MEDAP Gas-Jet Pumps Operating Instructions Ver 15 May 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.

V15 2020-05

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Table of contents

Table of contents 1

Introduction... 5

1.1

Foreword... 5

1.2

Environmental protection... 5 1.2.1

Packaging... 5

1.2.2

ATMOS products... 5

1.3

Disposal... 5

1.4

How to use these operating instructions... 5 1.4.1

General... 5

1.4.2

Abbreviations... 5

1.4.3

Symbols... 5

1.4.4

1.4.5 1.5

1.4.3.1

Cross-references... 5

1.4.3.2

Actions and responses... 6

Definitions... 6 1.4.4.1

Design of safety notes... 6

1.4.4.2

Design of other notes... 6

Symbols used... 6

Basic requirements... 8 1.5.1

Overview of gas-jet pump without gauge... 8

1.5.2

Overview of gas-jet pump with gauge... 9

1.5.3

Use in accordance with the intended purpose... 9

1.5.4

Applicable standards... 10

1.5.5

Intended purpose... 10 1.5.5.1

1.5.6

1.5.7

Possible applications... 11

Interface description... 11 1.5.6.1

General... 11

1.5.6.2

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

1.5.6.3

Fine regulator... 11

1.5.6.4

Overflow protection device... 11

1.5.6.5

Vacuum connection tube... 12

1.5.6.6

Hydrophobic bacterial and viral filter... 12

1.5.6.7

Fingertip... 12

1.5.6.8

Applicator (lance, suction tip, etc.)... 12

1.5.6.9

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

1.5.6.10

Suction tube, Shore hardness 60... 12

Versions... 13 1.5.7.1

Gas-jet pump without gauge... 13

1.5.7.2

Gas-jet pump with gauge... 13

2

Principal safety notes... 14

2.1

Principal safety notes... 14

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Table of contents

3

Initial operation... 17

3.1

General... 17

3.2

Equipment inspection... 17

3.3

Assembly of gas-jet pump... 18 3.3.1

Operation with hydrophobic bacterial and viral filter... 18

3.3.2

Operation without a hydrophobic bacterial and viral filter... 19

4

Operation... 20

4.1

Gas-jet pump with gauge... 20

4.2

Disassembly of gas-jet pump... 20

4.3

Replacing the bacterial filter paper ... 21

5

Cleaning and disinfection... 22

5.1

General... 22

5.2

Cleaning... 23

5.3

5.2.1

General... 23

5.2.2

Cleaning procedure... 23

Disinfection... 23 5.3.1

General... 23

5.3.2

Suitable disinfectants... 24

5.3.3

Disinfection procedure... 24

5.3.4

Disinfection procedures... 24

5.4

Product-specific safety notes... 25

6

Maintenance... 26

6.1

General... 26

6.2

Periodic tests... 26

6.3

Malfunctions and troubleshooting... 26

6.4

Repairs... 27

6.5

Service hotline... 27

6.6

Sending in the device... 27

7

Technical specifications... 28

7.1

General... 28

7.2

Ambient conditions... 28

7.3

Dimensions and weight... 28

8

Accessories... 29

8.1

Accessories... 29

8.2

Consumables... 29

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GA 5750 4196 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

Environmental protection

1.2.1

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

1.2.2

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

1.3

Disposal WARNING! Disposal! The product is used in the treatment of patients. The product or some of its components may be contaminated after use. Clean and disinfect the product before disposal.

1.4

How to use these operating instructions

1.4.1

General 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.

1.4.2

Abbreviations EN EEC

1.4.3

Symbols

1.4.3.1

Cross-references

European standard European Economic Community

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

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Introduction How to use these operating instructions

1.4.3.2

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.

1.4.4

Definitions

1.4.4.1

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:

1.4.4.2

Design of safety notes

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

Tab. 2:

1.4.5

Reference to

NOTE

Supplementary assistance or further useful information.

ENVIRONMENT

Information regarding proper disposal.

Design for other notes

Symbols used Symbols

Identification

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6

Descriptor

GA 5750 4196 GB 15

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.

