Medap OXYRATOR User guide

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OPERATING INSTRUCTIONS

OXYRATOR OXYRATOR WITH ASPIRATOR

GA 5752 5555 GB 05

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Subject to technical modification!

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

V05 2019-12

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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

1.2.2.1 Cross-references ....................................................................................................... 5

1.2.2.2 Actions and responses .............................................................................................. 5

1.2.3 Definitions ....................................................................................................................................6

1.2.3.1 Design of safety notes ............................................................................................... 6

1.2.3.2 Structure of notes ......................................................................................................6

1.2.4 Symbols used ..............................................................................................................................6

1.3 Disposal ......................................................................................................................................................7

1.3.1 Packaging ....................................................................................................................................7

1.3.2 ATMOS products .......................................................................................................................... 7

1.4 Overview of Oxyrator (REF 5752 5548) ..................................................................................................... 8

1.5 Overview of Oxyrator with aspirator (REF 5752 5549) ............................................................................... 9

1.6 Basic requirements .....................................................................................................................................9

1.6.1 Use in accordance with the intended purpose ............................................................................. 9

1.6.2 Applicable standards ..................................................................................................................10

1.6.3 Treatment system as per Article 12 ............................................................................................ 10

1.6.4 Intended purpose ....................................................................................................................... 10

1.6.5 Interface description of Oxyrator ................................................................................................ 12

1.6.5.1 Oxygen cylinder ....................................................................................................... 12

1.6.5.2 Connection tube ......................................................................................................12

1.6.5.3 Bubble humidifier (REF 5752 5315) ........................................................................ 12

1.6.6 Interface description of Oxyrator with aspirator ......................................................................... 12

1.6.6.1 Oxygen cylinder ....................................................................................................... 12

1.6.6.2 Vacuum connection tube ......................................................................................... 12

1.6.6.3 Suction tube .............................................................................................................13

1.6.6.4 Connection tube ......................................................................................................13

1.6.6.5 Bubble humidifier (REF 5752 5315) ........................................................................ 13

2 Safety notes ............................................................................................................................................14

3 Initial operation .......................................................................................................................................15

3.1 General .....................................................................................................................................................15

3.2 Connecting the pressure regulator ........................................................................................................... 15

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Table of contents

3.3 Oxyrator (REF 5752 5548) ....................................................................................................................... 16

3.3.1 Oxygen supply via tube adapter ................................................................................................ 16

3.3.2 Connecting accessories (optional) ............................................................................................. 17

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

3.3.2.2 Connection of disposable humidifiers from other manufacturers ............................ 17

3.4 Oxyrator with aspirator (REF 5752 5549) ................................................................................................. 18

3.4.1 Connecting the fine regulator ..................................................................................................... 18

3.4.2 Connecting the gas-jet pump ..................................................................................................... 18

3.4.3 Mounting the tubes ....................................................................................................................19

3.4.4 Aspiration and oxygen therapy .................................................................................................. 19

3.4.4.1 Oxygen supply via tube adapter .............................................................................. 19

3.4.4.2 Connecting accessories (optional) .......................................................................... 20

4 Operation ................................................................................................................................................22

4.1 Function test ............................................................................................................................................. 22

4.2 Check the filling level of the oxygen cylinder............................................................................................ 22

4.3 Oxygen extraction ....................................................................................................................................23

4.4 Setting the vacuum level (only for Oxyrator with aspirator) ...................................................................... 23

5 Taking the unit out of operation ............................................................................................................ 24

5.1 Stopping oxygen extraction ...................................................................................................................... 24

5.2 Replacing the oxygen cylinder .................................................................................................................24

5.3 Oxyrator with aspirator ............................................................................................................................. 26

5.3.1 Detaching tubes ......................................................................................................................... 26

6 Cleaning and disinfection ......................................................................................................................27

6.1 General .....................................................................................................................................................27

