Boscarol OB 1000 User manual

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BOSCAROL MEDICAL SUCTION UNIT
OPERATING INSTRUCTIONS
OB 1000 - OB1000 AVIO type FA
OB 1000 - OB1000 AVIO type FM
CORMOS type FA
CORMOS type LN

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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 the manufacturer and the medical device:
•Oscar Boscarol applies a quality management system in accordance with international standards
ISO 13485 and ISO 9001.
•The OB1000 medical device (in all its configurations) complies with MDD 93/42/EEC (and
subsequent amendments) and bears the CE mark (CE 0123 notify body TÜV SUD Italia).
•The medical devices meets the essential requirements described in Annex I of MDD 93/42/EEC
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 1000 FA
OB 1000 FM
CORMOS (CORMOS FA and CORMOS FM versions are similar to the respective OB1000 FA and
OB1000 FM versions. They differ from these only in the colour of the bag).
OB 1000 AVIATION FA
OB 1000 AVIATION FM
REFERENCE CODES:
BSU210
BSU210PJ
BSU210ST
BSU212
BSU216
BSU216UK
BSU220
BSU220ST
BSU226
BSU226UK
BSU228
BSU228ST
XAS0106
XAS0110
XAS0504
BSU230
BSU232
REFERENCE CODES FOR CORMOS SUCTION UNITS:
11010/FA
11010/LN
11011/FA
11011/LN

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INDEX
INDEX 4
0. MEANING OF SYMBOLS AND PICTOGRAMS ..................................................................................................... 5
0.1. Symbols used in these operating instructions to call the reader's attention.................................................... 5
0.2. Symbols used on the device and accessories.................................................................................................... 5
0.3. Symbols used on the battery and referred to in these operating instructions................................................. 6
1. INTENDED USE ................................................................................................................................................. 7
2. WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION ......................................................................... 8
3. IMPORTANT INFORMATION TO KNOW BEFORE USE........................................................................................ 9
4. CONTRAINDICATIONS (DO NOT USE FOR).......................................................................................................10
5. SIDE EFFECTS (POSSIBLE DURING SUCTION OPERATIONS) ..............................................................................10
6. MEDICAL SUCTION UNITS OB1000 AND OB1000 AVIO....................................................................................11
6.1. Description of the suction unit........................................................................................................................ 11
6.2. Controls, operation and control panel............................................................................................................ 11
6.3. Indicator lights................................................................................................................................................. 12
6.4. Periodic testing of OB1000 and OB1000 AVIO suction units .......................................................................... 12
6.4.1. Daily periodic testing of OB1000 and OB1000 AVIO suction units ................................................................. 13
6.4.2. Six-monthly/annual periodic testing of OB1000 and OB1000 AVIO suction units.......................................... 13
6.5. Periodic safety maintenance........................................................................................................................... 15
6.6. Safety information for the safety of users, patients and third parties............................................................ 15
7. SECRETION JARS FOR OB1000 AND OB1000 AVIO...........................................................................................15
7.1. Autoclavable secretion collection jar OB-J FA................................................................................................. 15
7.2. Antibacterial filter ........................................................................................................................................... 16
7.3. OB-J LINER: jar of secretions for SERRES® disposable bags............................................................................. 16
7.4. Secrets jar connection..................................................................................................................................... 17
7.5. Sterile disposable Yankauer catheter with suction control system ................................................................ 17
7.6. Silicone suction tube and sterile Fingertip (conical fitting) ............................................................................. 17
7.7. Warnings concerning the re-use of single-use parts....................................................................................... 17
8. REUSE, CLEANING AND DISINFECTION ............................................................................................................18
8.1. Re-use of OB-J FA secretion jar ....................................................................................................................... 18
8.2. Cleaning, disinfection and/or sterilisation of OB-J FA secretion jar and silicone tube.................................... 19
8.3. Jar assembly and connection of the silicone suction tube.............................................................................. 20
8.4. Replacing the antibacterial filter..................................................................................................................... 20
8.5. Cleaning the secretion jar with SERRES® disposable bags .............................................................................. 20
8.6. Disinfection and/or sterilisation of the OB-J secretion jar and silicone tube.................................................. 22
8.7. Assembling the secretion jar with the SERRES® disposable bag..................................................................... 23
8.8. Disposal of contaminated single-use parts ..................................................................................................... 23
8.9. Cleaning and disinfection of the suction unit.................................................................................................. 23
8.10. Cleaning and disinfection plan ........................................................................................................................ 24
9. ACCESSORIES AND OPTIONS FOR OB1000 AND OB1000 AVIO ........................................................................25
10. OB1000 AND OB1000 AVIO SUCTION UNITS INTERNAL BATTERY....................................................................26
11. SPECIAL CONDITIONS OF USE..........................................................................................................................26
12. DEMOLITION OF SUCTION UNIT......................................................................................................................26
13. ACCESSORIES, CONSUMABLES AND SPARE PARTS ..........................................................................................27
14. TECHNICAL SERVICE ........................................................................................................................................27
14.1. Solving common problems.............................................................................................................................. 27
15. TECHNICAL DATA AND COMPLIANCE DATAFOR OB1000 AND OB1000 AVIO ..................................................28
16. INFORMATION CONCERNING ELECTROMAGNETIC COMPATIBILITYEMC (OB1000 - OB1000 AVIO) .................30
16.1. RISKS OF MUTUAL INTERFERENCE WITH OTHER DEVICES .............................................................................. 30
16.2. METHODS TO PREVENT ELECTROMAGNETIC INTERFERENCE ......................................................................... 31
16.3. GUIDELINES AND MANUFACTURER'S DECLARATIONS - ELECTROMAGNETIC EMISSIONS .............................. 31
16.4. GUIDELINES AND MANUFACTURER'S DECLARATIONS - ELECTROMAGNETIC IMMUNITY .............................. 31
17. DECLARATION OF CONFORMITY .....................................................................................................................33
18. WARRANTY.....................................................................................................................................................33

