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MAN 06-0015 Rev. A

Ziehm VISION Digital Mobile C-Arm

Copyright

© 2004 Ziehm Imaging, Inc.

Documentation, trademark, and software are copyrighted with all rights reserved. Under copyright laws
this documentation may not be copied, photocopied, reproduced, translated or reduced to any electronic
medium or machine-readable form - in whole or in part - without the prior written permission of Ziehm
Imaging, Inc.

This manual was originally drafted, approved, and supplied by Ziehm Imaging, Inc. in English.

Ziehm Imaging, Inc. reserves the right to revise this publication from time to time, and to make changes in
content, without obligation to notify any person of such revisions or changes.

Manufactured By

Ziehm Imaging, GmbH
Isarstrasse 40, D-90451
Nuremberg, Germany
E-mail: www.ziehm-eu.com

Ziehm Imaging, Inc.
4181 Lathram Street
Riverside, CA 92501
E-mail: www.ziehm.com

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Содержание VISION

Страница 1: ...s Ziehm VISION Installation Manual and CDRH Report...

Страница 2: ...ole or in part without the prior written permission of Ziehm Imaging Inc This manual was originally drafted approved and supplied by Ziehm Imaging Inc in English Ziehm Imaging Inc reserves the right t...

Страница 3: ...Service Dept 4181 Latham Street Riverside CA 92501 Fax 909 781 6457 If you have any questions call 909 781 2020 Equipment Installation Date Model Number Serial Number Final Destination Street Address...

Страница 4: ...iation Indicators 12 Fluoroscopy Time see 21 CFR 1020 31 a 12 Check kV Values 12 Check Tube Current 14 Check Radiographic Tube Current 14 Check Reproducibility 15 Beam Quality 18 Exposure Times 21 Max...

Страница 5: ...Table of Contents Page 2 MAN 06 0015 Chapter Rev A...

Страница 6: ...ed by Instrumentarium Imaging Ziehm Inc hereafter referred to as the manufacturer Unpacking the C Arm Shipping Container The system is shipped on a single pallet and contains a mobile stand monitor ca...

Страница 7: ...s will keep the C Arm from tipping over as it is removed 8 Remove the metal brackets that hold the C Arm mobile stand to the pallet Take care not to scratch the mobile stand 9 Lift the lever located i...

Страница 8: ...he bottom of the monitor case 5 Connect the AC power cords and video BNC connectors to their respective monitors left and right 6 Connect the CAN BUS cables to the RJ45 connector on the CAN module boa...

Страница 9: ...ZIEHM VISION INSTALLATION MANUAL Mounting Page 4 MAN 06 0015 Rev A 2 2...

Страница 10: ...below 110 VAC or optional 230 VAC operation adjust module 10 line voltage Verify power input to the Monitor Cart and adjust Module 10 trans former input according to the wall outlet drop off For 110 V...

Страница 11: ...unrestricted move ment of the C Arm Secure the brake 2 Repeat step one for each brake 3 Release the hand brake on the mobile cart by pulling the handle up and check that the cart moves freely and can...

Страница 12: ...MAN 06 0015 Rev A Page 7 ZIEHM VISION INSTALLATION MANUALInstallation This page is intentionally blank...

Страница 13: ...ZIEHM VISION INSTALLATION MANUAL CDRH Report Page 8 MAN 06 0015 Rev A...

Страница 14: ...are performed every six months Failure to comply with this require ment relieves the manufacturer and his agents of all responsibility in this matter The equipment user is responsible for ensuring th...

Страница 15: ...ervisor 5 Make sure that you raise the C Arm high enough to allow the C to rotate freely without interference from the C Arm base or floor Verify that the C Arm is high enough and that the control loc...

Страница 16: ...11 12 2 4 13 34 29 13 6 30 31 33 32 8 35 7 14 14 15 16 17 17 15 14 16 18 Keep Out Radiation Control Area 1m Circle Distance 4m MANUF ACTURED MONTH OCTOBER YEAR 2001 MANUF ACTUREDBY ZIEHM IMAGINGGMBH...

