Lowenstein Medical LUISA User manual

EN-US Instructions for use for patients
For devices of type: LM150TD
LUISA
Ventilator for home environment

Contents
2 | EN
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
1.7 General information .................................... 4
1.8 Clinical benefit.............................................. 4
2 Safety 5
2.1 Safety information ....................................... 5
2.2 Safety information in these instructions
for use ...........................................................
6
3 Product description 7
3.1 Overview ....................................................... 7
3.2 Display........................................................... 8
3.3 Symbols in the display................................. 8
3.4 Operating states .......................................... 9
3.5 Batteries........................................................ 9
3.6 Data management/compatibility............... 10
3.7 Trolley 2.0...................................................... 10
4 Preparation and operation 11
4.1 Setting up and connecting device ............. 11
4.2 Connect circuit ............................................. 11
4.3 Before first use............................................. 12
4.4 Switch device on and off / Start and end
therapy ..........................................................
13
4.5 Circuit test..................................................... 13
4.6 Performing SpO2 measurement ................ 13
4.7 Calibrating the FiO2 cell............................... 14
4.8 Pairing device with LUISA app.................... 14
4.9 Contaminated components........................ 14
5 Settings in the menu 15
5.1 Navigating in the menu .............................. 15
5.2 Menu structure ............................................ 15
6 Reprocessing and maintenance 17
6.1 Hygiene treatment....................................... 17
6.2 Function check ............................................. 18
6.3 Servicing........................................................ 19
6.4 Disposal......................................................... 20
7 Alarms 21
7.1 General information .................................... 21
7.2 Reacting to an alarm ................................... 21
7.3 set alarms ..................................................... 21
7.4 Physiological alarms.................................... 21
7.5 Technical alarms .......................................... 23
7.6 Nurse call and remote alarm ...................... 25
8 Troubleshooting 26
9 Technical data 27
9.1 Ambient conditions ...................................... 27
9.2 Physical specifications and classifications. 27
9.3 Materials........................................................ 27
9.4 Electronics and physical interfaces ............ 27
9.5 Therapy.......................................................... 28
9.6 Noise .............................................................. 29
9.7 Batteries ........................................................ 29
9.8 Software......................................................... 30
9.9 Accessories.................................................... 30
9.10 Accuracy of measuring devices used......... 30
9.11 SpO2 sensor................................................... 30
10 Annex 31
10.1 Pneumatic diagram...................................... 31
10.2 System resistances....................................... 33
10.3 Emission of electromagnetic interference 33
10.4 Electromagnetic interference immunity ... 33
10.5 Markings and symbols................................. 34
10.6 Scope of supply............................................. 35
10.7 Accessories and spare parts ....................... 35
10.8 Declaration of Conformity........................... 36
10.9 Warranty........................................................ 36
LMT 68691 12/2023

1 Introduction
EN | 3
1 Introduction
1.1 Intended use
The LM150TD 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 envi-
ronment, 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 spe-
cialist users can operate the device.
1.2 Description of function
The blower takes in ambient air through a filter and
pumps it to the device outlet. From the device outlet,
air flows through the patient circuit and the patient
interface to the patient.
Blower output is controlled and therapy pressure thus
modified based on the signals detected by the pres-
sure and flow sensors.
An external SpO2 sensor can be connected to measure
oxygen saturation and pulse rate.
On the leakage circuit, exhaled air containing CO2 es-
capes via an exhalation system. On the single circuit
with valve and on the double circuit, exhaled air con-
taining CO2 escapes via the patient valve on the cir-
cuit.
A FiO2 cell can be fitted to measure the proportion of
oxygen in the inhaled air.
Oxygen equipment can be connected.
The device is operated via the display, the on/off key,
and the alarm acknowledgement key.
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 in how to operate the
device. The device must only be used as specified in
the training and instruction sessions. A distinction is
made between specialist users (experts) and lay
users, composed of the following groups of people:
Person Description User qualification
Patient Person receiving treatment with no
expert medical or nursing knowl-
edge.
Following an introduction by a health-
care professional in how the device
works and how to use it, patients, rela-
tives, and other caregivers are lay users.
Relatives and other caregivers Person in a domestic environment
supporting the patient with routine
tasks and who has no expert medi-
cal or nursing knowledge.
Owner/operator Healthcare facility responsible for
ensuring the compatibility of the de-
vice and of all the components or
accessories associated with the pa-
tient before use (e.g., a hospital).
Following training by the manufacturer
or by service personnel expressly autho-
rized by the manufacturer in how the de-
vice works and how to use it, health insti-
tutions are specialist users.
Healthcare professional Person with state-approved qualifi-
cation in a medical profession (e.g.,
physicians, respiratory therapists,
medical technicians).
Following training by the manufacturer
or by trained health institutions in how
the device works and how to use it,
healthcare professionals and nurses are
specialist users.
Nursing specialist Person with state-approved qualifi-
cation in a nursing profession.
Service personnel Person with state-approved qualifi-
cation in a technical profession. Following training by the manufacturer in how the device works and how to use
it, service personnel are specialist users.
Specialist dealer Person or organization that mar-
kets, but does not itself manufac-
ture a product. The specialist dealer
can provide a support function.
Following training by the manufacturer
in how the device works and how to use
it, specialist dealers are specialist users.
As an owner/operator or user, you must be familiar
with the operation of this medical device.
For blind and partially-sighted users
An electronic version of the instructions for use
is also available on the manufacturer’s website.

