MEDAP FINA RV O2/AIR User manual

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

GA 5752 3125 GB 10
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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
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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
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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
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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
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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
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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
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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