Boscarol OB 2012 FA, OB 2012 LINER User Manual

Rev. 08-2016 USMAN2012 - EN

MEDICAL SUCTION UNIT

OB2012 FA

OB2012 LINER

USER MANUAL

MANUFACTURED BY:

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INDEX

SYMBOLS ............................................................................................................................................................................. 4

WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION ........................................................................................... 6

IMPORTANT INFORMATION ............................................................................................................................................... 7

OB2012 SUCTION UNIT ....................................................................................................................................................... 8

□ DESCRIPTION AND INTENDED USE STATEMENT.................................................................................................... 8

□ CONTRA INDICATION FOR USE .............................................................................................................................. 8

□ CONTROLS, INDICATIONS AND CHECK PANEL ....................................................................................................... 8

□ INDICATOR LIGHTS................................................................................................................................................. 9

□ UNIT TESTING ........................................................................................................................................................ 9

□ COLLECTION JAR .................................................................................................................................................. 10

□ OB-J FA COLLECTION JAR................................................................................................................................. 10

□ PROTECTION FILTER ........................................................................................................................................ 10

□ OB-J COLLECTION JAR WITH SERRES DISPOSABLE LINER ................................................................................ 11

□ JANKAUER SUCTION TUBE AND FINGER-TYP END-PIECE..................................................................................... 11

□ ACCESSORIES & OPTIONALS ................................................................................................................................ 12

□ CHECKING THE BATTERY ...................................................................................................................................... 12

REUSE, SCHEDULED MAINTENANCE AND DISPOSAL ........................................................................................................ 12

□ AFTER EACH REUSE .............................................................................................................................................. 12

□ REUSABLE COLLECTION JAR OB-J FA ................................................................................................................... 13

□ DECONTAMINATION/STERILISATION OF THE COLLECTION JAR .......................................................................... 14

□ REPLACING THE PROTECTION FILTER .................................................................................................................. 14

□ REUSABLE COLLECTION JAR OB-J......................................................................................................................... 14

□ DISPOSAL OF CONTAMINATED PARTS ................................................................................................................. 15

□ CLEANING THE SUCTION UNIT ............................................................................................................................. 15

□ SUCTION UNIT SAFETY ......................................................................................................................................... 16

□ DISPOSING OF THE SUCTION UNIT ...................................................................................................................... 16

ACCESSORIES, CONSUMABLES AND SPARE PARTS ........................................................................................................... 17

TECHNICAL SERVICE .......................................................................................................................................................... 18

TROUBLESHOOTING ......................................................................................................................................................... 18

TECHNICAL DATA AND CONFORMITY TO INTERNATIONAL LAW ...................................................................................... 19

THE RISKS OF RECIPROCAL INTERFERENCE WITH OTHER DEVICES .............................................................................. 21

RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES ..................................................................... 21

GUARANTEE ...................................................................................................................................................................... 24

DECLARATION OF CONFORMITY ....................................................................................................................................... 25

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SYMBOLS

S.1 Symbols used on the device and recalled in the user manual

Double insulation. The device is doubly electrically isolated from the user and the work
environment (there is no ground conductor or connection equipotential point).

Applied part type BF

Only use the device in the indicated temperature range. The use of the OB2012 outside these
limits might hinder its operation, reduce battery autonomy and make internal security
intervene.

Read the user manual

The accessories and/or consumables of the device, which show this symbol, are disposable.
After use, they must be disposed of and replaced with another product.

Specific warnings regarding the device, which must always be taken into consideration.

CE mark perform to the MDD 93/42/EEC for Medical devices with class above I

Device homologated under the ECE-R10 International Regulation

Manufacturer

Production date

The device contains electrical and/or electronic equipment that must be recycled per EC
Directive 2012/19/EC – Waste Electrical and Electronic Equipment (WEEE)

Electric and magnetic fields generated by radiographic or tomographic equipment, portable
radio equipment, RF radio and devices marked by the symbol on the side might have an impact
on the proper operation of the device. In these cases the device should not be used or a proper
distance should be kept from this equipment.

The materials composing the device can be recycled following specific procedures provided by
national laws and local regulations.

The device complies to the European Directive 2011/65/UE (RoHS)

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Authorized Representative in the European Community, if the manufacturer is not resident
therein.

Expiration date

Do not use if the packaging is not intact

Catalogue ID code

Sterile device. Sterilization method: ethylene oxide

Sterile device. Sterilization method: ionizing radiation

Production batch number

Serial number

S.2 Symbols used in the user manual to recall the reader’s attention

Important safety information to avoid the risk of injury to the user or patient and / or damage
to the device

Information to which you should pay special attention

Note or information for correct use of device

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WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION

Read carefully

This User Manual has been prepared using simple, easy-to-understand language. If you have difficulty
interpreting the above, contact the manufacturer for further clarification

 Read all instructions carefully before using the unit. Careful, proper use will ensure smooth operation and protect

both patients and operators alike.

 The unit is designed exclusively to remove non-flammable organic fluids (secretions) during medical procedures.

For this reason, it should only be used by duly trained personnel.

 Never use the suction unit in the presence of flammable and/or explosive liquids, gases and mixtures as this could

lead to explosion and/or fire.

 Using the suction unit under environmental conditions other than those indicated herein can seriously compromise

function and modify its technical parameters (e.g. the maximum suction value or battery life).

 If suction is performed without the collection jar and/or filter in place, or if you suspect that substances may have

entered the suction circuit (i.e. inside the suction unit), immediately contact the nearest service centre or the
manufacturer to have the unit serviced.

 Before cleaning the unit or proceeding with any maintenance, unplug the unit from the external power supply. Do

not submerge in liquids as this could damage the suction unit and cause the safety devices to cut in.

 The unit does not require any maintenance on the operator’s part. The only operations authorized are those listed

herein. For technical support, periodic overhaul and any repairs that may be needed, contact your authorized
service centre.

 The manufacturer provides authorized personnel — who have taken a specific technical assistance training course

— with the documentation necessary to carry out the work (service manual).

 To ensure patient safety, precision of the displayed values and proper unit function, use only original spare parts.

By failing to comply with this warning, the operator assumes responsibility for any patient injury or property
damage.