1 Introduction
4 | EN
1.4 Indications
Obstructive ventilation disorders (e.g. COPD), restric-
tive ventilation disorders (e.g. scolioses, deformities of
the thorax), neurological, muscular, and neuromuscu-
lar disorders (e.g. types of muscular dystrophy, pare-
ses of the diaphragm), central respiratory regulation
disorders, obesity hypoventilation syndrome, hypox-
emic respiratory failure.
1.5 Contraindications
The following contraindications are known - in the in-
dividual case, responsibility for deciding whether to
use the device rests with the healthcare professional.
Threatening situations have not ever been observed.
Absolute contraindications: Severe epistaxis, high risk
of barotrauma, pneumothorax or pneumomedi-
astinum, pneumoencephalus, status following brain
surgery and following surgical procedures on the hy-
pophysis 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 signifi-
cant swallowing problems (bulbar syndrome) with the
risk of aspiration.
Relative contraindications: Cardiac decompensation,
severe cardiac arrhythmias, severe hypotension, espe-
cially in combination with intravascular volume deple-
tion, 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 si-
nuses, irritated conjunctiva in the eyes, gastrointesti-
nal insufflation of air ("bloating"), nosebleeds; muscu-
lar atrophy in the case of long-term ventilation. These
are general side effects not attributable specifically to
use of devices of type LM150TD.
1.7 General information
The device is a medical device which must only be
used on the instruction and in accordance with the
specifications of a healthcare professional.
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 responsi-
ble authority.
1.8 Clinical benefit
The clinical benefit for the patient is improved ventila-
tion (improved blood gas values, relief of the airway
musculature under strain).
NIV / IV / MPV in standard mode:
Restoring proper ventilation/regulation of breathing
either via permanent settings or via automatic reac-
tions to the patient’s requirement, maintaining ade-
quate gas exchange in the event of acute respiratory
failure, relieving the respiratory pump/supporting the
respiratory musculature, improving alveolar ventila-
tion and blood gases, reducing sleepiness during the
day, improving health-related quality of life and long-
term prognosis of illness, reducing inpatient hospital
stays/exacerbation of existing conditions.
Additional clinical benefit of HFT mode on the
LM150TD:
Flushing out the dead space in the nasopharynx and
reducing CO2 level as a result, improving mucociliary
clearance by moistening and warming the upper air-
way, improving oxygenation/gas exchange, adminis-
tering a slight positive pressure to the upper airway,
reducing the requirement for ventilation, respiratory
work and respiratory distress, potentially reducing
respiratory rate in spontaneous breathing.
LMT 68691 12/2023 en-US

2 Safety
EN | 5
2 Safety
2.1 Safety information
2.1.1 Energy supply
Operating the device outside the specified energy
supply may cause personal injury, damage the device
or impair the performance of the device.
⇒All settings are retained in the event of a power
outage.
⇒Keep access to plug and power supply clear.
⇒Operate the power supply unit only at voltages
from 100 V to 240 V.
⇒The device is intended for operation on voltages of
12 V, 24 VDC and 48 VDC.
2.1.2 Electromagnetic compatibility
(EMC)
The device is subject to special precautions with re-
gard to EMC (electromagnetic compatibility). If these
precautions are not followed, the device may malfunc-
tion and individuals may be injured.
⇒Do not operate the device if the housing, cables or
other equipment for electromagnetic shielding are
damaged.
⇒Operate the device only within the EMC environ-
ment specified for this device (See Resistance to
electromagnetic interference [}33]) in order to
prevent key performance characteristics being af-
fected - for example, therapy parameters being af-
fected by electromagnetic interference.
⇒Portable high-frequency communication equip-
ment (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.
⇒The use of third-party accessories, third-party in-
verters, and third-party cables may lead to in-
creased electromagnetic interference or reduced
electromagnetic interference immunity of the de-
vice and to faulty operation. Only use the manufac-
turer’s cables.
⇒Do not use the device in the vicinity of active high-
frequency surgical equipment.
⇒Do not operate the device in the immediate vicinity
of other devices or in a stacked arrangement, oth-
erwise 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 Ambient conditions
⇒Only operate, store and transport the device under
the specified ambient conditions (See Ambient con-
ditions [}27]).
⇒If device and battery have been stored outside the
quoted operating temperature, the device can only
be started up once it has warmed up or cooled
down to the permitted operating temperature
(wait at least 4 hours).
⇒Minimize the risks of the domestic setting (pests,
dust, heat from heat sources etc.). Keep devices
and device accessories away from children and
pets.
⇒Keep small parts which may be inhaled or swal-
lowed away from young children in particular.
⇒Do not use the device in an MRI environment or in
a hyperbaric chamber.
⇒Position non-medical equipment away from the pa-
tient's vicinity.
2.1.4 Therapy
⇒Always keep an alternative ventilation option to
hand in order to prevent a life-threatening situa-
tion if the device fails.
⇒Ensure that the circuit and the patient interface are
correctly and securely fitted.
⇒The accuracy of the device may be impaired by the
gas supplied by a nebulizer. Do not use or supply
anesthetic gases.
⇒Eliminate unintentional leakage on the breathing
mask or circuit. In the event of unintentional leak-
age, the values displayed for volume will deviate
from actual patient values.
2.1.5 Alarms
⇒In order to react to an alarm and, if necessary, to
perform emergency ventilation, subject both pa-
tient and device to regular monitoring.
⇒Set alarm volume high enough for the alarm sound
to be heard.
⇒All alarm settings are retained in the event of a
power outage.
⇒Connection by cable to a patient monitor is not a
substitute for a remote alarm system. Alarm data
are transmitted only for documentation purposes.
2.1.6 Handling oxygen
Supplying oxygen without a special safety device can
lead to fire and injure people.
⇒Follow the Instructions for Use for the oxygen sup-
ply system.

