Boscarol PAL32000 User manual

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BOSCAROL MANUAL RESUSCITATORS
OPERATING INSTRUCTIONS

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MANUFACTURED BY:
OSCAR BOSCAROL srl
Via Enzo Ferrari 29
39100 Bolzano
ITALY
Tel. [phone]
Fax: [phone]
[email protected]
www.boscarol.it
Information on manufacturer and medical device:
•Oscar Boscarol applies a quality management system compliant with international standards ISO
13485 and ISO 9001.
•The medical devices of category "Manual resuscitation" (in all their configurations) are compliant
with MDD 93/42/EEC (as subsequently amended) and bear the CE marking (CE 0123 notified body
TÜV SÜD PRODUCT SERVICE GmbH).
•The medical devices meet the essential requirements described in annex I of MDD 93/42/EEC.
Information on these operating instructions:
•This document contains important information for safe, effective and compliant use of the medical
device.
•Use this information to train users and confirm their training.
•This manual may not be modified in any way (not even partially). Only the device manufacturer can
make changes when necessary.
•These instructions must always accompany the device. We recommend using the electronic version
and making it available on operator PDAs, tablets and cell phones.
These operating instructions apply to the following devices:
-Resuscitator bags and accessories
REF CODE:
PAL32000
PAL32004
PAL32010
PAL32014
PAL32050
PAL32054
PAL32058
PAL32062
PAL32066
PAL32070
PAL32100
PAL32104
PAL32110
PAL32114
PAL32120
PAL32124
PAL32150
PAL32154
PAL32158
PAL32162
PAL32166
PAL32170
PAL32200
PAL32210
PAL32220
PAL32350
PAL32356
PAL32370
PAL32375
PAL34350
PAL34356
PAL34371

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INDEX
INDEX ......................................................................................................................................................................... 4
0MEANING 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
1INTENDED USE ................................................................................................................................................... 5
2WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION............................................................................ 6
3INFORMATION THAT IS IMPORTANT TO KNOW BEFORE USE ............................................................................. 7
4CONTRAINDICATIONS (DO NOT USE FOR) .......................................................................................................... 7
5SIDE EFFECTS (POSSIBLE DURING ASPIRATION OPERATIONS)............................................................................. 7
6OSCAR BOSCAROL RESUSCITATOR BAGS ............................................................................................................ 7
7OPERATING PRINCIPLE ....................................................................................................................................... 8
8CONFIGURATION OF THE DEVICE AND SPARE PARTS ......................................................................................... 8
8.1 Device structure ................................................................................................................................................ 8
8.1.1 PEEP positive pressure regulating valve (OPTIONAL)...................................................................................... 10
8.2 Device safety ................................................................................................................................................... 10
8.3 Spare parts ...................................................................................................................................................... 10
8.4 Optional accessories ....................................................................................................................................... 10
9USE OF THE DEVICE ...........................................................................................................................................10
9.1 Before using on patients ................................................................................................................................. 10
9.2 Use of the PEEP valve...................................................................................................................................... 10
9.3 Use on patients ............................................................................................................................................... 10
9.4 General instruction for use ............................................................................................................................. 11
10 CLEANING AND STERILIZATION .........................................................................................................................11
10.1 After use.......................................................................................................................................................... 11
10.1.1 Cleaning ...................................................................................................................................................... 11
10.1.2 Sterilization of the device ........................................................................................................................... 11
11 FUNCTIONAL TESTING OF THE DEVICE...............................................................................................................12
14 MAINTENANCE..................................................................................................................................................12
15 TECHNICAL DATA AND CONFORMITY ................................................................................................................12
16 WARRANTY .......................................................................................................................................................14

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0MEANING OF SYMBOLS AND PICTOGRAMS
0.1 Symbols used in these operating instructions to call the reader’s attention
Danger: important safety-related information covering correct use of the resuscitator bag to prevent
operator or patient injury and/or damage to unit itself
Warnings: information requiring special attention
Notes or information on preventing damage to the device or injury to others. Implement correct
prevention measures
1. List of actions to be performed: follow them step by step
These operating instructions
Maintenance service required (contact the manufacturer and/or its authorized service centres)
0.2 Symbols used on the device and accessories
Use the resuscitator bag only within the specified temperature range. Using the resuscitator bag outside
these limits could compromise its functional performance and damage it.
