AIRcon Gen2 User Manual and Technical Description Ver 1.3 Sept 2017 PDF download

EN

AIRcon Gen2 Respiratory Humidifier User manual and technical description www.wilamed.com

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Content 1. 2.

3. 4.

5.

6. 7.

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Intended use�� 4 Warnings, Cautions and Guidelines � �� 5 2.1 Warnings � �� 5 2.2 Precautions�� 7 2.3 Guidelines�� 8 Side effects / Contraindications�� 9 Basic equipment and resources needed�� 10 4.1 Delivery�� 10 4.2 Consumables � �� 11 Installation and commissioning� �� 12 5.1 Connecting components�� 12 5.2 Installation / Mounting the base unit � �� 13 5.3 Installing the humidification chamber�� 13 5.4 Connecting the breathing tube system�� 15 5.5 Turning on the base unit�� 18 5.6 Turning off the base unit � �� 19 Operation�� 20 6.1 Display in normal mode�� 20 Function buttons � �� 21 7.1 Operation in normal mode� �� 21 7.1.1 Reset to factory settings�� 22 7.1.2 Treatment interruption�� 22 7.2 Operation in edit mode�� 22 7.2.1 Reducing condensation in the inspiration tube�� 23 7.2.2 Adjusting humidity�� 23 7.2.3 Reducing condensation in the expiration tube�� 23 7.3 Operation in configuration mode� �� 24 7.3.1 Operating mode�� 25 7.3.2 Respiratory flow ranges�� 26 7.3.3 Adjusting temperatures� �� 26 7.3.4 Adjusting humidification capacity�� 27 7.3.5 Adjusting water fill level detection�� 27

7.4

8.

9. 10. 11. 12. 13. 14. 15.

Operation in alarm mode�� 28 7.4.1 Alarm muting�� 28 7.4.2 Alarm delaying � �� 28 7.4.3 Warm-up time � �� 29 7.4.4 Impact on the performance�� 29 7.4.5 Event list � �� 29 Alarms�� 30 8.1 Inspiration heating missing/defective � �� 30 8.2 Expiration heating missing/defective� �� 30 8.3 Breathing gas temperature too high � �� 31 8.4 Breathing gas temperature too low�� 31 8.5 Humidifier chamber temperature too high�� 31 8.6 Humidifier chamber temperature too low� �� 32 8.7 Temperature probe missing/defective�� 32 8.8 Chamber temperature probe missing/defective�� 33 8.9 Patient temperature probe missing/defective�� 33 8.10 Temperature probe cable defective�� 33 8.11 Heating plate sensor defective�� 34 8.12 Humidification chamber missing � �� 34 8.13 Water fill level too low � �� 34 8.14 Water fill level too high� �� 35 8.15 HW alarm�� 35 8.16 Forced shutdown of the heating wire and the heating plate� �� 36 8.17 Initialization error�� 36 Weekly cleaning � �� 37 Maintenance�� 37 Legend � �� 38 Technical specifications � �� 40 Storage and disposal�� 42 Supplement to the technical description�� 43 EMC proof�� 43

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1. Intended use AIRcon Gen2 respiratory gas humidifier is a device for heating and humidifying respiratory gases, such as medical oxygen and/or compressed air or else room air during mechanical ventilation or respiratory therapy in both the clinical and home care environments. AIRcon Gen2 can be used for invasive as well as noninvasive ventilation/ respiratory therapy for adults, children and newborn babies. This device may only be operated by trained personnel. User training will be provided by WILAmed or WILAmed authorized agents. AIRcon Gen2 is always positioned between therapy device and patient. A breathing tube system and a humidifier chamber are always necessary for this connection. This breathing tube system must be matched beforehand to the therapy device being used, to the medical indication and to the respective patient group.

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Connect AIRcon Gen2 with approved therapy devices (such as ventilators, bilevel devices, CPAP devices, etc.) only if patient/user safety and the environment are not impaired. The user must make sure that the combination is safe. If in doubt, the manufacturer must be contacted. Respiratory gas is passed from the therapy device or oxygen source to the humidifier chamber, where it is heated, humidified with water vapor and then passed via the inspiratory tube to the patient. Three different basic modes and the freely adjustable temperatures at the outlet of the humidifier chamber as well as the patient's proximity make it possible to adjust or regulate the moisture output for each application. AIRcon Gen2 respiratory gas humidifier is not suitable or intended for atomization of medications.

2. Warnings, Cautions and Guidelines 2.1 Warnings Warnings are indicated by the term WARNING. Warnings alert the user when potentially serious consequences for the patient or the user may occur, which can lead to injury with negative consequences including death. WARNING Before the patient is connected to the breathing tube system, a check must be made to ensure the breathing gas is flowing unimpeded through the breathing tube system. WARNING To avoid penetration of any condensate in the breathing tube system and its flow to the patient, the humidifier should be positioned below the actual level of the patient. WARNING Risk of burns! Under continuous operation, the heating plate and the humidifier chamber can reach temperatures of over 85°C. Before removing the humidification chamber from the respiratory humidifier, the humidification chamber must be allowed to cool down sufficiently.

