Page 1
OPERATING INSTRUCTIONS
MEDAP
S FLOW FLOWMETER
GA 5752 4980 GB 13
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Subject to technical modification!
4
Illustrations and technical specifications may vary slightly from those in these Operating
Instructions as a result of ongoing product development.
V13 2020-02
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GA 5752 4980 GB 13
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Table of contents
Table of contents
1 Introduction ..............................................................................................................................................5
1.1 Foreword .................................................................................................................................................... 5
1.2 How to use these operating instructions .................................................................................................... 5
1.2.1 Abbreviations ...............................................................................................................................5
1.2.2 Symbols .......................................................................................................................................5
1.2.2.1 Cross-references ....................................................................................................... 5
1.2.2.2 Actions and responses .............................................................................................. 5
1.2.3 Definitions ....................................................................................................................................6
1.2.3.1 Design of safety notes ............................................................................................... 6
1.2.3.2 Design of other notes ................................................................................................ 6
1.2.4 Symbols used ..............................................................................................................................6
1.3 Disposal ......................................................................................................................................................7
1.3.1 Packaging ....................................................................................................................................8
1.3.2 ATMOS products .......................................................................................................................... 8
1.4 Overview of S FLOW flowmeter ................................................................................................................. 8
1.5 Basic requirements .....................................................................................................................................8
1.5.1 Use in accordance with the intended purpose ............................................................................. 8
1.5.2 Applicable standards / directives ................................................................................................. 9
1.5.3 Intended purpose ......................................................................................................................... 9
1.5.3.1 Possible applications ............................................................................................... 10
1.5.4 Versions of S FLOW / S DFLOW flowmeter ..............................................................................10
1.5.5 Interface description ................................................................................................................... 11
1.5.5.1 Approved interface for compressed gas supply ...................................................... 11
1.5.5.2 Flowmeter outlet ...................................................................................................... 11
1.5.5.3 Connection tube ...................................................................................................... 11
1.5.5.4 Tube adapter for Air and O2 .................................................................................... 11
2 Safety notes ............................................................................................................................................12
2.1 General safety notes ................................................................................................................................ 12
2.2 Product safety notes .................................................................................................................................12
3 Initial operation .......................................................................................................................................14
3.1 Product testing .........................................................................................................................................14
3.2 Connection to the terminal unit.................................................................................................................14
3.2.1 General ......................................................................................................................................14
3.2.2 Version A ....................................................................................................................................15
3.2.3 Version B ....................................................................................................................................15
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Table of contents
3.3 Mounting accessories ...............................................................................................................................15
3.3.1 General ......................................................................................................................................15
3.3.2 Connection of bubble humidifier (REF 5752 5315) .................................................................... 16
3.3.3 Connection of disposable humidifiers from other manufacturers ............................................... 16
4 Operation ................................................................................................................................................17
4.1 Function check ......................................................................................................................................... 17
4.2 Use in conjunction with magnetic resonance imaging scanners .............................................................. 18
4.3 Setting the flow for treatment ...................................................................................................................18
5 Taking the unit out of operation ............................................................................................................ 20
6 Cleaning and disinfection ......................................................................................................................21
6.1 General .....................................................................................................................................................21
6.2 Cleaning ................................................................................................................................................... 22
6.2.1 General ......................................................................................................................................22
6.2.2 Cleaning procedure ....................................................................................................................22
6.3 Disinfection ............................................................................................................................................... 22
6.3.1 General ......................................................................................................................................22
6.3.2 Suitable disinfectants ................................................................................................................. 23
6.3.3 Disinfection procedure ...............................................................................................................23
6.4 Special safety notes ................................................................................................................................. 24
7 Maintenance ............................................................................................................................................25
7.1 General .....................................................................................................................................................25
7.2 Periodic tests ............................................................................................................................................ 25
7.3 Malfunctions and troubleshooting.............................................................................................................25
7.4 Repairs ..................................................................................................................................................... 26
7.5 Service hotline .......................................................................................................................................... 26
7.6 Type plate position ...................................................................................................................................26
7.7 Sending in the device ............................................................................................................................... 26
8 Technical specifications ........................................................................................................................ 28
8.1 General .....................................................................................................................................................28
8.2 Technical specifications ............................................................................................................................ 28
8.3 Ambient conditions ................................................................................................................................... 28
8.4 Dimensions and weights ..........................................................................................................................28
9 Approved accessories ...........................................................................................................................29
9.1 Accessories .............................................................................................................................................. 29
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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
Introduction
Foreword
1
EN European standard
EEC European Economic Community
VDE Verband der Elektrotechnik Elektronik Informationstechnik (Association for
Electrical, Electronic & Information Technology)
S Standard
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.