 Do not use any batteries except those approved by the manufacturer.

 Do not make any mechanical and/or electrical modifications to the wall/charging bracket. Replacing any parts

thereof, and/or modifying the bracket itself, can seriously affect unit anchoring.

 The OB2012 suction unit does not perform any clinical diagnostics on the patient.
 Il dispositivo non può essere utilizzato per assistere pazienti durante indagini attraverso RMN (risonanza magnetica

nucleare).

□ BATTERY

 Before using the suction unit for the first time (and/or upon receiving it), charge the internal battery for at least 24

consecutive hours.

 Keep the device under load even when not in using. Remaining plugged into the vehicle power supply (12 ÷ 15 VDC)

does not damage the suction unit, but allows maximum autonomy of the battery.

 Failure to regularly recharge the battery will lead to a ‘deep discharge’ at which time the battery will need to be

replaced.

□ WARNING ON REUSE OF DISPOSABLE PARTS

 Reuse of disposable parts may compromise the suction unit function and be direct or indirect source of operator

and patient contamination.

 Sterilization and/or cleaning of disposable parts (antibacterial filters, suction tubes, Yankauer suction catheters, etc.)

can cause structural damage leading to the risks of lost mechanical integrity.

Tel.: [phone]

[e-mail]
[e-mail]

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IMPORTANT INFORMATION

Note:

The suction unit was designed and tested according to the latest regulatory standards. If the suction unit
is hooked up to a non-compliant electrical system and/or if the work is not performed by professional
installer, both the suction unit and the electrical system could be damaged. Always consult a qualified
technician with knowledge of the latest requirements!

Preventive maintenance and safety inspection:

The device should be checked at least once every 12 months from the authorized service center. Every 24
months an inspection of safety and technical maintenance is required instead. Refer to authorized service
centers for planning of inspection. The periodic safety inspection of the device does not fall under
warranty.

Contamination:

Sending a contaminated suction unit to the manufacturer, installer or service centre is strictly forbidden.
Any device received in such condition will be rejected and health authorities notified of possible
contamination. Here the term contaminated means a suction unit that has not been cleaned of the
secretions aspirated from the patient. If the substances aspirated have entered the suction unit, it must
be discarded. For Oscar Boscarol srl, the safety of its employees and authorized service centre staff is
important. The suction units will not be demolished according to the WEEE Directive (Waste Electrical and
Electronic Equipment) if the suction unit is contaminated and there is the risk of infection (application of
It. Legislative Decree 81).

□ Operator responsibilities

 The OB2012 suction unit is designed for emergency health services and must therefore be ready for use at any

time and in any situation.

 Always make certain that the internal battery is sufficiently charged.
 Immediately replace any components/parts that are damaged, altered or missing, and/or for which a unit

malfunction is suspected. Always replace such parts with original spares. The suction unit should be stored in
a place inaccessible to children.

 Dispose of packaging in accordance with current regulations and make certain that it is out of the reach of

children.

 Read these instructions carefully before using the suction unit. Careful, proper use will ensure smooth

operation and protect both patients and operators alike.

 Operate the suction unit only in compliance with the technical specifications laid out by the manufacturer in

this manual.

□ Intended Use

 The suction unit can be used on all types of patients following the correct medical technique.
 The suction unit is designed to clear the upper airways. Clearing the lower respiratory tract is to be performed

by medical and/or health care professionals trained and authorized to perform this function.

 In some countries, this information must be verified according to the protocols implemented by the local

emergency medical services.

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OB2012 SUCTION UNIT

INSPECT THE SUCTIN UNIT AND ALL OF ITS PARTS BEFORE USING.

DO NOT USE THE DEVICE IF IT HAS DAMAGED OR MISSING PARTS.

NOTE

For accessories and options available, see the catalogue at www.boscarol.it or send an email to

[e-mail].

□ Description and intended use statement

The OB2012 is a portable electrical medical suction device designed to remove fluids and substances obstructing the
upper airways and restore spontaneous and/or assisted respiration. High vacuum is normally used for oropharyngeal
tract suction while low vacuum values are used for tracheal suction and/or applications in children and infants. The
device can be used in emergency health services, first aid, home care and in hospitals and/or mobile medical units. The
device comes with a carrying/storage bag. The unit is designed to meet the classification for “HIGH VACUUM – HIGH
FLOW” medical suction equipment (see ISO10079-1).

□ Contra indication for use

Do not use the OB2012 for thorax drainage.

□ Controls, indications and check panel

All controls are on the front of the suction unit. The unit can be controlled when fitted on the wall-bracket or in the
carrying bag.
To activate the device, press the switch (4), which is protected against infiltration of moisture, splashing of water and
other cleansers. Vacuum can be adjusted by turning the knob (5). Turning the control knob clockwise increases the
vacuum. The vacuum produced by the internal pump can be read on the analogue vacuum gauge (1) and is expressed
in millibars (mbar) and kilo-pascals (kPa) or millimetres of mercury (mmHg). The vacuum gauge is fluorescent and can
be seen in the dark. On the back are two contacts (7) that allow the charging of the device if fitted on the wall bracket.
Alternatively, you can use the charging cable plugged into the external 3-pin connector (6) on the side of device.

Model BSU150:

1. Suction unit

2. OB-J FA jar

3. Protection filter

4. 90° plastic joint

5. Silicone tube for filter connection

6. Conical connector

Model BSU100:

1. Suction unit

2. OB-J jar

3. 90° plastic joint

4. Disposable bag SERRES

5. Conical connector

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□ Indicator lights

All lights are placed on the front and display the operation of the device (see Fig1): 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:

LEDS STATUS

BATTERY POWER LEVEL

4 LEDS on

>80% maximum power

3 LEDS on

50-75% of the maximum power

2 LEDS on

20-40% of the maximum power

1 LED on

<20% battery low – the suction unit twill shut down soon

The indicator for charging <ON/CHG> (2), placed next to the indicators of autonomy, 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.

