 9 2 Connection of foot switch cable To replace the hand or foot switch do the following e Unscrew the safety sleeve of the twist lock using an
71. g 12 17 Wrapped C arm stand e Jam a foam rubber block between the generator and the monitor cart Fig 12 18 Foam rubber block between generator and monitor cart 12 14 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet 12 8 Packing the monitor head To pack the monitor head do the following e Clean the screen with Foam Cleaner e Wrap the monitor head in bubble wrap gt Fig 12 19 Bubble wrap Transport rack for monitor head Fig 12 19 Monitor head on the transport rack e Place the transport rack with monitor head on the pallet between monitor cart and C arm stand Fig 12 20 The screws M6x12 that held the monitor head to the monitor cart base are not required at this point Put them in the accessories box gt Ch 1 3 p 1 4 Styrofoam material Fig 12 20 Transport racket with packed monitor head on the pallet Ziehm 8000 12 15 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet e Attach the styrofoam material on the rear of the monitor head gt Fig 12 20 e Attach the transport rack to the pallet using the corresponding wood screws gt Fig 12 21 USA Drill the holes for the round head square neck bolts and attach the transport rack to the pallet using the round head square neck bolts Fig 12 21 Mounted transport rack with packed monitor head 12 16 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 12 Mounting the
72. g from the manufacturer Laser beam apertures 4 Laser beam apertures Fig 2 1 Laser beam apertures on an image intensifier with integrated laser positioning device left and on the generator right 2 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 video printer you must tear off the printer paper Please refer to the Operating Instructions of the corresponding printer NOTICE NOTICE Temperatures above 40 C and relative air humidity above 60 may cause stains on the printer s heat sensitive paper Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 2 Safety Instructions 2 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 N 9 System failure ACAN 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 procedure Please keep an emergency plan ready for this case CAUTION Data transmission of the system can fail This
73. gnetic immunity The Ziehm 8000 Ziehm Compact and Ziehm Compact Litho are intended for use in the electromagnetic environment specified below The customer or the user of the Ziehm 8000 Ziehm Compact or Ziehm Compact Litho should assure that the systems are used in such an environment Immunity tests IEC 60601 test Compliance Electromagnetic environment level level guidance Portable and mobile RF communications equipment should be used no closer to the Ziehm 8000 Ziehm Compact or Ziehm Compact Litho including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vims 3 Vims d 1 2 x SQRT P disturbances acc t EC 61000 48 190 zt 80 MHz Radiated RF 3 V m 3 V m d 1 2 x SQRT P 80 MHz to disturbances acc 800 MHz to IEC 61000 4 3 A ws d 2 3 x SQRT P 800 MHz to 2 5 GHz Table A 3 Guidance and Manufacturer s Declaration electromagnetic immunity Ziehm 8000 A 3 P_26471_CD_28218 EN 11 05 2009 Appendix A Immunity tests IEC 60601 test Compliance Electromagnetic environment level level guidance where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an elec
74. graphy SC Secondary Capture The original images furnished by Ziehm NetPort are of type XA Since some servers do not support the XA SOP class CR and SC are provided as alternatives Under Image attributes included you define which HEDIS filter algorithms are applied to the DICOM image prior to saving By default all attributes are set to Off and the raw image is saved DICOM storage The DICOM format must have been set as storage format for writing format images to USB stick or CD gt Ch 6 2 10 p 6 6 6 36 ehm 8000 Zi P_26471_CD_28218 EN 11 05 2009 6 Configuration To configure Media Storage do the following e Press the MENU key The Configuration Menu appears lt gt 3 3 e Select the Service settings menu item e Type the password and press the Enter key sal gt T T JF E i a z e Select the DICOM settings menu item e Type the password and press the Enter key e Select the Media storage menu item The DICOM Settings Media Storage menu appears gt cy DICOM Settings Media Storage OR K 5 0N _ 13 Save Cancel abc lt a Fig 6 27 DICOM Settings Media Storage menu e Enter the AE title and the SOP class When the cursor is in certain lines of the input screen additional function keys for entering lower case letters and special characters are displayed e To enter lower case letters press key F3 abc F3 m
75. han 3 s The radiation time display is reset to zero f Iris collimator Open and close X oO Slot collimator Open and close turn in both directions X until reaching the right left limit stops Direct radiography Exposure time can be set between 0 1 and X option 4s All film sizes can be selected the LED of X the corresponding key must light up An audible alarm sounds throughout the X exposure time Table 8 2 Regular electrical checks with radiation release Ziehm 8000 8 3 P_26471_CD_28218 EN 11 05 2009 8 Maintenance 8 3 Mechanics WARING WARNING Maintenance of this system must be carried out by trained personnel only Some checks may only be performed by authorized service engineers Those checks are marked accordingly Check the following functions or perform the following maintenance work at the specified time intervals Object Action required gt 5 E o e s gt N c fo a gt X ray generator Inspect for physical damage e g oil X leakage C arm stand wheels Clean tread surfaces cable guards and X bearings Monitor cart wheels Clean tread surfaces cable guards and X bearings 3 Check proper locking of the parking brake X 5 C arm Clean gliding surface X Check retention force of orbital rotation 2 i m X 5 brake in all C arm positions Check C arm bearing for running noise X 5 Motorized vertical Clean gliding surface o
76. he 23 or 24 flat screen monitor NOTICE Always wear cotton gloves when installing testing or making settings on displays or screens To mount the 23 or 24 flat screen monitor to the monitor cart base do the following Fig 4 1 Monitor cart base without monitor head Transport rack Fig 4 2 23 or 24 flat screen monitor on the transport rack NOTICE Never place the flat screen monitor directly on some surface always place them on the transport rack 4 2 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 4 Assembling the System e Remove the rear cover of the monitor cart base Fastening screw holes Fig 4 3 Holes for the four screws M6x16 for attaching the flat screen monitor to the monitor cart base e With the help of a second person lift the flat screen monitor and place them on the monitor cart base WARRING WARNING The flat screen monitor cannot be lifted by one person alone Therefore always ask a second person to assist you in placing the monitor on the monitor cart base e Attach the flat screen monitor from below using 4 screws M6x16 NOTE The screws M6x 16 needed for attaching the flat screen monitor to the monitor cart base are contained in the cardboard box with the accessories gt Ch 1 3 p 1 4 e Remove the rear cover of the monitor neck Radiation warning lamp cable labeled Xray Ind Ground connection internal Video cable labeled LM Po
