MEDAP VENTA SP 26 User manual

OPERATING INSTRUCTIONS
MEDAP
SEPTIC FLUID ASPIRATOR
VENTA SP 26
GA 5752 4412 GB 17

GA 5752 4412 GB 17
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.
V17 2022-05

GA 5752 4412 GB 17 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 Structure of notes ...................................................................................................... 7
1.2.4 Explanation of pictograms, symbols and codes........................................................................... 7
1.3 Disposal......................................................................................................................................................9
1.3.1 Packing ........................................................................................................................................ 9
1.3.2 ATMOS products.......................................................................................................................... 9
1.3.3 Batteries and rechargeable batteries ........................................................................................... 9
1.3.4 Used electrical devices ................................................................................................................ 9
1.4 Overview ..................................................................................................................................................10
1.4.1 VENTA SP 26 N ......................................................................................................................... 10
1.4.2 VENTA SP 26 A.......................................................................................................................... 11
1.4.3 Trolley ........................................................................................................................................ 12
1.4.4 Aspirator holder, universal ......................................................................................................... 13
1.5 Basic requirements...................................................................................................................................13
1.5.1 Use in accordance with the intended purpose ........................................................................... 13
1.5.2 Applicable standards.................................................................................................................. 14
1.5.3 Intended purpose ....................................................................................................................... 14
1.6 Interface description.................................................................................................................................15
1.6.1 Hydrophobic bacterial and viral filter.......................................................................................... 15
1.6.2 Vacuum connection tube............................................................................................................ 15
1.6.3 Septic fluid jar including septic fluid jar cap ............................................................................... 16
1.6.4 Suction tube ............................................................................................................................... 16
1.6.5 Fingertip ..................................................................................................................................... 16
1.6.6 Utensil ........................................................................................................................................16
1.6.7 Connection of equipment mount ............................................................................................... 17
1.6.8 Application sets.......................................................................................................................... 17
1.6.9 Trolley ........................................................................................................................................ 17
1.6.10 Aspirator holder.......................................................................................................................... 17
1.7 Aspirator variants .....................................................................................................................................17

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Table of contents
2 Safety notes............................................................................................................................................19
2.1 General safety notes ................................................................................................................................ 19
2.2 Product safety notes.................................................................................................................................21
3 Initial operation.......................................................................................................................................23
3.1 General.....................................................................................................................................................23
3.2 Equipment mount interface ...................................................................................................................... 23
3.2.1 Attaching the septic fluid jar to the equipment mount ................................................................ 23
3.3 Mounting the hydrophobic bacterial and viral filter................................................................................... 24
3.4 Mounting the tubes...................................................................................................................................24
3.5 Connecting cables....................................................................................................................................25
3.5.1 Mains variant.............................................................................................................................. 25
3.5.2 Battery variant............................................................................................................................ 25
3.6 Mounting accessories...............................................................................................................................26
3.6.1 Mounting the aspirator to the trolley........................................................................................... 26
3.6.1.1 Attaching the catheter holder (REF 5750 8002) ...................................................... 27
3.6.1.2 Catheter tubular (REF 5752 5150) incl. catheter tubular cover (REF 5752 5151) .. 28
3.6.1.3 Insert the septic fluid jar to the equipment mount.................................................... 28
3.6.2 Mounting the aspirator to the aspirator holder ........................................................................... 29
3.6.3 Septic fluid jar caps.................................................................................................................... 31
3.6.4 Disposable suction systems....................................................................................................... 31
3.6.5 Fastening the aspiration set....................................................................................................... 31
4 Operation ................................................................................................................................................32
4.1 Functional test..........................................................................................................................................32
4.2 Switching on the aspirator........................................................................................................................32
4.2.1 Mains variant.............................................................................................................................. 32
4.2.2 Battery variant............................................................................................................................ 33
4.2.2.1 Operating status display of battery variant with mains operation ............................ 33
4.2.2.2 Operating status display of battery variant with battery operation........................... 34
4.3 Suction .....................................................................................................................................................34
4.3.1 Mains operation ......................................................................................................................... 35
4.3.2 Battery operation........................................................................................................................ 35
4.4 Setting the vacuum level .......................................................................................................................... 36
4.5 Utensil ......................................................................................................................................................36
4.6 Completing the aspiration process...........................................................................................................37
4.7 Empty the septic fluid jar .......................................................................................................................... 37
4.8 Disassembly.............................................................................................................................................38

