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Ziehm VISION™ Installation Manual and CDRH Report
Ziehm VISION™ Installation Manual and CDRH Report
Ziehm VISION™ Installation Manual and CDRH Report
Ziehm VISION™
Installation Manual
and CDRH Report
Copyright
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
Fax: 909-781-6457
Final Destination:
Street Address:
City / State / Zip Code
Contact Person:
Phone Number:
Dealer:
Street Address:
City / State / Zip Code
Contact Person:
Phone Number:
MAN 06-0015A
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 .................................................................................................. 2
Documentation .................................................................................... 2
Image intensifier .................................................................................. 2
Labels .................................................................................................. 3
Switch Safety Cutoff .......................................................................... 12
Radiation 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
Maximum Dose Rate ......................................................................... 22
Checking Central X-Ray Beam.......................................................... 23
Adjusting Central X-Ray .................................................................... 25
Tube Head Adjustment ...................................................................... 26
Check Collimation.............................................................................. 30
Image Intensifier Format.................................................................... 32
Cassette Format ................................................................................ 32
Smallest Field Size ............................................................................ 34
Mechanical ........................................................................................ 36
........................................................................................................... 39
Technical data ................................................................................... 39
........................................................................................................... 42
Cleaning, Disinfecting, and Sterilization ............................................ 42
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.
This manual is written to qualified Service Engineers. It does not con- Audience
tain any procedures that can be performed by the System Users. Do
NOT allow System Users to perform any of the service tasks described
in this manual, or any tasks that are not described in the User Manual.
Item Quantity
User Manual 2
Technical Manual 2
- C-arm Technical Data
- Approval Certificate
Foot Switch 1
Hand Switch 1
Connection Cable 1
Carefully inspect the equipment for damage. If you find any damage,
immediately report it to the shipping carrier in the form of a damage
claim.
Unpacking
Mounting Monitors The monitors are the only components that need to be mounted. They
are clearly marked Left and Right (as viewed from the front of the
monitor cart).
3. There are four screw holes located on the bottom of the monitor
case. Attach the monitor case to the cart with four allen screws.
4. Route the mobile cart wiring through the hole in the bottom of the
monitor case.
5. Connect the AC power cords and video BNC connectors to their
respective monitors (left and right).
6. Connect the CAN-BUS cables to the RJ45 connector on the CAN
module boards on each monitor.
7. Attach the ground wires to the rear panel and cart.
8. Apply power to the C-Arm and Monitor Cart and verify that the
system works properly. Test All functions. If the system is set-up to
be non-fluoroscopic, then confirm that it cannot produce radiation.
9. Re-attach the rear panels and access plates
2-2: .
The monitor cart and mobile stand are connected with a single, heavy- System
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.
Ensure that the system’s AC power cord is compatible with the AC AC Power Check
power receptacle. The system must be grounded through the U-shaped
grounding prong of the line.
Ensure that the AC line voltage is compatible with the power require-
ments of the system. Line voltage must be set to match service. For
voltages above and 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 VAC sys-
tems, if the wall outlet idles at 115 VAC and drops to 110 VAC when
the x-ray system produces fluoroscopy at 90 kV, then tap the Monitor
Cart for 110 VAC. For 230 VAC operation, tap to the nearest line volt-
age.
WARNING: Failure to properly set line voltage taps may result in dam-
age to the system’s electronic components.
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). Test C-Arm movement and brakes in the following manner:
1. Release one brake and verify full the full and 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 be steered by turning
the brake/handle.
4. Turn on C-Arm power at the monitor cart control panel. Raise and
lower the C-Arm
CDRH Report Follow the instructions in the CDRH report and record the results into
the report.
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.
You are required by the Food and Drug Administration (FDA) to perform the checks Introduction
and inspections described in this document, at least every six months. This is to ensure
that the x-ray system complies with federal regulations (specifically, the applicable
sections of CFR 21, Subchapter J - Radiological Health).
Responsibilities
The equipment user is responsible for ensuring that the maintenance steps described
in this procedure 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 that only service technicians certified
by the manufacturer perform the tests and adjustments described in this procedure.
Service technicians are responsible for performing this procedure in the manner
described in this document.