Страница 17: ...HMIMAGING GMBH D 90451 NURNBERG ISARSTSSE 40 G ERMANY 27 26 25 10 22 DICOM DICOM TX RX 23 28 Warning For continued protection against risk of fire Replace only with the same type and rating of fuse 20...

Страница 18: ...TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONSARE OBSERVED Cet appareil de radiographie peut presenter des dangers pour le patient et l operateur si les facteurs d ex...

Страница 19: ...e accompanying documents 11 12 13 14 Only on systems with laser aiming device 15 Only on systems with laser aiming device Table 1 Labels on the Ziehm Vision USA Keep Out Radiation Control Area 1m Circ...

Страница 20: ...l MAN 06 0015 Rev A Page 7 Maintenance Report Labels 16 Only on systems with laser aiming device 17 Only on systems with laser aiming device 18 Only on systems with laser aiming device 19a Table 1 Lab...

Страница 21: ...ntial bonding 23 Spare earth terminal 24 Protection Class I Type B 25 26 DICOM Only on systems with DICOM option and RJ45 connection connection optionally either in the upper or lower half of the moni...

Страница 22: ...maging Inc Vision Installation Manual MAN 06 0015 Rev A Page 9 Maintenance Report Labels 27 TX RX Only on units with DICOM option and fiber optic connection 28 29 30 31 Table 1 Labels on the Ziehm Vis...

Страница 23: ...umber and model labels are present and legible Record the model number and serial number in the box below If new labels are required contact the Ziehm Service department 32 33 34 35 Table 1 Labels on...

Страница 24: ...sent and legible Record the model number and serial number in the box below If labels are required contact Ziehm Service department Laser label Optional Systems equipped with a laser alignment device...

Страница 25: ...e box below If radiation does not stop immediately contact Ziehm Service Radiation Indicators 1 Activate Radiography and verify that the radiation control indicator on the mobile stand control panel l...

Страница 26: ...5 Select Radiographic exposure 6 Press the manual kV button 7 Set the timer to 0 4 seconds and kV voltage to 40 kV 8 Press the hand switch and make an exposure 9 Observe the kV value displayed on the...

Страница 27: ...n the system 6 Select the Extremities mode and press the hand switch or foot switch 7 Observe the mA value displayed on the multimeter and compare to the value shown in the control panel display If th...

Страница 28: ...0 minutes from start to finish and that you do not exceed tube loading Dosimeter Information Write the following information regarding your dosimeter into the box below Coefficient of variation For an...

Страница 29: ...ing dose value into the box below on line one dose reading one and reset the dose meter indicator to zero 6 Repeat step 5 three times writing the resulting dose values into line one of the table below...

Страница 30: ...i X Difference 3 Calculate the difference squared Multiply the difference by itself Xi X 2 2 4 Calculate the square root Add the sum of the four differences squared and divide by 3 Write the result be...

Страница 31: ...RF 1020 30 m Half Value Layer 1 Check the calibration of mA kV and mAs 2 Select Radiography and set to 110 kVp 3 Set time to 2 0 seconds to obtain 30 mAs Note For steps 4 through refer to Figure 7 For...

Страница 32: ...nd write this number into the first row of the Exposure Data column in the table below 8 Add filter material Write the thickness of the added filter material into the next row of the AL Filtration col...

Страница 33: ...A blank graph form is included at the end of this document Fig 8 Exposure Data Plot 12 Under the first data point place a data point that is one half the value In this case 300 13 Draw a horizontal li...

Страница 34: ...on the U54 board 2 Place 3 mm of lead in the path of the x ray beam to block radiation to the image intensifier 3 Set the kV to 60 kV and time to 0 4 seconds 4 Press the hand switch to release radiat...

Страница 35: ...re 10 Fig 10 Set up of Maximum Dose Rate Test 2 Select full image intensifier format 3 Fully open the collimator 4 Cover the image intensifier input with 3 mm of lead blocker 5 Select Extremities and...

Страница 36: ...diation field must be centered on the image receptor within a tolerance of less that 2 of the Source to Image Distance SID The central x ray is checked through the monitors 1 Attach the beam alignment...