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Introduction
4
1
How to use these operating instructions
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.
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.
The text for the safety note
describes the type of risk and
how to avert it.
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
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 for the Notified Body.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Serial number’.
Labelling in compliance with the IEC 60601-1 standard.
Symbol for ‘Follow operating instructions’.
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Symbols Identification
Labelling in compliance with the IEC 62570 standard.
Symbol for ‘Conditionally MR safe’.
Packaging label.
Symbol for ‘Keep dry’.
Packaging label.
Symbol for ‘Fragile! Handle with care’.
Packaging label.
Symbol for ‘Top’.
Introduction
Disposal
1
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’.
Labelling on type plate.
Symbol for ‘Oil- and fat-free’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Product number’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Name and address of the manufacturer’.
Tab. 3: Symbols
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.
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Introduction
1
Overview of S FLOW flowmeter
1.3.1 Packaging
The packaging is made of materials compatible with the environment. ATMOS will dispose of the
packaging 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.
1.4 Overview of S FLOW flowmeter
Fig. 1: Overview of S FLOW flowmeter
1 Version A
Tapping unit with integrated gas pin
2 Regulating valve 11 Connection tube
3 Flowmeter outlet (UNF 9/16") 12 Tube adapter 4 mm, 6 mm, 8 mm (REF 5752 2746)
4 Plug
5 Flowmeter viewing tube 13 Tube adapter, plastic, 4 mm, 6 mm, 8 mm (REF
6 Version B
Tapping unit with rail clamp and NIST
connection
7 Equipment rail
8 NIST connection
1.5 Basic requirements
1.5.1 Use in accordance with the intended purpose
Product
As per Annex IX to the Medical Devices Directive 93/42/EEC, this product belongs to class IIa.
In accordance with this directive, the product may only be used by persons who have been
instructed how to use this product by an authorised person.
This product is to be used exclusively for human medicine.
10 NIST screw connection
9 NIST nipple
5752 5316)
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When employed in a 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.
1.5.2 Applicable standards / directives
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
with harmonised standards such as IEC 60601-1 and related standards and the respective
special sections.
1.5.3 Intended purpose
Introduction
Basic requirements
1
Name: S FLOW
S DFLOW
Main function: Designed for measuring the flow and determining the precise
dosage for the supply of oxygen and compressed air. In conjunction
with a hand-held nebuliser, the S FLOW is used to provide metered
administration of medication aerosols.
Medical indications /
application:
Specification of the main
function:
Inhalation and insufflation of oxygen within the scope of oxygen
enrichment via an inhalation mask or a nose latch for patients
breathing by themselves
Together with a hand-held nebuliser, administration of water soluble
drugs via an inhalation mask
Supply of oxygen or compressed air. For oxygen / compressed air
supply, the S FLOW is connected to an oxygen / compressed air
terminal unit of a central medical gas supply system having a
supply pressure within the inlet pressure specified on the product.
For humidification of oxygen from the central gas supply system, a
humidifier may additionally be connected. Supply of oxygen to the
patient takes place via connection tubes and an inhalation mask or
a nose latch. The administration of medication aerosols via
compressed air takes place via connection tubes to a hand-held
nebuliser. The patient presses the inhalation mask of the hand-held
nebuliser onto the mouth and nose.
User profile: Doctor, medically trained staff
Patient groups: Patients of all ages
Application organ: Lung
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 oxygen / compressed air system.