Company Information
Please provide the following information:
Company Name:
Phone Number:
Address:
C-Arm Serial Number:
Location/Room Number:
Name of Technician:
Required Equipment
The following equipment and material is required to perform this procedure:
1. Digital multi meter (e.g., Fluke 8040A, or Fluke 87)
2. Dosimeter kit
3. Beam center target, 40-400-T10
4. Storage oscilloscope
5. Fluorescent cross, 44-14-538 RH090
6. Vinyl lead sheets (3 mm lead blocker)
7. Maintenance Record
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 1
Ma inten ance Repo rt : Safety
Throughout this procedure you will be required to measure several equipment operat- Safety
ing values and record your measurements.
Checks or adjustments that require radiation exposure are marked with the radiation
symbol displayed on the right, to alert you to follow all applicable safety codes and
regulations.
Verify that the following documents were delivered to the customer. Documentation
If the customer cannot locate either of these documents, arrange to have the missing
documents replaced immediately.
Visually inspect the image intensifier to determine if there are any mechanical faults Image intensifier
(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
Ma inten ance Repo rt: Lab els
Labels
13
34
7 29
14
14 15
16
17 11&12
2&4
35
33 8
17
32
15 21 CF R S UBC HAPTER J SECTIO N 1020.32;
Ziehm Vision
Mobile Stand
SER IA L No.
ZV-3774
C 1275
1
31
C OMPLIES WI TH CD RH RA DIATION PERFORMAN CE
STAND AR DS, 21 C FR SU BCH APTER J. AS OF D ATE
OF MAN UFACTU RE
14
Keep Out
Radiation
Control Area 1m
Circle Distance 4m
18
16 6
30
13
8 17 15 14
18
14
16
15
18
17
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
Ma inten ance Repo rt: Lab els
28 28
DICOM
26
25
27 24
19
TX RX DICOM
10
20 VI SIONMC
Mon ito r Ca rt
SERI AL No.
MC-3774
C 1275
22
LIN E VO LTAGE: 12 0 va c 60 Hz
LIN E IMPEDANCE: < = 0. 6 o hm
CURRENT INPUT 10A Con tinu os/2 0AMomen tary
MAIN FUSE: 20A, 250 V
MANUFACTURED BY:
ZIEHM IMAGI NG GMBH
D-90451 NURNBE RG -ISARSTSSE 40 GE RMANY
MANUFACTURED: MONTH: O CTOBER YEAR: 200 1
Warning:
For continued protect ion agains t
risk of f ire. Replace only wit h t he
same t ype and rating of fuse.
2.
23
Fig. 3 Labels on the Ziehm Vision monitor cart (USA)
28 28
DICOM
25 26
27
24
DICOM
19 10
20 VISIONM C
LINE VOLTAGE:
LINE IMP EDAN C E:
C URR EN T IN PUT
MAI N FU SE:
M ANUFACTURED BY:
ZIEHM IMAGING G MBH
S ERI AL N o.
M C-3774
C
120 vac 60Hz
< = 0. 6 ohm
1275
23
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 4
Ma inten ance Repo rt: Lab els
2 —
3 —
4 —
EXPLOSION HAZARD!
DO NOT USE IN PRESENCE OF
FLAMMABLE ANESTHETICS.
5 —
RISQUE D’EXPLOSION!
NE PAS UTILISER EN PRESENCE
DE PRODUITS ANESTHESIANTS.
6 —
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 5
Ma inten ance Repo rt: Lab els
7 —
8 —
9 —
Keep Out
Radiation
Control Area 1m
Circle Distance 4m
10 Please observe
accompanying documents!
11 —
12 —
13 —
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 6
Ma inten ance Repo rt: Lab els
19a —
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 7
Ma inten ance Repo rt: Lab els
20 —
Warning:
For continued protection against
risk of fire. Replace only with the
same type and rating of fuse.
21 —
22 Equipotential bonding
25 —
VIDEO OUT
60Hz
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 8
Ma inten ance Repo rt: Lab els
28 —
29 —
30
31
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 9
Ma inten ance Repo rt: Lab els
32
WARNING
REMOVAL OF SKIN DISTANCE
CONE IS AGAINST THE RULES AND
REGULATIONS.
MANUFACTURED BY:
ZIEHM IMAGING GMBH
D-90451 NURNBERG -ISARSTSSE 40 GERMANY
MANUFACTURED: MONTH: YEAR:
33
34
35
WARNING
DO NOT USE CASSETTE LESS THAN
24 X 24 cm IN CONJUNCTION WITH
23 cm IMAGE INTENSIFIER.