WARNING

Always check that the plug is inserted correctly into the cigarette lighter: vehicle vibration could cause it
to come out. To ensure this, check the <ON/CHG> LED: it should be on, both during charging and once
charging has been completed!
A low battery compromises suction unit function, and thus its use. It’s always necessary to recharge the
battery after each use. The suction unit can be left steadily plugged into the charge. The battery has a 2­year life and is automatically replaced during the safety inspection. The battery cannot be replaced by the
user (contact your authorized service centre).

□ Unit testing

The test should be performed daily, to ensure that the suction unit is in good working order, there are no anomalies
and/or casing breakage and that the unit is functioning properly.

Daily test

This test lets you quickly check whether the suction unit is fit for use in the field; it involves functional tests that take no
more than 5 minutes.

 Disconnect the unit from the wall bracket or from the external charging cable;
 Set the unit on a stable surface in the upright position so the front is facing you. Do not withdraw the unit from its

carrying/storage bag;

 Turn on the unit with the switch on the front panel. The suction unit should run smoothly and you should not note

any fluctuation in the external pump rpm. You should not hear any unusual noise and/or sharp vibrations;

 Check the indicator lights for battery power (when the battery is fully charged, all of the lights will be on);
 Completely close the vacuum regulator (turning it clockwise) and, with your finger, plug the transparent silicone

tubing running from the filter or disposable bag to the container. The sound of the pump should change and the

4

5

7

6 3 2

1

Fig.1

Fig.2

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reading on the vacuum gauge should reach maximum value (about -800 mbar, -80 kPa, -600 mmHg) in a few
seconds.;

 While keeping your finger over the silicone tubing, turn the vacuum regulator counter-clockwise and check the

reading on the instrument to ensure that suction drops to nearly 0 (40-50 mbar);

 Turn off the suction unit and turn it 180° to check the contacts on the back side of the unit (they must be clean and

free of stains, oxidation and/or burns);

 Plug the external power supply cable into the cigarette lighter or optional adapter and check that the charging

process starts (orange LED is on).

When finished, compare the results of this test with the value on the table below:

Test – phase

Result

Recommended action in case of test failure

Start battery life test

The yellow LEDs go on according to the
battery charge (1 to four LEDs).

If the LEDs do not go on, the battery is fully discharged or
faulty. Try charging the battery with the external cable or
adapter. During these operations, bypass active suction
unit operation.

Check pump operation

Noise emitted by the motor is smooth,
rpm does not drop and there are no
abnormal vibrations

Uneven noise means that the pump is not operating
normally. A drop in rpm indicates that the current is
inadequate and the motor cannot run properly. Contact
an authorized service centre or the manufacturer

Check the maximum vacuum.

Value range between 700 and 800 mbar
(70 kPa ÷ 80 kPa; 525 ÷ 600 mmHg).

Check that the lid on the collection jar is tight and that all
connections are secure. Change the disposable liner.

Check the vacuum regulation.

Gauge reading ranges from maximum to
minimum (800÷30 mbar)

Check the vacuum connections and/or the regulator (anti­clockwise for minimum vacuum).

WARNING

In the event of continued problems after taking the action outlined above, send the unit to an
authorised service centre for service or repair.

□ Collection jar

The device is sold with two different types of jar with a capacity of 1000ml:

- reusable, autoclavable jar (OB2012FA)

- reusable, autoclavable jar with disposable 1000ml Liner (OB2012 LINER).

□ OB-J FA collection jar

The device is sold with a reusable jar OB-J FA (Fig. 3). The jar is made of transparent
plastic material (polyprophilen). It includes pot (1), cover (2), the shut-off valve (3) and
the 90° plastic pipe (4). The lid of the jar provides the direct inclusion of the protection
filter.

The jar can be sterilized in an autoclave (max. pressure 2 bar(g) and maximum
temperature 121°C) for a maximum of 15 minutes. It is strongly recommended that
the collection jar is replaced after 30 autoclave cycles. The jar must always be used
in the upright position, to avoid the intervention of shut-off valve. Should this occur,
switch the device off and disconnect the patient tube (‘VACUUM’ marked on the lid).

When used in a home environment, the jar can be cleaned using a special cleanser
able to guarantee medical device disinfection. The aspirated secretions must be disposed of in compliance with medical
doctrine, i.e. as prescribed by the physician according to the patient's medical condition.

□ Protection filter

The filter protects the suction circuit against contaminants aspirated during use. It is made of a
hydrophobic material and prevents the passage of any atomized fluids and aerosols, thus preventing
their uptake (complete absence of patient side suction).

Fig.3

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In case of possible contamination, discolouration and increased resistance to suction replace the filter.

Warnings and precautions on the use of protection filter

If the suction unit is used on a patient whose medical condition is not known, always replace the filter
after use. This will prevent contamination, even serious contamination, of the operating environment,

operator and patient. If, instead, the patient's medical condition is known and/or there is no danger of
cross contamination, we recommend replacing the filter after each shift or when the filter turns dark.

If the suction unit remains unused, it is advisable to replace the filter once a month. The material used in
its construction could even be damaged by particular environmental conditions (humidity, heat, cold).

Do not use the suction unit without the protection filter or jar!

□ OB-J collection jar with SERRES disposable liner

The OB-J jar for SERRES disposable liners (see Fig. 4) is made of a specific transparent plastic. It
includes a canister (1), adaptor for SERRES disposable liners (2), "L" connector (3) and disposable
liner (4). The filter integrated into the liner prevents aspirated fluids from flowing back into the
suction unit when it is completely full.
The jar can be sterilized in a conventional steam autoclave at a maximum temperature of 121 °C and
pressure of 2 bar (200kPa). The disposable liner must be replaced after use on a given patient.

When used in a home environment, the jar can be cleaned using a special cleanser able to guarantee
medical device disinfection. The disposable liner can never be emptied and reused. The liner
containing the aspirated secretions must be disposed of in compliance with medical doctrine, i.e. as
prescribed by the physician according to the patient's medical condition.

□ Jankauer suction tube and Finger-typ end-piece

The suction unit is sold complete with a sterile, Yankauer-type suction catheter and tubing for
connection to the jar. The suction tip and catheter are disposable and must be changed after
each use. To facilitate correct operation, the rigid suction tip is angled so it can reach all parts
of the mouth and upper airways.