The application of the product may only be performed by medically
trained and instructed staff.
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1
Introduction
Basic requirements
Contraindications: The S FLOW may not be used for the following purposes:
• Outside the medical sector
• In MR areas > 4.7 tesla
• In the home care sector
• Being operated directly by the patient
• For exclusive respiration
• With central gas supply systems with other supply pressures
than specified on the product
• When applying oxygen in its function as a medication, it is absolutely necessary to measure the flow rate.
The product is: Not active
Sterility: Not a sterile product
Single-use product /
reprocessing:
1.5.3.1 Possible applications
The following usage options are made possible by connecting products or accessories which are
contained in the list of accessories or which satisfy the specifications of the interface description.
• Appropriate connection tubes with inner diameters of 4 mm, 6 mm, and 8 mm may be connected to the flowmeter via a tube adapter (metal or plastic).
• With the bubble humidifier (REF 5752 5315) for humidifying oxygen. The bubble humidifier is
intended for inhalation. The bubble humidifier is connected without an adapter.
• Sterile water systems / disposable humidifiers (UNF 9/16") may be connected directly.
1.5.4 Versions of S FLOW / S DFLOW flowmeter
The connection of the tapping unit to the terminal unit depends on the type of product being used:
Version A: Tapping unit with integrated gas pin
• The tapping unit is plugged directly into the terminal unit.
Version B: Tapping unit with rail clamp and NIST connection
• The product is designed for mounting to an equipment rail 25–35 x 10 mm in accordance with
DIN EN 19054 and is supplied from a terminal unit via a NIST connection according to DIN EN
ISO 5359 with a connection tube with gas probe.
Products and accessories are only permitted with the ISO colour coding. In Germany, Austria and
Switzerland, products with neutral colour coding are also permitted.
The device and parts of the accessories are reusable. For
information on reprocessing, cleaning and disinfection, please see
the operating instructions.
10
NOTE
The products are supplied with ISO coding. The scope of delivery includes a label
for neutral colour coding.
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The product is available in the following versions:
• S FLOW O 15 Wall DIN (REF 5752 4906)
• S FLOW O 15 Wall MEDAP (REF 5752 4907)
• S FLOW O 15 Wall BOC (BS 5682) (REF 5752 4913)
• S FLOW O 15 Wall Air Liquide (NF S 90-116) (REF 5752 4914)
• S FLOW O 15 Wall AGA (SS 8752430) (REF 5752 4915)
• S FLOW O 15 NIST connection, equipment rail (REF 5752 5298)
• S DFLOW O 15 Wall DIN (REF 5752 4910)
• S DFLOW O 15 Wall MEDAP (REF 5752 5532)
• S DFLOW O 15 NIST connection, equipment rail (REF 5752 5299)
• S FLOW A 15 Wall DIN (REF 5752 4912)
• S FLOW A 15 Wall MEDAP (REF 5752 5269)
• S FLOW A 15 Wall BOC (BS 5682) (REF 5752 5579)
• S FLOW A 15 NIST connection, equipment rail (REF 5752 5300)
• S DFLOW A 15 Wall DIN (REF 5752 5750)
Introduction
Basic requirements
1
1.5.5 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. The configuration of the
overall system as well as the 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.
1.5.5.1 Approved interface for compressed gas supply
In order to supply compressed gas, the tapping unit is connected to the central medical gas
supply system (CGSS) with a pressure of 450 / 500 kPa. The pressure in the supply line must be
indicated and in the event of improper functioning must be limited to 1000 kPa by an integrated
pressure-relief valve.
1.5.5.2 Flowmeter outlet
External thread UNF 9/16" 18 turns.
The internal thread on the accessory must match the external thread on the flowmeter. Ensure
that the connection between the flowmeter and the accessory is leak-free.
1.5.5.3 Connection tube
The connection tube with an inner diameter of 4, 6 or 8 mm is connected with the tube adapter.
The connection tube must not collapse or must be pressure-resistant and must comply with the
hygiene standard of the hospital. The inside diameter of the connection tube must match the
outside diameter of the tube adapter.
