Luisa Manual Beatmung

EN Instructions for Use for devices of type LM150TD
LUISA
Ventilators
Contents
Contents
1 Introduction 3 5 Settings in the menu 15
1.1 Intended use .................................................... 3 5.1 Navigating in the menu ................................. 15
1.2 Description of function ..................................... 3 5.2 Menu structure for patient menu .................. 15
1.3 User qualification ............................................. 3
6 Hygiene treatment and servicing 17
1.4 Indications ........................................................ 3
6.1 Hygiene treatment ........................................ 17
1.5 Contraindications ............................................. 3
6.2 Function check .............................................. 19
1.6 Side effects ...................................................... 4
6.3 Checking alarms ............................................ 20
2 Safety 4 6.4 Servicing ....................................................... 20
2.1 Safety information ............................................ 4 6.5 Disposal ........................................................ 20
2.2 General information ......................................... 5
7 Alarms 21
2.3 Safety information in these instructions for
7.1 Sequence in which alarms are displayed ........ 21
use ...................................................................5
7.2 Muting alarms ............................................... 21
3 Product description 6 7.3 Configuring physiological alarms ................... 21
3.1 Overview .......................................................... 6
7.4 Technical alarms ............................................ 23
3.2 Control panel in display .................................... 7
7.5 Nurse call and remote alarm .......................... 27
3.3 Symbols in display ............................................ 8
3.4 Accessories (optional) ....................................... 8 8 Faults 27
3.5 Operating states ............................................... 9 9 Technical specifications 28
3.6 Batteries ........................................................... 9
10 Annex 33
3.7 Data management/compatibility ..................... 10 10.1 Pneumatic diagram ....................................... 33
4 Preparation and operation 11 10.2 System resistances ......................................... 34
4.1 Setting up and connecting device ................... 11 10.3 Emission of electromagnetic interference ....... 35
4.2 Connecting breathing tube ............................ 11 10.4 Electromagnetic interference immunity .......... 35
4.3 Before first use ............................................... 13 10.5 Markings and symbols ................................... 36
4.4 Switching on device ....................................... 13 10.6 Scope of delivery ........................................... 36
4.5 Starting therapy ............................................. 13 10.7 Accessories .................................................... 37
4.6 Ending therapy/switching off device ............... 13 10.8 Removable parts ............................................ 37
4.7 Performing tube test ...................................... 14 10.9 Warranty ...................................................... 38
4.8 Calibrating FiO2 cell ........................................ 14 10.10 Declaration of Conformity ........................... 38
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1 Introduction
1 Introduction Therapy data are stored in the device and can additionally be
loaded on a USB-C stick and analyzed by PC software.
1.1 Intended use 1.3 User qualification

The LM150TD LUISA ventilator is for the life-support and The person operating the device is referred to in these
non-life-support ventilation of patients who require instructions for use as the user. A patient is the person
mechanical ventilation. It can be used for pediatric or adult receiving the therapy. The patient is also intended to be a
patients with a minimum tidal volume of 30 ml. user. As an owner/operator or user, you must be familiar
The LM150TD is suitable for use in the domestic with the operation of this medical device. Training and
environment, in care facilities and in hospitals, as well as for instruction in operation of the device is absolutely essential
mobile applications, for example in a wheelchair or on a for the user and for the representative of the owner/
transport gurney. It can be used for invasive and non-invasive operator. When the device is handed over to the patient, the
ventilation. The LM150TD is not intended for use as a attending physician or hospital staff must instruct the patient
ventilator during transport or in intensive care. 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
1.2 Description of function accessories associated with the patient before these are
used.
The device is a medical device which may only be used by
The device can be used with both invasive and non-invasive
trained specialists as directed by a physician. Use the device
patient/ventilator interfaces. Leakage ventilation can also be
only as directed by a physician or other medical staff.
used invasively.
Notice for blind or partially-sighted users
A blower takes in ambient air through a filter and pumps it
through the breathing tube and the patient/ventilator An electronic version of the instructions for use is available
interface to the patient. The blower is controlled to suit on the website.
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
1.4 Indications
parameters and alarms.
The device can be used with a leakage circuit, with a single Obstructive ventilation disorders (e.g. COPD), restrictive
circuit with valve or with a double circuit. With leakage ventilation disorders (e.g. scolioses, deformities of the
ventilation, the exhaled air containing CO2 is continuously thorax), neurological, muscular, and neuromuscular
flushed out via an exhalation system. With a single circuit disorders (e.g. types of muscular dystrophy, pareses of the
with valve and with a double circuit, the patient’s exhalation diaphragm), central respiratory regulation disorders, obesity
is controlled by a valve. hypoventilation syndrome, hypoxemic respiratory failure.
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 1.5 Contraindications
humidity. The patient connection is made using accessories
suitable for HFT. HFT mode (if available) and MPV mode are The following contraindications are known - in the individual
not respiration support modes within the meaning of case, responsibility for deciding whether to use the device
standard ISO 80601-2-72. As no permanent and/or sealed rests with the attending physician. Threatening situations
connection is made between the corresponding interfaces have not ever been observed.
and the patient’s airway, some specifications such as
Absolute contraindications:
disconnection detection do not apply.
Severe epistaxis, high risk of barotrauma, pneumothorax or
Oxygen can be supplied via the oxygen inlet.
pneumomediastinum, pneumoencephalus, status following
If required, the FiO2 concentration delivered by the device brain surgery and following surgical procedures on the
can be measured using an integrated FiO2 sensor. External hypophysis or middle or inner ear, acute inflammation of the
SpO2 measurement can also be connected. nasal sinuses (sinusitis), middle ear infection (otitis media) or
The power is supplied by an external power supply unit. perforated eardrum. Mask ventilation must not be used in
The device has an integrated battery, so it can continue to be particular in the case of significant swallowing problems
operated without interruption in the event of a power (bulbar syndrome) with the risk of aspiration.
outage. In addition, a maximum of two external batteries
can be connected to operate the device.
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2 Safety
Relative contraindications:  Only use accessory parts from the manufacturer.

Cardiac decompensation, severe cardiac arrhythmias, severe  Do not use antistatic or electrically-conductive tubes.
hypotension, especially in combination with intravascular  The accuracy of the device may be impaired by the gas
volume depletion, head injury, dehydration. supplied by a pneumatic nebulizer.
 Regularly check the breathing system filter for increased
resistance and blockages. Moistening with nebulizers or
1.6 Side effects humidifiers may increase the resistance of breathing
system filters and thus change the therapeutic pressure
delivered. In order to prevent increased resistance and
When using the device, the following undesired side effects blockages, replace the breathing system filter more
may occur in short-term or long-term use: Pressure points frequently.
from the mask and the forehead cushion on the face,  Set up external humidifiers below the device and the
reddening of the facial skin, dry throat, mouth, nose, feeling patient connection. Water in the device may damage
of pressure in the sinuses, irritated conjunctiva in the eyes, the device or injure the patient.
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
2.1.2 Electromagnetic compatibility
devices of type LM150TD. 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
2 Safety 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
2.1 Safety information 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-
2.1.1 Handling the device, the frequency surgical equipment.
components and the accessories  Operate the device within the EMC environment
specified for this device (see "10.4 Electromagnetic
If the device is damaged or its function is restricted, people interference immunity", page 35) in order to prevent
may be injured. key performance characteristics being affected - for
 Only operate the device and its components if they are example, ventilation parameters being affected by
externally undamaged. electromagnetic interference.
 Perform a function check at regular intervals (see "8.2  Do not operate the device if the housing, cables or other
Function check", page 44). equipment for electromagnetic shielding are damaged.
 Only operate, store and transport the device within the  The use of third-party accessories, third-party inverters
specified ambient conditions (see "9 Technical and third-party cables may lead to increased
specifications", page 46). electromagnetic interference or reduced
 Always keep an alternative means of ventilation to hand electromagnetic interference immunity of the device
in order to avoid a life-threatening situation if the device and to faulty operation. Only use original connecting
fails. cables from the manufacturer.
 Keep small parts which may be inhaled or swallowed  Do not operate the device in the immediate vicinity of
away from young children in particular. other devices or in a stacked arrangement, otherwise
 Do not use the device in an MRT environment or in there may be malfunctions. If it is necessary to operate
a hyperbaric chamber. the device in the immediate vicinity of other devices or
in a stacked arrangement, keep all the devices under
 Do not reuse disposables. Disposables may be
observation to ensure that they are all operating
contaminated and/or their function may be impaired.
properly.
 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.
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2 Safety
2.1.3 Energy supply 2.2 General information

