Lowenstein Medical LM150TD User manual

EN Instructions for use for patients for devices of type LMT150TD
LUISA
Ventilators

Contents
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LMT 68651c 02/2022
Contents
1 Introduction 3
1.1 Intended use .................................................... 3
1.2 Description of function ..................................... 3
1.3 User qualification ............................................. 3
1.4 Indications ........................................................ 4
1.5 Contraindications ............................................. 4
1.6 Side effects ...................................................... 4
2 Safety 4
2.1 Safety information ............................................ 4
2.2 General information ......................................... 5
2.3 Safety information in these instructions
for use .............................................................6
3 Product description 7
3.1 Overview .......................................................... 7
3.2 Control panel in display .................................... 8
3.3 Symbols in display ............................................ 9
3.4 Accessories (optional) ....................................... 9
3.5 Operating states ............................................. 10
3.6 Batteries ......................................................... 10
3.7 Trolley 2.0 ...................................................... 10
3.8 Data management/compatibility ..................... 11
4 Preparation and operation 12
4.1 Setting up and connecting device ................... 12
4.2 Connecting circuit .......................................... 12
4.3 Before first use ............................................... 14
4.4 Switch device on and off / Start and end
therapy ..........................................................14
4.5 Performing circuit test .................................... 14
4.6 Calibrating FiO2 cell ........................................ 14
4.7 Pairing device with LUISA app ........................ 15
5 Settings in the menu 16
5.1 Navigating in the menu ................................. 16
5.2 Patient menu structure .................................. 16
6 Hygiene treatment and servicing 18
6.1 Hygiene treatment ........................................ 18
6.2 Function check .............................................. 19
6.3 Checking alarms ............................................ 20
6.4 Servicing ....................................................... 20
6.5 Disposal ........................................................ 21
7 Alarms 22
7.1 Sequence in which alarms are displayed ........ 22
7.2 Muting alarms ............................................... 22
7.3 Configuring physiological alarms ................... 22
7.4 Technical alarms ............................................ 24
7.5 Nurse call and remote alarm .......................... 28
8 Faults 28
9 Technical specifications 29
10 Annex 33
10.1 Pneumatic diagram ....................................... 33
10.2 System resistances ......................................... 34
10.3 Emission of electromagnetic interference ....... 35
10.4 Electromagnetic interference immunity .......... 35
10.5 Markings and symbols ................................... 36
10.6 Scope of delivery ........................................... 36
10.7 Accessories .................................................... 37
10.8 Removable parts ............................................ 37
10.9 Warranty ....................................................... 38
10.10 Declaration of Conformity ........................... 38

1 Introduction
LMT 68651c 02/2022
EN | 3
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.
Non-specialist users with adequate training and specialist
users can operate the device.
1.2 Description of function
The device can be used with both invasive and non-invasive
patient/ventilator interfaces. The leakage circuit can also be
used invasively.
A blower takes in ambient air through a filter and pumps it
through the ventilation 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 the leakage
circuit, the exhaled air containing CO2 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 FiO2 concentration delivered by the device
can be measured using an integrated FiO2 cell. External 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 flash drive 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. All users must receive
training or instruction on how to operate the device.
A distinction is drawn between specialist users (experts) and
non-specialist users. The following groups of people make
up both groups:
.
PERSON DESCRIPTION USER QUALIFICATION
Patient Person receiving the therapy Persons with no specialist medical or nursing knowledge.
Following an introduction by the medical professional on
how the device works and how to use it, these
individuals are regarded as non-specialist users.
Non-specialist
user Patient, relative and other caregivers
Owner/operator
Health care facility responsible for ensuring the
compatibility of the device and of all the
components or accessories associated with the
patient before use (e.g., a hospital).
Following training by the manufacturer or by a specialist
expressly authorized by the manufacturer on how the
device works and how to use it, these individuals are
regarded as specialist users.
Medical
professional
Person with state-approved qualification in a
medical profession (e.g., physician, respiratory
therapist, medical technician)
Following training by the manufacturer or trained
owner/operator on how the device works and how to
use it, the persons with specialist knowledge of the
therapy and device (e.g., medical specialists, nursing
specialists, service specialist) are regarded as specialist
users.
Nursing
specialist
Person with state-approved qualification in a
nursing profession
Specialist dealer
Person or organization that markets, but does
not itself manufacture a product. The specialist
dealer can also provide a support function.
Following training by the manufacturer on how the
device works and how to use it, these individuals are
regarded as specialist users.

