Boscarol OB WB User manual

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SUPPORT AND CHARGING BRACKET FOR BSU
FOR MEDICAL SUCTION UNIT OB2012, OB1000 and OB3000
OPERATING INSTRUCTIONS

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PRODUCT BY:
OSCAR BOSCAROL SRL
Via Enzo Ferrari 29
39100 Bolzano
ITALY
Tel. [phone]
Fax : [phone]
[email protected]
www.boscarol.it
Manufacturer and device information:
•Oscar Boscarol applies a quality management system in accordance with international standards ISO
13485 and ISO 9001.
•The OB WB is not a medical device and is intended as an auxiliary system for fixing and restraining
medical devices OB3000, OB2012 and OB1000.
•The device is intended for exclusive use on these devices
Information on these operating instructions:
•This document contains important information for the safe, effective and compliant use of the
medical device.
•Use the information reported to train users and confirm their training
•This manual may not be altered (even in part). Only the manufacturer of the device may make
changes where necessary.
•These instructions should always accompany the device. We recommend using the electronic version
and making it available on operators' PDAs, tablets and mobile phones.
These operating instructions apply to the following devices:
OB WB
BSU810

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INDEX
INDEX ........................................................................................................................................3
0MEANING OF SYMBOLS AND PICTOGRAMS .........................................................................4
0.1 Symbols used on the device and in this user manual ................................................................. 4
1WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION ..............................................5
2IMPORTANT INFORMATION ................................................................................................5
3OB WB SUPPORT AND CHARGING BRACKET.........................................................................6
4DEVICE DESCRIPTION...........................................................................................................6
4.1 Operation, controls and electrical connections ......................................................................... 6
4.2 Installing the wall bracket in vehicles....................................................................................... 7
4.3 Dimensions of the device complete with bracket ...................................................................... 8
4.4 Power cable connection........................................................................................................... 8
4.5 How to attach the suction unit to the OB WB bracket ............................................................... 8
4.6 Functionality test of the wall bracket ....................................................................................... 9
5REUSE AND MAINTENANCE .................................................................................................9
5.1 After docking the device .......................................................................................................... 9
5.2 Cleaning the bracket.............................................................................................................. 10
5.3 Checking the power supply .................................................................................................... 10
5.4 Dismantling the wall bracket ................................................................................................. 10
5.5 Demolition and decommissioning .......................................................................................... 10
6SPARE PARTS.....................................................................................................................10
7TECHNICAL ASSISTANCE SERVICE .......................................................................................11
8TECHNICAL SPECIFICATIONS AND REFERENCE TO STANDARDS ........................................... 11
9WARRANTY .......................................................................................................................11

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0MEANING OF SYMBOLS AND PICTOGRAMS
0.1 Symbols used on the device and in this user manual
Important warnings: important information for the correct use of the device and to avoid the
risk of injury to the operator, patient and/or damage to the device
Warnings: information to which attention should be paid
Notes or information for correct use of the device
1. List of actions to be performed: follow them step by step
Read these operating instructions carefully and completely
Indicates the need for the user to consult these operating instructions for information such as
warnings and precautions that cannot be displayed on the device in question
Manufacturer
Production date
Do not dispose of the device with normal household waste. European Community Directive
2012/19/EU - Waste Electrical and Electronic Equipment (WEEE).
Required maintenance service (contact the manufacturer and/or its authorised service centres)
Use this device only within the specified temperature range. Use outside these limits may impair
the function, safety and anchorage of the medical device for which it is intended.
Limits of use in relation to humidity
Order number (device code)
Please read the operating instructions in other languages available on the indicated website
Production batch
Serial number
Indoor use only

