Boscarol OB 2012 FA User manual

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MEDICAL SUCTION UNIT
OPERATING INSTRUCTIONS

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MANUFACTURED BY:
OSCAR BOSCAROL srl
Via Enzo Ferrari 29
39100 Bolzano
ITALY
Tel. [phone]
Fax: [phone]
[email protected]
www.boscarol.it
Information on manufacturer and medical device:
•Oscar Boscarol applies a quality management system compliant with international standards ISO 13485
and ISO 9001
•The medical device OB2012 (in all its configurations) is compliant with MDD 93/42/EEC (as subsequently
amended) and bears the CE marking (CE 0123 notified body TÜV SÜD PRODUCT SERVICE GmbH)
•The medical device meets the essential requirements described in annex I of MDD 93/42/EEC
Information on these operating instructions:
•This document contains important information for safe, effective and compliant use of the medical device
•Use this information to train users and confirm their training
•This manual may not be modified in any way (not even partially). Only the device manufacturer can make
changes when necessary.
•These instructions must always accompany the device. We recommend using the electronic version and
making it available on operator PDAs, tablets and cell phones
These operating instructions apply to the following devices:
OB 2012 FA
OB 2012 LINER
BSU100
BSU104
BSU108
BSU150
BSU154
BSU158
XAS0200
XAS0210
XAS0220
XAS0230
XAS0240
XAS0250
XAS0260
XAS0300
XAS0302
XAS0304
XAS0356
XAS0400
XAS0402
XAS0222

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TABLE OF CONTENTS
TABLE OF CONTENTS .................................................................................................................................................. 3
0. MEANING OF SYMBOLS AND PICTOGRAMS ..................................................................................................... 4
0.1. Symbols used in these operating instructions to call the reader’s attention ................................................... 4
0.2. Symbols used on the device and accessories.................................................................................................... 4
0.3. Symbols used on battery and referred to in these operating instructions ....................................................... 5
1. INTENDED USE ................................................................................................................................................. 6
2. WARNINGS, PRECAUTIONS AND IMPORTANT INFORMTION ........................................................................... 7
3. INFORMATION THAT IS IMPORTANT TO KNOW BEFORE USE........................................................................... 9
4. CONTRAINDICATIONS (DO NOT USE FOR).......................................................................................................10
5. SIDE EFFECTS (POSSIBLE DURING ASPIRATION OPERATIONS) .........................................................................10
6. MEDICAL SUCTION UNITS OB 2012 .................................................................................................................10
6.1. Description of the suction unit........................................................................................................................ 11
6.2. Controls, operations and control panel .......................................................................................................... 11
6.3. Indicator lights................................................................................................................................................. 12
6.4. Periodic testing of suction units OB2012 ........................................................................................................ 12
6.4.1. Daily periodic testing of suction units OB2012 ............................................................................................... 12
6.4.2. Six-monthly/yearly test of suction units OB2012............................................................................................ 13
6.5. Periodic safety maintenance........................................................................................................................... 15
6.6. Safety information to ensure user, patient and third part safety................................................................... 15
7. JARS FOR OB2012 ...........................................................................................................................................15
7.1. Autoclavable jar OB-J FA ................................................................................................................................. 16
7.2. Antibacterial filter ........................................................................................................................................... 16
7.3. OB-J LINER: jars for SERRES® disposable liners ............................................................................................... 17
7.4. Connecting the jar........................................................................................................................................... 17
7.5. Sterile, disposable Yankauer catheter with suction control system ............................................................... 17
7.6. Silicone suction tube and sterile Fingertip connection (conical connector) ................................................... 18
7.7. Warnings regarding the reuse of disposable parts ......................................................................................... 18
8. REUSE, CLEANING AND DISINFECTION ............................................................................................................18
8.1. Reuse of jar OB-J FA ........................................................................................................................................ 19
8.2. Cleaning, disinfection and/or sterilization of jar OB-J FA and silicone tube ................................................... 20
8.3. Assembling the jar and connecting the silicone suction tube......................................................................... 21
8.4. Replacing the antibacterial filter..................................................................................................................... 21
8.5. Cleaning the jar with SERRES® disposable liners............................................................................................. 22
8.6. Disinfection and/or sterilization of jar OB-J and silicone tube........................................................................ 23
8.7. Assembly of jar with SERRES® disposable liners ............................................................................................. 24
8.8. Disposal of contaminated parts ...................................................................................................................... 24
8.9. Suction unit cleaning and disinfection ............................................................................................................ 24
8.10. Cleaning and disinfection plan ........................................................................................................................ 26
9. ACCESSORIES AND OPTIONAL PARTS FOR OB2012 .........................................................................................26
10. INTERNAL BATTERY FOR SUCTION UNITS FOR OB2012 ...................................................................................27
11. SPECIAL USAGE CONDITIONS ..........................................................................................................................27
12. DEMOLITION OF THE SUCTION UNIT...............................................................................................................27
13. ACCESSORIES, CONSUMABLES AND SPARE PARTS ..........................................................................................28
14. TECHNICAL SERVICE ........................................................................................................................................29
14.1. Troubleshooting .............................................................................................................................................. 29
15. TECHNICAL AND COMPLIANCE DATA FOR OB2012..........................................................................................30
16. INFORMATION ON ELECTROMAGNETIC COMPATIBILITY EMC FOR SUCTION UNITS OB2012 ..........................31
16.1. RISKS OF MUTUAL INTERFERENCE WITH OTHER DEVICES .............................................................................. 31
16.2. METHODS TO PREVENT ELECTROMAGNETIC INTERFERENCE ......................................................................... 32
16.3. MANUFACTURER GUIDELINES AND DECLARATION – ELECTROMAGNETIC EMISSIONS .................................. 32
16.4. MANUFACTURER GUIDELINES AND DECLARATION – ELECTROMAGNETIC IMMUNITY .................................. 32
17. DECLARATION OF CONFORMITY .....................................................................................................................34
18. WARRANTY.....................................................................................................................................................35