Operating the device outside the specified energy supply
may injure the user, damage the device or impair the • In order to react to an alarm and, if necessary, to use
performance of the device and injure the patient. emergency ventilation, you must subject both patient
 Operate the power supply unit only at voltages from and device to regular monitoring.
100 V to 240 V.
• The use of third-party articles may lead to incompatibility
 Use DC cable LMT 31597 for operation on voltages of
12 V or 24 V. with the product. In such cases, please be aware that any
 Keep access to the power supply connector and the claim under warranty and liability will be void if original
power supply free at all times. spare parts are not used.
 When using a battery-operated wheelchair: Connect • Connection by cable to a patient monitor is not a
the device to the wheelchair battery only if a connection substitute for a remote alarm system. Alarm data are
of that kind is expressly provided in the instructions for transmitted only for documentation purposes.
use for the wheelchair.
 When operating using the cigarette lighter socket in a • Have measures such as repairs, servicing, and
car: Disable the car’s auto start/stop feature. Start the maintenance work, as well as modifications to the
car first, then connect the device. product, carried out exclusively by the manufacturer or
by specialists expressly so authorized by the
2.1.4 Handling oxygen manufacturer.
Supplying oxygen without a special safety device can lead to • Connect only the licensed products and modules in
fire and injure people. accordance with these instructions for use. The products
 Follow the instructions for use for the oxygen supply must meet the product standard applicable to them.
system. Non-medical equipment should be positioned out of the
 Set up oxygen sources at a distance of over 1 m from patient's vicinity.
the device.
• Follow the section on hygiene treatment (see "6 Hygiene
 The oxygen rate supplied in l/min must not exceed the
treatment and servicing", page 17) to avoid infection or
oxygen flow prescribed by the physician.
bacterial contamination.
 The oxygen rate supplied in l/min may not exceed the
set HFT flow rate. • In the event of a power outage, all settings including
 At the end of therapy, shut off the oxygen supply and alarm settings are retained.
allow the device to run on briefly to flush residual
oxygen out of the device. • In the EU: As a user and/or patient, you must report any
serious incident occurring in conjunction with the
product to the manufacturer and to the responsible
2.1.5 Transport authority.
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. 2.3 Safety information in
 Only operate the device in the associated LUISA mobility
bag. these instructions for use
 Transport or store the device in the associated LUISA
protective bag. Indicates an unusually significant
hazardous situation. If you ignore this
2.1.6 Wireless module instruction, severe irreversible or fatal
injuries may result.
The device contains a wireless module. Operating the device Indicates a hazardous situation.
in the immediate vicinity of people and/or other antennas If you ignore this instruction, mild or
may injure people, damage the device or impair device moderate injuries may result.
performance. Indicates a harmful situation.
 Set up the device at least 20 cm away from any people. If you ignore this instruction, material
 Do not set up or operate the device with other damage may result.
antennas.
Indicates useful information within
procedures.
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3 Product description
3.1 Overview
1 2 3 4 5 6
23
22 12
21 7 8 9 10 11
13
18 17
14
20 16 15
19
1 External battery connection 13 Filter compartment with coarse dust filter and fine filter
2 Connection for monitor/prismaHUB 14 Compartment for internal battery
3 USB-C connection 15 Exhalation tube connection
4 Nurse call system connection 16 Device outlet port
5 Power supply indicator 17 Handle
6 Alarm acknowledgement key 18 On/off key
7 Pressure measuring tube connection 19 Power supply unit with power supply unit cable
8 Valve control tube connection 20 Power cable
9 SpO2 connection 21 O2 supply connection
10 CO2 connection (not in use) 22 Loudspeaker
11 Nebulizer connection (not in use) 23 Power supply unit connection
12 Breathing tube
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3.2 Control panel in display
9 2
8 5
7 6
1
1 Status line - symbols indicate current device status (e.g. accessories connected, battery capacity).
2 Alarm 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.
3 Home key - switches the view back to the home screen.
4 Menu keys - provide access to the individual menus.
5 Display lock key - locks or unlocks the display, so that no settings can be changed as a result of incorrect contact.
6 Dimmer 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.
8 Ventilation key - starts or stops ventilation.
9 Access key - locks or unlocks the expert menu.
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3.3 Symbols in display SYMBOL DESCRIPTION
Network connection present.

SYMBOL DESCRIPTION Green: Bluetooth® (wireless technology)
activated.
Device in patient menu. Expert menu locked.
Gray: Bluetooth® (wireless technology)
not activated.
Expert menu enabled.
Flight mode activated.
Indicates respiratory status:
• Arrow pointing upward: Inspiration Green: USB flash drive connected.
• Arrow pointing downward: Exhalation Gray: USB flash drive faulty.
• S: Spontaneous breath
• T: Mandatory breath Low-priority alarm triggered.
Device set for pediatric applications/children.

Medium-priority alarm triggered.
Device set for adults.

High-priority alarm triggered.
Leakage ventilation set. All physiological alarms have been

deactivated.
Single circuit with valve set.
Acoustic signal for alarm paused.
Double circuit set.
Battery charging. If the gray area reaches 3.4 Accessories (optional)

the top, the battery is fully charged.
Battery capacity high, battery discharging. PART DESCRIPTION

For remote transmission and display
VENTIremote alarm of the alarm signals output by the
Battery capacity medium, battery discharging. device
Determines SpO2 and pulse
SpO2 sensor
Battery capacity low, battery discharging. frequency data
Prevents the transmission of particles
Breathing system
Battery capacity low. and microorganisms to the breathing
filter
system
Battery error Performs permanent FiO2
FiO2 cell
measurement
Filter change function (only if function is Supplies the patient with respiratory
activated). Circuit
air
Service reminder function (only if function Routes exhaled air into the
Exhalation valve
is activated). environment
SpO2 sensor: Serves as an additional external
External battery
Gray: Not connected energy supply for the device
Green: Connected and high signal quality Protective bag for Serves to transport and store the
Yellow: Connected and moderate signal LUISA device with protection
quality
Red: Connected and poor signal quality Follow the instructions for use for the accessories.
FiO2 sensor Here you will find further information about
Green: Activated and full operation and combining accessories with the device.
Gray: Activated and empty
Green and flashing: Calibration process in
progress
Patient monitor connected.

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3.5 Operating states 3.6.2 External batteries

• External batteries can be connected to the device as an
• On: Therapy is in progress. It is possible to make device additional energy supply. If the device is connected to
and therapy settings. the power supply, the batteries are charged; first the
internal battery, then the external batteries. In operation
• Standby: The blower is off and therapy is not in
via a 12 V or 24 V supply, the batteries are charged only
progress. However, the device is ready for operation
when the device is in the Standby or Off state.
immediately. It is possible to make device and therapy
settings. • If no power supply is connected, a battery supplies the
device. The external batteries connected are discharged
• Off: The device is switched off. No settings can be made
first, followed by the internal battery.
and the display remains dark.
3.6.3 Display of remaining device life

3.6 Batteries Remaining device life in the case of battery and power supply
operation is displayed in the status line and in the Views
3.6.1 Internal battery menu (see "5.2.1 Menu views in the patient menu",
page 15).
• The device is fitted with an internal battery. If the device
DEVICE ON DEVICE DELIVERING
is no longer connected to the power supply or there is a STANDBY THERAPY
power outage, the battery automatically starts supplying POWER SUPPLY Value in % Value in %
the device without interruption. This discharges the
Value in % Remaining battery life
battery. The battery is charged automatically again as BATTERY SUPPLY in h and min
soon as the device is connected to the power supply.
In operation via a 12 V or 24 V supply, the battery is Remaining life is a prediction and always relates to the
charged only when the device is in the Standby or current mean consumption of the device.
Off state. Following the start of ventilation, no more than 3 minutes
will elapse before remaining life is displayed.
• The internal battery is replaced by the manufacturer or
by a specialist dealer so authorized by the manufacturer.
• Battery life depends on ventilation settings and ambient
temperature (see "9 Technical specifications", page 28).
• 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.
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3.7 Data management/

compatibility
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.
3.7.1 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.
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
stick 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.
3.7.2 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.
3.7.3 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.
In the System menu, check whether the Bluetooth®
(wireless technology) function is activated.
After the first pairing operation, the app will recognize the
Bluetooth connection of the device. The pairing does not
then need to be performed again.
The saved pairing connection can be deleted in the
LUISA app.
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4 Preparation and operation
4 Preparation and
operation
4.1 Setting up and connecting
device
Risk of injury from inadequate therapy if air inlet and

air outlet are blocked! 2. Connect the power cable to the power supply unit and
A blocked air inlet and/or air outlet can cause the device to the socket.
overheat, impair therapy and damage the device. 3. Connect the power supply unit cable to the device.
 Keep the air inlet clear.
 Keep the filter compartment clear (symbol ). Alternatively, you can connect a direct voltage
 Keep the outlet for the patient’s exhaled air free electricity supply (12 VDC or 24 VDC) as per
(symbol ). ISO 80601-2-72.
 Keep the intake opening for the cooling system free
(symbol ).
4.2 Connecting breathing tube
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.
1. If required: Tilt the device in a horizontal or vertical

position.
The display adapts to the orientation automatically.
Risk of injury from incorrectly routed tubes and
cables!
Incorrectly routed tubes or cables may injure the patient.
 Do not route tubes and cables along the neck.
Material damage from overheating!  Do not crush tubes and cables.
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.
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4.2.1 Connecting leakage circuit 4.2.3 Connecting double circuit

1
1 2
1. Push the breathing tube onto the device outlet port. 1. Push the free end of the breathing tube 1 onto the
device outlet port.
2. Connect the invasive or non-invasive patient/ventilator
interface to the leakage circuit (see instructions for use 2. Push exhalation tube 3 onto the device inlet for exhaled
for the patient/ventilator interface). air.
3. Connect the pressure measuring tube 2 to
4.2.2 Connecting single circuit with connection P .
valve 4. Connect the patient/ventilator interface (e.g. mask) to
the Y-piece of the circuit.
4.2.4 Connecting circuit for mouthpiece