77. he CD writer Table 10 2 Troubleshooting Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 10 5 10 Problem Report 10 3 Failure of the power supply If the power supply fails the system switches off automatically Any unsaved patient data and or images are lost Patient data and images that were saved to hard disk with the save function are preserved even after a power supply failure NOTE Save all images that you might need later to hard disk with the save function during operation of the unit Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 11 11 1 NOTICE Always wear cotton gloves when installing testing or making settings on displays or screens To dismount the flat screen monitor from the monitor cart base do the following Remove the rear cover of the monitor cart base Remove the rear cover of the monitor neck To detach the ground wire from the monitor neck housing gt Fig 11 1 p 11 2 remove nut and washer from the screw remove the ground wire from the screw place the washer on the screw again and retighten the nut Unplug the video cable labeled LM and the radiation warning lamp cable cable labeled Xray Ind connection labeled X ray lamp from the image memory Inside the monitor cart base detach the flat screen monitor power plug from the power supply unit Pull the following cables from the monitor cart base up into the monitor neck gt Fig 11 1 p 11 2
78. hm 8000 P_26471_CD_28218 EN 11 05 2009 6 49 6 Configuration abe F4 F1 Save i Returning to the print server 1 configuration A Vv DICOM Settings Print server 2 IP addr DICOM server 192 168 127 042 IP subnet mask 255 255 255 908 Host mame DICOM server ROTERMUND AE title DICOM server CONQUESTSRV4 Port addr DICOM server 5678 IP address gateway 192 168 127 254 IP address ZiehmNetPort 192 168 127 811 AE title ZiehmNetPort EXP8GQ0 FYYYY Number of copies 1 Print priority LOW Media type CLEAR FILM Film destination PROCESSOR Film session label ZIEHM Film size ID Number Page 4 Min Density Max Density Fa F2 F4 F5 F6 Save Cancel lt gt Verify Fig 6 36 DICOM Settings Print Server 2 menu e Enter the network parameters When the cursor is in certain lines of the input screen additional function keys for entering lower case letters and special characters are displayed e To enter lower case letters press key F3 abc e To enter a special character press and hold down key F4 lt or F5 gt until the desired special character appears e Specify the print configuration parameters e Press key F1 Save To return from the DICOM Settings Print Server 2 menu to the DICOM Settings Print Server 1 menu do the following e Inthe DICOM Settings Print Server 2 menu place the cursor on the IP a
79. hm Compact Litho Source image receptor 97 cm distance Vertical free space 76 cm generator i i C arm depth 68 cm Orbital rotation 115 135 Angulation 225 Swiveling panning 0 Horizontal movement Ocm Vertical movement 23 cm Table 7 1 Technical data Ziehm 8000 Ziehm Compact and Ziehm Compact Litho cont Ziehm 8000 7 3 P_26471_CD_28218 EN 11 05 2009 7 Technical Data Voltage frequency rating 230 Vac 10 50 60 Hz C arm stand Width 80 cm a Depth 230 cm 2 Height 214 cm Monitor cart Width 71cm A Depth 69 5 cm Height 169 cm C arm stand Ziehm 8000 approx 264 kg 23 cm Ziehm Compact bi Ziehm Compact Litho i Anm approx 280 kg 23 cm i i D Monitor cart Ziehm 8000 with 24 flat approx 150 kg screen monitor Ziehm 8000 with 23 flat approx 148 kg screen monitor Ziehm 8000 with 18 1 flat approx 153 kg screen monitors Table 7 1 Technical data Ziehm 8000 Ziehm Compact and Ziehm Compact Litho cont a Option not available for Ziehm Compact TONGE Temperatures above 40 C and relative air humidity above 60 may cause stains on the printer s heat sensitive paper 7 4 Ziehm 8000 i P_26471_CD_28218 EN 11 05 2009 7 Technical Data 7 2 Power plug specification 7 2 1 Systems with a voltage rating of 200V 220V 230V and 240V Cables 2 5 mm three wire supply voltage two wires ground wire one wir
80. hould be used with caution or be avoided altogether However the final decision lies with the attending physician or attending surgeon The Ziehm 8000 product family comprises the following systems Ziehm 8000 not available in the USA Ziehm Compact not available in the USA Ziehm Compact Litho not available in the USA Ziehm 7000 Plus available only in the USA Ziehm 7000 Plus Compact Version available only in the USA Unless stated otherwise all information given here for the Ziehm 8000 also refers to the Ziehm Compact and Ziehm Compact Litho Only authorized personnel are allowed to assemble and repair the medical equipment described in this manual Authorized personnel are persons who have attended an appropriate training course provided by the manufacturer These persons will receive the entire documentation that is required for service work 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 use
81. iation protection Laser radiation 2 5 X rays 2 2 Recursive filter 6 4 6 28 6 29 6 31 Reset Dose display 5 2 RSA Showing or hiding the native image 6 6 S Safety instructions 12 1 Definition 1 3 Electromagnetic compatibility 2 4 Equipotential grounding 2 4 Laser radiation 2 5 Protective grounding 2 4 System failure 2 7 X rays 2 2 Scope of validity 12 2 Screen settings 23 flat screen monitor 6 9 Flat screen monitors 6 10 Service life 1 1 Service settings 6 25 DICOM settings 6 33 Filter factors 6 27 HEDIS data 6 57 Software update 6 58 Step windowing 6 26 System settings 6 54 Windowing settings for subtraction modes 6 32 Settings 6 2 software version 1 1 Stack filter 6 28 6 29 6 31 6 32 For continuous pulse 6 30 For snapshot 6 30 Step windowing Activating 6 26 Default windowing step after power up 6 30 Defining windowing steps 6 26 Storage formats DICOM 6 6 Selecting 6 6 TIFF 6 6 Switching off 5 1 Switching on 5 1 System date 6 7 System time 6 7 T Technical Data Dose meter 7 6 Generator 7 2 Image intensifier 7 2 Laser 7 5 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 Index Monitors 7 2 Temperature symbol 5 1 10 2 Typographical conventions 1 2 U Unpacking the system 3 1 4 1 W Weight C arm stand 7 4 Monitor cart 7 4 Ziehm Compact 7 4 Windowing Default values for CO2 6 32 Default values for DSA 6 32 Default values for MSA 6 32 Default values for RSA 6 32 X
82. ings MPPS Server menu Enter the network parameters Enter the name of the radiological technologist under Operator s Name When the cursor is in certain lines of the input screen additional function keys for entering lower case letters and special characters are displayed To enter lower case letters press key F3 abc To enter a special character press and hold down key FA lt or F5 gt until the desired special character appears Press key F6 Verify The system checks the network connection between SCU and SCP by means of a ping the DICOM settings e g AE title and common SOP classes association negotiation It sends an ECHO request to the SCP and waits for an ECHO response If all network parameters have been entered correctly the message Verification successful is displayed error messages Ch 6 5 4 7 p 6 57 If the connection has been successfully established the following message appears Do you want to activate MPPS Y N ES m m Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 45 6 Configuration I IF 5 Ik IF e Press the Y key if you want to activate the MPPS function or G r e e e lle Ie 6 s D p e Press the N key if you do not want to activate the MPPS function If the system was unable to establish a connection the MPPS function is automatically deactivated Fi e Press key F1 Sav
83. inuous Continuous pulse 1 2 4 8 16 images pulse fluoroscopy Snapshot Snapshot 1 2 4 8 16 images stack filter Table 6 2 Filters for anatomical programs cont The recursive filter adds the 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 suppression but also the greater motion blurring The values can be set independently for normal view magnification 1 and magnification 2 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 edge enhancement 2 Medium edge enhancement 3 Strong edge enhancement 4 Extreme edge enhancement Table 6 3 Edge filter levels Increasing the level of edge enhancement will also cause any noise in the image to become more apparent though Recursive filter Stack filter Edge filter Ziehm 8000 P_26471_CD_28218 EN 11 05 20