2 Safety
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LMT 68651c 02/2022
As an owner/operator or user, you must be familiar with the
operation of this medical device.
The device is a medical device which may only be used as
specified by the medical professional or the owner/operator.
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
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 medical professional. 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
hypophysis or middle or inner ear, acute inflammation of the
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.
Relative contraindications:
Cardiac decompensation, severe cardiac arrhythmias, severe
hypotension, especially in combination with intravascular
volume depletion, head injury, dehydration.
1.6 Side effects
When using the device, the following undesired side effects
may occur in short-term or long-term use: Pressure points
from the mask and the forehead cushion on the face,
reddening of the facial skin, dry throat, mouth, nose, feeling
of pressure in the sinuses, irritated conjunctiva in the eyes,
gastrointestinal insufflation of air ("bloating"), nosebleeds;
muscular atrophy in the case of long-term ventilation. These
are general side effects not attributable specifically to use of
devices of type LM150TD.
2 Safety
2.1 Safety information
2.1.1 Handling the device, the
components, and the accessories
If the device is damaged or its function is restricted, people
may be injured.
Only operate the device and its components if they are
externally undamaged.
Perform a function check at regular intervals (see “6.2
Function check”, page 19).
Only operate, store, and transport the device within the
specified ambient conditions (see “9 Technical
specifications”, page 29).
Do not use the device if the automatic function check
issues error messages.
Always keep an alternative means of ventilation to hand
in order to avoid a life-threatening situation if the device
fails.
Keep small parts which may be inhaled or swallowed
away from young children in particular.
Do not use the device in an MRT environment or in a
hyperbaric chamber.
Do not reuse disposables. Disposables may be
contaminated and/or their function may be impaired.
Do not use or supply anesthetic gases.
Set acoustic alarm volume high enough for the acoustic
alarm to be heard.
Use breathing tubes with an internal diameter of
10 mm only on patients with a tidal volume <50 ml.
Eliminate leaks on the breathing mask or breathing
tube. In the event of unintended leaks, the values
displayed for volume and exhaled CO2 will deviate from
actual patient values.
Only use accessory parts from the manufacturer.
Do not use antistatic or electrically-conductive tubes.
The accuracy of the device may be impaired by the gas
supplied by a pneumatic nebulizer.
Regularly check the breathing system filter for increased
resistance and blockages. Moistening with nebulizers or
humidifiers may increase the resistance of breathing
system filters and thus change the therapeutic pressure
delivered. In order to prevent increased resistance and
blockages, replace the breathing system filter more
frequently.
Set up external humidifiers below the device and the
patient connection. Water in the device may damage
the device or injure the patient.

2 Safety
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2.1.2 Electromagnetic compatibility
The device is subject to special precautions with regard to
EMC (electromagnetic compatibility). If these precautions
are not followed, the device may malfunction and individuals
may be injured.
Portable high-frequency communication equipment
(e.g. radios and cell phones), including their accessories
such as antenna cables and external antennas, for
example, must be used at a distance of at least 30 cm
from the device and its cables.
Do not use the device in the vicinity of active high-
frequency surgical equipment.
Operate the device within the EMC environment
specified for this device (see “10.4 Electromagnetic
interference immunity”, page 35) in order to prevent
key performance characteristics being affected - for
example, ventilation parameters being affected by
electromagnetic interference.
Do not operate the device if the housing, cables or other
equipment for electromagnetic shielding are damaged.
The use of third-party accessories, third-party inverters,
and third-party cables may lead to increased
electromagnetic interference or reduced
electromagnetic interference immunity of the device
and to faulty operation. Only use the manufacturer’s
cables.
Do not operate the device in the immediate vicinity of
other devices or in a stacked arrangement, otherwise
there may be malfunctions. If it is necessary to operate
the device in the immediate vicinity of other devices or
in a stacked arrangement, keep all the devices under
observation to ensure that they are all operating
properly.
2.1.3 Energy supply
Operating the device outside the specified energy supply
may cause personal injury, damage the device or impair the
performance of the device.
Operate the power supply unit only at voltages from
100 V to 240 V.
Use DC cable LMT 31597 for operation on voltages of
12 V or 24 V.
Keep access to the power supply connector and the
power supply free at all times.
When using a battery-operated wheelchair: Connect
the device to the wheelchair battery only if a connection
of that kind is expressly provided in the instructions for
use for the wheelchair.
When operating using the cigarette lighter socket in a
car: Disable the car’s auto start/stop feature. Start the
car first, then connect the device.
2.1.4 Handling oxygen
Supplying oxygen without a special safety device can lead to
fire and injure people.
Follow the instructions for use for the oxygen supply
system.
Set up oxygen sources at a distance of over 1 m from
the device.
The oxygen rate supplied in l/min must not exceed the
oxygen flow prescribed by the medical professional.
The oxygen rate supplied in l/min may not exceed the
set HFT flow rate.
At the end of therapy, shut off the oxygen supply and
allow the device to run on briefly to flush residual
oxygen out of the device.
2.1.5 Transport
Operating the device in any kind of carrying bag may impair
device performance and injure the patient. Water and dirt in
the device may damage the device.
Only operate the device in the associated LUISA mobility
bag.
Transport or store the device in the associated LUISA
protective bag.
2.1.6 Wireless module
The device contains a wireless module. Operating the device
in the immediate vicinity of people and/or other antennas
may injure people, damage the device or impair device
performance.
Set up the device at least 20 cm away from any people.
Do not set up or operate the device with other
antennas.
2.2 General information
• In order to react to an alarm and, if necessary, to use
emergency ventilation, you must subject both patient
and device to regular monitoring.
• The use of third-party articles may lead to incompatibility
with the product. In such cases, please be aware that any
claim under warranty and liability will be void if original
spare parts are not used.
• Connection by cable to a patient monitor is not a
substitute for a remote alarm system. Alarm data are
transmitted only for documentation purposes.
• Have measures such as repairs, servicing, and
maintenance work, as well as modifications to the
product, carried out exclusively by the manufacturer or
by specialists expressly so authorized by the
manufacturer.
• Connect only the licensed products and modules in
accordance with these instructions for use. The products
must meet the product standard applicable to them.
Non-medical equipment should be positioned out of the
patient's vicinity.