1.5.5.4 Tube adapter for Air and O2
The tube adapter is used to connect the tapping unit and the connection tube. The internal thread
of the tube adapter must match the external thread of the tube connector of the flowmeter output
(UNF 9/16").
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Safety notes
2
General safety notes
2 Safety notes
2.1 General safety notes
DANGER!
Incorrect use can result in fatalities!
Instructions for using components made by other manufacturers are not part of
these operating instructions.
Ensure that the manufacturer's instructions are followed.
DANGER!
Observe hygiene guidelines!
Contaminated components may be hazardous to the patient's health.
Prepare the product according to the hygiene guidelines before using it for the first
time. Clean and disinfect the product.
DANGER!
Fire/explosion hazard!
Air, oxygen and oxygen compounds react explosively with oils, greases and
lubricants. Fire and explosion hazard due to compressed gases.
Always keep the product free of oils, greases and lubricants.
DANGER!
Risk of fire!
Escaping oxygen increases the risk of fire.
Never smoke near equipment which carries oxygen and avoid using open fires or
glowing objects. Check the connector for leaks and tight fit when mounting
accessories.
DANGER!
Defective product!
Using incorrect spare parts and accessories can cause injuries or equipment
failure.
Only use original accessories or spare parts.
WARNING!
Risk of injury!
Hazard resulting from incorrect handling.
Follow the operating instructions for all accessories.
2.2 Product safety notes
CAUTION!
Malfunction!
Ensure that the connection between the product and the accessory is leak-free.
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Safety notes
Product safety notes
CAUTION!
Property damage
Exposure to UV rays can cause material fatigue. The stability would no longer be
ensured.
Do not expose the product to strong UV light.
CAUTION!
Observe ambient conditions
The precision, operation, mechanical stability and tightness of the product cannot
be guaranteed if the ambient temperature range is undercut or exceeded.
WARNING!
Impacts!
Impacts may cause damage to sensitive, precision mechanical components.
Do not expose the product to impacts.
2
WARNING!
Non-permissible load!
If the permissible load is exceeded, leakages may occur at the connection between
the terminal unit and gas probe.
In accordance with DIN EN ISO 9170-1, the overall weight of the product and
accessories may not exceed 2 kg.
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Initial operation
3
Product testing
3 Initial operation
3.1 Product testing
DANGER!
Imprecise display in the event of deviations in system pressure!
If the system pressure of 500 kPa or 450 kPa is undercut or exceeded, it will no
longer be possible to accurately display the measured values of the flowmeter.
DANGER!
Fluctuations in flow rate!
Flow accuracy may be influenced by the following factors:
• Fluctuations of the supply pressure (terminal unit)
• Fluctuations of the back pressure (accessories)
• Fluctuations of the ambient temperature
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.
WARNING!
Measurement accuracy!
The product may only be operated in a vertical position.
Pay special attention to the tight fit of the flowmeter viewing tube and to any possible cracks in
the flowmeter viewing tube. Do not use the product if there are any signs of cracks.
Check whether the connection tubes are undamaged.
Check whether the product has been properly cleaned and that there are no residues or
soiling.
Do not use damaged components.
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.
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3.2.2 Version A
1
2
2
1
3
4
6
5
8
7
Initial operation
Mounting accessories
Tapping unit with integrated gas pin
The tapping unit (1) is plugged directly into
the terminal unit (2).
3
Fig. 2: Version A
3.2.3 Version B
8
7
5
Fig. 3: Version B
2
1
Tapping unit with rail clamp and NIST
connection
1
2
3
4
6
With the upper edge of the guide groove at
the front, position the rail clamp (1) at a
slight angle onto 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 down the cap nut
(6) by hand.
Plug the gas probe (7) 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.
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Initial operation
1
2
3
Mounting accessories
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.
3.3.2 Connection of bubble humidifier (REF 5752 5315)
2
1
Connecting the bubble humidifier
Ensure that the NIST screw connection of
the humidifier contains a flat seal.
