Ziehm Imaging, Inc. VISION Installation Manual
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Ziehm Imaging, Inc. VISION Installation Manual

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Summary of Contents for Ziehm Imaging, Inc. VISION

  • Page 1 Ziehm VISION™ Installation Manual and CDRH Report...
  • Page 2 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 MAN 06-0015 Rev. A Ziehm VISION Digital Mobile C-Arm...
  • Page 3 FDA Equipment Locator Card Please make a copy of this page, fill it out and send to Ziehm imaging, Inc. within two (2) weeks of equip- ment installation. May mail or fax as instructed below: Mail:Ziehm Imaging, Inc., Attention: Service Dept., 4181 Latham Street, Riverside, CA 92501 Fax: 909-781-6457...

  • Page 4: Table Of Contents

    Ta b l e o f C o n t e n ts Audience....................1 Unpacking the C-Arm ....................1 Mounting Monitors ................2 AC Power Check ................. 4 Mechanical Movement................. 5 CDRH Report ..................5 Maintenance Report Introduction ..................1 Safety ....................
  • Page 5 Ta b l e o f C o n t e n ts Page 2 MAN 06-0015: Chapter Rev. A...

  • Page 6: Audience

    Z IEHM VI SION INSTAL LATION MANUALIns talla tion Installation Manual This Installation Manual supplements the ZIEHM VISION Service Manual. By no means should installation be attempted without consult- ing the Service Manual in addition to this Installation Manual. Audience This manual is written to qualified Service Engineers.

  • Page 7: Mounting Monitors

    Z IEHM VI SION INSTAL LATION MANUAL: Mo unti ng 3. Lower the unloading ramp into position. 4. The Monitor Cart is secured to the pallet by a bracket and four bolts. Remove the bolts and carefully slide the Monitor Cart off the pallet.
  • Page 8 Z IEHM VI SION INSTAL LATION MANUALIns talla tion Caution: Do not attempt to move the monitor assembly by your self. 3. There are four screw holes located on the bottom of the monitor case. Attach the monitor case to the cart with four allen screws. 4.
  • Page 9 Z IEHM VI SION INSTAL LATION MANUAL: Mo unti ng 2-2: . Page 4 MAN 06-0015: Rev. A...

  • Page 10: Ac Power Check

    Z IEHM VI SION INSTAL LATION MANUALIns talla tion System The monitor cart and mobile stand are connected with a single, heavy- duty cable which attaches at the rear of the monitor cart. Connect the Interconnect monitor to the monitor cart before turning on the system’s power. Plug the monitor cart power cord into a properly-rated and grounded power outlet.

  • Page 11: Mechanical Movement

    Z IEHM VI SION INSTAL LATION MANUAL: Me chanic al Mechanical The C-Arm is capable of moving in a 115º arc: 90º from horizontal to Movement vertical, and 25º beyond the vertical plane; rotating in the vertical plane around the horizontal cross arm (+225º), or swinging from side-to-side (+12º).
  • Page 12 Z IEHM VI SION INSTAL LATION MANUALIns talla tion This page is intentionally blank. MAN 06-0015: Rev. A Page 7...
  • Page 13 Z IEHM VI SION INSTAL LATI ON MAN UA L: CD RH Re por t Page 8 MAN 06-0015: Rev. A...

  • Page 14: Maintenance Report

    Ma inten ance Repo rt : In tro ducti on Maintenance Report This is a master copy of Ziehm’s Maintenance Report for the ZIEHM VISION C-Arm. Make photocopies and safeguard the original for future use. Introduction You are required by the Food and Drug Administration (FDA) to perform the checks and inspections described in this document, at least every six months.

  • Page 15: Safety

    (e.g., broken or missing covers). If there is a mechanical fault, write a description of the fault below and contact Ziehm Imaging, Inc. _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 2...

