OPERATING INSTRUCTIONSMEDAPHAND-HELD NEBULISER

GA 5750.4172 EN 14

GA 5750.4172 EN 142

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 3

Table of contents

Table of contents

1 Introduction ..............................................................................................................................................51.1 Foreword ....................................................................................................................................................51.2 Environmental protection ............................................................................................................................5

1.2.1 Packing ........................................................................................................................................51.2.2 ATMOS products ..........................................................................................................................5

1.3 Disposal ......................................................................................................................................................51.4 How to use these operating instructions ....................................................................................................5

1.4.1 General ........................................................................................................................................51.4.2 Abbreviations ...............................................................................................................................51.4.3 Symbols .......................................................................................................................................5

1.4.3.1 Cross-references ....................................................................................................... 51.4.3.2 Actions and responses .............................................................................................. 6

1.4.4 Definitions ....................................................................................................................................61.4.4.1 Design of safety notes ............................................................................................... 61.4.4.2 Design for other notes ............................................................................................... 6

1.4.5 Symbols used ..............................................................................................................................61.5 Hand-held nebuliser ...................................................................................................................................8

1.5.1 Pictorial guide for hand-held nebuliser .........................................................................................81.5.2 Use in accordance with the intended purpose .............................................................................81.5.3 Applicable standards .................................................................................................................... 91.5.4 Intended purpose .........................................................................................................................9

1.5.4.1 Incorrect operation/contraindications ....................................................................... 101.5.4.2 Possible applications ............................................................................................... 10

1.5.5 Interface description ................................................................................................................... 111.5.5.1 General .................................................................................................................... 111.5.5.2 Dimensions for the connector keyed to a particular type of gas .............................. 111.5.5.3 Regulating unit ......................................................................................................... 11

2 Principal safety notes ............................................................................................................................122.1 General safety notes ................................................................................................................................12

3 Initial operation .......................................................................................................................................153.1 Equipment inspection ...............................................................................................................................153.2 Assembly of hand-held nebuliser .............................................................................................................153.3 Filling the hand-held nebuliser .................................................................................................................153.4 Assembly and connection of accessories ................................................................................................16

3.4.1 Connection of FINA FLOW O 15 ................................................................................................ 163.4.2 Connection of the S FLOW flowmeter .......................................................................................173.4.3 Connection of the LS FLOW flowmeter .....................................................................................173.4.4 Connection of FINA fine regulating valve ...................................................................................18

GA 5750.4172 EN 144

Table of contents

3.4.5 Connection of O2 pressure reducing valve with flowmeter ........................................................ 18

4 Operation ................................................................................................................................................194.1 Regular operation .....................................................................................................................................194.2 Continuous nebulisation ...........................................................................................................................204.3 Taking the unit out of operation ................................................................................................................20

5 Malfunctions and troubleshooting .......................................................................................................225.1 Malfunctions and troubleshooting.............................................................................................................22

6 Cleaning and disinfection ......................................................................................................................236.1 General .....................................................................................................................................................236.2 Disassembly .............................................................................................................................................246.3 Cleaning ...................................................................................................................................................24

6.3.1 General ......................................................................................................................................246.3.2 Cleaning procedure ....................................................................................................................256.3.3 Cleaning of suction sleeve and nozzle .......................................................................................25

6.4 Disinfection ...............................................................................................................................................266.4.1 General ......................................................................................................................................266.4.2 Suitable disinfectants ................................................................................................................. 266.4.3 Disinfection procedure ............................................................................................................... 276.4.4 Disinfection procedures ............................................................................................................. 276.4.5 Special safety notes ................................................................................................................... 27

7 Maintenance ............................................................................................................................................297.1 Visual and functional inspections .............................................................................................................297.2 Maintenance .............................................................................................................................................297.3 Repairs .....................................................................................................................................................29

8 Technical specifications ........................................................................................................................318.1 General .....................................................................................................................................................318.2 Ambient conditions ...................................................................................................................................318.3 Dimensions and weight ............................................................................................................................318.4 Particle size distribution ............................................................................................................................328.5 Cumulative frequency ...............................................................................................................................33

9 Delivery program ....................................................................................................................................349.1 Accessories ..............................................................................................................................................34

IntroductionForeword

GA 5750.4172 EN 14 5

1

1 Introduction

1.1 ForewordYour 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 PackingThe packing is made of materials compatible with the environment. ATMOS will dispose of the packing materials upon request.

