s Ziehm VISION™ Installation Manual and CDRH Report · Ziehm Imaging, Inc. Vision Installation...

sZiehm VISION™

Installation Manualand CDRH Report

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 ByZiehm Imaging, GmbHIsarstrasse 40, D-90451Nuremberg, GermanyE-mail: www.ziehm-eu.com

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

MAN 06-0015A

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

If you have any questions, call: 909-781-2020.

Equipment: Installation Date:

Model Number: Serial Number:

Final Destination:

Street Address:

City / State / Zip Code

Contact Person:

Phone Number:

Dealer:

Street Address:

City / State / Zip Code

Contact Person:

Phone Number:

Ziehm Imaging, Inc., 4181 Latham Street, Riverside, CA 92501

FDA Equipment Locator Card

MAN 06-0015: Chapter Rev. A Page 1

Table of Contents

Audience.............................................................................................. 1Unpacking the C-Arm .................................................................................................. 1Mounting Monitors ............................................................................... 2AC Power Check ................................................................................. 4Mechanical Movement......................................................................... 5CDRH Report ...................................................................................... 5

Maintenance ReportIntroduction.......................................................................................... 1Safety .................................................................................................. 2Documentation .................................................................................... 2Image intensifier .................................................................................. 2Labels .................................................................................................. 3Switch Safety Cutoff .......................................................................... 12Radiation Indicators........................................................................... 12Fluoroscopy Time (see 21 CFR 1020.31 (a)) .................................... 12Check kV Values ............................................................................... 12Check Tube Current .......................................................................... 14Check Radiographic Tube Current .................................................... 14Check Reproducibility ........................................................................ 15Beam Quality ..................................................................................... 18Exposure Times................................................................................. 21Maximum Dose Rate ......................................................................... 22Checking Central X-Ray Beam.......................................................... 23Adjusting Central X-Ray .................................................................... 25Tube Head Adjustment ...................................................................... 26Check Collimation.............................................................................. 30Image Intensifier Format.................................................................... 32Cassette Format ................................................................................ 32Smallest Field Size ............................................................................ 34Mechanical ........................................................................................ 36........................................................................................................... 39Technical data ................................................................................... 39........................................................................................................... 42Cleaning, Disinfecting, and Sterilization ............................................ 42

Table of Contents

Page 2 MAN 06-0015: Chapter Rev. A

MAN 06-0015: Rev. A Page 1

ZIEHM VISION INSTALLATION MANUALInstallation

Installation ManualThis 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.

AudienceThis manual is written to qualified Service Engineers. It does not con-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.

In order to be qualified to perform the Installation procedures described in this manual, Service Engineers must attend formal training provided 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 cart, case assembly (unmounted), and the items listed in the table below.

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

Unpacking of the x-ray system is to be carried out by authorized, quali-fied personnel.

1. To avoid damage being caused to the equipment by condensation resulting from temperature differences, make sure that all parts of the equipment have reached room temperature before turning the equipment on

2. Remove the outside of the shipping container and inspect.

Item QuantityUser Manual 2Technical Manual- C-arm Technical Data- Approval Certificate

2

Foot Switch 1Hand Switch 1Connection Cable 1

ZIEHM VISION INSTALLATION MANUAL: Mounting

Page 2 MAN 06-0015: Rev. A

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.

5. Remove the two straps that hold the monitors and take the monitors off the pallet.

6. Remove all of the brackets from the pallet.

7. Loosen the Wig-Wag knob and straighten the C-Arm as shown in Figure 2.1. This 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 in the center of the control panel (the hand brake) and carefully move the mobile stand off the pallet and onto the floor.

2-1: C-Arm in the Transport Position

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).

1. Remove the monitor’s rear panels.

2. Have a qualified person help you place the monitor assembly onto the mobile cart’s mounting surface.



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. 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

ZIEHM VISION INSTALLATION MANUAL: Mounting


2-2: .