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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 information on the correct use of the suction unit to prevent injury to
the operator or patient and/or damage to the suction unit.
Warnings: information requiring special attention
Notes or information to prevent damage to the device or others. Activate the 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 may affect the operation of the
suction unit. In such cases, the suction unit should not be used, or should be kept at an
appropriate distance from such equipment.
The OB1000 and OB1000 AVIO suction units contain electrical or electronic parts that must be
recycled according to the WEEE Directive/19/EU - Waste Electrical and Electronic Equipment.
The suction unit complies with the European Directive 2011/65/EU (RoHS).
Required maintenance service (contact the manufacturer and/or its authorised service centres)
0.2. Symbols used on the device and accessories
Insulation class II (according to IEC 60601-1)
Patient Applied Part Grade BF (according to IEC 60601-1)
Use the suction unit only within the specified temperature range. Using the suction unit outside
this range may impair its operation, shorten battery life and cause the internal safety devices to
activate.
Limits of use referring to atmospheric pressure
Limits of use in relation to humidity
Read these operating instructions carefully and completely
Accessories and/or consumables bearing this symbol are disposable. They cannot be reused and
must be discarded after use and replaced with new ones. The symbol is placed on consumables
Symbol indicating that the device is multiple-use but single-patient (in practice it can only be
used more than once on the same patient)

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Indicates the need for the user to consult these operating instructions for information such as
warnings and precautions that cannot be displayed on the medical device in question
CE mark in accordance with MDD 93/42/EEC for medical devices in class above I
Manufacturer
Production date
OB1000 and OB1000 AVIO suction units contain electrical and/or electronic equipment that
must be recycled in accordance with European Directive 2012/19/EU - Waste Electrical and
Electronic Equipment (WEEE).
Authorised representative in the European Community if the producer is not resident in Europe
Expiry date
Order number (device code)
Please read the operating instructions in other languages available on the indicated website
Do not use the device in environments where MRI investigations are conducted
Production batch
Serial number
Indicates that the suction unit is a medical device
Connection/patient suction tube (cover for collection jar and Serres® disposable liner)
INPUT The external mains power supply indicates the accepted input voltage range
OUTPUT On the external mains power supply it indicates the output voltage value
Indoor use only
Continuous current
Alternating current
0.3. Symbols used on the battery and referred to in these operating instructions
BATTERY The battery is sealed and installed in the device. The battery cannot be opened, disassembled
or repaired.
SLA Sealed lead-acid battery
Warnings, important information

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Do not short-circuit the battery and its contacts
Do not incinerate or throw into fire
Do not cut the battery or the plastic case. Do not saw or puncture the battery (risk of explosion,
fire or short circuit).
Do not crush the battery or apply strong deformation pressure. Do not pierce the battery with
tools, drills or other mechanisms.
Storage and preservation conditions for the battery (battery pack only):
Temperature (optimal): 0 ÷ 25° C
Humidity (optimum): 60 ± 25 % RH
Do not dispose of the battery with household waste. Follow national and local regulations for
proper dismantling and recycling. Follow the European recycling plan
Read the operating instructions
Production batch number
1. INTENDED USE
Device name Medical suction units OB1000 and OB1000 AVIO BOSCAROL
Primary use
Suction unit designed to remove secretions, blood and other body fluids, solid pieces of
food or tissue in the medical field
Other uses The device can also be used as a pump to evacuate mattresses and vacuum splints (but
must be used with the filter and secretion jar)
Medical purpose Upper and lower airway suction
Part of application in
the human body
Upper airways: nose, nasal cavity, throat, mouth
Lower airways: larynx, trachea, bronchi
Type of patients Babies, children and adults of both sexes
Time of application on
the same patient < 60 minutes - Temporary use
Information on use
•The suction unit can be used on all types of patients following the correct medical
technique
•Lower respiratory tract release must be performed by medical professionals and/or
healthcare personnel (including paramedics and rescuers) trained and authorised for
such actions
•Upper respiratory tract release should be performed by medical professionals and/or
healthcare personnel (including paramedics and rescuers) trained and authorised for
such actions.
In some countries, this information should be verified according to the
protocols implemented by local emergency health services.