Страница 37: ...below Fig 12 Evaluating the Central X Ray Beam 9 Place the C Arm in the Left position shown in Figure 13 and repeat steps 5 through 8 10 Write the actual deviation in the box below Fig 13 C Arm in the...

Страница 38: ...number 10 400 T10 3 Initiate fluoroscopy by pressing the foot switch 4 Adjust the iris collimator to approximately 10 cm in diameter 5 Manually reduce kV until the target s markings can be clearly see...

Страница 39: ...ro file Number 3 in the figure 15a below 5 Place a level on the bottom of the image intensifier Number 1 and 2 in the figure 15a below if necessary adjust the I I by loosening the mounting screws at t...

Страница 40: ...ete the adjustment of the Generator assembly 9 Remove collimator assembly and place next to the generator housing 10 With the generator cover removed place the level on the generator edge Number 4 in...

Страница 41: ...g device on the top of the generator output port and center to the mount See Figure 17 3 Check if the device is in the right position by starting radiation and viewing image on the monitors 4 The larg...

Страница 42: ...al MAN 06 0015 Rev A Page 29 Maintenance Report Tube Head Adjustment Fig 18 Correct adjustment of generator beam center Fig 19 Beam centering device The vertical tilt is correctly adjusted when the bl...

Страница 43: ...then no further tests are required If all six of the iris diaphragm leaves are not visible in the monitor proceed to step 5 Fig 20 Iris Collimator Leaves Still Visible in Monitor 5 Attach a light cros...

Страница 44: ...4 Calculate the percent deviation of the length width and length combined with width by multiplying their deviations by 100 and dividing the results by the SID 97 cm or 38 2 inches Write the results i...

Страница 45: ...s of the x ray field from the corresponding edges of the selected part of the image indi cator may not exceed 3 of SID in the plane of the image indicator in either length or width of the x ray field...

Страница 46: ...sic position 3 Insert film into the cassette 10 x 12 inches 4 Lay the cassette onto the image intensifier and fully open the iris diaphragm 5 Select Radiography 6 Set kV to 60 7 Set exposure time long...

Страница 47: ...be no larger than 5 x 5 cm at the image intensifier input 1 Load film into a film cassette and place the cassette on the image intensifier 2 Enter the Integrated Service Functions mode and select Pro...

Страница 48: ...ng the Smallest Field Size 7 Enter the Integrated Service Functions mode select Program 1 and restore the value to the one recorded earlier Save these settings and exit the Integrated Ser vice Functio...

Страница 49: ...tions 1 Check cable and make sure that they are in good condition 2 Make sure that all locks work properly 3 Make sure that all wheels are clean and that they move freely 4 Make sure that the C Sectio...

Страница 50: ...stops being emitted immediately after the hand switch and foot switch are released 2 Make sure that the exposure light on top of the monitor lights up when radiation is emitted and only when radiatio...

Страница 51: ...Ziehm Imaging Inc Vision Installation Manual MAN 06 0015 Rev A Page 38 Maintenance Report Mechanical...

Страница 52: ...ent 10 A continuous 22 A short time at 120VAC 16 A short time at 120VAC Power supply in standby mode 3 75 A 450 W at 120 VAC applies to the following configuration Standard monitors printer UP980 CD w...

Страница 53: ...min 18 mA max 40 kHz Max operating data Fluoroscopy Direct radiography Digital radiography 110 kV 15 mA 110 kV 18 mA 80 kV 20 mA 110 kV 16 mA 80 kV 18 mA Max power output Fluoroscopy Direct radiograp...

Страница 54: ...s During storage Temperature Relative air humidity 10 C to 60 C 95 max During operation Temperature Relative air humidity 10 C to 35 C 75 max Dimensions C arm Source image receptor distance 970 mm Ver...

Страница 55: ...e display screens only use pure alcohol or a mixture of 1 3 alcohol to 2 3 distilled water Immediately after you clean the X ray system and or display screens rub them dry with a soft cotton cloth Dis...

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