Risk of injury if patient valve is covered! ventilation
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.
1. Push the free end of the breathing tube onto the device
outlet port.
2. Connect mouthpiece to the tube (see instructions for use
1. Push the free end of the breathing tube onto the device for the patient/ventilator interface).
outlet port.
As an alternative to the leakage circuit, it is also
2. Connect the pressure measuring tube to possible to use a single circuit with valve or double
connection P . circuit for mouthpiece ventilation.
3. Connect the valve control tube to connection .
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4.2.5 Connecting the circuit for Alternatively

In battery mode: Press and hold On/off key for
HFT mode approx. 1 second.
The device automatically performs a few function tests.
The alarm system is tested automatically. If the device is
fully functional, the home screen is displayed and the
1 device switches to standby.
4.5 Starting therapy

2 Requirement
• Device is set up and connected (see "4.1 Setting up and
connecting device", page 11).
4 3
• Patient/ventilator interface is connected (see instructions
1. Push the free end of short breathing tube 1 onto the for use for patient/ventilator interface).
device outlet port.
• Device is switched on (see "4.4 Switching on device",
2. Push the other end of short tube 1 onto the connection page 13).
for humidifier chamber 4 marked In.
3. Push long breathing tube 3 onto the connection for
humidifier chamber 4 marked Out.
4. Connect High Flow interface 2 to long tube 3. Risk of injury from a device with restricted function.
If the device is damaged or its function is restricted, the
5. If necessary, connect the tube heater and temperature
patient may be injured.
probe to breathing tube 3 (see instructions for use for
 Only operate the device and its components if they are
external humidifier).
externally undamaged.
As an alternative to the leakage circuit, it is also  Perform a function check at regular intervals.
possible to use the single circuit with valve or the  Do not use the device if the automatic function check
double circuit in HFT mode. issues error messages.
 Always keep an alternative means of ventilation to
hand.
4.3 Before first use 1. If required: Turn device to a horizontal or vertical
position.
The device must be configured before being used for the first 2. Briefly press On/off key .
time. If your specialist dealer has not yet done so, you must Alternatively
set language and time on the device. Press the Start ventilation ventilation key in the display.
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. 4.6 Ending therapy/switching
off device
4.4 Switching on device
1. Press On/off key .
Alternatively
Requirement
Press the Stop Ventilation ventilation key in the display
• Device is set up and connected (see "4.1 Setting up and long enough for the green progress bar to run through
connecting device", page 11). completely. Confirm the end of therapy.
The device switches to standby.
• Patient/ventilator interface is connected (see instructions
for use for patient/ventilator interface). 2. To switch off the device completely, press On/off key
on the display long enough for the message Shut
1. Briefly press On/off key . down device to disappear and the display to go dark.
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4.7 Performing tube test

Perform a tube test at every function check, on change of
patient and as required. This checks for resistance,
compliance and leaks.
Requirement
Type of tube used is selected in the Ventilation menu.
1. Connect tube, patient/ventilator interface (e.g. mask)
and accessories to the device. If present: Disconnect the
connection to the patient.
2. Select the System > Tube test menu.
3. In the Tube test overview area, press the Start key.
4. Press the Ok key to start the tube test.
5. Remove the patient/ventilator interface so that the tube
is open.
6. In order to continue with the tube test, press the
Continue key.
7. If the tube test is successful, press the Finish key.
If the tube test is not successful, follow the instructions
in the display and eliminate the faults.
4.8 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).
Calibration is performed in the System > FiO2 cell >
Start calibration menu.
1. Disconnect the FiO2 supply.
2. Press the Ok key to start calibration.
3. If calibration is successful, press the Finish key.
If calibration is not successful, follow the instructions in
the display and eliminate the faults.
4. Reconnect the FiO2 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 an authorized specialist dealer.
To stop the alarm occurring, you can deactivate the
cell in the System > FiO2 cell menu.
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5 Settings in the menu
5.1 Navigating in the menu
ACTION FUNCTION ACTION FUNCTION
Function keys have a gray Opens range of values for setting
Press on value
background and the function is ventilation parameters
displayed on the key in text or as Move range of values
Decrease or increase value
a symbol (e.g. System, Start up or down
ventilation, or .
Press function key Confirm value
Symbols on a black background are
not function keys, but serve to Discard selection
provide information about device
status (see "3.3 Symbols in display", Switches the view back to the home
page 8). screen
Scroll in list Navigate up or down
5.2 Menu structure for patient menu
Ventilation programs
Remaining life/charging status
Alarm list
Tube test
Event list
FiO2 cell
Alarm/event list Alarm volume
Export therapy data
Trends Display
p y
Flight mode Language
Parameter overview
Device settings Date and time
Device usage
Device status
5.2.1 Menu views in the patient menu In the On state: Remaining device life if
being supplied by battery
The Views menu shows 2 views. In the Standby state: Charging state of
the internal battery in percent assuming
a power supply
Parameters and set values for the
ventilation programs 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.
LMT 68651 11/2020
EN | 15
5.2.2 Report menu in the patient menu 5.2.4 Device settings submenu
(usage data)
Information about the parameters in this menu can be found PARAMETER DESCRIPTION
in the table below. The patient can set the alarm level here.
1= very quiet, 2= quiet, 3= loud, 4=
PARAMETER DESCRIPTION Alarm volume
very loud
Lists the alarms which have occurred. You can test the alarms here.
The log is retained when the alarm You can set brightness, orientation,
system or the device is switched off. Display
and the screen background here.
The start and end of ventilation is
You can set the language and, if
recorded.
Language required, another language for the
The log is retained even if the device is
Alarm list alarm messages here.
disconnected from the power supply
and the batteries are removed. You can set the current date and time
Date and time
The log can store 1,000 alarms. Once here.
this capacity limit has been reached,
the oldest alarm is deleted and the 5.2.5 Ventilation menu
new alarm is saved.
Event list Lists the events that have occurred. The Ventilation menu shows the settings of the current
Lists the alarms and events which have ventilation parameters. The parameters which can be
Alarm/event list displayed and modified vary depending on the ventilation
occurred in chronological order.
mode set.
Displays daily summaries (median and
Trends In the Ventilation menu, you can
percentiles) for selected signals.
Lists all parameters and set values for • select a ventilation mode
Parameter overview the up to 4 ventilation programs
which can be configured. • set ventilation parameters
Obtain information here about the • set a circuit
patient’s therapy (duration, days used,
program proportions) and about • select the patient type: Child or adult
Device usage
device usage (operating time, internal
battery life remaining or charging 5.2.6 Alarms menu
state of internal battery in percent).
Obtain information here about the The Alarms menu shows the alarms and alarm limits set for
device (name, type, serial number of the selected ventilation mode. You can adjust the values.
Device status
device and components, firmware
version).
5.2.3 Menu system in the patient menu

Perform a tube test here on change of
Tube test patient and as required. This checks
for resistance, compliance and leaks.
Activate or deactivate the FiO2 cell
FiO2 cell
and calibrate the FiO2 cell here.
You can export the set device settings
Export therapy data
here.
You can activate/deactivate flight
mode here. With flight mode
Flight mode
activated, all wireless communication
(Bluetooth) is ended.
Device settings You can configure the device here.
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16 EN
6 Hygiene treatment and servicing
6.1 Hygiene treatment 6.1.2 Cleaning intervals
INTERVAL ACTION
Clean device (see "6.1.3 Subjecting device
Weekly
to a hygiene treatment", page 17).
Clean coarse dust filter (see " Cleaning
Risk of infection when the device is used again! coarse dust filter (gray filter)", page 18).
If the device is used by several patients, infections may be
Replace fine filter (see " Replacing fine filter
transmitted to the next patient and the device contaminated.
Monthly (white filter)", page 18).
 Do not reuse disposables.
Clean filter for cooling air fan
 Use the breathing system filter.
(see " Cleaning filter for cooling air fan",
page 19).
Every Replace coarse dust filter (see " Cleaning
6 months coarse dust filter (gray filter)", page 18).
Risk of injury due to contaminated or infected patient • Have the device subjected to a hygiene
circuit!
A contaminated or infected patient circuit may transmit treatment by the manufacturer or by an
contamination or infections to the next patient. authorized specialist dealer in line with
 Do not reprocess disposable circuits. the service and repair instructions. The
Keredusy process can be used as an
6.1.1 General information alternative to manual disinfection.
On change
• Clean or replace the exhalation module.
of patient
• Wear appropriate safety gear (e.g. safety gloves) for the The black exhalation module (included
disinfecting process. in scope of delivery) is a disposable and
must be replaced. The black translucent
• Follow the instructions for use for the disinfectant used.
exhalation module (has to be ordered
Solutions containing alcohol (25 g ethanol (94 %-
separately) is suitable for autoclaving.
strength), 35 g propan-1-ol per 100 g) are suitable.
Set device to factory settings.
Recommended: Mikrozid AF liquid or perform advanced
Alcohol EP.
6.1.3 Subjecting device to a hygiene
• Following a hygiene treatment by the authorized
specialist dealer, the device is suitable for using again treatment
with other patients.
• The following gas route components may be
contaminated following use of the device:
Risk of injury from electric shock!
• LMT 31494 Device outlet port Ingress of liquids may lead to a short-circuit, injure the user
• LMT 31497 O2 measuring cell seal and damage the device.
 Disconnect the device from the power supply before the
• LMT 31496 Flow sensor hygiene treatment.
• LMT 31505 Nonreturn valve, complete  Do not immerse the device and components in liquids.
 Do not pour liquids over the device and components.
• LMT 31530 Sound insulation case, pressure side
1. Wipe over the housing including the device outlet port,
• LMT 31490 Blower the power cable, and the display with a damp cloth.
Use water or mild detergent.
• LMT 31525 Sound insulation case, intake side
2. Replace the mask, breathing tube, coarse dust filter, fine
• LMT 31446 Central part of housing filter, filter for the cooling air fan, and the breathing
• WM 29389 Fine filter system filter.
3. Perform function check (see "6.2 Function check",
• LMT 31487 Coarse dust filter
page 19).
• LMT 31422 Filter holder
LMT 68651 11/2020
EN | 17
Cleaning coarse dust filter (gray filter) Cleaning exhalation module
1. Open filter compartment flap.

