MEDAP LS FLOW FLOWMETER Operating Instructions Ver 15 Dec 2019.pdf
Page 1
OPERATING INSTRUCTIONS
MEDAP
LS FLOW FLOWMETER
GA 5752 4981 GB 15
Page 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.
V15 2019-12
4
2
GA 5752 4981 GB 15
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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
1.2.3
1.2.4
1.3
1.2.2.1
Cross-references........................................................................................................ 5
1.2.2.2
Actions and responses............................................................................................... 5
Definitions..................................................................................................................................... 6
1.2.3.1
Design of safety notes................................................................................................ 6
1.2.3.2
Structure of notes....................................................................................................... 6
Symbols used............................................................................................................................... 6
Disposal....................................................................................................................................................... 7
1.3.1
ATMOS products........................................................................................................................... 8
1.3.2
Packaging..................................................................................................................................... 8
1.4
Overview of LS FLOW flowmeter................................................................................................................ 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
Versions of LS FLOW / LS 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....................................................................................................... 12
1.5.5.4
Tube adapter for Air and O2..................................................................................... 12
2
Safety notes............................................................................................................................................. 13
2.1
General safety notes................................................................................................................................. 13
2.2
Product safety notes.................................................................................................................................. 13
3
Initial operation........................................................................................................................................ 15
3.1
Equipment inspection................................................................................................................................ 15
3.2
Connection to the terminal unit................................................................................................................. 15
3.3
3.2.1
General....................................................................................................................................... 15
3.2.2
Version A..................................................................................................................................... 15
3.2.3
Version B..................................................................................................................................... 16
3.2.4
Version C.................................................................................................................................... 16
Mounting accessories................................................................................................................................ 16
3.3.1
General....................................................................................................................................... 16
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Table of contents
3.3.2
Connection of bubble humidifier (REF 5752 5315)..................................................................... 17
3.3.3
Connection of disposable humidifiers from other manufacturers................................................ 17
4
Operation................................................................................................................................................. 18
4.1
Functional test........................................................................................................................................... 18
4.2
Use in conjunction with magnetic resonance imaging scanners............................................................... 18
4.3
Setting the flow for treatment.................................................................................................................... 19
5
Taking the unit out of operation............................................................................................................. 20
5.1
Taking the unit out of operation................................................................................................................. 20
6
Cleaning and disinfection....................................................................................................................... 21
6.1
General...................................................................................................................................................... 21
6.2
Cleaning.................................................................................................................................................... 22
6.3
6.2.1
General....................................................................................................................................... 22
6.2.2
Cleaning procedure..................................................................................................................... 22
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
Period 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......................................................................................................................... 27
8.1
General...................................................................................................................................................... 27
8.2
Technical specifications............................................................................................................................. 27
8.3
Ambient conditions.................................................................................................................................... 27
8.4
Dimensions and weights........................................................................................................................... 27
9
Approved accessories............................................................................................................................ 29
9.1
Accessories............................................................................................................................................... 29
4
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Introduction
Foreword
1
Introduction
1.1
Foreword
1
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
EEC
PD
1.2.2
Symbols
1.2.2.1
Cross-references
European standard
European Economic Community
Punched disc
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.
9 Lamp lights up.
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1
Introduction
How to use these operating instructions
1.2.3
Definitions
1.2.3.1
Design of safety notes
Pictogram
Descriptor
Text
DANGER!
The text for the safety note
describes the type of risk and
how to avert it.
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.
Tab. 1:
1.2.3.2
Design of safety notes
Structure of notes
Notes not referring to personal injury or property damage are structured as follows:
Pictogram
Tab. 2:
1.2.4
Descriptor
Reference to
NOTE
Supplementary assistance or further useful information.
ENVIRONMENT
Information regarding proper disposal.
Structure of notes
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’.
6
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Introduction
Disposal
Symbols
1
Identification
Labelling in compliance with the IEC 62570 standard.
Symbol for ‘Conditionally MR safe’.
Packaging label.
Symbol for ‘Keep dry’.
Packaging label.
Symbol for ‘Caution! Do not overturn’.
Packaging label.
Symbol for ‘Top’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Temperature limitations’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Relative humidity’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Atmospheric pressure’.
Meaning of 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:
1.3
Symbols
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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1
1.3.1
Introduction
Overview of LS FLOW flowmeter
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.
1.3.2
Packaging
The packaging is made of materials compatible with the environment. ATMOS will dispose of the
packaging materials upon request.
1.4
Overview of LS FLOW flowmeter
A
B
1
5
7
6
11
C
Fig. 1:
1
2
3
4
5
6
Overview of LS FLOW flowmeter
Version A
Tapping unit with integrated gas pin
Hand wheel
Viewing window
Gas probe
Flowmeter outlet
Version B
Tapping unit with rail clamp and
NIST connection
Equipment rail
NIST connection
7
8
9
10
NIST nipple
NIST screw connection
Connection tube
Tube adapter, 4 mm, 6 mm, 8 mm (REF 5752
2746)
11 Tube adapter, plastic, 4 mm, 6 mm, 8 mm
(REF 5752 5316)
Version C
Tapping unit with NIST connection, for screwing
(without rail clamp)
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.
