Important Field Safety Notice
Contents
1. Location or e g linac if applicable Site No Acknowledgement by customer This notification to be signed by the customer acknowledge that have read and understood this Notice and accept implementation of any given recommendations Name Title Signature Date New installation confirmation This notification to be signed by the installing Elekta or Representative employee Name Title Signature Date This Notice has been notified to the appropriate Regulatory Authorities FCO 200 01 507 081 VID 1 0 Elekta Limited Linac House Fleming Way Manor Page 5of 5 Royal Crawley West Sussex RH10 9RR Tel 44 0 1293 544422 Fax 44 0 1293 654321 Copyright 2013 Elekta AB All rights reserved www elekta com gPOL0007 1 VID 2 02. patient and an external beam limiting device BLD if e The external BLD does not operate with the touchguard attached e The external BLD extends out more than the touchguard lf this error occurs with an external BLD attached to the digital accelerator you can cause fatal injury to the patient When the error occurs it is not possible to get the Table Move Assistant values in tolerance Therefore it is not possible to apply an incorrect correction to the patient position before treatment delivery Solution Monitor the Relative Actual column see Figure 1 of the Table Move Assistant dialog box Table Move Assistant rooms ln reese Table Longitudinal 7 ef e cm j G This table correction exceeds the limit for remota movement using the Function Key Pad and must be performed in the treatment room Figure 1 Table Move Assistant dialog box Isocentric Rotation If the Relative Actual column is blank do not press the Table ASU buttons on the FKP To correct the error 1 Close the XVI program 2 Shutdown and restart the XVI control system 3 Put the patient in their initial setup position 4 Acquire the VolumeView again and continue the usual workflow Always monitor the patient when you do RATM When you do VolumeView acquisitions with an external BLD attached make sure that the stop angle of the VolumeView parameters is in the lower half of the gantry rotation This decreases the risk of a col
3. Important Field Safety Notice t ao CT MN 2 2 Eg i 7 est r A es PD gt vaste bs i Giit j ON PA CAT nA 7 ova P Dh ike J e i fon vs re ay r aa Wade eee ee ey n EO Beda A eR tan tg NON AN JI 4 i R Altes NN r AL ag yi i i se MANA Nichi aor E i Any y f AW EEA Aa EE AO t 7 oe Possible risk of a collision when you use XVI and an external beam limiting device Product XVI Date November 2013 FCO 200 01 507 081 gt ELEKTA ELEKTA Important Field Safety Notice We are providing the information in this Notice to notify you of an important safety issue that may exist on your equipment and to inform you of any actions needed to safeguard both your staff and your patients We ask that you please read and understand the content of this notice and implement any recommendations provided We also need you to acknowledge and accept this FCO by signing and returning the statement on the FCO Action Notification Report We advise you to insert this Notice in the applicable copy of the User Manual Possible risk of a collision when you use XVI and an external beam limiting device Product XVI Date November 2013 FCO 200 01 507 081 XVI R4 2 1 R4 5 R4 5 1 and R5 0 Description XVI can incorrectly calculate the target position of the treatment table because of an error that does not occur very frequently This is the sequence of events
4. com gPOLO0007 1 VID 2 0 Please complete the details below and sign the appropriate acknowledgement section e Existing installations Acknowledgement by the customer e New installations New installation confirmation by the installing Elekta or Representative employee Please return this report to your local Elekta Office or Representative as soon as possible and within 30 days at the latest The information in this FCO has been provided to address a safety issue and therefore the customer is expected to acknowledge and accept the recommendations given and ensure they are implemented By refusing to implement the recommendations the customer assumes full responsibility and liability for all matters including costs losses claims and expenses resulting whether directly or indirectly from not implementing such recommendations Further the customer will hold Elekta harmless from all matters including costs losses claims and expenses resulting whether directly or indirectly from not implementing such recommendations Failure to sign and return the acknowledgement may affect any follow up actions necessary for us to take and may require Elekta to report to the Regulatory Authorities in your country Classification Important Field Safety Notice FCO Ref 200 01 507 081 FCO ae Possible risk of a collision when you use XVI and an external beam limiting device description XVI R4 2 1 R4 5 R4 5 1 and R5 0 Hospital Device Serial No
5. lision with the patient A later software release of XVI will give a solution to this problem Technical Reference CLM 01690462 This Notice has been notified to the appropriate Regulatory Authorities FCO 200 01 507 081 VID 1 0 Elekta Limited Linac House Fleming Way Manor Page 3 of 5 Royal Crawley West Sussex RH10 9RR Tel 44 0 1293 544422 Fax 44 0 1293 654321 Copyright 2013 Elekta AB All rights reserved www elekta com gPOLO0007 1 VID 2 0 ELEKTA Important Field Safety Notice If you have any queries about this Notice please contact your local Elekta office Safety reference The following warnings and cautions are associated with this notice WARNING Make sure that the gantry and treatment table movements are in view at all times when you do ASU If you ignore this warning it can cause fatal injury and clinical mistreatment WARNING Make sure that collisions between persons and equipment do not occur if you use ASU to activate the gantry and table isocentric movements Be more careful in these conditions If you ignore this warning it can cause fatal injury and clinical mistreatment This Notice has been notified to the appropriate Regulatory Authorities FCO 200 01 507 081 VID 1 0 Elekta Limited Linac House Fleming Way Manor Page 4 of 5 Royal Crawley West Sussex RH10 9RR Tel 44 0 1293 544422 Fax 44 0 1293 654321 Copyright 2013 Elekta AB All rights reserved www elekta
6. when this error occurs You do an online VolumeView acquisition and registration You accept the registration and the Table Move Assistant dialog box appears The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank When this occurs XVI does not read the Absolute Actual position of the treatment table This causes XVI to calculate the treatment table moves from the zero position of the treatment table 0 0 0 0 0 0 In XVI R5 0 if the Relative Set values are less than or equal to 2 5 cm for earlier releases of XVI the value is 2 cm you can do remote automatic table movement RATM from the function keypad FKP When you press the Table ASU automatic setup buttons the treatment table moves to a position that was incorrectly calculated from XVI This Notice has been notified to the appropriate Regulatory Authorities FCO 200 01 507 081 VID 1 0 Elekta Limited Linac House Fleming Way Manor Page 2 of 5 Royal Crawley West Sussex RH10 9RR Tel 44 0 1293 544422 Fax 44 0 1293 654321 Copyright 2013 Elekta AB All rights reserved www elekta com gPOLO0007 1 VID 2 0 ELEKTA Important Field Safety Notice Clinical impact If you do not monitor the patient and treatment table movements and you keep the Table ASU buttons pressed the treatment table continues to move It only stops when a touchguard activates Therefore this error can cause a collision between the
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