Maquet Medap Instructions Manual
OPERATING INSTRUCTIONS
MEDAP
HAND-HELD NEBULISER
GA 5750.4172 EN 14
GA 5750.4172 EN 14
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.
V14 2016-07
GA 5750.4172 EN 14
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Table of contents
Table of contents
1 Introduction ..............................................................................................................................................5
1.1 Foreword .................................................................................................................................................... 5
1.2 Environmental protection ............................................................................................................................5
1.2.1 Packing ........................................................................................................................................5
1.2.2 ATMOS products .......................................................................................................................... 5
1.3 Disposal ......................................................................................................................................................5
1.4 How to use these operating instructions .................................................................................................... 5
1.4.1 General ........................................................................................................................................5
1.4.2 Abbreviations ...............................................................................................................................5
1.4.3 Symbols .......................................................................................................................................5
1.4.3.1 Cross-references ....................................................................................................... 5
1.4.3.2 Actions and responses .............................................................................................. 6
1.4.4 Definitions ....................................................................................................................................6
1.4.4.1 Design of safety notes ............................................................................................... 6
1.4.4.2 Design for other notes ............................................................................................... 6
1.4.5 Symbols used ..............................................................................................................................6
1.5 Hand-held nebuliser ................................................................................................................................... 8
1.5.1 Pictorial guide for hand-held nebuliser ......................................................................................... 8
1.5.2 Use in accordance with the intended purpose ............................................................................. 8
1.5.3 Applicable standards ....................................................................................................................9
1.5.4 Intended purpose ......................................................................................................................... 9
1.5.4.1 Incorrect operation/contraindications ....................................................................... 10
1.5.4.2 Possible applications ............................................................................................... 10
1.5.5 Interface description ................................................................................................................... 11
1.5.5.1 General .................................................................................................................... 11
1.5.5.2 Dimensions for the connector keyed to a particular type of gas .............................. 11
1.5.5.3 Regulating unit ......................................................................................................... 11
2 Principal safety notes ............................................................................................................................12
2.1 General safety notes ................................................................................................................................ 12
3 Initial operation .......................................................................................................................................15
3.1 Equipment inspection ............................................................................................................................... 15
3.2 Assembly of hand-held nebuliser ............................................................................................................. 15
3.3 Filling the hand-held nebuliser ................................................................................................................. 15
3.4 Assembly and connection of accessories ................................................................................................ 16
3.4.1 Connection of FINA FLOW O 15 ................................................................................................16
3.4.2 Connection of the S FLOW flowmeter ....................................................................................... 17
3.4.3 Connection of the LS FLOW flowmeter ..................................................................................... 17
3.4.4 Connection of FINA fine regulating valve ...................................................................................18
GA 5750.4172 EN 14
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Table of contents
3.4.5 Connection of O2 pressure reducing valve with flowmeter ........................................................ 18
4 Operation ................................................................................................................................................19
4.1 Regular operation ..................................................................................................................................... 19
4.2 Continuous nebulisation ........................................................................................................................... 20
4.3 Taking the unit out of operation ................................................................................................................ 20
5 Malfunctions and troubleshooting .......................................................................................................22
5.1 Malfunctions and troubleshooting.............................................................................................................22
6 Cleaning and disinfection ......................................................................................................................23
6.1 General .....................................................................................................................................................23
6.2 Disassembly ............................................................................................................................................. 24
6.3 Cleaning ................................................................................................................................................... 24
6.3.1 General ......................................................................................................................................24
6.3.2 Cleaning procedure ....................................................................................................................25
6.3.3 Cleaning of suction sleeve and nozzle ....................................................................................... 25
6.4 Disinfection ............................................................................................................................................... 26
6.4.1 General ......................................................................................................................................26
6.4.2 Suitable disinfectants ................................................................................................................. 26
6.4.3 Disinfection procedure ...............................................................................................................27
6.4.4 Disinfection procedures ............................................................................................................. 27
6.4.5 Special safety notes ................................................................................................................... 27
7 Maintenance ............................................................................................................................................29
7.1 Visual and functional inspections .............................................................................................................29
7.2 Maintenance ............................................................................................................................................. 29
7.3 Repairs ..................................................................................................................................................... 29
8 Technical specifications ........................................................................................................................ 31
8.1 General .....................................................................................................................................................31
8.2 Ambient conditions ................................................................................................................................... 31
8.3 Dimensions and weight ............................................................................................................................ 31
8.4 Particle size distribution ............................................................................................................................32
8.5 Cumulative frequency ...............................................................................................................................33
9 Delivery program ....................................................................................................................................34
9.1 Accessories .............................................................................................................................................. 34
Introduction
Foreword
GA 5750.4172 EN 14
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1
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 Environmental protection
1.2.1 Packing
The packing is made of materials compatible with the environment. ATMOS will dispose of the
packing materials upon request.
