MEDAP S VAC INT User manual

OPERATING INSTRUCTIONS
MEDAP
TAPPING UNIT
S VAC INT
GA 5752 5727 GB 03

GA 5752 5727 GB 03
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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.
V03 2020-07
4

GA 5752 5727 GB 03 3
Table of contents
Table of contents
1 Introduction ..............................................................................................................................................6
1.1 Foreword ....................................................................................................................................................6
1.2 How to use these operating instructions ....................................................................................................6
1.2.1 Abbreviations ............................................................................................................................... 6
1.2.2 Symbols ....................................................................................................................................... 6
1.2.2.1 Cross-references ....................................................................................................... 6
1.2.2.2 Actions and responses .............................................................................................. 6
1.2.3 Definitions .................................................................................................................................... 7
1.2.3.1 Design of safety notes ............................................................................................... 7
1.2.3.2 Design of other notes ................................................................................................ 7
1.2.4 Symbols used .............................................................................................................................. 7
1.2.5 Disposal ....................................................................................................................................... 8
1.2.5.1 Packaging.................................................................................................................. 8
1.2.5.2 ATMOS products ....................................................................................................... 8
1.3 Overview ....................................................................................................................................................9
1.3.1 S VAC INT.................................................................................................................................... 9
1.3.2 S VAC INT versions ................................................................................................................... 10
1.4 Basic requirements...................................................................................................................................10
1.4.1 Use in accordance with the intended purpose ........................................................................... 10
1.4.2 Applicable standards.................................................................................................................. 10
1.4.3 Intended purpose ....................................................................................................................... 11
1.4.4 S VAC INT versions ................................................................................................................... 12
1.4.5 Interface description................................................................................................................... 12
1.4.5.1 Vacuum connection tube ......................................................................................... 12
1.4.5.2 Hydrophobic bacterial and viral filter ....................................................................... 12
1.4.5.3 Septic fluid jar including septic fluid jar cap ............................................................. 13
1.4.5.4 Suction tube............................................................................................................. 13
1.4.5.5 Fingertip................................................................................................................... 13
1.4.5.6 Utensil...................................................................................................................... 13
1.4.5.7 Mechanical overflow protection ............................................................................... 14
2 Safety notes............................................................................................................................................15
2.1 General safety notes ................................................................................................................................ 15
2.2 Product safety notes.................................................................................................................................15
3 Initial operation.......................................................................................................................................17
3.1 Product testing .........................................................................................................................................17
3.2 Connection to the terminal unit.................................................................................................................17
3.2.1 General ...................................................................................................................................... 17
3.2.2 Version A.................................................................................................................................... 17
3.2.3 Version B.................................................................................................................................... 18

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Table of contents
3.3 Mounting accessories...............................................................................................................................18
3.3.1 General ...................................................................................................................................... 18
3.3.2 Mounting the mechanical overflow protection............................................................................ 19
3.3.3 Connection of the mechanical overflow protection .................................................................... 19
3.3.4 Connection of hydrophobic bacterial and viral filter ................................................................... 20
4 Operation ................................................................................................................................................21
4.1 Function test.............................................................................................................................................21
4.2 Adjusting the selector switch....................................................................................................................21
4.3 Setting the vacuum level .......................................................................................................................... 22
5 Taking the unit out of operation............................................................................................................24
5.1 Completing the aspiration process...........................................................................................................24
5.2 Disassembly.............................................................................................................................................24
5.2.1 General ...................................................................................................................................... 24
5.2.2 Dismantling the mechanical overflow protection........................................................................ 25
6 Cleaning and disinfection...................................................................................................................... 26
6.1 General.....................................................................................................................................................26
6.2 Cleaning ...................................................................................................................................................27
6.2.1 General ...................................................................................................................................... 27
6.2.2 Cleaning procedure.................................................................................................................... 27
6.3 Disinfection...............................................................................................................................................27
6.3.1 General ...................................................................................................................................... 27
6.3.2 Suitable disinfectants ................................................................................................................. 28
6.3.3 Disinfection procedure ............................................................................................................... 28
6.3.4 Disinfection procedures ............................................................................................................. 28
6.4 Product-specific safety notes ................................................................................................................... 29
7 Maintenance............................................................................................................................................30
7.1 General.....................................................................................................................................................30
7.2 Periodic tests............................................................................................................................................30
7.3 Malfunctions and troubleshooting.............................................................................................................30
7.4 Repairs.....................................................................................................................................................31
7.5 Service hotline..........................................................................................................................................31
7.6 Type plate position ...................................................................................................................................32
7.7 Sending in the device...............................................................................................................................32
8 Technical specifications ........................................................................................................................33
8.1 General.....................................................................................................................................................33
8.2 Technical specifications............................................................................................................................33
8.3 Ambient conditions...................................................................................................................................33
8.4 Dimensions and weight ............................................................................................................................ 33