Introduction How to use these operating instructions

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’. 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:

Symbols

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1

Introduction Basic requirements

1.5

Basic requirements

1.5.1

Overview of gas-jet pump without gauge 8 7

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4 3 2

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Fig. 1:

Overview of gas-jet pump without gauge

1 Bacterial filter cap 2 Bacterial filter paper 3 Seal VITON 4 Sintered filter

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5 Bacterial filter housing 6 Housing 7 Cap nut G3/8" (O2) / M18x1 (AIR) 8 Seal

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Introduction Basic requirements

1.5.2

Overview of gas-jet pump with gauge

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6 9 5 4 3 2

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Fig. 2:

Overview of gas-jet pump with gauge

1 Bacterial filter cap 2 Bacterial filter paper 3 Seal VITON 4 Sintered filter 5 Bacterial filter housing

1.5.3

6 Gauge 7 Cap nut G3/8" (O2) / M18x1 (AIR) 8 Seal 9 Housing

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 1.5.4

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 is certified by compliance with harmonised standards such as IEC 60601-1 and related standards and the respective special sections.

1.5.5

10

Intended purpose Name:

Gas-jet pumps

Main function:

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

Medical indications / application:

For all applications which require aspiration, e.g. general surgeries (e.g. aspiration of wound cavities, abscesses) and bronchial aspiration and where a flow rate of 32 l/min or 12 l/min, respectively, is sufficient.

Specification of the main function:

The gas-jet pump has a media-coded screw connection either to the outlet of a fine regulator for compressed air or to the outlet of a fine regulator for oxygen. The gas-jet pump converts compressed air or oxygen, respectively, into vacuum via Venturi principle. When using a version without an integrated vacuum gauge in systems with controllable vacuum, a separate vacuum gauge must be connected between the gas-jet pump and the septic fluid jar. The permissible nominal pressure is 500 kPa ± 10%. A septic fluid jar, which has to be used, allows a temporary collection of the derived body fluids.

User profile:

Doctor, medically trained staff

Patient groups:

Patients of all ages

Application organ:

Natural and artificial body orifices

Application time:

Product designed 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. The product may only be applied by medically trained and instructed staff.

Contraindications:

The gas-jet pumps may not be used: • 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 without the connection of an intermediate smoke filter • For drainages and thoracic drainages • With a supply pressure other than 500 kPa ± 10%

The product is:

Active

GA 5750 4196 GB 15

Introduction Basic requirements

1.5.5.1

1

Sterility:

Not a sterile product

Single-use product / reprocessing:

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

Possible applications The gas-jet pump may be operated in combination with a fine regulator: • Fine regulator AIR (REF 5752 3708 - 5752 3710): The volumetric flow delivered to the gas-jet pump AIR HF/HV (REF 5750 7542) is regulated by means of fine regulator AIR. • Fine regulator O2 (REF 5752 3705): The volumetric flow delivered to the gas-jet pump O2 LF/HV (REF 5750 7540) and LF/HV with gauge (REF 5750 7543) is regulated by means of fine regulator O2.

1.5.6

Interface description

1.5.6.1

General 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 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.

1.5.6.2

Dimensions for the gas type specific connection for compressed gas The geometric gas coding for the screw connectors of the gas-jet pump depends on the product version and is in accordance with national MEDAP factory standards for AIR: M18x1; O2: G3/8".

1.5.6.3

Fine regulator The fine regulator is used to regulate the volumetric flow applied to the oxygen gas-jet pumps. The fine regulator is connected to a central gas supply system (CGSS) pursuant to DIN EN ISO 7396-1, DIN EN 737-3 or DIN 13260-1. Prerequisites • Fine regulator AIR: Thread M18x1 • Fine regulator O2: Thread G3/8"

1.5.6.4

Overflow protection device The mechanical overflow protection system protects the vacuum source against oversuction. If no overflow protection system is integrated in the vacuum source or suction set, a separate mechanical overflow protection must be connected between the vacuum source and the suction set. Prerequisites • Connections of the overflow protection system must match the inner diameter of the connection tube.

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Introduction Basic requirements

1.5.6.5

Vacuum connection tube The vacuum connection tube is used to connect the gas-jet pump and the septic fluid jar. Technical specifications • Shore hardness of 60 • Inner diameter 6–7 mm • Tube length maximum 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.