2 Safety
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• Follow the section on hygiene treatment (see “6 Hygiene
treatment and servicing”, page 18) to avoid infection or
bacterial contamination.
• In the event of a power outage, all settings including
alarm settings are retained.
• In the EU: As a user and/or patient, you must report any
serious incidents occurring in conjunction with the
product to the manufacturer and to the responsible
authority.
2.3 Safety information in
these instructions for use
Indicates an unusually significant
hazardous situation. If you ignore this
instruction, severe irreversible or fatal
injuries may result.
Indicates a hazardous situation. If you
ignore this instruction, mild or
moderate injuries may result.
Indicates a harmful situation. If you
ignore this instruction, material
damage may result.
Indicates useful information within
procedures.

3 Product description
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3 Product description
3.1 Overview
123456
78
14
10 11
16
18
17
13
12
9
19
21
22
23
24
20
15
1Connection for external batteries 13 Filter compartment with coarse dust filter and
fine filter
2Connection for monitor / prisma HUB 14 Compartment for internal battery
3USB-C port 15 Intake area for cooling fan
4Connection for nurse call system 16 Device inlet port
5Power supply indicator 17 Device outlet port
6Alarm acknowledgement key 18 Handle
7Inlet port for pressure measuring tube 19 On/off key
8Inlet port for valve control tube 20 Power supply unit with power supply unit cable
9Inlet port for SpO2 sensor 21 Power cord
10 CO2 outlet port (not in use) 22 O2 inlet
11 Inlet port for nebulizer (not in use) 23 Loudspeaker
12 Circuit (single circuit with valve) 24 Connection for power supply unit

3 Product description
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3.2 Control panel in display
3
4
5
6
8
9
1
2
7
1Status line - symbols indicate current device status (e.g. accessories connected, battery capacity).
2Alarm acknowledgement key -
Press briefly: Acknowledges alarm. If the alarm persists, the alarm is muted for 120 seconds.
Press and hold: Mutes all acoustic alarms for 2 minutes.
Press briefly again: Suspends alarm muting.
3Home key - switches the view back to the start screen.
4Menu keys - provide access to the individual menus.
5Display lock key - locks or unlocks the display, so that no settings can be changed as a result of incorrect contact.
6Dimmer key - switches to night mode and the display goes dark.
Touch the display to reactivate it.
Keep key depressed - opens the Display menu.
7
Program key - provides access to the ventilation programs. The medical professional or specialist dealer can
preconfigure and enable up to four programs in the device for you. If you need different ventilation settings during the
day compared to during the night, for example, you can change the program yourself here.
8Ventilation key - starts or stops ventilation.
9Access key - locks or unlocks the Expert menu.