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Introduction
Basic requirements
1
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
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
LS 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 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 a nose latch for patients
breathing by themselves
Together with a hand-held nebuliser administration of water soluble
drugs via an inhalation mask
Specification of the main
function:
Supply of oxygen or compressed air. For oxygen / compressed air
supply, the LS FLOW is connected to an oxygen / compressed air
terminal unit of a central medical gas supply system having a
supply pressure within the supply 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
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.
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1
Introduction
Basic requirements
1.5.3.1
Contraindications:
The LS 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
• For central gas supply systems with supply pressures other than
that 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:
No 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.
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 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 LS FLOW / LS 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.
Version C: Tapping unit with NIST connection, for screwing
• The product is designed for direct screw connection and is supplied from a terminal unit via a
NIST connection according to DIN EN 5359 with a connection tube with gas probe.
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Introduction
Basic requirements
1
The product is available in the following versions:
• LS FLOW O 15 Wall DIN (REF 5752 4916)
• LS FLOW O 15 Wall DIN P5 (REF 5752 5705)
• LS FLOW O 15 Wall MEDAP (REF 5752 4917)
• LS FLOW O 15 Wall BOC (BS 5682) (REF 5752 4921)
• LS FLOW O 15 Wall Air Liquide (NF S 90-116) (REF 5752 5161)
• LS FLOW O 15 Wall AGA (SS 8752430) (REF 5752 5162)
• LS FLOW O 15 NIST connection, equipment rail (REF 5752 5301)
• LS FLOW O 15 NIST connection, equipment rail P5 (REF 5752 5704)
• LS FLOW O 15 NIST connection, screw connection (REF 5752 5708)
• LS FLOW O 05 Wall DIN (REF 5752 5304)
• LS FLOW O 05 NIST connection, equipment rail (REF 5752 5305)
• LS FLOW O 01 Wall DIN (REF 5752 5306)
• LS FLOW O 01 NIST connection, equipment rail (REF 5752 5307)
• LS DFLOW O 15 Wall DIN (REF 5752 4919)
• LS DFLOW O 15 Wall DIN P5 (REF 5752 5702)
• LS DFLOW O 15 Wall MEDAP (REF 5752 5706)
• LS DFLOW O 15 Wall AGA (SS 8752430) (REF 5752 5183)
• LS DFLOW O 15 NIST connection, equipment rail (REF 5752 5302)
• LS FLOW A 15 Wall DIN (REF 5752 5235)
• LS FLOW A 15 Wall DIN P5 (REF 5752 5703)
• LS FLOW A 15 Wall MEDAP (REF 5752 5450)
• LS FLOW A 15 Wall AGA (SS 8752430) (REF 5752 5240)
• LS FLOW A 15 NIST connection, equipment rail (REF 5752 5303)
• LS FLOW A 15 NIST connection, screw connection (REF 5752 5709)
• LS DFLOW A 15 Wall DIN (REF 5752 5607)
• LS DFLOW A 15 NIST connection, equipment rail (REF 5752 5608)
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, its air tightness 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 300 - 550 kPa (P5 versions: 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
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.
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1
Introduction
Basic requirements
1.5.5.3
Connection tube
The connection tube with the 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.
1.5.5.4
Tube adapter for Air and O2
The tube adapter is used to connect the tapping unit and the connection tube. The inner thread of
the tube adapter must match the outer thread of the tube connector of the flowmeter output (UNF
9/16").
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Safety notes
General safety notes
2
Safety notes
2.1
General safety notes
2
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 tight fitting and firm seat of the connector 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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2
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 maximum upper and lower ambient temperatures are
exceeded.
WARNING!
Impacts!
Impacts may cause damage to sensitive, precision mechanical components.
Do not expose the product to impacts.
WARNING!
Non-permissible load!
If the permissible load is exceeded, leakages may occur at the connection between
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
Equipment inspection
3
Initial operation
3.1
Equipment inspection
3
DANGER!
Product testing!
Only product parts which are in perfect condition can ensure proper functioning of
the product.
The product parts will thus have to be carefully inspected before mounting.
_ 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
Connection to the terminal unit
3.2.1
General
NOTE
Please refer to the manufacturer’s instructions for the particular terminal unit for
information on connecting the gas probe to the terminal unit.
3.2.2
Version A
Tapping unit with integrated gas pin
_ The tapping unit (1) is plugged directly into
the terminal unit (2).
2
1
Fig. 2:
Version A
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3
3.2.3
Initial operation
Mounting accessories
Version B
Tapping unit with rail clamp and NIST
connection
2
8
_ 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.
1
7
_ Tighten the handle screw (3) of the rail
clamp.
5
3
4
6
Fig. 3:
3.2.4
_ 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).
Version B
Version C
Tapping unit with NIST connection, for
screwing
_ Insert the NIST nipple (1) of the connection
tube into the NIST connection (2) of the
tapping unit and tighten the cap nut (3) by
hand.