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Device application
sites in accordance
with the standard
ISO 10079-1:2019
OB1000 and OB1000 AVIO suction units can be used in hospitals/clinics, accident and
emergency departments, general emergency rooms, home care and nursing facilities, as
well as for outdoor application and during transport.
2. WARNINGS, 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]
•Read these instructions carefully before using the device. Careful and correct use of the device will ensure
smooth operation and 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 trained personnel.
•Never use the suction unit in the presence of flammable and/or explosive liquids, gases and anaesthetic
mixtures as this may lead to explosions and/or fires.
•If aspiration is performed without the secretion jar and/or without the antibacterial filter, or if you suspect
that substances may have entered the aspiration circuit (i.e. in the OB1000 and OB1000 AVIO devices),
contact your nearest service centre or the manufacturer immediately to have the device checked.
•Do not spray substances on the device. Before cleaning, make sure that the suction hole on the device
container is closed (apply a piece of tape or connect the tube of the secretion jar).
•Disconnect the suction unit from the external power supply or support bracket before cleaning or
performing any maintenance. Do not immerse the device in liquids as this may damage it and cause safety
devices to trip.
•The OB1000 and OB1000 AVIO suction units require no maintenance by the operator. The only authorised
operations are those listed in these instructions. For technical assistance, periodic inspection and repairs,
please contact the authorised service centre or the manufacturer.
•
The manufacturer provides authorised personnel, who have followed a specific technical training course,
with the documentation and tools required to carry out service operations (service manual).
•
To ensure patient safety, the accuracy of the displayed values and correct functionality, use only original
spare parts. The operator assumes responsibility for any injury to the patient or damage to property if this
is not observed.
•Do not use batteries other than those approved by the manufacturer.
•Do not modify the mechanical or electrical parts of the wall bracket. Replacing parts of the wall bracket
and/or altering it can seriously affect the safety anchorage of the device.
•OB1000 and OB1000 AVIO suction units do not perform diagnostic functions on the patient.
LATEX
OB1000 and OB1000 AVIO devices are designed and manufactured without the use of latex.
However, it cannot be excluded that during the entire production chain latex may have come into
contact with
Do not use the device in an MRI environment. The device may be dangerous to users and patients.
Portable RF communications equipment (including peripherals such as antenna cables and the
antennas themselves) should not be used closer than 30 cm (12 inches) to any part of the OB1000
and OB1000 AVIO, including cables specified by the manufacturer. Failure to do so may result in
reduced performance of this equipment.

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•
Warning: The use of this equipment adjacent to or stacked on other equipment should be
avoided because it may cause improper operation. If such use is necessary, it should be verified
that this equipment and other equipment are operating normally.
•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 electromagnetic immunity of this device and cause
improper operation.
DEVICE
CONTAMINATE
•Warning: Device contamination. If you use the suction unit according to these instructions,
with the original collection container and the bacterial filter, the circuit of the suction unit will
not be contaminated. However, if aspirated substances have entered the device, the suction
unit must be immediately removed from service. Sending a contaminated suction unit to the
manufacturer, installer or service centre is strictly prohibited. The risk of spreading pandemics
is high and must be avoided.
•Any device received in this condition will be rejected and the health authorities will be alerted
to the risk of possible contamination. In this case, the term contaminated indicates a suction
unit that has not been cleaned and disinfected by the secretions aspirated by the patient. If
aspirated substances have entered the suction unit, it must be demolished. For Boscarol, the
safety of its employees and the staff of the authorised service centre is of paramount
importance. If the suction units are contaminated, they may not be dismantled according to
the WEEE (Waste Electrical and Electronic Equipment) directive, leading to a possible risk of
infection (application of international worker protection law, where applicable).
•
If you have any doubts before sending a device for repair, please contact Boscarol's technical
service department by sending an email to [email protected] or by calling [phone]
REUSE OF
DISPOSABLE
PARTS
•Caution: Reuse of disposable parts may impair the functionality of the suction unit and be a
direct or indirect source of contamination of the operator and patient.
•Sterilisation and/or cleaning of disposable parts (anti-bacterial filters, suction tubes, Yankauer
suction catheters, etc.) can cause structural damage such that they lose their mechanical
integrity.
SLA BATTERY
•Before using the suction unit for the first time (and/or after receiving it), charge the internal
battery for at least 16 consecutive hours.
•The suction unit has a special test function that shows the remaining battery charge.
•Recharge the suction unit immediately if only one or no LEDs light up.
•Leaving the device permanently connected to the vehicle power supply (12÷15 VDC) will not
damage it.
•The battery cannot be replaced by the operator.
3. IMPORTANT INFORMATION TO KNOW BEFORE USE
The suction unit has been designed and tested according to the latest legal and regulatory standards. If the suction
unit is connected to a non-compliant electrical system and/or if the connection work is not carried out by a
professional installer, both the suction unit and the electrical system may be damaged. Always consult a qualified
technician who is aware of all legal and regulatory aspects involved in the process.
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]

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PERIODIC SAFETY
INSPECTION
Preventive maintenance and periodic safety inspection:
The suction unit should be checked at least once a day (function check).
The
device should be checked at least once every 12 months by the authorised service
centre.
On the other hand, a safety inspection and technical maintenance must be carried out every
24 months from the date of manufacture of the device as indicated on the label. Please refer
to the manufacturer or to the authorised technical assistance centres for the scheduling of
the safety inspection. The periodic safety inspection is not part of the device's warranty.
Responsibility
of operators/users
•The OB1000 and OB1000 AVIO suction units are designed for emergency medical service
and must therefore be ready for use at any time and in any situation.
•Always ensure that the internal battery is sufficiently charged (press the test button).
•Immediately replace any components/parts that are damaged, altered or missing and/or
are suspected of malfunctioning of the suction unit. Always replace these parts with
original spare parts. The suction unit must be stored in a place inaccessible to children.
•Dispose of packaging in accordance with local regulations and ensure that it is out of the
reach of children.
Intervention
of the overflow
valve
WHAT TO DO IF THE OVERFLOW VALVE TRIPS?
•Wear protective gloves, splash goggles and an FFP2 or FFP3 type mask.
•Switch off the suction unit and disconnect the silicone tube from the secretion container
to the device.
•Check whether the level of aspirated liquids has reached the maximum level in the
secretion container.
•Carefully remove the secretion container and store it in a safe place.
•Empty the secretion container safely by first removing the filter (which must be
discarded), then the lid. Empty the secretion container and carry out thorough cleaning
and disinfection (sterilisation if necessary).
•Clean and disinfect the device according to these operating instructions
4. CONTRAINDICATIONS (DO NOT USE FOR)
CONTRAINDICATIONS
•Low vacuum values, e.g. chest drainage or wound drainage in general
•Permanent endoscopic use
•Surgical rooms where potential equalisation is required (e.g. operating theatres for
heart surgery)
•Outside the medical field
•Extraction of flammable, corrosive or explosive substances
•Suction in explosive environments
5. SIDE EFFECTS (POSSIBLE DURING SUCTION OPERATIONS)
EFFECTS
COLLATERAL
•Bleeding in general in the nasal pharyngeal area. Also throat and tongue.
•Damage to the vocal cords
•Cardiovascular instability
•Side effects caused by vagus nerve stimulation
•Tachycardia caused by stress
•Choking, nausea, vomiting and coughing
•Respiratory tract infection (typical of hospitals)
•Convulsions by patients who tend to have cramps
SIDE EFFECTS
Attention: To minimise side effects, it is important to observe what is indicated in these
operating instructions