7 Maintenance ............................................................................................................................................28

7.1 General .....................................................................................................................................................28

7.2 Periodic tests ............................................................................................................................................ 28

7.3 Visual and functional inspections .............................................................................................................28

7.4 Malfunctions and troubleshooting.............................................................................................................29

7.5 Repairs ..................................................................................................................................................... 29

7.6 Service hotline .......................................................................................................................................... 30

7.7 Sending in the device ............................................................................................................................... 30

8 Technical specifications ........................................................................................................................ 31

8.1 Ambient conditions ................................................................................................................................... 31

8.2 Technical specifications ............................................................................................................................ 31

8.3 Dimensions and weights ..........................................................................................................................31

9 Approved accessories ...........................................................................................................................32

9.1 Accessories .............................................................................................................................................. 32

9.2 Consumables ...........................................................................................................................................32

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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.

Introduction

Foreword

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.

 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!

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.

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

Tab. 1: Design of safety notes

1.2.3.2 Structure of notes

Notes not referring to personal injury or property damage are structured as follows:

Pictogram Descriptor Reference to

NOTE Supplementary assistance or further useful information

ENVIRONMENT Information regarding proper disposal.

Tab. 2: Structure of notes

1.2.4 Symbols used

Symbols are attached to products, type plates and packaging.

Symbols Identification

without potential injury to persons or property damage is described in the text of the note.

Labelling in compliance with the ISO 15223-1 standard.

Symbol for ‘Serial number’.

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Labelling in compliance with the ISO 15223-1 standard.

Symbol for ‘Product number’.

Labelling in compliance with the ISO 15223-1 standard.

Symbol for ‘Follow operating instructions’.

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Symbols Identification

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’.

Introduction

Disposal

Tab. 3: Symbols

1.3 Disposal

1.3.1 Packaging

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

1.3.2 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.

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 ‘Name and address of the manufacturer as well as date of manufacture’.

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Introduction

Overview of Oxyrator (REF 5752 5548)

1.4 Overview of Oxyrator (REF 5752 5548)

Fig. 1: Overview of Oxyrator

1 Valve cap 4 Cylinder cover 2 Pressure regulator 5 Cylinder jacket 3 Tube adapter 6 Cylinder trolley

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Overview of Oxyrator with aspirator (REF 5752 5549)

1.5 Overview of Oxyrator with aspirator (REF 5752 5549)

Introduction

Fig. 2: Overview of Oxyrator with aspirator

1 Valve cap 5 Gas-jet pump 2 Gauge of pressure regulator 6 Cylinder cover 3 Pressure regulator 7 Cylinder jacket 4 Fine regulator 8 Cylinder trolley

1.6 Basic requirements

1.6.1 Use in accordance with the intended purpose

This product is a medical device according to the Medical Devices Directive 93/42/EEC.

This product is to be used exclusively in human medicine.

Patients may be placed on the device and put in position only under the supervision of medical personnel.

Accessories

Accessories or combinations of accessories may be utilised only as and when indicated in these operating instructions.

Use other accessories, combinations and parts subject to wear only if these are intended expressly for the application and will not adversely affect performance features or safety requirements.

9 Aspiration set

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Introduction

Basic requirements

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

1.6.3 Treatment system as per Article 12

The product consists of several components which together comprise one treatment system as per Article 12 of the Medical Devices Directive 93/42/EEC (Paragraph 10 of the Medical Devices Act).

The Oxyrator consists of the following components:

• O2 pressure regulator with flowmeter (REF 5752 5543)

• Cylinder trolley for 10 or 11 litre oxygen cylinders (REF 5752 4675)

• Cylinder jacket for 10 or 11 litre oxygen cylinders, complete with valve cap and cylinder cover (REF 5752 4676).

