Boscarol OB OXIKIT PLUS User manual

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COMPLETE DISTRIBUTION OXYGEN KIT FOR AMBULANCE
OB OXIKIT PLUS
USER MANUAL
PRODUCED BY:

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INDEX
INDEX................................................................................................................................................................. 3
SYMBOLS ........................................................................................................................................................... 4
LIST OF OBLIGATIONS & PROHIBITIONS CONCERNING THE DEVICE................................................................. 5
WARNINGS & PRECAUTIONS: READ CAREFULLY!.............................................................................................. 6
INTRODUCTION ................................................................................................................................................. 8
INTENDED USE .............................................................................................................................................. 8
GENERAL INFORMATION & STRUCTURE OF THE DEVICE.............................................................................. 8
USE CONTRAINDICATIONS ............................................................................................................................ 9
SAFETY WARNINGS ....................................................................................................................................... 9
INSTALLATION OF THE OXYGEN DISTRIBUTION KIT .......................................................................................... 9
INSTALLATION OF THE COMPONENTS.......................................................................................................... 9
INSTALLATION OF CONNECTION HOSES ..................................................................................................... 10
INSTALLATION OF THE OXYGEN BAR .......................................................................................................... 10
LOW PRESSURE ELECTRIC TRANSDUCER..................................................................................................... 10
FUNCTIONAL CHECK ON THE EXCHANGER...................................................................................................... 11
CHECK ON PERMANENT CONNECTIONS ..................................................................................................... 11
PREPARATION & OPERATION .......................................................................................................................... 12
START .......................................................................................................................................................... 12
AFTER USE ................................................................................................................................................... 12
LONG-TERM NON-USE ................................................................................................................................ 12
PREPARATION FOR RE-USE.............................................................................................................................. 12
FUNCTIONAL CHECKS ...................................................................................................................................... 13
PERIODIC CHECKS........................................................................................................................................ 13
CHECKING THE KIT FOR LEAKS .................................................................................................................... 13
WHAT TO DO IN CASE OF ANY LEAK? ......................................................................................................... 13
REPLACEMENT OF LOW PRESSURE SEALING RINGS ................................................................................... 14
TROUBLESHOOTING ........................................................................................................................................ 14
MAINTENANCE ................................................................................................................................................ 15
DISPOSAL OF THE OB OXIKIT STD/C KIT .......................................................................................................... 16
ACCESSORIES, CONSUMABLES & REPLACEMENT PARTS ................................................................................ 16
ASSISTANCE SERVICE ....................................................................................................................................... 16
TECHNICAL SPECIFICATIONS & REFERENCE STANDARDS................................................................................ 17
WARRANTY ...................................................................................................................................................... 19

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SYMBOLS
S.1 Symbols used on the device and referred to in the instruction manual
Red carefully the user manual before using and/or install the OB OXIKIT PLUS
Specific warnings for the device which must always be taken into consideration
CE marking in accordance with Leg. 46/97 for medical devices of Class 1 and higher (European
Directive 93/42/EEC)
Use the device only in the temperature range indicated
Manufacturer
Date of manufacture
Materials used in the device may be recycled following appropriate procedure under national
laws and local regulations
Do not use if the packaging is not found to be intact
Catalogue identification code
Manufacturing lot number
Serial number
Use on the kit or its components of lubricants, grease, oil-based products or oil-based
derivatives is prohibited
Do not dispose of the product in the local environment

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S.2 Symbols used in the instruction manual to alert the reader to specific issues
Alert: important information how to use correct the device and avoidance of risk of injury to
the operator, patient and/or damages to the device.
Warnings: information requiring special attention.
Notes and information on correct use of the device.
LIST OF OBLIGATIONS & PROHIBITIONS CONCERNING THE DEVICE
•Do not apply oils, grease or other substances to the input or output fittings. The device is designed
for dry use only and not for the lubrication of any of its components.
•Do not tamper with the oxygen distribution kit, its fittings or its terminals. In case of any malfunction
contact the kit installer, the manufacturer or one of its authorized service centres.
•Never immerse (even partially) the oxygen regulator in disinfectant substances, water or
detergents. If the need arises, use a soft cloth (which does not leave traces of tissue or residue)
moistened with hot water. Always use clean disposable gloves (not to be reused) when acting on
the device. Human skin is not free of oil or grease: when such substances meet compressed oxygen,
they may cause spontaneous combustion or explosion.
•It is strictly prohibited to smoke or use an open flame near the device connected to the source
(oxygen cylinder), whether in operation or with the valve closed.
•Liquids must be prevented from entering the device as they may cause spontaneous combustion or
explosion.
•During assembly and disassembly of the pressure regulator, it is prohibited to use any type of
mechanical tool. Screw the fitting to the oxygen cylinder exclusively with hands. Forces exerted on
fittings by mechanical tools may damage thread or seals thus provoking dangerous gas leaks.
•Always secure the oxygen cylinder so that it may not fall. For use in emergency vehicles, refer to
the reference standard EN1789 (European Norm) on safely securing medical devices. Remember
that the oxygen cylinder is heavy, and its fall may easily provoke serious damage to the pressure
regulator with consequent risk of explosion and/or high-pressure gas escape.
•Never completely empty the oxygen cylinder so that ambient air does not enter the cylinder and
cause corrosion. This happens when atmospheric pressure is greater than that inside the cylinder
itself.
•Open and close the oxygen cylinder slowly and cautiously. Otherwise the compressed gas may
cause damage to the device and provoke dangerous vibrations to the distribution kit that can
propagate to the connected medical devices. Pressure shocks, or ‘hammer’ effects, are
dangerous because they increase the risk of ignition and spontaneous combustion.