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Danger: Do not connect the bracket to mains voltage.
Continuous current
1WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION
Read carefully
These operating instructions have been prepared using simple, easy-to-understand language. If
you have
difficulty in interpreting what is written, contact the manufacturer for further
clarification.
Phone [phone] [e-mail]
•Please read these instructions carefully before using and installing the device.
•The wall bracket is designed to allow the OB2012, OB1000 and OB3000 aspirators to be attached to emergency
vehicles, hospitals, clinics and/or other medical facilities.
•The bracket cannot be used to fix other medical devices than those of the BSU family produced by Oscar Boscarol
srl.
•The OBWB wall bracket, appropriately connected, with the supplied cable, to the external power source (SELV type
only) allows the internal battery to be recharged and the suction unit to be powered.
•The bracket must be installed in accordance with the instructions in this manual and in compliance with the
requirements of EN 1789:2021. Failure to do so may jeopardise the safety of patients and users. The bracket is
tested to withstand positive and negative accelerations of up to 10 g.
•Never alter the mechanical, electrical and structural parts of the bracket. Such interventions make the device
dangerous and do not allow its correct use, also damaging the fixed and powered device.
•No technical intervention by the user is allowed on the device. The only operations allowed are those indicated in
these operating instructions. Any technical problems, periodic inspection and repairs should be referred to the
authorised service department and/or the manufacturer.
•Always use only spare parts, supplied by the manufacturer (Oscar Boscarol srl), in order to ensure maximum
efficiency and safety of the device.
•Do not remove and/or modify the coupling and release spring in order to ensure that the anchored device is held
up to negative acceleration forces of 10g.
If the user or patient becomes aware of a danger in use, a side effect, an accident caused
by the device or a critical issue (operational and design) not covered in these instructions
for use, he must immediately report this to the manufacturer at the following e-mail
address: [e-mail]
The bracket is designed in accordance with the requirements of EN 1789 for wall mounting
of the BSU Boscarol OB1000, OB2012 and OB3000 family of suction units. The power supply
is only for 12 VDC (OB2012-OB1000) and 11 to 30 VDC for the OB3000 suction unit. Never
connect the bracket to mains voltage or outside the range for SELV voltages.
2IMPORTANT INFORMATION
The device has been designed and tested in accordance with the latest standards. Connecting the
device to vehicle electrical systems that are not compliant and/or not carried out by a professional
installer may damage the device and cause damage to the electrical system itself.

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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.
3OB 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.
4DEVICE 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.

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The two red plastic flaps on the lower part are designed to allow the attachment of all aspirators of the BSU family
(Boscarol suction unit). The OB2012 and OB3000 suction units have the "L" flap reference on the right, while the OB1000
suction unit has it on the left (see picture above). In the event of incorrect assembly, simply pry a flat screwdriver into
the slot in the plastic part and remove it. Reinsert it correctly by pressing it into the metal part of the bracket (see picture
below).
The power supply and charging system (see contact holder in the figure above) is designed in such a way as to exclude
the possibility of a short circuit between the two contacts (positive and negative) and to guarantee a discrete resistance
even in the event of incorrect insertion in the bracket. The contacts are made of copper-coated stainless steel (to reduce
electrical contact resistance). The electrical cable of the bracket is suitable for use with SELV voltage and must never be
connected to the mains voltage.
Protect the power supply line with a fuse of suitable rating (fuse with a break value of 15 A recommended). Electronic
protection systems can be used. The suction unit is equipped with a suction pump consisting of an electric motor and it
is therefore important to bear in mind the effects caused by switching it on and off (effect of inductance).
4.2 Installing the wall bracket in vehicles
The installation of the bracket on board emergency vehicles requires a preliminary study and tests on the structure of
the vehicle. Standard EN 1789:2021 imposes specific conformity tests for medical devices installed in the vehicle. The
following factors must always be taken into account:
1. The wall bracket and device must be installed in such a way that acceleration/deceleration forces of up to 10 g
do not allow the bracket, with the device anchored and secured, to detach from the wall. Appropriate
reinforcement of the body or structure of the patient compartment must always be considered by the fitter
when designing and drafting the risk analysis.
2. According to EN 1789:2021, the device must be able to be operated and controlled when the operator is seated
and secured with the safety belt. Suitable surrounding spaces must be designed to comply with this
requirement.
Flaps configuration for
OB3000 - OB2012
Flaps configuration for
OB1000
Release BUTTON
Harmonized
symbology
Contacts holder
Top retaining
hook
Plastic reference flap