84. isk as soon as possible and then delete the backed up patient folders E106 Error Hard disk access error Please contact after sales service 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 10 1 List of error and alert messages cont 10 4 Ziehm 8000 i P_26471_CD_28218 EN 11 05 2009 10 Problem Report 10 2 What to do if Situation Remedy The monitor screens remain dark for more than approx 1 min after switching on the system e Press the MENU key The LED of the MENU key lights up The memory software is running e Check the voltage supply of the monitors and the video connection If all of the green LEDs on the monitor chassis plate are lit the monitor voltage supply and the video connection are O K or e Check whether the I C bus cable is connected to the I2C connector and not to the CRT connector or e Check whether the flat screen monitors are switched on small switches on the back of the monitors The monitor screens remain dark for more than approx 1 min after switching on the system e Press the MENU key The LED of the MENU key does not light up The memory software is not running e Check the voltage supply of the image memory module The main switch may be off or e Check the voltage supply and the data cable of t
85. k the C arm stand do the following e Remove all packing materials bubble wrap foam rubber styrofoam The C arm stand is attached to the pallet by means of 5 retaining brackets 3 6 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 3 Unpacking the System Bracket 1 Bracket 3 Fig 3 12 Overview of all retaining brackets e Undo the screws holding retaining bracket 3 to retaining bracket 4 and remove retaining bracket 3 e Undo all screws holding retaining brackets 1 2 and 4 to the pallet e Remove all retaining brackets from the pallet e Remove the wooden laths from below the C arm stand gt Fig 3 13 p 3 7 Lift the C arm stand slightly for that purpose Fig 3 13 Position of the wooden laths e Put the C arm into an upright position orbital rotation e Remove the styrofoam block jammed between the image intensifier and the horizontal carriage e Carefully push the C arm stand down from the pallet using a ramp Ziehm 8000 3 7 P_26471_CD_28218 EN 11 05 2009 3 Unpacking the System 3 1 5 Unpacking the monitor cart The monitor cart is mounted on the pallet by means of a transport rack wer 4 Foam rubber block R Fig 3 14 Monitor cart on the pallet To unpack the monitor cart do the following e Remove the foam rubber block and all other packing materials bubble wrap foam rubber e Undo the wood screws holding the transport rack to the pallet e Place
86. laced by the new image If it was unsaved it will be irretrievably lost 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 are illuminated Function Moving the fluoroscopic image Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 3 6 Configuration 6 2 2 Displaying a crosshair Positioning aid The Crosshair menu item allows you to control whether a crosshair is displayed as positioning aid e g for foreign body localization in the center of the live screen image during fluoroscopy The central point of the crosshair corresponds to the position of the central X ray beam Crosshair On A crosshair appears on the live screen during fluoroscopy 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 6 2 3 p 6 4 6 2 3 Function of the F key Variable The F key menu item allows you to control which function is assigned to assignment the F key on the C arm stand This enables you to activate the corresponding function directly from the C arm stand using the F key The following assignment options are available Crosshair If you have activated this op
87. lays or screens To mount the flat screen monitors to the monitor cart base do the following Fig 4 7 Monitor cart base without flat screen monitors Fig 4 8 Flat screen monitors on the transport rack NOTICE Never place the flat screen monitors directly on some surface always place them on the transport rack Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 4 5 4 Assembling the System e Remove the rear cover of the monitor cart base Fastening screw holes Fig 4 9 Holes for the four screws M6x16 for attaching the flat screen monitors to the monitor cart base e With the help of a second person lift the flat screen monitors and place them on the monitor cart base WARNING WARNING The flat screen monitors cannot be lifted by one person alone Therefore always ask a second person to assist you in placing the monitors on the monitor cart base e Attach the flat screen monitors from below using 4 screws M6 x 16 NOTE The screws M6x16 needed for attaching the flat screen monitors to the monitor cart base are contained in the cardboard box with the accessories gt Ch 1 3 p 1 4 e Remove the rear cover of the flat screen monitors Pull the following cables from the monitor housing down into the monitor cart base 2 video cables golden Radiation warning lamp cable Ground wire Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 4 Assembling the Sys
88. lean n a for USA 12 10 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet e Wrap the generator and image intensifier in bubble wrap e Jama 40mm styrofoam block between the image intensifier and the horizontal carriage B Styrofoam block 3 ji Fig 12 12 Styrofoam block between image intensifier and horizontal carriage e Glue the corresponding rubber strips on top of the wooden laths e Place the wooden laths below the C arm stand as illustrated in Fig 12 13 and Fig 12 14 Lift the C arm stand slightly for that purpose Fig 12 14 C arm stand with wooden laths placed below Ziehm 8000 12 11 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet e First place foam rubber and then retaining bracket 1 over the C arm stand foot as illustrated in Fig 12 14 e Place retaining brackets 2 over the laterally protruding feet as illustrated in Fig 12 15 e Connect the C arm stand by means of the coupling cable to the monitor cart e Connect the monitor cart to the power supply e Switch on the C arm stand WARNING When you press the hand or foot switch the system starts to emit radiation e Press the Move Up Down keys to adjust the vertical position of the C arm so that retaining bracket 4 can be placed below the C e Place retaining bracket 3 over the C arm so that its feet rest on retaining bracket 4 e Attach retaining bracket 3 to re
89. m 8000 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet Fig 12 29 Labels on the long side e Secure the cardboard box together with the pallet with plastic straps as illustrated in Fig 12 28 and Fig 12 29 Ziehm 8000 12 21 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet 12 22 Ziehm 8000 i P_26471_CD_28218 EN 11 05 2009 Appendix A A 1 Manufacturer s Declaration concerning Electromagnetic Compatibility acc to IEC 60601 1 2 Class B Guidance and Manufacturer s Declaration electromagnetic emissions The Ziehm 8000 Ziehm Compact and Ziehm Compact Litho are intended for use in the electromagnetic environment specified below The customer or the user of the Ziehm 8000 Ziehm Compact or Ziehm Compact Litho should assure that the systems are used in such an environment flicker emissions acc to IEC 61000 3 3 Emissions tests Compliance Electromagnetic environment guidance RF emissions acc to Group 1 The Ziehm 8000 Ziehm Compact and Ziehm CISPR 11 Compact Litho use RF energy only for their internal function Therefore their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions acc to Class B The Ziehm 8000 Ziehm Compact and Ziehm CISPR 11 Compact Litho are suitable for use in all or establishments including domestic Harmonic emissions Class A establishments