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WARNINGS & PRECAUTIONS: READ CAREFULLY!
Read carefully
This user manual has been prepared with simple language to be easily understood by all. In case you
have any difficulty in interpreting the instructions, contact the manufacturer for clarification, using
the following contact details.
•Before using the ambulance oxygen distribution kit, please read this instruction manual. For best performance and
utmost safety, it is necessary to fully understand the operation of the device and to take all safety precautions
indicated in the manual.
•Use of this kit is only intended for the purposes indicated in this manual.
•The kit is designed for the distribution of medical oxygen to one or more terminals in emergency vehicles, such as
ambulances. Oxygen is a combustive agent that may easily cause spontaneous combustion. The use of lubricants,
oils, grease, fats, disinfectants or any other type of substance on the kit is strictly prohibited! Always refer to the
instructions contained in this instruction manual before acting and/or intervention that might endanger the safety
of persons or the integrity of vehicles.
•The kit may be installed, operated and controlled exclusively by experienced and properly trained personnel. All
other uses are strictly prohibited! The parts of the kit may not be used separately and may not be altered or replaced
by other similar components.
•Because of the type of gas used, adequate safety and prevention measures must be adopted in periodic inspections,
cleaning, disinfection, decontamination and storage of the device and its components. The labelling plates,
conditions of use and storage, periodic overhauls and scheduled maintenance must all be respected.
•The laboratory tests on the OB OXIKIT device (biocompatibility according to ISO 18562-1) showed that flexible pipes
made of PVC could, in the long time, release harmful substances to the human body. A proper risk analysis and the
absence of reports to the contrary, allows us to say that a use of the device for a maximum of 3 hours continuous
on the same patient does not create any danger to the patient’s health. However, since the use of oxygen in
ambulances is linked to serious respiratory diseases, in this case it is justified to use it for a longer time and this to
safeguard the life of the patient.
•Before proceeding with any type of operation on the kit, it is mandatory to disconnect the source (compressed
oxygen cylinder). Never place any parts of the device in water or fluid substances. These substances can damage
the device and create dangerous situations.
•The only assistance service authorized for repair, maintenance and technical inspection is the manufacturer (Oscar
Boscarol Srl) or a service centre authorized by the manufacturer. Any intervention by anyone not directly authorized
by the manufacturer is expressly prohibited and renders the warranty null and void. Any person that intervenes on
the kit or its components is directly liable for any harm thus caused to persons and/or things. Product certification
and approval expire automatically in case of improper intervention on and/or alteration of the kit and/or its
components by any unauthorized person.
•To replace the inlet filter of the pressure regulator, please refer to the instruction manual for the pressure regulator.
The use of alternative replacement parts, which, although similar, may endanger the safety of operation or
compromise the performance of the device, is strictly prohibited.
•We recommend having a spare pressure regulator always available to be used in case of failure of any in use (to
avoid not being able to supply gas to a patient in case of any fault in the used component).
•Always carefully observe all indications in this instruction manual for cleaning, disinfection and decontamination of
the kit components. Establish a series of training courses for personnel to be instructed in operational use,
maintenance and preparation for reuse.
•Periodically check (at least once a month) the state of wear of connecting hoses between pressure regulators,
oxygen rail and cylinder exchanger.
•This manual is to be considered a document mandatorily attached to the device. It must therefore always be
available to operators in the place where the device is installed or used. In case of loss, deterioration or damage to
this instruction manual, request a copy or download it from the manufacturer's website www.boscarol.it.
Tel.: [phone]
[e-mail] or
[e-mail]

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If the user or patient becomes aware of a user hazard, side effect, accident caused by the
device or a criticality (operational and constructive) not addressed in these instructions for
use, must immediately notify the manufacturer at the following e-
mail address:
[e-mail]
HAZARDS IN USING OXYGEN: SYMBOLS & DEFINITIONS
OXYGEN
Warning! Compressed oxygen that meets substances such as oils, fats, alcohol and organic
substances may cause spontaneous combustion or explosion.
This manual uses several graphical symbols to draw the reader's attention to certain precautions and/or warnings. These
symbols refer to the applicable regulations in standard EN ISO 15223-1:2017 Medical devices – Symbols to be used
with medical device labels, labelling and information to be supplied.
SAFETY INSPECTION
Always refer to the instructions contained in this instruction manual for maintenance operations and their
frequency. At least every six months, a general check (of functionality, leakage and wear) must be
performed on the device. At least every two years, the filters of the inlet fitting must be replaced. At least
every five years, the kit shall be fully overhauled and inspected by the manufacturer or an authorized
service centre. The hoses must be immediately replaced in case of leakage or damage and in any case
every five years from the date of initial installation (whether they have been used or not).
Operator responsibilities
The operator (meaning the end user) must always observe the following operating rules:
•Immediately replace damaged, altered, missing or suspected faulty components or parts. Always only use
original replacement parts (purchased by the manufacturer)!
•Before using the device, carefully and thoroughly read this instruction manual and ask the manufacturer for
further clarification in case of any doubt.
•Only attentive and correct use of the device can guarantee optimal operation and total protection of patients
and operators from harm.
•Only operate the device in accordance with the technical specifications and conditions of use indicated by the
manufacturer and referred to in this instruction manual. Use other than the intended use this device is strictly
prohibited.

