MEDAP FINA Fine Regulator Vac Operating Instructions Ver 10 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.

V10 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

1.2.4 1.3

1.4

1.5

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

General... 7

1.3.2

Packaging... 7

1.3.3

ATMOS products... 8

Overview... 8 1.4.1

FINA Fine regulator VAC... 8

1.4.2

Versions of FINA fine regulator VAC... 9

Basic requirements... 9 1.5.1

Use in accordance with the intended purpose... 9

1.5.2

Applicable standards... 10

1.5.3

Intended purpose... 10

1.5.4

Versions of FINA fine regulator VAC... 11

1.5.5

Interface description... 11 1.5.5.1

Dimensions for the gas type specific connection for compressed gas... 11

1.5.5.2

Vacuum connection tube... 11

1.5.5.3

Hydrophobic bacterial and viral filter... 12

1.5.5.4

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

1.5.5.5

Suction tube... 12

1.5.5.6

Fingertip... 12

1.5.5.7

Utensil... 13

1.5.5.8

Mechanical overflow protection... 13

2

Safety notes... 14

2.1

General safety notes... 14

2.2

Product safety notes... 14

3

Initial operation... 17

3.1

Equipment inspection... 17

3.2

Connection to the terminal unit... 17

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Table of contents

3.3

3.2.1

General... 17

3.2.2

Version A... 17

3.2.3

Version B... 18

Mounting accessories... 18 3.3.1

General... 18

3.3.2

Connection of the mechanical overflow protection... 19

3.3.3

Connection of the hydrophobic bacterial and viral filter... 19

3.3.4

Connection of the septic fluid jar with integrated overflow protection... 20

4

Operation... 21

4.1

Function test... 21

4.2

Setting the flow... 21

5

Taking the unit out of operation... 23

6

Cleaning and disinfection... 24

6.1

General... 24

6.2

Cleaning... 25

6.3

6.2.1

General... 25

6.2.2

Cleaning procedure... 25

Disinfection... 25 6.3.1

General... 25

6.3.2

Suitable disinfectants... 26

6.3.3

Disinfection procedure... 26

6.4

Product-specific safety notes... 26

7

Maintenance... 28

7.1

General... 28

7.2

Periodic tests... 28

7.3

Malfunctions and troubleshooting... 28

7.4

Repairs... 29

7.5

Service hotline... 29

7.6

Sending in the device... 29

8

Technical specifications... 30

8.1

General... 30

8.2

Technical specifications... 30

8.3

Ambient conditions... 30

8.4

Dimensions and weight... 30

9

Approved accessories... 31

9.1

Accessories... 31

9.2

Consumables... 31

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GA 5752 3125 GB 10

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 VDE

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)

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

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Introduction Disposal

Symbols

1

Identification 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’. Material designation for the plastic PA (polyamide).

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’. Tab. 3:

1.3

Disposal

1.3.1

General

Symbols

Used products or parts thereof may be contaminated. To prevent potential infection, please clean and disinfect the product prior to return/disposal. 1.3.2

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

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1 1.3.3

Introduction Overview

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

1.4.1

FINA Fine regulator VAC

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3 6 4

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Fig. 1:

Overview of FINA fine regulator VAC

1 Adjusting screw 2 Tube connector VAC 3 Vacuum connection tube A Inner diameter 6 mm 4 Hydrophobic bacterial and viral filter

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5 Vacuum connection tube B Inner diameter 6 mm 6 Tube connector for mechanical overflow protection 7 Mechanical overflow protection

Introduction Basic requirements

1.4.2

1

Versions of FINA fine regulator VAC 2

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5

3

7

6

4

8 10

9 11

12

Fig. 2:

Overview of FINA fine regulator VAC versions

1 Version A Tapping unit with integrated gas pin 2 Terminal unit VAC 3 Gas pin VAC 4 Fine regulator inlet 5 Version B Tapping unit with rail clamp and NIST connection

6 Equipment rail 7 Rail clamp 8 Locking lever 9 NIST housing 10 NIST nipple 11 Cap nut 12 Connection tube

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. 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 1.5.2

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 Products 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

10

Intended purpose Name:

FINA FRV VAC

Main function:

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

Medical indications / application:

For all aspirations where a regulation of the vacuum strength is not necessary and a regulation of the volume flow is sufficient, e.g. general surgeries (aspiration of wound cavities, abscesses) and bronchial aspiration of adults.

Specification of the main function:

Drainage and temporary collection of body fluids. For the supply of vacuum, FINA FRV VAC 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 the drained body fluids.

User profile:

Doctor, medically trained staff

Patient groups:

Surgical aspiration: patients of all ages; bronchial aspiration of 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 FRV VAC 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 • If not reducing the vacuum of the central gas supply poses a danger for the patient (e.g. in drainage, in paediatrics and neonatology). Usage in combination with disposable thoracic drainage systems with integrated vacuum regulation is excepted. • For vacuum extraction • For the aspiration of flammable or explosive liquids • For the aspiration of smoke that is generated during HF and laser surgery without the connection of an intermediate smoke filter • With central gas supply systems with supply pressures other than -100 kPa to -60 kPa

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Introduction Basic requirements

1.5.4

1

The product is:

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.

