MEDAP FINA O2 User manual

OPERATING INSTRUCTIONS
MEDAP
FINA FINE REGULATOR O2 / AIR
GA 5752 2806 GB 10

GA 5752 2806 GB 10
2
Subject to technical modification!
Illustrations and technical specifications may vary slightly from those in these Operating
Instructions as a result of ongoing product development.
V10 2018-04
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GA 5752 2806 GB 10 3
Table of contents
Table of contents
1 Introduction ..............................................................................................................................................5
1.1 Foreword ....................................................................................................................................................5
1.2 How to use these operating instructions .................................................................................................... 5
1.2.1 Abbreviations ............................................................................................................................... 5
1.2.2 Symbols ....................................................................................................................................... 5
1.2.2.1 Cross-references ....................................................................................................... 5
1.2.2.2 Actions and responses .............................................................................................. 5
1.2.3 Definitions .................................................................................................................................... 6
1.2.3.1 Design of safety notes ............................................................................................... 6
1.2.3.2 Structure of notes ...................................................................................................... 6
1.2.4 Symbols used .............................................................................................................................. 6
1.3 Disposal......................................................................................................................................................8
1.3.1 Packing ........................................................................................................................................ 8
1.3.2 ATMOS products.......................................................................................................................... 8
1.4 Overview ....................................................................................................................................................9
1.4.1 Overview of FINA fine regulator O2 / AIR .................................................................................... 9
1.4.2 Overview of FINA fine regulator versions, O2 / AIR ................................................................... 10
1.5 Basic requirements...................................................................................................................................10
1.5.1 Use in accordance with the intended purpose ........................................................................... 10
1.5.2 Applicable standards.................................................................................................................. 11
1.5.3 Intended purpose ....................................................................................................................... 11
1.5.4 Versions of FINA fine regulator O2 / AIR.................................................................................... 12
1.5.5 Possible applications ................................................................................................................. 13
1.5.6 Interface description................................................................................................................... 13
1.5.6.1 Approved interface for compressed gas supply ...................................................... 13
1.5.6.2 Dimensions for the gas type specific connection for compressed gas .................... 13
1.5.6.3 Fine regulator outlet................................................................................................. 13
1.5.6.4 Connection tube ...................................................................................................... 13
1.5.6.5 Tube adapter for Air and O2 .................................................................................... 14
1.5.6.6 Gas jet pump for Air and O2, with and without gauge ............................................. 14
2 Safety notes............................................................................................................................................15
2.1 General safety notes ................................................................................................................................ 15
2.2 Product safety notes.................................................................................................................................15
3 Initial operation.......................................................................................................................................17
3.1 Product testing .........................................................................................................................................17
3.2 Connection to the terminal unit.................................................................................................................17
3.2.1 General ...................................................................................................................................... 17
3.2.2 Version A.................................................................................................................................... 17

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Table of contents
3.2.3 Version B.................................................................................................................................... 18
3.3 Mounting accessories...............................................................................................................................18
3.3.1 General ...................................................................................................................................... 18
3.3.2 Connection of gas-jet pump ....................................................................................................... 19
4 Operation ................................................................................................................................................20
4.1 Functional test..........................................................................................................................................20
4.2 Setting the flow for treatment ................................................................................................................... 20
5 Taking the unit out of operation............................................................................................................22
6 Cleaning and disinfection...................................................................................................................... 23
6.1 General.....................................................................................................................................................23
6.2 Cleaning ...................................................................................................................................................24
6.2.1 General ...................................................................................................................................... 24
6.2.2 Cleaning procedure.................................................................................................................... 24
6.3 Disinfection...............................................................................................................................................25
6.3.1 General ...................................................................................................................................... 25
6.3.2 Suitable disinfectants ................................................................................................................. 25
6.3.3 Disinfection procedure ............................................................................................................... 26
6.4 Special safety notes ................................................................................................................................. 26
7 Maintenance............................................................................................................................................27
7.1 General.....................................................................................................................................................27
7.2 Period tests ..............................................................................................................................................27
7.3 Malfunctions and troubleshooting.............................................................................................................27
7.4 Repairs.....................................................................................................................................................28
7.5 Service hotline:.........................................................................................................................................28
7.6 Type plate position ...................................................................................................................................28
7.7 Sending in the device...............................................................................................................................28
8 Technical specifications ........................................................................................................................30
8.1 General.....................................................................................................................................................30
8.2 Ambient conditions...................................................................................................................................30
8.3 Technical specifications............................................................................................................................30
8.4 Dimensions and weight ............................................................................................................................ 30
9 Approved accessories...........................................................................................................................31
9.1 Accessories..............................................................................................................................................31
9.2 Consumables ...........................................................................................................................................31