System Interconnect

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 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.

AC Power CheckEnsure that the system’s AC power cord is compatible with the AC power receptacle. The system must be grounded through the U-shaped grounding prong of the line.

WARNING: DO NOT use a 3-prong to 2-prong adapter, unless properly installed by a licensed electrician. Failure to comply may result in seri-ous or fatal injuries to the System User and other persons in the sur-rounding area.

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.

Check Leakage Current

We recommend that you perform a check of leakage current, using a calibrated leakage meter, in the following manner:

1. Inspect ground leads to ensure that ground connections are solid.

2. Insert the meter (with 100 ohm input impedance) in series with the line cord, per the meter manufacturer’s instructions.

3. Turn the meter on and verify that leakage current does not exceed 100 µA, in either normal or reversed line polarity.

4. Connect the black lead of the meter to an exposed metal surface on the x-ray system.

5. Turn the meter on and verify that leakage current does not exceed 100 µA.

ZIEHM VISION INSTALLATION MANUAL: Mechanical


Mechanical Movement

The C-Arm is capable of moving in a 115º arc: 90º from horizontal to 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

2-3: .ON / OFF Keys

Caution: The starting circuit is always powered - even when power is switched off! To completely disconnect from Mains Power, remove the power cord from the wall power outlet.

CDRH Report Follow the instructions in the CDRH report and record the results into the report.



This page is intentionally blank.

ZIEHM VISION INSTALLATION MANUAL: CDRH Report


Ziehm Imaging, Inc. Vision Installation Manual MAN 06-0015, Rev. A Page 1

Maintenance Report: Introduction

Maintenance ReportThis is a master copy of Ziehm’s Maintenance Report for the ZIEHM VISION C-Arm. Make photocopies and safeguard the original for future use.

IntroductionYou are required by the Food and Drug Administration (FDA) to perform the checks 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:

Required EquipmentThe following equipment and material is required to perform this procedure:

1. Digital multi meter (e.g., Fluke 8040A, or Fluke 87)2. Dosimeter kit3. Beam center target, 40-400-T104. Storage oscilloscope5. Fluorescent cross, 44-14-538 RH0906. Vinyl lead sheets (3 mm lead blocker)7. Maintenance Record

Company Name:

Phone Number:

Address:

C-Arm Serial Number:

Location/Room Number:

Name of Technician:


Maintenance Report: Safety

SafetyThroughout this procedure you will be required to measure several equipment operat-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.

CAUTION: Follow all safety rules regarding the use of radiation-emitting equipment including the following:

1. Make all earth-lead connections provided by the manufacturer. For example, equipment metal panels may expose you to dangerous voltages, unless they are grounded. Therefore, ground metal panels.

2. Use a digital multi meter to check each ground lead connection. Measure from ground point to outside cover, to ensure that positive grounding has been achieved.

3. Follow all local occupational safety laws and state codes that pertain to your installation site.

4. If an accident occurs, or if there are hazards which may result in an accident, immediately notify your supervisor.

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 locks work properly with the C in various positions. Ensure that there are no objects which may impede the free movement of the C-Arm.

DocumentationVerify that the following documents were delivered to the customer.

If the customer cannot locate either of these documents, arrange to have the missing documents replaced immediately.

Image intensifierVisually inspect the image intensifier to determine if there are any mechanical faults (e.g., broken or missing covers). If there is a mechanical fault, write a description of the fault below and contact Ziehm Imaging, Inc.______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Document Documents Received?