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6. MEDICAL SUCTION UNITS OB1000 AND OB1000 AVIO
After receiving the device, make sure that all parts are present. All Boscarol suction units are assembled and ready for
use except for 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 Reusable 1000 ml jar of Boscarol secretions complete with overflow valve in the lid
01 Antibacterial filter complete with silicone tube
01 Sterile Yankauer catheter (unassembled)
01 Ready-made power cable for SELV voltage (12÷15 Vdc)
01 Operating instructions in Italian or specific language depending on the destination and technical documentation
Package contents for FM version
01 Complete suction unit
01 Reusable collection container complete with SERRES disposable liner already inserted in the jar of secretions
01 Sterile Yankauer catheter (unassembled)
01 Ready-made power cable for SELV voltage (12÷15 Vdc)
01 Operating instructions in Italian or specific language depending on the destination and technical documentation
Depending on the chosen configuration, the device can be equipped with the following accessories:
01 External mains power supply for supplying and charging the suction unit
01 Support bracket and 01 power supply complete with cable for connection to SELV voltage (12÷15 Vdc)
6.1. Description of the suction unit
OB1000 and OB1000 AVIO are medical suction units that comply with all relevant standards.
They can be used in motor vehicles (ambulances), in the field, in hospitals, clinics and for home treatment by trained
and/or medical personnel.
The suction unit units have an internal battery of the SLA type (Hermetic Lead Battery) which contains hazardous
substances; it is a battery consisting of lead and a sulphuric acid solution, so it cannot be opened, disassembled, cut or
recharged.
The OB1000 and OB1000 AVIO suction units are available in two basic versions: with a reusable jar or with a disposable
jar.
For available accessories and options, see the catalogue at www.boscarol.it or send an email to
[e-mail].
6.2. Controls, operation and control panel
All the controls for operating the device are located on the front panel to facilitate its use even when it is anchored to
the support bracket. To activate the device, simply press the switch (6), which is protected against the entry of liquids
OB1000 FA and OB1000 AVIO FA models with
reusable jar:
1. Suction unit
2. Autoclavable jar OB-J FA
3. Antibacterial filter
4. Angle connection (90°)
5. Silicone tube for filter connection.
OB1000 FM and OB1000 AVIO FM models
with disposable jar
1. Suction unit
2. Autoclavable jar OB-J
3. SERRES disposable bag
4. Connecting pipe with red angle
fitting

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and solids, splashing water and cleaning substances. The vacuum can be adjusted by turning the knob (2). By turning
the knob clockwise, the vacuum increases up to the maximum value that can be read on the analogue instrument (1)
expressed in millibars (mbar) or kilo-pascals (kPa) or, on request, also in millimetres of mercury (mmHg). The instrument
is fluorescent and is also visible in the dark. On the back of the device there are two contacts (9) which allow charging
and operation when fixed on the support bracket. The external charging cable can also be used to charge the device by
connecting it to the socket on the front of the device (8). The connector is sealed and has two electrical poles.
6.3. Indicator lights
On the front are the indicator lights (LEDs) that show the operation of the device (see figure above): the battery life (3-
4-5) and the charging phase in progress (7). All the indicator lights are located on the front panel and are easily visible
even with direct light on the device. The table below summarises the battery charge status based on the number of
LEDs lit:
SIGNAL
AUTONOMY FOR EFFICIENT BATTERY
Green LED on (3)
>70% maximum autonomy
Yellow LED on (4)
40-50% average autonomy
Orange LED on (5)
10-20% low autonomy (low battery, recharge immediately)
The charging indicator < ON/CHG> (7) on the figure above has two different colours: yellow indicates that charging is
in progress; green indicates that charging is complete. The indicator lights up whenever the device is connected for
charging. If the LED does not light up, it may indicate a malfunction of the internal charging circuit, lack of power supply
(12 VDC) or failure to connect the external cable to a 12 VDC power source.
VERY LOW BATTERY
The device will switch off immediately after the orange LED goes out, because the
battery is completely discharged.
FLAT BATTERY
Caution: a discharged battery will impair the operation of the device and therefore its use. It takes
approx. 15 hours to fully charge the battery. The suction unit can be left charging at all times. The
battery has a life of 2 years and is automatically replaced during the safety inspection.
Electrical
connections
Always check that the plug of the charging cable is correctly inserted into the cigarette lighter
socket: vehicle vibrations may cause the plug to come loose. Therefore, always check the charging
LED on the device: it remains yellow during charging and changes to green when charging is
complete.
6.4. Periodic testing of OB1000 and OB1000 AVIO suction units
In order to ensure proper functioning of the device, two types of periodic tests are foreseen:
the first should be on a daily basis to ensure the efficiency of the device, the absence of mechanical anomalies,
breakage of the external plastic casing and correct functioning
and the second half-yearly/annually to enable the full functionality of the device to be assessed and therefore
its compliance. These times should be reduced in case of heavy use, use in severe conditions and/or outside
the recommended limits.
The daily test allows you to check (quickly) whether the device is suitable for use in the field and includes functional
checks that can be completed in a maximum of 5 minutes.
9