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Table of contents
9 Approved accessories...........................................................................................................................34
9.1 Accessories..............................................................................................................................................34
9.2 Consumables ...........................................................................................................................................34

Introduction
Foreword
6GA 5752 5727 GB 03
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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
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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 ‘Serial number’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Product number’.

Introduction
How to use these operating instructions
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Symbols Identification
Labelling in compliance with the IEC 60601-1 standard.
Symbol for ‘Follow operating instructions’.
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 ‘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
1.2.5 Disposal
WARNING!
Infection hazard!
The product or some of its components may be contaminated after use.
Clean and disinfect the product before disposal.
1.2.5.1 Packaging
The packaging is made of materials compatible with the environment. ATMOS will dispose of the
packaging materials upon request.
1.2.5.2 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
GA 5752 5727 GB 03 9
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1.3 Overview
1.3.1 S VAC INT
8 9
10
2
1
5
3
6
7
4
Fig. 1: Overview of S VAC INT
1 S VAC INT 6 Terminal unit
2 Vacuum indicator 7 Air inlet
3 Control valve 8 Mechanical overflow protection
4 Selector switch OFF - CONT - INT 9 Adapter for the hydrophobic bacterial and viral filter
5 Plug 10 Hydrophobic bacterial and viral filter

Introduction
Basic requirements
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1.3.2 S VAC INT versions
2
1
5
8
6 7
3
4
Fig. 2: Overview of S VAC INT versions
1Version A 4Version B
Tapping unit with integrated gas pin Tapping unit with rail clamp and NIST
connection
2 Gas pin
3 Terminal unit 5 NIST nipple
6 NIST screw connection
7 Connection tube
8 Rail clamp
1.4 Basic requirements
1.4.1 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.
1.4.2 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 is certified by compliance

Introduction
Basic requirements
GA 5752 5727 GB 03 11
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with harmonised standards such as IEC 60601-1 and related standards and the respective
special sections.
1.4.3 Intended purpose
Name: S VAC INT
Main function: Aspiration of secretion, blood and serous fluids
Medical indications /
application:
For precise regulation of vacuum for postoperative aspiration of
wound exudate, secretion, blood or serous fluids. Additional fields
of application are the aspiration of air as well as rinsing and wound
drainage.
Specification of the main
function:
Drainage and temporary collection of body fluids. For the supply of
vacuum, S VAC INT is connected to a terminal unit for vacuum of a
central medical gas supply system (−100 kPa to −60 kPa). A septic
fluid jar, which has to be used, allows for temporary collection of
drained body fluids.
In the position intermittent, the S VAC INT is particularly suitable for
subglottic aspiration.
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.
Contraindications: The S VAC INT 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 bronchial aspiration, except for intermittent subglottic aspira-
tion
• For 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

Introduction
Basic requirements
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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.
1.4.4 S VAC INT versions
The connection of the S VAC INT to the terminal unit depends on the model being used.
Version A: Tapping unit with integrated gas pin
• S VAC INT is fitted directly to the terminal unit.
Version B: Tapping unit with rail clamp and NIST connection
• S VAC INT is designed for mounting onto a 25−35 x 10 mm equipment rail in accordance with
DIN EN 19054 and is supplied from a terminal unit for vacuum via a NIST connection with a
connection tube with gas probe.
The S VAC INT is available in the following versions:
• S VAC INT Wall DIN (REF 5752 5730)
• S VAC INT Wall BOC (BS 5682) (REF 5752 5731)
• S VAC INT equipment rail (REF 5752 5732)
1.4.5 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.
1.4.5.1 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.
1.4.5.2 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 against the ingress of bacteria and viruses.

