Introduction; Intended Use; Description Of Function; User Qualification - Lowenstein Medical LUISA Instructions For Use Manual

1 Introduction

1 Introduction

1.1 Intended use

The LM150TD LUISA ventilator is for the life-support and
non-life-support ventilation of patients who require
mechanical ventilation. It can be used for pediatric or adult
patients with a minimum tidal volume of 30 ml.
The LM150TD is suitable for use in the domestic
environment, in care facilities and in hospitals, as well as for
mobile applications, for example in a wheelchair or on a
transport gurney. It can be used for invasive and non-invasive
ventilation. The LM150TD is not intended for use as a
ventilator during transport or in intensive care.

1.2 Description of function

The device can be used with both invasive and non-invasive
patient/ventilator interfaces. Leakage ventilation can also be
used invasively.
A blower takes in ambient air through a filter and pumps it
through the breathing tube 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 leakage
ventilation, the exhaled air containing CO
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 concentration delivered by the device
2
can be measured using an integrated FiO
SpO2 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 are 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 hospital 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.
Notice for blind or partially-sighted users
An electronic version of the instructions for use is available
on the website.

1.4 Indications

Obstructive ventilation disorders (e.g. COPD), restrictive
ventilation disorders (e.g. scolioses, deformities of the
thorax), neurological, muscular, and neuromuscular
is continuously
2
disorders (e.g. types of muscular dystrophy, pareses of the
diaphragm), central respiratory regulation disorders, obesity
hypoventilation syndrome, hypoxemic respiratory failure.

1.5 Contraindications

The following contraindications are known - in the individual
case, responsibility for deciding whether to use the device
rests with the attending physician. Threatening situations
have not ever been observed.
Absolute contraindications:
Severe epistaxis, high risk of barotrauma, pneumothorax or
pneumomediastinum, pneumoencephalus, status following
brain surgery and following surgical procedures on the
sensor. External
hypophysis or middle or inner ear, acute inflammation of the
2
nasal sinuses (sinusitis), middle ear infection (otitis media) or
perforated eardrum. Mask ventilation must not be used in
particular in the case of significant swallowing problems
(bulbar syndrome) with the risk of aspiration.
|
3
EN