Lowenstein Medical LUISA, Instructions Manual

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1 Introduction
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1 Introduction
1.1 Indications for Use
The LUISA provides continuous or intermittent ventilatory
support for adult patients who require mechanical
ventilation. The LUISA device is intended to be used in home,
institution/hospital and portable applications for both
invasive and non-invasive ventilation.
Caution : The LUISA device is not intended for use as an
emergency transport ventilator.
Caution: In the US, Federal law restricts this device to sale by
or on the order of a physician."
The LUISA Ventilator has NOT been FDA cleared or
approved. The LUISA Ventilator has been authorized by FDA
under an EUA and is authorized only for the duration of the
declaration that circumstances exist justifying the
authorization of the emergence use of ventilators, ventilator
tubing connectors, and ventilator accessories under section
564(b)(1) of the Act U.S.C. § 360bbb-3(b)(1), unless the
authorization is terminated or revoked sooner.
This EUA will be effective until the declaration that
circumstances exist justifying the authorization of the
emergence use of ventilators, ventilator tubing connectors,
and ventilator accessories during the COVID-19 pandemic is
terminated under section 564(b)(2) of the Act or the EUA is
revoked under section 564(g) of the Act.
1.2 Description of function
A blower takes in ambient air through a filter and pumps it
through the circuit and the patient/ventilator interface to the
patient. The blower is controlled to suit respiratory phases on
the basis of the signals detected by the pressure and flow
sensors.
The user interface is for displaying and setting the available
parameters and alarms.
The device can be used with a leakage circuit, with a single
circuit with valve or with a double circuit. With the leakage
ventilation, the exhaled air containing CO
2
is continuously
flushed out via an exhalation system. With a single circuit
with valve and with a double circuit, the patient’s exhalation
is controlled by a valve.
In High Flow mode (HFT mode), the device pumps the set
flow to an external humidifier suitable for HFT. This
conditions the respiratory gas in terms of temperature and
humidity. The patient connection is made using accessories
suitable for HFT. HFT mode (if available) and MPV mode are
not respiration support modes within the meaning of
standard ISO 80601-2-72. As no permanent and/or sealed
connection is made between the corresponding interfaces
and the patient’s airway, some specifications such as
disconnection detection do not apply.
Oxygen can be supplied via the oxygen inlet.
If required, the FiO
2
concentration delivered by the device
can be measured using an integrated FiO
2
sensor. External
SpO
2
measurement can also be connected.
The power is supplied by an external power supply unit.
The device has an integrated battery, so it can continue to be
operated without interruption in the event of a power
outage. In addition, a maximum of two external batteries
can be connected to operate the device.
Therapy data is stored in the device and can additionally be
loaded on a USB-C stick and analyzed by PC software.
1.3 User qualification
The person operating the device is referred to in these
instructions for use as the user. A patient is the person
receiving the therapy. The patient is also intended to be a
user. As an owner/operator or user, you must be familiar
with the operation of this medical device. Training and
instruction in operation of the device is absolutely essential
for the user and for the representative of the owner/
operator. When the device is handed over to the patient, the
attending physician or clinical staff must instruct the patient
in the function and operation of the device.
The owner/operator is responsible for ensuring the
compatibility of the device and of all the components or
accessories associated with the patient before these are
used.
The device is a medical device which may only be used by
trained specialists as directed by a physician. Use the device
only as directed by a physician or other medical staff.
1.4 Contraindications
If the patient has any of the following conditions, consult
their health care professional before using the device in a
non-invasive mode:
Inability to maintain a patent airway or adequately clear
secretions; at risk for aspiration of gastric contents;
diagnosed with acute sinusitis or otitis media; epistaxis,
causing pulmonary aspiration of blood; hypotension.