Read these operating instructions carefully and thoroughly
Accessories and/or consumables displaying this symbol are disposable. They cannot be reused and, after
use, must be discarded and replaced with new ones.
Indicates that the user must consult these operating instructions for information, e.g. warnings and
precautions that may not be displayed on the medical device in question
CE marking in accordance with MDD 93/42/EEC for medical devices rated higher than class I
Manufacturer
Date of manufacture
Expiry date
Order number (device code)
Production batch
These operating instructions are available in other languages on the indicated website. Please read them.
Indicates that the resuscitator bag is a medical device
1INTENDED USE
Device name
Resuscitator bag and accessories
Primary use
Portable, manually operated device used in life emergency situations to provide lung ventilation (by
means of pressing the compressible part of the device) to patients with respiratory deficiencies.
Medical Purpose
Manual ventilation of patients with apnea (suspension of pulmonary respiration) or insufficient
respiration
Site of application to
human body
Resuscitation masks are intended to be used on the patient's face, covering the nose and mouth
Patient type
Adults, children, and infants of both sexes.
The size and shape of the resuscitator bags and masks are different for use in the adult, pediatric and
neonatal setting to meet the different needs of compression frequency and volume of oxygen
required.
Length of application on
a given patient
"Short-term" use (maximum 60 continuous minutes on the same patient)

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Information on usage
•The resuscitation bags are available in three different materials: rubber, PVC and silicone.
Resuscitation bags in rubber and PVC are available in neonatal, child and adult versions. Silicone
resuscitation bags are available in child and adult versions.
•The ventilation masks are available in two different materials: silicone and PVC. each type is
available in six sizes, all designed with an anatomical shape to ensure minimal patient
discomfort.
•The resuscitator bag can be connected to a source of therapeutic oxygen and can be equipped
with a reservoir to ensure optimal administration.
•The use of this medical device is allowed only to authorized and appropriately trained persons.
2WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION
Read carefully
These operating instructions have been prepared using simple, easy to understand language. If you have
difficulty interpreting what is written, please contact the manufacturer for further clarification.
Phone [phone] [e-mail]
•
Read these instructions carefully before using the device. Careful, correct use of the device ensures smooth operation and
will protect both patients and operators.
•The use of this device is reserved for authorized and appropriately trained personnel. Training on how to position the face
mask is advisable to obtain an optimal seal. Ensure that personnel are aware with the contents of this manual.
•The efficiency of ventilation must always be checked by observing the movement of the chest and listening to the expiratory
flow coming out of the valve. If the ventilation is insufficient, immediately proceed to mouth-to-mouth respiration.
•Insufficient, reduced or no air flow can cause brain damage to the ventilated patient.
•The use of the PEEP valve can have negative effects such as barotraumas and/or reduced cardiac output. Only
qualified medical personnel trained to use the PEEP valve should use the device supplied with the PEEP valve.
•Do not sterilize the device and the disposable parts marked with the symbol shown at right →.
•Do not use the resuscitator bag in rooms where the air is toxic or contaminated, in presence of explosives or
where the air may be contaminated with anaesthetic agents.
•Before using the reusable silicone resuscitator bag, clean and/or sterilize it. Proceed with a full functional testing, after
sterilization/disinfection, before using the device on patients.
•Only use original spare parts, provided by the manufacturer (Oscar Boscarol srl).
•The parts of the device must be disposed following national and local indications for the disposal of substances based on
PVC, silicone, rubber.
•Do not use any type of grease, oil or other lubricant on the device (including hydrocarbon-based substances). These
substances, in combination with oxygen, can trigger combustion and/or spontaneous outbursts.
•Do not remove the safety valve on the resuscitator bag. Its dismantling may cause immediate damage.
•Before using the device on patients, the user must be able to disassemble/reassemble all its parts and must be aware of all
the maintenance and reuse operations.
•Improper ventilations performed with devices with and without the safety valve may create harmful effects to the patient's
cardio-respiratory system.
•During the emergency ventilation always place patient’s head in order to ensure the passage of air or oxygen into the airways.
•Do not override the pressure-limiting valve (for pop-off models only) to prevent excessive ventilation pressures that may
cause lung rupture on patients. However, if medical assessment indicates the necessity of overriding the pressure-limiting
valve, a manometer must be used to monitor ventilatory pressure and avoid the possibility of lung rupture.
•Remove the oxygen reservoir and reservoir valve if supplemental oxygen is not being administered. Failure to do so will
affect refill rate and maximum ventilation frequency capabilities.