2. Remove gray coarse dust filter.
3. Wash coarse dust filter under running water. 1. To open the exhalation module compartment on the
4. Allow coarse dust filter to dry. rear of the device, turn the latch counterclockwise to the
symbol.
5. Replace coarse dust filter in the holder.
2. Remove cover.
6. Close filter compartment flap.
3. Remove exhalation module.
Replacing fine filter (white filter)
1. Open filter compartment flap.

2. Remove gray coarse dust filter.
3. Remove and replace white fine filter. Only the black translucent module is suitable for
cleaning. The black module is a disposable and must
4. Replace coarse dust filter in the holder.
be replaced.
5. Close filter compartment flap. 4. Remove membrane from the exhalation module.
5. Wipe over exhalation module and membrane with
disinfectant.
Both parts can be disinfected in an autoclave at 134 °C
and 3.15 bar with a process time of 5 minutes
(maximum 50 cycles).
6. Check exhalation module for cracks and damage. If
necessary: Replace exhalation module.
7. Leave exhalation module and membrane to dry.
8. Put membrane back on exhalation module.
9. Replace exhalation module in the compartment.
10. Close exhalation module compartment.
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18 EN
Cleaning filter for cooling air fan 10. Check the functionality of the batteries:
1. Open exhalation module compartment (see " Cleaning • Disconnect the device from the power supply.
exhalation module", page 18). 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 Menu views in the patient menu", page 15).
If the batteries are not charged, leave the device
connected to the power supply to charge batteries.
2. Remove filter for cooling air fan. 12. If a FiO2 measuring cell is in use: Perform FiO2 calibration
(see "5.2.3 Menu system in the patient menu",
3. Wash filter under running water.
page 16).
4. Allow filter to dry.
13. If one of the items is not OK or pressure deviates by
5. Replace filter in the holder. > 1 hPa: Do not use device and contact your specialist
6. Close exhalation module compartment. dealer.
14. If required: Check alarms (see "6.3 Checking alarms",
page 20).
6.2 Function check
Carry out a function check before using the device for the
first time, after every hygiene treatment and repair, but at
least every 6 months.
1. Check device for external damage.
2. Check connectors, cables, and breathing tube 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 components are connected to the device
correctly (see "4.2 Connecting breathing tube",
page 11).
5. Connect the device to the power supply
(see "4.1 Setting up and connecting device", page 11).
6. Switch on device (see "4.4 Switching on device",
page 13).
The device automatically performs a few function tests
on the sensor system. If the device is fully functional, the
home screen is displayed and the device switches to
standby.
7. Perform a tube test (see: System > Tube test menu).
If the tube test is failed, proceed according to the
troubleshooting table (see "8 Faults", page 27).
8. Seal the end of the tube and start ventilation. A brief
alarm signal must be audible on starting. The device
automatically performs a few function tests.
The alarm key lights up yellow and red.
LMT 68651 11/2020
9. Compare the pressure shown in the display with the

prescribed pressure.
EN | 19
6.3 Checking alarms
6.3.1 Non-specialist user
(patient or relatives)
ALARM ID NO. REQUIREMENT TEST
On a single circuit with valve:
Alarm limit is set to a value <150 l/m
With leakage ventilation: Leave breathing tube open at patient connection.
Leakage high
Alarm limit is set to a value <60 l/m Start ventilation.
(High level of 459
On a double circuit, 15 mm / 22 mm: Wait at least 30 seconds, more alarms may occur
leakage)
Alarm limit is set to a value <60 l/m during this period.
On a double circuit, 10 mm:
Alarm limit is set to a value < 35 l/min
Pressure low
(Low airway
Alarm limit is set to a Leave breathing tube open at patient connection.
pressure, low 457
value  6 hPa Start ventilation.
pressure on
inspiration)
Connect lung bag. Start ventilation.
Exhalation Single circuit with valve is connected. On a single circuit with valve: Seal exhalation opening
blocked 757 Alternatively of patient valve.
(Obstruction) Double circuit is connected. On a double circuit: Take the exhalation tube off the
device and seal the connection on the tube.
Start ventilation.
Tidal volume low
Disconnect breathing tube at the exhalation
(Low volume 450 Double circuit: Alarm limit is set.
connection of the device.
exhaled)
Wait 3 breaths.
FiO2 low O2 cell is fitted and activated.
Start ventilation.
(Oxygen 494 Alarm limit is set.
concentration) No external oxygen supply available.
Start ventilation until the internal battery has
Battery capacity Device is not connected to the power
551 15 minutes’ life remaining before it discharges
low supply.
completely.
Start ventilation until the internal battery has
Battery capacity Device is not connected to the power
550 5 minutes’ life remaining before it discharges
critical supply.
completely.
Energy supply via Disconnect power cable from device. Disconnect the
584 None
internal battery cable for the external batteries from the device.
6.4 Servicing The membrane of the nonreturn valve must be replaced

every 4 years.
The blower must be replaced after an operating time of
The device is designed for a service life of 10 years. 35,000 h.
If the device is used beyond this period, it needs checking by
the manufacturer or by an authorized specialist dealer.
6.5 Disposal
For Germany: In accordance with §11 of the German law
governing the owners/operators of medical devices Do not dispose of the product or any batteries present with
[Medizinprodukte-Betreiberverordnung], the device must be domestic waste. To dispose of these items properly, contact
subjected to a Technical Safety Check [Sicherheitstechnische a licensed, certified electronic waste disposal merchant. This
Kontrolle (STK)] every 2 years. Country-specific requirements address is available from your Environment Officer or from
apply to all other countries. your local authority.
The internal and the external battery must be replaced every The device packaging (cardboard and inserts) can be
LMT 68651 11/2020
4 years or after 500 cycles. disposed of in paper recycling facilities.
|
20 EN
7 Alarms
7 Alarms 7.3 Configuring physiological

alarms
A distinction is made between two types of alarm:
Physiological alarms relate to ventilation of the patient. All physiological alarms are deactivated on delivery or when
Technical alarms relate to configuration of the device. the device is reset to factory settings. The attending
The technical alarms are active and cannot be configured. physician can decide which physiological alarms are
activated and make the alarm settings suitable for the
patient. Various alarms can be configured depending on the
7.1 Sequence in which alarms ventilation mode selected.
Following a power supply outage of < 30 seconds, the set
are displayed alarm settings are restored automatically.
Alarms are divided into the three priority levels low ,

medium and high .
If several alarms are triggered simultaneously, the highest- Risk of injury due to extreme alarm limit settings!
Alarm limits set to an extreme value may make the alarm
priority alarm is always shown first. The lower-priority alarm
system unusable and put the patient at risk.
is retained and is displayed again once the higher-priority
alarm has been rectified.  Set sensible alarm limits.
7.2 Muting alarms

Risk of injury due to different alarm presets in
different clinical spheres!
FUNCTION ACTION
All physiological alarms are deactivated on delivery or on
Press alarm acknowledgement key resetting the device to factory settings. It can put the patient
briefly. at risk if different alarm settings are used in different clinical
If the alarm persists, the alarm is muted spheres.
Acknowledge
for 120 seconds. The fault continues to  Make identical alarm settings in different spheres.
alarm
be displayed in the status line and the
 Before using the device, check whether the alarm
alarm acknowledgement key flashes
presets are suitable for the patient.
until the fault has been rectified.
Mute all acoustic
Press and hold alarm acknowledgement
alarm signals for
key .
2 minutes
Suspend alarm Press alarm acknowledgement key
muting again briefly.
DISPLAY CODE CAUSE ACTION

Apnea
458 No spontaneous breathing within set time. Check therapy and alarm settings.
Pressure high
456 Maximum pressure exceeded. Check therapy and alarm settings.
Minimum therapy pressure undershot. Clean/change dirty filters.

