Atmos MEDAP LS FLOW User manual

OPERATING INSTRUCTIONS
MEDAP
LS FLOW FLOWMETER
INSTALLATION VERSION
GA 5752 5678 GB 07

GA 5752 5678 GB 07
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.
V07 2019-12
4

GA 5752 5678 GB 07 3
Table of contents
Table of contents
1 Introduction ..............................................................................................................................................5
1.1 Foreword ....................................................................................................................................................5
1.2 How to use these operating instructions .................................................................................................... 5
1.2.1 Abbreviations ............................................................................................................................... 5
1.2.2 Symbols ....................................................................................................................................... 5
1.2.2.1 Cross-references ....................................................................................................... 5
1.2.2.2 Actions and responses .............................................................................................. 5
1.2.3 Definitions .................................................................................................................................... 6
1.2.3.1 Design of safety notes ............................................................................................... 6
1.2.3.2 Design of other notes ................................................................................................ 6
1.2.4 Symbols used .............................................................................................................................. 6
1.3 Disposal......................................................................................................................................................7
1.3.1 ATMOS products.......................................................................................................................... 7
1.3.2 Packaging .................................................................................................................................... 8
1.4 Overview ....................................................................................................................................................8
1.5 Basic requirements.....................................................................................................................................8
1.5.1 Use in accordance with the intended purpose ............................................................................. 8
1.5.2 Applicable standards.................................................................................................................... 9
1.5.3 Intended purpose ......................................................................................................................... 9
1.5.3.1 Possible applications ............................................................................................... 10
1.5.4 Version LS FLOW flowmeter installation version ....................................................................... 10
1.5.5 Interface description................................................................................................................... 10
1.5.5.1 Flowmeter outlet ...................................................................................................... 10
1.5.5.2 Connection tube ...................................................................................................... 11
1.5.5.3 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 Equipment inspection...............................................................................................................................14
3.2 Mounting accessories...............................................................................................................................14
3.2.1 General ...................................................................................................................................... 14
3.2.2 Connection of bubble humidifier (REF 5752 5315).................................................................... 14
3.2.3 Connection of disposable humidifiers from other manufacturers............................................... 14
4 Operation ................................................................................................................................................15
4.1 Function check .........................................................................................................................................15
4.2 Setting the flow for treatment ................................................................................................................... 15

GA 5752 5678 GB 07
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Table of contents
5 Taking the unit out of operation............................................................................................................17
6 Cleaning and disinfection...................................................................................................................... 18
6.1 General.....................................................................................................................................................18
6.2 Special safety notes ................................................................................................................................. 19
6.3 Cleaning ...................................................................................................................................................19
6.3.1 General ...................................................................................................................................... 19
6.3.2 Cleaning procedure.................................................................................................................... 19
6.4 Disinfection...............................................................................................................................................20
6.4.1 General ...................................................................................................................................... 20
6.4.2 Suitable disinfectants ................................................................................................................. 20
6.4.3 Disinfection procedure ............................................................................................................... 21
7 Maintenance............................................................................................................................................22
7.1 General.....................................................................................................................................................22
7.2 Periodic tests............................................................................................................................................22
7.3 Malfunctions and troubleshooting.............................................................................................................22
7.4 Repairs.....................................................................................................................................................23
7.5 Service hotline..........................................................................................................................................23
7.6 Type plate position ...................................................................................................................................23
7.7 Sending in the device...............................................................................................................................23
8 Technical specifications ........................................................................................................................24
8.1 General.....................................................................................................................................................24
8.2 Technical specifications............................................................................................................................24
8.3 Ambient conditions...................................................................................................................................24
8.4 Dimensions and weight ............................................................................................................................ 24
9 Approved accessories...........................................................................................................................25
9.1 Accessories..............................................................................................................................................25

Introduction
Foreword
GA 5752 5678 GB 07 5
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1 Introduction
1.1 Foreword
Your facility has selected the leading-edge medical technology made by ATMOS. We sincerely
appreciate the trust you have placed in us.
1.2 How to use these operating instructions
These operating instructions are provided to familiarise you with the features of this ATMOS
product. They are subdivided into several chapters.
Please note:
• Please read these operating instructions carefully and completely before using the product for
the first time.
• Always proceed in accordance with the information contained herein.
• Store these operating instructions in a location near the product.
1.2.1 Abbreviations
EN European standard
EEC European Economic Community
LS Lochscheibe (Punched disc)
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
6GA 5752 5678 GB 07
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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 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’.