1.2.2 ATMOS productsATMOS 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 GeneralThese 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 standardEU European Economic CommunityVDE Verband der Elektrotechnik Elektronik Informationstechnik (Association for

Electrical, Electronic & Information Technology)

1.4.3 Symbols

1.4.3.1 Cross-referencesReferences to other pages in these operating instructions are identified with a double arrow symbol „“.

IntroductionActions and responses

6 GA 5750.4172 EN 14

1

1.4.3.2 Actions and responsesThe „“ 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 notesNotes not referring to personal injury or property damage are used as follows:

Pictogram Descriptor Reference toNOTE Supplementary assistance or further useful information.

ENVIRONMENT Information regarding proper disposal.

Tab. 2: Design for other notes

1.4.5 Symbols used

Symbols IdentificationLabelling for products which were developed and are marketed in compli-ance 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.

IntroductionSymbols used

GA 5750.4172 EN 14 7

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 man-ufacture".

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

IntroductionHand-held nebuliser

8 GA 5750.4172 EN 14

1

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 oxygen2 Fastening chain 10 Seal3 Nebuliser housing 11 Profile seal4 Medicine cup 12 O-ring5 Adapter 13 Nozzle6 Knurled head screw 14 Suction sleeve7 Connector 15 Piece of tube8 Connection thread 16 Cleaning needle

1.5.2 Use in accordance with the intended purpose

ProductAs 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.

IntroductionApplicable standards

GA 5750.4172 EN 14 9

1

When employed in a commercial or business use, this product shall be entered in the inventory.

AccessoriesAccessories 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 standardsThe 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 compo-

nents

1.5.4 Intended purposeThe 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.

IntroductionIncorrect operation/contraindications

10 GA 5750.4172 EN 14

1

1.5.4.1 Incorrect operation/contraindicationsThe 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)

IntroductionInterface description

GA 5750.4172 EN 14 11

1

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 GeneralAll 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 inletThe geometric gas coding at the inlet screw connection of the hand-held nebuliser is designed in accordance with DIN 13252, M 15x1,O2/Air.

1.5.5.3 Regulating unitThe 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

Principal safety notesGeneral safety notes

12 GA 5750.4172 EN 14

2

2 Principal safety notes

2.1 General safety notes

DANGER!Danger to life!The user must check the functionality and suitability of the components for the respective application and verify biocompatibility.

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!UV radiation!Exposure to UV rays can cause material fatigue. The stability would no longer be ensured.Do not expose the product to strong UV light.

DANGER!Defective device!Using incorrect spare parts or accessories can cause injuries or equipment failure.Only use original accessories or spare parts.

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.Keep product, in particular for oxygen, free of oils, greases, lubricants and hand cream. Only use lubricants which are approved by ATMOS. Observe fire protection regulations when dealing with flammable gases. Contact Technical Services about any leakages in the 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 tight fitting and firm seat of the connector when mounting accessories.

Principal safety notesGeneral safety notes

GA 5750.4172 EN 14 13

2

DANGER!Risk of fire!The product may ignite if the maximum operating pressure or the maximum operating temperature is exceeded.Do not exceed the maximum operating pressure or maximum operating temperature.

DANGER!Health hazard!Pay attention that the product is connected to the appropriate gas type and that the screw connection is firmly seated.

WARNING!Risk of injury!Hazard resulting from incorrect handling.Follow the operating instructions for all accessories.

WARNING!Risk of injury!Worn or damaged products can cause injuries.Use only products which are in perfect condition.