1.5.6.6

Hydrophobic bacterial and viral filter The hydrophobic bacterial and viral filter protects against contaminants which could be present in the form of particles or aerosols in the gas drawn in. Moreover, the hydrophobic filter serves as protection against oversuction; the filter closes off the flow of gas to the product in the event of oversuction. In its function as bacterial and viral filter, it protects the interior of the pump from the ingress of bacteria and viruses. This ATMOS product (REF 5750 0630) is a hydrophobic bacterial and viral filter with a pore size of 1.0 μm (disposable article). Prerequisites • Pore size ≤ 1.0 μm. • Use a bacterial filter suitable for the particular application. • The tube connector must match the tube being used. • The hydrophobic filter must close tightly against water passage at an absolute pressure of up to 10 kPa.

1.5.6.7

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

1.5.6.8

Applicator (lance, suction tip, etc.) The outer diameter of the applicator connection must match the inner diameter of the suction tube; the utensil must be sterilisable or a sterilised disposable item.

1.5.6.9

Septic fluid jar including septic fluid jar cap Low leakage; volumes of 0.7 to 5.0 l; the outer diameter of the tube connector for the vacuum source must match the inner diameter of the connection tube; it must be possible to fix the septic fluid jar securely to a support or on an equipment rail.

1.5.6.10

Suction tube, Shore hardness 60 The suction tube acts as the connection between the septic fluid jar and the utensil: the suction tube (1.3–3.0 m in length) must not collapse; the outer diameter of the patient side of the tube connector on the septic fluid jar must match the inner diameter of the suction tube.

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Introduction Basic requirements

1.5.7

Versions

1.5.7.1

Gas-jet pump without gauge • Gas-jet pump O2, low flow / high vac (REF 5750 7540) • Gas-jet pump AIR, high flow / high vac (REF 5750 7542)

1.5.7.2

Gas-jet pump with gauge • Gas-jet pump with gauge O2, low flow / high vac (REF 5750 7543)

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Principal safety notes Principal safety notes

2

Principal safety notes

2.1

Principal safety notes DANGER! Infection hazard due to use of oversucked filter! Do not use oversucked hydrophobic filter. Replace oversucked hydrophobic filter. 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! UV radiation! Exposure to UV rays can cause material fatigue. The stability would no longer be ensured. Do not expose the product to strong UV light. DANGER! Fire/explosion hazard! Air, oxygen and oxygen compounds react explosively with oils, greases and lubricants. Fire and explosion hazard due to compressed gases. Keep product, in particular for oxygen, free of oils, greases, lubricants and hand cream. Only use lubricants which are approved by ATMOS. Observe fire protection regulations when dealing with flammable gases. Contact Technical Services about any leakages in the product. DANGER! Risk of fire! Escaping oxygen increases the risk of fire. Never smoke near equipment which carries oxygen and avoid using open fires or glowing objects. Check the connector for leaks and tight fit when mounting accessories. DANGER! Risk of fire! The product may ignite if the maximum operating pressure or the maximum operating temperature is exceeded. Do not exceed the maximum operating pressure or maximum operating temperature. DANGER! Health hazard! Only use the product with central gas supply systems in accordance with DIN EN ISO 7396-1, DIN EN 737-3 or DIN 13260-1 which are equipped with an alarm facility for improper operating pressures.

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Principal safety notes Principal safety notes

2

DANGER! Health hazard! Only connect the product to compressed gas cylinders with filling level indication and pressure reducer. The humidifier can only be used in conjunction with units which are equipped with a pressure reducer in accordance with DIN EN ISO 10524-1 or DIN EN 738-1. DANGER! Defective device! Using incorrect spare parts or accessories can cause injuries or equipment failure. Only use original accessories or spare parts. DANGER! Health hazard! Pay attention that the product is connected to the appropriate gas type and that the screw connection is firmly secured. DANGER! Danger to life! The product is not suitable for drainage. WARNING! Risk of injury! Worn or damaged products can cause injuries. Use only products which are in perfect condition. WARNING! Malfunction! Do not expose the product to torsion, as this might impair its proper function. Mount accessories in such a way that they remain torsion-free and tension-free. WARNING! Ambient conditions! If the ambient temperature range specified for shipping, operation and/or storage conditions is undercut or exceeded, then no guarantee can be assumed for the accuracy, mechanical strength or sealing of the product. WARNING! Configuration of the overall system! The configuration of the overall system as well as the functional testing are subject to the overall responsibility of the medical staff. The operator must check proper functionality and suitability of the product for each intended application before every use, in particular connection parts, tightness and suitability concerning material, work pressure and flow. WARNING! Risk of injury! Products which are improperly mounted can loosen and cause injuries. Mount the product properly.