Fill the humidifier bottle up to the marking
‘Filling level’ with distilled water and screw
the bubble humidifier cap into place.
Screw cap nut (1) of the bubble humidifier
onto the flowmeter output (2) and tighten
finger-tight until it stops.
Pay attention that no tensile forces affect
the bubble humidifier.
Fig. 4: Connection of bubble humidifier
3.3.3 Connection of disposable humidifiers from other manufacturers
Disposable humidifiers complying with the interface description may be connected to the
flowmeter outlet.
Screw the disposable humidifier directly onto the flowmeter output (2) and tighten finger-tight
until it stops.
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4 Operation
4.1 Function check
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.
Perform a complete function check of the tapping unit prior to use. During function testing, pay
attention to the following conditions:
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 gas probe of the connection tube is secured correctly in the terminal unit.
• The NIST nipple of the connection tube is correctly secured in the NIST connection of the
tapping unit.
• The NIST screw connection is tightly fastened.
• The tapping unit is locked firmly to the equipment rail.
Operation
Function check
4
All versions:
• The tube connectors are firmly seated 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.
• The accessories are correctly connected.
• The device is leak-free.
• It is possible to variably adjust the flow rate from zero to the maximum flow.
• The device is in good hygienic condition.
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Operation
4
Use in conjunction with magnetic resonance imaging scanners
4.2 Use in conjunction with magnetic resonance imaging scanners
WARNING!
Danger to life!
Please strictly observe the operating instructions of your magnetic resonance
imaging scanner.
WARNING!
Risk of injury!
Accessories of the product (e.g. humidifier, adapter, hand-held nebuliser,
connection tubes, accessories) may be affected by the magnetic field.
If the product is used in conjunction with accessories within the 0.5 mT line, all
connected accessories must be MR compatible. Observe the operating instructions
of all connected accessories or consult the manufacturer of the product.
NOTE
If the product is used in conjunction with accessories outside the 100 mT line, the
product does not create artefacts on the MR images.
4.3 Setting the flow for treatment
WARNING!
Compressed gas setting!
The regulating mechanism is sensitive. Make the compressed gas settings very
carefully!
DANGER!
Over-pressure!
The product is under pressure whenever it is connected to the terminal unit, even if
the valve is closed.
The flowmeter viewing tube may not be unscrewed when the product is connected.
NOTE
The rate of gas flow is displayed on the flowmeter viewing tube in the centre of the
indicator ball.
NOTE
When applying oxygen in its function as a medication as per the monograph in the
European Pharmaceuticals Reference, it is absolutely necessary to measure the
flow rate.
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Operation
1
Setting the flow for treatment
Setting the flow for treatment
1
Open the control valve (1) by turning it
anticlockwise. Use the control valve to set
the gas flow rate to the required value for
treatment:
Increase the gas flow rate
Turn the control valve anticlockwise.
Reduce the gas flow rate
Turn control valve clockwise.
4
Fig. 5: Working with the unit
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Taking the unit out of operation
5
Setting the flow for treatment
5 Taking the unit out of operation
WARNING!
Disengage!
When the product is disengaged (removed) from the terminal unit, the pressure
energy may cause recoil.
Use the terminal unit into the parking position or support when disengaging.
NOTE
To protect the product from damages, cover with cloths when storing.
NOTE
Refer to the medical gas distributor instructions for information regarding detaching
the gas probe from the terminal unit.
All versions:
After having completed the treatment, close the control valve by turning it clockwise and check
to ensure that it is closed.
Disconnect the tapping unit / gas probe from the terminal unit.
Version B: Tapping unit with rail clamp
Remove the unit from the equipment rail. For this purpose, open the handle screw and lift the
unit off the equipment rail.
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6 Cleaning and disinfection
6.1 General
The product must be wipe or spray disinfected after every use.
DANGER!
Risk due to incorrect use of detergents and disinfectants!
It is strictly advised to observe the manufacturer’s instructions regarding how to
use the detergents and disinfectants as well as to observe the valid hospital
hygiene rules.
WARNING!
Infection hazard!