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0. MEANING OF SYMBOLS AND PICTOGRAMS
0.1. Symbols used in these operating instructions to call the reader’s attention
Danger: important safety-related information covering correct use of the suction unit to prevent
operator or patient injury and/or damage to unit itself
Warnings: information requiring special attention
Notes or information on preventing damage to the device or injury to others. Implement correct
prevention measures
1. List of actions to be performed: follow them step by step
These operating instructions
Electric and magnetic fields generated by radiographic or tomographic equipment, portable
radio equipment, RF radios and devices bearing this symbol could have an impact on proper
operation of the suction unit. In these cases, suction units must not be used, or must be kept at
a suitable distance from such equipment
Suction units OB 2012 contain electrical or electronic parts that must be recycled in accordance
with WEEE/19/EU - Waste Electrical and Electronic Equipment.
The suction unit complies with European Directive 2011/65/EU (RoHS)
Maintenance service required (contact the manufacturer and/or its authorized service centres)
0.2. Symbols used on the device and accessories
Class II insulation (as per IEC 60601-1)
Class BF for part applied to the patient (as per IEC 60601-1)
Use the suction unit only within the specified temperature range. Using the suction unit outside
these limits could compromise its operation, reduce battery life and trip the internal safety
devices.
Usage range for atmospheric pressure (from 70 kPa to 110 kPa)
Usage range for humidity (from 15% to 95%)
Read these operating instructions carefully and thoroughly
Accessories and/or consumables displaying this symbol are disposable. They cannot be reused
and, after use, must be discarded and replaced with new ones. The symbol is posted on
consumables

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Indicates that the user must consult these operating instructions for information, e.g. warnings
and precautions that may not be displayed on the medical device in question
CE marking in accordance with MDD 93/42/EEC for medical devices rated higher than class I
Manufacturer
Date of manufacture
Suction units OB 2012 contain electrical and/or electronic equipment that must be recycled in
compliance with European Directive 2012/19/UE - Waste Electrical and Electronic Equipment
(WEEE).
Authorized representative within the European Community if the manufacturer does not reside
in Europe
Expiry date
Order number (device code)
These operating instructions are available in other languages on the indicated website. Please
read them.
Do not use the device in environments where magnetic resonance imaging is performed
Production batch
Serial Number
Indicates that the suction unit is a medical device
Follow the operating instructions
Connection/patient suction tube (cover for collection jar and Serres® disposable liner)
INPUT The accepted input voltage range is indicated on the external power supply inlet
OUTPUT The output voltage is indicated on the external power supply outlet
Internal use only
Direct current
Alternating current
0.3. Symbols used on battery and referred to in these operating instructions
BATTERY The battery is enclosed in a stiff plastic case and has a special internal electronic circuit to
prevent damage. The battery cannot be opened, disassembled or repaired
SLA Sealed lead acid battery

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Warnings, important information
Do not short circuit the battery and its contacts
Do not incinerate or throw into a fire
Do not cut the battery or plastic case. Do not saw or puncture the battery (risk of explosion, fire
or short circuit)
Do not crush the battery or apply strong deforming pressures. Do not drill the battery with tools,
drills or other mechanisms.
Battery storage conditions (battery pack only):
Temperature (optimal): 0 ÷ 25° C
Humidity (optimal): 60 ± 25% RH
Do not
dispose of the battery with normal household wastes. Follow national and local
regulations for proper demolition and recycling. Follow the European recycling plan
Read the operating instructions
Production batch number
1. INTENDED USE
Device name Medical suction unit OB 2012 BOSCAROL
Primary use Suction unit designed to remove secretions, blood and other bodily fluids, solid pieces of
food or tissue in the medical field
Other Uses The device can also be used as a pump to empty vacuum mattresses and splints (but must
be used with the jar complete of the antimicrobial filter)
Medical Purpose Suction of the upper and lower airways
Site of application to
human body
Upper airways: nose, nasal cavity, throat, mouth
Lower airways: larynx, trachea, bronchial tube
Patient type Infants, children and adults of both sexes
Length of application
on a given patient < 60 minutes - Temporary use
Information on usage
•The suction unit can be used on all types of patients as long as correct medical
technique is followed
•Obstruction of the lower airways must be freed by medical professionals and/or health
care personnel (including paramedics and emergency personnel) train
ed and
authorized to perform such procedures
•Obstruction of the upper airways must be freed by medical professionals and/or health
care personnel (including paramedics and emergency personnel) trained and
authorized to perform such procedures. In some countries, this information must be
verified according to protocols implemented by local emergency health care services

