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