Spectra series powered wheelchairs 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2013/057

CON297517

2013-07-25

2013-07-25

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON297517?tabName=allTabs

Potential for wheelchair components to overheat in the event of a stall condition. this can occur when the control system is programmed with parameters different to those recommended by invacare. the manufacturer issued a field safety notice (fsn), dated 14 may 2013, but has not had confirmation from a significant number of customers that they have received and acted upon this information. in a stall condition, where the user is powering the wheelchair forwards or backwards and the wheelchair is prevented from doing so by an obstacle or rough terrain, there is potential for the wheelchair to overheat. where third parties have replaced (or amended the software parameters for) the joysticks or control modules and set the foldback parameters incorrectly, the chances of an overheat condition are increased.

Ensure that those responsible for maintenance of these devices: identify affected devices assess and verify that the foldback parameters of the control system are correct as instructed in the FSN inform Invacare that the FSN has been received and the required action completed. The foldback parameters can be verified and adjusted using the current issue of the Dealer Level PC Programmer software from PG Drives Technology (Software Version – 11.3.0).  The latest version of the programmer software is available to download: Technical Manuals & Software Updates (external link) Contact Invacare for the correct original equipment manufacturer level programming file, and if required, for assistance obtaining the Programmer handheld device. The PG Pilot+ digital wheelchair control system should be set with the following Invacare defined foldback parameters: Current foldback time (seconds) - 15 seconds Current foldback level (%) - 25% PG Drives Technology have provided additional guidance for verifying and adjusting the foldback parameters: Using the Dealer Level PC Programmer (Software Revision 11.3.0) extract the current programming file from the Pilot+ control system using ‘Controller/read from controller’ in the toolbar and save it against the client’s name. This will preserve all the client specific changes that may have been made to speeds, accelerations or perhaps joystick-throw. Using the same Dealer Level PC Programmer open the OEM level programming file required for the chair, as provided by Invacare. This will contain the recommended current fold-back parameters for the chair. Click on the ‘Program’ shortcut on the programmer or select ‘Controller/Write to controller’ from the tool bar to update the programming file. Still using the same Dealer Level PC Programmer, once the Invacare file has been successfully uploaded to the controller, reopen the saved client file from step 1 and reprogramme the controller with these settings. This will overwrite just the dealer level parameters to ensure the chair will behave in the same way for the client as prior to the corrective action whilst the current fold-back parameters will remain as per the Invacare corrective action.