•
The device is not marketed sterile.
LATEX
The resuscitator bags and accessories are built and manufactured without the use of latex. However, the
possibility that they may have come into contact with latex at some time during the production chain cannot
be ruled out
CONTAMINATED
DEVICE
Warning: Device contamination
THESE OPERATIONS ARE EXCLUSIVELY EXECUTABLE ON SILICONE REUSABLE DEVICES. CLEANING AND
STERILIZATION OF DISPOSABLE DEVICES (PVC AND RUBBER) IS STRICTLY FORBIDDEN!
Contact with the patient during resuscitation may be a source of contamination. For this reason, after each
use, the device must be cleaned and disinfected to eliminate any residual risk. Follow the instructions in this
user manual.

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When in doubt, send an e-mail to the Boscarol technical service at [e-mail] or call [phone]
REUSE OF
DISPOSABLE
PARTS
•Reuse of disposable parts/components may compromise the device function and be
direct or indirect source of operator and patient injures. The disposable
parts/components are manufactured with substances and processes which do not
guarantee their operation in a safe way and in compliance with the imposed
requirements if reused.
•The sterilization and/or cleaning of disposable parts can cause structural damage leading to the risks of
lost mechanical integrity. All parts/components treated with autoclavable sterilization processes can be
100% destructive (result of melting, burning and chemical alteration) and damage the use of the
autoclave itself.
•If the devices or parts are disposable, they must be disposed of as a result of their use in accordance with
national and local regulations.
3INFORMATION THAT IS IMPORTANT TO KNOW BEFORE USE
The resuscitator bag has been designed and tested to meet the requirements of Directive 93/42/EEC concerning medical devices.
Resuscitator bags and ventilation masks are medical devices of risk class IIa.
If the user or patient becomes aware of a user hazard, a side effect, an accident caused by the device
or a criticality (operational and constructive) not treated in these instructions for use, must
immediately notify the manufacturer at the email address: [e-mail]
PERIODIC
MAINTENANCE
Periodic maintenance:
No parts/components of the device require particular periodic maintenance, except for standard
functional verification operations as described in this manual.
If defects, malfunctions or failed tests are detected, the device shall be removed and replaced by a new
one.
When in doubt, send an e-mail to the Boscarol technical service at [e-mail] or call +39 0471
932893.
LIFESPAN
Boscarol resuscitator bags and ventilation masks have a lifespan of 5 years from the date of
manufacture if stored and used in accordance with these operating instructions
Operator/User
Responsibility
•
Boscarol resuscitator bag is designed for emergency medical service and must therefore be ready
for use at any time and in any situation.
•Immediately replace any damaged, altered or missing components/parts and/or those for which
resuscitator bag malfunction is suspected. Always replace these parts with original spare parts.
The resuscitator bag must be stored in a place that is out of the reach of children.
•Dispose of packaging in accordance with applicable regulations and make certain it is out of the
reach of children.
•Tampering, alterations and modifications of the device are not permitted without the consent of
the manufacturer.
4CONTRAINDICATIONS (DO NOT USE FOR)
CONTRAINDICATIONS
•Resuscitation in rooms where the air is toxic or contaminated, in presence of explosives or where
the air may be contaminated with anaesthetic agents.
•Do not use the device on conscious people or without breathing difficulties.
•Do not use a ventilation mask for a specific age group on a patient other than the recommended
age group (such as adult mask used in infant patient or vice versa).
5SIDE EFFECTS (POSSIBLE DURING ASPIRATION OPERATIONS)
SIDE EFFECTS
•Irritation and skin reactivity phenomena due to direct contact of the device on the patient face.
•Passage of ventilated gases in the esophagus and stomach, especially in case of hyperextension of
the neck. Gastric distention makes it difficult to expand the lungs and promotes regurgitation of
gastric material in the esophagus and pharynx and subsequent inhalation in the tracheo-bronchial
tree.
•Damage to children’s lungs due to excessive pressure of ventilation.
•Brain damage to ventilated patient due to insufficient, reduced or no airflow.
•
Barotraumas and/or reduced cardiac output due to incorrect use of the device with PEEP valve.
6OSCAR BOSCAROL RESUSCITATOR BAGS
After receiving the device, make sure that all parts are present (in case of complete resuscitator bag).