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3. The position of the bracket on the wall must also take into account the height
of the operators and the need to use two hands to safely hook or unhook the
device (see photo on the right). It is advisable not to install the bracket higher
than 130 cm from the floor of the vehicle.
4.3 Dimensions of the device complete with bracket
Before proceeding with the installation of the bracket it is necessary to carefully
evaluate the overall dimensions of the suction unit depending on the model.
Otherwise it may happen that after fixing the bracket to the wall it is not possible to fix
the suction unit due to its dimensions that protrude from the shape of the bracket itself.
Installation risks
The support and power supply bracket has a smaller size than the anchored device. Before
attaching it to the wall always consider how much space is required depending on the type of
suction unit. It must always be possible to attach/remove the device safely and with relative ease.
The dimensions of the suction units can be found in the respective user manuals, which can also
be downloaded from the website: https://www.boscarol.it/ita/eifu.php.
4.4 Power cable connection
The OBWB bracket is equipped with an electrical cable for connection to the vehicle's electrical source. This cable is
designed to be inserted into the wall where the bracket is fixed.
Connect the electric cable to the 12 Vdc power source for the OB2012 and OB1000 suction units and 11÷30 Vdc for the
OB3000 suction unit only. The connection of the cable must always be carried out on lines with a suitable section and
protected by an appropriate electrical
safety device, normally a fuse or similar
component with a value of not less
than 15 A. This protection will
intervene in the event of short circuits,
malfunctions of the bracket and/or the
connected suction unit. The
connection to the power source must
be made respecting the polarity of the
power cable (see photo on the side).
Incorrect connection will not cause
device failures or malfunctions but will
not allow regular operation and
recharging of the medical device.
In accordance with IEC 60601-1-2
about electromagnetic compatibility,
the instructions for use of the medical
device must be observed.
Risks of interference
The positioning and fixing of the OBWB bracket and the medical device should consider the
possible effects of electromagnetic interference that may develop when the device, in its
final fixing position, is placed near or adjacent to other electrical medical devices. It is
recommended that a minimum distance of not less than 30 cm between devices should
always be observed. The risk analysis carried out at the design stage of the vehicle shall also
take account of these effects (EMC).
4.5 How to attach the suction unit to the OB WB bracket
The OBWB wall bracket has been designed and manufactured to make operation simple and easy. The usability study
conducted has minimised the risks involved in attaching or detaching the medical device.
It is always preferable to use two hands when attaching and detaching the medical device.
The figures on the next page illustrate the correct operations to be carried out. The picture shows the OB2012 suction
unit, which is the heaviest version of the BSU family.
Black wire
(negative -)
Red wire
(positive +)
Fuse T15A
Cable polarity
FIXING WALL
Suction
unit
Floor
Suggested max
high: 130 cm