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Table of contents
5 Cleaning and disinfection...................................................................................................................... 39
5.1 General.....................................................................................................................................................39
5.2 Cleaning ...................................................................................................................................................40
5.2.1 General ...................................................................................................................................... 40
5.2.2 Cleaning procedure.................................................................................................................... 40
5.3 Disinfection...............................................................................................................................................41
5.3.1 General ...................................................................................................................................... 41
5.3.2 Suitable disinfectants ................................................................................................................. 41
5.3.3 Disinfection procedure ............................................................................................................... 42
5.3.4 Disinfection procedures ............................................................................................................. 42
6 Maintenance............................................................................................................................................43
6.1 General.....................................................................................................................................................43
6.2 Visual and functional inspections ............................................................................................................. 43
6.3 Period tests ..............................................................................................................................................44
6.4 Malfunctions and troubleshooting.............................................................................................................44
6.4.1 General ...................................................................................................................................... 44
6.4.2 Battery variant............................................................................................................................ 45
6.4.3 Replace mains fuse ................................................................................................................... 46
6.5 Repairs.....................................................................................................................................................47
6.6 Type plate position ...................................................................................................................................47
6.7 Service hotline:.........................................................................................................................................47
6.8 Spare parts...............................................................................................................................................48
6.9 Handling of batteries ................................................................................................................................ 48
6.10 Sending in the device...............................................................................................................................48
7 Technical specifications ........................................................................................................................ 49
7.1 VENTA SP 26 N ....................................................................................................................................... 49
7.2 VENTA SP 26 A........................................................................................................................................50
8 Approved accessories...........................................................................................................................52
8.1 General accessories.................................................................................................................................52
8.2 Application sets ........................................................................................................................................52
9 Refer to EMC........................................................................................................................................... 54

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
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 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
1.2.4 Explanation of pictograms, symbols and codes
Symbols are attached to products, type plates and packaging.
Symbols Identification
This device complies with the relevant requirements of the EU regulations.
Follow operating instructions (blue)
Consult operating instructions
Manufacturer

Introduction
How to use these operating instructions
8GA 5752 4412 GB 17
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Symbols Identification
DE
Date of manufacture
Country of manufacture: Germany
REF Reference number
UDI Unique Device Identifier of a medical device
MD Medical device
SN Serial number
Specification of the degree of protection against the ingress of solids and
moisture
Type B applied part
Professional disposal
Fuse
Battery power display
Charging display
On/off button
This side up
Fragile, handle with care
Keep dry
Temperature limit
Humidity limitation
700
1060
Atmospheric pressure limitation
Tab. 3: Pictograms, symbols, codes

Introduction
Disposal
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UDI-Code
(01) UDI-DI: Identification of the manufacturer and the device
(11) Date of manufacture
(13) Packing date
(21) Serial number
Tab. 4: UDI-Code
1.3 Disposal
WARNING!
Infection hazard!
The product or some of its components may be contaminated after use.
Clean and disinfect the product before disposal.
1.3.1 Packing
The packing is made of materials compatible with the environment. ATMOS will dispose of the
packing materials upon request.
1.3.2 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.
1.3.3 Batteries and rechargeable batteries
Rechargeable batteries/batteries can be turned in to your local disposal system.
1.3.4 Used electrical devices
Within the European Economic Community
This product is governed by the 2002/96/EU Directive (Directive on Waste Electrical and
Electronic Equipment). This product has not been registered for use in private households.
Disposal at municipal collection points for used electrical equipment is not authorised. Please
contact your ATMOS representative for more detailed information on correct and legal disposal.
Outside the European Economic Community
When disposing of this product, ensure compliance with the applicable national regulations on
the handling and disposal of used electrical equipment.