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3.3 Symbols in display
3.4 Accessories (optional)
SYMBOL DESCRIPTION
Device in Patient menu. Expert menu locked.
Expert menu unlocked.
Indicates respiratory status:
• Arrow pointing upward: Inspiration
• Arrow pointing downward: Exhalation
• S: Spontaneous breath
• T: Mandatory breath
Device set for pediatric applications/children.
Device set for adults.
Leakage circuit set.
Single circuit with valve set.
Double circuit set.
Battery charging. If the gray area reaches the
top, the battery is fully charged.
Battery capacity high, battery discharging.
Battery capacity medium, battery discharging.
Battery capacity low, battery discharging.
Battery capacity low.
Battery fault
Filter change function (only if function is
activated).
Service reminder function (only if function is
activated).
SpO2 sensor:
Gray: Not connected
Green: Connected and high signal quality
Yellow: Connected and moderate signal
quality
Red: Connected and poor signal quality
FiO2 cell
Green: Activated and full
Gray: Activated and empty
Green and flashing: Calibration process in
progress
Patient monitor connected.
Network connection present.
Green: Bluetooth® (wireless technology)
activated.
Gray: Bluetooth® (wireless technology) not
activated.
Wireless connection present.
Flight mode activated.
Green: USB flash drive connected.
Gray: USB flash drive faulty.
Low-priority alarm triggered.
Medium-priority alarm triggered.
High-priority alarm triggered.
All physiological alarms have been
deactivated.
Acoustic signal for alarm paused.
PART DESCRIPTION
VENTIremote alarm
For remote transmission and display
of the alarm signals output by the
device
SpO2 sensor Determines SpO2 and pulse
frequency data
Breathing system
filter
Prevents the transmission of particles
and microorganisms to the breathing
system
FiO2 cell Performs permanent FiO2
measurement
Circuit Supplies the patient with respiratory
air
Exhalation system Routes exhaled air into the
environment
External battery Serves as an additional external
energy supply for the device
Protective bag for
LUISA
Serves to transport and store the
device with protection
Follow the instructions for use for the accessories.
Here you will find further information about
operation and combining accessories with the device.
SYMBOL DESCRIPTION

3 Product description
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3.5 Operating states
•On: Therapy is in progress. It is possible to make device
and therapy settings.
•Standby: The blower is off and therapy is not in
progress. However, the device is ready for operation
immediately. It is possible to make device and therapy
settings.
•Off: The device is switched off. No settings can be made
and the display remains dark.
3.6 Batteries
3.6.1 Internal battery
• The device is fitted with an internal battery. If the device
is no longer connected to the power supply or there is a
power outage, the battery automatically starts supplying
the device without interruption. This discharges the
battery. This discharges the battery. The battery is
charged automatically again as soon as the device is
connected to the power supply.
In operation via a 12 V or 24 V supply, the battery is
charged only when the device is in the Standby or Off
state.
• The internal battery is replaced by the manufacturer or
by a specialist dealer.
• Battery life depends on ventilation settings and ambient
temperature (see “9 Technical specifications”, page 29).
• When the Battery capacity low alarm appears, only a
minimum of 15 minutes’ life remains. When the Battery
capacity critical alarm appears, the device will switch
off in a few minutes’ time (less than 5 minutes’ life
remaining). Have an alternative ventilation option to
hand and connect the device to the power supply.
• If device and battery have been stored outside the
quoted operating temperatures, the device can only be
started up once it has warmed up or cooled down to the
permitted operating temperature.
3.6.2 External batteries
• External batteries can be connected to the device as an
additional energy supply. If the device is connected to
the power supply, the batteries are charged; first the
internal battery, then the external batteries. In operation
via a 12 V or 24 V supply, the batteries are charged only
when the device is in the Standby or Off state.
• If the device is not connected to the power supply, a
battery powers the device. The external batteries
connected are discharged first, followed by the internal
battery.
3.6.3 Display of remaining device life
Remaining device life in the case of battery and power supply
operation is displayed in the status line and in the Views
menu (see “5.2.1 Views menu in the Patient menu”, page
16).
Remaining life is a prediction and always relates to the
current mean consumption of the device.
Following the start of ventilation, no more than 3 minutes
will elapse before remaining life is displayed.
3.7 Trolley 2.0
You can use the oxygen cylinder clamp with oxygen cylinders
up to 120 mm in diameter (this corresponds to a cylinder size
of approx. 4 l to 6 l per cylinder). Note total cylinder height
(cylinder including valve and accessories).
DEVICE ON
STANDBY
DEVICE IN THE
ON STATE
POWER SUPPLY Value in % Value in %
BATTERY
SUPPLY Value in % Remaining battery life in h and min.

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3.8 Data management/
compatibility
3.8.1 Saving and transmitting therapy
data
Therapy data for the previous 30 therapy days (24 hours/day)
are saved in the device. Pressure, flow and volume are saved
at 20 Hz, all other recorded values at 1 Hz.
Statistical data for the previous 12 months are saved in the
device.
A file in edf format is created for every day saved.
If you plug USB flash drive LMT 31414 into the device, the
therapy data saved in the device will be transmitted to the
flash drive in the form of edf files.
The therapy data saved on the USB flash drive can be read
into and displayed in the prismaTS software.
3.8.2 Updating the firmware
In order to perform a firmware update, plug a USB flash drive
with an update file (one version higher than the current
version) into the device and confirm that the update should
go ahead.
The device configuration is retained following the update.
3.8.3 Setting up a connection to the
LUISA app
The LUISA app is an app on a mobile terminal. The device can
be connected to the LUISA app (see “4.7 Pairing device with
LUISA app”, page 15).
Material damage if incorrectly configured!
If trolley 2.0 is not used properly, it may tip over or be
damaged.
Use the circuit holder only for the circuit.
Use the water bag holder only for the refill unit of the
active humidification system.
Use trolley 2.0 only on a maximum incline of 10°.
Ensure that the total weight of trolley 2.0 when fully
equipped is < 25 kg.
Before moving the trolley: Put the circuit holder in the
folded-away position.
Anyone who integrates medical devices or medical
software products in an IT network or installs them
on a PC or integrates devices or software products in
a medical IT network or installs them on a PC is
responsible for complying with IEC 80001-1.
According to IEC 80001-1, the owner/operator is
responsible for the risk management of any
interactions in medical IT networks. Please note that
the manufacturer does not accept any warranty or
liability for interactions between system components
in an IT network.

