ED01_REV01-2021 IFU OBWB_EN
6- 12
The device must be checked at least once every
12 months
by the authorised service centre or the
manufacturer. The device must be inspected electrically and mechanically every
2 years
. This may
only be carried out by an authorised service centre or by the manufacturer. The lifetime of the device,
if all safety maintenance is carried out, is
10 years
from the date of manufacture.
Contamination of the device
:
It is strictly forbidden to send contaminated devices to the manufacturer, installer or authorised
service centre. Any device received in such a condition will be refused and returned to the sender
with all the appropriate consequences. Health authority will be informed of possible contamination.
3
OB WB SUPPORT AND CHARGING BRACKET
The device must be installed in emergency vehicles. This operation may only be carried out by authorised personnel
and vehicle fitters, after having performed a careful risk assessment (see ISO 14971 latest edition) related to the specific
type of process. After installation the device must be tested. Tests of a dynamic nature or conducted with computer
simulations (must be validated) to ensure the tightness and fixation of the device, which must withstand
acceleration/deceleration forces of up to 10 g. Never use a damaged or altered device.
4
DEVICE DESCRIPTION
The OBWB wall bracket has been designed and manufactured to allow the medical suction units OB2012, OB1000 and
OB3000 to be fixed to the wall. It can be fixed in ambulances and medical vehicles, hospitals and/or surgeries. The
bracket is equipped with an electrical cable that has to be connected to the appropriate direct current source (SELV)
depending on the type of aspirator:
•
Aspirator OB 1000 and OB 2012
12 V DC
•
OB 3000 suction unit
10 to 30 VDC (direct current)
The connection to the external direct current electrical source allows the device to be powered and the internal battery
to be recharged at the same time. Easy fixing, safety and compliance with current standards guarantee the user easy
and safe use, safeguarding users and patients in the event of accidents and/or overturning of the rescue vehicle.
SELV power
source
Power source
:
The power source must comply with the requirements imposed by laws and regulations. Power
supplies that have not passed compliance testing for medical devices cannot be used. The
conformity of the external power supply must refer to IEC 60601-1, IEC 60601-1-2 and all other
standards involved in the verification.
4.1
Operation, controls and electrical connections
The OBWB bracket is constructed to reduce the risks of device insertion and typical critical use in moving vehicles. It is
manufactured from a steel plate folded in several separate stages and has no welding or screw assembly.
The bracket is made up primarily of three metal parts and a hook-and-loop button made of shockproof ABS. The primary
part has holes for fixing it to the wall, while the latch/release button is attached to a steel plate that slides vertically on
the base plate. The retention security of the device is guaranteed by a calibrated spring with a defined elastic coefficient
that allows it to be effective up to acceleration/deceleration forces of 10 g.
The figure on the next page shows the bracket complete with all its parts.
