MEDAP S Flow Flowmeter Operating Instructions Ver 13 Feb 2020

Subject to technical modification! Illustrations and technical specifications may vary slightly from those in these Operating Instructions as a result of ongoing product development.

V13 2020-02

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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

Design of other notes... 6

Symbols used... 6

Disposal... 7 1.3.1

Packaging... 8

1.3.2

ATMOS products... 8

1.4

Overview of S FLOW flowmeter... 8

1.5

Basic requirements... 8 1.5.1

Use in accordance with the intended purpose... 8

1.5.2

Applicable standards / directives... 9

1.5.3

Intended purpose... 9 1.5.3.1

Possible applications... 10

1.5.4

Versions of S FLOW / S DFLOW flowmeter... 10

1.5.5

Interface description... 11 1.5.5.1

Approved interface for compressed gas supply... 11

1.5.5.2

Flowmeter outlet... 11

1.5.5.3

Connection tube... 11

1.5.5.4

Tube adapter for Air and O2... 11

2

Safety notes... 12

2.1

General safety notes... 12

2.2

Product safety notes... 12

3

Initial operation... 14

3.1

Product testing... 14

3.2

Connection to the terminal unit... 14 3.2.1

General... 14

3.2.2

Version A... 15

3.2.3

Version B... 15

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Table of contents

3.3

Mounting accessories... 15 3.3.1

General... 15

3.3.2

Connection of bubble humidifier (REF 5752 5315)... 16

3.3.3

Connection of disposable humidifiers from other manufacturers... 16

4

Operation... 17

4.1

Function check... 17

4.2

Use in conjunction with magnetic resonance imaging scanners... 18

4.3

Setting the flow for treatment... 18

5

Taking the unit out of operation... 20

6

Cleaning and disinfection... 21

6.1

General... 21

6.2

Cleaning... 22

6.3

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

Periodic tests... 25

7.3

Malfunctions and troubleshooting... 25

7.4

Repairs... 26

7.5

Service hotline... 26

7.6

Type plate position... 26

7.7

Sending in the device... 26

8

Technical specifications... 28

8.1

General... 28

8.2

Technical specifications... 28

8.3

Ambient conditions... 28

8.4

Dimensions and weights... 28

9

Approved accessories... 29

9.1

Accessories... 29

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Introduction Foreword

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Introduction

1.1

Foreword

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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 VDE S

1.2.2

Symbols

1.2.2.1

Cross-references

European standard European Economic Community Verband der Elektrotechnik Elektronik Informationstechnik (Association for Electrical, Electronic & Information Technology) Standard

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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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

Design of other notes Notes not referring to personal injury or property damage are used as follows: Pictogram

Tab. 2:

1.2.4

Descriptor

Reference to

NOTE

Supplementary assistance or further useful information.

ENVIRONMENT

Information regarding proper disposal.

Design of other 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’.

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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 ‘Fragile! Handle with care’. Packaging label. Symbol for ‘Top’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Temperature limitations’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Relative humidity’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Atmospheric pressure’. Labelling on type plate. Symbol for ‘Oil- and fat-free’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Product number’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Name and address of the manufacturer’. 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 S FLOW flowmeter

Packaging The packaging is made of ‌materials compatible with the environment. ATMOS will dispose of the packaging ‌materials upon request.

1.3.2

ATMOS products ATMOS will take back used products or those which are no longer in service. Please contact your ATMOS representative for more detailed information.

1.4

Overview of S FLOW flowmeter

Fig. 1:

Overview of S FLOW flowmeter

1 Version A Tapping unit with integrated gas pin 2 Regulating valve 3 Flowmeter outlet (UNF 9/16") 4 Plug 5 Flowmeter viewing tube 6 Version B Tapping unit with rail clamp and NIST connection 7 Equipment rail 8 NIST connection

9 NIST nipple 10 NIST screw connection 11 Connection tube 12 Tube adapter 4 mm, 6 mm, 8 mm (REF 5752 2746) 13 Tube adapter, plastic, 4 mm, 6 mm, 8 mm (REF 5752 5316)

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 / directives The product satisfies the basic requirements set forth in Annex I to Council Directive 93/42/EEC concerning medical devices (Medical Devices Directive) as well as the applicable national (German) codes and the Medical Devices Act (MPG) in Germany. This is certified by compliance with harmonised standards such as IEC 60601-1 and related standards and the respective special sections.