Introduction
Foreword
GA 5752 2806 GB 10 5
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1 Introduction
1.1 Foreword
Your facility has selected the leading-edge medical technology made by ATMOS. We sincerely
appreciate the trust you have placed in us.
1.2 How to use these operating instructions
These operating instructions are provided to familiarise you with the features of this ATMOS
product. They are subdivided into several chapters.
Please note:
• Please read these operating instructions carefully and completely before using the product for
the first time.
• Always proceed in accordance with the information contained herein.
• Store these operating instructions in a location near the product.
1.2.1 Abbreviations
EN European standard
EEC European Economic Community
VDE Verband der Elektrotechnik Elektronik Informationstechnik (Association for
Electrical, Electronic & Information Technology)
1.2.2 Symbols
1.2.2.1 Cross-references
References to other pages in these operating instructions are identified with a double arrow
symbol „“.
1.2.2.2 Actions and responses
The „“ symbol identifies an action taken by the user while the „“ symbol identifies the reaction
that this will induce in the system.
Example:
Turn on the light switch.
Lamp lights up.

Introduction
Definitions
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1.2.3 Definitions
1.2.3.1 Design of safety notes
Pictogram Descriptor Text
DANGER!
Indicates a direct and immediate risk to
persons, which may be fatal or result in
most serious injury.
The text for the safety note
describes the type of risk and
how to avert it.
WARNING!
Indicates a potential risk to persons or
property which may result in health hazard
or grave property damage.
CAUTION!
Indicates a potential risk to property which
may result in property damage.
Tab. 1: Design of safety notes
1.2.3.2 Structure of notes
Notes not referring to personal injury or property damage are structured as follows:
Pictogram Descriptor Reference to
NOTE Supplementary assistance or further
useful information without potential injury
to persons or property damage is
described in the text of the note.
ENVIRONMENT Information regarding proper disposal.
Tab. 2: Structure of notes
1.2.4 Symbols used
Symbols are attached to products, type plates and packaging.
Symbols Identification
4
Labelling for products which were developed and are marketed in
compliance with the 93/42/EEC Medial Products Directive. Class Is, Im, IIa,
IIb and III products are also marked with the identifying number for the
notified body.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for "Name and address of the manufacturer as well as date of
manufacture".

Introduction
Symbols used
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Symbols Identification
Labelling in compliance with the ISO 15223-1 standard.
Symbol for "Product number".
Labelling in compliance with the ISO 15223-1 standard.
Symbol for "Serial number".
Labelling in compliance with the ISO 15223-1 standard.
Symbol for "Follow Operating Instructions".
Material designation for the plastic PA (polyamide).
Packaging label.
Symbol for "Keep dry".
Packaging label.
Symbol for "Fragile! Handle with care".
Packaging label.
Symbol for "Top".
Labelling in compliance with the ISO 15223-1 standard.
Symbol for "Temperature limitations".
Labelling in compliance with the ISO 15223-1 standard.
Symbol for "Relative humidity".
Labelling in compliance with the ISO 15223-1 standard.
Symbol for "Atmospheric pressure".
Meaning of type plate.
Symbol for "oil- and fat-free".
Tab. 3: Symbols

Introduction
Disposal
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1.3 Disposal
WARNING!
Infection hazard!
The product or some of its components may be contaminated after use.
Clean and disinfect the product before disposal.
1.3.1 Packing
The packing is made of materials compatible with the environment. ATMOS will dispose of the
packing materials upon request.
1.3.2 ATMOS products
ATMOS will take back used products or those which are no longer in service. Please contact your
ATMOS representative for more detailed information.