WARNING!Malfunction!No mechanical forces of the connected accessory may affect the product in order to avoid functional failures or damages.

WARNING!Configuration of the overall system!The configuration of the overall system as well as the functional testing are subject to the overall responsibility of the medical staff. The operator must check proper functionality and suitability of the product for each intended application before every use, in particular connection parts, tightness and suitability concerning material, work pressure and flow.

WARNING!Ambient conditions!If the ambient temperature range specified for shipping, operation and/or storage conditions is not maintained, then no guarantee can be assumed for the accuracy, mechanical strength or sealing of the product.

CAUTION!Malfunction!The hand-held nebulizer may only be filled with the maximum permitted volume of 10 ml of medicine.

Principal safety notesGeneral safety notes

14 GA 5750.4172 EN 14

2

WARNING!Malfunction!The hand-held nebulizer may only be operated when it is vertical. The patient must be cooperative and must be able to press the hand-held nebulizer to his/her mouth and nose in vertical position.

WARNING!Reasons for poor performance!Operating pressures other than 500 kPa ± 10% may cause deviations in the performance of the hand-held nebuliser.

Initial operationEquipment inspection

GA 5750.4172 EN 14 15

3

3 Initial operation

3.1 Equipment inspection

DANGER!Equipment inspection!Only components which are in perfect condition can ensure proper functioning of the product.The components will thus have to be carefully inspected before using the unit.

WARNING!Infection hazard!Contaminated components may endanger the health of the staff and the patients.Ensure the product is prepared as per hygiene standards before using it for the first time.

Ensure that the unit has been properly cleaned and that there are no residues or soiling. Ensure proper functionality of the unit. Do not use damaged parts. Ensure that the thread (M 15x1) of the handheld nebuliser matches the thread of the connection tube to be connected. Ensure that the thread (G 3/8“ / M 18x1) of the fine regulating valve, flowmeter or pressure reducing valve with flowmeter matches the connection tube to be connected.

3.2 Assembly of hand-held nebuliser

7

8

6

4

9 12

3

5

Fig. 2: Assembly of hand-held nebuliser

Insert the groove of the nozzle (1) into the gap of the suction sleeve (2).

The nozzle engages with an audible click.

Bore holes of suction sleeve and nozzle are congruent one on top of the other.

Plug the piece of tube (3) onto the suction sleeve. Insert profile gasket (4) into nebulizer housing (5). Screw medicine cup (6) onto nebulizer housing. Plug adapter (7) onto inhalation mask (8). Plug inhalation mask with adapter onto connector (9).

3.3 Filling the hand-held nebuliser Unscrew the medicine cup from the nebuliser housing. Hold medicine cup with one hand and fill with medication. Screw the medicine cup onto nebuliser housing and hand to patient or suspend with fastening chain.

Initial operationAssembly and connection of accessories

16 GA 5750.4172 EN 14

3

3.4 Assembly and connection of accessories

DANGER!Danger to life!Hazard resulting from incorrect handling.Be absolutely sure to observe the operating instructions for all the products used in the configuration.

WARNING!Configuration of accessory!The design of the accessory is crucial for the proper function of the tapping unit. Use of improper accessory will reduce the tapping unit's performance or even cause the unit to fail.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.

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.

NOTEConnection thread of hand-held nebuliser: M 15x1Connection thread for O2 connection tube to regulating unit: G 3/8“Connection thread for Air connection tube to regulating unit: M 18x1

3.4.1 Connection of FINA FLOW O 15

2

1

3

4

56

Fig. 3: Connection of FINA FLOW O 15

Ensure that the coupling ring of the connection tube is fitted with flat gaskets. Ensure that the adapter (1) contains a flat gasket. Screw adapter directly to the flowmeter output (2) and tighten fingertight until stop. Tighten the connection tube (3) with the larger coupling ring (4) fingertight onto the connector. Tighten the connection tube with the smaller coupling ring (5) onto the connector (6) of the hand-held nebulizer. Pay attention that no tensile forces affect the hand-held nebulizer.