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Device application
sites according to
ISO 10079-1:2019
Suction units OB 2012 can be used in many situations: in hospitals/clinics, at sites of
accidents and emergency health services, for first aid in general, at home care and health
care facilities, for outdoor application and during transport.
2. WARNINGS, PRECAUTIONS AND IMPORTANT INFORMTION
Read carefully
These operating instructions have been prepared using simple, easy to understand language. If
you have difficulty interpreting what is written, please contact the manufacturer for further
clarification.
Phone [phone] [e-mail]
•Read these instructions carefully before using the device. Careful, correct use of the device ensures smooth
operation and will protect both patients and operators.
•The suction unit is designed exclusively to remove organic fluids (secretions) during medical procedures. For
this reason, it should only be used by properly trained personnel
•Never use the suction unit in the presence of flammable and/or explosive liquids, gases or anaesthetic
mixtures as this could result in explosion and/or fire.
•If suction is performed without the jar and/or antibacterial filter, or if you suspect that substances may have
entered the suction circuit (i.e., the OB 2012
device), contact your nearest service centre or the
manufacturer immediately to have the device checked.
•Do not spray substances on the device. Before cleaning the device, make certain that the suction hole on
the container is closed (cover it with a piece of tape or connect the tube to the jar).
•Before cleaning the suction unit or performing any maintenance, disconnect the unit from the external
power supply or from the wall bracket. Do not immerse the device in liquids since this could damage it and
cause the safety devices to trip.
•Suction unit OB 2012 requires no maintenance by the operator. The only authorized operations are those
indicated in these instructions. For technical support, periodic service and repairs, contact the authorized
service centre or the manufacturer.
•For authorized personnel — who have taken a specific technical training course — the manufacturer
provides the documentation and tools needed to perform all service operations (service manual).
•To ensure patient safety, accuracy of the values displayed and correct operation, use only original spare
parts. In the case of non-compliance, the operator is held responsible for any patient injury or property
damage.
•Do not use any batteries other than those approved by the manufacturer.
•Do not modify the mechanical or electrical parts of the support bracket. Replacing any parts of the wall
bracket and/or modifying the bracket itself can seriously affect safe anchoring of the device.
•Suction units OB 2012 do not perform any diagnostic functions on the patient.
LATEX
Devices OB 2012 are built and manufactured without the use of latex. However, the possibility
that they may have come into contact with latex at some time during the production chain cannot
be ruled out
Do not use the device in environments where magnetic resonance imaging is performed. The
device could be dangerous for users and patients

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Portable RF communications equipment (including peripherals such as antenna cables and the
antennas themselves) must not be used at a distance of less than 30 cm (12 inches) from any part
of the OB 2012, including the cables specified by the manufacturer. Failure to comply with this
may reduce unit performance.
•Caution: Never use this unit near or on top of other equipment as it could result in improper
operation. If such use proves necessary, always check that this unit and other equipment
function properly.
•Caution: use of accessories, external power supplies, transducers, and cables other than
those specified or supplied by the manufacturer of this medical device may result in increased
electromagnetic emissions or decreased device electromagnetic immunity and cause the unit
to function incorrectly.
CONTAMINATED
DEVICE
•Warning: Device contamination. If the suction unit is used following these instructions, with
the original jar and antibacterial filter, the suction unit will not become contaminated.
Nevertheless, if the substances sucked up have entered the device, the suction unit must be
taken out of service immediately. Sending a contaminated suction unit to the manufacturer,
installer or service centre is strictly forbidden. The risk of spreading a pandemic is high and
must be avoided.
•Any device received in such conditions will be rejected and the health authorities will be
notified of the risk of possible contamination. In this case, the term contaminated indicates
a suction unit that has not been disinfected and cleaned of the secretion aspirated from the
patient. If the aspirated substances have entered the suction unit, it must be demolished. For
Boscarol, the safety of its employees and authorized service centre personnel is of primary
importance. If the suctions units are contaminated, they cannot be demolished according to
the WEEE (Waste Electrical and Electronic Equipment) directive, as this would result in a
possible risk of infection (international law regarding worker protection must be applied,
where applicable).
•When in doubt, before sending a device in for repair, send an e-mail to the Boscarol technical
service at [e-mail] or call [phone]
REUSE OF
DISPOSABLE
PARTS
•Caution: reuse of disposable parts can compromise suction unit function and be a source of
contamination — whether direct or indirect — for operator and patient.
•Sterilization and/or cleaning of disposable parts (antibacterial filters, suction tubes, Yankauer
suction catheters, etc.) can cause structural damage and thus result in a loss of mechanical
integrity.
SLA BATTERY
•Before using the suction unit for the first time (and/or after having received it), the internal
battery must be placed under continuous charge for at least 16 hours.
•Recharge the suction unit immediately if only one or none of the LEDs go on.
•Leaving the device always connected to the vehicle power supply (12÷15 Vdc) will not
damage it.
•The battery cannot be replaced by the operator.