  • Page 16: Labels

    Labels on the C-arm stand (USA) 15 14 Fig. 2 Labels on systems with laser aiming device on the image intensifier (left) and on the generator (right) - USA Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 3...
  • Page 17 For continued protection against risk of fire. Replace only with the same type and rating of fuse. Fig. 4 Labels on a Ziehm Vision monitor cart with flat screens (USA) Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A...
  • Page 18 DO NOT USE IN PRESENCE OF FLAMMABLE ANESTHETICS. — RISQUE D’EXPLOSION! NE PAS UTILISER EN PRESENCE DE PRODUITS ANESTHESIANTS. — Table 1 Labels on the Ziehm Vision (USA) Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 5...
  • Page 19 Only on systems with laser CAUTION aiming device LASER RADIATION-DO NOT STARE INTO BEAM PEAK POWER: WAVELENGTH: CLASS II LASER PRODUCT Table 1 Labels on the Ziehm Vision (USA) Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 6...
  • Page 20 Only on systems with laser aiming device Only on systems with laser LASER aiming device APERTURE Only on systems with laser aiming device — Table 1 Labels on the Ziehm Vision (USA) Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 7...
  • Page 21 Only on systems with DICOM option and RJ45 connection, connection optionally either in the upper or lower half of the monitor cart Table 1 Labels on the Ziehm Vision (USA) Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 8...
  • Page 22 Ma inten ance Repo rt: Lab els TX RX Only on units with DICOM option and fiber-optic connection — — Table 1 Labels on the Ziehm Vision (USA) Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 9...
  • Page 23 23 cm IMAGE INTENSIFIER. Table 1 Labels on the Ziehm Vision (USA) 1. Refer to Figures 1, 2, 3 and 4 and Table 1. Inspect the C-Arm and verify that all applicable labels for the model being installed are present and legible. If labels are required, contact the Ziehm Service department 2.
  • Page 24 Systems equipped with a laser alignment device have the additional labels shown in Figure 2. DICOM label (Optional) Systems equipped with DICOM connectivity have additionally either label 26 or label Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 11...

  • Page 25: Switch Safety Cutoff

    1. Turn off the Z I E H M V I S I O N and disconnect the power cord from the wall power supply. 2. Remove the tube head cover. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 12...
  • Page 26 12. Observe the kV value displayed on the oscilloscope and write the value below. 40 kV 110 kV 13. If kV value displayed by the oscilloscope is > 10% of 40 kV or 110 kV, the generator’s board must be replaced. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 13...

  • Page 27: Check Tube Current

    5. Connect the system power cord to the wall power supply and turn on the system. 6. Select 75 kVp and 3 seconds of exposure time. 7. Press the hand switch to release exposure. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 14...

  • Page 28: Check Reproducibility

    Technical Data at the end of this manual. 2. Place a dosimeter probe in the center of the x-ray path, 70 cm from the focal spot, as shown below. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 15...
  • Page 29 9. Repeat step 8 three times, writing the resulting dose values into line two of the table below. Dose [mR] Line Avg. * Note: If the system is wired for 230V , mA will be 20 not 15 Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 16...
  • Page 30 Add the sum of the four differences squared and divide by 3. Write the result below. Sum = Sum divided by 3 = 5. Calculate the variation coefficient Divide the sum (obtained in step 4) by the average value (obtained in step 1). Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 17...

  • Page 31: Beam Quality

    5. Place a dose probe chamber in the center of the beam, 70 cm from the focal spot. 6. Block input to the image intensifier with 3 mm of lead blocker. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 18...
  • Page 32 9. Determine the exposure value (R) and write this number into the next row of the Exposure Data column. 10. Repeat steps 8 and 9 at four more times. Thickness (mm) of Exposure AL Filtration Data Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 19...
  • Page 33 13. Draw a horizontal line from the data point to the curve. 14. Draw a vertical line from the point of this intersection to the horizontal axis (see Data Plot Figure 10 above. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 20...

  • Page 34: Exposure Times

    Exposure Time 0.4 sec. ________ s 1 sec. ______________ ms If the variation in exposure time is greater than 10%, determine the cause and take cor- rective action. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 21...

  • Page 35: Maximum Dose Rate

    Entrance dose rate = _______________ R/min Pelvic Entrance dose rate = _______________ R/min Thoracic Entrance dose rate = _______________ R/min Reject if entrance dose rate is greater than 9.9 R/min. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 22...

