Atmos MEDAP FINA VAC T 50 User manual

OPERATING INSTRUCTIONS
TAPPING UNIT FOR DRAINAGE
MEDAP-FINA VAC T 50
GA 5752 3075 GB 13

GA 5752 3075 GB 13
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.
V13 2020-07
4

GA 5752 3075 GB 13 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 Overview of the FINA VAC T 50................................................................................................... 8
1.5.2 Overview of the FINA VAC T 50 versions .................................................................................... 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 ..................................................................................................................................... 11
1.6.5 Interface description................................................................................................................... 12
1.6.5.1 Mechanical overflow protection ............................................................................... 12
1.6.5.2 Vacuum connection tube ......................................................................................... 12
1.6.5.3 Hydrophobic bacterial and viral filter ....................................................................... 12
1.6.5.4 Septic fluid jar including septic fluid jar cap ............................................................. 12
1.6.5.5 Suction tube............................................................................................................. 13
1.6.5.6 Utensil...................................................................................................................... 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
3.2.2.1 General.................................................................................................................... 17

GA 5752 3075 GB 13
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Table of contents
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.......................................................................................................................... 21
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 part.................................................................................................................................................28
7.7 Sending in the device...............................................................................................................................29
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
GA 5752 3075 GB 13 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
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
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 ‘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
GA 5752 3075 GB 13 7
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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 Overview of the FINA VAC T 50
3
3
1
1
1
1
6
6
9
9
2
2
1
1
5
5
8
8
7
7
6
6
4
4
1
1
0
0
Fig. 1: Overview of the FINA VAC T 50
1 Vacuum gauge 7 Hydrophobic bacterial and viral filter
2 Housing 8 Tube connector of mechanical overflow protection
3 Control valve 9 Mechanical overflow protection
4 Shunt air openings of control valve 10 Pressure-relief valve
5 Tube connector 11 NIST connection
6 Vacuum connection tube

Introduction
Basic requirements
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1
1.5.2 Overview of the FINA VAC T 50 versions
7
7
2
2
9
9
1
1
3
3
4
4
8
8
6
6
5
5
Fig. 2: Overview of the FINA VAC T 50 versions
1Version A
Tapping unit with integrated gas pin
6 Locking lever
7 NIST nipple
2 Plug 8 NIST screw connection
3 Terminal unit 9 Connection tube
4Version B
Tapping unit with rail clamp and NIST
connection
5 Rail clamp
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.

Introduction
Basic requirements
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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.
1.6.2 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 T 50
Main function: Aspiration of secretion, blood and serous fluids
Medical indications /
application:
Maintaining the vacuum in the regulation range 0 to −5 kPa
Specification of the main
function:
Drainage and temporary collection of body fluids. For the supply of
vacuum, the FINA VAC T 50 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: Patients of all ages
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.

Introduction
Basic requirements
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Contraindications: The FINA VAC T 50 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 surgical aspiration
• For bronchial aspiration
• For thoracic drainage without additional use of a water
manometer
• In combination with disposable thoracic drainage systems which
require a flow higher than 12 l/min or a vacuum higher than
−5 kPa
• With central gas supply systems with supply pressures other
than −100 kPa to −60 kPa
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.
1.6.4 Versions
The connection of the FINA VAC T 50 to the terminal unit for vacuum depends on the model
being used:
Version A: Tapping unit with integrated gas pin
• FINA VAC T 50 is fitted directly to the terminal unit.
Version B: Tapping unit with rail clamp and NIST connection
• FINA VAC T 50 is designed for mounting onto a 25 x 10 mm equipment rail 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 VAC T 50 Wall DIN (REF 5752 3747)
• FINA VAC T 50 Equipment rail (REF 5752 3748)

Introduction
Basic requirements
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1.6.5 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.
1.6.5.1 Mechanical overflow protection
The mechanical overflow protection device protects the product against the ingress of fluids. The
tube connector must match the vacuum connection tube.
1.6.5.2 Vacuum connection tube
The vacuum connection tube is used to connect the tapping unit and the septic fluid jar.
Technical specifications
• Shore hardness of 60
• Inner diameter 6 mm
• Length 50 cm (± 10 cm)
• Vacuum resistant down to −95 kPa (must not collapse)
Prerequisites
• The inner diameter of the vacuum connection tube should match the outer diameter of the
tube connector on the septic fluid jar cap of the pump.
The vacuum connection tube will be referred to only as ‘connection tube’ below.
1.6.5.3 Hydrophobic bacterial and viral filter
In its function as overflow protection device, the hydrophobic bacterial and viral filter protects the
product against the ingress of particles, fluid and foam. In its function as bacterial and viral filter, it
protects the product against the ingress of bacteria and viruses.
Prerequisites
• Pore size ≤ 1.0 μm
• 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).
1.6.5.4 Septic fluid jar including septic fluid jar cap
The septic fluid jar and septic fluid jar cap are used to collect the secretions extracted.
The special requirements for the thoracic drainage must be fulfilled.
Prerequisites
• Maximum leakage: ≤3 bubbles in 10 s
• 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.

