Wilamed Aircon gen2 Parts list manual

EN

0197

AIRcon Gen2

Respiratory

Humidifier

User manual and

technical description

www.wilamed.com

2

Content

1. Intended use �� 4

2. Warnings, Cautions and Guidelines �� 5

2�1 Warnings�� 5

2�2 Precautions �� 7

2�3 Guidelines �� 8

3. Side effects / Contraindications �� 9

4. Basic equipment and resources needed�� 10

4�1 Delivery �� 10

4�2 Consumables�� 11

5. 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

6. Operation�� 20

6�1 Display in normal mode �� 20

7. 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

3

7�4 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

8. 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

9. Weekly cleaning�� 37

10. Maintenance �� 37

11. Legend�� 38

12. Technical specifications�� 40

13. Storage and disposal �� 42

14. Supplement to the technical description �� 43

15. EMC proof �� 43

4

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�

Connect AIRcon Gen2 with approved

therapy devices (such as ventilators,

bilevel devices, CPAP devices, etc�) only

if patient/user safety and the environ-

ment 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�

5

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�

6

WARNING

Risk of burns!

The heated breathing tube system must

not touch the patient's skin�

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

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�

WARNING

It is important to note that the

environmental conditions change after

opening a window�

WARNING

Children and pets are to be supervised

during operation of the AIRcon Gen2

respiratory humidifier�

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�

7

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

8

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�

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�

9

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�

10

4. Basic equipment and

resources needed

4.1 Delivery

 Basic device AIRcon Gen2

(230V 101200, 115V 101201)

 Heating wire distributor cable

((i) 100942 or (i+e) 100929)

 Temperature probe

(160cm 100910 or 180cm 100909)

 Power cord (country-specific)

 User instructions (country-specific)

 Quick Start guide (country-specific)

Mains cableBasic device

Temperature probe

(160cm 100910)

Heating wire distributor

cable (i) (100942)

Temperature probe

(180cm 100909)

Heating wire distributor

cable (i+e) (100929)

D

E

F

C

1

2 3

4

B

A

32

1

5

C

D

4

6

7 8

A

B

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.

87

6

F

E

WILAmed

GmbH

Aurachhöhe 5-7 , 91126 Kammerstein

BEZEICHNUNG:

ZEICHNUNGSNR.:

A3

270678

BTS3167A - WILAmed Beatmungssystem mit

Heizung (insp. + exsp.) für Erwachsene (22 mm ID)

Länge ca. 150 cm mit Verbindungsschlauch 60 cm

und Auto-Refill Befeuchterkammer

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.

5

Symboldarstellung

Muster

Version 04

D

E

F

C

1

2 3

4

B

A

32

1

5

C

D

4

6

7 8

A

B

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.

87

6

F

E

-

WILAmed

GmbH

Aurachhöhe 5-7 , 91126 Kammerstein

BEZEICHNUNG:

ZEICHNUNGSNR.:

A3

270745

BTS1154A_Doppelschlauchsystem für Intensa

10mm 120cm beheizt (i+e) Befeuchterkammer

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.

5

Symboldarstellung

Muster

Version 09

11

4.2 Consumables

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�

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

BTS1154A (270745)

WILAqua (500186)

BTS3167A (270678)

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�

12

5. Installation and commissioning

5.1 Connecting components

The power cord is inserted under the machine�

USB port for serviceMains cable

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 )�

13

5.2 Installation /

Mounting the base unit

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�

5.3 Installing the

humidification chamber

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�

14

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�

OUT IN

First push the bottom edge of the

humidification chamber under the front

flap on the base device

Front flap

and thereafter fix under the movable

mounting bracket, which can be pulled

back until the bracket audibly clicks

into place�

Mounting bracket

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!

15

5.4 Connecting the

breathing tube system

The T- ensor of the temperature probe

must be in the opening of the angle

connector,

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�

Both sensors must be firmly and

securely inserted in the respective

opening� The cable of the temperature

probe can be fixed in the corresponding

hook of the hose brackets�

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

The basic device AIRcon Gen2 is only

ready to operate if the inspiration

heating wire is connected�

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�

16

Heating wire plug White coupling

Lines must be routed in such a way

that no-one can become tangled up in

them�

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

Seal plates

Rubber membrane

and the perforator of the connector

instrument is inserted into the rubber

membrane�

17

Perforator

For water bottles, the blue vent cap on

the perforator must be opened�

Venting cap

The water gradually fills the

humidification chamber and maintains

a constant level�

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�

18

5.5 Turning on the base

unit

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�

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

to factory settings is described under

"7�1 Operation in normal mode"�

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

Version 1.3.2

84 h

19

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�

20

6. Operation

6.1 Display in normal mode

Symbol indicates that

the device is in

treatment interruption�

Symbol indicates that the

service interval has expired�

Display for the

currently set

mode(IV, NIV, FREE)

Humidification capacity

setting in the humidifier

chamber, in three stages�

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�

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�

Expiratory heating

power (only by heated

double limb circuits)

39.0°C

37.0°C

IV

EXP.

WILAmed AIRcon Gen2 Parts list manual

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