Breas HA 20 Manuale utente
Doc. 004949 En-EU Z-1b
User Manual for
Breas
HA 20 Humidifier
2
Breas HA 20 Humidifier User Manual Doc. 004949 En-EU Z-1b
Table of Contents
1 Intended use of the HA 20 Humidifier ........................................................................... 3
1.1 What is the HA 20 Humidifier?.......................................................................... 3
1.2 Indications for Use ............................................................................................ 3
1.3 Contraindications .............................................................................................. 4
1.4 About this Manual ............................................................................................. 4
2 Safety Information........................................................................................................... 5
2.1 General User Precautions ............................................................................... 5
2.2 Electrical Safety ............................................................................................... 6
2.3 Environmental Conditions ................................................................................ 6
2.4 Cleaning and Maintenance .............................................................................. 7
3 Product Description......................................................................................................... 8
3.1 Components ..................................................................................................... 8
3.2 Equipment Designation and Safety Label ...................................................... 10
4 Installing the HA 20 Heating Unit .................................................................................. 11
5 Using the HA 20 Humidifier........................................................................................... 13
5.1 Adding Water to the HA 20 Water Chamber ................................................... 13
6 Setting up the HA 20 Humidifier.................................................................................... 15
7 Cleaning........................................................................................................................ 16
7.1 Cleaning and Disinfecting the HA 20 Water Chamber .................................... 16
7.2 Cleaning the HA 20 Heating Unit .................................................................... 18
7.3 Change of Patient ........................................................................................... 18
8 Maintenance ................................................................................................................. 19
8.1 Storage............................................................................................................ 19
8.2 Disposal .......................................................................................................... 19
8.3 Troubleshooting .............................................................................................. 20
9 Technical Specifications ................................................................................................ 22
9.1 Data ......................................................................................................... 22
9.2 Compliance of Standards ............................................................................... 24
3Intended use of the HA 20 Humidifier
Breas HA 20 Humidifier User Manual
Doc. 004949 En-EU Z-1b
1 Intended use of the HA 20 Humidifier
1.1 What is the HA 20 Humidifier?
The Breas HA 20 is an integrated humidifier intended to increase the breathing
comfort for patients using Breas breathing therapy equipment. It is connected
to the Breas iSleep or Vivo device through a smooth click-on design.
Under normal conditions, the nose and the airways keep the air we breathe in
sufficiently humid. When using a CPAP device or ventilator, the normal humid-
ification may not be sufficient. When the air you breathe in is too dry, you may
suffer from dryness of the nose, throat or mouth, and from mucus build up,
which in turn may cause pain, irritation or infection. Humidified air may relieve
these symptoms of dry airways.
1.2 Indications for Use
The HA 20 Humidifier is intended to humidify the patient air during breathing
therapy. It is intended for non-invasive use only.
The HA 20 Humidifier can only be used together with the following breathing
therapy equipment:
• Breas CPAP devices: iSleep 20, iSleep 20+, iSleep 20i, iSleep 22, and
iSleep 25
• Breas Bilevel ventilators: Vivo 30 and Vivo 40
It must always be prescribed by a licensed physician.
• Read this manual thoroughly so that you completely understand
how the HA 20 Humidifier is operated and maintained before tak-
ing it into use, to ensure correct usage, maximum performance
and serviceability.
• Also read the Breas breathing therapy equipment manual, before
you install the HA 20 Humidifier.
Breas Medical AB reserves the right to make changes to this product
without any prior notification.
For complete instructions on how to set up the humidifier, refer to the Breas breath-
ing therapy equipment manual.
4 Intended use of the HA 20 Humidifier
Breas HA 20 Humidifier User Manual Doc. 004949 En-EU Z-1b
1.3 Contraindications
The HA 20 Humidifier must not be used with patients whose supraglottic air-
ways have been bypassed.
1.4 About this Manual
Icons
In this manual, icons are used to highlight specific information. The meaning of
each icon is explained in the table below.
Refer to the Breas breathing therapy equipment manual for a complete list of con-
traindications associated with breathing therapy.
ICON EXPLANATION
Warning!
Risk of serious personal injury.
Caution!
Risk of minor or moderate injury. Risk of equipment damage,
loss of data, extra work, or unexpected results.
Note
Information that may be valuable but is not of critical impor-
tance, tips.
Reference
Reference to other manuals with additional information on a
specific topic.
5Safety Information
Breas HA 20 Humidifier User Manual
Doc. 004949 En-EU Z-1b
2 Safety Information
2.1 General User Precautions
• The HA 20 Humidifier must only be used:
– for the intended treatment in accordance with this manual and with the
instructions given by the responsible clinical personnel;
– in accordance with the operating conditions specified in this manual;
– in original and unmodified shape and only with accessories specified or
approved by Breas Medical AB.
• Do not use the HA 20 Humidifier if the patient’s upper (supraglottic) air-
ways have been bypassed.
