MEDAP Tapping Unit S Vac Int Operating Instructions Ver 03 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.

V03 2020-07

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Table of contents

Table of contents 1

Introduction... 6

1.1

Foreword... 6

1.2

How to use these operating instructions... 6 1.2.1

Abbreviations... 6

1.2.2

Symbols... 6

1.2.3

1.3

1.4

1.2.2.1

Cross-references... 6

1.2.2.2

Actions and responses... 6

Definitions... 7 1.2.3.1

Design of safety notes... 7

1.2.3.2

Design of other notes... 7

1.2.4

Symbols used... 7

1.2.5

Disposal... 8 1.2.5.1

Packaging... 8

1.2.5.2

ATMOS products... 8

Overview... 9 1.3.1

S VAC INT... 9

1.3.2

S VAC INT versions... 10

Basic requirements... 10 1.4.1

Use in accordance with the intended purpose... 10

1.4.2

Applicable standards... 10

1.4.3

Intended purpose... 11

1.4.4

S VAC INT versions... 12

1.4.5

Interface description... 12 1.4.5.1

Vacuum connection tube... 12

1.4.5.2

Hydrophobic bacterial and viral filter... 12

1.4.5.3

Septic fluid jar including septic fluid jar cap... 13

1.4.5.4

Suction tube... 13

1.4.5.5

Fingertip... 13

1.4.5.6

Utensil... 13

1.4.5.7

Mechanical overflow protection... 14

2

Safety notes... 15

2.1

General safety notes... 15

2.2

Product safety notes... 15

3

Initial operation... 17

3.1

Product testing... 17

3.2

Connection to the terminal unit... 17 3.2.1

General... 17

3.2.2

Version A... 17

3.2.3

Version B... 18

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Table of contents

3.3

Mounting accessories... 18 3.3.1

General... 18

3.3.2

Mounting the mechanical overflow protection... 19

3.3.3

Connection of the mechanical overflow protection... 19

3.3.4

Connection of hydrophobic bacterial and viral filter... 20

4

Operation... 21

4.1

Function test... 21

4.2

Adjusting the selector switch... 21

4.3

Setting the vacuum level... 22

5

Taking the unit out of operation... 24

5.1

Completing the aspiration process... 24

5.2

Disassembly... 24 5.2.1

General... 24

5.2.2

Dismantling the mechanical overflow protection... 25

6

Cleaning and disinfection... 26

6.1

General... 26

6.2

Cleaning... 27

6.3

6.2.1

General... 27

6.2.2

Cleaning procedure... 27

Disinfection... 27 6.3.1

General... 27

6.3.2

Suitable disinfectants... 28

6.3.3

Disinfection procedure... 28

6.3.4

Disinfection procedures... 28

6.4

Product-specific safety notes... 29

7

Maintenance... 30

7.1

General... 30

7.2

Periodic tests... 30

7.3

Malfunctions and troubleshooting... 30

7.4

Repairs... 31

7.5

Service hotline... 31

7.6

Type plate position... 32

7.7

Sending in the device... 32

8

Technical specifications... 33

8.1

General... 33

8.2

Technical specifications... 33

8.3

Ambient conditions... 33

8.4

Dimensions and weight... 33

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Table of contents

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Approved accessories... 34

9.1

Accessories... 34

9.2

Consumables... 34

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1

Introduction Foreword

1

Introduction

1.1

Foreword 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.

1

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 ‘Serial number’. Labelling in compliance with the ISO 15223-1 standard. Symbol for ‘Product number’.

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Introduction How to use these operating instructions

Symbols

Identification Labelling in compliance with the IEC 60601-1 standard. Symbol for ‘Follow operating instructions’. 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 ‘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:

1.2.5

Symbols

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

1.2.5.1

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

1.2.5.2

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

1.3

Overview

1.3.1

S VAC INT

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1 2 6

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7 4 8

9

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Fig. 1:

Overview of S VAC INT

1 S VAC INT 2 Vacuum indicator 3 Control valve 4 Selector switch OFF - CONT - INT 5 Plug

6 Terminal unit 7 Air inlet 8 Mechanical overflow protection 9 Adapter for the hydrophobic bacterial and viral filter 10 Hydrophobic bacterial and viral filter

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1 1.3.2

Introduction Basic requirements

S VAC INT versions 4

1 2

8

5

3 6

Fig. 2:

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Overview of S VAC INT versions

1 Version A Tapping unit with integrated gas pin 2 Gas pin 3 Terminal unit

1.4

Basic requirements

1.4.1

Use in accordance with the intended purpose

4 Version B Tapping unit with rail clamp and NIST connection 5 NIST nipple 6 NIST screw connection 7 Connection tube 8 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. 1.4.2

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

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Introduction Basic requirements

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with harmonised standards such as IEC 60601-1 and related standards and the respective special sections. 1.4.3

Intended purpose Name:

S VAC INT

Main function:

Aspiration of secretion, blood and serous fluids

Medical indications / application:

For precise regulation of vacuum for postoperative aspiration of wound exudate, secretion, blood or serous fluids. Additional fields of application are the aspiration of air as well as rinsing and wound drainage.