Operating Instructions Yes No

Maintenance Instructions Yes No


Maintenance Report: Labels

Labels

Fig. 1 Labels on the C-arm stand (USA)

Fig. 2 Labels on systems with laser aiming device on the image intensifier (left) and on the generator (right) - USA

19

11&122&4

1334

29

13

630

31

33328

35

7 1414 15

1617

1715

14

16

18

Keep Out Radiation

Control Area 1mCircle Distance 4m

MANUFACTURED: MONTH: OCTOBER YEAR: 2001

MANUFACTURED BY: ZIEHM IMAGING GMBHD-90451 NURNBERG -ISARSTSSE 40 GERMANY

COMPLIES WITH CDRH RADIATION PERFORMANCESTANDARDS, 21 CFR SUBCHAPTER J. AS OF DATEOF MANUFACTURE

CZiehm Vision

SERIA L No.ZV-3774

1275Mobile Stand

21 CFR SUBC HAPTER J SECTION 1020.32;

14

15

8 15 14

18

17

17

16

18



Fig. 3 Labels on the Ziehm Vision monitor cart (USA)

Fig. 4 Labels on a Ziehm Vision monitor cart with flat screens (USA)

2.

LIN E VOLTAGE: 120 vac 60HzLIN E IMPEDANCE: < = 0. 6 ohmCURRENT INPUT 10A Continuos/20A Momentary

20A, 250 V MAIN FUSE:

C

VISIONMC

SERI AL No.MC-3774

1275Monitor Cart

MANUFACTURED: MONTH: OCTOBER YEAR: 2001

MANUFACTURED BY: ZIEHM IMAGING GMBHD-90451 NURNBERG -ISARSTSSE 40 GERMANY

27

2625

1022

DICOM

DICOM

TX RX

23

28

Warning:For continued protect ion agains trisk of f ire. Replace only with the same type and rating of fuse.

2019

24

28

DICOM

DICOM

272625

1022

23

28

2019

24

28

LINE VOLTAGE: 120 vac 60Hz

LINE IMP EDANCE: < = 0. 6 ohmCURRENT INPUT 10A Continuos /20A Momentary

20A, 250 V MAI N FUSE:

CVISIONMC

S ERI AL No.MC-3774

1275Moni tor Cart

MANUFACTURED: MONTH: OCTOBE R YE AR: 2001

MANUFACTURED BY: ZIEHM IMAGING G MBHD-90451 NURNBERG -ISARSTSSE 4 0 GERMANY

Warning:For continued protection againstrisk of fire. Replace only with the same type and rating of fuse.



No. Label Comments Present & Legible?

1 —

2 —

3 —

4 —

5 —

6 —

Table 1 Labels on the Ziehm Vision (USA)

THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED.

Cet appareil de radiographie peut presenter des dangers pour le patient et l’operateur si les facteurs d’exposition en securite et les instructions d’utilisation ne sont pas respectes.

EXPLOSION HAZARD!DO NOT USE IN PRESENCE OF

FLAMMABLE ANESTHETICS.

RISQUE D’EXPLOSION!NE PAS UTILISER EN PRESENCE DE PRODUITS ANESTHESIANTS.



7 —

8 —

9 —

10 Please observe accompanying documents!

11 —

12 —

13 —

14 Only on systems with laser aiming device



Keep Out Radiation

Control Area 1mCircle Distance 4m

CAUTIONLASER RADIATION-DO NOTSTARE INTO BEAMPEAK POWER: 1mWWAVELENGTH: 5nmCLASS II LASER PRODUCT

63






19a —


LASERAPERTURE



19b This label is for 220VAC applications within the USA.

20 —

21 —

22 Equipotential 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 monitor cart


Warning:For continued protection againstrisk of fire. Replace only with the same type and rating of fuse.

2.

60HzVIDEO OUT



27 TX RX Only on units with DICOM option and fiber-optic connection

28 —

29 —

30

31




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.

32

33

34

35


MANUFACTURED: MONTH: YEAR:

WARNINGREMOVAL OF SKIN DISTANCE

CONE IS AGAINST THE RULES AND REGULATIONS.

MANUFACTURED BY: ZIEHM IMAGING GMBH

D-90451 NURNBERG -ISARSTSSE 40 GERMANY

WARNINGDO NOT USE CASSETTE LESS THAN24 X 24 cm IN CONJUNCTION WITH

23 cm IMAGE INTENSIFIER.