The Oxyrator with aspirator consists of the following components:

• Pressure regulator with flowmeter and additional DIN coupling (REF 5752 5544)

• Cylinder trolley for 10 or 11 litre oxygen cylinders (REF 5752 4675)

• Cylinder jacket for 10 or 11 litre oxygen cylinders, complete with valve cap and cylinder cover (REF 5752 4676).

• 20 cm equipment rail with holder for cylinder trolley (REF 5752 4677)

• FINA fine regulator O2 (REF 5752 3705)

• Gas-jet pump O2 LF/HV (REF 5750 7540)

• Application set aspiration (REF 5752 4681)

All Oxyrator and Oxyrator with aspirator components may be reused after disinfection. Combined use with the Oxyrator is restricted exclusively to equipment or parts which have been approved by ATMOS for such use. The intended purposes and operating instructions of the application parts must be observed.

1.6.4 Intended purpose

Name: Oxyrator

Main function: Treatment system consisting of several components for

Medical indications / application:

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Oxyrator with aspirator

administration of oxygen, in addition, the Oxyrator with aspirator is suitable for bronchial aspiration

Supply of patients with medical oxygen if a central gas supply is not available (e.g. interhospital transport). The Oxyrator with aspirator also allows for the conversion of the oxygen into vacuum using the Venturi principle for bronchial aspiration.

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Introduction

Basic requirements

Specification of the main function:

User profile: Doctor, medically trained staff

Patient groups: Patients of all ages

Application organ: Outlet flowmeter: Lung

The Oxyrator and the Oxyrator with aspirator are treatment systems as per Article 12 of the Medical Devices Directive 93/42/EEC (Paragraph 10 of the Medical Devices Act).

The components are listed in the following chapter of this operating instructions.

The cylinder trolley provides a basis for a 10 or 11 l oxygen cylinder. A pressure reducer is connected to the oxygen cylinder and reduces the pressure to the usual pressure of central gas supply systems. An integrated flowmeter in the pressure reducer can be used for inhalation or insufflation of oxygen within the scope of oxygen enrichment for patients breathing by themselves. For the Oxyrator with aspirator the pressure reducer has an additional coupling DIN. In the coupling DIN a fine regulator oxygen can be inserted. A gas-jet pump can be connected to the outlet of the fine regulator, converting the oxygen into vacuum via the Venturi principle. The application set aspiration consists of a septic fluid jar with lid for bronchial aspiration. The permissible pressure in the oxygen cylinder is 200 bar.

Outlet coupling: No specific organ

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

Contraindications: The Oxyrator and Oxyrator with aspirator may not be used for the

following purposes:

• Outside the medical sector

• In MR areas

• For ultra-pure gases

• For corrosive, aggressive and toxic gases, acetylene, propane, butane and other flammable gases

• With a supply pressure higher than 200 bar

• The undosed supply of medical oxygen (connection of tapping units intended for this purpose is strictly necessary)

• When applying oxygen in its function as a medication, it is absolutely necessary to measure the flow rate

The product is: Active

Sterility: Not a sterile product

Single-use product / reprocessing:

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

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Introduction

Basic requirements

1.6.5 Interface description of Oxyrator

1.6.5.1 Oxygen cylinder

The oxygen cylinder is mounted to the carrying board with a clamp bracket and supplies oxygen to the emergency oxygen unit.

Technical specifications

• 10 or 11 l

• Cylinder diameter 140 mm

• Cylinder height approximately 1000 mm

• Weight maximum 16 kg

• 200 bar / 20000 kPa

• Connection DIN 477-1

1.6.5.2 Connection tube

The connection tube is used to connect the tube adapter on the flowmeter outlet of the pressure regulator to the inhalation mask.

Technical specifications

• Inner diameter 5 mm

Prerequisites

• The inner diameter of the connection tube should match the tube connector on the flowmeter outlet of the pressure regulator and the tube connector of the inhalation mask.