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Suction unit insertion and extraction operations (OB2012 model pictured):
•After grasping the suction unit with two hands as shown in the first photo, place the bottom of the suction unit on
the skid of the wall bracket.
•Place the device on the right side on the plastic flap (red) as shown in the picture. For the OB1000 suction unit refer
to the left side of the wall bracket.
•Place the device in a vertical position and with your hand inserted in the upper handle, place your fingers on the
red button and push it downwards. At this point, press the suction unit into place and release the button, which
must slide upwards.
•Before removing your hands from the suction unit, make sure that it is properly secured (by pulling slightly forward,
the suction unit must be locked). Make sure that the bracket guide is positioned at the highest upper point.
•The final position of the suction unit is shown in the photo above right.
•To remove the suction unit from the bracket, put your hand into the handle and use your fingers to press the red
button. With the other hand grasp the device and rotate it slightly downwards to remove it from the bracket.
Never force insertion of the suction unit. Once the device has been secured, check that the battery is
recharged by checking that the indicator light on the front of the suction unit is on (green = end of charge,
yellow = charging in progress.
4.6 Functionality test of the wall bracket
The test operations described in this paragraph allow the user to check the functionality of the support from a
mechanical and electrical point of view. If the test fails or if the state of charge and power supply does not comply,
contact the authorised service centre. This check should be carried out at least once a day at the beginning of your work
shift. Perform these checks monthly or when necessary:
•Check the operation of the bracket (without suction unit) by repeatedly pressing the lock and unlock button. The
movement must be smooth and there must be no jamming of the mechanism.
•Always ensure that the fixing screws are fully tightened (using a screwdriver of a suitable diameter for the screw).
•Ensure that the two red plastic fins are fully inserted into the metal housings provided.
•Insert the suction unit into the bracket as shown in the previous photos.
•Visually check that the indicator light on the front of the secretion suction unit is on.
•Switch on the suction unit and check its operation
WARNINGS
If the test described above is not passed, contact the authorised service department or the
manufacturer immediately. Do not tamper with the mechanical parts, the contact box and/or the
safety spring. Tampering with the wall bracket and/or its mechanical and electrical devices will
seriously compromise the safety and effectiveness of the device in the field.
5REUSE AND MAINTENANCE
5.1 After docking the device
Always check that the indicator light on the front of the suction unit is on, confirming that the suction unit is powered
and the internal battery is being recharged. Always make sure that the suction unit is properly seated in the wall bracket.
Final position

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Pulling the suction unit towards you must not cause it to come loose. In the event of an accident, always have the wall
bracket and suction unit checked by the authorised service centre or manufacturer.
5.2 Cleaning the bracket
The bracket does not require any special cleaning, but disinfection may be necessary. In this case, proceed as follows:
•Wear personal protective equipment (FFP2 masks, etc.).
•Disconnect the fuse or the power cable of the bracket
•Blow out the bracket with a compressed air source (not exceeding 2 bar) to remove any residue or scale.
•Use non-aggressive disinfectants to clean the bracket (use disinfectants suitable for medical devices). Facilitate this
by using brushes or rags soaked in disinfectant.
•When finished, dry all clean parts and reconnect the power supply.
•Perform all tests described in chapter 4.6
In order to properly disinfect and decontaminate the device, we recommend that you purchase specific, approved
disinfectants for cleaning medical devices that are not harmful to humans or the environment. Do not use abrasive
substances.
Oscar Boscarol srl can supply you with such disinfectants (also suitable for our suction units). These disinfectants,
available in various formats (wipes, sprays, liquids) are laboratory tested and guarantee the deactivation of viruses,
bacteria and microorganisms. Used periodically, they destroy and prevent the formation of dangerous biofilms (surface
layers that easily harbour bacteria, moulds, viruses and microorganisms).
Deformation of the
electrical contacts
In the event of oxidation or alteration of the contacts, contact the authorised service
centre or the manufacturer.
For more detailed information, please contact us by email at [e-mail].
5.3 Checking the power supply
The wall bracket is also designed to allow powering and charging of the OB2012, OB1000 and OB3000 suction units. The
supply voltage must be between 12 and 15 Vdc for the OB2012 and OB1000 aspirators and between 11 and 30 Vdc for
the OB3000 aspirator. Any electrical checks on the vehicle's power supply system must always be carried out by
experienced and qualified personnel.
To check the voltage present on the contacts, use a voltmeter set for DC voltage range and measure the voltage present
on the two contacts of the bracket. The voltage measured must be as indicated in this user manual and in the following
figure. If there is no voltage or if there is a reversal of polarity, proceed as follows:
•If the polarity is reversed, the device cannot be recharged and powered. Contact an authorised service centre
or the vehicle manufacturer.
•If there is no voltage present, contact an authorised service centre or
reset the fuse.
•If functional faults occur when switching on the device, contact a service
centre or the vehicle manufacturer.
5.4 Dismantling the wall bracket
When replacing or removing the wall bracket, always contact an authorised
service centre or the vehicle manufacturer.
5.5 Demolition and decommissioning
The device contains electrical parts that must be recycled according to the European Directive WEEE
2012/19/EU - Waste Electrical and Electronic Equipment and implemented in Italy by Legislative Decree
49/2014. The device also complies with Directive 2011/65/EC, which restricts and prohibits the use of
certain harmful substances in electronic and electrical equipment. No harmful substances that
violate the above-mentioned Directive are used in the production and assembly of the
electronic boards, in the wiring and in the connection of the electrical cables.
6SPARE PARTS
There are no spare parts available for the device that can be bought and installed by users. You should always contact
the service centres or the manufacturer if you need to maintain or repair the device.
Positive pole (+)
Negative pole (-)