90. m 8000 7 13 P_26471_CD_28218 EN 11 05 2009 7 Technical Data 7 14 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 8 Maintenance 8 1 General requirements WARING WARNING Maintenance of this system must be carried out by trained personnel only Some checks may only be performed by authorized service engineers Those checks are marked accordingly The regulation for designing operating and using medical devices MPBetreibV in Germany or other relevant federal regulations applicable in other countries require regular inspections safety related inspections In general the equipment owner is held liable for performing them Ziehm Imaging GmbH recommends safety related inspections every 12 months and will gladly assist you in performing them Keep a record of all checks and inspections the equipment is subject to and include them with the medical devices log book which you are obliged to keep as the equipment owner The Food and Drug Administration FDA requires that the checks and USA inspections described in the related document CDRH Maintenance Report be performed at least every six months in order to ensure that the X ray system complies with federal regulations specifically the applicable sections of CFR 21 Subchapter J Radiological Health The equipment owner is responsible for ensuring that the maintenance steps described in the said document are performed every six months Failure to compl
91. m position 7 10 Monitor cart with flat screen monitors 7 11 7 12 Tolerances of C arm movements on systems with 23 cmi i 7 10 Ziehm Compact 7 12 Ziehm Compact Litho 7 13 Displays Dose display 5 2 Temperature symbol 5 7 10 2 X ray symbol 5 1 Dose display 5 2 Reset 5 2 Dose meter Technical Data 7 6 DSA Showing or hiding the native image 6 6 DSA Cine 6 5 DSA native image 6 6 E Edge filter 6 28 6 29 6 31 6 32 Environmental compatibility 1 7 Environmental conditions Operation 7 3 Storage 7 3 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 Index F F key 6 4 Filter settings Edge filter 6 28 6 29 6 31 6 32 Recursive filter 6 28 6 29 6 31 Stack filter 6 28 6 29 6 31 6 32 Stack filter for continuous pulse 6 30 Stack filter for snapshot 6 30 Windowing step 6 29 6 30 First power up ofthe system 5 1 Flat screen monitors 7 12 Dimensions of monitor cart 7 11 7 12 Unpacking 3 6 Focal spot position 7 8 L Laser Laser Class 2 5 Laser positioning device 2 6 Laser radiation 7 5 Technical Data 7 5 Live screen 6 7 H Hospital data Department 6 8 Hospitalname 6 8 Physician 6 8 I Illustrations C arm stand 4 8 Image swapping Automatic 6 3 K Key F 6 4 Key MENU 6 2 Key min 5 2 Key OFF 5 1 Key ON 5 7 Keys Alphanumeric keys 6 26 6 32 M Maintenance schedule Electrics 8 2 Mechanics 8 4 Material 12 3 MENU key 6 2 Menus Configura
92. m the USB stick to the system and saved e Press the ESC key 7 N ESC ez 5 7 Software update To perform a software update do the following e Inthe Service Settings menu press the up arrow or down arrow key until the cursor is on the Software update menu item e Plug the USB stick that contains the first part of the backup copy into the USB port Press the Enter key The following confirmation prompt appears Do you really want to update Y N fe lt gt an Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration Service Settings Step windowing Filter factors Subtr windowing DICOM settings System settings Monitor calibration HEDIS data Software update Do you really want to update Y N Service Settings menu Software update menu item Fig 6 40 Seek Press the Y key on the alphanumeric keypad A A iq EI The software update is installed Lele Jk le ie HF following message is displayed Software update is completed e Once the complete software update package has been installed the Please switch the system OFF and ON e Switch the system off and back on Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 59 6 Configuration 6 60 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 7 Technical Data 7 1 Ziehm 8000 Ziehm Compact and Ziehm Compact Litho In compliance with the requirements of international stand
93. mage is transferred To configure the storage server do the following e Press the MENU key The Configuration Menu appears 6 34 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration Select the Service settings menu item A E Type the password and press the Enter key a aa malin Peed lt lt oF le le Select the DICOM settings menu item A amp Type the password and press the Enter key KEL IR TE lke Select the Storage server menu item A The DICOM Settings Storage Server menu appears lt L DICOM Settings Storage Server 192 168 127 088 IP subnet mask 255 255 255 008 Host name DICOM server S RVER AE title DICOM 3 INOARCHI VE Port addr DICOM server 62080 IP address gateway 900 900 008 008 IP address ZiehmNetPort 192 168 127 811 AE title ZiehmNetPort EXP8G08 F yyyy SOP class KA Image attributes included Rotation On Horizontal mirror On Vertical mirror On Window ing On Edge filter On I rt On On On SO8 HR 3 PLN 113 Fa F2 F3 F4 FS Fe Save Cancel abc lt gt Verify Fig 6 26 DICOM Settings Storage Server menu e Enter the network parameters When the cursor is in certain lines of the input screen additional function keys for entering lower case letters and special characters are displayed e To enter lower case letters press key F3 abc F3 abc e To enter a special character press and hold down k
94. may cause obstructions to the operational procedure Please keep an emergency plan ready for this case CAUTION The system can fail due to mechanical defects This may cause obstructions to the operational procedure Pi gt l Please keep an emergency plan ready for this case Ziehm 8000 2 7 P_26471_CD_28218 EN 11 05 2009 2 Safety Instructions 2 8 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 3 Unpacking the System BEAUTION CAUTION Only authorized personnel gt p 2 are allowed to unpack and assemble the system 3 1 Unpacking the system on the pallet Upon delivery the pallet contains the following system parts Monitor cart gt Ch 3 1 5 p 3 8 23 24 flat screen monitor or 18 flat screen monitors gt Ch 3 1 3 p 3 6 C arm stand gt Ch 3 1 4 p 3 6 Ramp for drop shipments gt Ch 3 1 2 p 3 3 Accessories gt Ch 1 3 p 1 4 3 1 1 Unpacking the pallet on delivery to distributors To unpack the full pallet do the following E Pa Fig 3 1 Packed pallet Ziehm 8000 3 1 P_26471_CD_28218 EN 11 05 2009 3 Unpacking the System e Cut the plastic straps and remove them e Check the two shock watch devices e Remove the shipping tape from the cardboard box and open it e Remove the clout nails holding the cardboard box to the pallet e Lift the cardboard box off the pallet Fig 3 2 Pallet with foil wrapping e Cut
95. ng brackets 2 with 65828 4 wood screws 10x40 56285 Retaining bracket 3 with 65829 2 Allen screws M8x20 56137 Retaining bracket 4 with 65830 2 wood screws 10x40 56285 Rigid foam 26240 Wooden laths 380mm x 80mm x 60mm with 13112 rubber strips 54067 Cardboard box for the pallet 26372 Cardboard box for accessories 26392 Bubble wrap Foam rubber Detergents Bioclean Foam Cleaner Nitro solvent Styrofoam material Table 12 1 Packing material Ziehm 8000 12 3 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet 12 4 2 Article 4 particle board screws 80mm long Clout nails Particle board 740mm x 460mm x 20mm with Art No 2 boards Cross lath 2 shock watch devices Label Transportkontrolle Monitored shipment Address label Label Vorsicht Glas Glass Handle With Care Monitors 4 screws M6x12 and 4 wood screws 10x40 Transport rack for flat screen monitors with 6 03364 1 56232 56285 Table 12 1 Packing material cont Fig 12 1 Packing material Parts to be packed Monitor cart C arm stand Flat screen monitors monitor head Ramp for drop shipments Accessories 12 4 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet 12 5 How to pack the accessories To pack the accessories on the pallet do the following Assemble the cardboard box fo