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3. INFORMATION THAT IS IMPORTANT TO KNOW BEFORE USE
The suction unit has been designed and tested according to current law and the latest regulatory standards. If the
suction unit is connected to a non-compliant electrical system and/or if the connection is not made by a professional
installer, both the suction unit and the electrical system may be damaged. Always consult a qualified technician who
knows all the legal and regulatory aspects involved in the process.
PERIODIC SAFETY
INSPECTION
Preventive maintenance and periodic safety inspection:
The device must be checked at least once a day (functionality check).
The device should be checked at least once every 12 months by the authorized service centre.
On the other hand, starting from the date of manufacture (see the date of manufacture on
the label) an inspection of safety and technical maintenance is required every 24 months.
Refer to the manufacturer itself or to the authorized service centers for planning of inspection.
The periodic safety inspection of the device does not fall under warranty.
Operator/User
Responsibility
•Suction units OB 2012 are designed for emergency medical service and must therefore be
ready for use at any time and in any situation.
•Always make certain that the internal battery is sufficiently charged (press the test
button).
•Immediately replace any damaged, altered or missing components/parts and/or those for
which suction unit malfunction is suspected. Always replace these parts with original spare
parts. The suction unit must be stored in a place that is out of the reach of children.
•Dispose of packaging in accordance with applicable regulations and make certain it is out
of the reach of children.
Tripping of
overflow valve
WHAT TO DO IF THE OVERFLOW VALVE TRIPS?
•Put on protective gloves, protective eyewear and a type FFP2 or FFP3 mask.
•Turn off the suction unit and disconnect the silicone tube running from the jar to the
device.
•Check whether the aspirated liquids have reached the maximum level in the jar.
•Carefully remove the jar and store it in a safe place.
•Empty the jar safely by first removing the filter (which must be discarded) and then
removing the lid. Empty the jar and perform thorough cleaning and disinfection
(sterilization if necessary).
•Clean and disinfect the device as indicated in these operating instructions.

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4. CONTRAINDICATIONS (DO NOT USE FOR)
CONTRAINDICATIONS
•Low vacuum values, e.g. drainage of chest or wounds in general
•Permanent endoscopic use
•Operating rooms where potential must be equalized (e.g. operating theatres for heart
surgery)
•Outside the medical field
•Aspiration of flammable, corrosive or explosive substances
•Aspiration in environments presenting risk of explosion
5. SIDE EFFECTS (POSSIBLE DURING ASPIRATION OPERATIONS)
SIDE
EFFECTS
•General bleeding in the nasal pharyngeal area. Also of the throat and tongue.
•Vocal cord damage
•Cardiovascular instability
•Side effects caused by stimulation of the vagus nerve
•Stress-induced tachycardia
•Suffocation, nausea, vomiting and coughing
•Respiratory tract infection (typical of hospital environments)
•Convulsions by patients who tend to have cramps
SIDE
EFFECTS
Caution: to minimize side effects, it is important to follow the indications given in these
operating instructions
6. MEDICAL SUCTION UNITS OB 2012
After receiving the device, make certain that all parts are present. All Boscarol suction units come ready to use, fully
assembled with everything except the antibacterial filter (in the version with reusable jar) which is not connected to the
device (for transport and storage reasons).
Package contents for FA version
01 Complete suction unit
01 Boscarol reusable 1000 ml jar complete with overflow valve in lid
01 Antibacterial filter complete with silicone tube
01 Yankauer catheter, sterile (not installed)
01 SELV (12÷15 Vdc) voltage supply cable, ready to use
01 Operating instructions in Italian or a specific language depending on the destination and technical documentation
Package contents for LINER version
01 Complete suction unit
01 Reusable jar complete with SERRES disposable liner already inserted in jar
01 Yankauer catheter, sterile (not installed)
01 SELV (12÷15 Vdc) voltage supply cable, ready to use
01 Operating instructions in Italian or a specific language depending on the destination and technical documentation
Depending on the configuration chosen, the device can be equipped with the following accessories:
01 External power supply from the mains to power and recharge the suction unit
02 Wall bracket and power supply, complete with SELV voltage cable (12÷15 Vdc)

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6.1. Description of the suction unit
The OB2012 is a medical suction unit compliant with all reference standards.
It can be used in motor vehicles (ambulances), in the field, in hospitals, clinics and for home treatment by doctors or
trained authorized personnel (paramedics).
The suction unit has an internal SLA battery (sealed lead acid battery) that contains dangerous substances (lead and a
solution of sulfuric acid) and cannot be open, disassembled, cut or topped up.
The suction units OB2012 come in two basic versions: with reusable and disposable jar.
For the accessories and options available, see the catalogue at www.boscarol.it or send an email to
[e-mail]
6.2. Controls, operations and control panel
All device operating controls are located on the front to facilitate its use, even when anchored to the wall bracket. To
activate the device, press switch (4), which is protected against ingress of liquids and solids, splashes of water and
cleansers. The vacuum can be adjusted by turning knob (5) located over the switch. Turning the knob clockwise increases
the vacuum to maximum — the value can be read on the analogue instrument (1), expressed in millibar (mbar) or kilo-
pascal (kPa) or, upon request, even in millimetres of mercury (mmHg). The instrument is fluorescent and can be seen in
the dark. On the back are two contacts (7) that allow the device to be charged and operated when fitted on the wall
bracket. The device can also be charged using the external charging cable, plugging it into the outlet on the back of the
device. The connector is sealed air-tight and has two electrical poles (6).
Model OB2012 with reusable jar:
1. Suction unit
2. OB-J FA jar
3. Protection filter
4. 90° plastic joint
5. Silicone tube with conical connector
for filter connection
Model OB2012 with disposable jar:
1. Suction unit
2. OB-J jar
3. 90° plastic joint
4. Disposable bag SERRES
5. 90° connector

