Lowenstein Medical prisma VENT30 User guide

prisma VENT30
prisma VENT30-C
prisma VENT40
prisma VENT40-C
prisma VENT50
prisma VENT50-C
Ventilators
EN Instructions for use for patients for devices of type WM110TD and WM120TD

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LMT 68431 09/2021
Contents
Contents
1 Introduction 5
1.1 Intended use ............................................................................................. 5
1.2 Description of function ............................................................................. 5
1.3 User qualifications ..................................................................................... 6
1.4 Indications ................................................................................................ 6
1.5 Contraindications ...................................................................................... 6
1.6 Side effects ............................................................................................... 7
1.7 Clinical benefits ........................................................................................ 7
2 Safety 8
2.1 Safety information .................................................................................... 8
2.2 General information .................................................................................. 9
2.3 Warnings in this document ..................................................................... 10
3 Product description 11
3.1 Overview prisma VENT30, prisma VENT30-C, prisma VENT40, prisma
VENT40-C ...............................................................................................11
3.2 Overview prisma VENT50, prisma VENT50-C ........................................... 12
3.3 Operating states ..................................................................................... 13
3.4 Control panel .......................................................................................... 13
3.5 Symbols in the display ............................................................................. 14
4 Preparation and operation 16
4.1 Set up the device .................................................................................... 16
4.2 Connecting circuit ................................................................................... 17
4.3 Before first use ........................................................................................ 21
4.4 Start therapy ........................................................................................... 22
4.5 End therapy/switch off device ................................................................. 22
4.6 Set humidifier ......................................................................................... 23
4.7 Select a preconfigured program .............................................................. 23
4.8 LIAM (prisma VENT50, prisma VENT50-C only) ........................................ 24
4.9 Switching softSTART on and off .............................................................. 24
4.10 Use SD card (optional) ............................................................................ 25

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Contents
4.11 Use battery (optional) ............................................................................. 25
5 Settings in the menus 27
5.1 Navigating in the device .......................................................................... 27
5.2 Patient menu .......................................................................................... 28
6 Hygiene treatment 32
6.1 General information ................................................................................ 32
6.2 Intervals .................................................................................................. 32
6.3 Hygiene treatment for device .................................................................. 33
6.4 Clean air filter (gray filter) ....................................................................... 34
6.5 Replace pollen filter (white filter) ............................................................. 35
6.6 Function check ........................................................................................ 35
7 Alarms and faults 37
7.1 Sequence for display of alarms ................................................................ 37
7.2 Deactivating physiological alarms ............................................................ 37
7.3 Muting alarms ........................................................................................ 37
7.4 Physiological alarms ................................................................................ 38
7.5 Technical alarms ..................................................................................... 40
7.6 Troubleshooting ...................................................................................... 44
8 Servicing 45
8.1 Safety information .................................................................................. 45
8.2 General information ................................................................................ 45
9 Transport and storage 45
10 Disposal 46
11 Appendix 47
11.1 Technical data ........................................................................................ 47
11.2 Emission of electromagnetic interference ............................................... 54
11.3 Electromagnetic interference immunity .................................................. 55
11.4 Electromagnetic interference immunity for ME equipment and
ME systems .............................................................................................56
11.5 Markings and symbols ............................................................................ 57
11.6 Scope of supply ...................................................................................... 59
11.7 Accessories and replacement parts ......................................................... 59

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Contents
11.8 Warranty ................................................................................................ 61
11.9 Declaration of conformity ....................................................................... 61

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1 Introduction
1 Introduction
1.1 Intended use
WM110TD
(prisma VENT30, prisma VENT30-C, prisma VENT40, prisma VENT40-C)
Device WM110TD is for ventilating patients with an independent respiratory drive. It
can be used on patients who weigh over 10 kg and have respiratory insufficiency. It
can be used in both stationary and mobile applications in both domestic and clinical
environments.
WM120TD
(prisma VENT50, prisma VENT50-C)
Device WM120TD is for ventilating patients with an independent respiratory drive. It
can be used on patients who weigh over 10 kg and have respiratory insufficiency. It
can be used in both stationary and mobile applications in both domestic and clinical
environments.
1.2 Description of function
The device can be used with both non-invasive and invasive patient/ventilator
interfaces.
The blower takes in ambient air through a filter and pumps it to the patient at therapy
pressure through the circuit and the patient/ventilator interface. The blower is
controlled to suit respiratory phases on the basis of the signals detected by the
pressure and flow sensors.
The user interface is for displaying and setting the available parameters and alarms.
The device can be used with both a leakage circuit and also with a single circuit with
valve (prisma VENT50 and prisma VENT50-C only). On the leakage circuit, an
exhalation system continuously flushes out the exhaled air containing CO2. On the
single circuit with valve, exhalation by the patient is controlled via the patient valve. If
the device has an integrated battery, it can continue to be operated without
interruption in the event of a power outage.
Modes HFT (prisma VENT40-C, prisma VENT50-C only) and MPV are no ventilatory
support modes within the scope of standard ISO 80601-2-79. As the corresponding
interfaces are not closely and/or sealingly connected to the patient's airways, some
specifications like detection of disconnection won't be applied.
Therapy data are saved on the SD card and can be evaluated using PC software.
prisma VENT40-C, prisma VENT50-C only
In High Flow mode (HFT mode), the device pumps the set flow rate to an external
humidifier suitable for HFT. This conditions the respiratory gas in terms of temperature
and humidity. The patient connection is made using accessories suitable for HFT.