2 Safety
6 | EN
⇒Set up oxygen source at a distance of over 1m
from the device.
⇒A healthcare professional specifies the oxygen
dosage. The set oxygen flow must not exceed the
specified oxygen flow.
⇒At the end of therapy, shut off the oxygen equip-
ment and allow the device to run on briefly to drive
out any residual oxygen.
⇒The oxygen flow supplied (in l/min) must not ex-
ceed the set HFT flow.
2.1.7 Wireless communication
The device contains components for wireless commu-
nication. Operating the device in the immediate vicin-
ity of people and/or other antennas may injure peo-
ple, 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 an-
tennas.
2.1.8 Cleaning and maintenance
Residues in the device and accessories or bacterial
contamination of the device and accessories may
cause infections and put the patient at risk.
⇒Follow the section on reprocessing (See Reprocess-
ing [}17]).
⇒Do not reuse disposables. Disposables may be con-
taminated and/or their function may be impaired.
⇒Do not use the device, components, accessories,
and spare parts if they are damaged or if the auto-
matic function test issues error messages.
⇒Perform a function check at regular intervals (at
least every 6 months) (See Function check [}18]).
⇒Have actions such as servicing, maintenance, and
repair work, as well as modifications to the prod-
uct, carried out only by the manufacturer or by ser-
vice personnel authorized by the manufacturer.
2.1.9 Accessories and spare parts
⇒Only use accessories and spare parts quoted in
these instructions for use. The products must meet
the product standard applicable to them.
⇒Only use accessories and spare parts from the
manufacturer. Using third-party accessories and
spare parts (third-party articles) voids any claim to
warranty and liability.
⇒Only connect accessory parts from the manufac-
turer intended for use with the device.
⇒Do not use antistatic or electrically-conductive
tubes.
⇒Regularly check the breathing system filter for in-
creased resistance and blockages. Use of nebuliz-
ers or humidifiers may increase the resistance of
breathing system filters and thus change the ther-
apy pressure delivered. Replace breathing system
filters more frequently to prevent increased resis-
tance and blockages.
⇒Set up external humidifiers below the device and
below the patient connection port. Water in the de-
vice may damage the device or injure the patient.
2.1.10 Transport and mobile use
Operating the device in any kind of 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 mobility
bag for mobile use.
⇒Transport and store the device only in the associ-
ated protection bag.
2.1.11 SpO2 measurement
⇒Only use the SpO2 sensors and cables quoted in
these instructions for use (See Accessories and
spare parts [}35]).
⇒For photodynamic treatments, note the peak val-
ues of wavelengths, optical output power, and the
use (see instructions for use of the 8000SX sensor).
⇒Check and, if possible, eliminate environmental in-
fluences that can impair the function or accuracy
of the SpO2 sensors: excessive periphery lighting,
excessive movement, interference due to electro-
surgical instruments, moisture in the sensor, incor-
rectly attached sensor, carboxyhemoglobin, re-
striction of the blood flow (due to arterial
catheters, blood pressure cuffs, infusion lines, etc.),
incorrect sensor type, poor pulse quality, venous
pulse, anemia or low hemoglobin concentrations,
cardiovascular dyes, dysfunctional hemoglobin, ar-
tificial fingernails or nail polish, residues (e.g.,
dried blood, dirt, oil, grease) in the light path.
2.2 Safety information in
these instructions for
use
WARNING
Indicates an unusually significant hazardous sit-
uation. If you ignore this instruction, severe irre-
versible or fatal injuries may result.
CAUTION
Indicates a hazardous situation. If you ignore
this instruction, mild or moderate injuries may
result.
NOTICE
Indicates a harmful situation. If you ignore this
instruction, material damage may result.
Indicates useful information and hints.
LMT 68691 12/2023 en-US