Component Model No. Serial No.

X-ray control

Image intensifier assembly

X-ray generator



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.

Laser label (Optional)

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 27.

Model No. Serial No.

Certification label


Maintenance Report: Switch Safety Cutoff

Switch Safety Cutoff

The purpose of this test is to verify that the system immediately stops emitting radia-tion once the hand switch or the foot switch are released. If either of the switches fail this test, contact Ziehm Service Department at once.

Radiography1. 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.

Fluoroscopy1. 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.

Record the results of this test in the 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 lights-up.

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.

Fluoroscopy Time (see 21 CFR 1020.31 (a))

1. Set manual fluoroscopy voltage to 40 kV.2. Close the iris diaphragm and cover the tube assembly with a lead apron.3. Switch on fluoroscopy.4. Verify that the audible alarm sounds once the system has reached five minutes of

fluoroscopy.5. Press the Zero Min button to turn off the alarm. The LED will continue to flash.

To turn off both the alarm and the LED, press and hold the Zero Min button.

Check kV Values1. Turn off the ZIEHM VISION and disconnect the power cord from the wall power supply.

2. Remove the tube head cover.

Switch Safety Cutoff Accept Reject

Radiation lights working? Yes No

Fluoroscopy time in order? Yes No


Maintenance Report: Check kV 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.

13. If kV value displayed by the oscilloscope is > 10% of 40 kV or 110 kV, the generator’s board must be replaced.

40 kV 110 kV


Maintenance Report: Check Tube Current

Check Tube Current

1. Tube current must be checked in each of the three fluoroscopic modes: (1) Extremities, (2) Head, Spinal Column, and Pelvis, and (3) Thorax.

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.

Test1. Turn off the ZIEHM VISION and disconnect the power cord from the wall

power supply.


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.


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.

Check Radiographic Tube Current

Rejection Criteria:• The mA value must be within 10% of the fixed 20 mA radiography value.

Test1. Turn off the ZIEHM VISION and disconnect the power cord from the wall

power supply.


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.


6. Select 75 kVp and 3 seconds of exposure time.

7. Press the hand switch to release exposure.

Extremities Chest Pelvic

40 kV

110 kV


Maintenance Report: Check Reproducibil i ty

8. Observe the mA value displayed by the multimeter and write this value into the box below.

9. If mA value displayed by the multimeter is > 10% of 20 mA, then the generator must be replaced.

Check Reproducibility

The purpose of the following test is to ensure that the system consistently produces a dose level that is within FDA tolerances, for every technique factor. This test consists of taking a set of four exposures, for each technique factor, within a sixty-minute time period.

Make sure that:• the dosimeter is calibrated and working properly• measurements are made one-after-another• exposure technique is reset to test settings after each measurement• all measurements are made within 60 minutes, from start to finish, and• that you do not exceed tube loading.

Dosimeter InformationWrite the following information regarding your dosimeter into the box below.

Coefficient of variationFor 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)).

Test1. 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.

Radiography mA value

Dosimeter number:

Manufacturer:

Model Number:

Serial Number:

Chamber Serial Number:

Date of last calibration:



Fig. 6 Dosimeter Probe Placement

3. Select Radiographic Mode. Cover the intensifier input with 3 mm of lead blocker.

4. Set-up the x-ray system as follows:

kV = 60, mA = 15, ms = 200 for 120V operation.kV = 60, mA = 20, ms = 200 for 230V operation

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.

* Note: If the system is wired for 230VAC, mA will be 20 not 15

Dose [mR]

Line kV mA ms 1 2 3 4 Avg.

1 60 *15 200

2 90 *15 200



Calculating the Coefficient CFor n individual measurements, the variation of the coefficient C is obtained from.