Versions of FINA fine regulator VAC The connection of the terminal unit to FINA FRV VAC depends on the model being used: Version A: Tapping unit with integrated gas pin • FINA FRV VAC is fitted directly to the terminal unit. Version B: Tapping unit with rail clamp and NIST connection • FINA VAC is designed for mounting onto an equipment rail 25 x 10 mm 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 fine regulator VAC Wall MEDAP (REF 5752 3712) • FINA fine regulator VAC Wall DIN (REF 5752 3713) • FINA fine regulator VAC equipment rail (REF 5752 3714)

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. 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.

1.5.5.1

Dimensions for the gas type specific connection for compressed gas The dimensions for plugs or terminal units are subject to national standards DIN 13260-2 (Germany) and MEDAP standard, depending on the product type.

1.5.5.2

Vacuum connection tube The vacuum connection tube is used to connect the hydrophobic bacterial and viral filter with the septic fluid jar cap. Technical specifications • Shore hardness of 60 • Inside diameter 6 mm • Length 50 cm (± 10 cm) • Vacuum resistant down to -95 kPa (must not collapse)

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Introduction Basic requirements

Prerequisites • The vacuum connection tube must comply with the hospital's standards for hygiene. • The inner diameter of the vacuum connection tube must match the outer diameter of the hydrophobic bacterial and viral filter. • The inner diameter of the vacuum connection tube must match the outer diameter of the tube connector on the bacterial and viral filter. The vacuum connection tube will be referred to only as ‘connection tube’ below. 1.5.5.3

Hydrophobic bacterial and viral filter In its function as overflow protection device, the hydrophobic bacterial and viral filter protects the product against ingress of particles, fluid and foam. In its function as bacterial and viral filter, it protects the product from the ingress of bacteria and viruses. Prerequisites • Pore size ≤ 1.0 µ. • 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).

1.5.5.4

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.

1.5.5.5

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 of 6 - 8 mm • Length 1.3 m - 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.

1.5.5.6

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.

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Introduction Basic requirements

1.5.5.7

1

Utensil The suction catheter, lance, etc., are referred to as utensils. The utensils are used to extract septic fluids. 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.

1.5.5.8

Mechanical overflow protection The mechanical overflow protection device protects the product from the ingress of particles, fluid and foam. The tube connector must match the vacuum connection tube.

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Safety notes General safety notes

2

Safety notes

2.1

General safety notes WARNING! Risk of injury! ATMOS products may be used only when fully functional. Ensure that the ATMOS product is fully functional and in good working order prior to use. 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. DANGER! Defective device! Using incorrect spare parts and accessories can cause injuries or equipment failure. Only use original accessories or spare parts. CAUTION! ATMOS recommends always having another aspirator ready to hand. That way you can perform aspiration even in the event of product failure.

2.2

Product safety notes DANGER! Infection hazard due to oversuction! To avoid the ingress of fluid or foam into the product or the vacuum source, a hydrophobic bacterial 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 hydrophobic bacterial 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! Risk of oversuction! The tapping unit may only be used with the mechanical overflow protection in an upright position.

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Safety notes Product safety notes

2

DANGER! Risk of injury to mucous membranes! Endobronchial aspiration in paediatrics and neonatology requires particularly careful limitation of the vacuum. For the regular endobronchial aspiration in paediatrics and neonatology, ATMOS also offers paediatric versions with a higher level of setting convenience. 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 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! 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! 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! Risk of injury! Immediately replace the hydrophobic bacterial and viral filter 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.

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Safety notes Product safety notes

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. • During storage, the unit should be protected against damage by using cloths, for example.

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Initial operation Equipment inspection

3

Initial operation

3.1

Equipment inspection

3

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 staff and patients. Ensure the product is prepared as per hygiene standards before using it for the first time. _ 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

Fig. 3:

1

Version A

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3 3.2.3

Initial operation Mounting accessories

Version B Tapping units 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

8

7

2 3 4

5 6

Fig. 4:

Version B

3.3

Mounting accessories

3.3.1

General

_ 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).

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.

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Initial operation Mounting accessories

3.3.2

3

Connection of the mechanical overflow protection 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 3

Fig. 5:

3.3.3

Connection of the mechanical overflow protection

_ Attach the connection tube (3) to the tube connector (4) of the mechanical overflow protection device and connect it 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.

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

4

_ Check the flow direction of the filter. The inlet side must face the patient, and the outlet must face the tapping unit. _ Then plug the connection tube (1) onto the tube connector (4) on the housing of the tapping unit.

1 3 2 Fig. 6:

_ Connect the connection tube (2) with the designated tube connector of the septic fluid jar.

Connection of the filter

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3 3.3.4

Initial operation Mounting accessories

Connection of the septic fluid jar with integrated overflow protection Connection of the septic fluid jar with integrated overflow protection _ Attach the connection tube (1) to the tube connector (2) on the housing of the tapping unit and connect it to the tube connector of the septic fluid jar. 2

1

Fig. 7:

20

Connection of the septic fluid jar

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