The resuscitator bag is an independently medical device and can be used without external accessories. It can be used connected to

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ventilation masks or directly to endotracheal cannulas. You can connect the resuscitator bag to a source of therapeutic oxygen (with
optional tubing not included) and provide it with a reservoir to ensure optimal dosing.
All resuscitator bags are available with and without overpressure valve. Adult resuscitator bags have an overpressure valve settled at
40 or 60 cmH2O (392,24 Pa or 588,36 Pa), while child and neonatal ones at 40 cmH2O (392,24 Pa). If necessary, the valve can be
deactivated with a simple twist or pressure.
Suggested ventilation bags according to the weight of the patient
Adult ventilation bag
For adult/child over 30 Kgs (about 66 lbs)
Child ventilation bag
For child between 5 and 30 kg (11÷66 lbs)
Infant ventilation bag
For infant till 5 Kg (about 11 lbs)
7OPERATING PRINCIPLE
The Boscarol resuscitator bag is a manual and portable device for the respiratory emergencies. The device ensures the administration
of air or oxygen through the manual compression of the bag itself. It is recommended to use the device complete with Boscarol mask,
choosing the proper size, to ensure a perfect grip the nose-mouth. The masks are available separately.
The Oscar Boscarol provides different device dimensions, depending on the patient's body size: this allows to obtain the maximum
benefits for the patient in critical respiratory conditions. Ventilation masks are available in sizes ranging from 0 (infant) to 5 (adult).
Other optional accessories are available for the completion of the device (see list of the manufacturer).
Depending on the production material, the Boscarol resuscitator bag could be REUSABLE or DISPOSABLE.
•Reusable resuscitator bags are made with specific materials (silicone and polycarbonate) to ensure the properties of sterilization
without damages.
•The other resuscitator bags, made with PVC or rubber synthetic materials, cannot be sterilized and should be considered
disposable.
ATTENTION
Disposable devices are identifiable by the labeling on their packaging. Once opened the packaging, the
device can only be used once. After use, the device must be disposed!
The operating principle of the device based on specific non-return valves installed on the device. Hitting the resuscitator bag with the
hands, the pressure conveys the air contained in the bag to the exit connected to the patient's mouth. Thanks to a non-return valve,
the air in the resuscitator bag cannot flow to the bottom of the device. The amount of air or oxygen flowing towards the patient’s
mouth depends on the force exerted on the resuscitator bag by the rescuer and on the maximum volume permitted by the device
(or by the reservoir, in case of use of oxygen).
The patient's exhaled air cannot flow back to the resuscitator bag due to the non-return valve and thanks to a special mechanism it
goes outside (to the ambient).
ATTENTION
If oxygen is not administered, disconnect the reservoir and the connecting pipe for the connection to
the oxygen source! Close the oxygen cylinder if not used!
8CONFIGURATION OF THE DEVICE AND SPARE PARTS
8.1 Device structure
Boscarol resuscitation bags are equipped with different safety valves that allow to release excess air or oxygen (or both mixed).
The valve "A" is called "patient valve" while the valve "A1" is called "pop-off valve". The pop-off valve opens with pressures equal to
or greater than 40 or 60 cmH2O (with a tolerance of ± 5%). To select the right value, raise the valve and rotating it. In the next figure
the scheme of the ventilation bag and its safety valves.

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The figure shows the composition of the device and its accessories. The masks can be disposable or reusable while the reservoir is
always disposable. The outlet plastic fitting (made by polycarbonate) and complete with the safety valve (called "duck’s beak"), also
includes the pop-off safety valve (overpressure). Always be very careful, after disassembly the device, to reassemble it correctly.
Carefully follow the figure on the previous page if in doubt.
Ref No.
Description
Material
A. Patient valve
A1
Pop-off valve
Polycarbonate
A2
Upper patient valve
Polycarbonate
A3
One way valve
Silicone
A4
Lower Patient valve with mask connector
Polycarbonate
A5
Patient valve O ring
Silicone
B. Resuscitator bag
B
Resuscitator Bag with connector
Chosen material + Polycarbonate
C. Intake valve
C1
O ring intake valve
Silicone
C2
Upper body intake valve
Polycarbonate
C3
Lower body intake valve
Polycarbonate
D. Reservoir two-way valve
D1
Main unit two-way valve
Polycarbonate
D2
Upper O ring two-way valve
Silicone
D3
Upper O ring support two-way valve
Polycarbonate
D4
Lower O ring two-way valve
Silicone
D5
Lower cover two-way valve
Polycarbonate
E. Reservoir bag with connector
E
Reservoir bag with connector
PVC + Polycarbonate
F. Face mask
F1
Face Mask Connector
Silicone
F2
Face Mask Dome
Polycarbonate
F3
Face Mask seal
Chosen material + Polycarbonate

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8.1.1 PEEP positive pressure regulating valve (OPTIONAL)
The PEEP valve is designed for use with resuscitator bags. It provides positive pressure and exhalation pressure during ventilation.