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6.4.1. Daily periodic testing of OB1000 and OB1000 AVIO suction units
DAILY TEST
•Disconnect the device from the bracket or external charging cable.
•Place the device on a stable surface in an upright position so that the front is facing you.
•Press the ON-OFF button located next to the vacuum adjustment knob. If all the LEDs are lit,
the battery is charged (operating time: approx. 45÷60 minutes). If not, remember to charge the
suction unit.
•By pressing the switch located on the front panel, switch on the suction unit (OFF - off, ON -
on). The suction unit should operate smoothly and no change in the speed of the internal pump
should be heard. You should not hear any unusual noise and/or abnormal vibrations.
•Close the vacuum regulator completely (by turning it clockwise) and squeeze the silicone tubing
towards the secretion jar (before the filter for the reusable OB-J jar) or before the connection
to the jar if SERRES® disposable bags are used. The noise generated by the pump should change
and the reading on the vacuum gauge should reach the maximum value (approximately 800
mbar, 80 kPa, 600 mmHg) in a few seconds.
•While holding the tube, turn the vacuum regulator anti-clockwise and check the reading on the
instrument to ensure that the suction falls to almost 0 (40÷50 mbar due to the filter).
•Switch off the suction unit and turn it 180 degrees to check the electrical contacts on the back
of the suction unit (they must be clean and free of stains, oxidation and/or burns).
•Attach the device to the bracket. If the battery is discharged, charging will begin (charging
indicator <ON/CHG> yellow if charging in progress, green if charging is not necessary). If the
device is not equipped with a wall bracket and the battery is discharged, connect the external
power cable to the cigarette lighter or to the optional power supply and check that the charging
process starts (yellow LED lit = charging in progress; green LED lit = charging finished).
•Check that the filter is clean and not contaminated. If the filter is not white, it must be replaced.
A dirty filter prevents the suction unit from working properly and reduces its performance by
increasing the risk of contamination. Do not use the suction unit without a filter.
At the end of the test operations compare them with the values in the table below:
Test phase
Test result
Recommended action with negative outcome
Operating the autonomy
test
The LEDs on the front of the device
light up depending on the battery
charge.
If the LEDs do not light up, the battery is either completely flat
or faulty. Try recharging the battery with the external cable or
power supply or refer to the authorized service centre. During
these operations, exclude the device from its active service.
Checking pump operation
Uniform engine noise, no rpm
drops, no abnormal vibration
Uneven noise indicates a fault in the pump operation. A drop in
speed indicates insufficient current to operate the motor
correctly. C
ontact the authorised service centre or the
manufacturer.
Check for maximum
suction by occluding the
tubing from the filter or
disposable bag to the
device with your fingers
The maximum vacuum value that
can be read on the vacuum gauge
should be around 800 mbar ±10 %
(70 kPa to 80 kPa; 525 to 600
mmHg).
If this value is not reached, close the vacuum regulator
completely by turning the knob clockwise. Check that the
occlusion exerted on the tube is complete. If this is not the case,
do not use the device and contact the authorised service centre.
Setting the maximum
vacuum value
Value between approximately 0
and maximum by turning the knob
If the vacuum value cannot be adjusted, contact the authorised
service centre. Remove the device from use
Checking the rear charging
contacts
The contacts must be clean and
free of oxidation. There must be no
burn marks on the metal.
Clean the contacts with a cloth soaked in ethyl alcohol. If they
are badly burnt, they must be replaced. In this case, contact the
authorised service centre
If you fail one or more of the tests, even after performing the recommended actions, send the device
to the service department or the manufacturer for a complete check or overhaul.
6.4.2. Six-monthly/annual periodic testing of OB1000 and OB1000 AVIO suction units
This test is used to verify whether the device is fully compliant with the original manufacturing characteristics and
therefore suitable for use in the field. The checks and controls should be carried out by persons and/or companies
specialised in this type of operation on medical devices and must have been instructed/authorised by the manufacturer.
Following the inspection, an electrical safety test in accordance with IEC 60601-1 should be performed and a test
summary document made available to the user.