Pressure low Patient/ventilator interface leaking. Re-adjust patient/ventilator interface.
457
Patient/ventilator interface defective. Replace patient/ventilator interface.
Settings implausible. Check therapy and alarm settings.
Frequency high
453 Maximum respiratory frequency exceeded. Check therapy and alarm settings.
Frequency low
452 Minimum respiratory frequency undershot. Check therapy and alarm settings.
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EN | 21
7 Alarms

Check connection from device to patient/
Leakage high ventilator interface at the patient via the
459 Leak breathing tube.
Check that the patient/ventilator interface is in
position correctly.
Minute volume high
455 Maximum minute volume exceeded. Check therapy and alarm settings.
Minute volume low

454 Minimum minute volume undershot. Check therapy and alarm settings.
Ventilation parameter settings not suitable

Pulse high (upper alarm setting for patient pulse
493 Check therapy and alarm settings.
frequency exceeded).
Alarm settings implausible
Pulse low Alarm settings implausible (lower alarm
492 setting for patient’s pulse frequency Check therapy and alarm settings.
undershot).
SpO2 high
Upper alarm setting for patient's oxygen
491 Check therapy and alarm settings.
saturation exceeded.
Check patient/ventilator interface and replace
Patient/ventilator interface faulty or defective.
if necessary.
SpO2 low Oxygen supply faulty or inadequate.
490 Ventilation parameter settings not suitable.
Alarm settings implausible (lower alarm Check therapy and alarm settings.
setting for patient’s oxygen saturation
undershot).
Find and eliminate leak. If necessary:
Leak in breathing tube.
Replace breathing tube.
Check oxygen sensor or exhalation module
Leak in pneumatic unit (oxygen sensor or and fit correctly (see , p. 18).
exhalation module). Perform tube test (see 4.7, p. 14).
Patient breathing as well. Check therapy settings.

Tidal volume low
450 Filter dirty. Clean/change filter.
Adjust headgear/headband so that the
Patient/ventilator interface leaking.
patient/ventilator interface seals.
Patient/ventilator interface defective. Replace patient/ventilator interface.
Settings implausible (lower alarm setting for
Check therapy and alarm settings.
tidal volume exceeded).
Minimum volume is not reached within the
Check therapy and alarm settings.
specified time in MPVv mode.
Tidal volume high
451 Patient breathing as well. Check therapy settings.
Check whether the prescribed oxygen flow is

Oxygen flow set too low. set correctly at the oxygen source. Check
FiO2 low settings.
494 Leakage Find and eliminate leak.
Oxygen supply interrupted. Check oxygen supply and connections.
Oxygen sensor incorrectly calibrated. Calibrate oxygen sensor.
Check whether the prescribed oxygen flow is
FiO2 high Oxygen supply too high due to incorrectly-set
set correctly at the oxygen source. Check
495 oxygen flow.
LMT 68651 11/2020
settings.
Oxygen sensor incorrectly calibrated. Calibrate oxygen sensor.
|
22 EN
7 Alarms
7.4 Technical alarms

Service necessary. Please Technical fault which can only be
get in touch with your Various eliminated by an authorized specialist Have device repaired.
specialist dealer/contact. dealer.
Intake air temperature
high Operate device at an ambient temperature
262 Ambient temperature too high.
of 5 °C to 40 °C.
Main board temperature

high Ambient temperature too high. Operate device at an ambient temperature
263
of 5 °C to 40 °C.
Computer module
temperature high Ambient temperature too high. Operate device at an ambient temperature
264
of 5 °C to 40 °C.
Unable to reach flow

364 Set flow not reached. Check flow setting and accessories.
Disconnection, device
outlet port Circuit is not connected to the device
460 Check circuit and tube connections.
correctly or is not connected at all.
Disconnection, airway
Pressure measuring tube is not
pressure
461 connected to the device correctly or is Check pressure measuring tube.
not connected at all.
Disconnection,
Circuit and/or exhalation module is not
exhalation module Check circuit, tube connections, and exhalation
463 connected to the device correctly or is
module.
not connected at all.
Disconnection, patient Device operated with open patient/

ventilator interface (mask not applied). Check circuit, tube connections, and patient/
464
Circuit is not connected to the device ventilator interface at the patient.
Temperature of battery
Battery will switch off due to temperature.
E1 critically high
547 External battery 1 too warm. Operate device at an ambient temperature
of 5 °C to 40 °C.
E2 critically high
548 External battery 2 too warm. Operate device at an ambient temperature
of 5 °C to 40 °C.
Internal battery fault

Contact your specialist dealer. Have internal
549 Internal battery defective.
battery replaced.
Battery capacity critical

Battery discharged (remaining battery
550 Connect the device to the power supply.
life: 5 minutes)
Battery capacity low

Battery discharged (remaining battery
551 Connect the device to the power supply.
life: 15 minutes)
No internal battery
Contact your specialist dealer. Have internal
553 No internal battery.
LMT 68651 11/2020
battery inserted.
EN | 23
7 Alarms

Temperature of internal
battery critically high
555 Internal battery too warm. Operate device at an ambient temperature
of 5 °C to 40 °C.
Internal battery
Battery has switched off due to temperature.
overheated
556 Internal battery overheated. Operate device at an ambient temperature
of 5 °C to 40 °C.
Unable to charge
internal battery Contact your specialist dealer.
558 Internal battery defective.
Have battery replaced.
battery high Operate device at an ambient temperature
559 Internal battery too warm.
of 5 °C to 40 °C.
battery low Operate device at an ambient temperature
560 Internal battery too cold.
of 5 °C to 40 °C.
Internal battery life at an

end Contact your specialist dealer. Have battery
561 Internal battery life at an end.
replaced.
E1 battery life at an end

External battery 1 life at an end. Replace battery.
562
E2 battery life at an end

External battery 2 life at an end. Replace battery.
563
Battery E1 overheated Battery has switched off due to temperature.

564 External battery 1 overheated. Operate device at an ambient temperature
of 5 °C to 40 °C.
Battery E2 overheated Battery has switched off due to temperature.
565 External battery 2 overheated. Operate device at an ambient temperature
of 5 °C to 40 °C.
Unable to charge battery
E1
566 External battery 1 defective. Contact your specialist dealer.
Unable to charge battery

E2
567 External battery 2 defective. Contact your specialist dealer.
E1 high Operate device at an ambient temperature
568 External battery 1 too warm.
of 5 °C to 40 °C.
E2 high Operate device at an ambient temperature
569 External battery 2 too warm.
of 5 °C to 40 °C.
E1 low Operate device at an ambient temperature
570 External battery 1 too cold.
of 5 °C to 40 °C.
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24 EN
7 Alarms

E2 low Operate device at an ambient temperature
571 External battery 1 too cold.
of 5 °C to 40 °C.
Internal battery
communication fault Internal battery defective.
572 Contact your specialist dealer.
Device defective.
Battery E1
communication fault External battery 1 defective.
Device defective.
Battery E2
communication fault External battery 2 defective.
Device defective.
Battery E1 fault
External battery 1 defective.
Battery E2 fault
External battery 2 defective.
Internal battery
temperature fault Operate device at an ambient temperature
of 5 °C to 40 °C.
Battery E1 temperature
fault Operate device at an ambient temperature
of 5 °C to 40 °C.
Battery E2 temperature
fault Operate device at an ambient temperature
of 5 °C to 40 °C.
Energy outage
580 Power supply outage. Use alternative ventilation option.
Energy supply via Check power cable is securely connected.

Power supply outage.
internal battery Check function of socket.
584
External battery and power supply Note remaining battery life (see 3.6.3, p. 9).
not connected. If necessary: Connect power supply.
No exhalation valve
Check circuit and patient interface.
753 No exhalation valve.
Connect exhalation valve.
Pressure permanently
low
755 Mask leakage too high. Check and correct position of mask.
Tidal volume
permanently low
756 Settings implausible. Check therapy and alarm settings.
Exhalation blocked
757 Exhaled air outlet is blocked. Check exhalation valve and exhalation module.
LMT 68651 11/2020
EN | 25
7 Alarms

Constant pressure level
Respiratory frequency or set pressure
758 Check therapy settings.
difference too low.
Intake area blocked

759 Intake area blocked. Keep intake area free.
Pressure measuring tube Valve control tube and pressure Check circuit and tube connections are
and valve control tube measuring tube switched. connected correctly (see 4.2.3, p. 12).
switched 760 Check valve control tube for blockages and
Valve control tube kinked. damage.
If necessary: Replace circuit.
FiO2 sensor fault
Contact your specialist dealer.
770 FiO2 sensor defective.
Replace FiO2 sensor.
No FiO2 cell
771 No FiO2 cell fitted.
Have FiO2 cell fitted.
FiO2 cell used up

773 FiO2 cell empty.
Have FiO2 cell replaced.
Blower temperature
Cool device immediately or therapy will end.
high Blower temperature too high. Cooling
789 Check cooling air filter. If necessary: Have
air filter blocked.
cooling air filter replaced by specialist dealer.
SpO2 signal weak 792 SpO2 sensor not connected to the Check connection with the finger. If alarm
finger correctly. persists: Contact your specialist dealer.
SpO2 signal weak 790 Signal interfered with by nail varnish or

Remove nail varnish. Clean finger.
contaminants.
SpO2 sensor removed To monitor SpO2 and pulse, reconnect SpO2

791 SpO2 sensor removed. sensor.
If the alarm persists: Replace SpO2 sensor.
SpO2 cable removed
To monitor SpO2 and pulse, reconnect SpO2
793 SpO2 cable removed.
cable.
Therapy ended
794 Device is switched off. Switch device back on.
Circuit with valve selected. Change circuit.