The use of the PEEP valve during ventilation does not affect inhalation resistance and oxygen concentration.
8.2 Device safety
The device is designed to ensure maximum reliability both in terms of safety and performance: a "non-return" safety valve (duck’s
beak), placed in the outlet fitting to the patient, prevents the backflow of fluid substances / liquid and air exhaled by the patient
inside the ventilation bag. The other valve, called pop-off, is calibrated to opens if the pressure inside the bag reaches too high values.
The pop-off valve is calibrated by the manufacturer and may have intervention pressures at 40 or 60 cmH2O (approximately 392 or
588 Pa*). The non-return valve instead placed in the air or oxygen inlet part (special group D of the previous figure) serves to make
the compressed air in the bag be directed towards the outlet (i.e. towards the mouth of the patient). D1 and D3, contained in the
inlet valve block, allow the complete filling of the reservoir.
* Pa = Pascal (1 Pa = 0,01 mbar)
8.3 Spare parts
Spare parts for this device are available only for the reusable resuscitator bag (silicone). For codes and list always refer to Oscar
Boscarol srl company.
8.4 Optional accessories
Auxiliary accessories for the device are available to facilitate the operations of emergency ventilation (e.g. helicoidal mouth/teeth
opener, Guedel airway, oxygen tubes ready to use). Ask Oscar Boscarol srl for them.
9USE OF THE DEVICE
9.1 Before using on patients
Before starting to use the device on the patient it is necessary to ensure its full and proper functionality (both of resuscitator bag and
of all the accessories included). Inspect the complete device to identify problems
of discoloration, surface erosion, safety valve malfunctions, breaks or tears. If
functional problems are detected, immediately put the device out of service. Ask
the manufacturer for the original spare parts.
The resuscitator bag can be connected to a portable or stationary oxygen-source
through a standard tube. Adjust oxygen to obtain a correct filling of the reservoir.
Pipe connection to oxygen shall be connected to the junction
near the reservoir connection (see image on the right side).
Example of a complete device, consisting of ventilation mask, resuscitator bag, reservoir and oxygen tube. The
reservoir must be connected on the bottom of the device (see picture on the left side).
9.2 Use of the PEEP valve
If you want to use the device with the PEEP valve, assemble the valve following the instructions below:
1. Clean and sterilise the valve regularly before each use.
2. Connect the diverter to the output of the patient valve.
3. Attach the appropriate PEEP valve.
4. Turn the PEEP valve knob to the appropriate pressure value indicated on the basis of the valve.
9.3 Use on patients
During ventilation ensure the following conditions of the patient:
1. Spontaneous or controlled respiratory rhythm.
2. Correct operation of the “lips-valve” situated on the mask connector.
3. If the device is connected to oxygen, check the correct filling of the reservoir.
4. If during the ventilation the colour of patient’s face became dark/dark purple (suspected respiratory deficiency) it is necessary
to check the results of previous operations and immediately inform a doctor.
ATTENTION
After each use reusable devices must be decontaminated and/or sterilized, while disposable ones
should be removed!
Ref No.
Description
A
Patient valve
G
Diverter
H
PEEP valve
Connection for oxygen
pipe connection
Connection for reservoir
connection

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9.4 General instruction for use
1Before starting with the ventilation, make sure that the patient is in stable and with face upward.
2Verify that patient's mouth and upper airways are free of obstructions (liquid and solid substances).
3Insert an airway into the mouth of the unconscious patient to ensure the opening of the airway and prevent obstruction of the
trachea due to the collapse of the tongue.
4A mask should be applied to the Boscarol resuscitator so to completely cover both nose and mouth. Make sure that the edge
of the mask adheres perfectly to the face. If available, use suitable masks size for patient's face.
5To facilitate ventilation operations the bag can rotate the most comfortable position for the rescuer. Keep the mask well
supported with one hand on patient's mouth and nose, and with the other begin the ventilation cyclically, pressing rhythmically
the body of the resuscitator bag.
