MEDAP LS FLOW FLOWMETER Operating Instructions Ver 15 Dec 2019

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

V15 2019-12

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Table of contents

Table of contents 1

Introduction... 5

1.1

Foreword... 5

1.2

How to use these operating instructions... 5 1.2.1

Abbreviations... 5

1.2.2

Symbols... 5

1.2.3

1.2.4 1.3

1.2.2.1

Cross-references... 5

1.2.2.2

Actions and responses... 5

Definitions... 6 1.2.3.1

Design of safety notes... 6

1.2.3.2

Structure of notes... 6

Symbols used... 6

Disposal... 7 1.3.1

ATMOS products... 8

1.3.2

Packaging... 8

1.4

Overview of LS FLOW flowmeter... 8

1.5

Basic requirements... 8 1.5.1

Use in accordance with the intended purpose... 8

1.5.2

Applicable standards... 9

1.5.3

Intended purpose... 9 1.5.3.1

Possible applications... 10

1.5.4

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

1.5.5

Interface description... 11 1.5.5.1

Approved interface for compressed gas supply... 11

1.5.5.2

Flowmeter outlet... 11

1.5.5.3

Connection tube... 12

1.5.5.4

Tube adapter for Air and O2... 12

2

Safety notes... 13

2.1

General safety notes... 13

2.2

Product safety notes... 13

3

Initial operation... 15

3.1

Equipment inspection... 15

3.2

Connection to the terminal unit... 15

3.3

3.2.1

General... 15

3.2.2

Version A... 15

3.2.3

Version B... 16

3.2.4

Version C... 16

Mounting accessories... 16 3.3.1

General... 16

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Table of contents

3.3.2

Connection of bubble humidifier (REF 5752 5315)... 17

3.3.3

Connection of disposable humidifiers from other manufacturers... 17

4

Operation... 18

4.1

Functional test... 18

4.2

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

4.3

Setting the flow for treatment... 19

5

Taking the unit out of operation... 20

5.1

Taking the unit out of operation... 20

6

Cleaning and disinfection... 21

6.1

General... 21

6.2

Cleaning... 22

6.3

6.2.1

General... 22

6.2.2

Cleaning procedure... 22

Disinfection... 22 6.3.1

General... 22

6.3.2

Suitable disinfectants... 23

6.3.3

Disinfection procedure... 23

6.4

Special safety notes... 24

7

Maintenance... 25

7.1

General... 25

7.2

Period tests... 25

7.3

Malfunctions and troubleshooting... 25

7.4

Repairs... 26

7.5

Service hotline... 26

7.6

Type plate position... 26

7.7

Sending in the device... 26

8

Technical specifications... 27

8.1

General... 27

8.2

Technical specifications... 27

8.3

Ambient conditions... 27

8.4

Dimensions and weights... 27

9

Approved accessories... 29

9.1

Accessories... 29

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GA 5752 4981 GB 15

Introduction Foreword

1

Introduction

1.1

Foreword

1

Your facility has selected the leading-edge ‌medical technology made by ATMOS. We sincerely appreciate the trust you have placed in us. 1.2

How to use these operating instructions These operating instructions are provided to familiarise you with the features of this ATMOS product. They are subdivided into several chapters. Please note: • Please read these operating instructions carefully and completely before using the product for the first time. • Always proceed in accordance with the information contained herein. • Store these operating instructions in a location near the product.

1.2.1

Abbreviations EN EEC PD

1.2.2

Symbols

1.2.2.1

Cross-references

European standard European Economic Community Punched disc

References to other pages in these operating instructions are identified with a ‌double arrow symbol ‘’. 1.2.2.2

Actions and responses The ‘’ symbol identifies an action taken by the user while the ‘’ symbol identifies the reaction that this will induce in the system. Example: _ Turn on the light switch. 9 Lamp lights up.

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Introduction How to use these operating instructions

1.2.3

Definitions

1.2.3.1

Design of safety notes Pictogram

Descriptor

Text

DANGER!

The text for the safety note describes the type of risk and how to avert it.

Indicates a direct and immediate risk to persons which may be fatal or result in most serious injury. WARNING! Indicates a potential risk to persons or property which may result in health hazard or grave property damage. CAUTION! Indicates a potential risk to property which may result in property damage. Tab. 1:

1.2.3.2

Design of safety notes

Structure of notes Notes not referring to personal injury or property damage are structured as follows: Pictogram

Tab. 2:

1.2.4

Descriptor

Reference to

NOTE

Supplementary assistance or further useful information.

ENVIRONMENT

Information regarding proper disposal.

Structure of notes

Symbols used Symbols are attached to products, type plates and packaging. Symbols

Identification

4

Labelling for products which were developed and are marketed in compliance with the Medical Devices Directive 93/42/EEC. Class Is, Im, IIa, IIb and III products are also marked with the identifying number for the notified body. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Serial number’. Labelling in compliance with the IEC 60601-1 standard. Symbol for ‘Follow operating instructions’.

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Introduction Disposal

Symbols

1

Identification Labelling in compliance with the IEC 62570 standard. Symbol for ‘Conditionally MR safe’. Packaging label. Symbol for ‘Keep dry’. Packaging label. Symbol for ‘Caution! Do not overturn’. Packaging label. Symbol for ‘Top’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Temperature limitations’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Relative humidity’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Atmospheric pressure’. Meaning of type plate. Symbol for ‘Oil- and fat-free’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Product number’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Name and address of the manufacturer as well as date of manufacture’.

Tab. 3:

1.3

Symbols

Disposal WARNING! Infection hazard! The product or some of its components may be contaminated after use. Clean and disinfect the product before disposal.

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1 1.3.1

Introduction Overview of LS FLOW flowmeter

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

1.3.2

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

1.4

Overview of LS FLOW flowmeter

A

B

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11

C

Fig. 1:

Overview of LS FLOW flowmeter

Version A Tapping unit with integrated gas pin 1 Hand wheel 2 Viewing window 3 Gas probe 4 Flowmeter outlet Version B Tapping unit with rail clamp and NIST connection 5 Equipment rail 6 NIST connection

7 NIST nipple 8 NIST screw connection 9 Connection tube 10 Tube adapter, 4 mm, 6 mm, 8 mm (REF 5752 2746) 11 Tube adapter, plastic, 4 mm, 6 mm, 8 mm (REF 5752 5316) Version C Tapping unit with NIST connection, for screwing (without rail clamp)

1.5

Basic requirements

1.5.1

Use in accordance with the intended purpose Product As per Annex IX to the Medical Devices Directive 93/42/EEC, this product belongs to class IIa. In accordance with this directive, the product may only be used by persons who have been instructed how to use this product by an authorised person. This product is to be used exclusively for human medicine.

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Introduction Basic requirements

1

When employed in a commercial or business use, this product must be entered in the inventory. Accessories Accessories or combinations of accessories may be utilised only as and when indicated in these operating instructions. Other accessories, combinations of accessories and consumable items may be used only if they have a valid certification, are intended expressly for the particular use and will not adversely affect performance, the prescribed ambient conditions or safety requirements. 1.5.2

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

1.5.3

Intended purpose Name:

LS FLOW LS DFLOW

Main function:

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

Medical indications / application:

Inhalation and insufflation of oxygen within the scope of oxygen enrichment via an inhalation mask or a nose latch for patients breathing by themselves Together with a hand-held nebuliser administration of water soluble drugs via an inhalation mask

Specification of the main function:

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

User profile:

Doctor, medically trained staff

Patient groups:

Patients of all ages

Application organ:

Lung

Application time:

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

Application site:

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

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Introduction Basic requirements

1.5.3.1

Contraindications:

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

The product is:

Not active

Sterility:

No sterile product

Single-use product / reprocessing:

The device and parts of the accessories are reusable. For information on reprocessing, cleaning and disinfection, please see the operating instructions.

Possible applications The following usage options are made possible by connecting products or accessories which are contained in the list of accessories or which satisfy the specifications of the interface description. • Appropriate tubes with inner diameters of 4 mm, 6 mm, and 8 mm may be connected to the flowmeter via a tube adapter (metal or plastic). • With the bubble humidifier (REF 5752 5315) for humidifying oxygen. The bubble humidifier is intended for inhalation. The bubble humidifier is connected without an adapter. • Sterile water systems / disposable humidifiers (UNF 9/16") may be connected directly.

1.5.4

Versions of LS FLOW / LS DFLOW flowmeter The connection of the tapping unit to the terminal unit depends on the type of product being used: Version A: Tapping unit with integrated gas pin • The tapping unit is plugged directly into the terminal unit. Version B: Tapping unit with rail clamp and NIST connection • The product is designed for mounting to an equipment rail 25–35 x 10 mm in accordance with DIN EN 19054 and is supplied from a terminal unit via a NIST connection according to DIN EN ISO 5359 with a connection tube with gas probe. Version C: Tapping unit with NIST connection, for screwing • The product is designed for direct screw connection and is supplied from a terminal unit via a NIST connection according to DIN EN 5359 with a connection tube with gas probe.

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Introduction Basic requirements

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The product is available in the following versions: • LS FLOW O 15 Wall DIN (REF 5752 4916) • LS FLOW O 15 Wall DIN P5 (REF 5752 5705) • LS FLOW O 15 Wall MEDAP (REF 5752 4917) • LS FLOW O 15 Wall BOC (BS 5682) (REF 5752 4921) • LS FLOW O 15 Wall Air Liquide (NF S 90-116) (REF 5752 5161) • LS FLOW O 15 Wall AGA (SS 8752430) (REF 5752 5162) • LS FLOW O 15 NIST connection, equipment rail (REF 5752 5301) • LS FLOW O 15 NIST connection, equipment rail P5 (REF 5752 5704) • LS FLOW O 15 NIST connection, screw connection (REF 5752 5708) • LS FLOW O 05 Wall DIN (REF 5752 5304) • LS FLOW O 05 NIST connection, equipment rail (REF 5752 5305) • LS FLOW O 01 Wall DIN (REF 5752 5306) • LS FLOW O 01 NIST connection, equipment rail (REF 5752 5307) • LS DFLOW O 15 Wall DIN (REF 5752 4919) • LS DFLOW O 15 Wall DIN P5 (REF 5752 5702) • LS DFLOW O 15 Wall MEDAP (REF 5752 5706) • LS DFLOW O 15 Wall AGA (SS 8752430) (REF 5752 5183) • LS DFLOW O 15 NIST connection, equipment rail (REF 5752 5302) • LS FLOW A 15 Wall DIN (REF 5752 5235) • LS FLOW A 15 Wall DIN P5 (REF 5752 5703) • LS FLOW A 15 Wall MEDAP (REF 5752 5450) • LS FLOW A 15 Wall AGA (SS 8752430) (REF 5752 5240) • LS FLOW A 15 NIST connection, equipment rail (REF 5752 5303) • LS FLOW A 15 NIST connection, screw connection (REF 5752 5709) • LS DFLOW A 15 Wall DIN (REF 5752 5607) • LS DFLOW A 15 NIST connection, equipment rail (REF 5752 5608) 1.5.5

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

1.5.5.1

Approved interface for compressed gas supply In order to supply compressed gas, the tapping unit is connected to the central medical gas supply system (CGSS) with a pressure of 300 - 550 kPa (P5 versions: 500 kPa). The pressure in the supply line must be indicated and in the event of improper functioning must be limited to 1000 kPa by an integrated pressure-relief valve.

1.5.5.2

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

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Introduction Basic requirements

1.5.5.3

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

1.5.5.4

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

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Safety notes General safety notes

2

Safety notes

2.1

General safety notes

2

DANGER! Incorrect use can result in fatalities! Instructions for using components made by other manufacturers are not part of these operating instructions. Ensure that the manufacturer's instructions are followed. DANGER! Observe hygiene guidelines! Contaminated components may be hazardous to the patient's health. Prepare the product according to the hygiene guidelines before using it for the first time. Clean and disinfect the product. DANGER! Fire/explosion hazard! Air, oxygen and oxygen compounds react explosively with oils, greases and lubricants. Fire and explosion hazard due to compressed gases. Always keep the product free of oils, greases and lubricants. DANGER! Risk of fire! Escaping oxygen increases the risk of fire. Never smoke near equipment which carries oxygen and avoid using open fires or glowing objects. Check tight fitting and firm seat of the connector when mounting accessories. DANGER! Defective product! Using incorrect spare parts and accessories can cause injuries or equipment failure. Only use original accessories or spare parts. WARNING! Risk of injury! Hazard resulting from incorrect handling. Follow the operating instructions for all accessories. 2.2

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

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Safety notes Product safety notes

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

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Initial operation Equipment inspection

3

Initial operation

3.1

Equipment inspection

3

DANGER! Product testing! Only product parts which are in perfect condition can ensure proper functioning of the product. The product parts will thus have to be carefully inspected before mounting. _ Check whether all tubes are undamaged. _ Check whether the unit has been properly cleaned and that there are no residues or soiling. _ Do not use damaged components. 3.2

Connection to the terminal unit

3.2.1

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

3.2.2

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

1

Fig. 2:

Version A

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3 3.2.3

Initial operation Mounting accessories

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

_ With the upper edge of the guide groove at the front, position the rail clamp (1) at a slight angle onto the equipment rail (2) and then press it against the equipment rail and allow it to click into place.

1

7

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

4 6

Fig. 3:

3.2.4

_ Make sure that the rail clamp is correctly secured and that the tapping unit is in a stable position on the equipment rail. _ Insert the NIST nipple (4) of the connection tube into the NIST connection (5) of the tapping unit and tighten down the cap nut (6) by hand. _ Plug the gas probe (7) into the terminal unit (8).

Version B

Version C Tapping unit with NIST connection, for screwing _ Insert the NIST nipple (1) of the connection tube into the NIST connection (2) of the tapping unit and tighten the cap nut (3) by hand.

5

_ Plug the gas probe (4) into the terminal unit (5).

4

2 1 3

Fig. 4:

Version C

3.3

Mounting accessories

3.3.1

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

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Initial operation Mounting accessories

3

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

Connection of bubble humidifier (REF 5752 5315) Connecting the bubble humidifier _ Ensure that the NIST screw connection of the humidifier contains a flat seal. _ Fill the humidifier bottle up to the marking ‘Filling level’ with distilled water and screw the bubble humidifier cap into place.

2 1

_ Screw cap nut (1) of the bubble humidifier to the flowmeter output (2) and tighten finger-tight until stop. _ Pay attention that no tensile forces affect the bubble humidifier.

Fig. 5:

3.3.3

Connection of bubble humidifier

Connection of disposable humidifiers from other manufacturers Disposable humidifiers complying with the interface description may be connected to the flowmeter outlet. _ Screw the disposable humidifier directly to the flowmeter output (2) and tighten finger-tight until stop.

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Operation Functional test

4

Operation

4.1

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

4.2

Use in conjunction with magnetic resonance imaging scanners WARNING! Danger to life! Please strictly observe the operating instructions of your magnetic resonance imaging scanner.

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Operation Setting the flow for treatment

4

WARNING! Risk of injury! Accessories of the product (e.g. humidifier, adapter, hand-held nebuliser, connection tubes, accessories) may be affected by the magnetic field. If the product is used in conjunction with accessories within the 0.5 mT line, all connected accessories must be MR compatible. Observe the operating instructions of all connected accessories or consult the manufacturer of the product. NOTE If the product is used in conjunction with accessories outside the 100 mT line, the product does not create artefacts on the MR images. 4.3

Setting the flow for treatment WARNING! Compressed gas setting! The regulating mechanism is sensitive. Make the compressed gas settings very carefully! NOTE The flow rate can be set to the following 14 values: 0; 0.2; 0.5; 0.7; 1; 1.5; 2; 3; 4; 5; 7; 10; 12; 15 (at 15 l/min), 0; 0.1; 0.2; 0.3; 0.4; 0.6; 0.8; 1; 1.5; 2; 2.5; 3; 4; 5 (at 5 l/min), 0; 0.1; 0.15; 0.2; 0.25; 0.3; 0.35; 0.4; 0.5; 0.6; 0.7; 0.8; 0.9; 1 (at 1 l/min), NOTE When applying oxygen in its function as a medication, as per the monograph in the European Pharmaceuticals Reference it is absolutely necessary to measure the flow rate. Use the rotation regulator to set the flow rate to the required value for the treatment. Increasing the flow rate 1

_ Turn the rotation regulator (1) anticlockwise. 9 The flow rate is increased. Reducing the flow rate _ Turn the rotation regulator (1) clockwise. 9 The flow rate is decreased.

Fig. 6:

Working with the unit

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5

Taking the unit out of operation Taking the unit out of operation

5

Taking the unit out of operation

5.1

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

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

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