Upon request, the suction unit can be outfit with a silicone
patient tubing (length: 130 cm) and one sterile Finger-tip joint so that sterile suction tips
of varying size can be connected. The finger-tip joint allows the user to control vacuum
directly with a finger, without requiring any commands. The silicone tubing can be

sterilised while the finger-tip joint is, instead, disposable.
The disposable devices supplied with the medical suction unit bear labels providing all information needed for proper
use.

Warning! Do not use sterile medical devices beyond their expiration date or if the package is damaged.

WARNING ON REUSE OF DISPOSABLE MEDICAL DEVICES

The suction unit comes with some sterile accessories that facilitate patient suction. Such devices are "DISPOSABLE" and
therefore cannot be used on different patients.

The disposable medical devices are made to withstand limited use and cannot be reused. Therefore, once used on a
patient, the operator must properly discard them and reset the suction unit with new accessories. Reuse of such devices
can be dangerous for both patient and operator.

The disposable liner cannot and must not be emptied. The upper cap is arranged so that secretion samples can be
taken for laboratory tests. Each time the filter comes into contact with fluids (of any nature), it is blocked and must be
replaced!

Fig.4

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□ Accessories & Optionals

The suction unit has a rechargeable internal battery (which cannot be replaced by the operator). The maximum battery
charging time (depending on residual charge) is about 15 consecutive hours. A fully charged battery will provide
approximately 45-60 minutes of continuous operation (at open flow). This time may also vary, even considerably, if the
suction unit is used outside of the parameters recommended by the manufacturer (e.g. when used in the presence of
very high or very low temperatures).
When properly charged, average battery life is 24 months. After this period, we recommend replacing the battery.
If the unit is not used for a long time, run a complete check and fully charge the battery every 15 days.
The suction unit can be charged using the cable (supplied), the wall bracket or optional adapter (100–230 Vac).
The charging cable must be connected to a 12–15 Vdc power supply that can provide at least 6A.

CAUTION

Check that the external 11–24 Vdc power supply is protected by a fuse rated at least 15A (time-delay).
Request such protection from the manufacturer if necessary.

The adapter is an exclusive accessory, available only from the manufacturer. It is approved for such function and cannot
be replaced with other brands. It can only be used indoors and on a power supply compliant with the law. The medical
suction unit can only be used with this adapter.

WARNING

Never tamper with and/or open the adapter. Danger of death. The adapter contains internal electronics
subject to line voltages that can be fatal.

□ Checking the battery

To verify and monitor the autonomy of battery and / or in case of suspicion of revocation of the same, do the following:

 Charge the device for at least 15 consecutive hours;
 set the maximum value of vacuum closing the vacuum regulator (clockwise);
 let the unit run without closing the patient tube for at least 20 consecutive minutes;
 if the unit stops working earlier than 20 minutes, the battery is damaged and must be replaced.

REUSE, SCHEDULED MAINTENANCE AND DISPOSAL

□ After each reuse

After each use, unplug the suction unit, disconnect the disposable parts and discard them. Check that the suction unit
is intact, check the connection tubing and check for any structural anomalies. Clean and disinfect the suction unit as
described below. Replace all single-use, disposable parts with new components and recharge the battery.
Run the daily function test as described under "Daily test” in page 9.

Charging cable

BSU854

OB20WB wall bracket

BSU800

Battery charger

BSU870 (EU) – BSU872 (UK) – BSU874 (JP)

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□ Occupational safety and health and PPE (Current legislation concerning workplace safety and

health)

The decontamination process is always a delicate process, which implies specific training, especially in the emergency
field where the patient’s medical condition and degree of contamination are mostly unknown. For this reason, the
operator must always wear personal protective equipment (PPE) to protect himself and others.
If proper PPE is not available, please contact your safety representative.

The organic secretions collected by the suction unit can cause severe
operator infection. For this reason, always use suitable PPE and
disinfection products as established by the competent authorities.

CLEANING INSTRUCTIONS

□ Reusable collection jar OB-J FA

Cleaning and disinfecting of the reusable jar:

1. Wear gloves and protective clothing.

2. Remove the patient tubing together with yellow angular connector. If the tube is equipped with a Yankauer

suction tip, it must be disposed of together with the curved tip (disposable devices). The angular connector can
be sterilized.

3. Disconnect the conical connection from the suction unit connector.

4. Remove the jar vertically out of the unit.

5. Disconnect the filter from the lid by turning it slightly in its housing.

6. Remove the lid (paying attention to possible contamination with the contents of the jar!). Empty the contents

of the jar in accordance with local regulations or hospital practice.

7. Remove the over-fill valve.

8. Separate all parts of over-fill valve.

9. Remove the silicone gasket.

10. All parts of the lid.

After having disposed of the disposable filter and Yankauer suction catheter, complete with tubing, set the reusable
parts in cold running water and rinse thoroughly. Then dip the same parts in hot water (temperature not higher than
60°C) containing a mild, non-alcoholic detergent. Rinse thoroughly and, if necessary, use a non-abrasive brush to remove
any deposits. After washing, rinse all parts with hot running water (30-40°C max.) and then dry with a soft, non-abrasive
cloth. Before reassembling, check that all parts are clean, dry and intact. If the suction unit is equipped with silicone
tubing and “finger-tip” connection, dispose of the connector and clean the silicone tubing. The tubing can be autoclave
sterilized.

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□ Decontamination/sterilisation of the collection jar

The collection jar and silicone tubing can be disinfected with any mild, non-abrasive chemical cleanser. Alcohol or
solvent-based detergents cannot be used. Do not use any coloured disinfectants as these may damage the plastic of the
jar and stain the silicone tubing, reducing its transparency (e.g. Betadine). Never use disinfectants undiluted. Sterilize
with a steam autoclave at a maximum temperature of 121°C for max. 15 minutes. Do not use pressures above 2 bar
(200 kPa). The jar should be placed in the autoclave upside-down (bottom facing upward). At the end of the autoclave
cycle, leave to cool to ambient temperature, check that it is intact and then reassemble the jar following the operations
used to dismantle it in inverse order.

WARNING

 Do not put weight on the parts during the sterilisation cycle.
 Observe the maximum limits for temperature, pressure and duration during the autoclave cycle.
 Never exceed the value of 60°C for washing or disinfection operations (with the exception of

sterilization in a steam autoclave).