4 Preparation and operation
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4 Preparation and operation
4.1 Setting up and connecting
device
1. If required: Tilt the device to a horizontal or vertical
position.
The display adapts to the orientation automatically.
2. Connect the power cord to the power supply unit and
the socket.
3. Connect the power supply unit cable to the device.
4.2 Connecting circuit
Risk of injury from inadequate therapy if air inlet and
air outlet are blocked!
A blocked air inlet and/or air outlet can cause the device to
overheat, impair therapy, and damage the device.
Keep the filter compartment clear ( symbol).
Keep the device inlet port free ( symbol).
Keep the intake area of the cooling fan free
( symbol).
Material damage from overheating!
Excessive temperatures may lead to the device overheating
and damage the device.
Do not cover device and power supply unit with textiles
(e.g. bedclothes).
Do not operate device in the vicinity of a radiator.
Do not expose device to direct sunlight.
Only operate the device in the associated mobility bag
for mobile use.
Alternatively, you can connect a direct voltage
electricity supply (12 VDC or 24 VDC) as per
ISO 80601-2-72.
Risk of asphyxia if invasive or non-invasive patient/
ventilator interfaces without an exhalation system are
used!
If invasive or non-invasive patient/ventilator interfaces
without an integrated exhalation system are used, CO2
concentration may rise to critical values and put the patient
at risk.
Use invasive or non-invasive patient/ventilator interfaces
with an external exhalation system if there is no
integrated exhalation system.
Follow the instructions for use for the exhalation
system.
Risk of injury from potential patient disconnection!
On circuits without proximal pressure measurement and
with additional accessories such as HME or tube extension,
for example, it is not possible to detect patient disconnection
reliably.
Use the VTe low alarm for the double circuit and the
VTi high alarm for the single circuit with valve.

4 Preparation and operation
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4.2.1 Connecting leakage circuit
1. Push the inspiration tube onto the device outlet port.
2. Connect the patient interface (e.g., breathing mask) to
the circuit (see instructions for use for the patient/
ventilator interface).
4.2.2 Connecting single circuit with
valve
1. Push the inspiration tube onto the device outlet port.
2. Push the pressure measuring tube onto the inlet port for
the pressure measuring tube .
3. Push the valve control tube onto the inlet port for the
valve control tube .
4. Connect the patient interface (e.g., breathing mask) to
the circuit (see instructions for use for the patient
interface).
4.2.3 Connecting double circuit
1. Push the inspiration tube 1 onto the device outlet port.
2. Push the expiration tube 3 onto the device inlet port.
3. Push the pressure measuring tube 2 onto the inlet port
for the pressure measuring tube .
4. Connect patient interface (e.g., breathing mask) to Y-
piece of the circuit (see instructions for use for the
patient interface).
4.2.4 Connecting circuit for HFT mode
1. Push inspiration tube (short) 1 onto the device outlet
port.
2. Push the other end of the inspiration tube (short) 1 onto
the inlet port of the humidifier chamber 4 marked In.
3. Push the inspiration tube (long) 3 onto the outlet port of
the humidifier chamber 4 marked Out.
4. Connect High Flow interface 2 to the inspiration tube
(long)3.
5. If necessary, connect the tube heater and temperature
probe to the inspiration tube (long) 3 (see instructions
for use for the external humidifier).
Risk of injury from incorrectly routed circuits and
cables!
Incorrectly routed circuits or cables may injure the patient.
Do not route circuits and cables along the neck.
Do not crush circuits and cables.
Risk of injury if patient valve is covered!
If the patient valve is covered, exhaled air can no longer be
routed away and the patient will be put at risk.
Always keep the patient valve free.
P
As an alternative to the leakage circuit, it is also
possible to use the single circuit with valve or the
double circuit in HFT mode.
12
3
P
1
2
3
4