96. nsssnnnnnnneennnnnennennnnn en 6 21 6 5 Service Setlings 2ur unens arten 6 25 6 5 1 Step windowing u 4444usnsnnnnnnnnennnnnnnnnnnnnnnnnnneennnnnneennn nme 6 26 6 5 2 Filter Tatto S eon nr e r A a 6 27 6 5 2 1 Filters for anatomical programs 2 4 nn 6 28 6 5 2 2 Filters for subtraction modes 224444e nennen nennen 6 30 6 5 2 3 Filters for subtraction modes with CO3 6 31 6 5 3 Windowing settings for subtraction modes nennen 6 32 6 5 4 DICOM settingS 12 2a Beni En 6 33 6 5 4 1 Network parametelrs ccccccccceeeeeeeeeseeeeeecececeeeeeeeeeeess 6 33 6 5 4 2 Configuration of Storage and Storage Commitment 6 34 6 5 4 3 Configuration of Media Storage us nn nenne 6 36 6 5 4 4 Configuration of DICOM Query Retrieve ee 6 38 6 5 4 5 Configuration of Worklist and MPPS ee 6 42 6 5 4 6 Configuration of the print servers nennen 6 46 6 5 4 7 DICOM Verification error messages uu nennen 6 51 6 5 4 8 DICOM Retrieve error messages nmne sn 6 52 6 5 4 9 Hardware with DICOM option 444444snnennen nenne 6 52 6 5 5 System Settings 22 ececcceeceeeccceeeeecceceeeceeceecenecneaceceneeseceeeeneneaeedenenneee 6 54 6 5 6 HEDIS dali eranen een a A 6 57 6 5 7 Software update ias e ae diaa e aaea ha i aa aaa 6 58 7 Technical Data 7 1 7 1 Ziehm
97. nterrupted E 45 Error Internal fault VacuDAP duo Acknowledge error message by briefly pressing hand or foot switch Table 10 1 List of error and alert messages cont 10 2 Ziehm 8000 i P_26471_CD_28218 EN 11 05 2009 10 Problem Report Code Type Description Measures E 46 Error During power up Error in VacuDAP duo dose Acknowledge error message by meter system briefly pressing hand or foot switch During operation Press min key long keystroke Error in VacuDAP duo dose meter system E47 Error Measuring value limit of 9999 9 Press min key long keystroke 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 reinitiate radiation E 48 Error Dose meter check VacuDAP Acknowledge error message by duo Error in dose meter briefly pressing hand or foot switch system 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 E 53 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
98. om above because of the pallet stringers and the round head square neck bolts from below to the pallet e Clean the monitor cart with Bioclean n a for USA NOTE At this point you must interrupt the monitor cart packing procedure and prepare the C arm stand first gt p 12 12 as the C arm stand needs to be connected to the monitor cart and the monitor cart to the power supply for proper packing gt Ch 12 7 p 12 10 e Wrap the monitor cart in foam rubber and bubble wrap e Attach a styrofoam block 20 mm to 50 mm on top of the monitor cart Styrofoam block Fig 12 9 Wrapped monitor cart Ziehm 8000 12 9 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet 12 7 Packing the C arm stand To mount the C arm stand on the pallet do the following e Carefully push the C arm stand onto the pallet using a ramp e Position the C arm stand as illustrated in Fig 12 10 e Position the C arm as illustrated in Fig 12 10 1 p Fig 12 10 Position of the C arm stand and the C arm on the pallet e Remove the ramp NOTE To use the ramp supplied with a drop shipment do the following Remove the fixing clamps attaching the ramp Hook up the fixing clamps into the drill holes on the pallet provided for that purpose gt Fig 12 11 Fixing clamp Fig 12 11 Fixing clamp hooked up in the drill holes on the pallet e Clean the C arm stand with Bioc
99. 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 6 6 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration 6 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 6 3 Basic Settings menu 6 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 6 3 2 Selecting the live screen The Live image menu item allows you to choose whether the left or the right screen acts as live screen The live screen is the screen where the fluoroscopic image live or saved is displayed The remaining screen then automatically becomes the reference screen Ziehm 8000 6 7 P_26471_CD_28218 EN 11 05 2009 6 Configuration 6 3 3 Entering the hospital data The Hospital
100. or DSA MSA and RSA If the system is equipped with the CO option the default windowing values for each individual subtraction mode in combination with CO can be set in addition Windowing Settings for Subtraction Modes Dam usa DSA L RSA W RSA L MSA W MSA L Fig 6 25 Windowing Settings for Subtraction Modes 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 Function key F3 CO2 moves the cursor to the column where the default windowing values for the subtraction modes with CO negative contrast medium are set 6 32 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration Function key F3 Normal returns the cursor to the column where the default windowing values for the subtraction modes with positive contrast medium are set 6 5 4 DICOM settings BEAUTION CAUTION 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 If you are an authorized person you can obtain the password from your local Ziehm dealer 6 5 4 1 Network parameters To enable the system to establish a connection for a DICOM data transfer you must specify the following network parameters
101. oscopy 0 5 mm Direct radiography 1 5 mm Total filtration gt 3 9 mm aluminum equivalent Tube Input screen Cesium iodide Nominal sizes S Ziehm 8000 and 23 15 10 cm or Ziehm Compact 15 10 cm Ziehm Compact Litho 23 15 10 cm Anti scatter grid Pb 8 40 Flat screen monitors Screen size 61 cm 24 Luminance max 400 Cd m Resolution 1920 x 1200 pixels 5 Refresh rate 85 Hz S Screen size 59 cm 23 S Luminance max 500 Cd m 5 Resolution 1280 x 720 pixels 5 Refresh rate 50 Hz S Screen size 46 cm 18 1 Luminance max 600 Cd m Resolution 1280 x 1024 pixels Refresh rate 75 Hz Table 7 1 Technical data Ziehm 8000 Ziehm Compact and Ziehm Compact Litho cont 7 2 Ziehm 8000 i P_26471_CD_28218 EN 11 05 2009 7 Technical Data Voltage frequency rating 230 Vac 10 50 60 Hz Flat screen monitor Screen size 46 cm 18 1 85 Luminance 600 Cd m 5 Resolution 1280 x 1024 pixels Er Refresh rate 75Hz During storage and Temperature 5 C to 55 C Ae ii Relative air humidity 20 70 E During operation Temperature 15 C to 35 C E 8 Relative air humidity 20 70 Ziehm 8000 and Ziehm Source image receptor 97 cm Compact distance Vertical free space 76 cm generator i i C arm depth 68 cm Orbital rotation 115 135 Angulation 225 E Swiveling panning 10 5 Horizontal movement 22 cm Vertical movement 43 cm 63 cm S Zie
102. packing procedure of the full pallet not yet performed gt Ch 12 10 p 12 19 12 18 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet 12 10 Packing the full pallet To complete packing of the full pallet do the following e Fold the wrap foil on the pallet around the system components and heat seal them but leave a small opening e Remove the air from the wrap foil through the opening using vacuum suction Fig 12 25 Removing the air with suction e Heat seal the small opening e Tape the wrap foil with shipping tape Fig 12 26 Taped wrap foil e Put the big cardboard box over the pallet e Attach the cardboard box to the pallet using clout nails Ziehm 8000 12 19 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet Fig 12 27 Close the cardboard box and tape shut it with shipping tape EEE losed cardboard box Affix one of the shock watch devices on the cardboard box as illustrated and a second one on the long side of the cardboard box Sr Fig 12 28 Position of the labels on the short side Affix a Transportkontrolle Monitored shipment label above each shock watch device on the outside of the cardboard box gt Fig 12 28 Affix the address label as well as the label Vorsicht Glas Glass Handle With Care on the cardboard box as illustrated in Fig 12 28 and Fig 12 29 12 20 Zieh
103. pears automatically OC NOTE Lowering the backlight level will increase the backlight lifetime Ziehm 8000 6 23 P_26471_CD_28218 EN 11 05 2009 6 Configuration Setting the menu language MENU SCROLL SCROLL MENU SCROLL Restoring the factory settings MENU SCROLL SCROLL MENU SCROLL The factory set menu language is English Alternatively you can choose German as the menu language To define the menu language do the following Press the key sequence MENU SCROLL MENU The OSD Onscreen Display gt Fig 6 18 p 6 23 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 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 6 18 p 6 23 appears on the screen Press the SCROLL key six times The utilities submenu is highlighted in white Press the ME