Specification of the main function:

Drainage and temporary collection of body fluids. For the supply of vacuum, S VAC INT is connected to a terminal unit for vacuum of a central medical gas supply system (−100 kPa to −60 kPa). A septic fluid jar, which has to be used, allows for temporary collection of drained body fluids. In the position intermittent, the S VAC INT is particularly suitable for subglottic aspiration.

User profile:

Doctor, medically trained staff

Patient groups:

Patients of all ages

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 S VAC INT 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 bronchial aspiration, except for intermittent subglottic aspiration • For 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:

1.4.4

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

S VAC INT versions The connection of the S VAC INT to the terminal unit depends on the model being used. Version A: Tapping unit with integrated gas pin • S VAC INT is fitted directly to the terminal unit. Version B: Tapping unit with rail clamp and NIST connection • S VAC INT is designed for mounting onto a 25−35 x 10 mm equipment rail in accordance with DIN EN 19054 and is supplied from a terminal unit for vacuum via a NIST connection with a connection tube with gas probe. The S VAC INT is available in the following versions: • S VAC INT Wall DIN (REF 5752 5730) • S VAC INT Wall BOC (BS 5682) (REF 5752 5731) • S VAC INT equipment rail (REF 5752 5732)

1.4.5

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.

1.4.5.1

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.

1.4.5.2

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 against the ingress of bacteria and viruses.

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Introduction Basic requirements

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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). 1.4.5.3

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.

1.4.5.4

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.

1.4.5.5

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.

1.4.5.6

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.

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Introduction Basic requirements

1.4.5.7

Mechanical overflow protection The mechanical overflow protection device protects the product against the ingress of particles and fluid. 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

2

DANGER! Danger to life! Danger due to unauthorised modifications. The product may not be modified. 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. CAUTION! ATMOS recommends always having another aspirator ready to hand. That way your can perform aspiration even in the event of product failure.

2.2

Product safety notes WARNING! Risk of injury to mucous membranes! Endobronchial aspiration in paediatrics and neonatology as well as intermittent aspiration require particularly careful limitation of the vacuum. WARNING! Risk of injury! ATMOS products may be used only when fully functional. Check that the ATMOS product is fully functional and in good working order prior to use. ATMOS always recommends having another aspirator ready to hand. This enables aspiration even in the event of product failure. 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.

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Safety notes Product safety notes

WARNING! Impacts! Impacts may cause damage to sensitive, precision mechanical components. Do not expose the product to impacts. WARNING! Measuring accuracy / oversuction! The product may only be operated in a vertical position. 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 secretions 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! 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! 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 26 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 product. • 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 continuous aspiration. • The product is not autoclavable.

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Initial operation Product testing

3

Initial operation

3.1

Product testing

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. 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. NOTE In order to ensure the functionality, carry out a function check prior to use.

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 _ Set the selector switch (1) to position OFF [ page 21]. 3

_ The tapping unit (2) is plugged directly into the terminal unit (3).

2 1

Fig. 3:

Version A

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3 3.2.3

Initial operation Mounting accessories

Version B Tapping units with rail clamp and NIST connection 1

2 7

8

_ Position the rail clamp (1) at a slight angle with the upper edge of the guide groove on the equipment rail (2) and then press it against the equipment rail and allow it to click into place. _ Tighten the handle screw (3) of the rail clamp. _ Make sure that the rail clamp is correctly secured and that the tapping unit is in a stable position on the equipment rail.

3 4 5

Fig. 4:

Version B

3.3

Mounting accessories

3.3.1

General

6

_ Insert the NIST nipple (4) of the connection tube into the NIST connection (5) of the tapping unit and tighten 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. NOTE The particle filter must be changed whenever the product is prepared for use.

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Initial operation Mounting accessories

3.3.2

3

Mounting the mechanical overflow protection Mounting the mechanical overflow protection

5

_ Insert the float (1) into the overflow container (2).

4

_ Fit the sealing ring (3) onto the cap (4). 1

3

_ Insert the cap into the overflow container. _ Fit the particle filter (5) onto the cap.

2

Fig. 5:

3.3.3

Mounting the mechanical overflow protection

Connection of the mechanical overflow protection Mounting the mechanical overflow protection device _ Plug the overflow protection device (1) directly onto the tapping unit (2) and press it up as far as it will go. _ Turn the overflow protection device (1) to the right. 9 The overflow protection device is locked. Removing the mechanical overflow protection device _ Turn the overflow protection device (1) to the left. 9 The overflow protection device is unlocked. Fig. 6:

Mounting/removing the mechanical overflow protection device

_ Pull the overflow protection device down.

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3 3.3.4

Initial operation Mounting accessories

Connection of hydrophobic bacterial and viral filter Mounting the hydrophobic bacterial and viral filter _ Remove the grub screw from the adapter (1) with an Allen key. 2

3

1 4

Fig. 7:

20

Mounting the hydrophobic bacterial and viral filter

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_ Insert the adapter (1) for the hydrophobic filter directly into the tapping unit (2) and turn. _ Tighten the grub screw into the opening (3) with an Allen key. _ Fit the hydrophobic bacterial and viral filter (4) onto the adapter for the hydrophobic filter and push it up.