Initial operationConnection of the S FLOW flowmeter

GA 5750.4172 EN 14 17

3

3.4.2 Connection of the S FLOW flowmeter

2

1

3

5

4

6

Fig. 4: Connection of the S FLOW flowmeter

Ensure that the coupling ring of the connection tube is fitted with flat gaskets. Ensure that the adapter contains a flat gasket. Screw adapter (1) directly to the flowmeter output (2) and tighten fingertight until stop. Tighten the connection tube (3) with the larger coupling ring (4) fingertight onto the connector. Tighten the connection tube with the smaller coupling ring (5) onto the connector (6) of the hand-held nebulizer. Pay attention that no tensile forces affect the hand-held nebulizer.

3.4.3 Connection of the LS FLOW flowmeter

1

2

3

4

56

Fig. 5: Connection of the LS FLOW flowmeter

Ensure that the coupling ring of the connection tube is fitted with flat gaskets. Ensure that the adapter contains a flat gasket. Screw adapter (1) directly to the flowmeter output (2) and tighten fingertight until stop. Tighten the connection tube (3) with the larger coupling ring (4) fingertight onto the connector. Tighten the connection tube with the smaller coupling ring (5) onto the connector (6) of the hand-held nebulizer. Pay attention that no tensile forces affect the hand-held nebulizer.

Initial operationConnection of FINA fine regulating valve

18 GA 5750.4172 EN 14

3

3.4.4 Connection of FINA fine regulating valve

2

3

15 4

Fig. 6: Connection of FINA fine regulating valve

Ensure that the coupling ring of the connection tube is fitted with flat gaskets. Tighten the connection tube (1) with the larger coupling ring (2) fingertight onto the connector (3) of the fine regulating valve. Tighten the connection tube with the smaller coupling ring (4) onto the connector (5) of the hand-held nebulizer. Pay attention that no tensile forces affect the hand-held nebulizer.

3.4.5 Connection of O2 pressure reducing valve with flowmeter

12

34

Fig. 7: Connection of O2 pressure reducing valve with flowmeter

Tighten the connection tube (1) with the larger coupling ring (2) fingertight onto the connector. Tighten the connection tube with the smaller coupling ring (3) onto the connector (4) of the hand-held nebulizer. Pay attention that no tensile forces affect the hand-held nebulizer.

OperationRegular operation

GA 5750.4172 EN 14 19

4

4 OperationThe FINA fine regulating valve is used to describe the operation of the unit.

WARNING!Risk of injury!The product may only be used in combination with a regulator unit.

NOTEA fastening chain is attached to the hand-held nebulizer to suspend the hand-held nebulizer to a rail bracket.

4.1 Regular operation

2

1

Fig. 8: Regular operation

To be performed by technical staff: Take hand-held nebulizer from the rail bracket (1) and hand it to the patient. Open regulating unit (2) on the fine regulating valve.

2

1

Fig. 9: Regular operation

To be performed by patient: Place inhalation mask (1) to mouth and nose with slight pressure. Turn knurled head screw upward.

Hand-held nebulizer is set to continuous nebulisation.

Press knurled head screw (2) down. Nebulisation is interrupted.

Inhalation may be adjusted to the respiratory rhythm by pressing down and releasing the knurled head screw.

OperationContinuous nebulisation

20 GA 5750.4172 EN 14

4

4.2 Continuous nebulisation

NOTEAn open knurled head screw allows continuous nebulisation.

1

Fig. 10: Continuous nebulisation

Turn knurled head screw (1) upward. Hand-held nebulizer is set to continuous nebulisation.

4.3 Taking the unit out of operationThe FINA fine regulating valve is used to describe how to take the unit out of operation.

12

Fig. 11: Taking the unit out of regular operation

Taking the unit out of regular operation Release the knurled head screw (1) and close. If the inhalation is interrupted for a longer time, close the gas supply on the regulating unit (2) of the fine regulating valve.