104. r manual The warranty becomes invalid in case 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 IIb according to Council Directive 93 42 EEC This document has been written and reviewed originally in German and translated Quality Standards Copyright 2009 Ziehm Imaging GmbH All rights reserved Transmission or reproduction of these Operating Instructions exploitation and disclosure of their contents to third persons is not permitted without express written consent of the manufacturer Infringements shall entitle to damage claims Registered Trademarks These Operating Instructions 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 These Operating Instructions were produced in accordance with a certified QM system as per DIN EN ISO 13485 It conforms to the requirements of Council Directive 93 42 EEC Annex I 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 03 2009 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 Contents
105. r the accessories Pad the cardboard box with bubble wrap Place all accessories gt Ch 1 3 p 1 4 inside the cardboard box Close the cardboard box and tape shut it with shipping tape After having mounted the monitor cart the C arm stand and the monitor head on the pallet see Ch 12 6 and Ch 12 7 place the accessories box on the pallet as illustrated in Fig 12 2 Styrofoam block Fig 12 2 Position of the accessories box on the pallet Place a styrofoam block between cardboard box and retaining bracket to prevent the box from moving back and forth Ziehm 8000 12 5 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet 12 6 Packing the monitor cart To mount the monitor cart on the pallet do the following e Place the ramp to the short front side of the pallet NOTE If you use the ramp supplied with a drop shipment then attach the ramp to the sides of the pallet using both fixing clamps gt Fig 12 3 Fixing clamp Fig 12 3 Pallet with attached ramp e Place a sufficiently dimensioned piece of wrap foil on the pallet e Fold the excessive wrap foil to the sides of the pallet Fig 12 4 Pallet with wrap foil e Carefully push the monitor cart onto the pallet using a ramp 12 6 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet Fig 12 5 Monitor cart base without monitor head e Place a foam rubber block as padding on the p
106. rdance 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 After this period Ziehm Imaging GmbH must check whether the technology used is appropriate Scope of validity of these Operating Instructions Separate operating instructions Environmental compatibility Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 1 1 1 General Information 1 1 Typographical conventions In this manual the following notations and formats are used to highlight certain elements of the control panel or the documentation itself Element Format Example Control panel elements buttons tabs and boxes operating modes functions Bold Fluoro Cross references Italic preceded by an arrow gt Ch 17 p 17 1 Procedure steps Preceded by ae e Press the OK button Table 1 1 Notations and formats used in this manual Ziehm 8000 i P_26471_CD_28218 EN 11 05 2009 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 measures However it does contain instructions which must be observed in order to ensure the personal safety of operating
107. s Visible damage No connection between correctly functioning components e g hub cable socket server Replace FOC sockets on the monitor cart If the defective sockets are within the hospital network Plug the monitor cart into another socket for checking Cable connection interrupted Cable is not plugged in cable is defective socket is defective Establish cable connection FOC version RX and TX cables are swapped The LINK LED on port 2 of the fiber optic converter is not lit Swap the RX and TX cables Table 6 8 Possible hardware faults FO connection Hardware faults Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 53 6 Configuration 6 5 5 System settings Vario 3D function DSA mask Ambient light sensor gain In the System Settings menu you can set or modify the following system parameters with the cursor keys Vario 3D function DSA mask Ambient light sensor Histogram Dose area product File check Collimators Language System Settings Vario 3D DSA mask Bri sensor gain Bri sensor Limit 2 Bri sensor speed Histogram Dose area product File check Collimator factor Collimator offset Language ENGLISH Fig 6 37 System Settings menu On a Ziehm 8000 the Vario 3D function must always be set to Off If the option Always is set a new mask image is acquired
108. s 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 radiation is 635 nm WARNING WARNING 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 CAUTION USA LASER RADIATION DO NOT STARE INTO BEAM CLASS IILASER PRODUCT in accordance with FDA 21 CFR Subchapter J Section 1040 10 11 Laser positioning device Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 2 5 2 Safety Instructions Maintenance The laser positioning device is maintenance free Any adjustment or repair which might become necessary must be carried out by the manufacturer or a suitable qualified service engineer who has received appropriate trainin
109. se from server Port address of DICOM server does not exist Application on the server is not running Required Configuration Info Missing v5 up to SW 15 No response from server Wrong mergecom app MERGE INI file cannot be located v1 up to SW 15 SYSTEM ERROR 3 Entry in autoexec bat is missing Communication takes too long gt 20 s dicom pctcp pctcpsrv drv file is incompatible Table 6 6 DICOM Verification error messages Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration Error message Network unexpectedly shutdown v11 Message service unacceptable for this association v8 Cause s Server does not send an ECHO response but association negotiation is okay Wrong mergecom app STANDARD_ECHO is missing Timed out waiting on network partner v11 Server does not recognize ECHO request or STANDARD_ECHO service It may be necessary to restart the server e g HIPAX server Network partner sent an invalid message v11 Table 6 6 Server does not recognize ECHO request or STANDARD_ECHO service It may be necessary to restart the server e g HIPAX server DICOM Verification error messages cont 6 5 4 8 DICOM Retrieve error messages The following error messages frequently occur at user level Response from server Cause s 0xa801 Ziehm NetPort is not properly connected to the server wrong network settings
110. service E 56 Error Internal fault Please contact after sales service E 57 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 E 65 Error Internal fault Please contact after sales service E 90 Alert Internal fault Please contact after sales service Table 10 1 List of error and alert messages cont Ziehm 8000 10 3 P_26471_CD_28218 EN 11 05 2009 10 Problem Report Code Type Description Measures E 91 Alert Internal fault Please contact after sales service monitor cart defective 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 User Settings E102 Error Internal fault Please contact after sales service E105 Alert Not enough hard disk space Delete a protected patient folder available for operation after unprotecting it with the key combination Shift F4 Perform a backup of the hard d