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SIX-
MONTHLY
OR
ANNUAL
TEST
•Replace the SERRES® disposable bag or antibacterial filter before performing these operations.
•Mechanical operation of the wall bracket: check that it is correctly fixed (to the wall of the vehicle),
that it works, and that the upper red plastic button slides (without any obstruction). 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 be altered, burnt or oxidised.
•Check the connection of the electrical cables to the bracket (they must be fixed).
•Carry out a complete check of the functionality of the suction unit: battery life, recharging function,
complete check of the LED functions (from maximum to minimum during battery discharge). Check
that the LEDs function as shown in chapter § 6.3 Indicator lights during charging.
•Check the operation of the internal pump by pressing the switch. The maximum vacuum value
must be between a minimum of 730 mbar and 880 mbar. Use a precision vacuum gauge to measure
this value (tolerance ±2.5 % or less). There should be no operational anomalies such as unusual
noise, rpm fluctuations, excessive gauge hand vibration and the operation of the vacuum regulator
knob should be linear and unimpeded: during operation, the device should be placed on a stable
surface to check the amount of vibration generated.
•
Check the vacuum regulator which should operate from minimum to maximum. Turn the knob
clockwise and anticlockwise. When the regulator is fully open, it is normal to measure a small
vacuum value (introduced by the antibacterial filter).
•Check the minimum operating time of the suction unit: switch it on and allow it to run in free-cycle
for at least 20 minutes. The suction unit should 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 (running mechanical parts).
•Check that all labels and screen prints are present and legible.
•Never open the suction unit for any reas
on. For technical assistance, contact only one of the
authorised service centres listed at the end of this manual.
•Check the function of the vacuum gauge. When the vacuum unit is switched off, the needle should
be at "0".
•Ensure that the carrying strap is functional, undamaged and not torn. The nylon hook of the strap
must be closed.
•Check that the secretion jar is intact and that there are no cracks or breaks that could impair
aspiration.
•Check the screws of the two steel plates fixed to the rear side of the device in order to be able to
securely attach it to the support bracket.
•Before declaring the suction uni
t compliant with the manufacturer's data plate, carry out an
electrical safety test according to IEC60601-1 with a specific safety analyser.
Contact the
manufacturer or the authorised service centre for information on how to carry out this test.
DEVICE
COMPLIANCE
Only use consumable or spare parts supplied by the manufacturer. Do not use similar or apparently
identical components. The conformity of the component can only be confirmed by the manufacturer.
Keep a document confirming that all checks have been carried out and, if possible, a photographic
report on the condition of the device before and after the check. Always also keep a copy of the safety
report carried out with the appropriate calibrated instrument.
OPERATION
In accordance with ISO 10079-1:2019, the device can only be operated in a vertical position and at an
angle of inclination not exceeding 20 degrees. If this limit is exceeded, the overflow valve may
intervene and block the suction.
If you have any doubts or concerns regarding the conduct of the tests, please always contact the manufacturer of the
device or its authorised service centre. If you fail even a single test, please contact a service centre or the manufacturer.
Do not use the device if you have not passed all tests.
For further information please call 0471 932893 or send an e-mail to [e-mail].

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6.5. Periodic safety maintenance
Depending on the use of the device, the OB1000 and OB1000 AVIO suction units should be checked at least every 24
months, even if not in use. Some parts inside the unit, e.g. the battery and the filter, may be adversely affected by a
long period of inactivity. Periodic maintenance includes specific maintenance, overhaul and updating of the unit. If
periodic maintenance is not performed, the life of the device will be reduced.
6.6. Safety information for the safety of users, patients and third parties
To avoid unwanted effects and risks, always follow the information below:
•Ensure that all accessories are in working order and replace any defective external power supply or cables. Do not
take unnecessary risks: always replace defective parts to ensure that the device is always efficient in use and
especially in emergencies.
•Always keep the device secured to the support bracket (in emergency vehicles) during transport to avoid injury to
the user and the patient.
•Even if you do not use the device, recharge the battery at least once a month.
•We recommend another suction unit in case this one does not work or is defective (e.g. manual suction unit).
•Always remember what is stated in the initial warnings regarding the risks of magnetic field (EMC) effects.
•Always select the appropriate level of vacuum according to the patient and medical guidelines.
•Do not alter or modify the medical device. Serious consequences for the patient and the user may occur.
•OB1000 and OB1000 AVIO suction units are not sterile devices and cannot be sterilised with the exception of the
secretion jar and silicone tubing.
•Keep children away from hoses and connecting cables. Also keep them away from small parts.
Risk of infection
•Improper use of the device can lead to transmission of infections, even fatal ones.
•Always wear disposable gloves, especially if there is a risk of coming into contact with aspirated secretions.
•Never use components marked as disposable more than once. Disposable parts or medical devices are
marked as in the figure opposite (number 2 crossed out).
•Never use the device without the bacterial filter.
•Always disconnect the unit from the power supply, bracket or SELV source before performing cleaning and
disinfection processes.
•Only use the power supply unit indoors and in a dry environment. Do not use the power supply outdoors!
•Always use only original accessories and original spare parts.
Attention
Assembly, repairs and modifications to the device are prohibited and may only be carried out
by the manufacturer or authorised personnel.
7. SECRETION JARS FOR OB1000 AND OB1000 AVIO
The device is marketed with two different types of jars with a capacity of 1000 ml:
•Suction unit with autoclavable secretion jar (OB1000 and OB1000 AVIO FA).
•Suction unit with secretion jar equipped with disposable bag (OB1000 and OB1000 AVIO FM)
7.1. Autoclavable secretion collection jar OB-J FA
The jar is made of transparent plastic (medical-grade polypropylene). It includes
the jar (1), the snap-on lid (2), the anti-reflux valve (3) and the 90° plastic
connection (4). The jar lid allows direct insertion of the antibacterial filter (from
the outside). The autoclavable jar can be sterilised conventionally in a steam
autoclave at a maximum temperature of 121° C and a pressure of 2 bar (200 kPa).
The jar must be replaced if it is deformed, broken or cracked. The secretion jar
must be used vertically to prevent the anti-reflux valve from tripping. If the anti-
reflux valve is triggered, switch off the device and disconnect the tube connected
to the suction unit, remove the antibacterial filter to rebalance the pressure
inside the jar.