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. Inspect the C-Arm and verify that the certification, serial number, 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.
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 10
Ma inten ance Repo rt: Lab els
3. Inspect the generator and skin cone. Verify that the certification and warning
labels are present and legible. Record the model number and serial number in the
box below. If labels are required, contact Ziehm Service department.
Systems equipped with a laser alignment device have the additional labels shown in
Figure 2.
Systems equipped with DICOM connectivity have additionally either label 26 or label
27.
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 11
Ma inten ance Repo rt : Swi tch Safe ty Cuto ff
The purpose of this test is to verify that the system immediately stops emitting radia- Switch Safety
tion once the hand switch or the foot switch are released. If either of the switches fail Cutoff
this test, contact Ziehm Service Department at once.
Radiography
1. At the mobile stand control panel, set exposure time to four seconds and kV to 40.
2. Press and release the hand switch and verify that radiation stops immediately after
releasing the hand switch.
Fluoroscopy
1. At the mobile stand control panel, select Fluoroscopy mode.
2. Press and the hand switch for a few seconds. Release and verify that radiation
stops immediately after releasing the hand switch.
3. Repeat steps 1 & 2 using the foot switch.
1. Activate Radiography and verify that the radiation control indicator on the mobile Radiation
stand control panel lights-up. Indicators
2. Activate Fluoroscopy and verify that the radiation control indicator on the mobile
stand control panel lights-up, and that the yellow radiation light on the monitor
cart lights-up.
1. Turn off the Z I E H M V I S I O N and disconnect the power cord from the wall Check kV Values
power supply.
2. Remove the tube head cover.
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 12
Ma inten ance Repo rt: Check k V Values
3. Set an oscilloscope to 2.0 volts on the DC scale (1 V = 10 kV). Connect the oscil-
loscope to TP OV and TP f (see Figure 5).
Fig. 5 Generator Components.
4. Connect the system power cord to the wall power supply and turn on the system.
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 oscilloscope and write the value below.
10. Set the timer to 0.4 seconds and 110 kV.
11. Press the hand switch and make an exposure.
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
Ma inten ance Repo rt: Check Tub e Cu rrent
1. Tube current must be checked in each of the three fluoroscopic modes: Check Tube
(1) Extremities, (2) Head, Spinal Column, and Pelvis, and (3) Thorax. Current
Rejection Criteria:
• At 0.2 to 1.2 mA, reject if mA readings in multimeter and control panel display are dif-
ferent by 15% or greater.
• At 1.3 to 8.0 mA, reject if mA readings in multimeter and control panel display are dif-
ferent by 10% or greater.
Test
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.
3. Remove the mA bridge and insert a multimeter probe in place of the jumper.
4. Adjust the multimeter to the lowest scale that displays a full 40 mAs.
5. Connect the system power cord to the wall power supply and turn on 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 the difference between the values equals or
exceeds the rejection criteria, then the generator must be replaced.
8. Write the mA value displayed by the multimeter in the box below.
9. Repeat steps 5 through 8 for the other two fluoroscopic modes.
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 14
Ma inten ance Repo rt: Check Reprodu cibil ity
8. Observe the mA value displayed by the multimeter and write this value into the
box below.
Radiography mA value
9. If mA value displayed by the multimeter is > 10% of 20 mA, then the generator
must be replaced.
The purpose of the following test is to ensure that the system consistently produces a dose Check
level that is within FDA tolerances, for every technique factor. This test consists of taking a Reproducibility
set of four exposures, for each technique factor, within a sixty-minute time period.
Dosimeter Information
Write the following information regarding your dosimeter into the box below.
Dosimeter number:
Manufacturer:
Model Number:
Serial Number:
Chamber Serial Number:
Date of last calibration:
Coefficient of variation
For any specific combination of selected technique factors, the estimated coefficient of
variation of radiation exposure must not exceed 0.045.
The FDA has established the following: “All variable controls for technique factors shall
be adjusted to alternate settings and reset to the test setting after each measurement. All
values for percent line voltage regulation shall be within + 1% of the mean value for all
measurements.” (See 32 CFR 1020.31 (b) (c)).
Test
1. Make sure that the available power supply meets the voltage requirements stated
in 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
Ma inten ance Repo rt: Check Reprodu cibil ity
3. Select Radiographic Mode. Cover the intensifier input with 3 mm of lead blocker.
4. Set-up the x-ray system as follows:
5. Take an exposure. Write the resulting 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.
7. Change kV to 90.
8. Take an exposure. Write the resulting dose value into the box below, on line two,
dose reading one, and reset the dose meter indicator to zero.