Product may be contaminated.
Always wear gloves for cleaning and disinfection.
Cleaning and disinfection
General
6
WARNING!
Infection hazard!
Particles of grime may become encapsulated and lead to the product not reaching
the desired germ reduction after disinfection.
Before disinfection, the product must be cleaned thoroughly of contamination and
encapsulated particles of grime.
DANGER!
Health hazard!
The product is also used to administer respiratory gas. Residues of sterilisation
gases or other substances in the unit could endanger the patient's health.
Do not disassemble the product and do not clean it by gas sterilisation or any other
mechanical cleaning or sterilisation method. Ensure that no disinfectant or cleaning
agent enters the product.
CAUTION!
Improper cleaning and disinfection can cause property damage!
Do not use the following products for cleaning and disinfection:
• Products containing alcohol (e.g. hand disinfectants)
• Halogenides (e.g. fluorides, chlorides, bromides, iodides)
• Dehalogenating compounds (e.g. fluorine, chlorine, bromine, iodine)
• Products that may scratch the surface (e.g. scouring agents, wire brushes, wire
wool)
• Standard commercial solvents (e.g. benzene, thinner)
• Water containing iron particles
• Cleaning sponges containing iron
• Products containing hydrochloric acid
Use a soft, lint-free cloth or a soft nylon brush to clean the product.
CAUTION!
Improper cleaning and disinfection can cause property damage!
Use only as much detergent and disinfectant as required.
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Cleaning and disinfection
6
Cleaning
6.2 Cleaning
6.2.1 General
CAUTION!
Improper cleaning and disinfection can cause property damage!
Perform visual and functional inspections after each cleaning and disinfection
process.
NOTE
Use only all-purpose cleaners which are slightly alkaline (soap solution) and which
contain surfactants and phosphates as the active cleaning agents.
In the event of heavily contaminated surfaces, use concentrated all-purpose
detergent.
CAUTION!
Improper cleaning can cause property damage!
Residues of physiological saline solutions (e.g. sodium chloride) can attack the
surfaces of the product.
Remove residues of physiological saline solutions with a cloth dipped in clean
water. Then dry the product with a dry, lint-free cloth.
CAUTION!
Improper cleaning can cause property damage!
Do not spray cleaning agent directly into the joints or gaps and never use a highpressure cleaning unit!
6.2.2 Cleaning procedure
Use the correct dose of all-purpose detergent with water for the degree of surface
contamination and in accordance with the instructions of the detergent manufacturer.
Thoroughly wipe off the product with a soft cloth slightly dampened in all-purpose detergent
solution.
Ensure that the product is free from contamination and encapsulated particles of grime.
Thoroughly wipe off the product with a soft cloth dipped in clean water.
Ensure that the product is free of detergent residues.
Dry the product with a dry, absorbent and lint-free cloth.
This will help to reduce pathogen growth on the product's surface.
Wipe or spray disinfect the product after every cleaning.
6.3 Disinfection
6.3.1 General
22
NOTE
In the event that product surfaces are very dirty, carry out an additional cleaning
procedure before disinfecting.
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CAUTION!
Material damage due to excessive exposure times!
Exceeding the specified exposure time of the disinfectant may damage the
surfaces.
Observe the exposure time specified by the disinfectant manufacturer.
WARNING!
Disinfectants for flowmeter viewing tube!
Only the following disinfectants are approved for instrument disinfection of the
flowmeter viewing tube:
• Indicin® Perfect* (surface disinfectant);
• Sekusept® forte S * (instrument disinfectant).
* (Registered trademark of Ecolab GmbH & CO OHG)
6.3.2 Suitable disinfectants
Only surface disinfectants based on the following combinations of active ingredients may be used
for disinfection:
• Aldehydes
• Quaternary compounds
• Guanidine derivatives
Cleaning and disinfection
Disinfection
6
Ingredient group Active ingredients
Aldehydes 2-ethyl-1-hexanal, formaldehyde, glutardialdehyde, glyoxal,
Quaternary compounds Alkyl-didecyl-polyoxethyl ammonium propionate, alkyl-dimethyl-
Guanidine derivatives Alkyl-biguanide, chlorhexidine-digluconate, cocospropylene-
Tab. 4: Active ingredients of disinfectants
6.3.3 Disinfection procedure
Wipe or spray disinfect the product in accordance with the instructions of the disinfectant
manufacturer.