6The number of ventilations per minute depends on many factors, such as the patient's disease or the adopted therapy. We can
say that normally respiratory cycle is:
ADULT
12÷15 breathing acts
CHILD
14÷20 breathing acts
NEWBORN
35÷40 breathing acts
7During respiration or ventilation, rescuer must continuously make sure of patient’s health: observe the thorax which expands
and contracts for breathing, the colour of lips and face, the heartbeat.
8If the administration of oxygen is necessary, the use of the reservoir should be a good choice. Normally the reservoir works
properly when filled up completely during patient exhalation and empties during his inspiration (obviously the quantity
administered to the patient depends on the rescuer).
9If the gas pressure is not enough to completely fill the bag, a special valve can compensate the aspiring air from the
environment, ensuring proper ventilation. In this case oxygen concentration decreases.
10 The concentration of oxygen administered to the patient therefore depends on many factors (oxygen flow towards the
resuscitator bag, number of breathing acts, operator’s technique, etc.).
11 If blood, vomit or other substances from the patient's mouth partially or completely block the “lips-
valve" on the resuscitator bag (close to the connector to the mask), remove the resuscitator bag
complete with mask from patient's face and remove substances that block its operation,
proceeding in this way: in a safe location, away from the patient’s face, repeatedly act one-handed
(or both) on the body of the bag, exerting great pressure and ensure that such substances might
be expelled from the device.
12 It is usually possible to restart ventilation regularly, but if this is not possible, use another
resuscitator/ventilator or proceed with the mouth-to-mouth breathing using a specific mask.
13 After each use carefully clean all parts as described in Chapter 6 of this manual. Before reuse the device, always be sure of its
full functionality.
10 CLEANING AND STERILIZATION
ATTENTION
THESE OPERATIONS ARE EXCLUSIVELY EXECUTABLE ON SILICONE REUSABLE DEVICES. CLEANING AND
STERILIZATION OF DISPOSABLE DEVICES IS STRICTLY FORBIDDEN!
10.1 After use
After each use on patients, or every 24 hours, provide specific cleansing and disinfection operations as described below.
If the devices are disposable (indicated by the symbol applied on packaging – see here on the side) they must be disposed
according to local and national regulations.
10.1.1 Cleaning
Before beginning the following steps, make sure that you are working with silicone reusable devices. Disassemble the device
following the scheme at the previous page. Pay attention to the part named HP (see picture): it is a
balanced valve, which cannot be disassembled. This valve, mounted on polycarbonate junction to the
mask-connector, can be safely cleaned, disinfected or sterilized without dismantling.
Proceed as follows, in order to clean and sterilize the device correctly:
1. Protect your hands with individual PPE (gloves, etc.)
2. After having dismantled all the components of the device wash them in warm water with a non-
aggressive cleaning.
3. After the wash rinse all parts with lukewarm water.
4. If you want to proceed with sterilization, follow the directions of next paragraph. Otherwise, dry all parts with a soft cloth that
does not loose fibres.
5. After drying, reassemble the device according to figure reported on chapter 8.
6. Before using the device perform a functional test, as described in paragraph 11.
10.1.2 Sterilization of the device
The device is not sold sterile. The user can sterilize it according to different types of process documented below, according to hospital
practice. It is important to sterilize the device only when it is completely disassembled.
The device can be sterilized as follows:

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1. Steam autoclave sterilization at a maximum temperature of 121°C (249.8°F) at a pressure of 1.1bar (= 110KPa ≒15.9psi), for 20
minutes maximum. The reservoir cannot be sterilized.
2. "ETO" sterilization (carbon monoxide).
3. Through specific substances used in the hospital and ensuring the effectiveness of the process. The process must be in
accordance with current hospital provisions and evidence shall be provided to validate the process.
After each process of sterilization (regardless of the type) it is necessary to wash all components under clean, lukewarm running
water:
1. Dry all components with a soft cloth and ensure their technical and functional integrity. If some components are faulty or have
structural abnormalities replaced them.
2. Reassemble the device according to the design of the previous page.
3. Perform a complete functional test as described in the next paragraph.
4. Keep the tested device in the nylon bag provided by purchasing.
5. Note on the packaging with a marker last performed sterilization.
ATTENTION
The device can be sterilized and reused for 25 times. Once a maximum number of sterilisations of 30
times has been reached, the device shall be discarded.