1.6.5.3 Bubble humidifier (REF 5752 5315)

The bubble humidifier can be integrated between the flowmeter outlet of the pressure regulator and the connection tube of the inhalation mask to humidify the oxygen. The bubble humidifier is connected to the flowmeter outlet of the pressure regulator. The connection tube to the inhalation mask is connected at the outlet of the bubble humidifier [ Page 17].

1.6.6 Interface description of Oxyrator with aspirator

1.6.6.1 Oxygen cylinder

The oxygen cylinder is mounted to the carrying board with a clamp bracket and supplies oxygen to the emergency oxygen unit.

Technical specifications

• 10 or 11 l

• Cylinder diameter 140 mm

• Cylinder height approximately 1000 mm

• Weight maximum 16 kg

• 200 bar / 20000 kPa

• Connection DIN 477-1

1.6.6.2 Vacuum connection tube

The vacuum connection tube is used to connect the tapping unit and the septic fluid jar.

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Technical specifications

• Shore hardness of 60

• Inner diameter 6 mm

• Length 50 cm (±10 cm)

• Vacuum resistant down to −95 kPa (may 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.

1.6.6.3 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 m to 3.0 m

• Vacuum resistant down to −95 kPa (may not collapse)

Introduction

Basic requirements

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.

1.6.6.4 Connection tube

The connection tube is used to connect the tube adapter on the flowmeter outlet of the pressure regulator to the inhalation mask.

Technical specifications

• Inner diameter 5 mm

Prerequisites

• The inner diameter of the connection tube should match the tube connector on the flowmeter outlet of the pressure regulator and the tube connector of the inhalation mask.

1.6.6.5 Bubble humidifier (REF 5752 5315)

The bubble humidifier can be integrated between the flowmeter outlet of the pressure regulator and the connection tube of the inhalation mask to humidify the oxygen. Instead of the tube adapter, the angled adapter (REF 5752 5606) is connected to the flowmeter outlet of the pressure regulator for this purpose. The bubble humidifier is connected at the outlet of the angled adapter, and the connection tube to the inhalation mask is connected at the outlet of the bubble humidifier [ page 21].

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Safety notes

Basic requirements

2 Safety notes

DANGER!

Danger to life! The undosed supply of gases is hazardous to the patient.

Use only tapping units with dosing systems.

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! Worn or damaged products or accessories can cause injuries.

Use only products and accessories which are in perfect condition.

CAUTION!

Observe ambient conditions! The precision, operation, mechanical stability and tightness of the product cannot

be guaranteed if the maximum upper and lower ambient temperatures are exceeded.

DANGER!

Danger to life! Danger due to improper configuration of the 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 the proper functionality and suitability of the connected accessories for each intended application prior to every use, in particular, connection parts, sealing properties and suitability with regard to material, work pressure and flow.

CAUTION!

Property damage! Danger of tipping if position is unstable!

Place the product on a firm, level surface. Operation is only permitted when the castors are in a locked position.

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3 Initial operation

3.1 General

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

Refer to the operating instructions of the cylinder trolley (REF 5752 4732) for information on how to assemble the cylinder trolley and the cylinder jacket.

NOTE

The oxygen cylinder is not included in the scope of delivery.

Initial operation

General

The scope of delivery includes the operating instructions as well as the ordered product version Oxyrator (REF 5752 5548) or Oxyrator with aspirator (REF 5752 5549) in line with the respective individual components.

Remove the product from its packaging and check the shipment for completeness and to ensure the scope of delivery is intact.

3.2 Connecting the pressure regulator

Mounting is described using the pressure regulator (REF 5752 5543) as an example.

 Remove the valve cap (1).

Fig. 3: Removing the valve cap

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Initial operation

Oxyrator (REF 5752 5548)

Connecting the pressure regulator

 Ensure that the pressure regulator is

closed.

 Plug the cap nut (1) of the pressure

regulator onto the thread of the connection valve (2) of the oxygen cylinder.

 Tighten the cap nut by hand.