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INTRODUCTION
INTENDED USE
This medical oxygen distribution kit has been carefully designed and manufactured to be installed in emergency vehicles
(e.g. ambulances). The need to have oxygen distribution points in such vehicles is defined in standard EN1789 and/or
by local regulations. To these terminals are to be attached medical devices capable of delivering the gas in the form and
quantity required to meet therapeutic needs. The nominal pressure of the kit exercise is 400kPa (4 bar). OB OXIKIT PLUS
is designed and manufactured in compliance with applicable legal requirements. The main reference standards adopted
are EN 1789, EN ISO 5359, EN ISO 7396-1 and EN ISO 15001. It is not possible for the user to modify the nominal pressure
of the kit. The class of risk, according to the 93/42/EEC is IIa for the kit without pressure regulators, and IIb for the kit
with pressure regulators.
A user is not supposed to adjust the nominal outlet pressure of the device. It is prohibited to modify the kit or substitute
the original parts with parts, which are not included in the kit. The installer is considered responsible for the use of the
device different from the one specified in this manual.
GENERAL INFORMATION & STRUCTURE OF THE DEVICE
The kit is supplied with operating instructions and specific declaration of conformity (IIa). The declarations of conformity
for pressure regulators are separate (if included in the kit). The kit includes all components for installation on board
ambulances. It consists of an oxygen rail (with two terminal points), an exchanger and connecting hoses. If required,
they are also available the pressure regulators type OXYWAY FIX III, produced by WEINMANN, in accordance with ISO
10524-1. The terminal points and pressure reducer outputs depend on customer requirements and applicable local
specifications (such as UNI, AFNOR, DIN). The kits are specifically coded according to the configuration (e.g. terminals,
hose length and connection fittings).
The terminal units are fixed to the oxygen rail by the manufacturer with torque tools (in accordance with reference
standards) and may not be removed by the installer or user.
AVAILABLE TERMINAL UNITS:
The exchanger allows selection of one of the two cylinders available on the ambulance. The exchanger is designed and
built to completely stop the flow of gas in the neutral position (0). To allow oxygen to flow to the oxygen rail, one of the
two cylinders must be selected by turning the knob to position 1 or 2. The nominal output pressure of the terminals is
equal to the outlet pressure of the applied regulators.
The mechanical cylinders switchers are available both as stand-alone (both inputs and outputs on the lateral side) or as
integrated in the rail (for this version the two inputs cab be lateral or on the back side and the output only lateral).
Please refer to the pictures 1 and 2 for the best understanding
Upon customer request, is available one front stainless-steel plate that allow to fix the rail as embedded version. Please
follow the next pictures for your best understanding.
mini UNI
mini AFNOR
mini DIN
Picture 1
Picture 2

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Hoses are made of technical materials and fittings and are labelled in compliance with the standard EN ISO 5359. The
fittings are fixed with a reproducible mechanical process and therefore may not be replaced by detaching them from
their respective hoses (if necessary, they must be cut off and disposed of). The internal diameter of each hose is 6.0 mm
while the external diameter may range from 12 to 13 mm, depending on manufacturing tolerances. In case of damage
and/or detection of leakages, the hose must be replaced with an equivalent product purchased from the manufacturer
Oscar Boscarol Srl. The hoses are sold tested and with fittings included (straight, 90° or AFNOR). Authorized service
centres can replace the fittings if they have specific equipment provided by the manufacturer.
Please follow specific use instruction on the user manual for the pressure regulators.
USE CONTRAINDICATIONS
This medical device must not be used with gases other than oxygen
SAFETY WARNINGS
Symbols on the device components inform users about risks arising from use and necessary
precautions to be taken. The symbol on the dial of the pressure regulator gauge (see right) indicates
that the device must never come into contact with oils, greases, lubricants, alcohols or
hydrocarbons. These substances in combination with compressed oxygen favour spontaneous
explosive reactions. The pressure regulators are labelled with important information summarized
on the product labelling plate. For details, see the instruction manual of the pressure regulator. On the back of the
oxygen rail is a label that summarizes the information on the product labelling plate, the CE marking and the date of
manufacture. The manufacturer maintains an electronic system for the traceability of kit components and parts.
NOTE
The CE marking on the device is to be understood to refer to the complete kit. Separation or partial use
of the components void the CE marking and certification! The individual markings of components of the
kit do not imply their conformity separately from the rest of the device!
INSTALLATION OF THE OXYGEN DISTRIBUTION KIT
Warning! Before any intervention on the device or its feed system, it is
obligatory to wash hands thoroughly. Any presence of fats, grease, oils,
hydrocarbon-based substances, creams, detergents and/or skin plasters may
cause explosive reactions if they come into contact with highly compressed
oxygen. Never use mechanical tools to fix, tighten or loosen fittings!
INSTALLATION OF THE COMPONENTS
All operations described in this manual must be carried out in a clean environment and away from flammable
substances and gases! Never use lubricants, grease, fats or detergents with the device. Always keep in mind the type
of gas used and take adequate preventive safety measures.
All components in the kit are fully tested and inspected before they are put on sale. Always confirm the physical and
mechanical integrity of the device and contact the manufacturer in case of any doubt.
Use clean and decontaminated areas (i.e. devoid of foreign hazardous substances and dust) for installation of the
components. All tools used for the installation must be thoroughly cleaned and degreased. When necessary use
disposable gloves to avoid contact of the parts with skin (which can release fatty substances that can be dangerous if
they come into contact with oxygen). Because the distribution kit is a medical device, the installer must document the
Tube O2 with joint
90° - 90°
Tube O2 with joint
90° - DIR
Tube O2 with joint
DIR - DIR