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6.3. Indicator lights
All lights are placed on the front and display the operation of the device (see figure above): the autonomy of the battery
(3) and the recharge state (2). The table below indicates the condition of the LEDs and the relative power of the battery:
SIGNALLING
BATTERY POWER LEVEL
4 LEDS on
>80% of the maximum power
3 LEDS on
50
÷
79% of the maximum power
2 LEDS on
20
÷
49% of the maximum power
1 LED on
<20% battery low - the device will shut down shortly
The indicator for charging <ON/CHG> (2) on the previous figure, has two different colors: yellow indicates that charging
is taking place; green indicates that charging is complete. The indicator lights up whenever the device is connected for
recharging. If the LED does not light up, there could be a malfunction of internal recharge circuit, lack of power (12 Vdc)
or lack of connection of external cable to a power source for 12 Vdc.
BATTERY
POWER VERY
LOW
The device will shut down soon after the last LED is switching off, because the battery is completely
drained.
BATTERY
COMPLETELY
DRAINED
Warning: a drained battery affects device operation and therefore its use. It takes about 15 hours
to charge a fully discharged battery. The suction unit can always be left charging. The battery has
a lifespan of 2 years and is automatically replaced during the safety inspection.
Electrical
connections
Always check that the charging cable plug is correctly inserted into the cigarette lighter socket:
vehicle vibration can cause the plug to come loose. Therefore, always check the charging LED on
the device: it remains yellow during charging and switch green until charging has been completed
6.4. Periodic testing of suction units OB2012
To ensure proper device operation, two types of periodic tests are envisaged:
the first is to be performed daily to ensure device efficiency, the absence of mechanical anomalies, breakage
of the external plastic casing and to ensure that the unit is functioning properly
the second, on the other hand, is performed on a six-monthly/annual basis so as to evaluate complete device
function and thus ensure its compliance. The timing of these must be reduced when the unit is subject to
intensive use, operated under severe conditions and/or outside the recommended limits.
The daily test makes it possible to check (quickly) whether the device is suitable for use in the field and provides function
tests that can be completed in a maximum of 5 minutes.
6.4.1. Daily periodic testing of suction units OB2012
DAILY TEST
•Disconnect the unit from the bracket or from the external charging cable
•Place the device in an upright position on a stable surface with the front facing you. Do not
withdraw the unit from its carrying/storage bag
•Press the ON-OFF button located near vacuum regulator. If all of the yellow LEDs are lit up, the
battery is fully charged (operating time: approx. 60 minutes). If not, remember to charge the
suction unit as soon as possible.

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•Using the switch on the front panel, turn on the suction unit (0 - off, 1 - on). The suction unit
must operate smoothly, no fluctuations in internal pump speed must be heard. There should not
be any unusual noise and/or vibrations.
•Fully close the vacuum regulator (turning it clockwise) and pinch the silicone tube near the jar
(before the filter for the reusable jar OB-J) or near the jar connection when using SERRES®
disposable liners. The noise generated by the pump should change and, in a few seconds, the
reading on the vacuum gauge should reach maximum value (about 800 mbar, 80 kPa, 600
mmHg).
•While keeping the tube pinched, turn the vacuum regulator counter-clockwise and check the
reading on the gauge to ensure that the suction drops to nearly 0 (40÷50 mbar due to filter
effect).
•Turn off the suction unit and turn it 180 degrees to check the electrical contacts on the back of
the unit (they must be clean and free of any signs of stains, oxidation and/or burning).
•Connect the device to the powered support bracket. If the battery is drained, it will start charging
(yellow LED flashing or on steady if charging is not necessary). If the device does not have a wall
bracket and the battery is low, connect the external power cord to the cigarette lighter or
optional power supply and check that the charging process starts (yellow LED on).
•Make certain that the filter is clean and not contaminated. If the filter is soiled, it must be
replaced. A soiled filter prevents the suction unit from functioning properly and reduces its
performance by increasing the risk of contamination. Do not use the suction unit without a filter.
When finished, compare the results of this test with the value on the table below:
Test – phase
Result
Remedy
Running the autonomy test
The yellow LEDs go on according to
the battery charge (1 to 4 LEDs).
If the LEDs do not go on, the battery is completely drained or
faulty. Try charging the battery with the external cable or power
supply. During these operations, take the device out of active
service
Pump function check
Noise from motor is uniform, no
drop in rpm, no abnormal
vibrations
Any noise that is not uniform indicates an anomaly in pump
operation. A drop in rpm indicates that the current is inadequate
and cannot run the motor correctly. Contact your service centre
or the manufacturer.
Check for maximum
suction by pinching closed
the tube running from the
device to the filter or
disposable liner.
The maximum vacuum value that
can be read on the vacuum gauge
should be around 800 mbar ±10 %
(70 kPa ÷ 80 kPa; 525 ÷ 600 mmHg)
If this value is not reached, close the vacuum regulator
completely by turning the knob clockwise. Check that the tube is
completely plugged. If not, take the device out of service and
contact your authorized service centre.
Setting the maximum
vacuum value
Value between around 0 and
maximum, achieved by turning the
knob
If the vacuum value cannot be adjusted, contact your authorized
service centre. Take the device out of service
Rear charging contacts
check
The contacts must be clean and
free of oxidation. The metal must
show no burn marks.
Clean the contacts with a cloth soaked in ethyl alcohol. If strong
burns are seen, they must be replaced. In this case, contact your
authorized service centre
If problems continue after the steps indicated above have been taken, send the unit to an authorised
service centre or to the manufacturer for service or repair.
6.4.2. Six-monthly/yearly test of suction units OB2012
This test checks whether the device is fully compliant with the original production characteristics and therefore suitable
for use in the field. The checks and controls should be performed by persons and/or companies specialized in performing
such operations on medical devices and who have been instructed/authorized by the manufacturer. Following
inspection, an electrical safety test must be performed in accordance with IEC 60601-1 and a test summary document
must be issued and made available to the user.