Introduction
Overview
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1.4 Overview
1.4.1 Overview of FINA fine regulator O2 / AIR
2
4
1
3
5
6
78
9
10 11
12
Fig. 1: Overview of FINA fine regulator O2 / AIR
1FINA fine regulator Air, Version A, with
integrated gas pin
6FINA fine regulator, Version B, with rail clamp
and NIST connection
2 Terminal unit 7 Rail clamp
3 Plug 8 Equipment rail
4 Fine regulator inlet 9 Locking lever
5FINA fine regulator for oxygen, Version
A, with integrated gas pin
10 NIST housing
11 NIST screw connection
12 Connection tube

Introduction
Overview of FINA fine regulator versions, O2 / AIR
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1.4.2 Overview of FINA fine regulator versions, O2 / AIR
3
4
2
9
1
5
6
7
8
3
Fig. 2: Overview of FINA fine regulator versions, O2 / AIR
1 Tube connector Air (M 18 x 1) 6 Air LF/HV gas-jet pump without gauge
(REF 5750 7542)
2 Tube adapter Air (M 18 x 1) for 4, 6, 8 mm
tube
7 O2LF/HV gas-jet pump without gauge
(REF 5750 7543)
3 Connection tube with internal diameter 4, 6 or
8 mm
8 O2LF/HV gas-jet pump with gauge
(REF 5750 7540)
4 Tube connector O2, (G 3/8“) 9 Gauge
5 Tube adapter O2(G 3/8) for 4, 6, 8 mm tube
1.5 Basic requirements
1.5.1 Use in accordance with the intended purpose
Product
As per appendix IX of the Medical Products Directive 93/42/EU this product belongs to class IIa.
In accordance with this directive the product may only be used by persons who have been
instructed how to use this product by an authorised person.
This product is to be used exclusively for human medicine.
When employed in a commercial or business use, this product shall be entered in the inventory.

Introduction
Applicable standards
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Accessories
Accessories or combinations of accessories may be utilised only as and when indicated in these
operating instructions.
Other accessories, combinations of accessories and consumable items may be used only if they
have a valid certification, are intended expressly for the particular use and will not adversely
affect performance, the prescribed ambient conditions or safety requirements.
1.5.2 Applicable standards
The product satisfies the basic requirements set forth in Annex I to the 93/42/EU Directive drafted
by the Medical Products Council (Medical Products Directive) as well as the applicable national
(German) codes and the Medical Products Act in Germany. This has also been demonstrated
through the application of the corresponding standards, which have been harmonised with the
93/42/EEC Directive.
1.5.3 Intended purpose
Name: FINA FRV O2 and AIR
Main function: The FINA FRV O2 and AIR may be used for the following main
functions:
• In conjunction with a gas-jet pump for aspiration of secretion,
blood, serous fluids, vomit and rinsing fluids along with any con-
tained particles
• In conjunction with a hand-held nebuliser to provide metered
administration of medication aerosols
Medical indications /
application:
Aspiration: For all aspirations, where a regulation of the vacuum
strength is not necessary and a regulation of the volume flow is
sufficient, e.g. general surgeries (e.g. aspiration of wound cavities,
abscesses) and bronchial aspiration of adults
Drug administration: Together with a hand-held nebuliser
administration of water soluble drugs via an inhalation mask
Specification of the main
function:
Connection of FINA FRV O2 or AIR is made to a central oxygen or
compressed air supply with a supply pressure of 300 to 500 kPa
±-10 % or to the pressure regulator of an oxygen gas cylinder,
whereby the initial pressure of the pressure regulator lies between
300 and 500 kPa ±-10 %.
Aspiration: Drainage and temporarily collection of body fluids. A
septic fluid jar which has to be used, allows a temporary collection
of the derived body fluids.
Drug administration: The administration of medication aerosols via
compressed air takes place via connection tubes to a hand-held
nebuliser. The patient presses the inhalation mask of the hand-held
nebuliser onto mouth and nose.
User profile: Doctor, medically trained staff
Patient groups: Aspiration: Surgical aspiration: Patients of all ages; bronchial
aspiration of adults
Drug administration: Patients of all ages
Application organ: Aspiration: Natural and artificial body orifices
Drug administration: Lung