1.5.3

Intended purpose Name:

S FLOW S DFLOW

Main function:

Designed for measuring the flow and determining the precise dosage for the supply of oxygen and compressed air. In conjunction with a hand-held nebuliser, the S FLOW is used to provide metered administration of medication aerosols.

Medical indications / application:

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 S FLOW is connected to an oxygen / compressed air terminal unit of a central medical gas supply system having a supply pressure within the inlet pressure specified on the product. For humidification of oxygen from the central gas supply system, a humidifier may additionally be connected. Supply of oxygen to the patient takes place via connection tubes and an inhalation mask or a nose latch. The administration of medication aerosols via compressed air takes place via connection tubes to a hand-held nebuliser. The patient presses the inhalation mask of the hand-held nebuliser onto the mouth and nose.

User profile:

Doctor, medically trained staff

Patient groups:

Patients of all ages

Application organ:

Lung

Application time:

For continuous operation; in practice, short-term use on the patient (< 30 days)

Application site:

The application site is the clinical environment and doctor’s practices which have a central oxygen / compressed air system. The application of the product may only be performed by medically trained and instructed staff.

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Introduction Basic requirements

1.5.3.1

Contraindications:

The S FLOW may not be used for the following purposes: • Outside the medical sector • In MR areas > 4.7 tesla • In the home care sector • Being operated directly by the patient • For exclusive respiration • With central gas supply systems with other supply pressures than specified on the product • When applying oxygen in its function as a medication, it is absolutely necessary to measure the flow rate.

The product is:

Not active

Sterility:

Not a sterile product

Single-use product / reprocessing:

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 connection tubes with inner diameters of 4 mm, 6 mm, and 8 mm may be connected to the flowmeter via a tube adapter (metal or plastic). • With the bubble humidifier (REF 5752 5315) for humidifying oxygen. The bubble humidifier is intended for inhalation. The bubble humidifier is connected without an adapter. • Sterile water systems / disposable humidifiers (UNF 9/16") may be connected directly.

1.5.4

Versions of S FLOW / S DFLOW flowmeter The connection of the tapping unit to the terminal unit depends on the type of product being used: Version A: Tapping unit with integrated gas pin • The tapping unit is plugged directly into the terminal unit. Version B: Tapping unit with rail clamp and NIST connection • The product is designed for mounting to an equipment rail 25–35 x 10 mm in accordance with DIN EN 19054 and is supplied from a terminal unit via a NIST connection according to DIN EN ISO 5359 with a connection tube with gas probe. Products and accessories are only permitted with the ISO colour coding. In Germany, Austria and Switzerland, products with neutral colour coding are also permitted. NOTE The products are supplied with ISO coding. The scope of delivery includes a label for neutral colour coding.

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Introduction Basic requirements

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The product is available in the following versions: • S FLOW O 15 Wall DIN (REF 5752 4906) • S FLOW O 15 Wall MEDAP (REF 5752 4907) • S FLOW O 15 Wall BOC (BS 5682) (REF 5752 4913) • S FLOW O 15 Wall Air Liquide (NF S 90-116) (REF 5752 4914) • S FLOW O 15 Wall AGA (SS 8752430) (REF 5752 4915) • S FLOW O 15 NIST connection, equipment rail (REF 5752 5298) • S DFLOW O 15 Wall DIN (REF 5752 4910) • S DFLOW O 15 Wall MEDAP (REF 5752 5532) • S DFLOW O 15 NIST connection, equipment rail (REF 5752 5299) • S FLOW A 15 Wall DIN (REF 5752 4912) • S FLOW A 15 Wall MEDAP (REF 5752 5269) • S FLOW A 15 Wall BOC (BS 5682) (REF 5752 5579) • S FLOW A 15 NIST connection, equipment rail (REF 5752 5300) • S DFLOW A 15 Wall DIN (REF 5752 5750) 1.5.5

Interface description All devices and accessories which are combined with the tapping unit must be listed in the accessories list or meet the specifications of the interface description. The configuration of the overall system as well as the functional testing are subject to the overall responsibility of the medical staff. Functionality and suitability of the connected accessory for each intended application must be checked by the operator before every use. This includes the functionality of the connector components, airtightness and suitability regarding material properties, working pressure and flow rate.