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SIX-
MONTHLY
OR
ANNUAL
TEST
•Replace the SERRES® disposable liner or antibacterial filter before performing these operations.
•Mechanical wall bracket function: check that it is secured properly (to the wall of the vehicle), that
it functions properly and that the upper red plastic button slides correctly (not hindered in any
way). After pressing the upper red part, release it and check that the locking hook returns to its
initial position. Check the charging contacts which must not show any signs of alteration, burning
or oxidation.
•Check connection of electrical cables to the bracket (they must be fixed).
•Run a complete suction unit function check: battery life, charging function, complete control of the
LED functions (from maximum to minimum during battery discharge). Make certain that, during
charging, the LEDs function as shown in section §6.3 Light indicators.
•Check internal pump function by pressing the switch. The maximum vacuum value must fall in the
730 mbar÷80 mbar range. Use a precision vacuum gauge to measure this value (tolerance ±2.5 %
or less). There should be no operating anomalies — i.e. unusual noise, fluctuations in rpm,
excessive vibration of the gauge needle — and the vacuum regulator knob should function
smoothly and show no obstructions: when running the test, the device should be set on a stable
surface to check the amount of vibrations generated.
•Check the vacuum regulator which must run at full range: from minimum to maximum. Turn the
knob clockwise and counter-clockwise. When the regulator is fully open, a small vacuum value is
normal (introduced by the antibacterial filter).
•Check the minimum suction unit operating time: turn it on and let the cycle run freely for at least
20 minutes. The suction unit must operate using only the internal battery. If the test fails, the
internal battery must be replaced.
•Check the unit container for cracks and fissures. Penetration of liquids or solids can damage the
unit and make it unsafe for operators and patients (mechanical parts running).
•Check that all labels and screen-prints are present and legible.
•Never open the suction unit for any reason whatsoever. For technical assistance, only contact one
of the authorized service centres listed at the end of this manual.
•Check that the vacuum gauge is functioning properly. When the suction unit is turned off, the
needle should be close to "0".
•Make certain that the carrying bag is functional, intact and shows no tears. The nylon strap must
be intact. No damages shall be reported.
•Check that the jar is intact and that there are no cracks or breaks that could compromise suction.
•Check the screws on the steel plate at the back of the device, ensuring that it can be securely
attached to the support bracket.
•Before declaring the suction unit compliant with the manufacturer's data plate, using a specific
safety analyser, run an electrical safety test as outlined in IEC60601-1. Contact the manufacturer
or an authorized service centre for information on performing this test.
DEVICE
CONFORMITY
Use only consumables or replacement parts supplied by the manufacturer. Do not use components
that are similar or appear identical. Component conformity can only be confirmed by the
manufacturer.
Keep on file a document certifying that all checks have been performed and, if possible, keep a
photograph recording the state of the suction unit before and after these checks in addition, always
keep a copy of the safety report, performed with the appropriate, duly calibrated instrument.
OPERATION
In accordance with ISO 10079-1:2019, the device can only be run in an upright position and at an
inclination of no more than 20 degrees. If this limit is exceeded, the overflow valve may trip, thus
blocking suction.

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If you have any doubts or concerns regarding how to perform the tests, we recommend always contacting the device
manufacturer or an authorised service centre. If even a single test fails, contact a service centre or the manufacturer.
Do not use the device if it has not passed all tests.
For any information, call 0471 932893 or send an e-mail to [e-mail].
6.5. Periodic safety maintenance
Depending on how the device is used, the OB2012 should be checked at least every 24 months even if not used. Some
parts inside of the unit, i.e. the battery and the filter may be affected by a long period of inactivity of problems. Periodic
maintenance includes specific maintenance, revision and updating of the device. If periodic maintenance is not
performed, the life span of the device decreases.
6.6. Safety information to ensure user, patient and third part safety
To prevent undesirable effects and risks, always follow the information given below:
•Make certain that all accessories are functioning properly and replace the external power supply or cables if
defective. Do not take unnecessary risks: always replace defective parts so as to ensure that the device is always
in good working order for use and emergencies.
•Always keep the device attached to the support bracket (in emergency vehicles) during transport as this will
prevent damage to user and patient.
•Even if the device is not used, recharge the battery at least once a month.
•We recommend keeping on hand another suction unit to stand in if this one does not work or is defective (e.g. a
manual suction unit).
•Always remember what was stated in the initial warnings regarding the risks arising from the effects of magnetic
fields (EMC).
•Always select the appropriate vacuum level for the patient and according to the medical guidelines.
•Do not alter or modify the medical device. Serious consequences may occur for patient and user.
•Units OB2012 are not sterile devices and cannot be sterilized, except for the jar and silicone tube.
•Keep children away from tubes and connection cables. Also keep them away from small parts.
Risk of infection
•Incorrect use of the device can lead to the transmission of infections, even fatal ones.
•Always wear disposable gloves, especially when there is the risk of coming into contact with the aspirated
secretions.
•Never use components marked as disposable more than once. Disposable parts or medical devices are
marked as shown in the figure to the side (a number 2 that has been crossed out).
•Never use the device without the antibacterial filter.
•Always disconnect the unit from the power supply, bracket, or SELV source before performing cleaning and
disinfection.
•Only use the power supply indoors and in dry areas. Never use the power supply outdoors!
•Always use only original accessories and original spare parts.
Caution
Assembly operations, repairs and modifications to the device are strictly forbidden and may only be
performed by the manufacturer or authorized personnel.
7. JARS FOR OB2012
The device is sold with two different types of 1000 ml jar:
•Suction unit with autoclavable jar (OB2012 FA).
•Suction unit with jar fit with disposable liner (OB2012 LINER)