 Cleaning and/or sterilisation operations should only be performed by trained personnel.
 Replace the collection jar if it presents fissures, cracks or even partial breakage.
 After reassembling the jar, always check that the lid is properly fitted so as to prevent loss of vacuum

and carryover of fluids.

Place all components of the jar on a flat, secure surface. During assembly and disassembly, always check all parts for
damage. The overflow valve has a float that slides on a plastic guide. Make certain that it slides easily and unhindered
and that the silicone seal is intact.

□ Replacing the protection filter

Carefully disconnect the silicone tubing from the contaminated filter and dispose of it in
accordance with current laws and regulations. Remove the filter from the
lid by screwing or unscrewing it from its housing. This operation facilitates
withdrawal and prevents it from breaking inside the lid! Install a new filter

ensuring that the part marked “IN” is connected to the jar inlet marked

VACUUM. Failure to heed this detail can cause filter failure and
contamination of the suction unit intake circuit.

NOTE

The filter must be inserted with the side marked “IN” facing toward the jar. Using the suction unit with

filter inserted incorrectly can lead to contamination of the suction circuit.

□ Reusable collection jar OB-J

The jar OB-J Liner is equipped with a specific disposable liner, approved for this type of use. Unlike the OB-J FA
version, the disposable filter is located inside the liner.

1. Wear the protection gloves.

2. Disconnect the conical connection from the suction unit connector.

3. Remove the jar vertically out of the unit.

4. Disconnect the patient tube and the white connector from the disposable liner.

5. Close the connection with the plug provided on the lid.

6. Remove the sealed liner from the jar.

7. Remove silicone tube from red connector.

8. Remove adapter for disposable bag. Unscrew the plastic elbow connector while keeping the screw pressed

inside the jar. Be careful with the seal ring.

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Dispose of the single-use parts and, after disassembling the collection jar, set the reusable parts under cold running
water and rinse thoroughly. Then dip the same parts in hot water (temperature not higher than 60°C) containing a mild,
non-alcoholic detergent. Rinse thoroughly and, if necessary, use a non-abrasive brush to remove any deposits. After
washing, rinse all parts with hot running water (30-40°C max.) and then dry with a soft, non-abrasive cloth. Before
reassembling, check that all parts are clean, dry and intact.
If the jar needs to be sterilised, proceed as described in page 13.

Reassembling the jar

Extract a new disposable bag from the packing, stretch it (picture 1) and insert it into the jar (picture 2). Connect the
complete jar to the suction unit. Activate the suction unit. Close with a finger the connector <PATIENT> and, at the same
time, press lightly the bag from the center of the lid (picture 3). Make sure the bag is completely swollen. Connect the
patient tube (Jankauer) to the connector <PATIENT>.

The disposable liner must be replaced after each use!

□ Disposal of contaminated parts

Always follow local regulations or hospital practices when dealing with contaminated materials. Never store
contaminated parts with new or sterile parts.

□ Cleaning the suction unit

Disconnect the suction unit from any external power supply. To clean the chassis of the suction unit, use a damp cloth
with mild detergent (type used for dishes and/or delicate clothing). When finished, dry the surface with a dry cloth or
paper towel.

Pic. 1

Pic. 2

Pic. 3

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WARNING

 Never submerge the suction unit in water or other liquids.
 Do not clean the unit with abrasive substances, alcohol or solvents that could deteriorate plastics or

remove printing/labels.

To correctly disinfect and decontaminate the suction unit, we recommend using specific, approved products. These
disinfectants must be free of alcoholic and/or abrasive substances. Oscar Boscarol srl can provide specific materials for
disinfection of medical equipment, including our suction units. These disinfectants, available in different formats (wipes,
spray, liquids), have been laboratory tested and guaranteed to deactivate viruses, bacteria and microorganisms. When
used periodically, they destroy and prevent the formation of dangerous biofilms (superficial layers that easily host
bacteria, moulds, viruses and microorganisms). Our disinfectants do not contain alcohol, chlorine, phenols, aldehydes
and halogens.

NOTE

For more detailed information, contact us at [e-mail] visit our website www.boscarol.it .

□ Suction unit safety

On the back side of the unit is placed a 15A fuse (delayed type function T), which protects
the battery circuit and the suction pump. In the event that it activates, replace it (spare
fuse delivered with the suction unit or requested from the manufacturer). Use a flat head
screwdriver to unscrew the head holder. Replace the fuse with a new one and screw the
head into place. If after replacing of the fuse the device does not work, contact the service
center.

□ Disposing of the suction unit

The unit contains electrical and/or electronic equipment that must be recycled according to EC Directive
2012/19/EU – Waste Electrical and Electronic Equipment (WEEE) enacted in Italy with Leg. Decree 49/2014.
The suction unit is also compliant with Directive 2011/65/EC which restricts and prohibits the use of certain
hazardous substances in electrical and electronic equipment. Harmful substances
that violate the above Directive are not used in the production and assembly of

electronic boards or in the wiring and connection of electric cables.

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ACCESSORIES, CONSUMABLES AND SPARE PARTS

Index code

Description

Accessories

BSU800

OB20WB wall bracket

BSU870

Battery charger 100/240 Vca 50/60 Hz - 3 poles and Euro-plug

BSU872

Battery charger 100/240 Vca 50/60 Hz - 3 poles and UK-plug

BSU874

Battery charger 100/240 Vca 50/60 Hz - 3 poles and Japan / USA-plug

User parts

BSU730

Protection filter for OB-J FA jar – 5 pcs

BSU732

Protection filter for OB-J FA jar – 15 pcs

BSU734

Protection filter for OB-J FA jar – 40 pcs

BSU705

Disposable bag SERRES – 6 pcs

BSU706

Disposable bag SERRES – 12 pcs

BSU707

Disposable bag SERRES – 36 pcs

BSU500

Autoclavable OB-J FA jar, without protection filter

BSU506

OB-J jar, without disposable bag

126140107191

Jankauer suction tube

BSU750

End-piece sterile disposable Finger-typ – 5 pcs

BSU752

End-piece sterile disposable Finger-typ – 15 pcs

BSU754

End-piece sterile disposable Finger-typ – 50 pcs

11214101003

Sterile suction catheter Ch.10 black

11214101104

Sterile suction catheter Ch.12 white

11214101005

Sterile suction catheter Ch.14 green

11214101006

Sterile suction catheter Ch.16 orange

11214101007

Sterile suction catheter Ch.18 red

11214101008

Sterile suction catheter Ch.20 yellow

Spare parts

BSU854

External charging cable with cigar lighter fitting and 3 poles plug

BSU902

Silicone patient tube - length 130cm / 51,2inch (int.diam.6mm/ext.12mm)