1.5.5.1

Approved interface for compressed gas supply In order to supply compressed gas, the tapping unit is connected to the central medical gas supply system (CGSS) with a pressure of 450 / 500 kPa. The pressure in the supply line must be indicated and in the event of improper functioning must be limited to 1000 kPa by an integrated pressure-relief valve.

1.5.5.2

Flowmeter outlet External thread UNF 9/16" 18 turns. The internal thread on the accessory must match the external thread on the flowmeter. Ensure that the connection between the flowmeter and the accessory is leak-free.

1.5.5.3

Connection tube The connection tube with an inner diameter of 4, 6 or 8 mm is connected with the tube adapter. The connection tube must not collapse or must be pressure-resistant and must comply with the hygiene standard of the hospital. The inside diameter of the connection tube must match the outside diameter of the tube adapter.

1.5.5.4

Tube adapter for Air and O2 The tube adapter is used to connect the tapping unit and the connection tube. The internal thread of the tube adapter must match the external thread of the tube connector of the flowmeter output (UNF 9/16").

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Safety notes General safety notes

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Safety notes

2.1

General safety notes DANGER! Incorrect use can result in fatalities! Instructions for using components made by other manufacturers are not part of these operating instructions. Ensure that the manufacturer's instructions are followed. DANGER! Observe hygiene guidelines! Contaminated components may be hazardous to the patient's health. Prepare the product according to the hygiene guidelines before using it for the first time. Clean and disinfect the product. DANGER! Fire/explosion hazard! Air, oxygen and oxygen compounds react explosively with oils, greases and lubricants. Fire and explosion hazard due to compressed gases. Always keep the product free of oils, greases and lubricants. DANGER! Risk of fire! Escaping oxygen increases the risk of fire. Never smoke near equipment which carries oxygen and avoid using open fires or glowing objects. Check the connector for leaks and tight fit when mounting accessories. DANGER! Defective product! Using incorrect spare parts and accessories can cause injuries or equipment failure. Only use original accessories or spare parts. WARNING! Risk of injury! Hazard resulting from incorrect handling. Follow the operating instructions for all accessories.

2.2

Product safety notes CAUTION! Malfunction! Ensure that the connection between the product and the accessory is leak-free.

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Safety notes Product safety notes

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CAUTION! Property damage Exposure to UV rays can cause material fatigue. The stability would no longer be ensured. Do not expose the product to strong UV light. CAUTION! Observe ambient conditions The precision, operation, mechanical stability and tightness of the product cannot be guaranteed if the ambient temperature range is undercut or exceeded. WARNING! Impacts! Impacts may cause damage to sensitive, precision mechanical components. Do not expose the product to impacts. WARNING! Non-permissible load! If the permissible load is exceeded, leakages may occur at the connection between the terminal unit and gas probe. In accordance with DIN EN ISO 9170-1, the overall weight of the product and accessories may not exceed 2 kg.

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Initial operation Product testing

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Initial operation

3.1

Product testing DANGER! Imprecise display in the event of deviations in system pressure! If the system pressure of 500 kPa or 450 kPa is undercut or exceeded, it will no longer be possible to accurately display the measured values of the flowmeter. DANGER! Fluctuations in flow rate! Flow accuracy may be influenced by the following factors: • Fluctuations of the supply pressure (terminal unit) • Fluctuations of the back pressure (accessories) • Fluctuations of the ambient temperature DANGER! Product inspection! Only product parts which are in perfect condition can ensure proper functioning of the product. The product parts will thus have to be carefully inspected before mounting. WARNING! Measurement accuracy! The product may only be operated in a vertical position. _ Pay special attention to the tight fit of the flowmeter viewing tube and to any possible cracks in the flowmeter viewing tube. Do not use the product if there are any signs of cracks. _ Check whether the connection tubes are undamaged. _ Check whether the product has been properly cleaned and that there are no residues or soiling. _ Do not use damaged components.

3.2

Connection to the terminal unit

3.2.1

General NOTE Please refer to the manufacturer’s instructions for the particular terminal unit for information on connecting the gas probe to the terminal unit.

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Initial operation Mounting accessories

3.2.2

3

Version A Tapping unit with integrated gas pin _ The tapping unit (1) is plugged directly into the terminal unit (2).