 The pressure regulator is mounted.

Fig. 4: Connecting the pressure regulator

3.3 Oxyrator (REF 5752 5548)

3.3.1 Oxygen supply via tube adapter

Screwing on the tube adapter

 Screw the tube adapter (1) onto the tube

connector (2) of the pressure regulator.

Fig. 5: Screwing on the tube adapter

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Initial operation

Oxyrator (REF 5752 5548)

Connecting the connection tube

 Attach the connection tube (1) to the tube

adapter.

 Attach the other end of the connection tube

to the inhalation mask (2).

 Oxygen supply is functional.

Fig. 6: Connecting the connection tube

3.3.2 Connecting accessories (optional)

3.3.2.1 Connection of bubble humidifier (REF 5752 5315)

Connecting the bubble humidifier

 Ensure that the tube connector of the

bubble humidifier has two seals.

 Screw the bubble humidifier (1) directly to

the flowmeter outlet (2) and tighten fingertight as far as it will go.

 Attach the connection tube (3) to the tube

connector (4) of the bubble humidifier.

 Attach the other end of the connection tube

to the inhalation mask (5).

 Oxygen supply is functional.

 Pay attention that no tensile forces affect

the bubble humidifier.

Fig. 7: Connection of bubble humidifier

3.3.2.2 Connection of disposable humidifiers from other manufacturers

Disposable humidifiers may be connected to the flowmeter outlet. An angled adapter must be used for disposable humidifiers.

 Screw the disposable humidifier directly to the flowmeter outlet (2) and tighten finger-tight as

far as it will go.

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Initial operation

Oxyrator with aspirator (REF 5752 5549)

3.4 Oxyrator with aspirator (REF 5752 5549)

NOTE

Oxygen supply via tube adapter [ Page 16] or connecting accessories.

3.4.1 Connecting the fine regulator

Connecting the fine regulator

 Insert the fine regulator (1) into the DIN

coupling (2) on the pressure regulator.

Fig. 8: Connecting the fine regulator

3.4.2 Connecting the gas-jet pump

Connecting the gas-jet pump

 Fit the cap nut (1) of the gas-jet pump onto

the connection thread (2) of the fine regulator.

 Tighten the cap nut.

 The gas-jet pump is mounted.

Fig. 9: Connecting the gas-jet pump

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3.4.3 Mounting the tubes

NOTE

Use the hydrophobic bacterial and viral filter (REF 5752 2557) instead of the tube adapter (REF 5752 2295) to increase safety.

Initial operation

Oxyrator with aspirator (REF 5752 5549)

Mounting the tubes

 Fit the adapter (1) into the septic fluid jar

cap.

 Attach the connection tube (2) to the

adapter.

 Attach the other end of the connection tube

to the tube connector (3) on the gas-jet pump.

 Attach the suction tube (4) to the patient-

side tube connector (5) on the septic fluid jar cap.

 Aspiration set is functional.

Fig. 10: Mounting the tubes

3.4.4 Aspiration and oxygen therapy

3.4.4.1 Oxygen supply via tube adapter

Screwing on the tube adapter

 Screw the tube adapter (1) onto the tube

connector (2) of the pressure regulator.

Fig. 11: Screwing on the tube adapter

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Initial operation

Oxyrator with aspirator (REF 5752 5549)

Connecting the connection tube

 Attach the connection tube (1) to the tube

adapter.

 Attach the other end of the connection tube

to the inhalation mask (2).

 Oxygen supply is functional.

Fig. 12: Connecting the connection tube

3.4.4.2 Connecting accessories (optional)

Connection of bubble humidifier (REF 5752 5315)

Fig. 13: Connecting the angled adapter / adapter

for humidifier

Connection of angled adapter (REF 5752

5606) (optional)

 Ensure that the adapter for humidifier

contains a flat gasket.

 Screw the angled adapter (1) onto the tube

connector (2) of the pressure regulator.