Introduction
Overview
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1.4 Overview
1.4.1 VENTA SP 26 N
-100
-80
-60 -40
-20
0
kPa
6
5
3
2
1
4
7
8
9
10
11
Fig. 1: Overview of the VENTA SP 26 N septic fluid aspirator
1 Setting ring vacuum 7 Mains cable
2 Vacuum gauge 8 Hydrophobic bacterial and viral filter
3 Interface for hydrophobic bacterial and viral
filter
9 Adapter
10 Suction tube
4 Equipment carrier 11 Equipment socket
5 On / Off switch
6 Septic fluid jar with equipment carrier and
septic fluid jar cap

Introduction
Overview
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1
1.4.2 VENTA SP 26 A
-100
-80
-60 -40
-20
0
kPa
6
1
4
7
8
9
10
11
2
3
5
13
14 12
Fig. 2: Overview of the VENTA SP 26 A septic fluid aspirator
1 On / Off switch 8 Septic fluid jar with equipment carrier and septic
fluid jar cap
2 Battery capacity display 9 Mains cable
3 Battery power display / Charging display 10 Hydrophobic bacterial and viral filter
4 Setting ring vacuum 11 Adapter
5 Vacuum gauge 12 Suction tube
6 Interface for hydrophobic bacterial and viral
filter
13 Equipment socket
14 12 V socket for car charger cable
7 Equipment mount

Introduction
Overview
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1.4.3 Trolley
Fig. 3: Trolley overview (REF 5752 5345)
1 Locking pin 4 Cable rewind
2 Handle screw 5 Support for catheter tubular
3 Height adjustment tube holder 6 Double castors with locking brake
2
1
5
34
6

Introduction
Basic requirements
GA 5752 4412 GB 17 13
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1.4.4 Aspirator holder, universal
2
2
1
1
5
5
3
3
4
4
Fig. 4: Overview of the aspirator holder, universal (REF 5752 5311)
1Mounting variant A 4 Fastening grip
2 Handle screw 5 Mounting variant B
3 Screws for fastening grip
1.5 Basic requirements
1.5.1 Use in accordance with the intended purpose
Product
As per appendix IX of the Medical Products Directive 93/42/EU 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 a commercial or business use, this product shall 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
14 GA 5752 4412 GB 17
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1.5.2 Applicable standards
The product satisfies the basic requirements set forth in Annex I to the 93/42/EU Directive drafted
by the Medical Products Council (Medical Products Directive) as well as the applicable national
(German) codes and the Medical Products Act in Germany. This has also been demonstrated
through the application of the corresponding standards, which have been harmonised with the
93/42/EEC Directive.
1.5.3 Intended purpose
Product name: VENTA SP 26 N
VENTA SP 26 A
Main functions: Aspiration of secretion, blood, serous fluids, vomit and rinsing fluids
along with any contained particles as well as temporary collection
of these fluids
Intended use: Drainage and temporary collection of body fluids. A negative
pressure is generated by means of an electrical aspiration pump. A
septic fluid jar, which must be installed, allows for temporary
collection of the drained body fluids.
Intended users / user
profile:
Doctors, trained medical staff
Intended patient target
groups:
Patients of all age groups with and without restrictions
Medical condition to be
diagnosed, treated or
monitored:
Patients requiring aspiration, e.g., bronchial aspiration
Organ(s) applied to: Natural and artificial body orifices
Duration of application: Device designed for continuous application; in practice, short-term
use on the patient (< 30 days)
Use environment: Environments for use are the hospital/clinical environment and
doctor’s practices. The device may only be used by trained and
instructed medical staff.
Patient selection criteria: All patients requiring aspiration
Indications: For all applications requiring aspiration, especially aspiration of the
nasopharynx, bronchial aspiration, during endoscopy for aspiration
of secretion or rinsing fluids
Medical contra-indications: • Vacuum extraction
• Smoke evacuation
• Use without a smoke evacuation filter if aggressive vapours
are also generated during the aspiration of liquids due to easily
volatile components (e.g., when using iodine as a disinfectant)
• In areas subject to explosion hazards (AP-M and AP-G areas)
• For drainages in the low-vacuum range (e.g., thoracic and
wound drainage)
• For emergency and rescue use