9. Repeat step 8 three times, writing the resulting dose values into line two of the
table below.
Dose [mR]
Line kV mA ms 1 2 3 4 Avg.
1 60 *15 200
2 90 *15 200
* Note: If the system is wired for 230VAC, mA will be 20 not 15
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 16
Ma inten ance Repo rt: Check Reprodu cibil ity
S=
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 17
Ma inten ance Repo rt: Beam Qual ity
C = __________________
If the calculated value of the variation coefficient is greater than 0.045, determine the
cause and take corrective action.
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 18
Ma inten ance Repo rt: Beam Qual ity
7. Initiate exposure. Determine the exposure value (R) and 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 column.
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.
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 19
Ma inten ance Repo rt: Beam Qual ity
12. Under the first data point, place a data point that is one-half the value. In this case,
300.
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
Ma inten ance Repo rt: Exposure Ti mes
This halving thickness is the half-value layer (HVL) of the useful x-ray beam. The
HVL must not be less than 3.0 mm at 110 kVp. If the HVL is lower that 3.0mm, deter-
mine the cause and take corrective action.
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
Ma inten ance Repo rt: Maxim um Dose Rate
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 22
Ma inten ance Repo rt: Checkin g Central X-Ray Beam
Note: If dose exceeds 10 R/min limit, you must reduce pulse width or maximum
mA as necessary. A trained and qulified Service Technician is required to
perform this task. Contact Service Support.
8. Write the model number and serial number of the dosimeter in the box below.
1. Attach the beam alignment target (p/n 40-400-T10) to the image intensifier.
2. Fully open both the slot collimator and iris diaphragm.
3. Select the full image intensifier format (i.e., no zoom).
4. Place the C-Arm in the Basic position, shown in Figure 11.
Fig. 11 C-Arm in the Basic Position
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 23
Ma inten ance Repo rt: Checkin g 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 Left Position
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 24
Ma inten ance Repo rt: Adjusting Cen tra l X-Ray
Note: alues given are for the monitor. At the C-Arm, full image intensifier format Adjusting Central
is selected. If actual deviations are larger than the amount permissible, X-Ray
make adjustments according to section Note: .
8. Carefully move the filter assembly aside to grant access to the area directly below
it.
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 25
Ma inten ance Repo rt: Tube Head Ad justm ent
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.
4. Check the level of the C-Profile by placing a water level on the side of the C-Pro-
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 the top
of the C-profile. If you can not level number 1 in figure below, insert a 1mm steel
shim to level the I.I.
Shim
6. Check the tilt adjustment of the generator mounting plate. This must be level from
side to side so the generator can be adjusted properly. Loosen the two rear mount-
ing bolts to adjust the mounting plate. See number 5 in figure 15.
7. Check the horizontal tilt of the generator by placing the water level (Number 4 in
figure 15 on the top of the generator tube port. Adjust by loosening the mounting
bolts in figure 15 and tilting the generator until the generator is level.
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 26
Ma inten ance Repo rt: Tube Head Ad justm ent
8. Now that the I.I , C-profile and the generator mounting plate are level we must
complete 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 figure 15) and check the vertical tilt.
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
Ma inten ance Repo rt: Tube Head Ad justm ent
Cam Bolt
2. Place the central beam testing 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 large black area in the image should look like a circle and the smaller center
black must be as close to center as possible. See Figure 18 below.
5. If the generator is not correctly adjusted as seen in Figure 18 use the tilt and side
adjustment outlined above in previous section of this document for proper align-
ment of the generator central beam.
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 28
Ma inten ance Repo rt: Tube Head Ad justm ent
Beam centering
device
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 29
Ma inten ance Repo rt: Check Coll imation
Federal regulations (21 CRF 1020.32 (b) (2) (1)) establish that, during fluoroscopic
operation, the x-ray field in the image indicator plate must not exceed 3% of the SID
of the visible image-indicator surface - in length or width. The sum of the lengths and
widths access may not be greater than 4% of the SID.
5. Attach a light cross, or a fluorescent screen, to the middle of the image intensifier
input.
6. Open the iris diaphragm to the maximum setting.
7. Initiate fluoroscopy by pressing the foot switch.
8. The light cross has four measuring sliders: two that move longitudinally, and two
that move latitudinally. Move both of the longitudinal sliders inwards, until they
are just visible at the edge of the monitor.
