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Micromed FSCA 18001, Manual

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Micromed FSCA 18001 Manual Download Page 6

 

 

FSN18001 

 

 

ANNEX A – MODIFIED SAFETY INSTRUCTIONS 

In the manual “Electroencephalography and evoked response digital acquisition systems and review stations 

-  BRAIN QUICK - Technical Guide to safety, use and maintenance of the system” (document    MBQ.EN ver. 

1.04 of 9 February 2018) The precautions section has been modified and a section reporting the instructions 

for the correct displacement of the system has been added. 

 

A copy of the full manual will be provided together with the new cart base. In the meanwhile, Please find 

attached a preview of the modified / added instructions. A full copy of the manual is available at the following 

link: 

FSCA18001 - Manuals 

(

https://www.dropbox.com/sh/1t3agtt2ft4bq3c/AACsJHmnVFoAU8LdHwqG8ZFIa?dl=0 

) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 

 

Summary of Contents for FSCA 18001

Page 1: ... annex 1 within Friday 16 February 2018 This Field safety Notice has been notified to the Competent Authority of your country Ministry of health or Medical Device agency We ll then ask you cooperation for proceed with the corrective actions described in the Field Safety Notice We thank you in advance for the cooperation For any information or clarification please contact directly our Quality and R...

Page 2: ...ia fax at the number 041 5937011 or email at regulatory micromed eu this page filled and signed for acceptance as soon as possible Field Safety Notice Receipt I confirm having received the Field safety Notice FSN18001 to be distributed to thecustomers I confirm having distributed the Field safety Notice FSN18001 to the followingcustomers HOSPITAL ORGANIZATION DATE For confirmation Name of the resp...

Page 3: ...FSN18001 ANNEX 2 LIST OF THE DISTRIBUTED CAR POLE CARTS ...

Page 4: ...acture with consequent system tilt and damage of the supported devices In remote conditions unexpected break of the base and inappropriate reaction of the operator harm to the operator such as bruises fractures can occur The failure occurrence probability is low up to now we had 4 failures on 100 sold carts and the probability of harm is lower failures are expected to be mostly related to the syst...

Page 5: ...icromed at the addresses provided in the form 6 Micromed support will perform the activities described in the section CORRECTIVE ACTIONS TO BE PERFORMED BY THE MANUFACTURER within the given timeframe FIELD SAFETY NOTICE TRANSMISSION This notice needs to be passed on all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been trans...

Page 6: ...uary 2018 The precautions section has been modified and a section reporting the instructions for the correct displacement of the system has been added A copy of the full manual will be provided together with the new cart base In the meanwhile Please find attached a preview of the modified added instructions A full copy of the manual is available at the following link FSCA18001 Manuals https www dr...

Page 7: ...st be carried out exclusively by pushing or pulling the handles intended for the purpose Pulling or pushing the system by grasping it in other places for example the keyboard tray the monitor or the PC can lead to damage to the support systems which are not designed to carry the weight of the entiresystem 11 The cable between the applied parts EEG headbox on their stand and the rest of the acquisi...

Page 8: ...mmunication cable from the side of the device leave it connected to the system and put the free end on the shelf of the trolley or fasten it to one of the supports so that it cannot interfere with the movement of the wheels Lower the adjustable supports of the PC monitor camera to the lower end position Lock the position of the supports again Close the amplifier supporting arms on the trolley and ...

Page 9: ...ng sure that the position of the trolley and or the stands does not create obstacles to movement near the system and that an adequate power outlet is available at a distance compatible with the length of the power cord Lock the brakes Restore the desired height setting of the PC monitor camera holder and lock it in place Restore the desired position of the arms and fix it with the appropriate bloc...

Page 10: ...eu This page filled and signed for acceptance as soon as possible User information Hospital name Hospital address System serial number s Field Safety Notice Receipt confirmation I have received the updated instructions for use I will use the system according to the updated instructions OR In the hospital there are no more systems affected by this corrective action Transferred to Decommissioned For...

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