Introduction
Basic requirements
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1.6.5.5 Suction tube
The suction tube acts as the connection between the septic fluid jar and the utensil.
Technical specifications
• Shore hardness of 60
• Inner diameter 6–8 mm
• Length 1.3–3.0 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 must match
the inner diameter of the suction tube.
1.6.5.6 Utensil
Suction catheters or lances, for example, 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 suction
tube.
• The utensil must be sterilisable or a sterile single-use item.
• Biocompatibility

Safety notes
General safety notes
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2 Safety notes
2.1 General safety notes
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.
WARNING!
Risk of injury!
ATMOS products may be used only when fully functional.
Ensure that this ATMOS product is fully functional and in good working order prior
to use. ATMOS recommends always having another aspirator ready to hand. This
enables aspiration even in the event of product failure.
CAUTION!
ATMOS recommends always having another aspirator ready to hand. This enables
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 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
bacterial and viral 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!
Impacts!
Impacts may cause damage to sensitive, precision mechanical components.
Do not expose the product to impacts.
WARNING!
Measuring accuracy / oversuction!
The product may only be operated in a vertical position.

Safety notes
Product safety notes
GA 5752 3075 GB 13 15
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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!
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!
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!
Risk of injury!
Replace the hydrophobic bacterial and viral filter immediately if it is discoloured,
contaminated or oversucked.
Furthermore, the filter must be changed if the vacuum displayed is −0.05 bar /
−5 kPa when the vacuum controller is in the ‘max’ position and the suction tube is
open.
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.
• Do not hold or lift the product by the vacuum gauge.
• The vacuum gauge is not autoclavable.
• During storage, the unit should be protected against damage by using cloths, for
example.

Initial operation
Equipment inspection
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3 Initial operation
3.1 Equipment inspection
DANGER!
Product inspection!
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.
DANGER!
Infection hazard!
Contaminated components may be hazardous to the patient's health.
Prepare the product according to the hygiene guidelines before using it. Clean and
disinfect the product.
NOTE
In order to ensure the functionality, carry out a function check prior to use.
3.2 Mounting
3.2.1 Mounting the vacuum gauge
NOTE
The vacuum gauge connection is pressure range specific. If it is not possible to
assemble the vacuum gauge, check the scale maximum and the unit designation to
see whether the parts can actually match.
Fig. 3: Assembly of the vacuum gauge
Insert the vacuum gauge into the basic unit
with a 90° twist and press downwards until
it stops. Turn the vacuum gauge by 90° to
the front to lock it.

Initial operation
Mounting
GA 5752 3075 GB 13 17
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3.2.2 Connection to the terminal unit
3.2.2.1 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.
3.2.2.2 Version A
1
1
2
2
Fig. 4: Version A
Tapping unit with integrated gas pin
The tapping unit (1) is plugged directly into
the terminal unit (2).
3.2.2.3 Version B
2
2
1
1
3
3
4
4
6
6
5
5
8
8
7
7
Fig. 5: Version B
Tapping unit 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).

Initial operation
Mounting
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3.2.3 Assembly of the septic fluid jar and accessories
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.
1
1
2
2
3
3
4
4
Fig. 6: 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 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.

Initial operation
Mounting
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1
1
4
4
3
3
2
2
Fig. 7: Connection of the hydrophobic bacterial
and viral filter
Connection of the hydrophobic bacterial
and viral filter
The connection tubes (1) and (2) are
plugged onto the tube connectors of the
hydrophobic bacterial and viral filter (3).
Check the flow direction of the bacterial and
viral filter. The inlet side must face the
patient, and the outlet must face the
tapping unit.
Then plug the connection tube onto the
tube connector (4) on the housing of the
tapping unit.
Connect the connection tube with the
designated tube connector of the septic
fluid jar.
1
1
2
2
Fig. 8: Connection of the septic fluid jar
Connection of the septic fluid jar with
integrated hydrophobic bacterial and viral
filter
Attach the connection tube (1) to the tube
connector (2) on the housing of the tapping
unit and to the tube connector of the septic
fluid jar.

Operation
Function test
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4 Operation
4.1 Function test
DANGER!
Function 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 function check every time before using the unit.
Prior to each use, carry out the following function check:
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 and NIST connection
• The tapping unit is locked firmly to the equipment rail.
1
1
Fig. 9: Pressure-relief valve of the tapping unit
All versions:
• The product has been properly cleaned
and neither residue nor contamination are
present.
• The control valve can be easily turned.
• The overflow protection device and the
hydrophobic bacterial and viral filter are
mounted, fully functional and no residue is
trapped in it.
• The tube connectors are firmly secured 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.
• A septic fluid jar is connected to the tapping
unit.
• The pressure-relief valve (1) of the tapping
unit is not clogged.
• The vacuum controller is working.
• The pressure-relief valve (silicone washer)
of the tapping unit is pressed tight and cen-
tred on the sealing edge of the pressure-re-
lief valve seat.
• The vacuum controller generates a maxi-
mum value of 6.5 kPa when fully opened.
• When regulating up and down from zero
setting to the maximum and back, there are
no jumps in the vacuum.
• Close the control valve very gently only.