1. Calculate the average

Add the four dose values and divide the sum by four.

X1 + X2 + X3 + X4 = X (Average) n

2. Calculate the difference

Subtract each measured value from the average.

Xi - 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 below.

S =

5. Calculate the variation coefficient

Divide the sum (obtained in step 4) by the average value (obtained in step 1).

S = calculated standard deviationX = average value of all individual measurementsXi = measured value of the ith measurementn = number of individual measurements∆ = difference∆2 = difference squared

Measurement Radiation Exposure

Average (X) = Difference Difference Squared

Sum = Sum divided by 3 =


Maintenance Report: Beam Quality

Variation coefficient C = S/X = _________________ / __________________

C = __________________

If the calculated value of the variation coefficient is greater than 0.045, determine the cause and take corrective action.

Beam QualityBeam Quality Test

Refer to 21 CRF 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 step 3, if system is wired for 230 V the mA will be 20mA for a total of 40 mAs.

4. Use the 6.0 cc chamber and collimate the beam so that it just covers the sensitive volume of the dose probe.

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.

∆ < 0.045 Accept Reject



Fig. 7 .Setting-Up for Beam Quality Test

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.

Thickness (mm) of AL Filtration

ExposureData

0



11. Plot the exposure data, as shown below.

Note: 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 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.


Maintenance Report: Exposure Times

Fig. 9 Plotting the Half-Value Layer

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.

Exposure TimesTest1. Connect an oscilloscope to test point F 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 radiation.

5. Read the exposure time on the oscilloscope (start from the beginning of a positive wave to the end of the negative wave that follows), and write the exposure time below.

6. Set the time to one second, make another exposure, and write the time below.

If the variation in exposure time is greater than 10%, determine the cause and take cor-rective action.

Exposure Time 0.4 sec. ________ s 1 sec. ______________ ms


Maintenance Report: Maximum Dose Rate

Maximum Dose Rate

Federal Regulations

Federal regulations (21 CFR 1020.32 (d) (1)) establish that fluoroscopic equipment with automatic dose rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 10 roentgens-per-minute at the point where the center of the useful beam enters the patient.

1. Position a dosimeter probe as shown in Figure 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 initiate fluoroscopy with the foot switch. Write the result-ing dose rate in the box below.

6. Select Pelvic and initiate fluoroscopy with the foot switch. Write the resulting dose rate in the box below.

7. Select Thoracic and initiate fluoroscopy with the foot switch. Write the resulting dose rate in the box below..

Reject if entrance dose rate is greater than 9.9 R/min.

Extremities Entrance dose rate = _______________ R/min

Pelvic Entrance dose rate = _______________ R/min

Thoracic Entrance dose rate = _______________ R/min


Maintenance Report: Checking 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.

9. Answer the question in the following box.

Checking Central X-Ray Beam

Federal Regulation

Federal regulations (21 CRF 1020.31 (e) (1)) establish that the radiation 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 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

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.

Dosimeter Model No.:

Dosimeter Serial No.:

Did x-ray production cease immediately when the hand and/or foot switch was released?

Yes No


Maintenance Report: Checking Central X-Ray Beam

7. Evaluate the position of the central beam as shown in Figure 12

8. Write the actual deviation in the box 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 Left Position

A = mid-point of the image intensifier inputB = middle of the radiation field∆ = deviation of A to B

Average Deviation Max. Permissible Actual Avg. Deviation

Basic = 19.0 mm ____________ mm

Left = 19.0 mm ____________ mm


Maintenance Report: Adjusting Central X-Ray

Adjusting Central X-Ray

Note: alues given are for the monitor. At the C-Arm, full image intensifier format is selected. If actual deviations are larger than the amount permissible, make adjustments according to section Note: .

Adjusting Central X-Ray in Relation to the Image Intensifier1. Place the C-Arm in the Basic position.

2. Attach the beam center target to the image intensifier (part 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 seen.