3 Product description
EN | 7
3 Product description
3.1 Overview
1 2 3 4 5 6
7 8 9 10 11
12
13
14
15
161718
1920
21
22
23
24
25
1Connection for external batteries 2Connection for monitor
3Connection for USB-C 4Remote alarm connection
5Power supply indicator 6Alarm acknowledgement key
7Inlet port for pressure measuring tube 8Inlet port for valve control tube
9Inlet for SpO₂ sensor 10 Inlet for CO₂ measurement (not in use)
11 Inlet port for nebulizer (not in use) 12 Circuit (single circuit with valve)
13 Filter compartment with coarse dust filter and fine filter 14 Patient air intake area
15 Compartment for internal battery 16 Intake area for cooling fan
17 Device inlet port 18 Device outlet port
19 Handle 20 On/off key
21 Power supply unit with power cord 22 Power cord
23 O₂ inlet 24 Loudspeaker
25 Connection for power supply unit

3 Product description
8 | EN
3.2 Display
1
2
3
4
5
6
7
8
9
1Status line - symbols indicate current device status (e.g.
accessories connected, battery capacity).
2Alarm acknowledgement key - acknowledges alarms
and mutes alarms.
3Home key - switches the view back to the home display. 4Menu buttons - provide access to the individual menus.
5Display lock key - locks or unlocks the display to pre-
vent settings being made as a result of incorrect con-
tact.
6Dimmer key - the display goes dark. Touch the display
to activate it. Keep key depressed to open the display
menu.
7Program key - provides access to the therapy pro-
grams.
8Ventilation button - starts or stops ventilation.
9Access button - locks or unlocks the Expert menu.
3.3 Symbols in the display
Symbol Description
Device in Patient menu. Expert menu locked.
Device in Expert menu. Expert menu unlocked.
S
Indicates respiratory status:
- Arrow pointing upward: Inspiration
- Arrow pointing downward: Exhalation
- S: Spontaneous breath
- T: Mandatory breath
Device set for pediatric applications/children (re-
stricted selection and setting of ventilation
modes).
Device set for adults.
Invasive patient interface set.
Symbol Description
Non-invasive patient interface set.
Leakage circuit set.
Single circuit with valve set.
Double circuit set.
I
I
Battery discharging.
- Green: Battery capacity high
- Yellow: Battery capacity moderate
- Red: Battery capacity low
- Letter “I”: Internal battery
- Letter “E”: External battery
Battery charging. If the gray area reaches the
top, the battery is fully charged.
Battery defective
LMT 68691 12/2023 en-US

3 Product description
EN | 9
Symbol Description
Filter change (only if function is activated)
Service reminder (only if function is activated)
Alarm triggered
- One symbol: Low priority
- Two symbols: Medium priority
- Three symbols: High priority
Pause alarm sound.
USB-C flash drive:
• Green: Data transfer
• Gray: Connected, no data transfer
• Red: Defective
SpO2 sensor
- Gray: Not connected
- Green: Connected, high signal quality
- Yellow: Connected, moderate signal quality
- Red: Connected, poor signal quality
FiO2 cell
- Green: Activated
- Gray: Inactive and empty
- Green and flashing: Calibration in progress
Flight mode activated
Bluetooth® (wireless technology)
- Green: Activated, device connected
- Gray: Not activated
3.4 Operating states
Operating status “On” and therapy in progress
• It is possible to make device and therapy settings.
• The on/off key is not illuminated.
After 10 minutes without operation, the display
switches to a screensaver showing the pressure curve
of the current therapy session. Touch the display or
press the on/off key to interrupt the screensaver.
The screensaver stops as soon as there is an alarm
message.
Operating status “On” and therapy not in
progress
• It is possible to make device and therapy settings.
• The on/off key is illuminated.
After 10 minutes without operation, the display goes
dark.
If the device is in battery mode and is not operated
for 40 minutes, it switches off to save energy. The on/
off key is not illuminated.
Operating state “Off”
The device is switched off. Therapy is not in progress.
It is not possible to make device and therapy settings.
The on/off key is not illuminated.
3.5 Batteries
3.5.1 Internal battery
The device is fitted with an internal battery.
If the device is disconnected from the power supply or
there is a power outage, the internal battery starts
supplying energy to the device. This discharges the in-
ternal battery.
The internal battery also discharges if the device is
not connected to the power supply for an extended
period.
If the device is always to be ready for use (internal
battery charged), do not disconnect the device from
the power supply.
The internal battery is replaced by the manufacturer
or by the specialist dealer.
3.5.2 External battery
External batteries can be connected as an additional
energy supply.
In battery mode, the external batteries connected are
discharged first, followed by the internal battery.
3.5.3 Battery charging
Internal and external batteries are charged as soon as
the device is connected to the power supply.
3.5.4 Battery life and battery capacity
Battery life depends on therapy settings and on ambi-
ent temperature (See Ambient conditions [}27]).
Battery life is reduced at low or high ambient temper-
atures.
Device life remaining in the case of battery and power
supply operation is displayed in the status line and in
the Views menu (See Views menu [}15]). Remaining
life is a prediction and always relates to the current
mean consumption of the device.
Following the start of therapy, no more than 3 min-
utes will elapse before life remaining is displayed.
In the event of battery capacity alarms, the device will
switch off within a few minutes (See Alarms [}21]).
Connect the device to the power supply as soon as
battery capacity alarms occur.
If using battery supply, always keep an alternative
ventilation option to hand.