Ensure that the product is free of disinfectant residue.
Perform visual and functional inspections.
o-phthaldialdehyde, succinaldehyde
alkylbenzyl ammonium chloride, alkyl-dimethyl-ethyl ammonium
chloride, alkyl-dimethyl-ethylbenzyl ammonium chloride,
benzalkonium propionate, benzalkonium chloride (alkyl-dimethylbenzyl ammonium chloride, coco-dimethyl-benzyl ammonium
chloride, lauryl-dimethylbenzyl ammonium chloride, myristyldimethyl-benzyl ammonium chloride), benzethonium chloride,
benzyl-dihydroxyethyl-coco-alkyl ammonium chloride, dialkyldimethyl ammonium chloride (didecyldimethyl ammonium chloride),
didecyl-methyl-oxyethyl ammonium propionate, mecetronium-ethyl
sulfate, methyl-benzethonium chloride, n-octyl-dimethyl-benzyl
ammonium chloride
diamine guanidinium diacetate, oliogomeric biguanide,
polyhexamethylene biguanide hydrochloride (oligo-diimino imiodocarbonyl imino-hexamethylene, polyhexanide)
GA 5752 4980 GB 13
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Cleaning and disinfection
6
Special safety notes
6.4 Special safety notes
DANGER!
Tension cracks!
Various components in the tapping unit are made of plastic materials. Solvents and
some disinfectants or some cleaning agents can soften plastic or cause tension
fissures. The gas pressure may cause the flowmeter viewing tube to burst.
Never use detergents that contain alcohol. Observe cleaning and disinfection
specifications.
CAUTION!
Property damage!
Using non-colour-fast surgical drapes can cause discolouration of surfaces.
Only use colour-fast surgical drapes.
24
GA 5752 4980 GB 13
Page 25
7 Maintenance
7.1 General
Maintenance, repairs and periodic tests may only be carried out by persons who have the
appropriate technical knowledge and are familiar with the product. To carry out these measures,
the person must have the necessary test devices and original spare parts.
ATMOS recommends: Work should be carried out by an authorised ATMOS service partner. This
ensures that repairs and testing are carried out professionally, original spare parts are used and
warranty claims remain unaffected.
DANGER!
Health hazard!
The product is used in the treatment of patients. The product or some of its
components may be contaminated.
Clean and disinfect the product before maintenance and repair. Repair work may
be performed by personnel authorised by ATMOS.
Maintenance
General
7
7.2 Periodic tests
At least every 5 years a test must be performed.
7.3 Malfunctions and troubleshooting
Defect Source of malfunction Corrective actions
Indicator ball does not rise
even when the control
valve is completely open
15 l/min are not reached
with the control valve
opened fully
Incorrect display of
flowmeter
Indicator ball does not rest
on seat with the control
valve in the closed position
Gas probe for gas supply is
only locked in the parking
position
The pressure from the central
gas supply system is not high
enough
Sintered filter is clogged Have the sintered filter replaced
Pressure fluctuations in the
gas supply system / pressure
is too low or too high
Flowmeter viewing tube
defective
Control valve is no longer
sealing
Bring gas probe for gas supply into
the operating position, i.e. push gas
probe in completely
Check the pressure supplied by the
central gas supply system
Contact technical service
Have flowmeter viewing tube and
indicator ball replaced. Note:
flowmeter viewing tube and
indicator ball function as a pair
Have flowmeter inspected
Indicator ball is stuck Flowmeter viewing tube is
contaminated
Gas probe does not fit into
the terminal unit
Wrong terminal unit selected Check the designation of the
Have flowmeter viewing tube
cleaned. Note: indicator ball and
flowmeter viewing tube function as
a pair
terminal unit
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Page 26
7
1
Maintenance
Repairs
Defect Source of malfunction Corrective actions
Full loss of pressure at the
flowmeter
Tab. 5: Malfunctions and troubleshooting
7.4 Repairs
The following issues may require repairs by the manufacturer or an authorised service partner:
• Liquid has penetrated the device.