111. staff and patients as well as to avoid damage to property These instructions are highlighted as follows ee 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 information and hints are provided for the operator here Pi Pi Ziehm 8000 1 3 P_26471_CD_28218 EN 11 05 2009 1 General Information 1 3 Accessories The accessories are in a separate cardboard box on the pallet Depending on the system configuration options the cardboard box contains the following accessory items Accessories Qty Operating Instructions CD Operating Instructions CD Technical Manual Specifications and Certificates Coupling cable 7 5 m All systems Equipotential grounding cable 6 m Art No 24054 a a Touch up paint RAL 9001 Art No 89655 Touch up paint RAL 6027 Art No 89615 Mounting material Art No 88711 CD writer CD RW 640 MB Video printer Operating instructions for video printer Printer paper 1 roll
112. taining bracket 4 by means of the corresponding screws as illustrated in Fig 12 15 e Press the Move Up Down keys to adjust the vertical position of the C arm so that retaining bracket 4 rests on the pallet BE L Bracket 2 Bracket 1 Bracket 4 Fig 12 15 Retaining brackets 1 4 12 12 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet USA Pre drilled wooden blocks K below bracket 2 on 3 left lateral wheel w Fig 12 16 Retaining bracket 2 over left lateral wheel for USA e Switch off the C arm stand e Disconnect the monitor cart from the power supply e Disconnect the C arm stand from the monitor cart NOTE After having disconnected the C arm stand from the monitor cart you must finish the monitor cart packing procedure gt p 12 9 e Screw down all retaining brackets using the corresponding screws USA Place the small wooden blocks with pre drilled holes below retaining bracket 2 over the left lateral wheel gt Fig 12 16 Drill 8 holes for the round head square neck bolts Attach all retaining brackets from below to the pallet using the corresponding round head square neck bolts Ziehm 8000 12 13 P_26471_CD_28218 EN 11 05 2009 12 Mounting the System on a Pallet e Wrap the C arm stand in bubble wrap and pad it with foam rubber and styrofoam material e Attach styrofoam material to the C arm stand as illustrated in Fig 12 17 Fi
113. tem Video signal of left monitor Video signal of Radiation Ground wire right monitor warning lamp connection Fig 4 10 Connections on the flat screen monitors e Connect the video cables and the radiation warning lamp cable to the image memory module e Connect the power supply units of the flat screen monitors right left to the corresponding connectors for non heating devices labeled RM LM in the monitor cart base e Toconnect the ground wire to the monitor cart base remove the nut fit the ground wire onto the screw and retighten the nut e Reattach the rear cover of the flat screen monitors e Reattach the rear cover of the monitor cart base Ziehm 8000 4 7 P_26471_CD_28218 EN 11 05 2009 4 Assembling the System 4 2 Cable connections Before switching on the system for the first time or after each transport you must establish different cable connections Ziehm 8000 To establish the cable connections do the following e Unwind the coupling cable from the upper cable support on the back of the monitor cart e Plug the coupling cable connector into the socket located at the side ofthe C arm stand and lock the connector by pulling the locking lever upward gt Fig 4 11 p 4 8 Image intensifier with integrated CCD camera Te C arm handle a C arm p ZZ Swivel arm we Horizontal carriage A z Lifting column Casse
114. the left or right half of the screen Ziehm 8000 6 9 P_26471_CD_28218 EN 11 05 2009 6 Configuration 6 4 2 Setting flat screen monitors of type 1 Safety measures Screen settings nr The system may only be set up and put into service by service engineers who are authorized by the manufacturer 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 On systems with flat screen monitors the screen settings are made directly at the monitors using a built in keypad You can change the following screen settings yourself Brightness Contrast Backlight Menu language for screen settings Video source Inputs Gamma Display settings Picture e g horizontal and vertical position sharpness scaling Menu setup Setup e g menu lock In addition you can restore the factory settings The factory set menu language is English Therefore the English designations are used in this document 6 10 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration 6 4 2 1 Built in keypad Each flat screen monitor has a built in k
115. tion you can show or hide a crosshair as positioning aid in the center of the live screen image with the F key gt Ch 6 2 2 p 6 4 The central point ofthe crosshair corresponds to the position of the central X ray beam Cine If you have activated this option you can activate and deactivate the cine loop mode with the F key co2 If you have activated this option you can activate and deactivate the CO function together with the DSA subtraction mode with the F key 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 6 5 2 p 6 27 As long as the recursive filter is reset the message Filter off is displayed on the live screen Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration 6 2 4 Storage medium for image retrieval 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 For systems with a CD writer the following applies CD recall Off default setting The Mosaic menu retrieves the patient folders from the hard disk CDrecall 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
116. tion Menu 6 2 min key 5 2 Monitor cart Dimensions flat screen monitors 7 11 7 12 Mounting on the pallet 12 6 Position on the pallet 12 8 Unpacking 3 8 Weight 7 4 Monitor cart with flat screen monitors 7 11 Monitor head Packing 12 15 Motion blurring 6 4 6 29 MSA Showing or hiding the native image 6 6 N Noise in the image 6 29 Noise suppression 6 29 O OFF key 5 1 ON key 5 1 Operation settings 6 3 Activating automatic image swapping 6 3 Combining DSA with a cine loop 6 5 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 Index Defining the storage format for removable storage media 6 6 Defining the USB stick storage format 6 6 Displaying a crosshair 6 4 Function of the F key 6 4 Selecting the storage medium for data re trieval 6 5 Setting the cine loop length 6 5 Setting the cine loop speed 6 5 Showing or hiding the native image 6 6 P Packing material 12 3 Pallet Mounting the C arm stand 12 10 Mounting the monitor cart 12 6 Packing 12 19 Position of the accessories box 12 5 Position of the C arm stand 12 10 Position of the monitor cart 12 8 Unpacking 3 1 3 3 Unpacking the C arm stand 3 6 Unpacking the monitor cart 3 8 Parts to be packed 12 4 Personnel authorized 12 1 Power cable 4 9 Power plug Specification 7 5 Printer media Paper 2 6 7 4 Protective grounding 2 4 Putting the system into service Assembling the system 3 1 4 1 Unpacking the system 3 1 4 1 R Rad
117. tle which is provided by the query server A glo Pea cats Retrieve server Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 39 6 Con figuration lt gt 3 3 E a Ir Zu e S z T a gt gt To configure a retrieve server do the following e Press the MENU key The Configuration Menu appears e Select the Service settings menu item e Type the password and press the Enter key e Select the DICOM settings menu item e Type the password and press the Enter key e Select the Query server menu item The DICOM Settings Query Server menu appears DICOM Settings Query Server IP addr DICOM server 192 168 127 042 IP subnet mask 255 255 255 000 Host mame DICOM server ROTERMUND AE title DICOM server MODALITY Port addr DICOM server 5184 IP address gateway 192 168 127 254 IP address ZiehmNetPort 192 168 127 011 AE title ZiehmNetPort EXP8QB0 FYYYY Query model STUDY ROOT Fi F2 F4 F5 F6 Save Cancel lt gt Verify Fig 6 29 DICOM Settings Query Server menu e Place the cursor on the IP addr DICOM server menu item 6 40 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration e PresskeyF4 lt orF5 gt F4 The DICOM Settings Retrieve Server menu for the selected retrieve lt server 1 or 2 is displayed or ES DICOM Settings gt gt Retrieve server 1