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Service life of OB-J FA secretion jar
The jar of secretions must be replaced after 30 sterilisation cycles or
5 years from the date of manufacture.
7.2. Antibacterial filter
The protective filter protects the suction circuit from any contaminants sucked
in during use. The filter is manufactured from hydrophobic PTFE material which
prevents fluids from entering the pneumatic circuit. Working in conjunction
with the overflow valve on the jar, the filter isolates the pneumatic suction
pump from gases and fluids. The filter is disposable and must be replaced after
each use
. In the event of contamination, discolouration and increased suction
resistance, it must always be replaced. The filter is not produced by the Boscarol
company.
Antibacterial
filter
If the device is used on patients where the infection status is unknown, always replace the filter
after use on the same patient. This will prevent even serious contamination of the environment
in which the device is placed and therefore of operators and patients. If, on the other hand, it is
known and/or there is no risk of indirect contamination, it is advisable to replace the filter after
each work shift or in any case when the suction level decreases or the filter changes colour.
Risk of infection
•Never use the device without the antibacterial filter. Please always keep at least three spare
filters in case of emergency.
•Always wear gloves and personal protective equipment when changing the antibacterial filter
and emptying the secretion jars.
•
Before each use, check that the filter is dry and clean (it must not be any colour other than
white). Replace the wet or contaminated filter with a new one.
•Never reuse the antibacterial filter (disposable).
7.3. OB-J LINER: jar of secretions for SERRES® disposable bags
The OB-J secretion jar for SERRES® disposable bags is made of transparent plastic
(medical grade polypropylene). It comprises a container (1), a SERRES® disposable bag
adapter (2), a red 90 degree connector (3) and a SERRES® disposable bag (4). The
antibacterial filter is integrated in the lid of the disposable bag and prevents aspirated
fluids from entering the suction unit. The secretion jar
can be sterilised in a
conventional steam autoclave at a maximum temperature of 121° C and a pressure of
2 bar (200 kPa). The disposable bag must be replaced after use on the same patient or
if it is full.
When used in a domestic environment, the jar of secretions can be cleaned using a
special detergent to ensure disinfection of medical devices. Contact Boscarol for
information on disinfectants.
Risk of infection
• Please always keep at least three ® SERRES bags in reserve.
•
Always wear gloves and personal protective equipment when changing the SERRES® bag and
for disposal.
•Before each use, check that the SERRES® container has not already been used.
•Always replace the contaminated disposable bag with a new one.

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17- 36
7.4. Secrets jar connection
The secretion jar is connected to the aspiration unit via a silicone tube
and a plastic connector (white for the FA version (Fig.1); red and 90°
for the FM version (Fig.2))
. Insert the connector into the device as
shown in the adjacent image. Do not force the insertion. This
operation is valid for both types of secretion jar.
7.5. Sterile disposable Yankauer catheter with suction control system
The OB1000 and OB1000 AVIO suction units are sold complete with a sterile Yankauer-
type suction catheter and tubing for connection to the jar. The suction probe and
catheter are disposable and must be changed after each use. To facilitate correct
functioning, the tip of the rigid suction probe is angled so that it can reach all parts of
the mouth and upper airway. The rigid suction tip is spherical and equipped with lateral
holes to avoid damage to tissue during suction.
Yankauer
The Yankauer suction catheter is a sterile, single-use medical device. Never reuse this
device. It must be disposed of after use on the patient.
Caution! Never use sterile medical devices beyond their expiry date or if the packaging is
damaged.
Always connect the Yankauer catheter to the "PATIENT" side on the lid of the reusable jar (FA) or
SERRES® disposable bag via the white conical fitting.
7.6. Silicone suction tube and sterile Fingertip (conical fitting)
On request, the device can be equipped with a silicone patient tube
(length: 130 cm) and a sterile conical Fingertip fitting that allows the use of
standard sterile catheters of an appropriate size. The tube is reusable.
The sterile Fingertip connection allows fingertip control of the suction
value by closing and opening the prepared hole. The disposable devices
supplied with the suction unit are identified with labels that provide all the
necessary information for correct use.
The Fingertip (also called catheter connector) allows
you to attach standard sterile catheters (see figure
opposite).
7.7. Warnings concerning the re-use of single-use parts
Disposable
medical devices
Risk of infection
Caution: The suction unit is supplied with a number of sterile disposable accessories to facilitate
patient aspiration. These devices may not be used on more than one patient. Disposable medical
devices are made of materials to withstand limited use and must not be reused. The operator
must dispose of them properly and restore the medical device to make it efficient for the next
use. Re-use of single use devices can be dangerous for both patient and operator and
can cause loss of performance by damaging the device irreparably.
SERRES®
disposable bag
The SERRES® disposable bag cannot and should not be emptied. The top cap is designed to
allow the extraction of secretion samples for laboratory analysis. Whenever the filter comes into
contact with fluids or liquids (of any kind), it is blocked and the bag must be replaced!
Fig.1
Fig. 2

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18- 36
8. REUSE, CLEANING AND DISINFECTION
After each use, disconnect the suction unit, disconnect the disposable parts and dispose of them. Check the integrity of
the suction unit, the connection tube and check that there are no 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 chapter §"6.4 Periodic test OB1000 and OB1000 AVIO" for the
daily test. The decontamination process is always a process to be followed meticulously, which implies specific training,
especially in medical emergencies where the medical condition of the patient and the degree of contamination are
mostly unknown. For this reason, the operator must always wear personal protective equipment (PPE) to protect
themselves and others. If PPE is not available, please contact your safety representative.
Risk of infection
Always wear gloves and personal protective equipment when changing
the antibacterial filter and emptying the secretion jars.
DANGER
Organic secretions collected in the suction unit jar can cause serious infections to the operator.
For this reason, always use PPE and disinfectants as recommended by the industry and
competent authorities.
8.1. Re-use of OB-J FA secretion jar
The steps required to separate the jar of secretions from the suction unit, disassemble it and assemble it after cleaning
and disinfection are described below. Before starting, wear protective gloves, also covering your forearms, mouth and
protecting your eyes.
Remove the patient tube together with the yellow 90 degree connector. The
Yankauer catheter should be disposed of together with the curved tip
(sterile disposable devices). Do not dispose of the yellow 90-degree
connector, which can be sterilised and reused.
Disconnect the conical fitting from the suction unit.
Open the strap on the side of the bag
Pull the secretion jar vertically out of the suction unit.
Remove the antibacterial filter from the cover by turning it on its seat and
discard it.