No circuit with valve connected. Have settings checked by attending physician.
Leakage circuit selected, circuit with Change circuit.
Faulty circuit
valve connected. Have settings checked by attending physician.
795
Pressure measuring tube not
Check tubing.
connected correctly.
Check circuit and tube connections.
Circuit defective.
Valve does not open in exhalation
(medication has caused it to stick,
Re-inhalation Check circuit and tube connections.
796 for example).
Patient's re-inhalation volume
excessive at high frequency.
Disconnection, valve
control pressure Circuit is not connected to the device Check circuit and tube connections.
798
correctly or is not connected at all. If necessary: Replace circuit.
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26 EN
7 Alarms

Blower overheated
Therapy will end.
799 Blower has overheated.
Allow device to cool down.
Maximum device pressure
exceeded Reduce resistance and restart device.
811 Resistance on inspiration too high.
If alarm recurs: Contact your specialist dealer.
Maximum device pressure

reached Reduce resistance and restart device.
825 Resistance on inspiration too high.
If alarm recurs: Contact your specialist dealer.
HFT MODE ONLY

Upper flow limit: Set a lower HFT flow and
Unable to reach flow. adjust O2 supply or use accessories with lower
Check FiO2, change flow resistance.
setting or accessories. Set flow cannot be used.
Lower flow limit: Set a higher HFT flow and
adjust O2 supply or use accessories with higher
resistance.
Device operated with open patient/
Disconnection, patient ventilator interface (mask not applied). Check circuit, tube connections, and patient/
465
Circuit is not connected to the device ventilator interface at the patient.
7.5 Nurse call and remote alarm

For support in monitoring patient and device, especially in In a domestic environment, you can connect the device to
the case of life-support ventilation, the device has a remote the VENTIremote alarm case via the remote alarm
alarm connection. All alarms are passed on to this connection. The remote alarm case is for the remote
connection. transmission and amplification of the acoustic and visual
In hospital, the device can be connected to the hospital's alarm signals output by the device.
internal alarm system via the remote alarm connection. Please also follow the instructions for use for the remote
alarm connection and the associated cables.
8 Faults
FAULT CAUSE ACTION
No running noise, no No power supply Check power cable is securely connected.
display on screen. present. Check function of socket.
Clean coarse dust filter. If necessary:
Coarse dust filter soiled.
Replace filter (see 6, p. 17).
Adjust headband so that the mask does not leak
Device does not reach (see instructions for use for the mask).
Breathing mask leaking.
set If necessary: Replace defective mask or patient/ventilator
target pressure. interface.
Check circuit and eliminate leaks.
Circuit leaking.
Device defective. Contact your specialist dealer.
Dark display does not react
to display being touched. Device is switched off. Switch on device (see 4.4, p. 13).
Display remains dark.
LMT 68651 11/2020
EN | 27
9 Technical specifications
SPECIFICATION DEVICE
Product class to 93/42/EEC IIb
Dimensions W x H x D in cm 30 x 13 x 21
Weight 3.8 kg
Temperature range
- Operation +5 °C to +40 °C
- Transport and storage -25 °C to +70 °C
- Transport and storage at +70 °C Allow to cool to room temperature for 4 hours before
starting up.
- Transport and storage at -25 °C Allow to heat to room temperature for 4 hours before
starting up.
Relative humidity 10 % to 90 %, no condensation
Permitted humidity for operation, transport and storage
> 35 °C to 70 °C at a water vapor pressure up to 50 hPa
700 hPa to 1100 hPa,
Air pressure range corresponds to an altitude of 3,000 m above mean sea level
Connection diameter for breathing tube Standard 22 mm tapered connector to ISO 5356-1
Maximum air flow at 20 hPa > 220 l/min
3 VDC/0.2 A
System interface When connecting the prismaHub device: 24 VDC/0.2 A
USB-C interface
Maximum power output 5 V/1.1 A
No power input
Power consumption on standby without battery charging 230 VAC/0.07 A
Screen brightness 90 % 48 VDC/0.3 A
24 VDC/0.61 A
12 VDC/1.21 A
Nurse call Maximum 60 V/1 A
Power consumption during ventilation without battery
charging
Screen brightness 90 %
Ventilation settings:
Mode: T
Configuration: Adult
Breathing tube with leakage circuit, 15 mm
Additional accessories: Breathing system filter, WilaSilent
exhalation system
IPAP: 40 230 VAC/0.18 A
EPAP: 4 48 VDC/0.81 A
24 VDC/1.61 A
F: 26.5 12 VDC/2.86 A
Ti: 1.1
Pressure increase: 1
Pressure reduction: 1
Test lung bag
Electrical connection, device maximum
48 VDC/2.7 A
24 VDC/5.4 A
12 VDC/7.0 A
Power supply unit 100 – 240 VAC/2.1 A
Input voltage/maximum current 50 – 60 Hz
Input frequency 48 VDC/2.7 A
Output voltage/maximum current Tolerance -20 % + 10 %
LMT 68651 11/2020
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28 EN
Internal/external battery
Type Li-ion
Nominal capacity 3200 mAh
29.3 V
Nominal voltage 93.7 Wh
Energy 500 charging cycles
Typical discharge cycles Battery capacity is reduced when the device is operated at low
temperatures.
Operating hours of internal battery assuming following
settings: Double circuit, PCV mode, f=20/min, Ti=1 s,
PEEP=off, Vt=800 ml  6 hours
Passive lung: Resistance R = 5 hPa/(l/s);
Compliance C = 50 ml/hPa
Duration of complete battery charge < 6 hours
Duration of 80 % battery charge < 5 hours
Classification to IEC 60601-1-11:
Class of protection against electric shock Protection class II
Degree of protection against electric shock Type BF
Protection against harmful ingress of solids and water IP22
Classification to IEC 60601-1:
Continuous duty
Operating mode
Patient/ventilator interface (e.g. mask, endotracheal tube,
Applied part tracheal cannula), breathing tube, breathing system filter,
SpO2 sensor
Medical electrical devices may only be installed and
Electromagnetic compatibility (EMC) to EN 60601-1-2
commissioned in a defined electromagnetic environment with
regard to emission and radio interference immunity.
More information, including test parameters and limit values,
can be obtained from the manufacturer if required.
EN 55011 B
Radio interference immunity
IEC 61000-4 Parts 2 to 6, Part 11, Part 8
IEC 61000-3 Parts 2 and 3
Heating of respiratory air Maximum +3 °C
Mean sound pressure level/operation to ISO 80601-2-72
at  500 ml 38.5 dB(A) ±3 dB(A), sound power level 46.5 dB(A) ±3 dB(A)
at  150 ml 37 dB(A) ±3 dB(A), sound power level 45 dB(A) ±3 dB(A)
at  30 ml 41 dB(A) ±3 dB(A), sound power level 49 dB(A) ±3 dB(A)
Level 1
Low priority: 59 dB(A)
Medium priority: 63 dB(A)
High priority: 68 dB(A)
Sound pressure level of acoustic alarm to IEC 60601-1-8 ±3 dB(A)
for all alarm conditions (high, medium, low priority)
Tolerance Level 4
Low priority: 78 dB(A)
Medium priority: 83 dB(A)
High priority: 87 dB(A)
±3 dB(A)
4 hPa – 50 hPa
IPAP pressure range Most disadvantageous circuit for leakage ventilation:
Breathing tube WM 29988, bacteria filter WM 27591
4 hPa – 60 hPa
Most disadvantageous circuit for valve ventilation:
Breathing tube LMT31383, bacteria filter WM27591
Accuracy of airway pressure ±(2 hPa + 4 % of the set value)

±(2 cmH2O + 4 % of the set value)
LMT 68651 11/2020
EN | 29
EPAP pressure range 4 hPa - 25 hPa
Most disadvantageous circuit for leakage ventilation:
0 hPa - 25 hPa
PEEP pressure range Most disadvantageous circuit for valve ventilation:
Breathing tube LMT31383, bacteria filter WM 27591
Accuracy of airway pressure ±(2 hPa + 4 % of the set value)
±(2 cmH2O + 4 % of the set value)
CPAP operating pressure range 4 hPa to 20 hPa
Most disadvantageous circuit for leakage ventilation:
±(2 hPa + 4 % of the set value)
Tolerance ±(2 cmH2O + 4 % of the set value)
Pressure increment 0.2 hPa
Maximum pressure in the event of a fault < 90 hPa
Respiratory frequency, adult 2 – 60 bpm
Respiratory frequency, child 5 – 80 bpm
Accuracy ± 0.5 bpm
Increment 0.5 bpm
Ti min, Ti max, Ti timed 0.2 s (child)
0.5 s (adult)
auto (Ti timed only)
0.05 s
Accuracy 0.05 s from 0.2 s to 0.8 s
Increment 0.1 s from 0.8 s to 4 s
Target volume/tidal volume/minute volume
(averaged over previous 5 breaths)
30 ml to 400 ml (child)
100 ml to 3,000 ml (adult)
Accuracy
Most disadvantageous circuit < 50 ml: < 50 ml: ±(4 ml + 20 % of current value)
Breathing tube LMT 31383
Most disadvantageous circuit  50 ml:  50 ml: ±(4 ml +15 % of current value)
Breathing tube LMT 31382
5 ml from 30 ml to 100 ml
Increment 10 ml from 100 ml to 3,000 ml
Trigger level
Inspiration 1 (high sensitivity) to 10 (low sensitivity) (step 1)
Exhalation 95 % to 5 % of maximum flow in 5 % steps
The trigger on inspiration is triggered when patient flow
exceeds the trigger threshold.
Trigger device The trigger on exhalation is triggered when patient flow on
inspiration drops to the percentage value of maximum patient
flow on inspiration.
Speed of pressure increase adult Level 1: 100 hPa/s
Level 2: 80 hPa/s
Level 3: 50 hPa/s
Level 4: 20 hPa/s
Speed of pressure increase child Level 1: 135 hPa/s
Level 2: 100 hPa/s
Level 3: 80 hPa/s
Level 4: 50 hPa/s
Speed of pressure increase MPV mode Level 1: 60 hPa/s
Level 2: 45 hPa/s
Level 3: 30 hPa/s
Level 4: 15 hPa/s
LMT 68651 11/2020
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30 EN
Speed of pressure reduction (in leakage ventilation only)
Level 1: -100 hPa/s
Adult Level 2: -80 hPa/s
Level 3: -50 hPa/s
Level 4: -20 hPa/s
Child Level 1: -135 hPa/s

