Lowenstein Medical prisma VENT AQUA 100506 Parts list manual

EN
prisma VENT AQUA
respiratory humidifier
Instructions for use and
technical description

2
Contents
1. Scope of use................................................................................................................4
2. Warnings, Cautions and Guidelines............................................................................5
2.1 Warnings ............................................................................................................5
2.2 Precautions ........................................................................................................7
2.3 Guidelines ..........................................................................................................8
3. Side effects / Contraindications...............................................................................10
4. Basic equipment and resources needed..................................................................10
4.1 Delivery and special accessories ......................................................................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 Connect the breathing tube system...................................................................15
5.5 Turn on the base unit........................................................................................18
5.6 Turn off the base unit........................................................................................19
6. Mode of operation .....................................................................................................19
6.1 Description of the operating modes ..................................................................20
6.1.1 NHW .....................................................................................20
6.1.2 HWC .....................................................................................20
6.1.3 HWT ......................................................................................21

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7. Operation ...................................................................................................................21
7.1 Representation of the operating controls...........................................................21
7.2 Status display of the current humidification ......................................................22
7.3 Configuration of humidification levels ...............................................................22
7.4 The temperature ranges NHW, HWC and HWT...................................................22
7.5 Respiratory flow areas......................................................................................23
7.6 Impact on the performance...............................................................................23
7.7 Muting the alarm ..............................................................................................23
7.8 Treatment interruption ......................................................................................23
7.9 Warm-up time ..................................................................................................23
7.10 Alarm delay ......................................................................................................24
8. Representation of the operating mode.....................................................................24
9. Representation of the Guidelines .............................................................................25
10. Alarms .......................................................................................................................25
10.1 Causes and Solutions .......................................................................................26
10.2 Alarm "OFF" Status ..........................................................................................26
11. Cleaning.....................................................................................................................27
12. Maintenance..............................................................................................................28
13. Legend .......................................................................................................................28
14. Technical specifications ...........................................................................................30
15. Storage and disposal ................................................................................................33
16. Supplement to the technical description .................................................................33
17. EMC proof ..................................................................................................................34

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1. Scope of use
The prisma VENT AQUA respiratory humidifier
is a device for heating and humidifying
respiratory gases such as medical oxygen
and/or compressed air or room air during
artificial respiration or respiratory therapy in
both clinical and non-clinical settings.
The prisma VENT AQUA can be used in non-
invasive respiration/respiratory therapy.
This device may only be operated by trained
personnel. User training will be provided by
Löwenstein Medical or Löwenstein Medical
authorized agents.
The prisma VENT AQUA is always operated
between the therapy device and patient.
A tube system with a humidification chamber
is always required for this connection. This
tube system must be matched beforehand
to the therapy device being used, suit the
medical indication and the respective patient
group.
The prisma VENT AQUA may only be
connected to approved therapy devices
(e.g. ventilators, bilevel and CPAP devices,
etc.) if the safety of patients, users and
the surrounding area is not compromised
by this combination. If the the safety of
the combination is not obvious, the user
must confirm it e.g. by an inquiry to the
manufacturers.
The respiratory gas is passed from the
treatment device or oxygen source into the
humidification chamber of the respiratory
humidifier, where it is warmed and enriched
with water vapor and then passed through
the inspiratory breathing tube to the patient.
Three different basic modes enable the
humidification power to be set or adjusted
optimally for each application.
The prisma VENT AQUA respiratory humidifier
is neither suitable nor intended for the
nebulization of medication.

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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 on whether 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 heater
and the humidifier chamber can reach
temperatures of over 85°C. Before removing
the humidification chamber from the
humidifier, the humidification chamber must
be allowed sufficient time to cool down.
WARNING
When using the temperature probe, the
temperature sensor must be inserted so
that the temperature of the respiratory gas
is measured in the middle of the breathing
tube. Failure to observe the temperature
of the supplied respiratory gas can lead to
exceedance of 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 a deformation to the point of
melting of the breathing tube.
WARNING
The prisma VENT AQUA respiratory humidifier
may be connected to all conventional
ventilators/therapy equipment, provided its
connection is made such that any danger
for the patient, user or environment can be
avoided.