4 Preparation and operation
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LMT 68651c 02/2022
4.3 Before first use
The device must be configured before being used for the first
time. If your specialist dealer has not yet done so, you must
set language and time on the device.
The device is supplied with a charged internal battery. To
charge the internal battery fully, leave the device connected
to the power supply for at least 1 hour.
4.4 Switch device on and off / Start and end therapy
4.5 Performing circuit test
Perform a circuit test at every function check, on change of
patient and as required. This checks for resistance,
compliance, and leaks.
Requirement
Specialist dealer or medical professional selects the used
circuit in the Ventilation menu.
1. Select the System > Circuit test menu.
2. In the Overview of circuit test section, select the
desired ventilation program and press the Start key.
3. Select the appropriate option as a function of the circuit
used:
For a leakage circuit, select whether an exhalation
system or a breathing mask (vented variant) is being
used.
or
For a single circuit with valve or for a double circuit,
select whether the circuit test is to be conducted with or
without proximal pressure measurement. You can tell
which is being used by checking whether or not the
pressure measuring tube is connected to the pressure
measuring tube inlet port .
4. Connect circuit, patient interface (e.g., breathing mask)
and accessories to the device. If present: Disconnect the
connection to the patient.
5. Follow instructions in the display.
6. Press the Next key to start the circuit test.
7. If the circuit test is successful, press the Finish key.
If the circuit test is not successful, follow the instructions
in the display and eliminate the faults.
4.6 Calibrating FiO2 cell
You can use the optional FiO2 cell to perform continuous
FiO2 measurement. You must activate the FiO2 cell before
use and calibrate it every 6 weeks.
Calibration can take place during ventilation. You cannot
perform FiO2 measurement during the calibration process
(duration approx. 5 minutes).
1. Calibration is performed in the System > FiO2 cell >
Start calibration menu.
2. Interrupt O2 supply. Wait approx. 30 seconds.
ACTION REQUIREMENT KEY RESULT
Switch on device1Briefly press the On/off key on the device Device on standby
Start therapy1Device is switched on
Briefly press the On/off key on the device
or
Press Start therapy in the display
Therapy starts
End therapy
Press and hold the On/off key on the device
or
Press and hold End therapy in the display
Device on standby
Switch off device Press and hold the On/off key on the device Display goes out
1The device automatically performs a few function tests. This may take a few seconds.
P

4 Preparation and operation
LMT 68651c 02/2022
EN | 15
3. Press the Ok key to start calibration.
4. If calibration is successful, press the Finish key.
If calibration is not successful, follow the instructions in
the display and eliminate the faults.
5. Continue O2 supply.
The FiO2 cell is continuously emptied as a result of contact
with oxygen. If the FiO2 cell is almost or completely empty,
an alarm message will appear. The FiO2 cell is fitted and
replaced by the specialist dealer.
4.7 Pairing device with LUISA
app
The LUISA app is an app on a mobile terminal which you can
use to read off the patient’s therapy data.
1. Activate the Bluetooth function in the System >
Device settings > Connectivity menu.
2. Select the entry Add new device in the Device list
menu.
3. Download the app onto a mobile terminal and follow
the instructions in the app.
After pairing, the app will recognize the Bluetooth
connection of the device. The pairing does not then need to
be performed again. The saved pairing can be deleted in the
LUISA app.
To stop the alarm occurring, you can deactivate the
cell in the System > FiO2 cell menu.

5 Settings in the menu
16 | EN
LMT 68651c 02/2022
5 Settings in the menu
5.1 Navigating in the menu
5.2 Patient menu structure
5.2.1 Views menu in the Patient menu
The Views menu shows 2 views.
To switch to the next view in each case, tap the Views key
again. The horizontal lines on the Views key are the number
of available views.
ACTION FUNCTION
Press function key
Function keys have a gray
background and the function is
displayed on the key in text or as a
symbol (e.g. System, Start
therapy, or .
Symbols on a black background are
not function keys, but serve to
provide information about device
status (see “3.3 Symbols in display”,
page 9).
Scroll in list Navigate up or down
Press “Value” Opens range of values for setting
ventilation parameters
Move range of values
up or down Decrease or increase value
Confirm value
Discard selection
Switches the view back to the start
screen
ACTION FUNCTION

FiO2cell
Export therapy data
Alarm list
Event list
Alarm/event list

Flight mode
Parameter overview
Device usage
Device status
FiO
Tube test
Device settings
Alarm volume
Display
Date and time

Ventilation programs
Remaining life/charging status
Filter timer
Connectivity
Parameters and set values for the
ventilation programs
In the On state: Remaining device life if
being supplied by battery
In the Standby state: Charging state of
the internal battery in percent assuming
a power supply