Introduction
Disposal
GA 5752 5678 GB 07 7
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Symbols Identification
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’.
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 as well as date of
manufacture’.
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.
1.3.1 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
8GA 5752 5678 GB 07
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1.3.2 Packaging
The packaging is made of materials compatible with the environment. ATMOS will dispose of the
packaging materials upon request.
1.4 Overview
Fig. 1: Overview
1 LS FLOW flowmeter installation version
2 Tube adapter, plastic, 4 mm, 6 mm, 8 mm
(REF 5752 5316)
3 Tube adapter 4 mm, 6 mm, 8 mm (REF 5752
2746)
4 Angled adapter (REF 5752 5606)
5 Rotation regulator
6 Flowmeter outlet (UNF 9/16")
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.
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.

Introduction
Basic requirements
GA 5752 5678 GB 07 9
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1.5.2 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
with harmonised standards such as IEC 60601-1 and related standards and the respective
special sections.
1.5.3 Intended purpose
Name: LS FLOW installation version
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 LS FLOW is used to
provide metered administration of medication aerosols.
Medical indications /
application:
Inhalation and insufflation of oxygen within the scope of oxygen
enrichment via an inhalation mask or nose latch for patients who
can breathe independently.
Together with a hand-held nebuliser, administration of water-soluble
medications via an inhalation mask.
Specification of the main
function:
Supply of oxygen or compressed air. The LS FLOW installation
version is permanently installed in a ceiling supply unit (pendant) or
in a wall duct having a supply pressure within the inlet pressure
specified on the product instead of an oxygen / compressed air
terminal unit. 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
connected to 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.

Introduction
Basic requirements
10 GA 5752 5678 GB 07
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Contraindications: The LS FLOW 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 exclusive respiration
• For central gas supply systems with a supply pressure other
than that specified on the product.
• When applying oxygen in its function as a medication, it is abso-
lutely necessary to measure the flow rate.
The product is: Not active
Sterility: Not a sterile product
Single-use product /
reprocessing:
The device and parts of the accessories are reusable. For
information on reprocessing, cleaning and disinfection, please see
the operating instructions.
1.5.3.1 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.
• A metal tube adapter (REF 5752 2746) or plastic (REF 5752 5316) can be used to connect
suitable connection tubes with inner diameters of 4 mm, 6 mm and 8 mm to the flowmeter.
• With the bubble humidifier (REF 5752 5315) for humidifying oxygen. The bubble humidifier is
intended for inhalation. The bubble humidifier is connected via the angled adapter (REF 5752
5606).
• Sterile water systems / disposable humidifiers (UNF 9/16") can be connected via the angled
adapter (REF 5752 5606).
1.5.4 Version LS FLOW flowmeter installation version
The device is installed in a ceiling supply unit (pendant) or in a wall duct.
The following versions of this product are available:
• LS FLOW O 15 DVE SA (REF 5752 5588)
• LS FLOW A 15 DVE SA (REF 5752 5589)
• LS FLOW O 15 DVE NIST (REF 5752 5590)
• LS FLOW A 15 DVE NIST (REF 5752 5591)
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 Flowmeter outlet
The internal thread on the accessory must match the external thread on the flowmeter (UNF
9/16" 18 gear). Ensure that the connection between the flowmeter and the accessory is leak-free.

Introduction
Basic requirements
GA 5752 5678 GB 07 11
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1.5.5.2 Connection tube
The connection tube with an inner diameter of 4, 6 or 8 mm is connected with the tube adapter.
The connection tube may 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.
1.5.5.3 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").

Safety notes
General safety notes
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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. Only use sliding
means (lubricants) approved by ATMOS for this product.
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 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
WARNING!
Impacts!
Impacts may cause damage to sensitive, precision mechanical components.
Do not expose the product to impacts.

Safety notes
Product safety notes
GA 5752 5678 GB 07 13
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WARNING!
Non-permissible load!
If the permissible load is exceeded, leakages may occur.
The overall weight of the products and accessories may not exceed 2 kg.
WARNING!
Property damage!
Product may not be dismantled or disassembled.
CAUTION!
Malfunction!
Ensure that the connection between the product and the accessory is leak-free.
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 leak tightness of the product
cannot be guaranteed if the ambient temperature range is undercut or exceeded.

Initial operation
Equipment inspection
14 GA 5752 5678 GB 07
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3 Initial operation
3.1 Equipment inspection
DANGER!
Product inspection!
Only product parts which are in perfect condition can ensure proper functioning of
the product. The product parts will thus have to be carefully inspected before
mounting.
Check whether all tubes are undamaged.
Check whether the unit has been properly cleaned and that there are no residues or soiling.
Do not use damaged components.
3.2 Mounting accessories
3.2.1 General
WARNING!
Tensile forces!
The connected accessories must not exert any mechanical forces which could
adversely affect the secure fit of the product.
3.2.2 Connection of bubble humidifier (REF 5752 5315)
1
1
3
3
2
2
Fig. 2: Connection of bubble humidifier
Connecting the bubble humidifier
Ensure that the cap nut of the humidifier
and the angled adapter contain 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 the angled adapter (1) to the
flowmeter output and tighten finger-tight
until it stops.
Screw the bubble humidifier cap (3) to the
angled adapter (1) and tighten finger-tight
until it stops.
Pay attention that no tensile forces affect
the bubble humidifier.
3.2.3 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 to the flowmeter output (2) and tighten finger-tight
until it stops.