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WARNING
Risk of burns!
Heated breathing tube systems must not
touch the patient's skin.
WARNING
Keep in mind that, when using the machine
near other electrical appliances, faulty
operation could occur. If this separation from
other equipment becomes necessary, it must
be checked that the devices are functioning
properly.
WARNING
The use of accessories and cables other
than those specified by the manufacturer
may result in an increased electromagnetic
emission or a decreased electromagnetic
compatibility of the humidifier.
WARNING
This device may not be altered without the
manufacturer's permission.
WARNING
If used correctly, the heating plate and the
chamber become hot.
WARNING
If the device is stored or transported at an
ambient temperature of -25°C or +70°C,
the device must then be acclimatized prior
to operation at an ambient temperature of
18°C to 28°C for 30 minutes.
WARNING
Operating temperatures are different from
storage and transport temperatures. The
prisma VENT AQUA may only be operated at
an ambient temperature of 18°C to 28°C.
WARNING
The prisma VENT AQUA respiratory humidifier
is not to be operated in the vicinity of
radiators and other heat sources. Solar
radiation and bright light sources must be
avoided.
WARNING
Please note that the ambient conditions
change if a window is opened.
WARNING
Children and pets are to be supervised when
the prisma VENT AQUA respiratory humidifier
is being operated.
WARNING
Portable HF communications devices (radio
equipment) (including their accessories,
such as antenna cables and external
antennae) should not be at a closer distance
than 30 cm (or 12 inches) from the parts and
lines of the prisma VENT AQUA indicated by
the manufacturer. If this is not observed, it
can lead to a reduction in the performance
of the device.

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WARNING
Small parts can be swallowed.
WARNING
This device may only be operated by trained
personnel. User training will be provided by
Löwenstein Medical or Löwenstein Medical
authorized agents.
2.2 Precautions
Precautions are indicated by the term
CAUTION. Precautions warn the user for
special precautions to be observed in order
to ensure safe and effective use of the
prisma VENT AQUA respiratory humidifier.
CAUTION
Breathing tubes with a diameter of 15 mm
may only be used as a heated system with
temperature probe and heating wire adapter.
CAUTION
The use of accessories that are not approved
by Löwenstein Medical may impair the
operational reliability of the system.
CAUTION
The output power of the humidity can
be affected if the device is operated
outside of the specified range of operating
temperatures.
CAUTION
To avoid overheating, a breathing gas flow
of at least 5 l/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 the
"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
Every servicing of the device - including
any maintenance and testing - must be
performed by trained service technicians.
For details, please refer to the additions
to the technical specifications, and to the
maintenance and service manual.
CAUTION
Defective humidifiers may not be used.
Disconnect defective devices from the power
and notify hospital maintenance technicians
or the supplier.

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CAUTION
Do not immerse the base unit or its
accessories in liquids to sterilize them!
Detailed instructions for cleaning and
maintaining the device are included in
the sections regarding 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 prisma VENT AQUA humidifier is
damaged or defective, it must not be used.
In addition, in this situation, please notify
the hospital maintenance technician or the
customer service department. Sort out the
damaged components of the system and do
not use them!
CAUTION
The determination of the operational shutoff
may only be performed by a physician or his/
her authorized representatives.
CAUTION
This operation manual does not replace
the medical prescription or the service
requirements for the appropriate care of the
patient. These requirements and service
regulations 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
Before use, follow the instructions of the
user manual of each accessory!
NOTE
A change in the room climate (for example,
heating, ventilation) or the entry of new
ventilation parameters can lead to increased
condensation in the breathing tube system.
NOTE
The abbreviation "(i)" means inspiratory
breathing.
NOTE
The prisma VENT AQUA humidifier and the
humidification chamber are not inhalers and
therefore are neither suitable nor intended
for administration of drugs!
NOTE
Portable and mobile high frequency
communication equipment (such as mobile
phones) can affect the proper functioning of
the prisma VENT AQUA humidifier. Further
evidence is included in the manufacturer's
EMC declaration in the Appendix.

9
NOTE
The maintenance and inspection of this
equipment should be performed only by
authorized and trained service engineers, in
compliance with applicable regulations.
NOTE
The operating life of the device is limited to
8 years.
NOTE
Its operation in a potentially explosive and
oxygen-rich environment is not allowed.
NOTE
If problems arise during commissioning, use
or possibly servicing, or if an unexpected
operating state or incident occurs, the
representative should be contacted.
NOTE
The prisma VENT AQUA humidifier and the
humidification chamber are not inhalers
and therefore are neither suitable nor
intended for administration of drugs, medical
substances or human blood derivatives.
NOTE
Only Löwenstein Medical approved
accessories and consumables may be used.
Accessories and consumables from third
party providers may affect the safety of the
device.
NOTE
The anticipated operating lifetime of
the device and of the jointly-supplied
accessories is limited to 8 years. The
anticipated operating lifetime of the
consumables is shown in the user
instructions for the consumables.
NOTE
The prisma VENT AQUA respiratory
humidifier is suitable for reuse. Prior to reuse
following a change of patient, cleaning and
disinfection pursuant to chapter 11 must be
carried out.

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3. Side effects /
Contraindications
There are no known adverse side effects.
4. Basic equipment and
resources needed
4.1 Delivery and special accessories
 prisma VENT AQUA base unit
(230V 100506, 115V 100507)
 Wire distribution cable for heating (i) (100.942)
 Temperature probe (160 cm 100910 or
180 cm 100909)*
 Power cord (country specific)
 User instructions (country specific)
 Quick Start Guide (country specific)
Base unit
Heating wire distributor cable Temperature probePower cord
* The 180 cm temperature probe (100909) is a special accessory and must be
ordered separately.