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7.1. Autoclavable jar OB-J FA
The jar is made of transparent plastic (medical-grade polypropylene).
It includes the jar (1), snap-on lid (2), overflow valve (3) and 90° plastic
connection (4). The jar’s lid makes it possible to directly insert the
antibacterial filter (from the outside). The jar can be sterilized in a
conventional steam autoclave at a maximum temperature of 121°C
and pressure of 2 bar (200 kPa). The jar must be replaced if it shows
any sign of deformation, breakage or fissuring. The jar must always
be used in the upright position, thus preventing the overflow valve
from tripping. If this protection does trip, turn off the device and
disconnect the tube connected to the suction unit, remove the
antibacterial filter to rebalance the pressure inside the jar.
Lifespan of jar OB-J FA
The jar must be replaced after 30 sterilization cycles or 5 years from the date of
manufacture.
7.2. Antibacterial filter
To prevent fluid overflow, a special protection filter is used between the jar and
the unit. The filter is produced with PTFE hydrophobic material which prevents
fluids entering the pneumatic circuit. Working together with the overflow valve
on the jar, the filter isolates the pneumatic suction pump from gas and fluid
substances. The filter is disposable and must be replaced after each use. If
contamination, discoloration and increased resistance to suction occurs, it must
always be replaced. The filter isn’t manufactured by the Boscarol company.
Antibacterial filter
If the device is used on patients whose infectiousness is unknown, always replace the filter
after use on that patient. This will prevent contamination, even serious contamination, of the
environment where the device is installed and thus protect operators and patients. Instead,
if the patient's infectiousness is known and/or if there is no risk of indirect contamination, we
recommend replacing the filter after each shift or whenever the degree of suction decreases
or the filter changes colour.
Risk of infection
•Never use the device without the antibacterial filter. Always keep at least three spare
replacement filters on hand in case of emergency.
•Always wear gloves and personal protective equipment when changing the antibacterial
filter and emptying the jars.
•Before each use, check that the filter is dry and clean (it must not be any colour other than
white). Change the wet or contaminated filter with a new one.
•Never reuse the antibacterial filter (disposable).

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7.3. OB-J LINER: jars for SERRES® disposable liners
The OB-J jar for SERRES® disposable liners is made of transparent plastic (medical grade
polypropylene). It includes a container (1), an adapter for SERRES® disposable liners (2),
a red 90 degree connector (3) and a SERRES® disposable liner (4). The antibacterial filter
is integrated into the cover of the disposable liner and prevents aspirated fluids from
entering the suction unit. The jar can be sterilized in a conventional steam autoclave at
a maximum temperature of 121°C and pressure of 2 bar (200 kPa). The disposable liner
should be replaced after use on a given patient or when full.
When used in a home environment, the jar can be cleaned using a special detergent
able to ensure medical device disinfection. Contact Boscarol for information about
disinfectants.
Risk of infection
•Always keep at least three spare SERRES® liners on hand.
•Always wear gloves and personal protective equipment when
changing and disposing of the SERRES® liner.
•Before each use, check that the SERRES® container has not already
been used.
•Always replace the contaminated disposable liner with a new one.
7.4. Connecting the jar
The jar is connected to the suction unit through a silicone
tube and a plastic connector (white for FA suction unit
version (Fig.1); red and at 90-degree for LINER suction unit
version (Fig.2)).
Insert the connector into the device as shown in the photo
to the side. Do not force insertion. This applies to both types
of jars.
7.5. Sterile, disposable Yankauer catheter with suction control system
The OB2012 units are sold complete with a sterile Yankauer-type suction catheter and
tubes for connection to the jar. The suction tip and catheter are disposable and must
be replaced after each use. To facilitate proper operation, the suction tip is tilted so
that it can reach all parts of the mouth and upper airways. The suction tip is spherical
and has side holes to prevent damaging tissues during aspiration.
Yankauer
The Yankauer suction catheter is a sterile, disposable medical device. This device must
never be reused and must be disposed of after use on the patient.
Caution! Never use sterile medical devices beyond their expiration date or if the packaging has
been damaged.
Always connect the Yankauer catheter to the "PATIENT" side of the lid of the reusable jar (FA) or
to the SERRES® disposable liner using the white conical connector.
Fig.1
Fig.2