5 Settings in the menu
LMT 68651c 02/2022
EN | 17
5.2.2 Report menu in the Patient menu
(usage data)
Information about the parameters in this menu can be found
in the table below.
5.2.3 System menu in the Patient menu
5.2.4 Device settings submenu
PARAMETER DESCRIPTION
Alarm list
Lists the alarms which have occurred.
The log is retained when the alarm
system or the device is switched off.
The start and end of ventilation is
recorded.
The log is retained even if the device is
disconnected from the power supply
and the batteries are removed.
The log can store 1,000 alarms. Once
this capacity limit has been reached,
the oldest alarm is deleted and the
new alarm is saved.
Event list Lists the events that have occurred.
Alarm/event list Lists the alarms and events which have
occurred in chronological order.
Parameter overview
Lists all parameters and set values for
the up to 4 ventilation programs
which can be configured.
Device usage
Obtain information here about the
patient’s therapy (duration, days used,
program proportions) and about
device usage (operating time, internal
battery life remaining or charging
state of internal battery in percent).
Circuit test
Perform a circuit test here on change
of patient and as required. This checks
for resistance, compliance, and leaks
(see “4.5 Performing circuit test”,
page 14).
FiO2 cell Activate or deactivate the FiO2 cell
and calibrate the FiO2 cell here.
Export therapy data
You can export the set device settings
here. A USB flash drive must be
connected for exporting.
Flight mode
You can activate/deactivate flight
mode here. With flight mode
activated, all wireless communication
(Bluetooth) is ended.
Device settings
You can configure the device here
(see “5.2.4 Device settings
submenu”, page 17).
Device status
Obtain information here about the
device (name, type, serial number of
device and components, firmware
version) and about the internal
battery.
PARAMETER DESCRIPTION
Alarm volume
The patient can set the alarm level here.
1= very quiet, 2= quiet, 3= loud,
4= very loud
You can test the alarms here.
Display You can set brightness and display
background here.
Filter timer You can activate and reset the filter
change reminder function here.
Date and time You can set the current date and time
here.
Connectivity
You can activate the Bluetooth
function and pair the device with the
LUISA app here.

6 Hygiene treatment and servicing
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LMT 68651c 02/2022
6 Hygiene treatment and servicing
6.1 Hygiene treatment
6.1.1 General information
• If you would like to use a disinfectant for cleaning
purposes, refer to the instructions for use of the
particular product. Solutions containing alcohol (25 g
ethanol (94 %-strength), 35 g propan-1-ol per 100 g)
are suitable. Recommended: Mikrozid AF liquid or
perform advanced Alcohol EP.
• To prevent foreign bodies being taken in, ensure that
new filters are inserted following cleaning, hygiene
treatment, servicing or repair.
• The following gas route components may be
contaminated following use of the device:
• LMT 31494 Device outlet port
• LMT 31497 Seal for FiO2 cell
• LMT 31496 Flow sensor
• LMT 31505 Nonreturn valve, complete
• LMT 31530 Sound insulation case, pressure side
• LMT 31490 Blower
• LMT 31525 Sound insulation case, intake side
• LMT 31446 Central part of housing
• WM 29389 Fine filter
• LMT 31487 Coarse dust filter
• LMT 31422 Filter holder
6.1.2 Cleaning intervals
6.1.3 Cleaning device
1. Wipe over the housing including the device outlet port,
the power cord, and the display with a damp cloth. Use
water or mild detergent.
2. Clean or replace the mask, circuit, coarse dust filter, fine
filter, filter for the cooling air fan, and the breathing
system filter (see “6.1.2 Cleaning intervals”, page 18).
Consult associated instructions for use.
3. Perform function check (see “6.2 Function check”, page
19).
Cleaning coarse dust filter (gray filter)
1. Open filter compartment.
2. Remove gray coarse dust filter.
3. Wash coarse dust filter under running water.
4. Allow coarse dust filter to dry.
Risk of infection when the device and accessories are
used again!
If the device is used by several patients, infections may be
transmitted to the next patient and the device contaminated.
Do not reuse disposables.
Use the breathing system filter.
INTERVAL ACTION
Weekly Clean device (see “6.1.3 Cleaning device”,
page 18).
Monthly
Clean coarse dust filter (see “Cleaning
coarse dust filter (gray filter)”, page 18).
Replace fine filter (see “Replacing fine filter
(white filter)”, page 19).
Clean filter for cooling air fan (see
“Cleaning filter for cooling air fan”, page
19).
Every
6 months
Replace coarse dust filter (see “Cleaning
coarse dust filter (gray filter)”, page 18).
Risk of injury from electric shock!
Ingress of liquids may lead to a short-circuit, injure the user
and damage the device.
Disconnect the device from the power supply.
Do not immerse the device and accessories in liquids.
Do not pour liquids over the device and accessories.

