MEDAP FINA VAC P 350 User manual

OPERATING INSTRUCTIONS
TAPPING UNIT PAEDIATRICS
MEDAP-FINA VAC P 350
GA 5752 2133 GB 21

GA 5752 2133 GB 21
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.
V21 2020-07
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GA 5752 2133 GB 21 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
1.3 Symbols used.............................................................................................................................................6
1.4 Disposal......................................................................................................................................................7
1.4.1 Packaging .................................................................................................................................... 7
1.4.2 ATMOS products.......................................................................................................................... 7
1.5 Overview ....................................................................................................................................................8
1.5.1 FINA VAC P 350........................................................................................................................... 8
1.5.2 Versions of the FINA VAC P 350.................................................................................................. 9
1.6 Basic requirements.....................................................................................................................................9
1.6.1 Use in accordance with the intended purpose ............................................................................. 9
1.6.2 Applicable standards.................................................................................................................. 10
1.6.3 Intended purpose ....................................................................................................................... 10
1.6.4 Versions of the FINA VAC P 350................................................................................................ 11
1.6.5 Interface description................................................................................................................... 11
1.6.5.1 Vacuum connection tube ......................................................................................... 11
1.6.5.2 Hydrophobic bacterial and viral filter ....................................................................... 12
1.6.5.3 Septic fluid jar including septic fluid jar cap ............................................................. 12
1.6.5.4 Suction tube............................................................................................................. 12
1.6.5.5 Fingertip................................................................................................................... 12
1.6.5.6 Utensil...................................................................................................................... 12
1.6.5.7 Mechanical overflow protection ............................................................................... 13
2 Safety notes............................................................................................................................................14
2.1 General safety notes ................................................................................................................................ 14
2.2 Product safety notes.................................................................................................................................14
3 Initial operation.......................................................................................................................................16
3.1 Equipment inspection...............................................................................................................................16
3.2 Mounting...................................................................................................................................................16
3.2.1 Mounting the vacuum gauge...................................................................................................... 16
3.2.2 Connection to the terminal unit .................................................................................................. 17

GA 5752 2133 GB 21
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Table of contents
3.2.2.1 General.................................................................................................................... 17
3.2.2.2 Version A.................................................................................................................. 17
3.2.2.3 Version B ................................................................................................................. 17
3.2.3 Assembly of the septic fluid jar and accessories ....................................................................... 18
4 Operation ................................................................................................................................................20
4.1 Function test............................................................................................................................................. 20
4.2 Working with the product.......................................................................................................................... 20
5 Taking the unit out of operation............................................................................................................22
5.1 Completing the aspiration process...........................................................................................................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...............................................................................................................................................24
6.3.1 General ...................................................................................................................................... 24
6.3.2 Suitable disinfectants ................................................................................................................. 25
6.3.3 Disinfection procedure ............................................................................................................... 25
6.4 Product-specific safety notes ................................................................................................................... 25
7 Maintenance............................................................................................................................................27
7.1 General.....................................................................................................................................................27
7.2 Periodic tests............................................................................................................................................27
7.3 Malfunctions and troubleshooting.............................................................................................................27
7.4 Repairs.....................................................................................................................................................28
7.5 Service hotline.......................................................................................................................................... 28
7.6 Spare parts...............................................................................................................................................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 Standard scope of delivery....................................................................................................................... 31
9.2 Accessories..............................................................................................................................................31
9.3 Consumables ...........................................................................................................................................31

Introduction
Foreword
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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
Symbols used
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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
1.3 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 ‘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’.

Introduction
Disposal
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Symbols Identification
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Name and address of the manufacturer as well as date of
manufacture’.
Packaging label.
Symbol for ‘Keep dry’.
Packaging label.
Symbol for ‘Caution! Do not overturn’.
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
1.4 Disposal
WARNING!
Infection hazard!
The product or some of its components may be contaminated after use.
Clean and disinfect the product before disposal.
1.4.1 Packaging
The packaging is made of materials compatible with the environment. ATMOS will dispose of the
packaging materials upon request.
1.4.2 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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1.5 Overview
1.5.1 FINA VAC P 350
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3
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9
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1
0
0
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Fig. 1: Overview of the FINA VAC P 350
1 Vacuum gauge 7 Tube connector of mechanical overflow protection
2 Housing 8 Mechanical overflow protection
3 Control valve 9 NIST connection
4 Tube connector 10 Shut-off valve
5 Vacuum connection tube
6 Hydrophobic bacterial and viral filter

Introduction
Basic requirements
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1.5.2 Versions of the FINA VAC P 350
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5
2
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7
7
1
1
3
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4
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8
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9
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Fig. 2: Overview of the FINA VAC P 350 versions
1Version A
Tapping unit with integrated gas pin
6 NIST screw connection
7 Connection tube
2 Plug 8 Locking lever
3 Terminal unit 9 Rail clamp
4Version B
Tapping unit with rail clamp and NIST
connection
5 NIST nipple
1.6 Basic requirements
1.6.1 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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1.6.2 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 Devices Act (MPG) in Germany. This has also been
demonstrated through the application of the corresponding standards which have been
harmonised with Directive 93/42/EEC.
1.6.3 Intended purpose
Name: FINA VAC P 350
Main function: Aspiration of secretion, blood, serous fluids and vomit along with
any contained particles
Medical indications /
application:
The FINA VAC P 350 is used to ensure the precise adjustment of
the vacuum and is particularly well suited for bronchial aspiration in
paediatrics and neonatology.
Specification of the main
function:
Drainage and temporary collection of body fluids. For the supply of
vacuum, the FINA VAC P 350 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 drained body fluids.
User profile: Doctor, medically trained staff
Patient groups: Bronchial aspiration in paediatrics and neonatology; the FINA VAC
B 800 should be used for bronchial aspiration in 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 VAC P 350 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
• For vacuum extraction
• For the aspiration of flammable or explosive liquids
• For the aspiration of smoke that is generated during HF and
laser surgery
• For drainages and thoracic drainages
• For surgical aspiration
• With central gas supply systems with supply pressures other
than−100kPato−60kPa
The product is: Active
Sterility: Not a sterile product