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19- 36
Remove the lid from the jar by pressing lightly on the jar and levering the lid
flap. Empty the contents of the jar.
Remove the overflow valve from the lid.
Separate all the parts.
Parts making up the lid:
•Polypropylene cage yellow
•Polypropylene float, yellow
•Red silicone gasket
•Red polypropylene lid
DANGER
Risk of infection due to leakage of potentially contaminated substances during emptying of
secretions. Possible transmission of life threatening
infections. Always use suitable PPE and
disinfectants as stipulated by hospital regulations and the relevant authorities.
Beware of certain disinfectants that may stain the jar of secretions and its parts even without
damaging it.
8.2. Cleaning, disinfection and/or sterilisation of OB-J FA secretion jar and silicone tube
The secretion jar and the silicone tube can be cleaned with specific non-abrasive substances for cleaning medical
devices. Alcohol-based cleaning agents can be used if diluted appropriately (follow the instructions for use on the label
of the disinfectants). Avoid using coloured disinfectants as they may stain the plastic of the jar and the silicone tube,
reducing its transparency. After disposing of the disposable antibacterial filter and Yankauer suction catheter, complete
with tubing, place the reusable parts in warm water (temperature not exceeding 60°C to avoid scalding) containing a
diluted disinfectant for medical devices. Rinse thoroughly and, if necessary, use a non-abrasive brush to remove any
deposits. After washing, dry all parts. Refer to the cleaning and disinfection plan on the following pages. In the event of
serious contamination, always refer to the instructions of health care personnel and the competent authorities. If
necessary, sterilize "REUSABLE PARTS" (see above) with steam autoclaves at a maximum temperature of 121°C for a
maximum of 15-20 minutes (typical cycle). Do not use autoclaves with pressures above 2 bar (200 kPa). The jar should
be placed upright and inverted. At the end of the cycle, allow the parts to cool to room temperature and check that
they are undamaged and not deformed.
CYCLE OF
DISINFECTION
WARNINGS
•Do not spray liquids onto the device. Clean the device with the suction inlet closed. Place a
piece of tape or leave the secretion jar connected to the unit.
•Do not use aldehyde and/or amine-based disinfectants to prevent discolouration.
•Use only disinfectants for cleaning medical devices. Before applying them to the surface of
the device and the secretion jar, check at an angle for damage.
•Consult specialised personnel in hospitals and clinics. Check for specific disinfection and
cleaning plans and/or protocols for the area concerned.

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STERILISATION
CYCLE
WARNINGS
•Never sterilise devices or parts that have not been previously cleaned.
•Do not place any weight on the parts or devices during the sterilisation cycle.
•Observe the maximum limits for temperature, pressure and sterilisation time (temperature:
121° C, pressure: 200 kPa, maximum time 15-20 minutes).
•Cleaning and/or sterilisation should only be carried out by qualified personnel.
•Replace the jar of secretion if it is cracked, fissured or even partially broken.
•After reassembling the jar, always check that the lid is fitted correctly to avoid loss of vacuum
and spillage of liquids or aspirated fluids.
•Always follow the instructions provided by the autoclave manufacturer.
8.3. Jar assembly and connection of the silicone suction tube
Place all jar components on a flat, stable surface. During assembly and disassembly, always check all parts for damage
or deformation. The overfill valve has a float that slides on a plastic cage. Ensure that it moves inside unhindered (by
sliding it) and that the red silicone gasket is intact. Assemble the jar by proceeding in the opposite direction to that seen
above.
AFTER
CLEANING
Warning
•Check after each cleaning if the device and its parts are functional.
•
If in doubt, send the device to the manufacturer or an authorised centre for review and
inspection.
•After the assembly process, always perform a function check as described in chapter § 6.4
Periodic test OB1000 and OB1000 AVIO of these operating instructions.
•Prepare the device for the next use.
8.4. Replacing the antibacterial filter
Carefully disconnect the silicone tube from the contaminated
filter. To easily remove the filter from the lid, proceed by screwing
and/or unscrewing it from its housing. This facilitates removal
from the lid and prevents it from breaking inside! Dispose of the
filter in accordance with local regulations for the disposal of
hospital waste.
Depending on our stock availability, we can supply two different
types of anti-bacterial filter: one has the inscription "IN" on the
side which must be connected to the vacuum socket on the lid.
The second one has a side with the inscription "PATIENT". Connect
this side to the "VACUUM" socket on the lid.
Failure to observe this detail may result in filter failure and
contamination of the suction unit's suction circuit.
ANTIBACTERIAL
FILTER
Attention
The filter must be inserted with the side marked "IN" or "PATIENT" facing the jar lid. Using the
suction unit with the filter inserted incorrectly may lead to contamination of the suction circuit.
8.5. Cleaning the secretion jar with SERRES® disposable bags
The OB-J Liner jar of secretions is equipped with a specific SERRES® disposable bag, which is certified for this type of
use. Unlike the OB-J FA version, the antibacterial filter is located inside the bag and is automatically replaced after each
bag change.
Inscription
PATIENT"