SPS6000

Bottle OB-J FA without lid

SPS6002

Shut-off valve – 3 pcs

SPS6004

90° plastic joint for OB-J FA jar – 3 pcs

SPS6006

Lid for OB-J FA complete with shut-off valve and 90° plastic joint

SPS6014

Conical connector – 5 pcs

SPS6023

Silicone tube 15 cm with conical connector for OB-J FA

SPS5092

“L” joint for OB-J jar – 3 pcs

SPS6021

Silicone tube 18 cm with conical connector for OB-J

BSU834

Red carrying bag

ZMA3000

User manual

NOTE

To make technical improvements, the parts listed may be changed by the manufacturer without prior
notice. Contact the manufacturer for additional information ([e-mail]).

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TECHNICAL SERVICE

No electrical and/or mechanical part of the suction unit is designed to be repaired by the dealer, customer and/or
operator. Do not open the suction unit and do not tamper with the electrical and/or mechanical parts. Always contact
your authorized service centre or the manufacturer. Performing even the most minor operation on the suction unit
voids the warranty. Unauthorized access to the suction unit can jeopardize its conformity with the applicable laws and
reduce safety for both operators and patients. Contact Oscar Boscarol srl for a list of authorized service centres by
sending an e-mail to [e-mail].

TROUBLESHOOTING

Malfunction

Possible cause(s)

Corrective action

The suction unit does not work

 Battery low

 Battery failure

 Internal electronic circuit failure

 Charge the suction unit with the

charging cable or power supply
adapter

 Contact an authorized service centre

to have the battery replaced

 Contact an authorized service centre

The suction unit doesn't work when
mounted on the wall bracket or with the
external charger cable.

 Cable damaged.
 Damaged wall bracket and/or

contacts on the suction unit.

 Power supply voltage is outside the

required range (12÷15 Vdc).

 Current insufficient to power the

suction unit (12÷15 Vdc - min.6A).

 Suction unit internal circuit failure.

 Replace the cable.
 Replace the wall-bracket.

 Check the external power source.

 The current rating must be at least

6A.

 Contact an authorized service centre

The suction unit works only when
connected to the mains or external power
cable.

 Fuses blown.
 Faulty battery.

 Replace the fuse (see page 16).
 Contact an authorized service centre

Suction unit does not charge when
connected to the mains power supply

 Power supply failure.

 Replace the adapter
 Contact an authorized service centre

The suction unit works, but the battery
power indicator lights are off.

 LED display or internal electronic

circuit failure

 Very low battery power.

 Check that the LED display work if

connected to the wall-bracket or to
the external charger cable. If works,
immediately charge the battery for at
least 24 hours. If does not works,
contact an authorized service centre.

 Charge the battery for at least 24

hours.

Suction unit battery life is significantly
reduced.

 Faulty battery.

 Internal recharging circuit failure.

 Test the suction unit as described in

page 12 of this manual or contact an
authorised service centre.

 Contact an authorised service centre.

Vacuum power on patient side is low or
absent

 Vacuum regulator completely open.

 Filter plugged
 Tubing connecting filter with device

is plugged, bent and/or disconnected

 Overflow valve of OB-J FA jar plugged

 Pump damaged

 Close vacuum regulator completely

and check vacuum on both
instrument and patient sides (by
turning the knob clockwise)

 Replace filter
 Connect tubing to filter and/or jar;

replace if plugged and eliminate any
bends

 Disconnect the tubing running to the

suction unit, empty the jar and check
that the valve moves properly (the
silicon gasket must be facing
upwards). The jar can only be used in
the upright position

 Contact an authorised service centre

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Vacuum is always at maximum even if the
jar is removed.

 Fault on the internal pneumatic

circuit.

 Contact an authorised service centre
High noise, low suction, high vibration.

 Internal pump damaged.

 Contact an authorised service centre

TECHNICAL DATA AND CONFORMITY TO INTERNATIONAL LAW

Classification according to the MDD93/42/EEC

The OB2012 suction unit is an ACTIVE MEDICAL SUCTION UNIT for use in the field and for transportable use in
accordance with ISO10079-1:2009.

MDD Classification:

IIb

Vacuum degree:

HIGH VACUUM-HIGH FLOW

Mode of operation:

TEMPORARY (maximum continuous use 60 minutes)

Electrical requirements:

SELV (12÷15 Vdc)

Use of the device in the home environment:

complying to IEC60601-1-11

Use of the device in the health emergency:

complying to IEC60601-1-12

Degree of protection against electric shock (IEC60601-1):

TYPE BF

With respect to protection from electric shock:

CLASS II

Degree of protection against ingress of liquids (IEC529):

IP34d

Accordance with general IEC60601-1:

Complying with the 3° Edition

Dimensions

Max dimensions:

350 mm (width) x 120 mm (depth) x 240 mm (height)

13.77 in (width) x 4.72 in (depth) x 9.44 in (height)

Weight:

4.6Kg max. complete with all accessories

Tolerance on all values:

±5%

Technical data

Max vacuum power:

800 mbar (80 kPa, 600 mmHg) ±10%

Vacuum Regulation:

linear

Vacuum range regulation:

30÷800 mbar (3÷80 kPa; 225÷600 mmHg)

Max flow rate:

30 litres per minute with free air ±10%

Max running time with the maximum current-load:

Approximately 45 minutes ±10%

Approximate maximum noise energy:

70 dBA

Accuracy of the analogue gauge:

±5%

Accuracy of the battery power monitor:

±5%

Power supply

Running/charging:

12÷15 Vdc (Direct Current)

Max current load:
70 W (max. current 6 A)

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Battery:

Internally mounted, rechargeable hermetically sealed
acid type, Capacity 4 Ah

Max time for recharging:

15 hours

Main safety:

T15A (user replaceable)

NOTE

The external direct current power supply must provide at least 8A to enable correct unit operation or
charging. With the mains powered battery charger, when the unit is running, the power is drawn from the
battery.