Operation
Function check
GA 5752 5678 GB 07 15
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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.
• The tube connectors are firmly secured and no mechanical forces are acting on the tubes.
• The plastic and rubber product parts are in perfect condition and show no signs of ageing.
• The accessories are correctly connected.
• The product is leak-free.
• It is possible to adjust the flow rate from zero to the maximum flow.
• The product is in perfect hygienic condition.
4.2 Setting the flow for treatment
WARNING!
Compressed gas setting!
The regulating mechanism is sensitive. Make the compressed gas settings very
carefully!
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.
NOTE
The flow rate can be set to the following 14 values: 0; 0.2; 0.5; 0.7; 1; 1.5; 2; 3; 4;
5; 7; 10; 12; 15.

Operation
Setting the flow for treatment
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1
1
Fig. 3: Setting the flow
Use the rotation regulator to set the flow rate
to the required value for the treatment.
Increasing the flow rate
Turn the rotation regulator (1) anti-
clockwise.
The flow rate is increased.
Reducing the flow rate
Turn the rotation regulator (1) clockwise.
The flow rate is decreased.

Taking the unit out of operation
Setting the flow for treatment
GA 5752 5678 GB 07 17
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5 Taking the unit out of operation
After having completed the treatment, close the rotation regulator by turning it clockwise as far
as it will go.
Check to ensure it is closed.
Arrow on the rotation regulator points to 0.

Cleaning and disinfection
General
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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.
DANGER!
Health hazard!
Disinfectants and cleaning agents may not enter the product.
DANGER!
Infection hazard!
Product may be contaminated.
Always wear gloves for cleaning and disinfection.
DANGER!
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.
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.
CAUTION!
Improper cleaning and disinfection can cause property damage!
Perform visual and functional inspections after each cleaning and disinfection
process.

Cleaning and disinfection
Special safety notes
GA 5752 5678 GB 07 19
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6.2 Special safety notes
DANGER!
Material damage!
Various components in the product are made of plastic materials. Solvents and
some disinfectants and some cleaning agents can soften plastic or cause tension
fissures.
Never use detergents that contain alcohol. Observe detergent and disinfectant
specifications.
6.3 Cleaning
6.3.1 General
NOTE
Use only multi-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 multi-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 high-
pressure cleaning unit!
6.3.2 Cleaning procedure
Use the correct dose of multi-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 a multi-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.

Cleaning and disinfection
Disinfection
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6.4 Disinfection
6.4.1 General
NOTE
In the event that product surfaces are very dirty, carry out an additional cleaning
procedure before disinfecting.
WARNING!
Property damage!
Disinfectants that contain volatile aromatic hydrocarbons, ammonia, amine, ester,
halogenated hydrocarbons and / or ketone may attack plastics made of
polycarbonate.
Do not use disinfectants with these ingredients.
CAUTION!
Material damage due to excessive exposure times!
Exceeding the specified exposure time of the disinfectant may damage the
surfaces.
Observe the specified exposure time of the disinfectant manufacturer.
NOTE
Heavily diluted disinfectants may be used for disinfection.
6.4.2 Suitable disinfectants
Only surface disinfectants based on the following combinations of active ingredients may be used
for disinfection:
• Aldehydes
• Quaternary compounds
• Guanidine derivatives
Ingredient group Active ingredients
Aldehydes 2-ethyl-1-hexanal, formaldehyde, glutardialdehyde, glyoxal,
o-phthaldialdehyde, succinaldehyde
Quaternary compounds Alkyl-didecyl-polyoxethyl ammonium propionate, alkyl-dimethyl-
alkylbenzyl ammonium chloride, alkyl-dimethyl-ethyl ammonium
chloride, alkyl-dimethyl-ethylbenzyl ammonium chloride,
benzalkonium propionate, benzalkonium chloride (alkyl-dimethyl-
benzyl ammonium chloride, coco-dimethyl-benzyl ammonium
chloride, lauryl-dimethylbenzyl ammonium chloride, myristyl-
dimethyl-benzyl ammonium chloride), benzethonium chloride,
benzyl-dihydroxyethyl-coco-alkyl ammonium chloride, dialkyl-
dimethyl ammonium chloride (didecyldimethyl ammonium chloride),
didecyl-methyl-oxyethyl ammonium propionate, mecetronium-ethyl
sulfate, methyl-benzethonium chloride, n-octyl-dimethyl-benzyl
ammonium chloride