6 Hygiene treatment and servicing
LMT 68651c 02/2022
EN | 19
5. Replace coarse dust filter in the holder.
6. Close filter compartment.
Replacing fine filter (white filter)
1. Open filter compartment.
2. Remove gray coarse dust filter.
3. Remove and replace white fine filter.
4. Replace coarse dust filter in the holder.
5. Close filter compartment.
Cleaning filter for cooling air fan
1. To open the expiration module compartment on the rear
of the device, turn the latch counterclockwise to the
symbol.
2. Remove cover.
3. Remove filter for cooling air fan.
4. Wash filter under running water.
5. Allow filter to dry.
6. Replace filter in the holder.
7. Close exhalation module compartment.
6.2 Function check
Carry out a function check before using the device for the
first time, after every hygiene treatment, and after every
repair, but at least every 6 months.
1. Check device for external damage.
2. Check connectors, cables, and circuit for external
damage.
3. Check accessories such as the breathing system filter,
external batteries, and SpO2 sensor for external damage.
Follow the associated instructions for use.
4. Check that accessories are connected to the device
correctly (see “4.2 Connecting circuit”, page 12).
5. Connect the device to the power supply (see “4.1
Setting up and connecting device”, page 12).
6. Switch on device (see “4.4 Switch device on and off /
Start and end therapy”, page 14).
The device automatically performs a few function tests
on the sensor system. If the device is fully functional, the
start screen is displayed and the device switches to
standby.
7. Perform a circuit test (see menu: System > Circuit test).
If the circuit test fails, follow the instructions on the
display and troubleshoot the faults.
8. Seal the end of the tube and start ventilation. A brief
acoustic alarm must be audible on starting. The device
automatically performs a few function tests.
The alarm key lights up yellow and red.
9. Compare the pressure shown in the display with the
prescribed pressure.
10. Check the functionality of the batteries:
• Disconnect the device from the power supply.
The first external battery (if present) takes over energy
supply (watch what is shown in display).
• Disconnect the first external battery from the device.
The second external battery (if present) takes over
energy supply.
• Disconnect the second external battery from the
device.
The internal battery takes over energy supply.
11. Check the charging state of the batteries (see “5.2.1
Views menu in the Patient menu”, page 16).
If the batteries are not charged, connect the device to
the power supply to charge the batteries.
12. If a FiO2 cell is in use: Perform FiO2 calibration (see “5.2.3
System menu in the Patient menu”, page 17).

6 Hygiene treatment and servicing
20 | EN
LMT 68651c 02/2022
13. If one of the items is not OK or pressure deviates by > 1
hPa: Do not use device and contact your specialist dealer.
14. If required: Check alarms (see “6.3 Checking alarms”,
page 20).
6.3 Checking alarms
To check alarm functionality, simulate the kind of user error
that triggers the particular alarm.
6.3.1 Non-specialist user
6.4 Servicing
The device is designed for a service life of 10 years.
If the device is used beyond this period, it needs checking by
the manufacturer or by the specialist dealer.
For Germany: In accordance with §11 Medizinprodukte-
Betreiberverordnung [German law governing the owners/
operators of medical devices], the device must be subjected
to a Technical Safety Check [Sicherheitstechnische Kontrolle
(STK)] every 2 years. Country-specific requirements apply to
all other countries.
The internal and the external battery must be replaced every
4 years or after 500 cycles.
The membrane of the nonreturn valve must be replaced
every 4 years.
The blower must be replaced after an operating time of
35,000 h.
ALARM ID NO. REQUIREMENT TEST
Leakage high
(High level of
leakage)
459
On a single circuit with valve: Alarm limit
is set to a value <150 l/m
With leakage circuit:
Alarm limit is set to a value <60 l/m
On a double circuit, 15 mm/22 mm:
Alarm limit is set to a value <60 l/m
On a double circuit, 10 mm: Alarm limit is
set to a value ≤35 l/min
Leave inspiration tube open at patient connection.
Start ventilation.
Wait at least 30 seconds, more alarms may occur
during this period.
Pressure low
(Low airway
pressure, low
pressure on
inspiration)
457 Alarm limit is set to a
value ≥6 hPa
Leave inspiration tube open at patient connection.
Start ventilation.
Exhalation blocked
(Obstruction) 757
Single circuit with valve is connected.
Alternatively
Double circuit is connected.
Connect test lung. Start ventilation.
On a single circuit with valve: Seal exhalation opening
of patient valve.
On a double circuit: Take the expiration tube off the
device inlet port and seal the connection on the tube.
Tidal volume low
(Low volume
exhaled)
450 Double circuit: Alarm limit is set.
Start ventilation.
Take expiration tube off device inlet port.
Wait 3 breaths.
FiO2 low
(Oxygen
concentration)
494
FiO2 cell is fitted and activated.
Alarm limit is set.
No external oxygen supply connected.
Start ventilation.
Battery capacity
low 551 Device is not connected to the power supply.
Start ventilation until the internal battery has
15 minutes’ life remaining before it discharges
completely.
Battery capacity
critical 550 Device is not connected to the power supply.
Start ventilation until the internal battery has
5 minutes’ life remaining before it discharges
completely.
Energy supply via
internal battery 584 None Disconnect power cord from device. Disconnect the cable for the external batteries from the device.