WARNING The temperature sensor must be inserted in such a way that the temperature of the respiratory gas is measured in the middle of the breathing tube. Failure to observe this requirement may result in the temperature of the supplied respiratory gas exceeding the critical temperature of 43°C. WARNING Do not cover the heated breathing tube system with any insulating material, such as towels or blankets or other materials, because the filament inside the tube will then become overheated at the covered spot. This can lead to deformation of the breathing tube, to the point of melting through. WARNING The AIRcon Gen2 respiratory humidifier can be connected to all conventional respirators/therapy devices, provided it is ensured that no danger can occur to the patient, user or environment due to the connection.

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WARNING Risk of burns! The heated breathing tube system must not touch the patient's skin.

WARNING It is important to note that the environmental conditions change after opening a window.

WARNING The use of this device directly next to other devices or with other devices in stacked form should be avoided, as this could result in a faulty operation. If it is nevertheless necessary to use it in that manner, this device and the other devices should be monitored to ensure that they are working properly.

WARNING Children and pets are to be supervised during operation of the AIRcon Gen2 respiratory humidifier.

WARNING The use of accessories, transformers or lines other than those specified or provided by the manufacturer of your device may result in increased electromagnetic noise emissions or impaired resistance of the device to electromagnetic interference, and result in faulty operation. WARNING This device may not be altered without the permission of the manufacturer. WARNING The AIRcon Gen2 respiratory humidifier should not be operated near radiators and other heat sources. Sunlight and bright light sources must be avoided.

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WARNING When used properly, the heating plate and the chamber become hot. WARNING The humidity output capacity can be affected if the device is operated outside the specified ambient temperature or ambient humidity range. WARNING Portable RF communication devices (radio devices) (including their accessories such as antenna cable and external antennas) should not be used at a distance of less than 30cm (or 12 inches) from the AIRcon Gen2 parts and lines specified by the manufacturer. Failure to comply may result in a reduction in the performance characteristics of the device.

WARNING Before use, the instructions in this user manual and those for the respective accessory are to be followed! WARNING This device may only be operated by trained personnel. User training will be provided by WILAmed or WILAmed authorized agents. WARNING The USB interface may be used only for service purposes. WARNING Temperatures in operation differ from the storage and transport temperatures. The AIRcon Gen2 may only be operated at an ambient temperature of 18°C to 26°C. WARNING If the device is stored or transported at an ambient temperature of -25°C or +70°C, then the device must be acclimatized prior to operation at an ambient temperature of 18°C to 26°C for 30 minutes. WARNING Small parts can be swallowed.

2.2 Precautions Precautions are indicated by the term CAUTION. Precautionary measures warn the user of special precautions to ensure safe and effective use of the AIRcon Gen2 respiratory humidifier. CAUTION To avoid overheating, a breathing gas flow of at least 2l/min is constantly required in the breathing tube system. If the breathing gas supply is interrupted, the device must be turned off. For applications that require the patient's separation from the humidifier, the device needs to be switched to "treatment interruption" mode. CAUTION The water used to fill the humidification chamber must not be warmer than the ambient temperature! CAUTION Before any maintenance, inspection or repair work, the device must be disconnected from the mains. CAUTION Any intervention in the device – including maintenance and testing – must be performed by trained service technicians in accordance with the applicable legal provisions. For details, please refer to the supplementary 7

technical description and maintenance and service instructions. CAUTION Do not immerse the base unit or its accessories in liquids or sterilize them! Detailed instructions for cleaning and maintaining the device are included in the sections on maintenance and cleaning. CAUTION Before each use, check that the base unit, the supplied system parts and the accessories used are free from defects. If the AIRcon Gen2 respiratory humidifier is defective or damaged, it must not be used. In addition, in this situation, please notify the hospital maintenance technician or the customer service department. Remove the damaged system components and do not use them! CAUTION Determination of operational shutoff may only be given by a physician or his/ her authorized representatives. CAUTION This user manual does not replace the physician's instructions or the official instructions for appropriate care of the patient. These medical and official instructions take precedence over this user manual. 8

2.3 Guidelines Guidelines are indicated by the term NOTE. Guidelines contain important information that should be respected. NOTE A change in the room climate (for example, heating, ventilation) or the entry of new ventilation parameters can lead to increased condensation present in the breathing tube system. NOTE The AIRcon Gen2 respiratory humidifier and the humidification chamber are not inhalers and neither suitable nor intended for administering drugs, medicinal substances or human blood derivatives. NOTE Portable and mobile RF communications equipment (such as mobile phones) can affect the AIRcon Gen2 respiratory humidifier. Further details are included in the manufacturer's EMC declaration in the Appendix. NOTE If problems occur during commissioning, use or, where applicable, maintenance or if there is an unexpected operation or incident, the representative is to be contacted.