3 Product description
10 | EN
3.6 Data management/com-
patibility
The health institution is responsible for applying
risk management to medical IT networks in ac-
cordance with IEC 80001-1. Medical IT networks
are IT networks which incorporate at least one
medical device.
The manufacturer does not accept any warranty
or liability for interactions between system com-
ponents within a medical IT network.
The manufacturer is not the system configura-
tor.
3.6.1 Saving and transmitting therapy
data
Therapy data for the previous 365 therapy days are
saved in the device at high resolution of up to 100 Hz.
Statistical data for the previous 12 months are like-
wise saved in the device.
Save therapy data to a USB-C flash drive
A file in . edf format is created for every therapy.
When you connect a USB-C flash drive, the therapy
and statistical data saved in the device are transmit-
ted to the USB-C flash drive in the form of .edf files.
It is likewise possible to save a detailed data set (See
System menu [}16]).
The therapy data saved on the USB-C flash drive can
be read into and displayed in the prismaTS software
and prisma CLOUD.
3.6.2 Performing the firmware update
1. Connect a USB flash drive with an update file (at
least one version higher than the current firmware
version).
2. Confirm that the firmware update is to be per-
formed.
The firmware update also updates the batteries.
The device configuration is retained following
the firmware update.
3.7 Trolley 2.0
NOTICE
Material damage if trolley 2.0 is not configured
correctly!
If trolley 2.0 is not used properly, it may tip over
or be damaged.
⇒Follow assembly instructions. Configure the
trolley in accordance with the manufacturer’s
instructions.
⇒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 trolley 2.0: Fold away the cir-
cuit holder.
LMT 68691 12/2023 en-US

4 Preparation and operation
EN | 11
4 Preparation and operation
4.1 Setting up and connect-
ing device
1. Place device freestanding on a level surface.
Caution! Risk of injury due to blocked air pas-
sages!
Observe the following safety precautions:
• Keep ventilation openings ( symbol) clear. Do
not cover device with textiles (e.g. blankets or cur-
tains).
• Do not set up the device in the immediate vicinity
of a heat source.
• Do not expose device to direct sunlight.
1. Connect the power cord to the power supply unit
and the socket.
2. Connect the power cord to the device.
Alternatively, you can connect the device to a di-
rect current power supply (12 VDC or 24 VDC) to
ISO 80601-2-72.
3. If required: Tilt the device to a horizontal or vertical
position.
The display adapts to the orientation automati-
cally.
4.2 Connect circuit
CAUTION
Risk of injury from incorrectly routed circuits and
cables!
⇒Do not route circuits and cables along the pa-
tient’s neck.
⇒Do not crush circuits and cables.
4.2.1 Connecting leakage circuit
1. If the patient interface or circuit is used without an
integrated exhalation system, connect an external
exhalation system (see instructions for use for ex-
halation system).
2. Push the inspiration tube onto the device outlet
port.
3. Connect the patient interface (e.g. breathing mask)
to the circuit.
4. Keep exhalation systems clear.
4.2.2 Connecting double circuit
1. Push the inspiration tube onto the device outlet
port.
2. Push the expiration tube onto the device inlet port.
3. Push the pressure measuring tube (blue marking)
onto the inlet for the pressure measuring tube
P
.
It is possible to use the device without a pres-
sure measuring tube. Use without a pressure
measuring tube must be selected during the cir-
cuit test.
4. Connect the patient interface (e.g. breathing mask)
to the circuit.
5. Keep exhalation systems clear.

4 Preparation and operation
12 | EN
4.2.3 Connecting single circuit with
valve
WARNING
Risk of injury from limited disconnection detec-
tion!
If proximal pressure measurement is not being
used, disconnection is detected to only a limited
extent when accessories (tube extension, HME/F
etc.) are connected.
⇒Check alarm settings and adjust to the ther-
apy if required.
WARNING
Risk of injury if patient valve is covered!
If the patient valve is covered, exhaled air can no
longer be routed away.
⇒Keep patient valve clear.
1. Push the inspiration tube onto the device outlet
port.
2. Push the pressure measuring tube (blue marking)
onto the inlet for the pressure measuring tube
P
.
It is possible to use the device without a pres-
sure measuring tube. Use without a pressure
measuring tube must be selected during the cir-
cuit test.
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.
4.2.4 Connecting circuit for mouthpiece
ventilation
1. Push the free end of the leakage circuit onto the
device outlet. It is likewise possible to use a single
circuit with valve or a double circuit.
2. Connect mouthpiece to the tube (see instructions
for use for the patient/ventilator interface).
4.2.5 Connecting the circuit for HFT
mode
As an alternative to the leakage circuit, it is also
possible to use a single circuit with valve or a
double circuit.
1. Push inspiration tube (short tube)onto the device
outlet.
2. Push the other end of the inspiration tube (short
tube) onto the inlet of the humidifier chamber
marked In.
3. Push the second inspiration tube (long tube) onto
the outlet port of the humidifier chamber marked
Out.
4. Connect the HFT nasal cannula to the inspiration
tube (long tube).
5. If necessary, connect the tube heater and tempera-
ture probe to the inspiration tube (long tube) (see
instructions for use for the external respiratory air
humidifier).
4.3 Before first use
Before using the device for the first time, you must
set the date and time on it if your specialist dealer has
not already done so.
The language can only be set by a specialist user
(expert).
The device can be 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.
LMT 68691 12/2023 en-US

