MEDAP FINA RV O2/AIR User manual

OPERATING INSTRUCTIONS
MEDAP
FINA FINE REGULATOR VAC
GA 5752 3125 GB 10

GA 5752 3125 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 2020-07
4

GA 5752 3125 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 Design of other notes ................................................................................................ 6
1.2.4 Symbols used .............................................................................................................................. 6
1.3 Disposal......................................................................................................................................................7
1.3.1 General ........................................................................................................................................ 7
1.3.2 Packaging .................................................................................................................................... 7
1.3.3 ATMOS products.......................................................................................................................... 8
1.4 Overview ....................................................................................................................................................8
1.4.1 FINA Fine regulator VAC.............................................................................................................. 8
1.4.2 Versions of FINA fine regulator VAC ............................................................................................ 9
1.5 Basic requirements.....................................................................................................................................9
1.5.1 Use in accordance with the intended purpose ............................................................................. 9
1.5.2 Applicable standards.................................................................................................................. 10
1.5.3 Intended purpose ....................................................................................................................... 10
1.5.4 Versions of FINA fine regulator VAC .......................................................................................... 11
1.5.5 Interface description................................................................................................................... 11
1.5.5.1 Dimensions for the gas type specific connection for compressed gas .................... 11
1.5.5.2 Vacuum connection tube ......................................................................................... 11
1.5.5.3 Hydrophobic bacterial and viral filter ....................................................................... 12
1.5.5.4 Septic fluid jar including septic fluid jar cap ............................................................. 12
1.5.5.5 Suction tube............................................................................................................. 12
1.5.5.6 Fingertip................................................................................................................... 12
1.5.5.7 Utensil...................................................................................................................... 13
1.5.5.8 Mechanical overflow protection ............................................................................... 13
2 Safety notes............................................................................................................................................14
2.1 General safety notes ................................................................................................................................ 14
2.2 Product safety notes.................................................................................................................................14
3 Initial operation.......................................................................................................................................17
3.1 Equipment inspection...............................................................................................................................17
3.2 Connection to the terminal unit.................................................................................................................17

GA 5752 3125 GB 10
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Table of contents
3.2.1 General ...................................................................................................................................... 17
3.2.2 Version A.................................................................................................................................... 17
3.2.3 Version B.................................................................................................................................... 18
3.3 Mounting accessories...............................................................................................................................18
3.3.1 General ...................................................................................................................................... 18
3.3.2 Connection of the mechanical overflow protection .................................................................... 19
3.3.3 Connection of the hydrophobic bacterial and viral filter ............................................................. 19
3.3.4 Connection of the septic fluid jar with integrated overflow protection ........................................ 20
4 Operation ................................................................................................................................................21
4.1 Function test.............................................................................................................................................21
4.2 Setting the flow.........................................................................................................................................21
5 Taking the unit out of operation............................................................................................................23
6 Cleaning and disinfection...................................................................................................................... 24
6.1 General.....................................................................................................................................................24
6.2 Cleaning ...................................................................................................................................................25
6.2.1 General ...................................................................................................................................... 25
6.2.2 Cleaning procedure.................................................................................................................... 25
6.3 Disinfection...............................................................................................................................................25
6.3.1 General ...................................................................................................................................... 25
6.3.2 Suitable disinfectants ................................................................................................................. 26
6.3.3 Disinfection procedure ............................................................................................................... 26
6.4 Product-specific safety notes ................................................................................................................... 26
7 Maintenance............................................................................................................................................28
7.1 General.....................................................................................................................................................28
7.2 Periodic tests............................................................................................................................................28
7.3 Malfunctions and troubleshooting.............................................................................................................28
7.4 Repairs.....................................................................................................................................................29
7.5 Service hotline..........................................................................................................................................29
7.6 Sending in the device...............................................................................................................................29
8 Technical specifications ........................................................................................................................30
8.1 General.....................................................................................................................................................30
8.2 Technical specifications............................................................................................................................30
8.3 Ambient conditions...................................................................................................................................30
8.4 Dimensions and weight ............................................................................................................................ 30
9 Approved accessories...........................................................................................................................31
9.1 Accessories..............................................................................................................................................31
9.2 Consumables ...........................................................................................................................................31

Introduction
Foreword
GA 5752 3125 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
How to use these operating instructions
6GA 5752 3125 GB 10
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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 Design of other notes
Notes not referring to personal injury or property damage are used as follows:
Pictogram Descriptor Reference to
NOTE Supplementary assistance or further useful information.
ENVIRONMENT Information regarding proper disposal.
Tab. 2: Design of other 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 Medical Devices Directive 93/42/EEC. Class Is, Im, IIa, IIb and III
products are also marked with the identifying number of 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’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Product number’.