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Initial operation

Oxyrator with aspirator (REF 5752 5549)

Connecting the bubble humidifier

 Ensure that the tube connector of the

bubble humidifier has two seals.

 Screw the bubble humidifier (1) directly to

the angled adapter (2) and tighten fingertight as far as it will go.

 Attach the connection tube (3) to the tube

connector (4) of the bubble humidifier.

 Attach the other end of the connection tube

to the inhalation mask (5).

 Oxygen supply is functional.

 Pay attention that no tensile forces affect

the bubble humidifier.

Fig. 14: Connecting the bubble humidifier

Connection of disposable humidifiers from other manufacturers

Disposable humidifiers may be connected to the flowmeter outlet. An angled adapter must be used for disposable humidifiers.

 Screw the disposable humidifier directly to the flowmeter outlet (2) and tighten finger-tight as

far as it will go.

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Operation

Function test

4 Operation

4.1 Function test

Prior to using the system, the operator must check that the product is fully functional and in good condition. Prior to each use, carry out the following functionality checks:

Pressure regulator

• State of manual tightening

• State of seal in cap nut

• Ease of movement at the connector threads (difficulty of movement is an indication of damage or soiling to the threads)

• Damage to supply tubes

• Airtightness

• Intact connection thread for accessories

NOTE

Unscrew manual tightening only after pressure has been fully released from the pressure regulator. First, close the valve on the oxygen cylinder; then release the pressure on the click-stop flowmeter.

Aspirator unit (only for Oxyrator with aspirator)

• Damage of seal rims of float in the overflow protection device

• Any cracks in septic fluid jar

• Splintering at the contact surfaces of the septic fluid jar

• Damage to seal of the septic fluid jar cap

• Cracked or hardened connection tubes

• State of seal in cap nut of gas-jet pump

• Free movement of fine regulator for gas-jet pump

Oxygen cylinder

• Sufficient filling level

4.2 Check the filling level of the oxygen cylinder

NOTE

Check airtightness of all accessory connections before beginning treatment. Manually retighten connecting nuts as necessary and readjust to the amount of oxygen required.

The duration of use in treatment depends on the filling level of the oxygen cylinder. The filling level may be checked as follows:

Cylinder pressure (kPa) * cylinder volume (V) / O2 dosage (l/min)

Example of calculation:

• Cylinder pressure = 200 kPa

• Cylinder volume = 10 l

• O2 dosage = 4 (l/min)

• 200 X 10 / 4 = 500 min

The cylinder contents will last for approximately 8 hours.

Checking the filling level

 Open the cylinder valve.

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 Set the hand wheel of the click-stop flowmeter at the pressure regulator.

 Check the gauge to see whether the cylinder contains sufficient oxygen for treatment.

4.3 Oxygen extraction

Operation

Oxygen extraction

Setting the flow

 Remove the valve cap.

 Set the hand wheel (1) of the click-stop

flowmeter to zero (2).

 Open the cylinder valve of the oxygen

cylinder and check whether the cylinder

contains sufficient content for treatment [ Page 22].

 Set the desired flow quantity on the hand

wheel.

 The arrow (3) on the pressure regulator

indicates flow quantity.

Fig. 15: Setting the flow

4.4 Setting the vacuum level (only for Oxyrator with aspirator)

NOTE

Check airtightness of all accessory connections before beginning treatment. Manually retighten connecting nuts as necessary and readjust to the amount of oxygen required.

Setting the vacuum level

 Close the control valve (1) on the fine

regulator.

 Open the cylinder valve of the oxygen

cylinder and check whether the cylinder contains sufficient content for treatment [ Page 22].

 Turn the control valve of the fine regulator

slowly one full rotation in an anticlockwise direction.

 Bend the suction tube (2).

 Set the suction rate required using the

control valve.