OperationTaking the unit out of operation

GA 5750.4172 EN 14 21

4

12

Fig. 12: Taking the unit out of continuous operation

Taking the unit out of continuous operation Close the knurled head screw (1) after completing inhalation. If the inhalation is interrupted for a longer time, close the gas supply on the regulating unit (2) of the fine regulating valve.

Malfunctions and troubleshootingMalfunctions and troubleshooting

22 GA 5750.4172 EN 14

5

5 Malfunctions and troubleshooting

5.1 Malfunctions and troubleshooting

Defect Source of malfunction Corrective actionsNone or reduced nebulisation

Closed knurled head screw Release or open knurled head screw

Nozzle, suction sleeve or piece of tube is contaminated

Clean contaminated parts

Defective connection tube or improper screw connection

Check, or, if necessary, replace connection tube

Connection tube is missing or defective

Check, or, if necessary, replace the seal

O-ring 4 x 1.5 is missing or defective

Check, or, if necessary, replace O-ring

Filling level too low Fill hand-held nebuliser

Medication is too viscous Observe notes of the medication manufacturer

Tab. 4: Corrective actions

Cleaning and disinfectionGeneral

GA 5750.4172 EN 14 23

6

6 Cleaning and disinfection

6.1 GeneralThe product must be cleaned as well as wipe 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.

WARNING!Infection hazard!Product may be contaminated.Always wear gloves for cleaning and disinfection.

WARNING!Risk of injury!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 and then be dried.

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. fluorites, 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 acidUse approved detergents and disinfectants only. 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. Thoroughly wipe off any excess detergent and disinfectant with a damp, soft cloth. Avoid surface drying of excess detergents and disinfectants.

CAUTION!Improper cleaning and disinfection can cause property damage!Perform visual and functional inspections after each cleaning and disinfection process.

Cleaning and disinfectionDisassembly

24 GA 5750.4172 EN 14

6

6.2 Disassembly

CAUTION!Improper cleaning can cause property damage!Disassemble inhalation mask, nebulizer housing, profile gasket and medicine cup for reconditioning. Separate nozzle, suction sleeve and piece of tube to avoid that the parts stick together during reconditioning.

1

3

4

7

26

58

Fig. 13: Disassembly

Disassembly Remove inhalation mask (1) and adapter (2). Unscrew nebulizer housing (3) and medicine cup (4). Remove profile gasket (5), turn off nozzle (6), separate suction sleeve (7) and piece of tube (8).

6.3 Cleaning

6.3.1 General

NOTEIn the event of very dirty product surfaces, carry out an additional disinfection procedure before cleaning the product.

NOTEUse only all-purpose cleaners which are slightly alkaline (soap solution) and contain tensides 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.

Cleaning and disinfectionCleaning procedure

GA 5750.4172 EN 14 25

6

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 wetted in a multi-purpose detergent solution. Ensure that the product is free of 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 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.

6.3.3 Cleaning of suction sleeve and nozzleSuction sleeve and nozzle may clog or contaminate. The scope of delivery includes a cleaning needle for cleaning.

1

2

Fig. 14: Cleaning the suction sleeve

Stick the cleaning needle (2) through the bore hole (1) of the suction sleeve.

Cleaning and disinfectionDisinfection

26 GA 5750.4172 EN 14

6

6.4 Disinfection

6.4.1 General

CAUTION!Material damage due to excessive exposure times!Exceeding the specified exposure time of the disinfectant may damage the surfaces.Remove disinfectant residues with a cloth dipped in clean water. Then dry the product with a dry, lint free cloth.

DANGER!Infection hazard!The product is used in the treatment of patients. Contaminated components may be hazardous to the patient's health.Prepare the product in accordance with hygiene regulations before every use!

DANGER!Reduced performance!Only clean the product by manual disinfection.Ensure that no disinfectants enter the unit. Check the functionality of the product after each disinfection.