NOTE The expected service life of the device is limited to 8 years. NOTE Its operation in a potentially explosive and oxygen-rich environment is not allowed. NOTE The abbreviation "(i)" means inspiratory the abbreviation "(e)" means expiratory NOTE During warming-up period (ca. 30min.) of the humidifier, an activation of the therapy-pause-function (chapter 7.1.2) is not possible.

NOTE Only WILAmed approved accessories and consumables may be used. Accessories and consumables from third parties may affect the safety of the device NOTE The AIRcon Gen2 respiratory humidifier must be set up and taken into operation as described in the user manual. NOTE The expected operational life of the accessories is included in the user instructions for the accessories. NOTE The AIRcon respiratory humidifier is suitable for reuse. Before each reuse following a change of patient, cleaning and disinfection must be performed according to section 9!

3. Side effects / Contraindications There are no known adverse side effects.

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4. Basic equipment and resources needed 4.1 Delivery { {Basic device AIRcon Gen2

{ {Power cord (country-specific)

(230V 101200, 115V 101201)

{ {User instructions (country-specific)

{ {Heating wire distributor cable

{ {Quick Start guide (country-specific)

((i) 100942 or (i+e) 100929) {{ Temperature probe

(160cm 100910 or 180cm 100909)

Basic device

Mains cable

Heating wire distributor cable (i) (100942)

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Heating wire distributor

Temperature probe

cable (i+e) (100929)

(160cm 100910)

(180cm 100909)

4.2 Consumables

1

Article number

Accessory

270678

BTS3167A - WILAmed ventilation system with heating (inspiratory + expiratory) for adults (22mm ID) length approx. 150cm with connecting tube 60cm and auto-refill humidification chamber

270745

BTS1154A_double_tube_system for Intensa 10mm 120cm heated (i+e) humidification chamber

500186

WILAqua, sterile water 1000ml bottle

500350

WILAmed C220R humidifier chamber, autoclavable

2

3

4

5

6

7

8

A

B

C

D

BTS3167A (270678)

The information in this drawing are the sole property of WILAmed GmbH. Any reproduction in detail or as a whole without the written permission of WILAmed GmbH is prohibited.

Depending on the specific instance, other accessories are necessary and available from WILAmed. For a complete list of all accessories available, please contact the manufacturer. Examples of accessories and consumables are listed in the following table.

1

3

4

5

B

C

D

BTS1154A (270745)

E

BEZEICHNUNG:

Symboldarstellung BTS1154A_Doppelschlauchsystem für Intensa 10mm 120cm beheizt (i+e) Befeuchterkammer Muster Version 09

E Die Informationen in dieser Zeichnung sind das alleinige Eigentum der WILAmed GmbH. Jede Reproduktion in einem Detail oder als Ganzes ohne schriftliche Genehmigung der WILAmed GmbH ist untersagt.

Symboldarstellung BTS3167A - WILAmed Beatmungssystem mit Heizung (insp. + exsp.) für Erwachsene (22 mm ID) Muster Länge ca. 150 cm mit Verbindungsschlauch 60 cm Version 04 und Auto-Refill Befeuchterkammer

2

3

WILAmed GmbH

ZEICHNUNGSNR.:

Aurachhöhe 5-7 , 91126 Kammerstein

4

5

WILAqua (500186)

6

7

270678

A3

8

B

F

1

7

A

BEZEICHNUNG:

Die Informationen in dieser Zeichnung sind das alleinige Eigentum der WILAmed GmbH. Jede Reproduktion in einem Detail oder als Ganzes ohne schriftliche Genehmigung der WILAmed GmbH ist untersagt.

6

A

E

F

2

A

F

1

2

3

WILAmed GmbH

ZEICHNUNGSNR.:

Aurachhöhe 5-7 , 91126 Kammerstein

4

5

6

7

270745 -

A3

F

8

Breathing tube system must be compatible with the treatment device used.

NOTE Only WILAmed-approved consumables may be used. Consumables from third party providers may affect the safety of the device. 11

5. Installation and commissioning 5.1 Connecting components The power cord is inserted under the machine.

Mains cable

USB port for service

Connect the power cord to an AC outlet or power strip with the permitted voltage. The connections for the heating wire distributor cable for heating and for the temperature sensor are mounted laterally on the device. These connectors are colored and mechanically coded, being marked with appropriate symbols.