Introduction
Versions of FINA fine regulator O2 / AIR
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Application time: For continuous operation; in practice short-term use on the patient
(< 30 days)
Application site: The application site is the clinical environment and doctor’s
practices. The application of the product may only be performed by
medically trained and introduced staff.
Contraindications: The FINA FRV O2 and AIR may not be used for the following
purposes:
• Outside the medical sector
• In MR areas
• In the home care sector
• Being operated directly by the patient
• If not reducing the vacuum of the central gas supply poses a
danger for the patient (e.g. in drainage, in paediatrics and neo-
natology). Usage in combination with disposable thoracic drain-
age systems with integrated vacuum regulation is excepted.
• For vacuum extraction
• For the aspiration of flammable or explosive liquids
• For the aspiration of smoke that is generated during HF and
laser surgery without the connection of an intermediate smoke
filter
• For the ventilation of patients
• With central gas supply systems with other supply pressures
than 500 kPa +/-10 %
The product is: Not active
Sterility: No sterile product
Single-use product /
reprocessing:
The device and parts of the accessories are reusable. For
information on reprocessing, cleaning and disinfection please see
the operating instructions.
1.5.4 Versions of FINA fine regulator O2 / AIR
The connection of the tapping unit to oxygen or compressed air depends on the model being
used:
• Version A: Tapping unit with integrated gas pin. The FINA fine regulator is fitted directly to the
terminal unit.
• Version B: Tapping unit with rail clamp and NIST connection. The FINA fine regulator is
designed for mounting to an equipment rail 25 x 10 mm and is supplied via a NIST connection
with oxygen or compressed air from a terminal unit connected using a connection tube with
probe.
Products and accessories are only permitted with the ISO colour coding. In Germany, Austria and
Switzerland, products with neutral colour coding are also permitted.
NOTE
The products are supplied with ISO coding. The scope of delivery includes a label
for neutral colour coding.

Introduction
Possible applications
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The product is available in the following versions:
• FINA fine regulator O2Wall DIN (REF 5752 3705)
• FINA fine regulator Air Wall MEDAP (REF 5752 3708)
• FINA fine regulator Air Wall DIN (REF 5752 3709)
• FINA fine regulator Air equipment rail (REF 5752 3710)
1.5.5 Possible applications
The following usage options are made possible by connecting products or accessories which are
contained in the list of accessories or which satisfy the specifications of the interface description.
• A tube adapter for compressed air (REF 5252 3104) or oxygen (REF 5752 3106) can be used
to connect suitable connection tubes with inner diameters of 4 mm, 6 mm and 8 mm to the
FINA fine regulator.
• With the gas-jet pumps for compressed air (REF 5750 7542) or oxygen (REF 5750 7540 and
5750 7543), the compressed air or oxygen is converted into vacuum to enable suction. The
FINA fine regulator acts to regulate the volume flow.
1.5.6 Interface description
All devices and accessories which are combined with the tapping unit must be listed in the
accessories list or meet the specifications of the interface description. The configuration of the
overall system as well as the functional testing are subject to the overall responsibility of the
medical staff. Functionality and suitability of the connected accessory for each intended
application must be checked by the operator before every use. This includes the functionality of
the connector components, its air tightness and suitability regarding material properties, working
pressure and flow rate.
1.5.6.1 Approved interface for compressed gas supply
In order to supply compressed gas, the tapping unit is connected to the medical gas supply
system (CGSS) with a pressure of 300 – 500 kPa ±10 %. The pressure in the supply line must be
indicated and in the event of improper functioning must be limited to 1000 kPa by an integrated
pressure-relief valve.
1.5.6.2 Dimensions for the gas type specific connection for compressed gas
The dimensions for plugs or terminal units are subject to national standards DIN 13260-2
(Germany) and MEDAP standard, depending on the product type.
1.5.6.3 Fine regulator outlet
• Tube connector Air: M 18 x 1
• Tube connector O2: G 3/8“
The inner thread of the cap nut of the accessory must match the outer thread of the tube
connector of the fine regulator Air or O2. Ensure that the connection between the fine regulator
and the accessory is leak-free.
1.5.6.4 Connection tube
The connection tube is connected to the tube adapter. The connection tube (Shore hardness 60),
internal diameter 4, 6 or 8 mm; may not collapse or must be compression-proof. The connection
tube must comply with the hospital's standards for hygiene. The inside diameter of the connection
tube must match the outside diameter of the tube adapter.