1

2

Fig. 2:

3.2.3

Version A

Version B Tapping unit with rail clamp and NIST connection _ 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 2 8

7

_ Tighten the handle screw (3) of the rail clamp. 5 4 6

Fig. 3:

Version B

3.3

Mounting accessories

3.3.1

General

3

_ 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).

WARNING! Tensile forces! The connected accessories must not exert any mechanical forces which could adversely affect the secure fit of the product.

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Initial operation Mounting accessories

WARNING! Tensile forces! Hold the basic unit with one hand when installing or removing accessories in order to compensate for the tensile forces which are created. 3.3.2

Connection of bubble humidifier (REF 5752 5315) 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 onto the flowmeter output (2) and tighten finger-tight until it stops. _ Pay attention that no tensile forces affect the bubble humidifier.

Fig. 4:

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 onto the flowmeter output (2) and tighten finger-tight until it stops.

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Operation Function check

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Operation

4.1

Function check

4

DANGER! Function check! The product is used in the treatment of patients. Any restriction in the unit's performance can result in serious complications in treatment. Perform a complete function check every time before using the unit. Perform a complete function check of the tapping unit prior to use. During function testing, pay attention to the following conditions: Version A: Tapping unit with integrated gas pin • The tapping unit is correctly plugged into the terminal unit Version B: Tapping unit with rail clamp and NIST connection • The gas probe of the connection tube is secured correctly in the terminal unit. • The NIST nipple of the connection tube is correctly secured in the NIST connection of the tapping unit. • The NIST screw connection is tightly fastened. • The tapping unit is locked firmly to the equipment rail. All versions: • The tube connectors are firmly seated and tightly sealed and no mechanical forces are acting on the tubes. • The plastic and rubber components are in perfect condition and show no signs of ageing. • The accessories are correctly connected. • The device is leak-free. • It is possible to variably adjust the flow rate from zero to the maximum flow. • The device is in good hygienic condition.

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Operation Use in conjunction with magnetic resonance imaging scanners

Use in conjunction with magnetic resonance imaging scanners WARNING! Danger to life! Please strictly observe the operating instructions of your magnetic resonance imaging scanner. WARNING! Risk of injury! Accessories of the product (e.g. humidifier, adapter, hand-held nebuliser, connection tubes, accessories) may be affected by the magnetic field. If the product is used in conjunction with accessories within the 0.5 mT line, all connected accessories must be MR compatible. Observe the operating instructions of all connected accessories or consult the manufacturer of the product. NOTE If the product is used in conjunction with accessories outside the 100 mT line, the product does not create artefacts on the MR images.

4.3

Setting the flow for treatment WARNING! Compressed gas setting! The regulating mechanism is sensitive. Make the compressed gas settings very carefully! DANGER! Over-pressure! The product is under pressure whenever it is connected to the terminal unit, even if the valve is closed. The flowmeter viewing tube may not be unscrewed when the product is connected. NOTE The rate of gas flow is displayed on the flowmeter viewing tube in the centre of the indicator ball. NOTE When applying oxygen in its function as a medication as per the monograph in the European Pharmaceuticals Reference, it is absolutely necessary to measure the flow rate.

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Operation Setting the flow for treatment

4

Setting the flow for treatment 1

_ Open the control valve (1) by turning it anticlockwise. Use the control valve to set the gas flow rate to the required value for treatment: Increase the gas flow rate _ Turn the control valve anticlockwise. Reduce the gas flow rate _ Turn control valve clockwise.

Fig. 5:

Working with the unit

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5 5

Taking the unit out of operation Setting the flow for treatment

Taking the unit out of operation WARNING! Disengage! When the product is disengaged (removed) from the terminal unit, the pressure energy may cause recoil. Use the terminal unit into the parking position or support when disengaging. NOTE To protect the product from damages, cover with cloths when storing.

NOTE Refer to the medical gas distributor instructions for information regarding detaching the gas probe from the terminal unit. All versions: _ After having completed the treatment, close the control valve by turning it clockwise and check to ensure that it is closed. _ Disconnect the tapping unit / gas probe from the terminal unit. Version B: Tapping unit with rail clamp _ Remove the unit from the equipment rail. For this purpose, open the handle screw and lift the unit off the equipment rail.

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