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entire installation process and provide for final checks, testing and inspection before any use. Seal the connection hoses
to prevent the ingress of substances and particulates.
INSTALLATION OF CONNECTION HOSES
The installation of the connection hoses in a ambulance is most probably the most difficult part of installation because
it involves the passage of the hoses through tight spaces and behind or under separating walls. In many cases specific
protection is necessary to avoid acute bends or damage to the hoses that would compromise the correct functionality
and safety of the entire kit. Oscar Boscarol Srl, in order to facilitate the installer's task, uses only hoses fully in accordance
with reference standards and with specific fittings available for straight, 90° or AFNOR connections (see figures below).
Selection of the hose fittings is clearly linked to the type and specific challenges of each installation. The length of the
hoses can vary from a minimum of 1 to a maximum of 10 metres. The PVC hoses are made to reduce the effects of
extreme bends or 90° angles. It is recommended to route the pipes through protected channels that allow easy
inspection without excessive or right-angle curves. Always check for burrs or sharp edges that could damage the hoses.
CAUTION
During gas supply the hoses are pressurized, and this may cause vibrations and movement to the hoses
themselves. The effects of these phenomena over time may be hazardous to their integrity. These effects
are accentuated by forces due to the vehicle’s movement. Consider these points carefully when installing
the device in the ambulance.
INSTALLATION OF THE OXYGEN BAR
The oxygen bar is made of aluminium alloy suitably treated to be
compatible with oxygen. It features a low-pressure gauge,
terminals that are fixed on the front part of the bar itself and a
manually controlled mechanical exchanger. Fixing of the bar to
walls or dedicated supports must be performed using the holes
designed for that purpose (see figure). The holes allow for the use
of screws of diameter 4 or 5 mm (M4 or M5). It is not
recommended to drill the structure to make extra holes as the
oxygen bar has a containment chamber in the central part. It can be configured with 1 to 4 terminal units. The terminals
units may be complaint to different standard like to e.g. UNI 9507, DIN 13260, AFNOR NF-S 90-116 (or other standards
on request). For any special requirements, please contact the technical office of the manufacturer Oscar Boscarol Srl.
WARNING
Always position the components in spaces that can be inspected and are accessible for maintenance!
LOW PRESSURE ELECTRIC TRANSDUCER
Upon customer request it is possible to connect an electric pressure transducer directly on the oxygen rail. The output
electric signal (0,5÷4,5 Vdc) depends on the working pressure, and can be using to drive an electronic display (to e.g. OB
OXID). On the next table it is possible to identify the colour of the wiring and the technical specification.
The transducer accept pressure in the range from 0 to 10 bars (0 to 1000 kPa).
The initial voltage threshold is set to 0,5 Vdc to prevent any reading error and to avoid considering an alarm the absence
of oxygen pressure (0 V = cable disconnected or broken, 0,5 V = no working pressure in the system).

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WARNING!
The wrong connection of the wires can damage the pressure transducer. In case of doubts please follow
the identification marked on the body of the transducers.
FUNCTIONAL CHECK ON THE EXCHANGER
After attaching all the components of the kit, proceed with a functional test without gas. Act on the exchanger by turning
the knob to the centre position (closed) and then positions 1 and 2. There should be no impediment to this movement.
All users must have easy and safe access to the exchanger.
Connect the pressure regulators to cylinders and tighten the ring to the fitting by hand. Connect the hoses to the
exchanger and check that the position of the knob is central (0). Slowly open one cylinder at a time and check the
pressure of the two regulators on the gauge. Now, turn the exchanger know to position 1. It should be possible to read
the nominal output pressure of the gas from the regulator on the gauge of the bar (which is not the same as that on the
regulator).
Bring the exchanger to the central position (closed) and empty the kit by inserting a plug into one of the terminals of
the bar. The pressure indicated by the gauge on the bar should rapidly be seen to fall to zero. At this point, remove the
plug from the terminal socket and turn the exchanger to position 2. Check the pressure via the gauge on the bar. Close
both cylinders and empty the kit as described above. Re-check the tightness of all hose and component fittings (by hand,
without the use of tools).
CHECK ON PERMANENT CONNECTIONS
Before release the vehicle to the user, installation ensure that there are no leaks in the oxygen OB OXIKIT. For this
operation proceed as follows:
1. Connect the cylinders to the pressure regulators without opening them.
2. Bring the exchanger to its central, closed position.
3. Slowly open the two cylinders by opening their valves. Apply one manometer (with high precision class) at one
of the terminal unit
4. Turn the knob of the exchanger to the position 1 and check the pressure value on the oxygen bar gauge. Make
a note of this value.
5. Close the oxygen cylinders and wait 60 seconds. Re-read the pressure value on the pressure gauge of the
oxygen bar and check for any difference with the value noted previously. Any difference after 60 seconds
should be less than 5 mbar. It is recommended to use a precision digital pressure gauge for this test. Some such
gauges can automatically detect any leak after one minute.
6. Perform the operations described above with the exchanger in the position 2.
7. Close the cylinder valves and safely empty the oxygen system.
All components are fully tested by the manufacturer and, except for faults resulting from poor installation, any possible
leakages may be attributed to the fittings on the exchanger, the oxygen rail or the regulator inputs or outputs. Carefully
check that these connections are carefully but thoroughly tightened.
WARNING
To remove a pressure regulator from a cylinder, first close the oxygen cylinder valve and empty the kit.
Otherwise the pressure on the inlet fitting will prevent the operator from loosening the ring and
consequently from detaching the regulator itself. Remember that working in close proximity to
compressed oxygen implies a certain risk of generating explosive and incendiary reactions if there is the presence of
specific substances and/or high temperature conditions. To empty the kit, simply insert a plug of a medical device into
one of the terminals and open it. The pressure gauge on the bar should go down to zero. This operation must be
Wiring colour
Type of signal
GREEN
GND - GROUND
WHITE (GRAY)
OUTUT SIGNAL 0,5÷4,5 Vdc
BROWN
+VDC – Power supply