The manufacturer recommends performing accurate inspections on device surface after each
operation of disinfection and/or sterilization!
11 FUNCTIONAL TESTING OF THE DEVICE
The device must be tested after the purchase, after each cleaning and/or sterilization process, after assembly operations and every
time there are doubts about its functioning. If the device is not frequently used, it should be tested at least once a month.
Please follow the testing procedure above reported:
1. To verify the correct operation of the intake valve, remove the reservoir. Remove the mask-connector and compress the
resuscitator bag with one hand, releasing the contained air. Close the higher output (the one from which the air was able to
exit) with the palm of the other hand and release the bag. The resuscitator bag must fill itself
immediately thanks to the air valve placed at the bottom of the bag itself. If this does not happen,
check the valve on the bottom of the resuscitator bag and if necessary, replace it with a new one.
Also check the correct assembly.
2. Assemble the mask-connector on the resuscitator bag (see figure above) and, if present, close the
POP-OFF valve (turn it 180° to “lock” indication). Close the outlet to the mask with the palm of the
hand. Compress the resuscitator bag with the other hand: it shouldn’t be easy. Otherwise verify the
correct assembly of the valve at resuscitator bag’s bottom. If the POP-OFF valve does have any
leakages, it means that it isn’t in “lock” position. Raise the valve plunger with the hand and turn it
180°.
3. To verify the correct operation of the safety valve in the mask-connector, first ensure the correct assembly
of it and then, without blocking the exit, compress the resuscitator bag. The air must freely exit from the
“lip-gasket” mounted in the mask-connector. When you release the bag, the seal must be closed.
Compress and release repeatedly the resuscitator bag to ensure its correct operating (being the
connecting tube section less than the inlet valve, the fill will be slower).
4. Connect the reservoir to the resuscitator bag. Compress and release the bag. Rapid re-expansion confirms
the efficiency of the integrated valve and reservoir. Compress and release repeatedly the resuscitator bag,
verifying the correct funcioning of valve and reservoir. A rapid re-expansion of the resuscitator bag after
releasing means that the valve operates properly.
ATTENTION
Immediately replace any defective or faulty component
14 MAINTENANCE
No parts/components of the device require periodic maintenance. Only standard functional testing is required, as described in this
manual. In case of defects, malfunctions or tests failure, replace the device with a new one. In case of doubts please send an e-mail
to the Boscarol technical service at [e-mail] or call [phone].
15 TECHNICAL DATA AND CONFORMITY
Device conformity
Device classification referred to Italian D. lg. 46/97 (MDD 93/42/CEE and subsequent
amendments)
IIa
Power source
Ambient air or therapeutic oxygen (O2) at low
pressure and controlled rate
Connection to O2 source
Directly to the device, through standard tube
Lifetime of the device
5 years from date of manufacturing
CE mark on the device
CE0123 (TÜV ITALIA srl)
POP-OFF Valve

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ATTENTION
LIFETIME OF THE DEVICE: maximum 5 years if the device is tested and verified monthly!
Technical characteristics of the device Adult (> 30 kg) Child (5÷30 Kg) Infant (< 5 Kg)
Bag Volume (ml)
1800
550
320
Stroke Volume (ml)
1060
320
140
Reservoir Bag (ml)
2700
2700
900
Expiratory/Inspiratory resistance
2.0 cmH2O/4.0 cmH2O
Dead Space
Less than 7.0 ml
Pressure relief (optional)
40 or 60 cmH2O
40 cmH2O
Operating temperature
-18÷50 °C (test according to the EN ISO 10651-4:2009)
Storage Temperature
15÷25 °C
ATTENTION
Higher respiratory pressure can be obtained by overriding the pressure limiting device, use only if
medical assessment indicates the need.
Connections Dimensions
Patient port
15 mm / 22 mm OD
Bag neck
25 mm ID
Reservoir valve
26 mm ID (to bag inlet) / 25 mm OD (to oxygen reservoir)
Oxygen gas inlet
6 mm OD
ID = internal diameter OD = outside diameter
Oxygen concentration delivered under different conditions (specified in the tables below). Values in parenthesis
are referred to the device without reservoir.