118. tness control appears on the screen Fig 6 10 The Brightness control on a 18 or 23 flat screen monitor Fig 6 11 The Brightness control on a 24 flat screen monitor 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 or Backlight Brightness control disappears automatically 6 12 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 Configuration NOTE Lowering the backlight level will increase the backlight lifetime 6 4 2 3 Setting the menu language The factory set menu language is English You can choose one of the following languages as menu language German French Italian Spanish Dutch Swedish 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 DVI analog 1024 x 768 60 Hz Picture Gamma Setup Defaults Menu Position Yd ks D a Menu Rotation on Language English DPMS Enable off Auto Source Select off Menu Lock on Fig 6 12 The Setup control on a 18 or 23 flat screen monitor MENU OO Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 6 13 6 Configuration Menu Position gog o E El EI El Cd DPMS Enable off On Auto Source Select off On off On Operating Hours 116 30 BIOS 5810001 Version A 00
119. to ensure optimum display settings Fig 6 16 Flat screen monitors of type 2 Safety measures NOTICE The system may only be set up and put into service by service engineers who are authorized by the manufacturer If service is needed the system may only be repaired by authorized service engineers WARNING 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 Ziehm 8000 6 21 P_26471_CD_28218 EN 11 05 2009 6 Configuration Built in keypad Each flat screen monitor has a built in keypad with four keys which are used for accessing the screen setting menus e000 MENU SCROLL Fig 6 17 Built in keypad of the flat screen 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 D brightness The settings become immediately active on the screen After a few seconds the Backlight Brightness control disappears automatically Contrast To set the screen contrast do the following e Press the SCROLL k
120. trained personnel under Operation USA the direction of a physician Ziehm 8000 2 1 P_26471_CD_28218 EN 11 05 2009 2 Safety Instructions Assembly and service 2 2 General X rays 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 BEGAUTION 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 radiation generating components to be defective or if the system exhibits 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 WARNING USA The system may only be operated by properly trained personnel under the direction of a physician
121. tromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol I NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 4 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Ziehm 8000 Ziehm Compact or Ziehm Compact Litho are used exceeds the applicable RF compliance level above the Ziehm 8000 Ziehm Compact or Ziehm Compact Litho should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Ziehm 8000 Ziehm Compact or Ziehm Compact Litho gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Table A 3 Guidance and Manufacturer s Declaration electromagnetic immunity cont A 4 ehm 8000 Zi P_26471_CD_28218 EN 11 05 2009
122. tte holder Control panel r Steering amp N N a i 9 Handle Ti i T X ray generator Hand switch al an Coupling le cable gt connection N 5 Foot switch Fe E Cable guards i i Fig 4 11 C arm stand Ziehm 8000 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 and the socket outlet for compatibility e Connect the system to the power supply ISWARING 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 4 8 ehm 8000 Zi P_26471_CD_28218 EN 11 05 2009 4 Assembling the System On a Ziehm Compact or Ziehm Compact Litho do the following e Unwind the power cable from the combined foot switch power cable support located at the side of the C arm stand 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 4 3 DICOM connection Depending on the system configuration different technologies are used for conn
123. uctions General safety instructions 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 It is important to observe all directions safety instructions and warnings The responsibility for any C arm assisted surgical intervention lies with the physician in charge NOTICE NOTICE 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 declaration 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 Only properly trained personnel are allowed to operate the system Operation The system may only be operated by properly
124. wer plug of the flat screen monitor gt Ground wire Fig 4 4 Cables inside monitor neck and monitor cart base Ziehm 8000 4 3 P_26471_CD_28218 EN 11 05 2009 4 Assembling the System Pull the following cables from the monitor neck down into the monitor cart base video cables golden Radiation warning lamp cable Pull the ground wire from the monitor cart base up into the monitor neck Connect the video cables and the radiation warning lamp cable to the image memory module Video cable connection labeled LM Radiation warning lamp cable Connection labeled X ray Lamp To connect the ground wire to the monitor neck housing remove nut and washer from the screw fit the ground wire and washer onto the screw and retighten the nut j Fig 4 5 Ground connection inside the monitor neck housing gt Fig 4 4 p 4 3 Inside the monitor cart base connect the power plug of the flat screen monitor with the power supply unit for the flat screen monitors Fig 4 6 23 or 24 flat screen monitor power plug connected to the power supply unit for the flat screen monitors Reattach the rear cover of the monitor neck Reattach the rear cover of the monitor cart base 4 4 Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 4 Assembling the System 4 1 2 Mounting the 18 flat screen monitors NOTICE Always wear cotton gloves when installing testing or making settings on disp
125. y with this requirement relieves the Manufacturer and his agents of all responsibility in this matter The equipment owner is furthermore responsible for ensuring that only service engineers certified by the manufacturer perform the tests and adjustments described in the above document Service engineers are responsible for performing the procedure in the sequence shown in the CDRH Maintenance Report Ziehm 8000 8 1 P_26471_CD_28218 EN 11 05 2009 8 Maintenance 8 2 Electrics WARING WARNING Maintenance of this system must be carried out by trained personnel only Some checks may only be performed by authorized service engineers Those checks are marked accordingly Check the following functions at the specified time intervals Object Action required gt G oO S D gt gt S e 5 gt N c lt fe a gt Consistency test Perform according to relevant national X regulation of the country of installation Power cable Inspect for physical damage x Electrical safety Check according to relevant national X 3 regulation of the country of installation c Hand switch Inspect cable for damage X 5 Foot switch Inspect cable for damage X 2 g Motorized vertical Move up and down to respective limit stops X S travel g Fr C arm stand control All segments are activated during power X panel up Flat screen monitors Contrast and brightness can be adjusted X Cl
126. ziehmimaging dedicated to clinical innovation Ziehm 8000 Technical Manual Ziehm 8000 P_26471_CD_28218 EN 11 05 2009 Normal use Contraindications to the use of X rays Ziehm 8000 product family Authorized personnel Exclusion of liability 1275 Copyright 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 The system is not suitable for interventional procedures acc to IEC 60601 2 43 The exposure of humans to ionizing radiation must always be medically justified Especially on pregnant women children and adolescents this procedure s

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