9. Release the foot switch to stop fluoroscopy.
10. Mark the position of the sliders on the light cross. (With a fluorescent screen,
mark the edge of the radiation field).
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
Ma inten ance Repo rt: Check Coll imation
14. Mark the position of the sliders on the light cross. (With a fluorescent screen,
mark the edge of the radiation field).
15. Measure the deviations of A1, B1, C and D (see Figure 20.
Fig. 21 X-Ray Field Observed on Monitor
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 in the box below.
Zoom Format
Length deviation ________ cm __________% < 2.4%
Width deviation ________ cm __________% < 2.4%
Length + width deviation ________ 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
Ma inten ance Repo rt: Ima ge In tensi fier Fo rmat
Federal regulations (21 CRF 1020.31 (g) (2)) establish that, if full coverage of the
selected part of the image indicator has been set, then the total deviation of the edges
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,. The absolute sum (disregarding the sign) of the deviation in
all orthogonal dimensions may not exceed 4% of the SID.
Note: In Radiographic mode, the iris collimator limits the cassette format.
1. Select Fluoroscopy.
2. Insert film into the cassette (14 x 14 inches).
3. Lay the cassette onto the image intensifier and fully open the iris diaphragm.
4. Select Radiography.
5. Set kV to 60.
6. Set radiographic exposure time long enough to fully expose the film without over-
exposing.
7. Initiate fluoroscopy by pressing the hand switch.
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
Ma inten ance Repo rt: Cassette Fo rmat
The following tests must be conducted with the C-Arm in the three positions as
described in “Check the central x-ray beam.”
1. Select Fluoroscopy.
2. Place the C-Arm in the Basic 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 enough to fully expose the film without over-exposing.
8. Initiate an exposure by pressing the hand switch.
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
Ma inten ance Repo rt: Smalles t Fi eld Size
11. Repeat steps 1 through with the C-Arm in the Left position.
SID 97 cm
A*=A-a
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Ma inten ance Repo rt: Mecha nical
1 Camera Cover
2 C-Section
3 Locks
4 Wheels
5 Cables
6 Skin Cone
7 Tube Head Cover
Mechanical Inspections
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-Section moves smoothly.
5. Inspect tube head cover seal. Reseal, if necessary.
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Ma inten ance Repo rt: Mecha nical
6. Inspect and confirm that the mechanical cone is properly installed and secured for
a SSD of 30 cm.
7. Inspect skin cone and replace if damaged.
8. Inspect camera cover seal. Reseal, if necessary.
9. Inspect for any physical damage to the generator and shutters that could affect
radiation shielding.
Radiation Checks
1. Make sure that radiation 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 radiation is emitted.
3. Make sure that the audible alarm sounds after five minutes of fluoroscopy, and
during radiographic exposure.
4. Make sure that the line cord has no physical damage.
Label checks
1. Make sure that all labels are attached and legible.
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.
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Ma inten ance Repo rt: Mecha nical
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 38
Ma inten ance Repo rt :
Technical data
Nominal supply voltage / 220VAC, 60Hz 120 VAC, 60 Hz
frequency
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 39
Ma inten ance Repo rt: Techni cal d ata
Operating 40 kHz
frequency:
Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 40
Ma inten ance Repo rt: Techni cal d ata
humidity:
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Ma inten ance Repo rt :
Turn the X-ray system off and disconnect it from the wall outlet power connection, Cleaning,
before cleaning or disinfecting it. Disinfecting, and
Sterilization
WARNING: Keep moisture out of the X-ray system! DO NOT spray the system
with water or any kind of liquid ! DO NOT use a cloth soaked in any kind of liquid to
clean the equipment.
Cleaning
You may clean the X-ray system with water, standard household cleaners, and a damp
cloth. Do not use any scouring cleaners, organic thinners, or cleaners that contain thin-
ners (i.e. alcohol, pure benzene, stain remover).
To clean the 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.
Disinfection
We guarantee that Incidin and Ultrasol, used as described above, will not degrade the
X-ray system’s painted surfaces. We do not guarantee the use of other disinfectants
and/or substances on painted surfaces.
Sterilization
The removable cassette holder and cotton covers can be sterilized. Appropriate steril-
ization methods must be used to ensure the sterility of cotton covers. 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