Level 2: -100 hPa/s
Level 3: -80 hPa/s
Level 4: -50 hPa/s
Maximum permitted flow for oxygen supply 30 l/min
Permitted pressure < 1,000 hPa
HFT flow range
Adult
5 l/min to 60 l/min
Child 5 l/min to 25 l/min
Increment 1 l/min
Tolerance ±(2 l/min +20 % of set value)
Pollen filter Filter class E10
up to 1 µm  99.5 %
up to 0.3 µm  85 %
Service life of pollen filter approx. 250 h
USB flash drive USB-C 3.1
Materials
Housing Fire-retardant technical thermoplastics and silicones,
stainless steel
Pollen filter Polyethylene
Air filter Polyurethane
Wireless module
Frequency band 2.412 GHz to 2.4835 GHz
Wireless standard ETSI EN 300 328
The physiological alarms are triggered 3 breaths after the alarm
threshold is reached. Exception: The Pulse high, Pulse low,
SpO2 high, and SpO2 low alarms are triggered 15 seconds after
Filtering and smoothing techniques
the alarm threshold has been reached.
The displays for pressure, flow and leakage have low-pass
filters.
Algorithm for alarm 758
Triggered when airway pressure is > 2 hPa and remains
(Constant pressure level)
continuously within a band of ±1 hPa for at least 17 seconds
Dead space: 26 ml
Breathing system filter Flow resistance: 2.0 cm H2O
at 60 l/min
TOLERANCES FOR MEASURING DEVICES USED

Pressure: ± 0.75 % of measured value or ± 0.1 hPa
Flow: ± 2 % of actual value
Volume ± 3 % of actual value
Temperature: ± 0.3 °C
Time ±0.05 Hz/±0.001 bpm
All physiological flow and volume values are displayed in Standard applied: EN ISO 80601-2-72: Lung ventilators for
BTPS (patient flow, target volume, breath volume, minute medical use - particular requirements for basic safety and
volume). All other flow and volume values are displayed in essential performance - Part 6: Home ventilation devices for
STPD. respiratory support
The right to make design modifications is reserved. Devices of the type LM150TD use the following open-source
All parts of the device are free from latex. software: Linux Kernel 4.19.132, Buildroot 2020.02.3
LMT 68651 11/2020
EN | 31
The software of this device contains code which is subject to
the GPL. You can obtain the source code and the GPL on
request.
LMT 68651 11/2020
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32 EN
10 Annex
10 Annex
10.1 Pneumatic diagram
10.1.1 Leakage ventilation
Leakage Circuit
O2 pathway
O2 supply
Patient Interface
inspiration
Pressure sensor
for patient
pressure
exhalation
Spontaneous
ambient air breathing & Optional Optional: Optional:
Air filter Blower Flow sensor non-return Patient circuit Leakage system
O2- sensor bacteria filter humidifier
valve unit
leakage / exhalation
Pressure sensor
for patient
pressure
Pressure sensor
for monitoring
outlet
cooling air
10.1.2 Single circuit with valve

Single Patient Circuit
O2 pathway
O2 supply
ambient air
Patient Interface
inspiration
Pressure sensor
valve control Pressure sensor
for patient
Control valves pressure
for exhalation
system exhalation
Spontaneous
ambient air breathing & Optional Optional: Optional: Exhalation
Air filter Blower Flow sensor non-return Patient circuit
O2- sensor bacteria filter humidifier system
valve unit
ambient air
Pressure sensor
for patient
pressure
Pressure sensor
for monitoring
outlet
cooling air
LMT 68651 11/2020
EN | 33
10 Annex
10.1.3 Double circuit

Double Patient Circuit
O2 pathway
O2 supply
ambient air ambient air
Exhalation
Flow sensor Patient circuit Patient Interface
system
exhalation
inspiration
Pressure sensor
valve control Pressure sensor
for patient
Control valves pressure
for exhalation
system
Spontaneous
ambient air breathing & Optional Optional: Optional:
Air filter Blower Flow sensor Patient circuit
non-return O2- sensor bacteria filter humidifier
valve unit
Pressure sensor
for patient
pressure
Pressure sensor
for monitoring
outlet
cooling air
10.2 System resistances

The total pneumatic resistance of the connected circuit and Circuits with a diameter of 10 mm (intended for volumes
of the connected accessories (e.g. humidifier, breathing delivered of < 50 ml): Pressure reduction < 3.2 hPa at
system filter) between the device and the patient connection a flow = 2.5 l/min (BTPS).
may not exceed the following value: The pressure reduction values of the individual components
Circuits with a diameter of 15 mm and 22 mm: can be added to form a total resistance value which must not
Pressure reduction < 3.2 hPa at a flow = 30 l/min (BTPS). exceed the value mentioned above.
Maximum error in pressure measurement: 0.0125 hPa
ARTICLE FLOW (BTPS) PRESSURE REDUCTION

ARTICLE NAME
NUMBER IN L/MIN IN HPA
LMT 31382 LUISA, single circuit with valve, 180 cm, 22 mm Ø 30 0.11
LMT 31383 LUISA, single circuit with valve, 150 cm, 15 mm Ø 30 0.46
LUISA, single circuit with valve, heated (i), autofill
LMT 31384 30 2.04
chamber, 150 cm + 60 cm, 15 mm Ø
LUISA, leakage ventilation, heated (i), autofill chamber,
WM 271704 30 2.03
passive valve, 150 cm + 60 cm, 15 mm Ø
LUISA, leakage ventilation, heated (i), autofill chamber,
WM 271705 30 0.31
passive valve, 150 cm + 60 cm, 22 mm Ø
Inspiration tube: 0.76
LUISA, double circuit, 150 cm, 15 mm Ø Inspiration tube from patient
LMT 31577 30
to device: 0.92
Exhalation tube: 0.69
Inspiration tube from patient
LMT 31581 LUISA, double circuit, 180 cm, 22 mm Ø 30
to device: 0.24
LMT 68651 11/2020
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34 EN
10 Annex
ARTICLE FLOW (BTPS) PRESSURE REDUCTION

ARTICLE NAME
NUMBER IN L/MIN IN HPA
LUISA, double circuit, heated (i+e), A-adapter, autofill
LMT 31582 chamber, 150 cm + 60 cm, 15 mm Ø 30
to device: 2.05
LUISA, double circuit, heated (i+e), A-shaped adapter,
LMT 31383 autofill chamber, 150 cm + 60 cm, 22 mm Ø 30
to device: 0.32
LUISA, double circuit, heated (i+e), A-shaped adapter,
LMT 31386 autofill chamber, 120 cm + 60 cm, 10 mm Ø
to device: 0.16
WM 27591 Teleflex Iso-Gard bacteria filter 2.5 0.06
10.3 Emission of electromagnetic interference

MEASUREMENTS OF INTERFERENCE EMISSION COMPLIANCE
HF emissions to CISPR 11 Group 1/Class B
Harmonic distortion Class A
Voltage fluctuations and flicker Complies
10.4 Electromagnetic interference immunity

INTERFERENCE IMMUNITY TESTS COMPLIANCE LEVEL
± 8 kV contact discharge
Discharge of static electricity (ESD) to IEC 61000-4-2
± 15 kV air discharge
3 V/m
Radiated HF interference to IEC 61000-4-3
80 MHz to 2.7 GHz
Test specifications for the interference immunity of sheathing to
Table 9 of EN 60601-1-2:2014
high-frequency wireless communication equipment
IEC 61000-4-3
± 2 kV for power supply cables
Electrical fast transients/bursts to IEC 61000-4-4
± 1 kV for input and output lines
± 1 kV line to line
Surge immunity to IEC 61000-4-5
± 2 kV line to ground
3 Vrms
150 KHz to 80 MHz
Conducted HF interference to IEC 61000-4-6
6 Vrms
in ISM frequency bands between 150 kHz and 80 MHz
Magnetic field at the power supply frequency
30 A/m
(50/60 Hz) to IEC 61000-4-8
Voltage dips/short interruptions and variations in power supply to
0 % UT; 250/300 periods
IEC 61000-4-11
Key performance characteristics of the device

as per ISO 80601-2-72
• Accuracy of airway pressure
• Accuracy of the volume delivered in a single breath
• No faulty setting of ventilation parameters
• Functionality of alarms
LMT 68651 11/2020
EN | 35
10 Annex
10.5 Markings and symbols SYMBOL DESCRIPTION
Type BF applied part