When using a heated breathing tube system, the plug of the heating wire distributor cable is connected with the yellow connector ). The plug of the heated breathing tube system is similarly color-marked (green) and mechanically coded. To use the temperature probe, the plug of the temperature probe is connected with the blue connector ).

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5.2 Installation / Mounting the base unit

5.3 Installing the humidification chamber

The AIRcon Gen2 is equipped with housing feet and can be placed on a flat, solid and level surface. Alternatively, the device can be suspended with the rear retaining tab on a suitable hook.

Unpack the humidification chamber with automatic refill device (for example, C200AF universal) and check it before use for any visible damage. Closing caps

Plug

Attention: Use only fault-free humidification chambers. Attention: Take the device into operation only with the chamber. Attention: Follow the user instructions for the respective humidification chamber! Unreel the plug to connect the water bag, pull off colored caps and dispose of appropriately.

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Connect the therapy device output with the humidification chamber input - marked with the inscription "IN"; connect the breathing tube (e.g. breathing system 271678) to the patient with the humidification chamber output - marked with the imprint "OUT". The humidification chamber should be oriented so that the and the breathing tube system is not convoluted.

Front flap

and thereafter fix under the movable mounting bracket, which can be pulled back until the bracket audibly clicks into place.

OUT

IN Mounting bracket

First push the bottom edge of the humidification chamber under the front flap on the base device

Full-surface heat transfer from the heating plate is only ensured if the humidification chamber is used correctly. Instruction: When changing the chamber, do not touch the heating plate!

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5.4 Connecting the breathing tube system

probe can be fixed in the corresponding hook of the hose brackets.

The T- ensor of the temperature probe must be in the opening of the angle connector,

The green coupling of the heating wire power supply is always connected to the green heating wire plug of the inspiration hose. Heating wire plug

T sensor in the opening of the angle connector

and the sensor at the end of the cable must be inserted into the patient-side opening at the end of the breathing tube system.

The basic device AIRcon Gen2 is only ready to operate if the inspiration heating wire is connected.

Both sensors must be firmly and securely inserted in the respective opening. The cable of the temperature

If the breathing tube system used is equipped with a heated expiration tube, the white coupling of the heating wire power supply is always connected with the white heating filament plug of the expiration tube. 15

Heating wire plug

White coupling

Seal plates

Lines must be routed in such a way that no-one can become tangled up in them. Rubber membrane

Instruction: Tube clamps and tube retaining brackets are to be used. It is recommended to use sterile water. However, other water can also be used, as instructed by the physician. However, this water must not contain any mineral additives or drugs. To ensure the automatic refill device functions, the container with the water (e.g. WILAqua 500186) is suspended at least 0.5 m above the humidifier, after which the seal plate on the bottle neck of the container is removed

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and the perforator of the connector instrument is inserted into the rubber membrane.

Perforator

For water bottles, the blue vent cap on the perforator must be opened. Venting cap

Before the patient is connected to the breathing tube system, make sure that the treatment device is working properly, that the treatment parameters are set correctly and that the breathing gas is flowing freely in the breathing tube system. The following figure shows the schematic set-up of the device.

The water gradually fills the humidification chamber and maintains a constant level.

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5.5 Turning on the base unit

to factory settings is described under "7.1 Operation in normal mode".

The humidifier is only to be turned on, using the lateral main switch, when the breathing tube system, the humidification chamber and the water reservoir are connected, plugged and punctured correctly.

After switching on, the device first displays the product model and version and performs a self-test. During this initialization, no entries are possible. NOTE The version number of the software is for illustration and may differ from the actual version.

WILAmed AIRcon 2 NOTE The AIRcon Gen2 respiratory humidifier saves the last setting and uses it for a restart (e.g. after power failure). NOTE After switching on, the warm-up phase lasts for no more than 30 minutes. After switching on, the heating and the water vapor saturation of the respiratory gas is steadily increased until an optimum value is reached. Resetting the device 18

Version 1.3.2 84 h

After initialization, the operating display appears.

39.0°C 37.0°C IV EXP.

5.6 Turning off the base unit The respiratory humidifier can be turned off with the power switch after the end of treatment. After switching off, the device should cool down for at least 30 minutes before it is dismantled, packed or transported, since the heating plate will still be hot.

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6. Operation 6.1 Display in normal mode

Symbol indicates that the service interval has expired.

Setpoint temperature on patient outlet and the chamber. By pressing the <+> or <-> button, the actual temperature at the patient outlet and the chamber is briefly displayed.

39.0°C 37.0°C IV

Humidification capacity setting in the humidifier chamber, in three stages.

Expiratory heating power (only by heated double limb circuits)

Symbol indicates that the device is in treatment interruption.

EXP.

Timer symbol indicates that the device is still in warming-up phase, i.e. alarms are ignored. More information can be found under section 7.4.3.

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Display for the currently set mode(IV, NIV, FREE)