Micromed FSN 18001 User manual

Dear distributor,
M19-01 Nota informativa
rev.1.06 del 30/08/2016
attached to this letter you’ll find an IMPORTANT SAFETY NOTICE regarding Micromed systems installed on
a CAR POLE cart.
Some of these systems or cart have been provided to the users through your company (see list in Annex 2).
We kindly ask you to inform all customers to which you provided the affected devices , by providing them the
attached document FSN18001, within 15 February 2018:
Formal confirmation must be provided to Micromed by filling and returning the specific form (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 Regulatory office (Ms. Monica
Camillo, [e-mail] , [phone]).
Best regards
Annexes
…
…
Micromed S.p.A.
- Annex 1 – Receipt Form to be returned filled and signedto [e-mail] within 16 February 2018
- Annex 2 – List of affected devices supplied to yourcompany
- Field safety Notice FSN18001 document for the system users (7pages)

FSN18001
ANNEX 1 RECEIPT CONFIRMATION (DISTRIBUTOR)
Reference to FSN 18001
Reference to FSCA 18001
Product Code: CAR POLE
From our data , it appear that some of these systems or carts have been provided to the users through your
company.
We kindly asked you to return via fax (at the number 041/5937011) or email at [e-mail] 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 responsible person
Role and company
Signature
Date
Contact mail/phone

FSN18001
ANNEX 2 LIST OF THE DISTRIBUTED CAR POLE CARTS

Mogliano Veneto, 07 February 2018
FSN18001 Field Safety Notice
M19-01 Nota informativa
rev.1.06 del 30/08/2016
Dear customer,
Micromed is making you informed of a potential failure discovered from the feedbacks analysis which, under
remote conditions, could lead to harm to the operator. From our data, it results that you received a device
which may be affected by this risk.
INVOLVED DEVICES
Micromed acquisition systems support carts models CAR POLE / CAR POLE STDsold
before 31 December 2017. The cart is represented in the figure on the side of the page.
FIELD SAFETY NOTICE REASON
The base of the CAR POLE cart used in some variants of the Micromed acquisition
system BQ2400ACQ, BQ2400ACQDV, BQ3200ACQ, BQ3200ACQDV and BRAIN
QUICK ICU CP may not tolerate intensive stress due to its displacement over steps or
obstacles. Possible consequences are the creation of cracks at the base of the support
pole , up to possibility of base fracture 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 system
displacement .
CORRECTIVE ACTIONS BY THE MANUFACTURER
Micromed will change the user manual and the device labelling to provide more detailed instructions on the
displacement of systems installed on a cart. Moreover, Micromed, to guarantee the maxiumum safety for the
users of its systems, will proceed with the replacement of the cart bases with a sturdier model, modified to
provide a greater resistance to impacts and stresses. If your device is affected by this corrective action, you’ll
be contacted by Micromed or the Authorized Dealer Support Department to schedule the replacement. The
replacement activity is short and require the device stop only for the duration of the replacement and the
possible maintenance activity.

FSN18001
ACTIONS TO BE PERFORMED BY THE USER
1. . Verify the status of the cart base: if there are any crack, move no more the cart and contact Micromed to
obtain priority in the corrective action
2. Immediately start following the improved safety instruction described in AnnexA
3. Limit as possible the systemdisplacement and take particular care duringtransport until the corrective action
is performed.
4. Fill in the Receipt confirmation (User) form provided in Annex B
If the carts are no more in use at your premise, please fill in the form providing the required information. This
allow us updating our traceability documentation and avoid you to be further interested by communication on
this issue.
5. Return the filled form to Micromed at the addresses provided in theform.
6. Micromed support will perform the activities described in the section “CORRECTIVE ACTIONS TO BE
PERFORMED BY THE MANUFACTURER” within the giventimeframe.
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 transferred. In this last case, please inform
Micromed about contacts of this organization..
This safety notice has been notified to the Competent Authority of your Country (typically, the Ministry of health
or specific Medical Device Agency).
We apologize in advance for all troubles and inconveniences that this may have caused, we are sure that you
will appreciate the effort that Micromed gives in supporting its customers.
We thank you once again for choosing Micromed, and we take the chance to express our very best regards.
…
…
Micromed S.p.A.

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 )

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 entiresystem.
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 systemitself.
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 intoconsideration.
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

Technical Guide to safety, use and maintenance of the system
The cart is designed to support the weight of the system. It must not be subjected to stresses
deriving from additional loads.
The trolley makes the system easily movable but not transportable. The trolley is not intended for
movements frequent, on long distances or which require passing steps or unevenness. If the use
environment includes these conditions, it is necessary to pay particular attention to the instructions
for the movement and to periodically monitor the conditions of the trolley.
The housing of the individual parts of the system on the trolley or table must remain unchanged.
During the transport of the system, special care must be taken to ensure that no movement or fall
of the devices occurs.
Before moving the system:
•Turn off the system.
•Disconnect the power supply cable and put the free end on the trolley shelf or fasten it to
one of the supports so that it cannot interfere with the movement of thewheels.
•If parts of the system are placed on other supports (e.g. stands for the amplifier or flash
stimulator), disconnect the power and communication 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 thewheels
•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, if necessary, fix the position with the
appropriate blocks.
•Close all drawers and pull-out shelves.
•Release the brakes of all the wheels
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 the damage of the support systems, not
designed to carry the weight of the entire system.
The handle is designed for the horizontal movement of the trolley (pushing or dragging) and only
horizontal forces must be applied to it.
Rev. 1.04 pag. 15 di 24
Do not lean on the keyboard tray when using the keyboard
Do not climb or place your feet on the shelves or on the wheels of the trolley
Do not lean heavily on the handle or push it down.
Do not subject the cart to kickback e.g. going down steps or overcoming obstacles
DISPLACEMENT OF
THE SYSTEM

Technical Guide to safety, use and maintenance of the system
The overcoming of differences in height (e.g. thresholds, steps, obstacles, fairleads) must be carried
out by lifting the trolley completely and relocating it gently after the obstacle. This operation may
require the presence of two operators. The CAR POLE trolley can be gripped along the vertical rod.
CAR TORO carriages can be lifted by gripping the side handles on both sides, making sure that the
carriage does not leverage forward or backward.
Repercussions during movement can damage the cart or the system itself.
After moving the system,
-Place the system and the possible amplifier/stimulator stand in the desired location, making
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 inplace
-Restore the desired position of the arms and fix it with the appropriateblocks.
-If necessary, reconnect the connecting cable between the applied parts (amplifiers)
supported by the stand and the rest of the acquisitionsystem.
-Restore the position of drawers and extractable shelves (e.g. keyboard tray, mouse
holder).
-Connect the power cord to the socket
The system can now be switched on again
Rev. 1.04 pag. 16 di 24
The cable may create a tripping hazard when it is left free on the floor. It is recommended to run
the cable in areas not accessible by users and patients.

FSN18001
ANNEX B RECEIPT CONFIRMATION (USER)
Ref. to FSN 18001
Ref. to FSCA 18001
Product Code: CAR POLE
From our data, you should have received a device affected by this Field Safety Corrective Action.
We kindly asked you to return via fax (at the number 041/5937011) or email at [e-mail] 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 foruse
□ I will use the system according to the updatedinstructions
OR
□ In the hospital there are no more systems affected by this correctiveaction
□ Transferred to
□ Decommissioned
For acknowledgement
(name of the responsible person)
(role)
(signature)
(date)
( contact mail/ phone)
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