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performed for both cylinder connections (whose valves have first been closed) by moving the knob of the exchanger to
both positions 1 and 2. After emptying the kit, bring the exchanger knob back to its central, closed position.
PREPARATION & OPERATION
START
Make sure the oxygen cylinders are full and have a pressure higher than 50 bar (5000kPa). Connect
the regulators to the kit following the indications in their instruction manual. Slowly open the
cylinder valves and bring the exchanger knob to the central, closed position. Apply a medical device
with rated input pressure of 4 bar (400kPa) onto one of the terminals of the oxygen bar (e.g. a flow
meter). Turn the exchanger knob to select one of the two cylinders.
Do not forget to close the cylinder valves and empty the kit after every use of the vehicle.
AFTER USE
During use, check the amount of gas present in each cylinder via the pressure gauge on the pressure regulator. Never
completely empty the cylinder. This is to prevent ambient air from entering the cylinder, which can cause corrosion and
rust formation (due to the presence of moisture in the air). The gauge is a valuable aid to understanding when to change
the cylinder. To ensure adequate operating life and to avoid any malfunctioning of the regulator, it is recommended to
replace the cylinder when the pressure reading on the pressure gauge falls slightly below 30 bar (3000kPa). To close the
cylinder valve, turn its dial clockwise. Do not try to remove the pressure regulator unit with the cylinder valve open.
WARNING
The pressure regulator is not an “on-off” stop-valve. This means that it may let a small amount of gas
through to the kit. For this reason, at the end of each use, the oxygen cylinders must always be closed
at their valves and the exchanger knob set to its central, closed position. It is recommended to always
empty the kit after use, having already fully closed the cylinders!
LONG-TERM NON-USE
If the device is not in use for prolonged periods of time the following precautions must be taken:
- Avoid disconnecting the pressure regulators from the cylinders to prevent substances from entering
the device or part of it.
- Disconnect all medical devices from the terminal sockets of the oxygen bar and store them in a safe
place. The sockets are designed to be closed when not in use.
- In case the vehicle requires maintenance or other attention, make sure that the medical compartment
of the ambulance is inaccessible and that the pressure regulators are protected from the ingress of
dangerous substances (usually present in mechanical workshops). If the cylinders are removed from
the vehicle compartment, ensure that the pressure regulators (on the side of the input fittings) are
adequately secured and protected.
IMPORTANT
Even if the device is not used for a long time scheduled maintenance must be performed as well as
checks at least every 6 months. Failure to comply with these requirements may lead to malfunctioning
at a time of need, thus compromising safety!
PREPARATION FOR RE-USE
Cleaning and disinfection
In case of any need to clean the exterior of the device, always use only clean cloths. In case of need, use a cloth slightly
moistened with clean water. Liquids must never penetrate inside kit components. Do not spray any liquid on the outlets
of the oxygen bar!
If there is a need to apply any disinfectant on the outer surfaces of the device, take appropriate
precautions to prevent such substances from entering the interior. If this were to occur, there would be