Introduction
Disposal
GA 5752 3125 GB 10 7
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Symbols Identification
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Serial number’.
Labelling in compliance with the IEC 60601-1 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’.
Tab. 3: Symbols
1.3 Disposal
1.3.1 General
Used products or parts thereof may be contaminated. To prevent potential infection, please clean
and disinfect the product prior to return/disposal.
1.3.2 Packaging
The packaging is made of materials compatible with the environment. ATMOS will dispose of the
packaging materials upon request.

Introduction
Overview
8GA 5752 3125 GB 10
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1.3.3 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.
1.4 Overview
1.4.1 FINA Fine regulator VAC
3
3
6
6
2
2
4
4
3
3
1
1
5
5
7
7
Fig. 1: Overview of FINA fine regulator VAC
1 Adjusting screw 5 Vacuum connection tube B
Inner diameter 6 mm
2 Tube connector VAC
3 Vacuum connection tube A
Inner diameter 6 mm
6 Tube connector for mechanical overflow protection
7 Mechanical overflow protection
4 Hydrophobic bacterial and viral filter

Introduction
Basic requirements
GA 5752 3125 GB 10 9
1
1.4.2 Versions of FINA fine regulator VAC
1
1
1
1
2
2
9
9
1
1
0
0
3
3
4
4
5
5
6
6
7
7
2
2
8
8
1
1
1
1
Fig. 2: Overview of FINA fine regulator VAC versions
1Version A 6 Equipment rail
Tapping unit with integrated gas pin 7 Rail clamp
2 Terminal unit VAC 8 Locking lever
3 Gas pin VAC 9 NIST housing
4 Fine regulator inlet 10 NIST nipple
5Version B 11 Cap nut
Tapping unit with rail clamp and NIST
connection
12 Connection tube
1.5 Basic requirements
1.5.1 Use in accordance with the intended purpose
Product
As per Annex IX to the Medical Devices Directive 93/42/EEC, 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 commercial or business use, this product must be entered in the inventory.
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.

Introduction
Basic requirements
10 GA 5752 3125 GB 10
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1.5.2 Applicable standards
The product satisfies the basic requirements set forth in Annex I to Council Directive 93/42/EEC
concerning medical devices (Medical Devices Directive) as well as the applicable national
(German) codes and the Medical Products Act (MPG) in Germany. This is certified by compliance
with harmonised standards such as IEC 60601-1 and related standards and the respective
special sections.
1.5.3 Intended purpose
Name: FINA FRV VAC
Main function: Aspiration of secretion, blood, serous fluids, vomit and rinsing fluids
along with any contained particles
Medical indications /
application:
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 (aspiration of wound cavities, abscesses) and
bronchial aspiration of adults.
Specification of the main
function:
Drainage and temporary collection of body fluids. For the supply of
vacuum, FINA FRV VAC is connected to a terminal unit for vacuum
of a central medical gas supply system with a pressure of -100 kPa
to -60 kPa. A septic fluid jar, which has to be used, allows for
temporary collection of the drained body fluids.
User profile: Doctor, medically trained staff
Patient groups: Surgical aspiration: patients of all ages; bronchial aspiration of
adults
Application organ: Natural and artificial body orifices
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 which have a central vacuum source. The application of
the product may only be performed by medically trained and
instructed staff.
Contraindications: The FINA FRV VAC 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
• With central gas supply systems with supply pressures other
than -100 kPa to -60 kPa

Introduction
Basic requirements
GA 5752 3125 GB 10 11
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The product is: Active
Sterility: Not a 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 VAC
The connection of the terminal unit to FINA FRV VAC depends on the model being used:
Version A: Tapping unit with integrated gas pin
• FINA FRV VAC is fitted directly to the terminal unit.
Version B: Tapping unit with rail clamp and NIST connection
• FINA VAC is designed for mounting onto an equipment rail 25 x 10 mm and is supplied via a
NIST connection with vacuum from a terminal unit connected using a connection tube with gas
probe.
Products and accessories are only permitted with 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.
The product is available in the following versions:
• FINA fine regulator VAC Wall MEDAP (REF 5752 3712)
• FINA fine regulator VAC Wall DIN (REF 5752 3713)
• FINA fine regulator VAC equipment rail (REF 5752 3714)
1.5.5 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. Configuration of the overall
system as well as 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, airtightness and suitability regarding material properties, working pressure and flow
rate.
1.5.5.1 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.
1.5.5.2 Vacuum connection tube
The vacuum connection tube is used to connect the hydrophobic bacterial and viral filter with the
septic fluid jar cap.
Technical specifications
• Shore hardness of 60
• Inside diameter 6 mm
• Length 50 cm (± 10 cm)
• Vacuum resistant down to -95 kPa (must not collapse)