Introduction
Interface description
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Other contra-indications: • Outside the medical field
• In the homecare area
• Use directly by the patient or his/her relatives
• For aspiration of flammable or explosive liquids
Warnings: None
The product is: active
Sterility / specific microbial
state:
Non-sterile device
Single-use device /
reprocessing:
The device is intended for multiple use. The device and part of the
accessories are reusable. For information on reprocessing and
disinfection, please see the operating instructions.
1.6 Interface description
Other connected products
To fulfill its intended use the product has to be connected according to the following interface
descriptions:
1.6.1 Hydrophobic bacterial and viral filter
NOTE
The use of a hydrophobic bacterial and viral filter is not necessary if a suitable
hydrophobic bacterial and viral filter is integrated for a specific purpose in the septic
fluid jar of a disposal aspiration system.
The hydrophobic bacterial and viral filter protects against contaminants which could be present in
the form of particles or aerosols in the gas drawn in. Moreover, the hydrophobic filter serves as
protection against oversuction; the filter closes off the flow of gas to the product in the event of
oversuction. In its function as bacterial and viral filter, it protects the inside of the aspirator from
the ingress of bacteria and viruses. The product sold by ATMOS (REF 57500630) is a
hydrophobic bacterial and viral filter.
Prerequisites:
• Pore size ≤ 1.0 μm
• Conical tube connector with an outer diameter of 6 to 8 mm
• The hydrophobic filter must close tightly against water passage at apressure of up to 10 kPa
• Observe the direction of flow (lable has to be visible).
1.6.2 Vacuum connection tube
The vacuum connection tube is used to connect the hydrophobic bacterial and viral filter with the
septic fluid jar.

Introduction
Interface description
16 GA 5752 4412 GB 17
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Technical specifications:
• Shore hardness of 60
• Inner diameter of 6-8 mm
• Length: maximum 1.1 m
• Vacuum resistant down to -95 kPa (may not collapse).
• Prerequisites:
• The vacuum connection tube must comply with the hospital's standards for hygiene.
• The inner diameter of the vacuum connection tube must match the outer diameter of the
hydrophobic bacterial and viral filter.
• 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.
1.6.3 Septic fluid jar including septic fluid jar cap
The septic fluid jar is used to collect the septic fluids extracted.
Prerequisites:
• Low leakage
• Only septic fluid jars with maximum volumes of 1.0 l may be attached to the aspirator.
• Always fasten the septic fluid jar securely.
• The tube connector for connection to the vacuum source must be compatible with the
connection tube.
• The outer diameter of the tube connector on the patient side must match the inner diameter of
the suction tube.
1.6.4 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 of 6-8 mm
• Length of 1.3 m to 3.0 m
• Vacuum resistant down to −95 kPa
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.
1.6.5 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 sterile disposable item.
• The outer diameter of the tube connector on the patient side should match the inner diameter
of the suction tube.
1.6.6 Utensil
The suction catheter, lance are referred to as utensils. The utensils are used to extract septic
fluids.

Introduction
Aspirator variants
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Prerequisites:
• The inner diameter of the utensil's connector must match the outer diameter of the fingertip.
• The utensil must be sterilisable or a sterile single-use item.
• Biocompatibility
• For endobronchial extraction, a utensil with side openings must be used.
1.6.7 Connection of equipment mount
The equipment mount interface is used to mount a septic fluid jar, or a holder for septic fluid jars.
Prerequisites:
• Maximum load on the equipment mount interface is 1 kg.
• The connection for the septic fluid jar or the holder for the septic fluid jar must match the
equipment mount interface as per DIN EN 19054.
1.6.8 Application sets
Application sets augment the basic unit. Application sets can be configured as required, using
individual accessories.
Prerequisites:
• Suitable connection tubes must be selected
• The interface descriptions for the aspirator must be observed.
1.6.9 Trolley
Only the specially designed trolley (REF 57525345) may be used with the aspirator.
Prerequisites:
• Up to two septic fluid jars with equipment mount and with a maximum of 4 litres each may be
attached to the trolley.
1.6.10 Aspirator holder
Only the aspirator holder (REF 57525311) may be used with the aspirator.
Prerequisites:
• For mounting on all commercially available equipment rails of up to a maximum of 40 x 10 mm
as well as on horizontal and vertical round pipes of up to a maximum of ø 35 mm.
1.7 Aspirator variants
These operating instructions apply to the versions listed below.
VENTA SP 26 N septic fluid aspirator / basic equipment (REF 5752 5133)
• Mains cable (2 m)
• Connection tube 8 x 14 mm (1 m)
• Hydrophobic bacterial and viral filter