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two possible serious effects in terms of safety: the first is that such substances come into contact with
oxygen at high pressure and thus may cause spontaneous combustion or explosion; the second is that
such substances may be conveyed together with the gas into the oral cavity of patients with clearly
dangerous consequences (risk of severe internal injury to the respiratory tract).
To disinfect the exterior of the device from contaminants (e.g. bodily secretions, blood), appropriate disinfectant
materials, available in the form of disposable wipes, may be purchased separately from Oscar Boscarol Srl. These
disinfectant wipes are laboratory tested to guarantee the neutralization of viruses, bacteria and microorganisms. Used
periodically, they destroy and prevent the formation of hazardous bio-films (surface layers that easily accommodate
bacteria, moulds, viruses and microorganisms).
NOTE
For more detailed information contact [email protected] or visit the website www.boscarol.it
FUNCTIONAL CHECKS
PERIODIC CHECKS
After every cylinder replacement, the device must be subjected to a full functional check. If there is any evidence of
possible defects, malfunctions or modifications to the device, the operator must immediately inform his or her line of
command and put the device out of use. If there are any suspicions at all of malfunctioning, it is recommended to subject
the device to a specific, in-depth inspection. A complete check of the kit must feature the following basic steps:
1. Visual inspection to identify possible defects or mechanical failure. Check (by hand) that the pressure gauge of
the regulator and of the oxygen bar is intact and properly fastened (it must not be possible to unscrew it by
hand). Check the fixing rings for damage and/or peeling of the chrome plating. The safety valve (located at the
rear) of the regulator must not be altered in any way. Verify that terminals of the oxygen bar are undamaged
and free of mechanical resistance to the insertion of medical device plugs. Check the external condition (if
possible) of the oxygen hoses.
2. Check the sealing of the device (see section “Check on Permanent Connections”).
3. Perform a functional and sealing check of the pressure regulator safety valve as described in the instruction
manual.
NOTE
It is recommended to always have available a kit of sealing rings for the connection hoses and of filters for
the input connector of the pressure regulator!
In case of deterioration, partial damage or presence of dirt, the input filter and the sealing O-ring of the regulator
(positioned on the fitting that connects to the cylinder) must immediately be replaced. The hoses of the connection kit
must be replaced in case of leakages or damage and in any case every five years from the date of initial installation
(whether used or not), due to the natural aging of the material. This period may decrease significantly in extreme
conditions. Replacements must always only be carried out by the original installer or an authorized service centre.
WARNING
Always use only replacement parts purchased directly from the manufacturer. The use of other parts
renders the device hazardous and immediately voids any outstanding warranty on the device.
CHECKING THE KIT FOR LEAKS
To check and test for leaks in the kit, proceed as described in the section “Check on Permanent Connections”.
WHAT TO DO IN CASE OF ANY LEAK?
Since this is a complex device consisting of many components, it is always preferable to refer to the original installers
and/or authorized service centres. If abnormalities are detected in any components, replace them exclusively with
original replacement parts. Since medical devices of Class IIa or IIb are involved (depending on the presence of pressure

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regulators or not), it is necessary to document all replacements and conserve serial and/or lot numbers for backwards
traceability. If a fault is due to the pressure regulator, it is necessary to send it to the manufacturer for repair.
WARNING
Never try to disassemble the pressure regulator to try to repair it yourself. Such operations are hazardous
and may cause harm to the operator due to mechanical parts contained within (e.g. springs and other
mechanical devices). Specific checks and safety tests are also necessary and may only be performed by
the manufacturer with specific tools and test devices. Both fittings and gauges are applied to the
components in accordance reference standards using precision calibrated tools. Refer to the pressure
regulator instruction manual for other checks and maintenance.
REPLACEMENT OF LOW PRESSURE SEALING RINGS
Each fitting with fixing ring contains a white-coloured sealing O-ring that
ensures the tightness of the fitting. These rings should be replaced
immediately if worn and/or partially damaged. O-rings normally available on
the market may not be used as they can cause explosions or leakages when
used with compressed oxygen. The figure here shows the hose complete with
connection fittings and sealing ring. To replace a ring, simply pull it out with
tweezers or hooked wire. Before inserting the new ring, wipe any deposits
from the lodging with a clean cloth while keeping the fitting facing down to
prevent fluid and solid substances from penetrating into the hose.
WARNING
Before carrying out such operations, make sure that the work environment is clean and use clean
protective gloves. Never clean or use detergents on the sealing rings. Never use lubricants or greases to
aid insertion of the rings into their lodgings.
TROUBLESHOOTING
The table below summarizes possible faults, defects and anomalies in the device and indicates the action to be taken
by the operator in each case:
Fault, defect, anomaly
Possible cause
Remedy
Leak between the regulator fitting and
the oxygen cylinder.
Sealing O-ring of the pressure regulator
damaged. Fitting fixing ring not
adequately tightened.
Change the sealing ring (see pressure
regulator
instruction manual). Tighten
the fitting fixing ring; by hand only!
Leak on the pressure regulator outlet
fitting (hose side).
Sealing O-ring damaged in hose
connection fitting. Fitting fixing ring not
adequately tightened.
Change the sealing ring in the hose
fitting. Tighten the fitting fixing ring; by
hand only!
Gas leak and intervention of the pressure
regulator safety valve.
Internal fault in the device. Send the device to an authorized service
centre or the manufacturer.
Faulty or damaged gauge. Mechanical
damage, damage to the threads of
fittings, cracking and/or peeling of the
regulator body.
Wear, alteration, mechanical or
accidental shock, cylinder dropped with
regulator connected, etc.
Send the device to an authorized service
centre or the manufacturer.
Distribution gauge not working.
Exchanger in central, closed position.
Connection hoses not connected or
defective.
Select cylinder 1 or 2 on the exchanger
knob. Open the cylinder valve. Faulty
pressure gauge; contact the
manufacturer.
Cylinder 1 and/or 2 cannot be selected.
Exchanger blocked or faulty mechanism.
Contact the installer authorized for
repairs.
Gas output from the terminals without
plugs or devices inserted devices.
Faulty terminal sockets.
Contact the installer authorized for
repairs.