• Never operate the HA 20 Humidifier if it is not working properly, if any
part of the humidifier has been dropped or damaged, or the heating unit
has been submerged in water. In the event of suspected damage to the
HA 20 Humidifier, do not use the humidifier and contact the responsible
care provider or service provider for an inspection.
• The installed HA 20 Humidifier must be located below the patient and on
a flat surface. This is to prevent personal injury from accidental spillage or
from excess water or condensation flowing down the patient tube and into
the patient’s mask. Extra cautions should be taken for patients who are una-
ble to guard their airways or cannot pull off the mask.
• Periodically check for moisture in the patient circuit. When present,
remove the moisture. Before attempting to dry the circuit, disconnect it
from the HA 20 Humidifier to ensure no water back-flow into the humid-
ifier. The frequency at which these checks must be performed will depend
on the patient’s own condition and the device used. This should be assessed
on an individual basis in accordance with the patient’s needs.
• If the condensation in the patient circuit is excessive, the use of a heated
humidifier may require the installation of a water trap in the circuit. The
water trap prevents any condensation in the patient circuit from running
into the patient airways and causing personal injury.
• Do not connect any filter to the HA 20 Humidifier.
6 Safety Information
Breas HA 20 Humidifier User Manual Doc. 004949 En-EU Z-1b
2.2 Electrical Safety
2.3 Environmental Conditions
• Handle the HA 20 Humidifier with care.
• To avoid burn injury, be careful not to touch the heater plate or the heated
water in the water chamber when the HA 20 Humidifier is switched on or
has not yet cooled down. Wait ten minutes for the heater plate and water to
cool.
• Before transportation of the Breas breathing therapy equipment with the
installed HA 20 Humidifier, always disconnect the water chamber from the
heating unit.
• Do not place the Breas breathing therapy equipment with the HA 20
Humidifier in a bag when the water chamber is attached.
• Do not use aromatic additives (such as scented oil or perfume) with the
water, as the may reduce the humidification effect and cause deterioration
of the water chamber.
When handling the HA 20 heating unit, always turn off and disconnect
the Breas breathing therapy equipment from any power source.
• The performance of the HA 20 Humidifier may deteriorate at:
– ambient temperatures below 5°C (41°F) and above 40°C (104°F).
– ambient relative humidity below 10% RH (room humidity) and above
95% RH.
– atmosphere pressure below 700 mbar and above 1060 mbar. At normal
atmospheric pressure, 700 mbar =~3000 metres above sea level,
1060 mbar = ~375 metres below sea level.
• The HA 20 heating unit, water chamber and any replaced parts must be dis-
posed of in accordance with the local environmental regulations regarding
the disposal of used equipment and waste.
7Safety Information
Breas HA 20 Humidifier User Manual
Doc. 004949 En-EU Z-1b
2.4 Cleaning and Maintenance
• The HA 20 heating unit and water chamber shall be cleaned and main-
tained in accordance with this manual.
• Do not under any circumstances attempt to service or repair the HA 20
Humidifier yourself. If you do so, the manufacturer will no longer be
responsible for the performance and safety of the humidifier.
HA 20 Heating Unit
• Do not place or drop the HA 20 heating unit into water or other liquid.
• Do not attempt to autoclave or sterilise the HA 20 heating unit.
HA 20 Water Chamber
• The recommended maximum usage period of the HA 20 water chamber is
12 months. Deficient cleaning may lead to impaired performance.
• Do not attempt to autoclave the HA 20 water chamber.
8 Product Description
Breas HA 20 Humidifier User Manual Doc. 004949 En-EU Z-1b
3 Product Description
3.1 Components
9Product Description
Breas HA 20 Humidifier User Manual
Doc. 004949 En-EU Z-1b
NO. COMPONENT FUNCTION
1
HA 20
heating unit
Used for docking the water chamber to
the Breas CPAP or ventilator. Contains
the electric heater.
2Lockingmecha-
nism
Locks the water chamber to the heating
unit.
3 Heater plate Heats the water in the water chamber.
Risk of burn during operation and up to
ten minutes after use.
4
HA 20
water chamber
Contains water used for humidifying the
patient’s air.
5 Air inlet From the Breas CPAP or ventilator to the
humidifier’s water chamber.
6 Swivel Connects the water chamber to the
patient circuit.
7 Cover Covers the water chamber.
8 Cover seal Used for sealing the cover and water
chamber. Prevents leaks.
9 Max Marking the maximum level of water.
10 Product Description
Breas HA 20 Humidifier User Manual Doc. 004949 En-EU Z-1b
3.2 Equipment Designation and Safety Label
SYMBOL EXPLANATION
Model designation
Serial number (the last six alphanumeric characters)
Class II electrical equipment; dual isolation
Body floating (Type BF, Isolated Applied Part according
to IEC 60601-1)
Read the user manual thoroughly before connecting the
HA 20 Humidifier to the patient.
CE marking applies in accordance with the directive
MDD 93/42/EEC.
The unit may be returned to Breas Medical AB for scrap-
ping and should not be discarded with the household
waste.
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