5
_ Plug the gas probe (4) into the terminal unit
(5).
4
2
1
3
Fig. 4:
Version C
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 seating of the product.
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Initial operation
Mounting accessories
3
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)
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.
2
1
_ Screw cap nut (1) of the bubble humidifier
to the flowmeter output (2) and tighten
finger-tight until stop.
_ Pay attention that no tensile forces affect
the bubble humidifier.
Fig. 5:
3.3.3
Connection of bubble humidifier
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 stop.
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4
Operation
Functional test
4
Operation
4.1
Functional test
DANGER!
Functional test!
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 functional test every time before using the unit.
Perform a complete functional test of the tapping unit prior to use.
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 seated 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.
Version C: Tapping unit with NIST connection, for screwing
• The gas probe of the connection tube is correctly inserted into 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 screwed tight.
All versions:
• The tube connectors are firmly seated and tightly sealed 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 device is in good hygienic condition.
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.
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Operation
Setting the flow for treatment
4
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!
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 (at 15 l/min),
0; 0.1; 0.2; 0.3; 0.4; 0.6; 0.8; 1; 1.5; 2; 2.5; 3; 4; 5 (at 5 l/min),
0; 0.1; 0.15; 0.2; 0.25; 0.3; 0.35; 0.4; 0.5; 0.6; 0.7; 0.8; 0.9; 1 (at 1 l/min),
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.
Use the rotation regulator to set the flow rate
to the required value for the treatment.
Increasing the flow rate
1
_ Turn the rotation regulator (1) anticlockwise.
9 The flow rate is increased.
Reducing the flow rate
_ Turn the rotation regulator (1) clockwise.
9 The flow rate is decreased.
Fig. 6:
Working with the unit
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5
Taking the unit out of operation
Taking the unit out of operation
5
Taking the unit out of operation
5.1
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 in 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 adjustment screw 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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Cleaning and disinfection
General
6
Cleaning and disinfection
6.1
General
6
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 instructions regarding how to use
the detergents and disinfectants as well as the valid hospital hygiene rules.
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.
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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6
Cleaning and disinfection
Cleaning
CAUTION!
Improper cleaning and disinfection can cause property damage!
Perform visual and functional inspections after each cleaning and disinfection
process.
6.2
Cleaning
6.2.1
General
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 wetted in an 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
NOTE
In the event that product surfaces are very dirty, carry out an additional cleaning
procedure before disinfecting.
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Page 23
Cleaning and disinfection
Disinfection
6
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.
6.3.2
Suitable disinfectants
Only surface disinfectants based on the following combinations of active ingredients may be used
for disinfection:
• Aldehydes
• Quaternary compounds
• Guanidine derivatives
Ingredient group
Active ingredients
Aldehydes
2-ethyl-1-hexanal, formaldehyde, glutardialdehyde, glyoxal,
o-phthaldialdehyde, succinaldehyde
Quaternary compounds
Alkyl-didecyl-polyoxethyl ammonium propionate, alkyl-dimethylalkylbenzyl 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
Guanidine derivatives
Alkyl-biguanide, chlorhexidine-digluconate, cocospropylenediamine guanidinium diacetate, oliogomeric biguanide,
polyhexamethylene biguanide hydrochloride (oligo-diimino imiodocarbonyl imino-hexamethylene, polyhexanide)
Tab. 4:
6.3.3
Active ingredients of disinfectants
Disinfection procedure
_ Wipe or spray disinfect the product in accordance with the instructions of the disinfectant
manufacturer.
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6
Cleaning and disinfection
Special safety notes
_ Ensure that the product is free of disinfectant residue.
_ Perform visual and functional inspections.
6.4
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 cleaning and disinfection
specifications.
CAUTION!
Property damage!
Using non-colour-fast surgical drapes can cause discolouration of surfaces.
Only use colour-fast surgical drapes.
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Maintenance
General
7
Maintenance
7.1
General
7
Maintenance, repairs and period 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.
7.2
Period tests
At least every 5 years a test must be performed.
7.3
Malfunctions and troubleshooting
Defect
Source of malfunction
No flow
Flow rate is set to the value ‘0’ Set the flow rate to the desired value
Flow does not stop
Troubleshooting
Product defective
Have the equipment repaired by a
service technician authorised by
ATMOS
Flow rate is not set to the
value ‘0’
Set the flow rate to the value ‘0’
Product defective
Have the equipment repaired by a
service technician authorised by
ATMOS
The value of 15 l/min
The pressure from the central
cannot be achieved even gas supply system is not high
if the flow rate is adjusted enough
to the max. value
Sintered filter is clogged
Check the pressure supplied by the
central gas supply installation
Gas probe does not fit
into the terminal unit
Wrong terminal unit selected
Check the designation of the
terminal unit
Full loss of pressure at
the flowmeter
Seal is missing or defective
Have the equipment repaired by a
service technician authorised by
ATMOS
There is a leak in the housing
Accessories are not tightened
Tab. 5:
Have the equipment repaired by a
service technician authorised by
ATMOS
Check seating of accessories
Troubleshooting
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