4 Preparation and operation
EN | 13
4.4 Switch device on and off / Start and end therapy
Action Requirement Key Operating state achieved
Switch on device1Device is connected (See
Setting up and connecting
device [}11]).
Briefly press on/off key
on the device.
On, therapy not in progress
Switch off device - Press and hold on/off key
on the device.
Off
Starting therapy Device is switched on. Briefly press the On/off
key on the device
or
Press Start therapy in the
display.
On, therapy in progress
End therapy - Press and hold on/off key
on the device.
or
Press and hold End ther-
apy in the display.
Confirm end of therapy in
the display (OK key).
On, therapy not in progress
1) The device performs function tests when it is switched on (approx. 20 seconds). It can only be operated after
the function tests are complete.
4.5 Circuit test
The circuit test checks the resistance, compliance, and
leaktightness of the circuit.
Perform a circuit test in the following scenarios:
• In the function check (See Function check [}18])
• Following a change of patient
• Following change or replacement of accessories
and spare parts
• As required
Perform circuit test
Requirement
üPatient type and patient interface have been set
by the specialist user (expert).
1. Select the System > Circuit test menu.
The therapy programs are listed in the Overview
of circuit test area. The green checkmark indicates
the therapy program selected.
2. If required, use the (See Display [}8]) program key
to select the therapy program for which a circuit
test is to be performed.
3. Press the Start key.
4. If using a leakage circuit: Select the configuration
of the circuit (with exhalation system/without exha-
lation system).
5. If using a single circuit with valve or a double cir-
cuit: Select the configuration of the circuit (with
proximal pressure measurement/without proximal
pressure measurement).
6. Follow instructions in the display.
7. If the circuit test is successful, press the Finish key.
8. If the circuit test fails, follow the instructions on the
display to eliminate the fault.
4.6 Performing SpO2 mea-
surement
You can measure oxygen saturation (SPO2) and pulse
rate with the SpO2 sensor. The measured values (SpO2
and pulse rate) are shown on the home display and
saved in the device. The measured values can be ex-
ported and read in the prismaTS software (See System
[}16]).
Alarms can be set to monitor the measurements
(SpO2 and pulse rate) (See set alarms [}21]).
Following a power outage lasting more than 30 sec-
onds, all settings and data are retained. The latest set-
tings for the SpO2 sensor are restored.
Requirement
üThe SpO2 sensor has been calibrated to display
functional oxygen saturation.
1. Connect the SpO2/Xpod® cable to the SpO2 sensor.

4 Preparation and operation
14 | EN
2. Connect the SpO2/Xpod® cable to the device.
CAUTION
Risk of injury due to pressure points!
⇒Avoid excessive pressure caused by the SpO2
sensor.
⇒Check the fit of the SpO2 sensor every 6 to 8
hours to ensure that the sensor is in the cor-
rect position and that the skin is undamaged.
The patient’s sensitivity may vary depending
on medical state or skin condition.
3. Place the SpO2 sensor on the patient (e.g., on the
finger).
4.7 Calibrating the FiO2 cell
You can use the optional FiO2 cell to perform continu-
ous FiO2 measurement. You must activate the FiO2 cell
before use and calibrate it every 6 weeks.
Calibration can take place during ventilation. You can-
not perform FiO2 measurement during the calibration
process (duration approx. 5 minutes).
1. Open the System > FiO2 cell > Calibrate menu.
2. Shut off the oxygen supply.
3. Wait approx. 30 seconds.
4. Press the OK key to start calibration.
5. If calibration is successful, press the Finish key.
If calibration is not successful, follow the instruc-
tions in the display and eliminate the faults.
6. Resume the supply of oxygen.
The FiO2 cell is continuously emptied as a result
of contact with oxygen. Once the FiO2 cell is al-
most empty, a message appears to say that the
FiO2 cell needs replacing. The FiO2 cell is re-
placed by an authorized specialist dealer or by a
specialist user (expert).
4.8 Pairing device with
LUISA app
The LUISA app (option) 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 > De-
vice settings > Connectivity menu.
2. In the Device list menu, select the Add new device
entry.
3. Download the LUISA app onto a mobile terminal
and follow the instructions in the LUISA app.
The pairing with the ventilator is saved in the LUISA
App and does not need to be repeated. The saved
pairing with the ventilator can be deleted in the LUISA
App.
4.9 Contaminated compo-
nents
After the device has been used, the following compo-
nents in the gas path may be contaminated:
• LMT 31494 Device outlet port
• LMT 31503 FiO₂ cell
• LMT 31497 FiO₂ cell sealing
• 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 Center part of housing LM150TD
• WM 29389 Fine filter
• LMT 31487 Filter for cooling fan
• LMT 31422 Filter holder
LMT 68691 12/2023 en-US

