FD 10 PPM METHOD STATEMENT Part 1

1. INTRODUCTION
The information in this section is PPM System check. It should ensure that the clinical user can using
the system without errors.

2. VERIFICATION ITEMS
2.1. POWER-ON/OFF
Switch off entire system.
Check that the NT shut-down dialogs come up on the data monitor.
Switch on system.
Verify normal power on.
Check that an 'Emergency Patient' comes up on the Patient Data Monitor after start-up.

2.2. SAFETY DEVICES

Check correct functioning of:
Door contacts.
Warning lights.
Emergency stop button(s). (A cold restart is required after using the stop button!)
Check that user messages for door contact and stop button are displayed on the Patient Data
Monitor.

2.3. WARM RESTART

Perform a warm restart.
Check if Fast Restart Fluoroscopy (if configured) is working.

2.4. CUSTOMIZATION
Select each application procedure on the Patient Data Monitor and check that these are valid.
Look at symbol in the lower-left corner of the monitor: green open circle = valid, red cross = invalid.
If many physicians have been customized: check a number of representing procedures.

2.5. SCHEDULE PATIENT

Schedule a patient.
Check if WLM (Work List Management) via RIS is possible. Drag the scheduled patient to Acquisition.

2.6. FLUOROSCOPY
Check if the available fluoroscopy flavors operate correctly.
Pay attention to:
X-ray on indicator.
Control loop (minimum / maximum kV/mA values) during Normal and High level fluo.
Patient Entrance Exposure rate (PEE) and SID correction (if applicable).
High level fluo buzzer / high level fluo control / fluo buzzer (if applicable).
Collimator shutters / wedge filter (shutters and wedges on last image hold).
Patient orientation.
FD field size.
LIH (if programmed).

2.7. EXPOSURE
Check if exposure operates correctly.
Try different procedures, with short and long runs.
Try a subtraction run.
Pay attention to:
X-ray on indicator.
Collimator shutters / wedge filter (during long run).
Control loop (minimum / maximum kV/mA values) during exposure.
2.8. MOVEMENT
Check stand and patient support movement.
Pay attention to:
Patient safety (bodyguard sensor, current limitation).
Emergency stop button (see 2.1, Power-on/off).
Range.
Smooth movement.
Tip: The Field Service Framework has procedures to program and run (complex) stand movements.
These procedures can be found in: Diagnostics > Geometry > Functional Test > Integrated
Subsystem Test.

2.9. VIEWING OPTIONS

Check if all viewing options that are included in the license are visible on the monitors.
Check if the viewing option icons can be activated:
Control room: Use mouse to click on the option icons on the Viewing monitor.
Examination room: Use viewpad to select the option icons on the Live monitor.

2.10. ARCHIVING
Check if patient data can be archived.
(Don't forget to remove this patient when you have finished the verification!)

2.11. XPER MODULES

Check if the touch screens on the Xper modules are working.

2.12. OPTIONS
Check if the requested options are present and working, such as:
Multivision
Physio display
3D-RA
Injector
Ultrasound
Paper printer
Film printer
Intercom
Video recorder
 FD 10 PPM METHOD STATEMENT Part 2

1. INTRODUCTION
This document gives the set of tests, checks and measurements on system level that are relevant for
system acceptance.
Acceptance tests are done after System Verification. The difference is:

System Verification:
Check that the system work without errors, so that the clinical user can start without problems. Only
functional checks, no measurements.

System Acceptance:
Check that the system’s performance is in accordance to regulations, standards and specifications.
The performance is measured and the measured values must be within defined limits.
Some tests are mandatory (e.g. for DHHS regulations).

For test procedures and limits, references are given to either on-line service procedures or service
documents.

2. ACCEPTANCE ITEMS

2.1. ELECTRICAL SAFETY

The electrical safety must be tested using the planned maintenance instructions:
Electrical Safety X-Ray Systems,
The test results can be written down in the measuring list, which also gives the test limits:
Measuring Record for Electrical Safety X-Ray Systems,

2.2. RADIATION SAFETY

2.2.1. DHHS / IEC REGULATIONS
For all countries the tests from the Comprehensive Compliance Testing (CCT) must be executed.
These tests cover the compliance to DHHS and IEC regulations and standards.

2.2.2. DOSE INDICATION

The dose indication (AEP-meter) must be tested using the procedure:
AEP-Meter Verification,

3. IMAGE QUALITY (IQ)

The IQ tests are done using on-line service procedures in the Field Service Framework.
For systems that have been installed shortly after production ('door to door' delivery), only the Level-
One IQ-tests are required.
For systems that have been stored in a warehouse for a longer time before installation, also the other
performance verification procedures are required (see 3.2).

3.1. LEVEL-ONE IQ TESTS

Performance Verification > System > Image Quality > Level One IQ Tests:
Energy and Signalflow 1
Monitor Performance
Dose Test and Dose Calibration

3.2. OTHER PERFORMANCE VERIFICATIONS

Performance Verification > System > Image Quality > Lower Level IQ Tests:
XRay Focus Alignment
XRay Beam Alignment
Limiting Resolution System Level
Focalspot Size
Geometric Distortion Monitor
Half Value Layer
XRay Output
Hard Copy Unit IQ
Lock detector movement
Unlock detector movement
Performance Verification > Generator:
Tube Temperature Supervision check
Tube Nomogram check
Performance Verification > Image Detector:
Spectral Field Flatness
Offset Stability