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Leaks from hoses or connection fittings.
Deteriorated hoses. Seal rings of fittings
faulty or broken.
Replace the O-rings of all fittings from the
regulator to the exchanger and oxygen
bar
. If the leak persists, contact an
authorized service centre.
MAINTENANCE
Maintenance of the pressure regulators
Refer to the indications in the instruction manual for maintenance operations. All repairs and maintenance must be
performed by the manufacturer or authorized service centre. Some specific preventive maintenance may be performed
by operators that are properly trained and familiar with prevention and safety standards and regulations for oxygen
systems.
The regulator input filter must be replaced at least once every 6 months or immediately if dirty or partially obstructed.
Please check in the user manual the lifetime of the pressure regulator and control how often the device needs to be
inspected and verified.
Replacement of the hoses and maintenance of the exchanger
The integrity of hoses deteriorates even when they are not in use. The materials used in their manufacture are prone
to decay regardless of usage. Deterioration is exacerbated by temperature and humidity fluctuations in the environment
in which they are installed in addition to the oxidizing power of concentrated oxygen. It is therefore recommended to
check their integrity at least once every six months and replace them every five years after first installation. Sealing rings
must be replaced immediately in case of any defect or leakage.
The exchanger is subject to mechanical wear and tear caused by the movement of the control knob. Scheduled
maintenance is required every five years after first installation and may only be performed by Oscar Boscarol Srl or one
of its authorized service centres. The following table shows the various maintenance frequencies of the kit.
Maintenance frequency
Maintenance operations
Maintenance operator
Every 6 months after first installation.
Full check of the functionality of the kit,
leaks and pressure regulator
functionality. Check of the proper
functioning of the exchanger. Full check
of the fastness of hoses. Check of the
functionality of gauges. Replacement of
regulator input filters.
Trained operator or installer of kit in the
vehicle.
When leaks are detected.
Replacement of all the seal rings of hose
fittings. Check of the mechanical integrity
of hoses and fixing rings. Careful check of
the functionality of the exchanger.
Trained operator, authorized service
centre or manufacturer.
Every 5 years or in case of faults or
malfunction.
Replacement of hoses and all parts
subject to wear, functional check of all
parts, full operation and compliance with
standards and medical device directives.
The manufacturer's assistance service.
The service life of the oxygen kit is 10 years provided that the maintenance indicated in this manual is performed.
WARNING
The cylinders must be regularly subjected to specific requalification tests. Such tests are to be performed
by competent certification bodies. The operator assigned to connecting the pressure regulator to the
cylinder must ensure that the connection meets all applicable regulatory requirements.

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DISPOSAL OF THE OB OXIKIT STD/C KIT
The kit does not contain hazardous parts or substances, but it must be disposed of as provided for by
international, national and local regulations for the disposal and recycling of waste. Refer to local
authorities for information and details of companies specialized in waste disposal and the recycling of
metal parts.
ACCESSORIES, CONSUMABLES & REPLACEMENT PARTS
The kit is sold ready to use and is fully tested by the manufacturer in accordance with specific and documented standard
protocols. On delivery of the device, the customer/user must verify the absence of mechanical faults, breakages or
alteration of the pressure gauges and the correct positioning of pointers at zero. The manufacturer delivers the device
in suitable and adequate packaging to ensure safe transportation and the integrity of the device.
For a complete list of components, accessories and replacement parts for the oxygen distribution kit, contact the Oscar
Boscarol Srl. office.
The components can be purchased individually and are CE marked. These markings certify the
conformity of individual parts, but do not alone indicate the conformity of the assembled kit. The
conformity of kits supplied by Oscar Boscarol Srl. is declared following final testing and inspection of
the complete device.
WARNING: for the assembling of the pneumatic fittings (see below) you need a special tool available by our company!
Code Description Image
SPS9128 5 pieces, O-ring ø 7x1.2 mm for hose fittings (can be white or another colour)
SPS9130 10 pieces, hose crimp ring
SPS9132 3 pieces, 90° outlet fitting (without hose)
SPS9136 3 pieces, straight outlet fitting (without hose)
NOTE
For parts not listed in the above table, please contact the manufacturer Oscar Boscarol Srl
ASSISTANCE SERVICE
The device requires professional installation by sector specialists. Only the interventions described in this manual are
expressly authorized. No specialist technical interventions may be performed by end-users on components and pressure
regulators. Always refer to the manufacturer codes for replacement parts. Unauthorized intervention, tampering,
alteration, disassembly of the device or failure to observe use and safety precautions shall immediately void the
warranty and free the manufacturer from any liability for damage or harm to property or persons. Conformity of the
device to European Directive 93/42/EEC, as amended, and all reference standards always refers to the complete original