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Principal safety notes Principal safety notes

WARNING! Vacuum gauge! Never expose vacuum gauge to any shocks as sensitive precision components may be damaged. WARNING! Oversuction! If septic fluid gets into the unit, it must be shut down immediately and then cleaned and/or repaired by authorised service personnel. WARNING! Risk of injury! Hazard resulting from incorrect handling. Follow the operating instructions for all accessories. CAUTION! Property damage due to oversuction! The product may only be operated with the overflow protection in place as otherwise oversuction could occur. A hydrophobic filter offers an additional protection against oversuction; in case of oversuction, it shuts off the gas supply to the product. Particles in the gaseous phase may clog the hydrophobic filter. ATMOS offers a bacterial and viral filter which also protects the inside of the pump from entering bacteria and viruses. WARNING! Risk of injury! The suction and aspiration of laser or coagulation vapours (protein-containing vapours) require the use of a flue gas filter which is appropriate for the specific application.

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Initial operation General

3

Initial operation

3.1

General

3

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! 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. CAUTION! Property damage due to foaming! Foam may be created when extracting secretion. Foam is detrimental to the functioning of the mechanical overflow protection. This gives rise to the risk of secretions entering and damaging the aspirator. Always use a hydrophobic bacterial and viral filter and, if possible, a commercially available foam inhibitor. NOTE Refer to the manufacturer's instructions for additional information on the use of the septic fluid jar and the extraction utensil.

3.2

Equipment inspection _ Ensure that the thread of the oxygen gas-jet pump matches the thread of the fine regulator. _ Check whether the unit has been properly cleaned and that there are no residues or soiling. _ Do not use damaged components.

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3 3.3

Initial operation Assembly of gas-jet pump

Assembly of gas-jet pump Mounting the oxygen gas-jet pump _ Ensure that a flat seal is located in the tapped hole of the cap nut (1) of the oxygen gas-jet pump. 2

_ Screw the cap nut of the oxygen gas-jet pump onto the outlet (2) of the fine regulator. 9 The oxygen gas-jet pump is mounted on the fine regulator.

1

Fig. 3: Mounting the oxygen gas-jet pump

3.3.1

Operation with hydrophobic bacterial and viral filter NOTE Please refer to the operating instructions of the bacterial and viral filter (REF 5752 4794) for information on the hydrophobic bacterial and viral filter (REF 5752 0630). 2

1

Mounting the hydrophobic bacterial and viral filter _ Attach the connection tube (1) to the tube connector (2) of the gas-jet pump. _ Attach the other end of the connection tube to the tube connector (3) of the hydrophobic bacterial and viral filter. 9 Hydrophobic bacterial and viral filter is mounted. _ Connect the hydrophobic bacterial and viral filter and the septic fluid jar using a second connection tube (4).

3

4 Fig. 4: Mounting the hydrophobic bacterial and viral filter

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Initial operation Assembly of gas-jet pump

3.3.2

3

Operation without a hydrophobic bacterial and viral filter Assembly of septic fluid jar with integrated overflow protection _ Attach the connection tube (1) to the tube connector (2) of the gas-jet pump. _ Attach the other end of the connection tube to the connector on the septic fluid jar. 2 1

Fig. 5: Connection of septic fluid jar

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Operation Gas-jet pump with gauge

Operation WARNING! Injury hazard if the catheter attaches itself to tissue! Always use a fingertip so that the extraction process can be interrupted quickly by releasing the fingertip.

4.1

Gas-jet pump with gauge _ Open the fine regulator (1). _ Read the set value on the gauge (2).

1

2

Fig. 6: Gas-jet pump with gauge

4.2

Disassembly of gas-jet pump Disassembling the gas-jet pump _ Close the fine regulator (1). _ Detach the connection tubes (2) and the hydrophobic bacterial and viral filter. 1 2

Fig. 7: Disassembling the gas-jet pump

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