Introduction
Tube adapter for Air and O2
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1.5.6.5 Tube adapter for Air and O2
The tube adapter is used to connect the tapping unit and the connection tube. The inner thread of
the tube adapter Air or O2must match the outer thread of the tube connector of the fine regulator
Air (M 18x1) or O2(G 3/8“).
1.5.6.6 Gas jet pump for Air and O2, with and without gauge
The inner thread of the cap nut of the gas-jet pump must match the outer thread of the tube
connector of the fine regulator Air (M 18x1) or O2(G 3/8“).

Safety notes
General safety notes
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2 Safety notes
2.1 General safety notes
DANGER!
Incorrect use can result in fatalities!
Instructions for using components made by other manufacturers are not part of
these operating instructions.
Ensure that the manufacturer's instructions are followed.
DANGER!
Observe hygiene guidelines!
Contaminated components may be hazardous to the patient's health.
Prepare the product according to the hygiene guidelines before using it for the first
time. Clean and disinfect the product.
DANGER!
Fire/explosion hazard!
Air, oxygen and oxygen compounds react explosively with oils, greases and
lubricants. Fire and explosion hazard due to compressed gases.
Always keep the product free of oils, greases and lubricants. Only use sliding
means (lubricants) approved by ATMOS for this product.
DANGER!
Fire hazard!
Fire hazard as a result of escaping oxygen.
Never smoke near equipment which carries oxygen and avoid using open fires or
glowing objects. Check tight fitting and firm seat of the connector when mounting
accessories.
DANGER!
Defective product!
Using incorrect spare parts and accessories can cause injuries or equipment
failure.
Only use original accessories or spare parts.
WARNING!
Risk of injury!
Hazard resulting from incorrect handling.
Follow the operating instructions for all accessories.
2.2 Product safety notes
DANGER!
Danger to life!
The user must check the functionality and suitability of the components for the
respective application.

Safety notes
Product safety notes
16 GA 5752 2806 GB 10
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WARNING!
Impacts!
Impacts may cause damage to sensitive, precision mechanical components.
Do not expose the product to impacts.
WARNING!
Non-permissible load!
If the permissible load is exceeded, leakages may occur at the connection between
terminal unit and probe.
In accordance with DIN EN ISO 9170-1, the overall weight of the product and
accessories may not exceed 2 kg.
CAUTION!
Malfunction!
Ensure that the connection between the product and the accessory is leak-free.
CAUTION!
Observe ambient conditions!
The precision, operation, mechanical stability and tightness of the product cannot
be guaranteed if the maximum upper and lower ambient temperatures are
exceeded.
DANGER!
Infection hazard!
During aspiration, use a hydrophobic bacterial or viral filter in order to keep
contamination from entering the unit.
CAUTION!
Property damage!
Exposure to UV rays can cause material fatigue. The stability would no longer be
ensured.
Do not expose the product to strong UV light.