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kit of components described in the declaration of conformity. For assistance, servicing and maintenance, please contact
the manufacturer or direct dealer.
TECHNICAL SPECIFICATIONS & REFERENCE STANDARDS
Classification of the device in reference to Legislative Decree 46/97 (MDD93/42/EEC as amended)
The OB OXIKIT PLUS kit is a medical device in accordance to Italian Legislative Decree 46/97 that transposes the
European Directive 93/42/EEC (as amended). The kit includes all components necessary for the administration of
therapeutic oxygen in emergency vehicles. The terminal points and pressure regulator connection fittings to cylinders
follow local, national and international regulations and standards.
Classification of the device according the MDD93/42/EEC: IIa (without pressure regulators)
Source: therapeutic oxygen (O2)
Conformity with reference standards: EN ISO 1789, EN ISO 7396-1, EN ISO 5359, ISO 18562-1
Conformity of the regulators to the reference standard: ISO 10524-1:2006
Process used for CE marking: Annex II via notified body
CE marking on the device: CE0123 TÜV–SÜD Product service
Maximum dimensions of the components
All kit components are manufactured to customer specifications. All dimensions are documented in technical
reference drawings and in the technical data file for the kit. The sizes of the pressure regulators are indicated in their
respective instruction manuals.
Device specifications
Regulator inlet fitting (cylinder): UNI 4406, DIN 477 N°9, NF E 29-650/F, SS M10x1
Terminals on the oxygen bar: UNI 9507, DIN 13260 or AFNOR NF-S 90-116
Maximum kit intake pressure: 4bar (+1 -0) 400kPa (+100 -0)
Minimum kit flow rate (Qrv): >100LPM
Materials used in the manufacture of the kit: Brass, bronze, steel, aluminium alloy, plastics
Oxygen bar pressure gauge: f.s. 10bar – conformity to UNI EN 837-1 degreased
Pressure gauge precision: Class 2.5 (f.s.). Reading tolerance ±2.5%.
Output pressure regulation: Preset to 400kPa (+100 -0)
Hoses used: Conformity to EN ISO 5359 (printed on hose)
Service life of the device (maximum): 10 years from first installation
Service life of hoses: 5 years when used in ambulances or other mobile
structures
Minimum P2, Q=40LPM, P1 compressed 10-200bar: >3.6bar (>360kPa)
Maximum P2, Q=40LPM, P1 compressed 10-200bar: <5.5bar (550kPa)
Conditions of use and storage
Operating temperature range: -20÷60 °C
Storage temperature range: -20÷70 °C
Operating humidity range: 20÷90 % (not condensed)
Storage humidity range: 10÷80 % (not condensed)
Recommended atmospheric pressure range: 700÷1060 mbar
Component preservation conditions: dry and protected environment
NOTE
Note storage times and check pressure regulators and exchanger at least once every six months (full
functional check). Do not use the device if unused for a prolonged period without first performing a full
functional check.

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Conversion formulas
Below are several useful formulas for correct operation of the device:
Calculation of the oxygen volume of the kit:
OXYGEN VOLUME = CAPACITY OF THE CYLINDER X PRESSURE READING VALUE
Conversion of pressure units:
1 bar = 100,000 Pa = 100 kPa = 1.0197 kg/cm² = 10.198 mH2O = 750 mmHg = 0.987 atm = 14.5 psi = 33.455 ftH2O
The oxygen administration kit allows delivery of a nominal flow of 100 LPM at the nominal pressure of 4 bar (400 kPa).
The connection to the terminals of the kit of medical devices that need oxygen flows exceeding this value inevitably
determines variations in the nominal pressure of the system and may cause possible malfunctioning of the devices.
Symbols and identification of the device
Symbols and labels are applied to all kit components to identify the device and date of manufacture. The pressure
regulators feature an indication of the due date of the next inspection, which is mandatory and is to be performed
exclusively by the manufacturer.
All medical devices connected to the kit must comply with European Directive 93/42/EEC, as amended. Medical devices
for assisted and controlled ventilation must be equipped with an integrated pressure regulator as required by applicable
reference standards.

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WARRANTY
Oscar Boscarol Srl. provides for a warranty on the OB OXIKIT PLUS of 24 months from the date of purchase. Oscar
Boscarol Srl warrants that every new OB OXIKIT PLUS is free from defects in materials due to production processes. This
warranty does not cover wear and tear arising from standard use, discoloration of external parts or discoloration and
other cosmetic irregularities which do not in any case degrade the device from a technical or structural point of view.
Any device that, during the twenty-four months of warranty, is found to be defective by the purchaser, must be sent to
Oscar Boscarol Srl together with written information on the suspected fault. Oscar Boscarol Srl. at its discretion may
repair or replace defective components or the entire device. All postal charges, shipping, customs clearance and
transport will be borne by the purchaser.
Warranty terms:
To take advantage of the warranty, fill in the product registration card included in the box and send it by post, fax or
email to:
OSCAR BOSCAROL SRL,V. E. Ferrari, 29 – 39100 BOLZANO, ITALY
Fax: [phone] – E-mail: [e-mail]
To confirm the validity of the warranty, documentation must be provided as follows:
•Copy of the invoice and/or statement of purchase that contains the device serial number and the date of purchase;
•Copy of the dispatch of the product registration card and warranty validation delivered with the product;
•Detection by the assistance service of a fault and/or defect attributable to material or production defects;
•Absence of tampering, modification or any other alteration not conforming to the original product as supplied.
In terms of safety, reliability, and functionality of the device, Oscar Boscarol Srl may be held liable only if:
•All interventions of assistance, repair, modification and preventive maintenance are performed directly by Oscar
Boscarol Srl or its authorized service centres;
•The device is used correctly in strict compliance with the indications in this instruction manual;
•Oxygen supply devices are in compliance with the requirements of European Directive 93/42/EEC, as amended, and
applicable specific local and national regulations.
In relation to warranty terms, Oscar Boscarol Srl may not be held liable for any incidental or consequential damages due
to unauthorized modifications, repairs or technical interventions on the distribution kit or its components or if any of
its parts have been damaged by accident or improper use. No other express or limited warranties of merchantability,
suitably or otherwise are provided for outside of that indicated in this instruction manual. Any legal disputes are to be
referred to the jurisdiction of the Court of Bolzano (Italy).
WARNING
IT IS STRICTLY FORBIDDEN to add to the device further pressure measurement devices or sensors. Any
intervention on the pressure gauges will render the device unusable and incompliant with provisions
of law. Oscar Boscarol Srl accepts no responsibility for damage or harm to property or persons due to
failure to observe these indications.

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Printed in Italy by Oscar Boscarol srl
OB OXIKIT PLUS REV11-2021_EN