SN 4853 INX100, Required calibrations after replacing certified parts and as part preventive maintenance

SN 4853 INX100, Required calibrations after replacing certified parts and as part preventive maintenance Rev. 2 5334338-8EN PURPOSE/SYMPTOM As prescribed in Service Documentation (SM/ASM) of Innova products, it is mandatory to perform some calibrations and checks in case of replacing certified parts (Tube, Collimator, Detector) and as part of regular Preventive Maintenance. Recent investigations revealed that these instructions are not properly followed each case. The purpose of this Service Note is to emphasize the importance of proper calibrations and checks. Potential effects of not following PM/CM calibration instructions properly: • The dose limit (Fluoro Taper) applied by the system may be inaccurate so that the patient and the user may be exposed to a significant overdose. • X-ray technique selection and regulation may not operate properly, which is raising the risk of overdose to the patient and staff and/or Image Quality degradation. • Outputs of the dose monitoring functions (Dose Rate, Cumulated Dose, DAP displayed in the console and exam dose reported by the system) may be inaccurate and thus prevent the user to detect overdose situations. PROBLEM If replacing the X-ray tube or other critical parts in the vascular X-ray system without re-calibrating it properly, the calibration values used by the system will not correspond to the actual part performances i.e. calibrations may be severely inaccurate / inappropriate. The part performances (e.g. mR/mAs value of the tube, Conversion Factor of the detector) may drift over time. As a consequence, not re-calibrating the X-ray systems as part of a regular Preventive Maintenance activity may have similar impact. Performing the calibrations in an inappropriate order (e.g. not performing Fluoro Taper after mR/mAs calibration as prescribed in system documentation) may put dose limits’ and dose monitoring accuracy at risk. SOLUTION If ever you have a doubt about the proper execution of calibrations after preventive and/or corrective maintenance of your system, use the information below (section “1 Calibration status check”) to confirm the actual calibration status of your system. You can also contact your OLC representative to have it done remotely. In the case of: 1. Replacing certified parts 2. Identifying gaps in the system calibration status following certified part replacements 3. Identifying overdue calibrations, or gaps in the regular re-calibrations i.e. if the calibrations are older than the PM interval (6 Months), or there is no firm proof that there was no certified part replacement since the last calibrations. follow the procedures prescribed in Service Documentation and outlined in section 2 CORRECTIVE MAINTENANCE. Check and re-calibrate the X-ray system on a regular basis as prescribed in Service Documentation and outlined in section “3. PREVENTIVE maintenance”.