6. Release the foot switch to stop fluoroscopy. The fluoroscopic image received by the image intensifier will be displayed on the monitor, and will show the target and iris openings.

7. Observe the position of the iris collimator opening on the screen. If the image is not centered to the beam target, proceed to section . 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 it.


Maintenance Report: Tube Head Adjustment

Tube Head Adjustment

Mechanical Pre-alignment Tube head 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.

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.

Fig. 15 Placement of water levels

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.

Shim



Fig. 16 Side tilt adjustment

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.



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.

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.

Vision Track Colimeter

Cam Bolt



Fig. 18 Correct adjustment of generator beam center.

Fig. 19

Beam centeringdevice

The vertical tilt is correctly adjusted when the black areas are almost centered in the image.


Maintenance Report: Check Coll imation

Check CollimationFederal Regulation

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.

1. Place the C-Arm in the Basic position.

2. Select the full image intensifier input format (i.e., no zoom).

3. Open the iris diaphragm to the maximum setting.


• If all six of the iris diaphragm leaves are visible at the edge of the monitor (as shown in Figure 19) 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 cross, or a fluorescent screen, to the middle of the image intensifier input.

6. Open the iris diaphragm to the maximum setting.


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).


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.


Maintenance Report: 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

1. Calculate the length deviation.

L = ∆Α + ∆C

2. Calculate the width deviation.

W = ∆B + ∆D

3. Calculate the sum of the length and width deviation

∆A + ∆B + ∆C + ∆D

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.

Image Intensifier Format

Zoom Format

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.

Length deviation ________ cm __________% < 2.4%

Width deviation ________ cm __________% < 2.4%

Length + width deviation ________ cm __________% < 3.2%

Length deviation ________ cm __________% < 2.4%

Width deviation ________ cm __________% < 2.4%

Length + width deviation ________ cm __________% < 3.2%


Maintenance Report: Image Intensif ier Format

Image Intensifier Format

Adjust the Image Intensifier Format1. Open the iris diaphragm to the maximum setting.


3. All six of the iris diaphragm leaves must be visible at the edge of the monitor (as shown in Figure 20). If this is not the case, then the iris control must be adjusted in normal mode, per the Service Manual.

Cassette FormatFederal Regulation

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.


Maintenance Report: Cassette Format

Fig. 22 Measuring the Exposed X-Ray Field

Cassette to X-Ray Field

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.

Exposed x-ray field: Length (A)________ cm Width (B)________ cm


Maintenance Report: Smallest Field Size

Fig. 23 Measuring the Cassette to the X-Ray Field

11. Repeat steps 1 through with the C-Arm in the Left position.

C-Arm in Basic Position

C-Arm in Left Position

C-Arm in Right Position

SID 97 cmA * = A - a

Reject if A + C > 23.28 mm (2.4% SID)

Smallest Field SizeCheck the Smallest Field SizeThe smallest field size should 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 Program 1

3. Record the current setting for later restoration, and close the iris completely.

4. Save this setting and exit the Integrated Service Functions mode.

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.

Shading ∆Α _________ + Β ________ = mm < 21.6 mm

Shading ∆Α _________ + Β ________ = mm < 21.6 mm

Shading ∆Α _________ + Β ________ = mm < 21.6 mm


Maintenance Report: Smallest Field Size

Fig. 24 Measuring 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 Functions mode.

Smallest field size: Film (A) ________ cm (B) __________ cma

a. Reject if smallest field size is greater than 5 cm x 5 cm.


Maintenance Report: Mechanical

MechanicalRoutine Inspectionsl

Mechanical Inspections1. 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.

1 Camera Cover2 C-Section3 Locks4 Wheels5 Cables6 Skin Cone7 Tube Head Cover



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 Checks1. 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 checks1. Make sure that all labels are attached and legible.

2. Make sure that the warning labels are not defaced.

Electrical Checks1. Make sure that power drive works properly in both the up and down directions.