Introduction
Basic requirements
GA 5752 5727 GB 03 13
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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).
1.4.5.3 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.
1.4.5.4 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 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 cap must
match the inner diameter of the suction tube.
1.4.5.5 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.
1.4.5.6 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.

Introduction
Basic requirements
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1.4.5.7 Mechanical overflow protection
The mechanical overflow protection device protects the product against the ingress of particles
and fluid. The tube connector must match the vacuum connection tube.

Safety notes
General safety notes
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2 Safety notes
2.1 General safety notes
DANGER!
Danger to life!
Danger due to unauthorised modifications.
The product may not be modified.
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.
CAUTION!
ATMOS recommends always having another aspirator ready to hand. That way
your can perform aspiration even in the event of product failure.
2.2 Product safety notes
WARNING!
Risk of injury to mucous membranes!
Endobronchial aspiration in paediatrics and neonatology as well as intermittent
aspiration require particularly careful limitation of the vacuum.
WARNING!
Risk of injury!
ATMOS products may be used only when fully functional.
Check that the ATMOS product is fully functional and in good working order prior to
use. ATMOS always recommends having another aspirator ready to hand. This
enables aspiration even in the event of product failure.
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.

Safety notes
Product safety notes
16 GA 5752 5727 GB 03
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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.
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
secretions may penetrate the product and cause it to break down.
Use an ordinary foam inhibitor.
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!
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!
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 26 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 product.
• 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 continuous aspiration.
• The product is not autoclavable.

Initial operation
Product testing
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3 Initial operation
3.1 Product testing
DANGER!
Product testing!
Only product parts which are in perfect condition can ensure proper functioning of
the product.
The product parts will thus have to be carefully inspected before mounting.
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.
NOTE
In order to ensure the functionality, carry out a function check prior to use.
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
3
2
1
Fig. 3: Version A
Tapping unit with integrated gas pin
Set the selector switch (1) to position OFF
[page 21].
The tapping unit (2) is plugged directly into
the terminal unit (3).

Initial operation
Mounting accessories
18 GA 5752 5727 GB 03
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3.2.3 Version B
8
2
1
7
3
6
5
4
Fig. 4: Version B
Tapping units with rail clamp and NIST
connection
Position the rail clamp (1) at a slight angle
with the upper edge of the guide groove on
the equipment rail (2) and then press it
against the equipment rail and allow it to
click into place.
Tighten the handle screw (3) of the rail
clamp.
Make sure that the rail clamp is correctly
secured and that the tapping unit is in a
stable position on the equipment rail.
Insert the NIST nipple (4) of the connection
tube into the NIST connection (5) of the
tapping unit and tighten 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.
NOTE
The particle filter must be changed whenever the product is prepared for use.

Initial operation
Mounting accessories
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3.3.2 Mounting the mechanical overflow protection
1
1
2
2
3
3
4
4
5
5
Fig. 5: Mounting the mechanical overflow protec-
tion
Mounting the mechanical overflow
protection
Insert the float (1) into the overflow
container (2).
Fit the sealing ring (3) onto the cap (4).
Insert the cap into the overflow container.
Fit the particle filter (5) onto the cap.
3.3.3 Connection of the mechanical overflow protection
Fig. 6: Mounting/removing the mechanical over-
flow protection device
Mounting the mechanical overflow
protection device
Plug the overflow protection device (1)
directly onto the tapping unit (2) and press
it up as far as it will go.
Turn the overflow protection device (1) to
the right.
The overflow protection device is locked.
Removing the mechanical overflow
protection device
Turn the overflow protection device (1) to
the left.
The overflow protection device is
unlocked.
Pull the overflow protection device down.

Initial operation
Mounting accessories
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3.3.4 Connection of hydrophobic bacterial and viral filter
1
2
3
4
Fig. 7: Mounting the hydrophobic bacterial and vi-
ral filter
Mounting the hydrophobic bacterial and
viral filter
Remove the grub screw from the adapter
(1) with an Allen key.
Insert the adapter (1) for the hydrophobic
filter directly into the tapping unit (2) and
turn.
Tighten the grub screw into the opening (3)
with an Allen key.
Fit the hydrophobic bacterial and viral filter
(4) onto the adapter for the hydrophobic
filter and push it up.