ADULT resuscitator bag
ADULT
Ventilation bag volume 1800ml – Reservoir volume 2700ml
Flow O2
L/min
(TIDAL) Delivered volume x ventilation rate
600x12
600x20
750x12
750x20
1000x12
1000x20
5
83(32)
58(34)
65(34)
50(30)
55(31)
45(31)
10
99(37)
80(38)
99(37)
99(36)
88(36)
62(36)
15
97(46)
97(45)
97(46)
97(44)
97(44)
90(46)
CHILD resuscitator bag
CHILD
Ventilation bag volume 550ml – Reservoir volume 2700ml
Flow O2
L/min
(TIDAL) Delivered volume x ventilation rate
70x30
200x30
1000x12
5
83(32)
65(34)
55(31)
10
99(37)
99(37)
88(36)
15
97(46)
97(46)
97(44)
INFANT resuscitator bag
INFANT
Ventilation bag volume 320ml – Reservoir volume 900ml
Flow O2
L/min
(TIDAL) Delivered volume x ventilation rate
20x30
20x60
40x60
70x60
5
97(75)
97(72)
92(59)
85(52)
10
97(75)
97(78)
97(78)
86(61)
15
97(95)
97(92)
97(82)
97(73)
Device performance Adult (> 30 kg) Child (5÷30 Kg) Infant (< 5 Kg)
Average volume for compression (ml)
900
250
130
Maximum loss
Less than 0,7 ml for all versions
Resuscitator bag nominal volume (ml)
1778
478
305
Breathing resistance Adult (> 30 kg) Child (5÷30 Kg) Infant (< 5 Kg)
Inspiration/exhalation
2,2 cmH2O (215 Pa) / 3,3
cmH2O (323 Pa)
per 50 LPM
2,2 cmH2O (215 Pa) /
3,3 cmH2O (323 Pa) per
50 LPM
2,2 cmH2O (215 Pa) /
3,3 cmH2O (323 Pa) per
50 LPM
Exhalation final pressure (normal use conditions)
3,2 cmH2O (323 Pa)
Pressure setting POP-OFF valve
40 cmH2O (3920 Pa) – manual block
Unloading pressure of patient valve
138 cmH2O (13500 Pa)
101 cmH2O (9900 Pa)
87 cmH2O (8530 Pa)
Dimensions and weights (without accessories)
Adult (> 30 kg)
Child (5÷30 Kg)
Infant (< 5 Kg)
Dimensions and weights (without accessories)
325x130x130 mm –
314 gr. (±5 %)
255x91x91 mm –
194 gr. (±5 %)
256x85x74 mm –
158 gr. (±5 %)

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16 WARRANTY
Oscar Boscarol guarantees the resuscitator bag (all variants) for a period of 1 year from the date of purchase from the original
distributor. The company guarantees that the device is free of material and/or manufacturing defects.
The warranty does not cover: the normal wear, discoloration and any other cosmetic irregularities that do not affect unit operation.
If, at any time during the entire 1-year warranty period, the product is found to be defective, before sending the device must be sent
to Oscar Boscarol srl a specific request for authorization to return. In case of acceptance of the return, the Oscar Boscarol Srl (Ltd)
will repair or replace the defective parts and/or the whole unit at its own discretion. All shipping costs are charged to the customer.
Warranty conditions:
To benefit from the warranty, the registration form found in the product documentation must be filled out and returned by mail, fax
or e-mail to the following address:
OSCAR BOSCAROL SRL V. E. Ferrari, 29 – 39100 BOLZANO, ITALY
Fax: [phone] – E-mail: [e-mail]
To validate the warranty process, the customer must provide evidence of the following documentation:
5. copy of the invoice and/or receipt of purchase containing the device serial number and date of purchase.
6. confirmation from the manufacturer or its representative that it really does involve a fault stemming from the manufacturing
process or components deemed defective from the time of their supply.
7. absence of any tampering, changes and/or anything that does not conform with the original product.
In terms of safety, reliability and functionality of the device, Oscar Boscarol S.r.l. can be held responsible only if the device has been
and is used correctly, strictly following the directions provided in these operating instructions.
With reference to what is described in these warranty conditions, Oscar Boscarol S.r.l. cannot be held liable for direct or indirect
accidental damage, if modifications have been made to the device or any of its parts have been damaged by accident and misuse. On
the resuscitator bag there are no other express or limited warranties of merchantability, fitness or or other outside those described
in this manual.

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Printed in Italy by Oscar Boscarol Srl (Ltd)
ED01_REV01-2021 IFU OB VENTI-BAG_ENG
Original language: Italian
https://www.boscarol.it/ita/eifu.php
MADE IN TAIWAN (R.O.C.)