Initial operation
Product testing
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3 Initial operation
3.1 Product testing
DANGER!
Product testing!
Only product parts which are in perfect condition can ensure proper functioning of
the product. The product parts will thus have to be carefully inspected before
mounting.
Check whether all tubes are undamaged.
Check whether the unit has been properly cleaned and that there are no residues or soiling.
Do not use damaged components.
3.2 Connection to the terminal unit
3.2.1 General
NOTE
Please refer to the manufacturer’s instructions for the particular terminal unit for
information on connecting the gas probe to the terminal unit.
3.2.2 Version A
1
2
Fig. 3: Version A
Tapping unit with integrated gas pin
The tapping unit (1) is plugged directly into
the terminal unit (2).

Initial operation
Version B
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3.2.3 Version B
2
1
3
4
6
8
5
7
Fig. 4: Version B
Tapping units with rail clamp and NIST
connection
With the upper edge of the guide groove at
the front, position the rail clamp (1) at a
slight angle onto the equipment rail (2) and
then press it against the equipment rail and
allow it click into place.
Make sure that the rail clamp is correctly
secured and that the tapping unit is in a
stable position on the equipment rail. The
locking lever (3) must be flush with the
railmounted stand holder.
Insert the NIST nipple (4) of the connection
tube into the NIST connection (5) of the
tapping unit and tighten down the NIST
screw connection (6) by hand.
Plug the gas probe (7) of the connection
tube into the terminal unit (8).
3.3 Mounting accessories
3.3.1 General
WARNING!
Tensile forces!
The connected accessories must not exert any mechanical forces which could
adversely affect the secure seating of the product.
WARNING!
Tensile forces!
Hold the basic unit with one hand when installing or removing accessories in order
to compensate for the tensile forces which are created.

Initial operation
Connection of gas-jet pump
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3.3.2 Connection of gas-jet pump
WARNING!
Oversuction!
Use the tapping unit in conjunction with gas-jet pump only when a properly
functioning hydrophobic filter and a bacterial and viral filter are in place.
1
2
Fig. 5: Connection of gas-jet pump
Mounting the oxygen gas-jet pump
Check to ensure that a flat seal is located in
the tapped hole of the cap nut (1) of the
oxygen gas-jet pump.
Screw the cap nut of the oxygen gas-jet
pump onto the outlet (2) of the fine
regulator.
The oxygen gas-jet pump is mounted on
the fine regulator.

Operation
Functional test
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4 Operation
4.1 Functional test
DANGER!
Functional check!
The product is used in the treatment of patients. Any restriction in the unit's
performance can result in serious complications in treatment.
Perform a complete functional check every time before using the unit.
Perform a complete functional check of the tapping unit prior to use. During functional testing,
pay attention to the following conditions:
Version A: Tapping unit with integrated gas pin
• The tapping unit is correctly plugged into the terminal unit
Version B: Tapping unit with rail clamp
• The gas pin of the connection tube is seated correctly in the terminal unit
• The NIST connection to the tapping unit has no leak
• The tapping unit is locked firmly to the equipment rail
For all versions:
• The tube connectors are firmly seated and tightly sealed and no mechanical forces are acting
on the tubes
• The plastic and rubber components are in perfect condition and show no signs of ageing
• The accessories are correctly connected
• The device is leak-free
• The fine regulator seals tightly when closed
• It is possible to variably adjust the flow rate from zero to the maximum flow
• The device is in good hygienic condition
4.2 Setting the flow for treatment
WARNING!
Compressed gas setting!
The regulating mechanism is sensitive. Make the compressed gas settings very
carefully!
NOTE
When applying oxygen in its function as a medication, it is absolutely necessary to
measure the flow rate, as per the monograph in the European Pharmaceuticals
Reference.