CAUTION!Risk of injury!Do not use any disinfection agents that would jeopardize patients, personnel or the functionality of the product.• Do not disinfect with phenoles or agents that split halogen, chlorine or oxygen;• Do not disinfect with solvents (benzene, thinner);• Do not spray-disinfect.

6.4.2 Suitable disinfectantsFor disinfection purposes, only use disinfectants based on the following combinations of active ingredients:• Aldehydes• Quaternary compounds• Guanidine derivatives.

Examples of surface disinfectants:• Incidin® Plus *• Incidin® Perfect *• Antiseptica, a combination surface disinfectant• Antifect® FF *• B 10 *

Examples of instrument disinfectants:• Lysetol® AF *• Gigasept® FF *• Sekusept® forte S ** Incidin® (Registered trademark of Ecolab GmbH & Co OHG)

Cleaning and disinfectionDisinfection procedure

GA 5750.4172 EN 14 27

6

* Antifect® (Registered trademark of Schülke und Mayr GmbH)* Lysetol® (Registered trademark of Schülke und Mayr GmbH)* Gigasept® (Registered trademark of Schülke und Mayr GmbH)* Sekusept® (Registered trademark of Ecolab GmbH & Co OHG)

6.4.3 Disinfection procedure After each cleaning process, wipe or spray disinfect the product in accordance with the instructions of the disinfectant manufacturer. Thoroughly wipe off the product with a soft cloth dipped in clean water. Ensure that the product is free of disinfectant residue. Dry product with a dry, absorbent and lint free cloth. Perform visual and functional inspections.

6.4.4 Disinfection proceduresDifferent disinfection procedures may be used for the various components, depending on the properties of the materials.

Components In solu-tion1

Wiping2 Autoclaving with heated steam3 (up to 134 °C)

Gas sterilisation

Nebulizer housing X

Medicine cup X X X X

Suction sleeve

Nozzle

Piece of tube

Inhalation mask

Adapter

Profile seal

1 After exposure (as prescribed in the manufacturer's instructions), rinse components thoroughly with water and dry them afterwards.2 After exposure (as prescribed in the manufacturer's instructions) remove disinfectant residues from the components using a moist cloth and dry them afterwards.3 Caution: Heated steam will accelerate the natural aging of plastics. Using non-colour-fast drapes can cause discolouration of plastic components.

Tab. 5: Disinfection procedures

6.4.5 Special safety notes

DANGER!Risk of fire!Cleaning agents and disinfectants may contain flammable substances which form a highly flammable compound together with oxygen. Fire hazard is increased with use of oxygen.Do not use flammable cleaning agents and disinfectants.

Cleaning and disinfectionSpecial safety notes

28 GA 5750.4172 EN 14

6

DANGER!Material changes!Autoclaving with heated steam accelerates the natural aging of plastics. The function of the equipment components may be impaired by material changes.Check the function of the equipment components after each treatment.

DANGER!Health hazard!The product is used to administer medication. Residues of sterilisation gases or other substances in the product can endanger the patient's health.Ensure the product is thoroughly degased after gas sterilisation.

CAUTION!Property damage due to tension cracks!Do not treat polysulphone containers with strong acids or alkaline solutions.

NOTEFor notes on cleaning, disinfection and sterilisation of the connected components please refer to the respective operating instructions.

MaintenanceVisual and functional inspections

GA 5750.4172 EN 14 29

7

7 MaintenanceDANGER!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 authorized by ATMOS.

7.1 Visual and functional inspectionsTo ensure correct operation, it is necessary to have visual and functional inspections performed by a trained person prior to each use of the operating table.Documentation of the results of the visual and functional inspections is recommend and should include the date and signature of the person who performed the inspections. The following table can be used as a template.

Suggestion:

No. Inspection Defects are present No defects1 Has the product been

cleaned and disinfected according to the hygiene guideline?

Do not use the product any longer. Clean and disinfect the product according to the guideline.