The following symbols may be applied to the device, the
device ID plate, accessories, or packaging.
SYMBOL DESCRIPTION Manufacturer and if necessary date of

manufacture
P Pressure measuring tube connection

Indicates the product is a medical device
Valve control tube connection

Permitted temperature range for transport
and storage
Do not block the patient’s exhaled air outlet
on the double circuit Permitted humidity range for transport and
storage
Input; do not block openings

Protect from moisture
Output
Fragile. Do not throw or drop
Follow instructions for use CE symbol (confirms that the product

conforms to the applicable European
directives and regulations)
Direct current: 12 V, 24 V or 48 V
Use multiple times on a single patient
TYPE: Type designation of the device
10.6 Scope of delivery

Order number
10.6.1 Scope of delivery for LMT 31380-

Suitable for use in aircraft. Meets
RTCA/DO-160G Section 21, Category M.
1110 LUISA with HFT mode
The parts below are included in the standard scope of
Unique device identifier delivery:
(uniform product code for medical devices) PART ARTICLE NUMBER
Basic device with HFT mode LMT 31410
Exhalation module (disposable) LMT 31425
Serial number
Single circuit with valve, 22 mm Ø LMT 31382
Power supply unit LMT 31569
Degree of protection against electric shock: Power cord (power cable) WM 24177
Protection class II product Oxygen connecting bushing WM 30669
Set, 12 fine filters WM 29652
Do not dispose of the product in domestic Set, 2 coarse dust filters WM 29928
waste
Protective bag LMT 31417
Patch for protective bag WM 29899
Consult instructions for use Bag pendant LMT 31408
USB flash drive LMT 31414
Degree of protection against contact with a Instructions for use LMT 68651
IP22 finger. Protection against vertically falling Patient record 1P-10088de2002
water drops when enclosure tilted up to 15°. LM patient information WM 28209
LMT 68651 11/2020
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36 EN
10 Annex
PART ARTICLE NUMBER PART ARTICLE

Set, documents in accordance with NUMBER
Medizinprodukte- LUISA hospital trolley, consisting of:
Betreiberverordnung [German law - Trolley 2.0 (LMT 31355)
WM 15100 -Set, LUISA plate for trolley 2.0
governing the owners/operators of
medical devices]: Medical devices (LMT 31371)
LMT 31370
manual, handover log -Power supply unit clamp (LMT 31351)
Final inspection log LMT 31588 -Water bag holder (LMT 31353)
-Oxygen cylinder clamp (LMT 31352)
Accessories bag LMT 31440
-Hinged arm (LMT 31354)
LUISA Homecare trolley, consisting of:
10.6.2 Scope of delivery for LMT 31390- - Trolley 2.0 (LMT 31355)
1110 LUISA with HFT mode -Set, LUISA plate for trolley 2.0 LMT 31360
(LMT 31371)
The parts below are included in the standard scope of -Power supply unit clamp (LMT 31351)
delivery: Trolley 2.0 LMT 31355
PART ARTICLE NUMBER
Power supply unit clamp for trolley 2.0 LMT 31351
Basic device with HFT mode LMT 31410
Water bag holder for trolley 2.0 LMT 31353
Oxygen cylinder clamp for trolley 2.0 LMT 31352
Hinged arm for trolley LMT 31354
Power supply unit LMT 31569
Set, LUISA mounting plate LMT 31359
Power cord (power cable) WM 24177
Set, LUISA plate for trolley 2.0 LMT 31371
Oxygen connecting bushing WM 30669
Wall clamp for ISO rail LMT 31368
Set, 12 fine filters WM 29652
Set, 2 coarse dust filters WM 29928
Exhalation module (autoclavable) LMT 31413
Protective bag LMT 31417
Replacement internal battery for LUISA LMT 31550
Patch for protective bag WM 29899
External battery, packed LMT 31540
Bag pendant LMT 31408
Battery charger LMT 31594
USB flash drive LMT 31414
VENTIremote alarm, 10 m LMT 31560
Instructions for use LMT 68651
VENTIremote alarm, 30 m LMT 31570
Final inspection log LMT 31588
Cable, 10 m, nurse call for LUISA LMT 31510
Accessories bag LMT 31440
Cable, 30 m, nurse call for LUISA LMT 31520
CD-ROM with prismaTS software WM 93331
10.7 Accessories USB flash drive

COM cable for monitor
LMT 31604
LMT 31578
Set, 90° tube adapter LMT 15984
ARTICLE Cable, 12 V/24 V (vehicle/FCC) LMT 31597
PART NUMBER SpO2 sensor, size S LMT 31580
Teleflex Iso-Gard breathing system filter WM 27591 SpO2 sensor, size M LMT 31396
Oxygen sensor, complete LMT 31502 SpO2 sensor, size L LMT 31388
Wilasilent exhalation valve WM 27589 Cable, SpO2/Xpod sensor LMT 31593
Silentflow 3 exhalation valve WM 25500
Single circuit with valve, 22 mm Ø LMT 31382 10.8 Removable parts
Double circuit, 15 mm Ø LMT 31577
Double circuit, 22 mm Ø LMT 31581
PART ARTICLE NUMBER
Leakage circuit, 15 mm Ø WM 29988
Filter holder LMT 31422
Leakage circuit, 22 mm Ø WM 23962
Exhalation module cover LMT 31481
Leakage circuit, autoclavable, 22 mm Ø WM 24667
Leakage circuit, mouthpiece ventilation
WM 27651 Set, exhalation module (can be
15 mm Ø LMT 15961
subjected to hygiene treatment)
Mobility bag LMT 31554
Exhalation module orifice LMT 31574
LMT 68651 11/2020
EN | 37
10 Annex
10.9 Warranty
Löwenstein Medical Technology gives the purchaser of
a new original product and of a spare part fitted by
Löwenstein Medical Technology a limited manufacturer
warranty in accordance with the warranty conditions
applicable to the product in question and in accordance with
the warranty periods from date of purchase listed below.
The warranty conditions are available on the manufacturer’s
website. We will also send you the warranty conditions on
request.
In the event of a claim under warranty, contact your
specialist dealer.
PRODUCT
WARRANTY
PERIODS
Devices including accessories
2 years
(Exception: Masks)
Masks including accessories, batteries
(unless quoted differently in the
6 months
technical documentation), sensors,
circuits
Disposable products None
10.10 Declaration of Conformity

Löwenstein Medical Technology GmbH + Co. KG,
Kronsaalsweg 40, 22525 Hamburg, Germany, the
manufacturer of the devices described in these instructions
for use, hereby declares that the product complies with the
relevant regulations of the Medical Device Directive 93/42/
EEC. The unabridged text of the Declaration of Conformity
can be found on the manufacturer's website.
LMT 68651 11/2020
|
38 EN
LMT 68651 11/2020 EN
Löwenstein Medical
Technology GmbH + Co. KG
Kronsaalsweg 40
22525 Hamburg, Germany
T: +49 40 54702-0
F: +49 40 54702-461
www.loewensteinmedical.de

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EN Instructions for Use for devices of type LM150TD

LMT 68651 11/2020

1.1 Intended use 1.3 User qualification

Relative contraindications:  Only use accessory parts from the manufacturer.

2 Safety may be injured.

2.1.3 Energy supply 2.2 General information

3.2 Control panel in display

3.3 Symbols in display SYMBOL DESCRIPTION

Network connection present.

Device set for pediatric applications/children.

Device set for adults.

Leakage ventilation set. All physiological alarms have been

Double circuit set.

Battery charging. If the gray area reaches 3.4 Accessories (optional)

Battery capacity high, battery discharging. PART DESCRIPTION

Patient monitor connected.

3.5 Operating states 3.6.2 External batteries

3.6.3 Display of remaining device life

3.7 Data management/

3.7.1 Saving and transmitting

3.7.2 Updating the firmware

3.7.3 Setting up a connection to the

Risk of injury from inadequate therapy if air inlet and

Risk of asphyxia if invasive or non-invasive patient/

1. If required: Tilt the device in a horizontal or vertical

4.2.1 Connecting leakage circuit 4.2.3 Connecting double circuit

4.2.4 Connecting circuit for mouthpiece

4.2.5 Connecting the circuit for Alternatively

4.5 Starting therapy

4.7 Performing tube test

4.8 Calibrating FiO2 cell

5.2 Menu structure for patient menu

 Remaining life/charging status

5.2.3 Menu system in the patient menu

1. Open filter compartment flap.

1. Open filter compartment flap.

9. Compare the pressure shown in the display with the

6.4 Servicing The membrane of the nonreturn valve must be replaced

4 years or after 500 cycles. disposed of in paper recycling facilities.

7 Alarms 7.3 Configuring physiological

Alarms are divided into the three priority levels low ,

7.2 Muting alarms

DISPLAY CODE CAUSE ACTION

Minimum therapy pressure undershot. Clean/change dirty filters.

DISPLAY CODE CAUSE ACTION

Minute volume low

Ventilation parameter settings not suitable

Patient breathing as well. Check therapy settings.

Check whether the prescribed oxygen flow is

7.4 Technical alarms

Main board temperature

Unable to reach flow

Disconnection, patient Device operated with open patient/

Internal battery fault

Battery capacity critical

Battery capacity low

DISPLAY CODE CAUSE ACTION

Internal battery life at an

E1 battery life at an end

E2 battery life at an end

Remaining life/charging status