Micromed FSCA 18001 Скачать руководство пользователя страница 7

Technical Guide to safety, use and maintenance of the system 

 

 

 

 

5.

 

The position of the single parts of the system on the trolley or the support table must not 

be changed. During the transport of the devices particular attention must be paid that 

violent movements or dropping do not occur. 

6.

 

The trolley renders the system 

easy to move 

but not 

transportable

. The cart is not intended 

for displacement of the system which are long, frequent or requiring passing steps or 

thresholds. If the use environment requires these characteristics, pay particular attention to 

the displacement instructions and periodically check the cart conditions. 

7.

 

The passing of level differences (i.e. thresholds, steps, obstacles, cable guards) must be 

performed by lifting entirely the cart and then resting it gently on the floor after the obstacle. 

This require the cooperation of two operators. 

8.

 

The cart is designed to support exclusively the weight of the system. 
8.1.

 

Do not lean on the keyboard shelf when using the keyboard. 

8.2.

 

Do not step or place the feet on the cart shelves, wheels supports or wheels. 

8.3.

 

Do not lean on the upper part of the cart or on the monitor/PC mounted on the 

VESA support when the cart is braked: the carts could tilt and fall. 

9.

 

The handle is designed for horizontal movement of the trolley and only horizontal forces 

must be applied to it. Do not lean heavily on the handle or push it down (for example, to tilt 

the carriage). 

10.

 

The movement of the system must 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 entire system. 

11.

 

The cable between the applied parts (EEG headbox) on their stand and the rest of the 

acquisition system can create stumbling hazards when left on the floor. Slide the cable into 

areas that are not normally accessible by users and patients. 

12.

 

Being a modular system having devices endowed with an arm or stand for the supports of 

some parts, special care must be taken to ensure that their position does not cause danger 

to users by creating obstacles to movement in the vicinity of the system itself. 

 

 

13.

 

Disconnect the device when it is not used for long periods of time, by turning off the power 

switch positioned on the isolation transformer case in order to assure the separation of all 

the powered elements from the mains. 

14.

 

No accessible parts of the system reach elevated temperatures during normal functions; 

however it is necessary to leave all the ventilation holes and slots free. 

15.

 

All the warnings relative to the patient and user safety shown in the user manuals of the 

various components of the acquisition system must be taken into consideration. 

 

 

16.

 

Inspect the containers, the accessories and the power and communication cables to notice 

eventual damages made by shipment and report all problems to your MICROMED S.p.A. 

representative before using the device. 

 

 

 

Rev. 1.04 

pag. 3 di 24 

Mechanical safety  

Other precautions 

DEVICE MAINTENANCE 

Содержание FSCA 18001

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Отзывы: