MEDAP FINA Vac P 350 Operating Instructions Ver 21 July 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.

V21 2020-07

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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

1.2.2.1

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

1.3

Symbols used... 6

1.4

Disposal... 7

1.5

1.6

1.4.1

Packaging... 7

1.4.2

ATMOS products... 7

Overview... 8 1.5.1

FINA VAC P 350... 8

1.5.2

Versions of the FINA VAC P 350... 9

Basic requirements... 9 1.6.1

Use in accordance with the intended purpose... 9

1.6.2

Applicable standards... 10

1.6.3

Intended purpose... 10

1.6.4

Versions of the FINA VAC P 350... 11

1.6.5

Interface description... 11 1.6.5.1

Vacuum connection tube... 11

1.6.5.2

Hydrophobic bacterial and viral filter... 12

1.6.5.3

Septic fluid jar including septic fluid jar cap... 12

1.6.5.4

Suction tube... 12

1.6.5.5

Fingertip... 12

1.6.5.6

Utensil... 12

1.6.5.7

Mechanical overflow protection... 13

2

Safety notes... 14

2.1

General safety notes... 14

2.2

Product safety notes... 14

3

Initial operation... 16

3.1

Equipment inspection... 16

3.2

Mounting... 16 3.2.1

Mounting the vacuum gauge... 16

3.2.2

Connection to the terminal unit... 17

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Table of contents

3.2.3

3.2.2.1

General... 17

3.2.2.2

Version A... 17

3.2.2.3

Version B... 17

Assembly of the septic fluid jar and accessories... 18

4

Operation... 20

4.1

Function test... 20

4.2

Working with the product... 20

5

Taking the unit out of operation... 22

5.1

Completing the aspiration process... 22

6

Cleaning and disinfection... 23

6.1

General... 23

6.2

Cleaning... 24

6.3

6.2.1

General... 24

6.2.2

Cleaning procedure... 24

Disinfection... 24 6.3.1

General... 24

6.3.2

Suitable disinfectants... 25

6.3.3

Disinfection procedure... 25

6.4

Product-specific safety notes... 25

7

Maintenance... 27

7.1

General... 27

7.2

Periodic tests... 27

7.3

Malfunctions and troubleshooting... 27

7.4

Repairs... 28

7.5

Service hotline... 28

7.6

Spare parts... 28

7.7

Sending in the device... 28

8

Technical specifications... 30

8.1

General... 30

8.2

Ambient conditions... 30

8.3

Technical specifications... 30

8.4

Dimensions and weight... 30

9

Approved accessories... 31

9.1

Standard scope of delivery... 31

9.2

Accessories... 31

9.3

Consumables... 31

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Introduction Foreword

1

Introduction

1.1

Foreword

1

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

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

1.2.1

Abbreviations EN

European standard

EEC

European Economic Community

VDE

Verband der Elektrotechnik Elektronik Informationstechnik (Association for Electrical, Electronic & Information Technology)

1.2.2

Symbols

1.2.2.1

Cross-references 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 Symbols used

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:

1.3

Descriptor

Reference to

NOTE

Supplementary assistance or further useful information without potential injury to persons or property damage is described in the text of the note.

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 of the Notified Body. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Product number’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Serial number’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Follow operating instructions’.

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Introduction Disposal

Symbols

1

Identification Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Name and address of the manufacturer as well as date of manufacture’. 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’.

Tab. 3:

1.4

Symbols

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

1.4.1

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

1.4.2

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.

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Introduction Overview

1.5

Overview

1.5.1

FINA VAC P 350

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2 3

9 4 8

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Fig. 1:

Overview of the FINA VAC P 350

1 Vacuum gauge 2 Housing 3 Control valve 4 Tube connector 5 Vacuum connection tube 6 Hydrophobic bacterial and viral filter

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7 Tube connector of mechanical overflow protection 8 Mechanical overflow protection 9 NIST connection 10 Shut-off valve

Introduction Basic requirements

1.5.2

1

Versions of the FINA VAC P 350 1

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9

3

2

8 5 6

7

Fig. 2:

Overview of the FINA VAC P 350 versions

1 Version A Tapping unit with integrated gas pin 2 Plug 3 Terminal unit 4 Version B Tapping unit with rail clamp and NIST connection 5 NIST nipple

1.6

Basic requirements

1.6.1

Use in accordance with the intended purpose

6 NIST screw connection 7 Connection tube 8 Locking lever 9 Rail clamp

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. When employed in 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.

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1 1.6.2

Introduction Basic requirements

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 has also been demonstrated through the application of the corresponding standards which have been harmonised with Directive 93/42/EEC.

1.6.3

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Intended purpose Name:

FINA VAC P 350

Main function:

Aspiration of secretion, blood, serous fluids and vomit along with any contained particles

Medical indications / application:

The FINA VAC P 350 is used to ensure the precise adjustment of the vacuum and is particularly well suited for bronchial aspiration in paediatrics and neonatology.

Specification of the main function:

Drainage and temporary collection of body fluids. For the supply of vacuum, the FINA VAC P 350 is connected to a terminal unit for vacuum of a central medical gas supply system with a pressure of −100 kPa to −60 kPa. A septic fluid jar, which has to be used, allows for temporary collection of drained body fluids.

User profile:

Doctor, medically trained staff

Patient groups:

Bronchial aspiration in paediatrics and neonatology; the FINA VAC B 800 should be used for bronchial aspiration in adults

Application organ:

Natural and artificial body orifices

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 vacuum source. The application of the product may only be performed by medically trained and instructed staff.

Contraindications:

The FINA VAC P 350 may not be used for the following purposes: • Outside the medical sector • In MR areas • In the home care sector • Being operated directly by the patient • For vacuum extraction • For the aspiration of flammable or explosive liquids • For the aspiration of smoke that is generated during HF and laser surgery • For drainages and thoracic drainages • For surgical aspiration • With central gas supply systems with supply pressures other than −100 kPa to −60 kPa

The product is:

Active

Sterility:

Not a sterile product

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Introduction Basic requirements

Single-use product / reprocessing:

1.6.4

1

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

Versions of the FINA VAC P 350 The connection of the FINA VAC P 350 to the terminal unit for vacuum depends on the model being used: Version A: Tapping unit with integrated gas pin • FINA VAC P 350 is fitted to the terminal unit. Version B: Tapping unit with rail clamp and NIST connection • FINA VAC P 350 is designed for mounting onto a 25 x 10 mm equipment rail and is supplied via a NIST connection with vacuum from a terminal unit connected using a connection tube with gas probe. Products and accessories are only permitted with 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. The product is available in the following versions: • FINA VAC P 350 Wall DIN (REF 5752 3731) • FINA VAC P 350 Equipment rail (REF 5752 3732)

1.6.5

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. Configuration of the overall system as well as 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.

1.6.5.1

Vacuum connection tube The vacuum connection tube is used to connect the tapping unit and the septic fluid jar. Technical specifications • Shore hardness of 60 • Inner diameter 6 mm • Length 50 cm (± 10 cm) • Vacuum resistant down to −95 kPa (must not collapse) Prerequisites • The inner diameter of the vacuum connection tube should match the outer diameter of the tube connector on the septic fluid jar cap of the pump. The vacuum connection tube will be referred to only as ‘connection tube’ below.

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1

Introduction Basic requirements

1.6.5.2

Hydrophobic bacterial and viral filter In its function as overflow protection device, the hydrophobic bacterial and viral filter protects the product against the ingress of particles, fluid and foam. In its function as bacterial and viral filter, it protects the product against the ingress of bacteria and viruses. Prerequisites • Pore size ≤ 1.0 μm • The tube connector must match the tube being used. • The hydrophobic bacterial and viral filter must close tightly against water passage at an absolute pressure of up to 10 kPa. • If required, observe the direction of flow (see note on the hydrophobic bacterial and viral filter).

1.6.5.3

Septic fluid jar including septic fluid jar cap The septic fluid jar and septic fluid jar cap are used to collect the secretions extracted. Prerequisites • Low leakage. • Always fasten the septic fluid jar securely. • The outer diameter of the tube connector on the patient side should match the inner diameter of the suction tube.

1.6.5.4

Suction tube The suction tube is used to connect the tube connector on the septic fluid jar on the patient side and the fingertip or the utensil. Technical specifications • Shore hardness of 60 • Inner diameter 6–8 mm • Length 1.3–3.0 m • Vacuum resistant down to −95 kPa (must not collapse) Prerequisites • The outer diameter of the tube connector on the patient side of the septic fluid jar cap must match the inner diameter of the suction tube.

1.6.5.5

Fingertip The fingertip serves to vent the suction tube in order to be able to quickly interrupt the aspiration process. Prerequisites • It must be possible to sterilise the fingertip or it must be a sterilised disposable item. • The outer diameter of the tube connector on the patient side should match the inner diameter of the suction tube.

1.6.5.6

Utensil Suction catheters or lances, for example, are referred to as utensils. The utensils are used to extract septic fluids.

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Introduction Basic requirements

1

Prerequisites • The inner diameter of the utensil's connector must match the outer diameter of the fingertip. • The utensil must be sterilisable or a sterile single-use item. • Biocompatibility • For endobronchial extraction, a utensil with side openings must be used. 1.6.5.7

Mechanical overflow protection The mechanical overflow protection device protects the product against the ingress of fluids. The tube connector must match the vacuum connection tube.

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Safety notes General safety notes

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Safety notes

2.1

General safety notes WARNING! Risk of injury! Hazard resulting from incorrect handling. Be absolutely sure to observe the operating instructions for all the products used in the configuration. WARNING! Risk of injury! ATMOS products may be used only when ‌fully functional‌. Ensure that this ATMOS product is fully func‌tional and in good working order prior to use. ATMOS recommends always having another aspirator ready to hand. This enables aspiration even in the event of product failure. CAUTION! ATMOS recommends always having another aspirator ready to hand. This enables aspiration even in the event of product failure.

2.2

Product safety notes DANGER! Danger to life! The product is not suitable for drainage and thoracic drainage. DANGER! Infection hazard due to oversuction! To avoid the ingress of fluid or foam into the product or the vacuum source, a hydrophobic filter must be used. If secretion enters the inside of the unit, the product must immediately be taken out of operation. Clean and disinfect the product and have it repaired by a service technician authorised by ATMOS to do so. DANGER! Infection hazard due to contamination! To avoid the ingress of contaminants into the product or the vacuum source, a bacterial and viral filter must be used. If bacteria or viruses enter the inside of the unit, the product must immediately be taken out of operation. Clean and disinfect the product and have it repaired by a service technician authorised by ATMOS to do so. WARNING! Impacts! Impacts may cause damage to sensitive, precision mechanical components. Do not expose the product to impacts.

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Safety notes Product safety notes

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WARNING! Measuring accuracy / oversuction! The product may only be operated in a vertical position. WARNING! Backflow of aspirated secretion! In the event of oversuction, the aspirated secretion may flow back to the patient if there is secretion still left in the suction tube. Before replacing the septic fluid jar in the event of oversuction or switching off the vacuum, always remove the tube from the patient first. WARNING! Foaming! Foam may be created when extracting secretion. Foam is detrimental to the functioning of the mechanical overflow protection. This raises the risk that secretion may penetrate the product and cause it to break down. Use an ordinary foam inhibitor. WARNING! Non-permissible load! If the permissible load is exceeded, leakages may occur at the ‍connection between the terminal unit and the gas probe. In accordance with DIN EN ISO 9170-1, the overall weight of the product and accessories may not exceed 2 kg. WARNING! Risk of injury! Replace the hydrophobic bacterial and viral filter immediately if it is discoloured, contaminated or oversucked. Furthermore, the filter must be changed if the vacuum displayed is above −0.3 bar / −30 kPa when the vacuum controller is in the ‘max’ position and the suction tube is open. WARNING! Risk of injury! The product may not be used for the following purposes or under the following conditions: • Never throw, hit or drop the unit. • The product is not suitable for vacuum extraction. • The product may not be used without a hydrophobic filter. • The product may not be used without a bacterial and viral filter. • The product may not be used without a septic fluid jar. • The product may not be used without a fingertip. • Do not hold or lift the product by the vacuum gauge. • The vacuum gauge is not autoclavable. • During storage, the unit should be protected against damage by using cloths, for example.

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3

Initial operation Equipment inspection

3

Initial operation

3.1

Equipment inspection 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. DANGER! Infection hazard! Contaminated components may be hazardous to the patient's health. Prepare the product according to the hygiene guidelines before using it. Clean and disinfect the product. NOTE In order to ensure the functionality, carry out a function check prior to use.