1.2.2 ATMOS products
ATMOS will take back used products or those which are no longer in service.
Please contact your ATMOS representative for more detailed information.
1.3 Disposal
WARNING!
Disposal!
The product is used in the treatment of patients. The product or some of its
components may be contaminated after use.
Clean and disinfect the product before disposal.
1.4 How to use these operating instructions
1.4.1 General
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.
1.4.2 Abbreviations
EN European standard
EU European Economic Community
VDE Verband der Elektrotechnik Elektronik Informationstechnik (Association for
Electrical, Electronic & Information Technology)
1.4.3 Symbols
1.4.3.1 Cross-references
References to other pages in these operating instructions are identified with a double arrow
symbol „“.
Introduction
Actions and responses
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GA 5750.4172 EN 14
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1.4.3.2 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.
1.4.4 Definitions
1.4.4.1 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
1.4.4.2 Design for 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 for other notes
1.4.5 Symbols used
Symbols Identification
Labelling for products which were developed and are marketed in compliance with the 93/42/EEC Medial Products Directive. Class Is, Im, IIa, IIb and
III products are also marked with the identifying number for the notified body.
Introduction
Symbols used
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1
Symbols Identification
Labelling in compliance with the EN 980 standard.
Symbol for "Product number".
Labelling in compliance with the EN 9801 standard.
Symbol for "Name and address of the manufacturer as well as date of manufacture".
Labelling in compliance with the EN 980 standard.
Symbol for "Serial number".
Labelling in compliance with the IEC 60601-1 standard.
Symbol for "Follow Operating Instructions".
Material designation for the plastic PA
(polyamide).
Material designation for the plastic PSU
(polysulfone).
Packaging label.
Symbol for "Keep dry".
Transportation label.
Symbol for "Temperature limitations".
Transportation label.
Symbol for "Relative humidity".
Transportation label.
Symbol for "Atmospheric pressure".
Tab. 3: Symbols
Introduction
Hand-held nebuliser
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GA 5750.4172 EN 14
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1.5 Hand-held nebuliser
1.5.1 Pictorial guide for hand-held nebuliser
1
2
6
10
13
14
3
5
4
7
9
11
15
8
12
16
Fig. 1: Pictorial guide for hand-held nebuliser
1 Inhalation mask 9 Connection tube for compressed air or oxygen
2 Fastening chain 10 Seal
3 Nebuliser housing 11 Profile seal
4 Medicine cup 12 O-ring
5 Adapter 13 Nozzle
6 Knurled head screw 14 Suction sleeve
7 Connector 15 Piece of tube
8 Connection thread 16 Cleaning needle
1.5.2 Use in accordance with the intended purpose
Product
As per appendix IX of the Medical Products Directive 93/42/EU this product belongs to class IIb.
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.
Introduction
Applicable standards
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1
When employed in a commercial or business
use, this product shall be entered in the inventory.
Accessories
Accessories or combinations of accessories may be utilised only as and when indicated in these
operating instructions.
Other accessories, combinations of accessories and consumable items may be used only if they
have a valid certification, are intended
expressly for the particular use and will not adversely affect performance, the prescribed ambient
conditions or safety requirements.
1.5.3 Applicable standards
The product satisfies the basic requirements set forth in Annex I to the 93/42/EU Directive drafted
by the Medical Products Council (Medical
Products Directive) as well as the applicable national (German) codes and the Medical Products
Act in Germany.
The applicable standards include the following:
• DIN EN ISO 15001 Anaesthetic and respiratory equipment - Compatibility with oxygen
• DIN EN 13544-1 Respiratory therapy equipment Part 1: Nebulising systems and their components
1.5.4 Intended purpose
The hand-held nebuliser (REF 5750 7534) is intended for administering water-soluble inhalation
medication.
The medication is separated into tiny drops in the medication cup (aerosol size of 0.5 - 7 μm at
500 kPa) and supplied to the patient through the inhalation mask (approx. 2 ml / 10 min).