• The performance has significantly decreased.
• Inexplicable notifications appear.
• Abnormal noises occur.
• Functional faults cannot be rectified according to the measures in chapter Malfunctions and
troubleshooting [ page 25].
If defects are detected, the product may not be used any longer.
Make a note of the deficiencies and the REF number on the data plate and inform your
responsible ATMOS representative.
Observe the information in chapter Sending in the device [ page 26].
7.5 Service hotline
+49 7653 689-0
Seal is missing or defective Have flowmeter inspected
There is a leak in the housing
Accessories are not tightened Ensure that the accessory is
properly fitted
7.6 Type plate position
1
Fig. 6: Type plate
7.7 Sending in the device
Remove and properly dispose of consumables.
Clean and disinfect the product and accessories according to the operating instructions.
Position of the type plate (1).
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GA 5752 4980 GB 13
Page 27
Maintenance
Sending in the device
Place used accessories with the product.
Fill in the form QD 434 ‘Delivery complaint / return shipment’ and the respective
decontamination certificate.
This form is enclosed with each delivery and can be found at www.atmosmed.com.
The device must be well padded and packed in suitable packaging.
Place the form QD 434 ‘Delivery complaint / return shipment’ and the respective
decontamination certificate in an envelope.
Affix the envelope to the outside of the package.
Send the product to ATMOS or to your dealer.
7
GA 5752 4980 GB 13
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Technical specifications
8
General
8 Technical specifications
8.1 General
Classification as per Annex IX to Directive 93/42/EEC Class IIa
8.2 Technical specifications
Input pressure of S FLOW flowmeter DIN / MEDAP /
NIST versions
Input pressure of S FLOW flowmeter BS / NF / SS
versions
Measurement range 0 - 15 l/min
Indication accuracy ± 10%
Input filter Sintered metal 60 μm pore width
Use in MR environment MR conditional (tapping unit without
* 100 kPa = 1 bar = 1000 mbar = 750 mmHg
** 1 T = 1000 mT = 10000 Gauss
8.3 Ambient conditions
Temperature -40 °C to +60 °C (shipping / storage)
Relative humidity less than 100% (shipping / storage)
Atmospheric pressure 700 hPa to 1060 hPa (shipping / storage)
500 kPa*
450 kPa*
humidifier / adapter / accessories) up to
4.7 T**
-20 °C to +60 °C (operation)
30% to 75% (operation)
8.4 Dimensions and weights
S FLOW flowmeter, version A DIN / MEDAP Dimensions: 25 x 150 x 130 mm
S FLOW flowmeter, version A BS / NF / SS Dimensions: 25 x 150 x 105 mm
S FLOW flowmeter, version B Dimensions: 40 x 170 x 125 mm
S FLOW twin flowmeter, version A Dimensions: 145 x 150 x 130 mm
S FLOW twin flowmeter, version B Dimensions: 145 x 150 x 130 mm
28
GA 5752 4980 GB 13
700 hPa to 1060 hPa (operation)
Weight: 230 g
Weight: 230 g
Weight: 360 g
Weight: 580 g
Weight: 730 g
Page 29
9 Approved accessories
The following accessories are not part of the scope of delivery and must be ordered separately:
9.1 Accessories
5752 2746 Tube adapter, metal 4 mm, 6 mm, 8 mm
5752 5316 Tube adapter, plaic 4 mm, 6 mm, 8 mm
5752 5315 Bubble humidier
5752 5707 Flow selector
Tab. 6: Accessories
Approved accessories
Accessories
9
GA 5752 4980 GB 13
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Page 30
Notes
Page 31
Notes
Page 32
Manufacturer:
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
79853 Lenzkirch
GERMANY
Telephone: +49 7653 689-0
www.atmosmed.com
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