Comment:

2 (Space for other tests)

Tab. 6: Visual and functional inspections

7.2 MaintenanceWe recommend having the unit inspected at least once a year to ensure optimal operating safety of the unit and complete functionality. A service engineer will perform a safety test to ensure proper functioning. Please request the test instructions from ATMOS Service.Service hotline:+ 49 7653 689-0

7.3 Repairs

NOTEExclusion of liability!Any and all liability by the manufacturer lapses in case of tampering by unauthorised persons.

Repairs may be carried out only by service technicians authorised by ATMOS to do so.

MaintenanceRepairs

30 GA 5750.4172 EN 14

7

These authorised service technicians can obtain descriptions, circuit diagrams, spare parts lists and testing schedules for system components that ATMOS has deemed to be repairable in the field.If defects are detected the product may not be used any longer.Make a note of the deficiencies and the REF number on the data plate and notify the responsible ATMOS Service. Inform the appropriate foreign representative outside Germany.

Technical specificationsGeneral

GA 5750.4172 EN 14 31

8

8 Technical specifications

NOTETechnical specifications refer to an operating pressure of 500 kPa. The technical specifications may be different if other operating pressures are used.

8.1 General

Classification as per Annex IX of the 93/42/EEC Directive

Class IIb

Operating principle Venturi system

Max. fill level 10 ml

Connection thread of O2 flowmeter M 15x1

Diameter of droplets (at 500 kPa) 0.5 - 7 µm

Nebulising volume (at 500 kPa) approx. 2 ml / 10 min

Gas consumption 13 Nl/min

* 100 kPa = 1 bar = 1000 mbar = 750 mmHg

8.2 Ambient conditions

Temperature -15 °C to +50 °C (shipping)

+15 °C to +30 °C (in operation)

Relative humidity 10 % to 95 % (shipping)

30 % to 75 % (in operation)

Atmospheric pressure 700 hPa to 1060 hPa (shipping)

700 hPa to 1060 hPa (in operation)

8.3 Dimensions and weight

Dimensions (L x W x D) 210 x 80 x 170 mm

Weight 225 g

Technical specificationsParticle size distribution

32 GA 5750.4172 EN 14

8

8.4 Particle size distributionParticle size distribution of the aerosol spray (share in %; particle size in μm). The dark bar indicates the mean value.

Fig. 15: Particle size distribution depends on the recorded particle size class

Technical specificationsCumulative frequency

GA 5750.4172 EN 14 33

8

8.5 Cumulative frequencyDiagram of cumulative frequency of the average particle size distribution of the aerosol spray (share in %; particle size in μm).The darker line indicates the mean value.

Fig. 16: Diagram of the cumulative size distribution of the results

Delivery programAccessories

34 GA 5750.4172 EN 14

9

9 Delivery program

9.1 AccessoriesThe following accessories are not part of the scope of delivery and must be ordered separately:

FINA FLOW O 15 See price information

FINA DFLOW O 15 See price information

FINA FLOW A 15 See price information

S FLOW O 15 See price information

S DFLOW O 15 See price information

S FLOW A 15 See price information

LS FLOW O 15 See price information

LS DFLOW O 15 See price information

LS FLOW A 15 See price information

FINA RV O See price information

FINA RV A See price information

9/16" - G 3/8 adapter 5752 27459/16" - M 18x1 adapter 5752 2762Connection tube oxygen, ISO colour coding 5752 5067Connection tube for compressed air, neutral colour 5752 5032Connection tube compressed air, ISO colour coding 5752 5033Holder with double hook 5750 8014Medicine cup for hand-held nebuliser 5750 6210Pressure reducing valve with flowmeter, 0-15 l/min 5752 4679Pressure regulator with flowmeter of 0-15 l/min and additional DIN coupling 5752 4680

Tab. 7: Accessories

Notes

Manufacturer:MAQUET GmbH Kehler Str. 31 76437 Rastatt Baden-Wuerttemberg GERMANY Telephone: +49 7222 932-0 www.maquet.com

Distributor:ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch GERMANY Phone: +49 7653 689-0 www.atmosmed.com