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7TECHNICAL ASSISTANCE SERVICE
No electrical and/or mechanical parts contained in the OBWB bracket are intended to be repaired by the dealer,
customer and/or user. Do not disassemble or tamper with the electrical and/or mechanical parts. Always contact the
authorised service department or the manufacturer for a list of authorised service centres. Any intervention, even
minimal, on the device will void the warranty. Unauthorised interventions on the device may compromise its compliance
with the laws in force and reduce the safety of users and patients.
8TECHNICAL SPECIFICATIONS AND REFERENCE TO STANDARDS
Classification and type of device
Accessory for BSU family devices
Not a medical device
Supply voltage: SELV
Compulsory periodic safety inspection
Every 24 months
Crash test of ambulance restraint systems EN 1789:2020
Dimensions OBWB
Maximum device size
240 mm (w) x 250 mm (h) x 50 mm (d)
9.44 in (l) x 9.84 in (h) x 1.96 in
Device weight
Max. 800 g.
Tolerance on all values
±5 %
Conditions of storage and use
Operating temperature range -18 to 50° C (-0.4 to 122 °F)
Temperature range for storage and transport -40 to 70° C (-40 to 158 °F)
Relative humidity for storage, transport and use 5÷95%, non-condensing
For indoor use only
9WARRANTY
The company Oscar Boscarol srl warrants the OBWB wall bracket for a period of twenty-four (24) months from the date
of purchase by the original user, against any defects due to workmanship, materials or construction.
The following are excluded from this guarantee: the electrical contact assembly, the electrical connection cable, normal
wear and tear of the mechanical parts, discolouration, colour changes, serigraphy and all other aesthetic irregularities
that do not affect the functionality of the bracket itself.
During the warranty period, the purchaser who discovers a defective product shall send it with a written notification of
the defect to the undersigned company or its authorised dealer who will, at its discretion, repair or replace the defective
parts or replace the entire product. All shipping and transport costs shall be borne exclusively by the purchaser.
Conditions of validity of the guarantee:
In order to benefit from the warranty, you must fill in the product registration form, which is included in the package,
and send it by post, fax or e-mail to the address:
OSCAR BOSCAROL SRL V. E. Ferrari, 29 - 39100 BOLZANO
Fax: [phone] - E-mail: [e-mail]
In order for the guarantee to be valid, the purchaser must submit the following documents:
•presentation of a copy of the invoice and/or purchase declaration containing the serial number of the device and
the date of purchase;

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•detection by the service department of a fault and/or defect attributable to the materials used or to faulty
workmanship
•absence of tampering, modifications and/or anything else that does not comply with the original product
Oscar Boscarol srl is responsible for the safety, reliability and operation of the suction unit only if:
•all service, repair, modification and preventive maintenance work is carried out by Oscar Boscarol srl or its
authorised service centres
•the device is used in a correct manner, exclusively and strictly in accordance with the provisions of this user manual
•the electrical system to which the device is connected is built in accordance with the relevant national and European
standards and laws
With reference to what is described in these warranty conditions, Oscar Boscarol srl cannot be held responsible for
accidental or indirect damages, if modifications, repairs, unauthorized technical interventions have been made on the
device or any of its parts have been damaged by accident, misuse and/or abuse. There are no other express or limited
warranties of merchantability, fitness or otherwise beyond those described in this user manual.
Printed in Italy by Oscar Boscarol Srl (Ltd)
ED01_REV01-2021 IFU OBWB ITA Language of editing: Italian
https://www.boscarol.it/ita/eifu.php