Fig. 16: Setting the vacuum level

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Taking the unit out of operation

Stopping oxygen extraction

5 Taking the unit out of operation

5.1 Stopping oxygen extraction

Closing the cylinder valve

 Remove the valve cap (1).

 Turn the hand wheel (2) of the cylinder

valve slowly in a clockwise direction.

 Cylinder valve is closed.

 Oxygen supply is interrupted.

Fig. 17: Closing the cylinder valve

Fig. 18: Closing the pressure regulator

5.2 Replacing the oxygen cylinder

NOTE

Releasing the pressure

 Set the hand wheel (1) of the click-stop

flowmeter to [15].

 Pressure is released.

Closing the pressure regulator

 Set the hand wheel (1) of the click-stop

flowmeter to [0].

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Taking the unit out of operation

Replacing the oxygen cylinder

 Release the pressure.

 Close the pressure regulator.

 Lock the brakes of the trolley castors.

 Unscrew the pressure regulator (1).

 Remove the cylinder cover (2).

Fig. 19: Replacing the oxygen cylinder

Fig. 20: Replacing the oxygen cylinder

 Remove the oxygen cylinder (3) from the

cylinder jacket.

 Insert a new oxygen cylinder into the

cylinder jacket and connect the pressure regulator.

 Put on the cylinder cover.

 Connect the pressure regulator.

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Taking the unit out of operation

Oxyrator with aspirator

5.3 Oxyrator with aspirator

5.3.1 Detaching tubes

Detaching tubes

 Remove the suction tube (1) from the

patient-side tube connector (5) on the septic fluid jar cap.

 Detach the adapter (2) and connection tube

(3) from the septic fluid jar cap.

 Remove the other end of the connection

tube from the connector (4) on the gas-jet pump.

Fig. 21: Detaching tubes

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6 Cleaning and disinfection

6.1 General

The product must be cleaned as well as wipe disinfected after every use. Perform visual and functional inspections after each cleaning and disinfection process. Please strictly observe the cleaning instructions in the operating instructions of the connected products.

DANGER!

Risk due to incorrect use of detergents and disinfectants!

It is strictly advised to observe the manufacturer’s instructions regarding how to use the detergents and disinfectants as well as to observe the valid hospital hygiene rules.

DANGER!

Infection hazard! Product may be contaminated.

Always wear gloves for cleaning and disinfection.

Cleaning and disinfection

General

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Maintenance

General

7 Maintenance

7.1 General

Maintenance, repairs and periodic tests may only be carried out by persons who have the appropriate technical knowledge and are familiar with the product. To carry out these measures, the person must have the necessary test devices and original spare parts.

ATMOS recommends: Work should be carried out by an authorised ATMOS service partner. This ensures that repairs and testing are carried out professionally, original spare parts are used and warranty claims remain unaffected.

WARNING!

Health hazard! The product is used in the treatment of patients. The product or some of its

components may be contaminated.

Clean and disinfect the product before maintenance and repair.

Repair work may be performed by personnel authorised by ATMOS.

7.2 Periodic tests

Observe the instructions for the individual components.

7.3 Visual and functional inspections

To ensure correct operation, it is necessary to have visual and functional inspections performed by a trained person prior to each use of the operating table.

Documentation of the results of the visual and functional inspections is recommend and should include the date and signature of the person who performed the inspections. The following table can be used as a template.

Suggestion:

No. Inspection Defects are present No defects

1 Has the product been cleaned

and disinfected according to the hygiene guideline?

Comment:

2 Is the product sealed?

 Do not use the product any



longer.

 Clean and disinfect the

product according to the guidelines.

 Do not use the product any



longer.



Comment:

3 Are there damages to

mechanical parts?

Comment:

GA 5752 5555 GB 05

 Do not use the product any



longer.

 Inform service personnel.