5 Settings in the menu
EN | 15
5 Settings in the menu
5.1 Navigating in the menu
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.
Symbols on a black background are not function keys, but serve to provide information
about device status (See Symbols in display [}8]).
Scroll in list Navigate up or down.
Press “Value” Open scale of values to set therapy parameters.
Move range of values
up or down Decrease or increase value.
Confirm value.
Discard selection.
Back to home display.
5.2 Menu structure
(Views)
Therapy programs
Life remaining/charging status
Report
System Circuit test
FiO2 cell
Export therapy data
Alarm volume
Display
Alarm list
Event list
Parameter overview
Filter timer
Connectivity
Flight mode
Device settings
Date and time
Device usage
Trends
Device status
Alarm and event listDisplay background*
* Only available in patient menu (if
enabled by the specialist user)
5.2.1 Views menu
The Views menu shows various views To switch to the
next view in each case, press the Views key again.
The horizontal lines on the Views key are the
number of available views.
Parameters and set values for the therapy pro-
grams
Operating status On, therapy in progress: Re-
maining device life if being supplied by battery
Operating status On, therapy not in progress:
Charging state of the internal battery in per-
cent assuming a power supply

5 Settings in the menu
16 | EN
View is only available in the patient menu if a
display background has been selected in the
device settings of the expert menu.
5.2.2 Report menu
Alarm list Lists the alarms which have
occurred.
Event list Lists the events that have oc-
curred.
Alarm and event list Lists the alarms and events
which have occurred in
chronological order.
Device usage Lists the usage time of the
device and the duration of
therapy for the patient.
Parameter overview Lists the parameters set for
the therapy programs.
Trends Displays therapy data for the
past 30 days in graphical
form.
5.2.3 System menu
Circuit test Perform a circuit test (See
Performing a circuit test
[}13]).
FiO2 cell Activate, deactivate and cali-
brate FiO2 cell (See Calibrat-
ing FiO2 cell [}14]).
Export therapy data Export detailed data set
(therapy data, statistical
data, log data etc.) to a USB-
C flash drive. A USB-C flash
drive must be connected.
Flight mode If flight mode is activated,
wireless communication (e.g.
wireless LAN, Bluetooth) is
impossible.
Device settings Set the device (see table be-
low).
Device status Information about the de-
vice (name, type, serial num-
ber of device and compo-
nents, firmware version) and
about the internal battery.
5.2.3.1 Device settings
Alarm volume Set alarm volume.
Display Set brightness, orientation,
and display background.
Filter timer Activate and reset the filter
change reminder function.
Date and time Set current date and time.
Connectivity Activate and deactivate Blue-
tooth.
LMT 68691 12/2023 en-US

6 Reprocessing and maintenance
EN | 17
6 Reprocessing and maintenance
6.1 Hygiene treatment
WARNING
Risk of infection if device and accessories are
reused!
Infections can be transmitted and the device
contaminated on change of patient.
⇒Use the breathing system filter.
⇒Do not reuse disposables.
⇒Do not reprocess disposables.
6.1.1 General information
• To prevent foreign bodies being taken in, ensure
that new filters are inserted following reprocess-
ing, maintenance or servicing.
• Following reprocessing by the specialist dealer, the
device is suitable for a change of patient.
Ensure that cleaning is completed with care and that
no detergent residues are left behind. Rinse all parts
with clean water.
6.1.2 Intervals
Interval Action
Weekly Clean device (See Cleaning device
[}17]).
Monthly Clean coarse dust filter (See Cleaning
coarse dust filter [}17]).
Replace fine filter (See Replacing fine fil-
ter [}17]).
Clean filter for cooling air fan (See Clean-
ing filter for cooling air fan [}18]).
Every 6months Replace coarse dust filter
6.1.3 Reprocessing device
WARNING
Risk of injury from electric shock!
Ingress of liquids may lead to a short-circuit, in-
jure the user, and damage the device.
⇒Disconnect the device from the power supply
before reprocessing.
⇒Do not immerse the device and components
in liquids.
⇒Do not pour liquids over the device and com-
ponents.
WARNING
Risk of injury from use of ozone!
Ozone cleaning devices may damage the materi-
als and thus put the patient at risk.
⇒Clean ventilator, accessories, and patient in-
terface only in accordance with the associ-
ated instructions for use.
⇒Do not use ozone cleaning devices.
Cleaning device
1. Disconnect accessories and cables from the device.
2. Wipe over the housing including the device outlet
port, the power cord, and the display with a damp
cloth. Use a lint-free cloth slightly moistened with
water and/or a mild detergent.
3. Clean or replace the mask, circuit, coarse dust fil-
ter, fine filter, filter for the cooling air fan, and the
breathing system filter. Follow the manufacturer’s
instructions for use for the accessory.
4. Perform a function check (See Function check
[}18]).
Clean coarse dust filter (gray filter)
1. Open filter compartment.
2. Remove coarse dust filter.
3. Wash coarse dust filter under running water.
4. Allow coarse dust filter to air-dry.
5. Insert coarse dust filter.
6. Close filter compartment.
Replace fine filter (white filter)
1. Open filter compartment.
2. Remove gray coarse dust filter.
3. Remove and replace white fine filter.