Only use the hand-held nebuliser in conjunction with a regulating unit (flowmeter, precision
regulation valve or pressure reducing valve with
O2 or Air flowmeter) which has a minimum litre capacity of 13 l/min and a pressure of 280 kPa 600 kPa (e. g. FINA RV O / RV A, FINA FLOW
O15 / A15, S FLOW flowmeter O15 / A15, LS FLOW flowmeter O15 / A15 and O2 pressure
reducing valve with flowmeter).
The hand-held nebuliser is designed for temporary operation (up to 60 min). The unit is designed
to be used by medical personnel who, on the basis of their professional experience and
instruction in safety matters, are able to evaluate their activities and recognise the potential risks
associated with the work.
The hand-held nebuliser is connected to a regulating unit by means of a connection tube.
This is an active product used in conjunction with accessories for therapeutic treatment of
individual patients, in medically used rooms (hospital, medical practices etc.) or in clinical
environments or nursing care. The product is not invasive, cannot be implanted and has no direct
application at human organs.
Only use medications which can safely be atomised in combination with compressed air or
oxygen.
Introduction
Incorrect operation/contraindications
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GA 5750.4172 EN 14
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1.5.4.1 Incorrect operation/contraindications
The hand-held nebuliser is not approved for the following purpose or under the following
conditions:
• for oil-based medication,
• for medication generating an explosive mixture with oxygen,
• for connection to respiratory systems,
• in MR areas,
• for application in intubated patients,
• • for other medical gases except O2 and Air.
1.5.4.2 Possible applications
Connection to O2 flowmeter:
The 9/16“ - G 3/8“ adapter and the O2 ISO M 15x1 - G 3/8“ connection tube are used for
connection to an O2 flowmeter. The flow of volume supplied to the hand-held nebuliser is
regulated by:
• S FLOW O 15
• S DFLOW O 15
• LS FLOW O 15
• LS DFLOW O 15
• FINA FLOW O 15
• FINA DFLOW O 15
Connection to Air flowmeter:
The 9/16“ - M 18x1 adapter and the Air M 15x1 - M 18x1 FN / ISO connection tube are used for
connection to an Air flowmeter. The flow of volume supplied to the hand-held nebuliser is
regulated by:
• S FLOW A 15
• LS FLOW A 15
• FINA FLOW A 15
Connection to FINA O2 precision regulation valve
• The flow of volume supplied to the hand-held nebuliser is regulated using the FINA RV O with
O2 M 15x1 - G 3/8“ connection tube.
Connection to FINA AIR precision regulation valve
The flow of volume supplied to the hand-held nebuliser is regulated using the FINA RV A with O2
M 15x1 - M 18x1 connection tube.
Connection to O2 pressure reducing valve with flowmeter:
The 9/16“ - G 3/8“ adapter and the O2 M 15x1 - G 3/8“ connection tube are used for connection
to an O2 pressure reducing valve with flowmeter. The flow of volume supplied to the hand-held
nebuliser is regulated by O2 pressure reducing valve with flowmeter, 0-15 l/min:
Accessories for inhalation:
• 9/16“ - G 3/8“ adapter (REF 5752 2745)
• 9/16“ - M 18x1 adapter (REF 5752 2762)
• O2 ISO M 15x1 - G 3/8“ connection tube (REF 5752 5067)
• 15x1 -M 18x1 AIR FN connection tube (REF 5752 5032)
• M 15x1 -M 18x1 AIR ISO connection tube (REF 5752 5033)
• Medication cup (REF 5750 6210)
Introduction
Interface description
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All the components of the hand-held nebuliser can be reused following appropriate conditioning.
Only devices or parts which are approved by ATMOS for combination in accordance with the
accessory list or in accordance with the mounting point description may be used in conjunction
with the hand-held nebuliser.
1.5.5 Interface description
1.5.5.1 General
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.
1.5.5.2 Dimensions for the connector keyed to a particular type of gas
Hand-held nebuliser inlet
The geometric gas coding at the inlet screw connection of the hand-held nebuliser is designed in
accordance with DIN 13252, M 15x1,O
2
/Air.
1.5.5.3 Regulating unit
The regulating unit is used to regulate the supplied oxygen or the supplied compressed air.
Prerequisites
• Minimum litre capacity of 13 l/min
• Pressure of 280 kPa - 600 kPa
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