2. Check power cord and plug for damage or wear.


Maintenance Report:

Technical data

Syst

em

Nominal supply voltage / frequency

220VAC, 60Hz 120 VAC, 60 Hz

Power supply fuse rating L 20 A at 120VAC L16 A at 220VAC

Required residual current circuit breaker (RCD)

IN ≥ 20 A, IAN = 30 mA at 120 VAC, 60HzIN ≥ 16 A, IAN = 30 mA at 220 VAC, 60Hz

Nominal supply current 10 A continuous, 22 A short-time at 120VAC16 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 writer, MO disk drive, floppy disk drive)

The values depend on the integrated documentation systems.

Internal fusing 20 A quick-blow (2 pcs.)

Maximum line impedance ≤ 0.6 Ω

Equipment protection classification

Protection Class I, Type B ( ), ordinary equipment, continuous operation

Radiation controlled area(with generator in lowermost position and C-arm vertical)

23/31 cm i.i.: 4 m


Maintenance Report: Technical dataG

ener

ator

Power Direct radiography:

Fluoroscopy:

- Pulsed mode:

40–110 kV15 mA min./20 mA max.,1.5 mAs min./100 mAs max.

40–110 kV0.1–15 mA at 120 VAC0.2 mA at 230 VACPulse width 10, 16, 20, 30 ms1, 2, 5, 10, 15, 30 pulses/s

Digital radiography (snapshot):

Operating frequency:

40–110 kV0.1 mA 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 radiography:

1650 W (110 kV / 15 mA)

1980 W (110 kV / 18 mA)

Digital radiography:

1760 W (110 kV / 16 mA)

Nominal electric power 2000 W at 100 kV / 20 mA / 0.1 s

X-ray tube Single-focus stationary-anode tube

Focal spot nominal size 0.6 acc. to IEC

Total filtration ≥ 3 mm Al, including 0.05 mm Cu

Imag

e in

tens

ifier Tube Input screen:

Nominal sizes:

Caesium iodide

31 / 23 / (17) cm or

23 / 17 / (10) cm

Anti-scatter grid Pb 8/40


Maintenance Report: Technical data

Table 2 Technical data of the Ziehm Vision (USA)

Mon

itors

Standard monitors Screen size:

Bandwidth:

Resolution:

440 mm (17")

140 MHz

1125 lines / 90 Hz

Flat screens 18.1" Screen size:

Resolution:

460 mm (18.1")

1280 × 1024

Flat screens 20.8" Screen size:

Resolution:

530 mm (20.8")

2048 × 1536

Envi

ronm

enta

lco

nditi

ons

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.

Dim

ensi

ons

C-arm Source–image receptor distance:

970 mm

Vertical free space: 750 mm

Immersion depth:

Orbital rotation:

Angulation:

Swivelling (‘wig-wag’):

Horizontal movement:

Vertical movement:

680 mm

115° / 135° a

± 225°

±10°

220 mm

430 mm

Wei

ght

C-arm stand Ziehm Vision: approx. 280 kg (23 cm i.i.)

Monitor cart Ziehm Vision: approx. 203 kg

Ziehm Vision with flat screens 18.1":

approx. 183 kg

Ziehm Vision with flat screens 20.8":

approx. 188 kg

a. Option, not available with 31 cm i.i.


Maintenance Report:

Cleaning, Disinfecting, and Sterilization

Turn the X-ray system off and disconnect it from the wall outlet power connection, before cleaning or disinfecting it.

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

To disinfect the system, we recommend using the following disinfectants:

Incidin (3% in water)

Ultrasol F (5:1 in water)

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.

s Ziehm VISION™ Installation Manual and CDRH Report · Ziehm Imaging, Inc. Vision Installation...

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Transcript of s Ziehm VISION™ Installation Manual and CDRH Report · Ziehm Imaging, Inc. Vision Installation...