3.2

Mounting

3.2.1

Mounting the vacuum gauge NOTE The vacuum gauge connection is pressure range specific. If it is not possible to assemble the vacuum gauge, check the scale maximum and the unit designation to see whether the parts can actually match. _ Insert the vacuum gauge into the basic unit with a 90° twist and press downwards until it stops. Turn the vacuum gauge by 90° to the front to lock it.

Fig. 3:

16

Assembly of the vacuum gauge

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Initial operation Mounting

3.2.2

Connection to the terminal unit

3.2.2.1

General

3

NOTE Please refer to the manufacturer’s instructions for the particular terminal unit for information on connecting the gas probe to the terminal unit. 3.2.2.2

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

2

Fig. 4:

3.2.2.3

1

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 on the equipment rail (2) and then press it against the equipment rail and allow it to click into place.

1

2 3

5

4 6

8 Fig. 5:

Version B

7

_ Make sure that the rail clamp is correctly secured and that the tapping unit is in a stable position on the equipment rail. The locking lever (3) must be flush with the rail clamp. _ Insert the NIST nipple (4) of the connection tube into the NIST connection (5) of the tapping unit and tighten down the NIST screw connection (6) by hand. _ Plug the gas probe (7) of the connection tube into the terminal unit (8).

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3 3.2.3

Initial operation Mounting

Assembly of the septic fluid jar and accessories WARNING! Tensile forces! The connected accessories must not exert any mechanical forces which could adversely affect the secure fit of the product. 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. NOTE Refer to the manufacturer's instructions for additional information on the use of the septic fluid jar and the extraction utensil. Connection of the mechanical overflow protection _ Plug the overflow protection device (1) directly onto the tube connector (2) on the housing of the tapping unit and press upwards until it stops. 2

4 1

Fig. 6:

18

3

Connection of the mechanical overflow protection

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_ Attach the connection tube (3) to the tube connector (4) of the mechanical overflow protection device and to the designated tube connector of the septic fluid jar. _ For disassembly, first remove the connection tube from the tube connector of the mechanical overflow protection device. Then remove the complete overflow protection device with lid from the tube connector of the tapping unit. Hold the tapping unit steady with one hand while doing so.

Initial operation Mounting

3

Connection of the hydrophobic bacterial and viral filter _ The connection tubes (1) and (2) are plugged onto the tube connectors of the hydrophobic bacterial and viral filter (3).

4

1

_ Then plug the connection tube onto the tube connector (4) on the housing of the tapping unit.

3 2

Fig. 7:

_ Check the flow direction of the bacterial and viral filter. The inlet side must face the patient, and the outlet must face the tapping unit.

_ Connect the connection tube with the designated tube connector of the septic fluid jar.

Connection of the hydrophobic bacterial and viral filter

Connection of the septic fluid jar with integrated hydrophobic bacterial and viral filter _ Attach the connection tube (1) to the tube connector (2) on the housing of the tapping unit and to the tube connector of the septic fluid jar. 2

1

Fig. 8:

Connection of the septic fluid jar

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4

Operation Function test

4

Operation

4.1

Function test 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. Prior to use, the following function check must be performed: Version A: Tapping unit with integrated gas pin • The tapping unit is correctly connected to the terminal unit. Version B: Tapping unit with rail clamp • The tapping unit is locked firmly to the equipment rail. All versions: • The product has been properly cleaned and neither residue nor contamination are present. • The control valve can be easily turned and the shut-off valve is functioning. • The overflow protection device and the hydrophobic bacterial and viral filter are mounted, fully functional and no residue is trapped in it. • The tube connectors are firmly secured 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. • A septic fluid jar is connected to the tapping unit.

4.2

Working with the product DANGER! Infection hazard! In the event of oversuction, the hydrophobic bacterial and viral filter must no longer be used. Replace the hydrophobic bacterial and viral filter with a new one. WARNING! Vacuum setting! Make the vacuum settings very carefully! The regulating mechanism is sensitive. WARNING! Air inlet! The drill hole on the underside of the unit must always be kept free so that airflow is always ensured. NOTE Check the vacuum setting once again immediately before using the unit!

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