Page 29

Maintenance

Malfunctions and troubleshooting

No. Inspection Defects are present No defects

4 (Space for other tests)

Comment:

Tab. 4: Visual and functional inspections

7.4 Malfunctions and troubleshooting

Defect Source of malfunction Troubleshooting

The maximum vacuum level

of −80 kPa cannot be

reached. No or reduced flow rate.

Cylinder pressure gauge is not working

No pressure available Check the contents of the oxygen

Gas-jet pump is defective Contact technical service

Oxygen cylinder is empty Replace the oxygen cylinder

 

cylinder; if necessary, replace the oxygen cylinder

Fit the fine regulator correctly

Open the oxygen cylinder

Open the fine regulator

No or only little oxygen released

Tab. 5: Troubleshooting

7.5 Repairs

The following issues may require repairs by the manufacturer or an authorised service partner:

• Liquid has penetrated the device.

• The performance has significantly decreased.

• Inexplicable notifications appear.

• Abnormal noises occur.

• Functional faults cannot be rectified according to the measures in chapter Malfunctions and troubleshooting [ page 29].

Oxygen cylinder is not open Open the oxygen cylinder

Pressure regulator is defective

No oxygen pressure Check the contents of the oxygen

Incorrect gauge display Have reducing valve and gauge

Clogged flowmeter Contact technical service

Leaking manual tightening Replace the tapping unit

Leaking or contaminated accessories

Contact technical service

cylinder; if necessary, replace the oxygen cylinder

of the gas-jet pump checked; if necessary, replace tapping unit

Replace or clean accessories

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Maintenance

Service hotline

If defects are detected, the product may not be used any longer.

Make a note of the deficiencies and the REF number on the data plate and inform your responsible ATMOS representative.

Observe the information in chapter Foreword [ page 5].

7.6 Service hotline

+49 7653 689-0

7.7 Sending in the device

 Remove and properly dispose of consumables.

 Clean and disinfect the product and accessories according to the operating instructions.

 Place used accessories with the product.

 Fill in the form QD 434 ‘Delivery complaint / return shipment’ and the respective

decontamination certificate.

This form is enclosed with each delivery and can be found at www.atmosmed.com.

 The device must be well padded and packed in suitable packaging.

 Place the form QD 434 ‘Delivery complaint / return shipment’ and the respective

decontamination certificate in an envelope.

 Affix the envelope to the outside of the package.

 Send the product to ATMOS or to your dealer.

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8 Technical specifications

8.1 Ambient conditions

Temperature: Shipping / storage −20 °C to +60 °C

Temperature: Operation −20 °C to +60 °C

Relative humidity: Shipping / storage 10% to 95%

Relative humidity: Operation 10% to 95%

Atmospheric pressure: Shipping / storage 700 hPa to 1060 hPa

Atmospheric pressure: Operation 700 hPa to 1060 hPa

8.2 Technical specifications

Observe the instructions for the individual components in the respective operating instructions.

Technical specifications

Ambient conditions

8.3 Dimensions and weights

Dimensions (L x W x H) 610 x 610 x 1170 mm

Weight Oxyrator (without oxygen cylinder) Approximately 11 kg

Weight Oxyrator with aspirator (without oxygen cylinder) Approximately 12 kg

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Approved accessories

Accessories

9 Approved accessories

The following accessories are not part of the scope of delivery and must be ordered separately:

9.1 Accessories

5752 5606 Angled adapter UNF 9/16"

5752 5315 Bubble humidifier

Tab. 6: Accessories

9.2 Consumables

5750 5045 Hydrophobic bacterial filter paper (100 pieces)

5752 2557 Hydrophobic bacterial and viral filter (pore size 1 μm)

000.0347.0 Fingertip

006.0009.0 Suction tube, silicone, Ø 6 mm, 1 m

Tab. 7: Consumables

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Page 33

Notes

Page 34

Notes

Page 35

Notes

Page 36

Manufacturer:

ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch GERMANY Phone: +49 7653 689-0 www.atmosmed.com