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7.6. Silicone suction tube and sterile Fingertip connection (conical connector)
Upon request, the device can be fit with a silicone patient tube (length: 130 cm)
and a sterile conical Fingertip connector that makes it possible to use standard
sterile catheters of appropriate size. The tube can be reused.
The sterile Fingertip connection makes it possible to control the suction value with
a finger, by closing and opening the hole present. The disposable devices supplied
with the suction unit are identified with labels containing all information required
for proper use.
The Fingertip connection (also called the catheter
connection) makes it possible to attach standard sterile
catheters (see figure to the side).
7.7. Warnings regarding the reuse of disposable parts
Disposable
medical devices
Risk of infection
Caution: the suction unit is supplied with some sterile disposable accessories to facilitate patient
aspiration. These devices cannot be used on more than one patient. Disposable medical devices
are manufactured with materials that can withstand limited use and must not be reused. The
operator must dispose of them properly and restore the medical device so that it is in good
working order for the next use. Reuse of disposable devices can be dangerous to both
patient and operator and can result in a drop in performance and irreparable damage
to the device.
SERRES®
disposable liner
The SERRES® disposable liner cannot and must not be emptied. The top cap is designed so that
samples of the secretion can be taken for laboratory analysis. Every time the filter comes into
contact with fluids or liquids (of any kind), it locks, and the liner must be replaced!
8. REUSE, CLEANING AND DISINFECTION
After each use, disconnect the suction unit, disconnect the disposable parts and dispose of them. Check that the suction
unit is intact, check the connection tube and check for structural anomalies. Clean and disinfect the suction unit as
described below. Replace all disposable parts with new ones and recharge the battery. After conducting the reuse
operations, perform the daily test as described in section §"6.4 Periodic Testing of OB2012” covering the daily test.
Decontamination is a process that must always be performed meticulously; this means that specific training is required,
especially in the field of emergency medicine where the patient's medical condition and degree of contamination are
for the most part unknown. For this reason, the operator must always use personal protective equipment (PPE) to
protect him/herself and other people. If PPE devices are not available, contact your safety representative.
Risk of infection
Always wear gloves and personal protective equipment when changing
the antibacterial filter and emptying the jars.
DANGER
Organic secretions collected in the suction unit jar can cause serious operator infection. For
this reason, always use PPE and disinfectants as indicated by industry operators and the
competent authorities.

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8.1. Reuse of jar OB-J FA
The steps needed to separate the jar from the suction unit, dismantle it and re-assemble it after cleaning and
disinfection are described below. Before starting, put on protective gloves that cover the forearms, and also wear mouth
and eye protection.
Remove the patient tube together with the yellow 90° connector. The
Yankauer catheter must be disposed of together with the curved tip (sterile
disposable devices). Do not dispose of the yellow 90° connector as it can be
sterilized and reused.
Disconnect the conical connector from the suction unit.
Withdraw the jar, pulling it vertically from the suction unit.
Remove the antibacterial filter from the lid by turning it in its seat and
discard it.
Remove the cover from the jar by pressing lightly on the lid itself and prying
its flap. Empty the contents of the jar in accordance with local regulations or
hospital practice.
Remove the overflow valve from the lid.

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Separate all component parts.
Parts that make up the lid:
•Yellow polypropylene cage
•Yellow polypropylene float
•Red silicone seal
•Red polypropylene lid
DANGER
Risk of infection due to the release of potentially contaminated substances when emptying
secretions. Possibility of transmission of fatal infections. Always use suitable PPE and disinfectants
as required by hospital regulations and the competent authorities.
Pay attention to some disinfectants that could stain the jar and parts thereof without damaging it.
8.2. Cleaning, disinfection and/or sterilization of jar OB-J FA and silicone tube
The jar and silicone tube can be cleaned with specific, non-abrasive substances designed for cleaning medical devices.
Alcohol-based cleaning agents may be used if diluted appropriately (follow the instructions given on the disinfectant
label). Do not use coloured disinfectants as they could stain the plastic of the jar and the silicone tube, reducing their
transparency. After disposing of the disposable antibacterial filter and Yankauer suction catheter, complete with tubes,
place the reusable parts in hot water (to prevent scalding, the temperature must not exceed 60°C) containing a diluted
medical device disinfectant. Rinse thoroughly and, if necessary, use a non-abrasive brush to remove any deposits. After
washing, dry all parts. Always contact the cleaning and disinfection plan on the following pages. In case of serious
contamination, always follow the instructions given by the health care personnel and competent authorities. If
necessary, sterilize the "REUSABLE PARTS" (see above) in a steam autoclave at a maximum temperature of 121° C and
for a maximum of 15-20 minutes (typical cycle). Do not use autoclaves with pressures above 2 bar (200 kPa). The jar
must be inserted upside down. At the end of the cycle, allow the parts to cool to room temperature and check that they
are intact and show no warping.
DISINFECTION
CYCLE
WARNINGS
•Do not spray liquids on the device. Clean the device with suction inlet closed. Apply a piece
of tape or leave the jar connected to the unit.
•To prevent discoloration, do not use aldehyde- and/or amine-based disinfectants.
•Use only disinfectants specific for cleaning of medical devices. Before applying the disinfect
on the surface of the device and jar, check it in a corner to ensure that it does not cause
damage.
•Consult with the hospital and clinic specialists. Check that specific disinfection and cleaning
plans and/or protocols are available for the area involved.
STERILIZATION
CYCLE
WARNINGS
•Never sterilize devices or parts that have not been previously cleaned.
•Never place weights on parts during the sterilisation cycle.
•Observe the maximum limits for temperature, pressure and sterilization time (temperature:
200 kPa, maximum time 15-20 minutes).
•Cleaning and sterilisation should be performed only by trained personnel.
•Replace the jar if it has cracks, fissures, or even partial breaks.
•After reassembling the jar, always check that the lid is fitted properly so as to prevent vacuum
leaks and avoid spilling aspirated liquids or fluids.
•Always follow the instructions given by the autoclave manufacturer.