Introduction
Aspirator variants
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VENTA SP 26 N septic fluid aspirator / complete unit (REF 5752 5129)
• Mains cable (2 m)
• Connection tube 8 x 14 mm (1 m)
• Hydrophobic bacterial and viral filter
• 1 l septic fluid jar with equipment mount plastic (PSU)
• Septic fluid jar cap, silicone, with mechanical overflow protection
• Connection tube 6 x 12 mm (1.3 m)
• Tube adapter
• Rinsing fluid jar
VENTA SP 26 A septic fluid aspirator / basic equipment (REF 5752 5134):
• Mains cable (2 m)
• Connection tube 8 x 14 mm (1 m)
• Hydrophobic bacterial and viral filter
VENTA SP 26 A septic fluid aspirator / complete unit (REF 5752 5130)
• Mains cable (2 m)
• Connection tube 8 x 14 mm (1 m)
• Hydrophobic bacterial and viral filter
• 1 l septic fluid jar with equipment mount plastic (PSU)
• Septic fluid jar cap, silicone, with mechanical overflow protection
• Connection tube 6 x 12 mm (1.3 m)
• Tube adapter
• Rinsing fluid jar

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.
DANGER!
Explosion hazard!
The equipment is not AP protected.
Be sure not to operate the unit inside the AP area.
Store product outside the AP-area.
DANGER!
Danger to life!
Electric shock!
Check to ensure that the available mains voltage corresponds with the specifica-
tions on the type plate before connecting the mains plug. Product can only be
separated from the power supply by unplugging at the socket.
DANGER!
Danger to life!
Electric shock resulting from an object being inserted from the outside, into the
case, and its making contact with live components.
Never insert any objects into the case.
DANGER!
Danger to life!
Electric shock!
The product may only be connected to voltage supplies with protected earth
connections.
DANGER!
Danger to life!
Patient may be endangered as a result of incorrect use.
Follow the operating instructions for all accessories.
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.

Safety notes
General safety notes
20 GA 5752 4412 GB 17
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WARNING!
Risk of injury to mucous membranes!
Endobronchial aspiration in paediatrics and neonatology requires particularly
careful limitation of the vacuum.
WARNING!
Risk of injury!
ATMOS products may be used only when fully functional.
Check to ensure that the ATMOS product is fully functional and in good working
order prior to use.
WARNING!
Risk of injury!
Electrical devices (e. g. mobile phones, radios, magnetic resonance tomographs)
may interfere with the functioning of the product when used near the product.
Do not use electrical devices that may interfere with the functionality of the product
in the vicinity of the product.
Observe the specifications regarding electromagnetic compatibility (EMC) (emis-
sion and resistance to interference).
Observe the specifications from the technical data for the use of electrical devices
and respond to any effects on the device or the product.
WARNING!
Risk of infection due to improper handling
Applicable rules for hygiene have to be observed in order to avoid infection or
bacterial contamination when suctioning off and disposing of secretions. Observe
the intended purpose of the bacterial and viral filter. Use only sterile utensils during
extraction and ensure that the patient is not injured during the procedure. Always
wear gloves while working.
WARNING!
Risk of infection when using a defective hydrophobic bacterial and viral filter!
During extraction, septic fluid enters the aspirator.
Stop using the aspirator. Clean and disinfect the aspirator and have it repaired by a
workshop authorised by ATMOS to do so.
WARNING!
Allergic reactions due to contact!
The materials used were examined for their compatibility. In exceptional cases,
allergic reactions to accessible materials on the unit and its accessories can occur.
This applies to contact injuries in the event of prolonged contact. In this case,
consult a doctor immediately.