6 Reprocessing and maintenance
18 | EN
4. Insert coarse dust filter.
5. Close filter compartment.
Clean filter for cooling air fan
1. To open the exhalation module compartment on
the rear of the device, turn the latch counterclock-
wise to the symbol.
2. Remove cover.
3. Remove filter.
4. Wash filter under running water.
5. Allow filter to air-dry.
6. Insert filter.
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 accessories for ex-
ternal damage. Consult associated instructions for
use.
3. Check that accessories are connected to the device
correctly.
4. Connect the device to the power supply (See Set-
ting up and connecting device [}11]).
5. Switch on the device (See Switching device on and
off / Starting and ending therapy [}13]).
The device automatically performs a few function
tests on the sensor system. If fully functional, the
device will show the home display.
6. 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 de-
vice. The second external battery (if present) takes
over energy supply.
• Disconnect the second external battery from the
device. The internal battery takes over energy sup-
ply.
7. Check battery capacity (See Battery life and battery
capacity [}9]).
If battery capacity is low, connect the device to the
power supply.
8. If one of the items is not OK: Do not use device or
accessory and contact your specialist dealer.
9. Perform a circuit test (See Performing a circuit test
[}13]). If the circuit test fails, follow the instruc-
tions on the display and eliminate the faults.
10.Seal the end of the circuit and start therapy. A brief
acoustic alarm must be audible on starting. The
device automatically performs a few function tests.
The alarm acknowledgement key lights up yellow
and red.
11.Compare the therapy pressure displayed with the
prescribed pressure. If the pressure deviation is >
1 hPa: Do not use device or accessory and contact
your specialist dealer.
12.If a FiO2 cell is in use: Calibrate FiO2 cell (See Cali-
brating FiO2 cell [}14]).
13.When using an SpO2 sensor:
• Check whether the SpO2 sensor determines mea-
sured values and shows them in the display (SpO2,
pulse rate).
• Check whether the symbol in the status line
lights up green.
Do not use a functional tester to assess the accuracy
of an SpO2 sensor or a pulse oximeter.
14.If required: Check alarms (See Checking alarms
[}19]).
LMT 68691 12/2023 en-US

6 Reprocessing and maintenance
EN | 19
6.2.1 Checking alarms
Physiological alarms
Alarm ID no. Requirement Test
Leakage high 459 On a single circuit with valve: Alarm
limit is set to a value < 150 l/min.
With leakage circuit: Alarm limit is set
to a value < 60 l/min.
On a double circuit, 15 mm/22mm:
Alarm limit is set to a value < 60 l/min.
Leave the inspiration tube on the pa-
tient connection port open.
Start therapy.
Wait at least 30 seconds, more alarms
may occur during this period.
Pressure low 457 Alarm limit is set to a value ≥ 6hPa. Leave the inspiration tube on the pa-
tient connection port open.
Start therapy.
Tidal volume low 450 Double circuit: Alarm limit is set. Start therapy.
Take expiration tube off device inlet
port.
Wait 3 breaths.
FiO2 low 494 FiO 2 cell is fitted and activated.
Alarm limit is set.
No external oxygen supply con-
nected.
Start therapy.
Technical alarms
Alarm ID no. Requirement Test
Exhalation blocked 757 Single circuit with valve is connected.
or
Double circuit is connected.
Connect test lung. Start therapy.
On a single circuit with valve: Seal pa-
tient valve.
On a double circuit:
Take the expiration tube off the de-
vice inlet and seal the expiration tube.
Battery capacity low 551 Device is not connected to the power
supply. Start therapy 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 therapy until the internal battery has 5minutes’ life remaining before it
discharges completely.
Supply via internal bat-
tery 581 None Disconnect power cord from device. Disconnect the external batteries
from the device.
6.3 Servicing
The device is designed for the following service life: 10
years. If the device is used beyond this period, it
needs checking by the manufacturer or by an autho-
rized specialist dealer.
For Germany: In accordance with §11 Medizinpro-
dukte-Betreiberverordnung [German law governing
health institutions using medical devices], the device
must be subjected to a Technical Safety Check [Sicher-
heitstechnische Kontrolle (STK)] every 2 years. Coun-
try-specific requirements apply to all other countries.
Expected useful life 10 years
Maintenance interval for batteries 4 years or 500 charge cycles
Maintenance interval for membrane of nonreturn
valve 4 years
Maintenance interval for blower 35,000h life

6 Reprocessing and maintenance
20 | EN
6.4 Disposal
Do not dispose of the product or any batteries
present with domestic waste. To dispose of properly,
contact a licensed, certified electronic waste disposal
merchant. This address is available from your Environ-
ment Officer or from your local authority. The device
packaging (cardboard and inserts) can be disposed of
in paper recycling facilities.
LMT 68691 12/2023 en-US