Introduction
Basic requirements
12 GA 5752 3125 GB 10
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Prerequisites
• The vacuum connection tube must comply with the hospital's standards for hygiene.
• The inner diameter of the vacuum connection tube must match the outer diameter of the hy-
drophobic bacterial and viral filter.
• The inner diameter of the vacuum connection tube must match the outer diameter of the tube
connector on the bacterial and viral filter.
The vacuum connection tube will be referred to only as ‘connection tube’ below.
1.5.5.3 Hydrophobic bacterial and viral filter
In its function as overflow protection device, the hydrophobic bacterial and viral filter protects the
product against ingress of particles, fluid and foam. In its function as bacterial and viral filter, it
protects the product from the ingress of bacteria and viruses.
Prerequisites
• Pore size ≤ 1.0 µ.
• The tube connector must match the tube being used.
• The hydrophobic bacterial and viral filter must close tightly against water passage at an abso-
lute pressure of up to 10 kPa.
• If required, observe the direction of flow (see note on the hydrophobic bacterial and viral filter).
1.5.5.4 Septic fluid jar including septic fluid jar cap
The septic fluid jar and septic fluid jar cap are used to collect the secretions extracted.
Prerequisites
• Low leakage.
• Always fasten the septic fluid jar securely.
• The outer diameter of the tube connector on the patient side should match the inner diameter
of the suction tube.
1.5.5.5 Suction tube
The suction tube is used to connect the tube connector on the septic fluid jar on the patient side
and the fingertip or the utensil.
Technical specifications
• Shore hardness of 60
• Inner diameter of 6 - 8 mm
• Length 1.3 m - 3.0 m
• Vacuum resistant down to -95 kPa (must not collapse)
Prerequisites
• The outer diameter of the tube connector on the patient side of the septic fluid jar cap must
match the inner diameter of the suction tube.
1.5.5.6 Fingertip
The fingertip serves to vent the suction tube in order to be able to quickly interrupt the aspiration
process.
Prerequisites
• It must be possible to sterilise the fingertip or it must be a sterilised disposable item.
• The outer diameter of the tube connector on the patient side should match the inner diameter
of the suction tube.

Introduction
Basic requirements
GA 5752 3125 GB 10 13
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1.5.5.7 Utensil
The suction catheter, lance, etc., are referred to as utensils. The utensils are used to extract
septic fluids.
Prerequisites
• The inner diameter of the utensil's connector must match the outer diameter of the fingertip.
• The utensil must be sterilisable or a sterile single-use item.
• Biocompatibility.
• For endobronchial extraction, a utensil with side openings must be used.
1.5.5.8 Mechanical overflow protection
The mechanical overflow protection device protects the product from the ingress of particles, fluid
and foam. The tube connector must match the vacuum connection tube.

Safety notes
General safety notes
14 GA 5752 3125 GB 10
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2 Safety notes
2.1 General safety notes
WARNING!
Risk of injury!
ATMOS products may be used only when fully functional.
Ensure that the ATMOS product is fully functional and in good working order prior
to use.
WARNING!
Risk of injury!
Hazard resulting from incorrect handling.
Be absolutely sure to observe the operating instructions for all the products used in
the configuration.
DANGER!
Defective device!
Using incorrect spare parts and accessories can cause injuries or equipment
failure.
Only use original accessories or spare parts.
CAUTION!
ATMOS recommends always having another aspirator ready to hand. That way you
can perform aspiration even in the event of product failure.
2.2 Product safety notes
DANGER!
Infection hazard due to oversuction!
To avoid the ingress of fluid or foam into the product or the vacuum source, a
hydrophobic bacterial filter must be used. If secretion enters the inside of the unit,
the product must immediately be taken out of operation. Clean and disinfect the
product and have it repaired by a service technician authorised by ATMOS to do
so.
DANGER!
Infection hazard due to contamination!
To avoid the ingress of contaminants into the product or the vacuum source, a
hydrophobic bacterial filter must be used. If bacteria or viruses enter the inside of
the unit, the product must immediately be taken out of operation. Clean and
disinfect the product and have it repaired by a service technician authorised by
ATMOS to do so.
WARNING!
Risk of oversuction!
The tapping unit may only be used with the mechanical overflow protection in an
upright position.