  • Page 36: Checking Central X-Ray Beam

    5. Initiate fluoroscopy with the foot switch. 6. While watching the monitor, slowly close the iris until the edges of the iris are vis- ible on the monitor. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 23...
  • Page 37 10. Write the actual deviation in the box below. Fig. 13 C-Arm in the Left Position Average Deviation Max. Permissible Actual Avg. Deviation Basic = 19.0 mm ____________ mm Left = 19.0 mm ____________ mm Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 24...

  • Page 38: Adjusting Central X-Ray

    . If the image is centered on the beam target, then no further adjustment is necessary. Fig. 14 8. Carefully move the filter assembly aside to grant access to the area directly below Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 25...

  • Page 39: Tube Head Adjustment

    Adjustment Follow these instructions to install a replacement tube head or if tube head needs alignment. 1. Turn off the Ziehm Vision and disconnect the power cord from the wall power outlet 2. Remove tube head cover. 3. Set the C-Profile to zero using the rotation lock and the orbital locks to level the C-Profile in both directions See Number 3 in the figure 15 a below.
  • Page 40 11. If the vertical tilt is not level then loosen the Cam bolt nut and turn the cam bolt to raise or lower the tilt of the tube. Retighten the Cam bolt when you have leveled the generator. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 27...
  • Page 41 Ma inten ance Repo rt: Tube Head Ad justm ent Vision Track Colimeter Cam Bolt Fig. 17 Vertical tilt adjustment Central Beam Adjustment: 1. Plug in the power cord into the wall power outlet and turn on the C-arm. WARNING: To avoid exposure to radiation always use appropriate radiation safety measures during testing.
  • Page 42 Beam centering device Fig. 18 Correct adjustment of generator beam center. The vertical tilt is correctly Fig. 19 adjusted when the black areas are almost centered in the image. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 29...

  • Page 43: Check Collimation

    11. Initiate fluoroscopy by pressing the foot switch. 12. Move both of the latitudinal sliders inwards, until they are just visible at the edge of the monitor. 13. Release the foot switch to stop fluoroscopy. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 30...

  • Page 44: Image Intensifier Format

    ________ cm __________% < 3.2% If deviations are greater than 3.2%, adjust the control system or collimator align- ment until a deviation of less than 3.2% is achieved. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 31...

  • Page 45: Cassette Format

    8. When the exposure is finished, release the hand switch. 9. Develop the film and measure the exposed x-ray field, as shown in Figure 22. Write the results in the box below. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 32...
  • Page 46 9. When the exposure is finished, release the hand switch. 10. Develop the film and measure the shading of the film edge as shown in Figure 22. Write the results in the box below. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 33...
  • Page 47 5. Select Radiographic mode and make a very “light” exposure. 6. Measure the image on the film, as shown in Figure 24, and write the results in the box below. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 34...

  • Page 48: 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 Functions mode. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 35...

  • Page 49: Mechanical

    3. Make sure that all wheels are clean and that they move freely. 4. Make sure that the C-Section moves smoothly. 5. Inspect tube head cover seal. Reseal, if necessary. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 36...
  • Page 50 2. Make sure that the warning labels are not defaced. Electrical Checks 1. Make sure that power drive works properly in both the up and down directions. 2. Check power cord and plug for damage or wear. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 37...
  • Page 51 Ma inten ance Repo rt: Mecha nical Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 38...

  • Page 52: Technical Data

    Equipment protection Protection Class I, Type B ( ), ordinary equipment, classification continuous operation Radiation controlled area 23/31 cm i.i.: (with generator in lowermost position and C-arm vertical) Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 39...
  • Page 53 ≥ 3 mm Al, including 0.05 mm Cu Total filtration Tube Input screen: Caesium iodide Nominal sizes: 31 / 23 / (17) cm or 23 / 17 / (10) cm Anti-scatter grid Pb 8/40 Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 40...
  • Page 54 18.1": Ziehm Vision with approx. 188 kg flat screens 20.8": a. Option, not available with 31 cm i.i. Table 2 Technical data of the Ziehm Vision (USA) Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 41...

  • Page 55: Cleaning, Disinfecting, And Sterilization

    Ziehm does not supply pre-sterilized cotton covers. The sterilization facility operator is responsible for ensuring proper sterilizations methods are used. Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 42...

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