Environmental and transport conditions

Operating temperature range:

0÷50 °C (32÷122 °F)

Recommended temperature for charging

15÷30 °C (59÷86 °F)

Storage and transport temperature range (with original
packaging):

-25÷55 °C (-77÷131 °F)

Storage and transport temperature range (without
packaging):

0÷50 °C

Storage, use and transport relative humidity:

15÷95%, not condensed

Storage and transport atmospheric pressure:

70÷106 kPa (700÷1060 mbar; 525÷795 mmHg)

Operating in the rain

The OB2012 suction unit is protected against ingress of liquids and solids. However, it is always best to
protect the unit from heavy rains. During operation and storage, the unit must be kept in its
carrying/storage bag and kept dry. If the suction unit is completely wet, move it to a dry area, dry the
outside and wait at least 30 minutes before attempting to restart.

High altitude operation

The operator must take into account the altitude when using the unit. Under such conditions, the vacuum produced by
the internal pump may drop, even considerably, as a result of the reduced atmospheric pressure.

Technical filter specifications

The antibacterial/antiviral filter consists of a PTFE filter support and an air-tight polypropylene container.
Max pressure applicable: 1bar (100kPa)

Retention capacity: for aqueous solutions - up to 0.9 bar (90 kPa); for airborne particles - 0.1 µm 99.99%

Storage of SERRES products

SERRES® products are factory disinfected and should be stored in warm, indoor locations. Protect the package from
humidity, dirt and dust. The SERRES® disposable liners are manufactured in Europe and bear CE marking. This device is
a Class I medical device. Disposable suction bags can be used for 5 years after the date on the label.

Battery charger’s technical data

Input: 100÷240 Vac 50/60Hz, 600mA
Output: 24 Vcc 1 A max

Manufacturer: GLOBTEK DEUTSCHLAND GMBH - HAFENWEG, 26/A – 48155 MÜNSTER

Technical and product conformity specifications available from Oscar Boscarol srl

Symbology

Vac = Voltage (alternating current)
Vdc = Voltage (direct current)
°C degrees °C
bar unit for pressure and vacuum

kPa unit for pressure and vacuum
mmHg unit for pressure
Conversion formula: 1bar = 100kPa = 750mmHg

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THE RISKS OF RECIPROCAL INTERFERENCE WITH OTHER DEVICES

The OB2012 suction unit does not create interferences with other medical devices that are operating in the same area
during the conduct of investigations and clinical treatments. The unit must not be connected to other equipment for its
operation and has an internal power source.

RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES

The electro medical units required special precautions of use with regard to electromagnetic compatibility. For this
reason, must be installed and/or used in accordance with the information specified in the accompanying documents (in
our case the following tables).
Portable radio devices and mobile may affect the functioning of the medical device.
The electro medical units and medical systems should not be used in proximity, adjacent or overlapping with other
electrical apparatus or radio. If such use is necessary and unavoidable, special precautions must be taken to ensure that
the medical device is functioning properly in its configuration of use envisaged (for example, checking constantly and
visually the absence of anomalies or failures). The following tables provide information about the features of EMC
(electromagnetic compatibility) of this electro medical unit. The full functionality of this unit is considered "essential
services" for the purposes of electromagnetic immunity.

POSSIBLE METHODS TO AVOID THE RISKS OF ELECTROMAGNETIC INTERFERENCE

In the case that medical unit can influence or be influenced by other electrical appliances places nearby, try to change
the place of use, remove sources that emit radio frequency (cell phones, two-way radios, mobile antennas). Try to move
away from where you are (if possible) or turn off all non-essential appliances nearby places (including the electro­domestics) and follow the directions below.

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The OB2012 suction unit is intended for use in the electromagnetic environment specified below. The customer or
the
user of the OB2012 suction unit should assure that it is used in such an environment.

Emissions tests

Compliance

Electromagnetic environment - guidance

RF emissions

CISPR11

Group 1

The OB2012 suction unit uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not likely cause
any interference in nearby electronic
equipment.

RF emissions

CISPR11

Class B

The OB2012 suction unit is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network
that supplies buildings used for domestic
purposes.

Harmonic Emissions
IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions
IEC 61000-3-3

Complies

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GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The OB2012 suction unit is intended for use in the electromagnetic environment specified below. The user of the OB2012 suction
unit should assure that it’s used in such an environment.

IMMUNITY test

IEC 60601 test level

Compliance level

Electromagnetic environment -

guidance

Electrostatic discharge
(ESD)

IEC 61000-4-2

±6 kV contact

±8 kV in air

±6 kV contact

±8 kV in air

Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.

Electrical fast transient
/ burst

IEC 61000-4-4

±2 kV power supply

±1 kV power supply
(IN/OUT)

±2 kV power supply

±1 kV power supply (IN/OUT)

Mains power quality should be that
of a typical commercial or hospital
environment.

Voltage dips, short
interruptions and
voltage variations on
power supply input
lines.

IEC 61000-4-11

<5%U

T

(>95% dip in UT)
for 0,5 cycle

40% UT
(60% dip in UT )
for 5 cycles

70% U

T

(30% dip in UT)
for 25 cycles

<5% U

T

(>95% dip in UT)
for 5 sec

<5%U

T

(>95% dip in UT)
for 0,5 cycle

40% UT
(60% dip in UT )
for 5 cycles

70% U

T

(30% dip in UT)
for 25 cycles

<5% U

T

(>95% dip in UT)
for 5 sec

Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
suction unit OB2012 requires
continued operation during power
mains interruptions, it is
recommended

that the suction unit be powered
from an uninterruptible power

supply or a battery.

Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8

3 A/m

0,3 A/m

If abnormal performance is
observed on the suction unit
OB2012, it may be necessary to
position the suction unit OB2012
further from sources of power
frequency magnetic fields or to
install magnetic shielding. The
power frequency magnetic field
should be measured in the intended
installation location to assure that it
is sufficiently low.

NOTE: UT is the AC mains voltage prior to application of the test level.

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GUIDELINES AND DECLARATION OF COMPLIANCE FOR MEDICAL DEVICES

TEST OF CONDUCTED AND RADIATED ELECTROMAGNETIC IMMUNITY

For the purposes of conducting the tests using test levels IEC60601, V1=3 and E1=10

The BSU suction units are intended for use in the electromagnetic environment specified below. The user of the OB2012 suction
unit should assure that it’s used in such an electromagnetic environment.

IMMUNITY test

IEC 60601

TEST LEVEL

Compliance level

Electromagnetic environment -

guidance

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz

3 Vrms

Portable and mobile RF
communications equipment should be
used no closer to any part of the OB2012
suction unit, including cables, than the
recommended separation distance
calculated from the equation applicable
to frequency of the transmitter:

Recommended separation distance

d= 1,2√P

d= [3,5/E1] x √P = 0,35√P

da 80MHz a 800MHz

d= [7/E1] x √P = 0,7√P
da 800MHz a 2,5GHz

where <P> is the maximum output
power rating of the transmitter in watts
(W) according to the transmitter
manufacturer and <d> is the
recommended separation distance in
meters (m).

Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey (a), should
be less than the compliance level in each
frequency range (b).

Interference may occur in the vicinity of
equipment marked with the following
symbol:

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2,5 GHz

10 V/m

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.

(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the suction unit OB2012 is used exceeds the applicable RF compliance level above, the
suction unit OB2012 should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the suction unit OB2012.
(b) Over the frequency range 150 kHz to 80 MHz, field strength should be less than 1 V/m.

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GUARANTEE

Oscar Boscarol Company supplies the OB2012 with a 36-month guarantee from the date of purchase. The company
guarantees that each new OB2012 unit is free from defects in materials and workmanship.

Items excluded from this guarantee are: the collection jar and/or the liner, the external cable for battery charging, the

internal battery, normal wear and tear of the unit, discoloration, and any other aesthetic irregularities which do not
affect the operation of the unit.

The product that during the 36 months’ warranty is found defective, should be sent to Oscar Boscarol srl with a note
describing the defect. The Oscar Boscarol Company will, at their discretion, arrange for repairs or complete replacement
within the terms of this guarantee. All shipping costs are borne by the customer.

Conditions of guarantee:

To use the warranty, it is necessary to fill in and return the product registration form below, via post, fax or mail, to the
following address:

OSCAR BOSCAROL COMPANY V. E. Ferrari, 29 – 39100 BOLZANO - ITALY

Fax: [phone] – E-mail: [e-mail]

To validate the guarantee, the customer shall provide the following documentation:
 presentation of a copy of the invoice and / or declaration of purchase containing the device serial number and date

of purchase;

 recognition by the service of a failure or defect attributable to defects in materials or workmanship;
 absence of tampering, changes and / or anything not conforming to the original product.

Effects of safety, reliability and functioning of suction unit, Oscar Boscarol srl is liable only if:
 All technical operations, repairs, modifications and maintenance actions are carried out at the Oscar Boscarol

company factory or by an authorised service centre.

 The device is used correctly, as indicated in this user manual.
 The suction unit charger is only to be connected to the correct voltage supply for the Country it was supplied.

With reference to what was described in these guarantee conditions, Oscar Boscarol Company cannot be responsible
for accidental or indirect damage resulting from unauthorised modification or repair, unauthorised technical
interventions or when any parts of the unit are damaged in instances of accidental or incorrect use. On the OB2012
suction unit are no other warranties expressed or limited, of merchantability, fitness or other outside those described
in this manual.

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DECLARATION OF CONFORMITY

We, the manufacturer:

OSCAR BOSCAROL SRL

Via E. Ferrari , 29 – 39100 BOLZANO – ITALY
Tel. [phone] – Fax. [phone]
Web: www.boscarol.it - Email : [e-mail]
Certifies EN ISO 13485:2012 + AC 2012
Certificate N° Q1N 15 07 42208 025
Certifies UNI EN ISO 9001:2008
Emission: TÜV–SÜD Product service (CE0123)
EC Certificate N° G1 15 05 42208 024

Il produttore:

We declare under our sole responsibility that the device
(name):

MEDICAL SUCTION UNIT

Dichiariamo sotto nostra responsabilità che il dispositivo
(nome):

ASPIRATORE MEDICALE DI SECRETI

Type:
Tipo:

OB2012 FA – OB2012 LINER

UMDNS code:

15016

Boscarol code:

BSU100 - BSU104 - BSU108 - BSU150 - BSU154 -BSU158
XAS0200 - XAS0210 - XAS0220 - XAS0230
XAS0240 - XAS0250 - XAS0260 - XAS0300
XAS0302 - XAS0304 – XAS0356 – XAS0400 – XAS0402

Devices classification (MDD 93/42/EEC – Annex IX):
Classificazione dispositivo ( MDD93/42/CEE – Allegato IX):

Class IIb

Meets all the provisions of the directive MDD 93/42/EEC and subsequent amendments which apply to it.
Soddisfa tutte le disposizioni della direttiva MDD 93/42/CEE e successivi emendamenti che lo riguardano.

Applied harmonised standards, national standards or other normative
documents:
Norme armonizzate o nazionali applicate, altri documenti normative applicate:

ISO10079-1:2016
UNI EN 1789:2014
IEC60601-1 ed. 3.0.
IEC60601-1-11
IEC60601-1-12
ECE-R10

Conformity assessment procedure:
Procedimento di valutazione della conformità:

MDD93/42/EEC, Annex II (Allegato II)

Notify body:
Organismo di notifica incaric. della valut. della conformità:

TÜV – SÜD Product Service GmbH
CE 0123

Bolzano, 01/07/2016

DI/RAQ – Quality Manager DI/GM – General Manager
Dott.ssa PERINI LAURA BRAZZO DANIELE

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Printed in Italy by Oscar Boscarol Company
Rev. 08-2016 USMAN2012 - EN