Safety notes
Product safety notes
GA 5752 3125 GB 10 15
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DANGER!
Risk of injury to mucous membranes!
Endobronchial aspiration in paediatrics and neonatology requires particularly
careful limitation of the vacuum. For the regular endobronchial aspiration in
paediatrics and neonatology, ATMOS also offers paediatric versions with a higher
level of setting convenience.
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
the terminal unit and the gas probe.
In accordance with DIN EN ISO 9170-1, the overall weight of the product and
accessories may not exceed 2 kg.
WARNING!
Foaming!
Foam may be created when extracting secretion. Foam is detrimental to the
functioning of the mechanical overflow protection. This raises the risk that secretion
may penetrate the product and cause it to break down.
Use an ordinary foam inhibitor.
WARNING!
Measuring accuracy / oversuction!
The product may only be operated in a vertical position.
WARNING!
Backflow of aspirated secretion!
In the event of oversuction, the aspirated secretion may flow back to the patient if
there is secretion still left in the suction tube.
Before replacing the septic fluid jar in the event of oversuction or switching off the
vacuum, always remove the tube from the patient first.
WARNING!
Risk of injury!
Immediately replace the hydrophobic bacterial and viral filter if it is discoloured,
contaminated or oversucked.
Furthermore, the filter must be changed if the vacuum displayed is above -0.3 bar /
-30 kPa when the vacuum controller is in the ‘max’ position and the suction tube is
open.

Safety notes
Product safety notes
16 GA 5752 3125 GB 10
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WARNING!
Risk of injury!
The product may not be used for the following purposes or under the following
conditions:
• Never throw, hit or drop the unit.
• The product is not suitable for vacuum extraction.
• The product may not be used without a hydrophobic filter.
• The product may not be used without a bacterial and viral filter.
• The product may not be used without a septic fluid jar.
• The product may not be used without a fingertip.
• During storage, the unit should be protected against damage by using cloths, for
example.

Initial operation
Equipment inspection
GA 5752 3125 GB 10 17
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3 Initial operation
3.1 Equipment inspection
DANGER!
Equipment inspection!
Only components which are in perfect condition can ensure proper functioning of
the product. The components will thus have to be carefully inspected before using
the unit.
WARNING!
Infection hazard!
Contaminated components may endanger the health of staff and patients.
Ensure the product is prepared as per hygiene standards before using it for the first
time.
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
1
2
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
Mounting accessories
18 GA 5752 3125 GB 10
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3.2.3 Version B
2
2
1
1
3
3
4
4
6
6
8
8
5
5
7
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 on the equipment rail (2) and
then press it against the equipment rail and
allow it to 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 rail
clamp.
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 fit 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.
NOTE
Refer to the manufacturer's instructions for additional information on the use of the
septic fluid jar and the extraction utensil.

Initial operation
Mounting accessories
GA 5752 3125 GB 10 19
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3.3.2 Connection of the mechanical overflow protection
1
1
2
2
3
3
4
4
Fig. 5: Connection of the mechanical overflow
protection
Connection of the mechanical overflow
protection
Plug the overflow protection device (1)
directly onto the tube connector (2) on the
housing of the tapping unit and press
upwards until it stops.
Attach the connection tube (3) to the tube
connector (4) of the mechanical overflow
protection device and connect it to the
designated tube connector of the septic
fluid jar.
For disassembly, first remove the
connection tube from the tube connector of
the mechanical overflow protection device.
Then remove the complete overflow
protection device with lid from the tube
connector of the tapping unit. Hold the
tapping unit steady with one hand while
doing so.
3.3.3 Connection of the hydrophobic bacterial and viral filter
1
1
4
4
3
3
2
2
Fig. 6: Connection of the filter
Connection of the hydrophobic bacterial
and viral filter
The connection tubes (1) and (2) are
plugged onto the tube connectors of the
filter (3).
Check the flow direction of the filter. The
inlet side must face the patient, and the
outlet must face the tapping unit.
Then plug the connection tube (1) onto the
tube connector (4) on the housing of the
tapping unit.
Connect the connection tube (2) with the
designated tube connector of the septic
fluid jar.

Initial operation
Mounting accessories
20 GA 5752 3125 GB 10
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3.3.4 Connection of the septic fluid jar with integrated overflow protection
1
1
2
2
Fig. 7: Connection of the septic fluid jar
Connection of the septic fluid jar with
integrated overflow protection
Attach the connection tube (1) to the tube
connector (2) on the housing of the tapping
unit and connect it to the tube connector of
the septic fluid jar.