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1 Introduction
1.3 User qualifications
The person operating the device is referred to in these Instructions for Use as the user.
A patient is the person receiving the therapy.
As an owner/operator or user, you must be familiar with the operation of this medical
device. The owner/operator is responsible for ensuring the compatibility of the device
and of all the components or accessories connected to the patient before use.
The device is a medical device which may only be used by trained specialists as directed
by a physician. Use the device only as directed by a physician or other medical staff.
When the device is handed over to the patient, the attending physician or hospital staff
must instruct the patient in the function of the device.
Notice for blind or partially-sighted users
An electronic version of the instructions for use is also available on the website.
1.4 Indications
Obstructive ventilation disorders (e.g. COPD), restrictive ventilation disorders (e.g.
scolioses, deformities of the thorax), neurological, muscular, and neuromuscular
disorders if inducing respiratory insufficiency (e.g. pareses of the diaphragm), central
respiratory regulation disorders, obstructive sleep apnea (OSA), obesity
hypoventilation syndrome (OHS), hypoxemic respiratory insufficiency.
1.5 Contraindications
Devices shall not be used for patients with:
Absence of spontaneous breathing or acute respiratory failure, unconsciousness,
clouding of consciousness or coma unless permanently supervised, pneumothorax or
pneumomediastinum, pneumoencephalus or liquor fistula, severe epistaxis, high risk
of barotrauma, blocked airways, otitis media or perforated tympanum, status
following brain surgery and following surgical procedures on the hypophysis or middle
or inner ear, acute intolerance to elevated upper airway pressure of other nature.
Devices shall be used only with special caution and consideration by a physician for
patients with:
Acute cardiac decompensation or infarction, severe cardiac arrhythmias, severe
hypotension, esp. in combination with intravascular volume depletion, severe heart
failure, dehydration, acute sinusitis or infection of airways, severe injuries of cranium,
face, ear or airways, chronic infection of airways or middle ear.

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1 Introduction
1.6 Side effects
When using the device, the following undesired side effects may occur in short-term
or long-term use: (Allergic) rhinitis, feeling unwell, aerophagia, central sleep apnea,
rhinorrhea, headaches, otitis/earache, aerophagia/aspiration, inability to tolerate
pressure, anxiety, fatigue, chest complaints.
These are general side effects not attributable specifically to use of devices of type
WM110TD/WM120TD.
If patient and device are poorly synchronized, there are additional risks such as reduced
efficacy, sleep disorder, feeling unwell or injury to the respiratory tract. These make it
necessary to set trigger sensitivity and inspiration time appropriately.
The following potential undesired effects reported may be alleviated by adding a
humidifier: Dry mouth, dry nose, sinusitis, epistaxis.
Therapy accessories such as masks or humidifiers may cause additional side effects.
Follow the instructions for use for the accessories in question.
The following potential side effects reported may be alleviated by activating comfort
functions such as softSTART (pressure ramp during the first minutes of therapy) or
softSTOP (inverse pressure ramp when ventilation is switched off): Feeling of
asphyxiation, more difficult exhalation, insomnia, dyspnea in the mornings.
Use of HFT mode (prisma VENT40-C, prisma VENT50-C only) is an option for reducing
side effects and simultaneously obtaining benefit for the individual patient; evidence
is greatest in COPD patients.
1.7 Clinical benefits
Standard NIV / IV / MPV modes:
Restore proper ventilation / ventilatory drive either by fixed settings or by some
automatic responses to patient needs, unload the respiratory pump/support of
respiratory muscles, improve alveolar ventilation and blood gases, reduced daytime
sleepiness, iImprovement in health related quality of life and long-term prognosis of
disease, reduction of hospitalization periods / exacerbations.
Additional clinical benefits for LIAM function in prisma VENT50, prisma VENT50-C:
Assistance for secretion management with cough support
Additional clinical benefits for HFT mode in prisma VENT40-C, prisma VENT50-C are:
Wash out nasopharyngeal dead space and and thereby eliminates CO2, improve
mucociliary clearance by humidifying and warming the upper airways, improve
oxygenation / gas exchange, increase inspiratory flow / volume, apply a small positive
pressure to upper airways, reduce spontaneous breathing frequency.

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2 Safety
2 Safety
2.1 Safety information
2.1.1 Handling the device, the components and the accessories
If the device is damaged or its function is restricted, people may be injured.
Only operate the device and its components if they are externally undamaged.
Perform a function check at regular intervals (see "6.6 Function check", page 35).
Only operate device within the specified ambient conditions (see "11.1 Technical
data", page 47).
Do not use the device in an MRI environment or in a hyperbaric chamber.
Do not reuse disposables. Disposables may be contaminated and/or their function may
be impaired.
Set the acoustic alarm volume high enough for the acoustic alarm to be heard.
Only use circuits with an internal diameter of Ø 15 mm or more.
Only use accessory parts from the manufacturer. Third-party electrical connecting
cables, in particular, may cause the device to malfunction.
Only use undamaged accessories.
Do not use antistatic or electrically-conductive tubes.
The device is subject to special precautions with regard to EMC (electromagnetic
compatibility). Maintain a minimum distance of 30 cm between the device and
equipment that emits HF radiation (e.g. cell phones). This also applies to accessories
such as antenna cables and external antennas, for example. Ignoring this requirement
may lead to the device exhibiting reduced performance characteristics.
Do not operate the device outside the EMC environment specified for this device (see
"1.1 Intended use", page 5) in order to prevent undesired events for the patient or
operator due to electromagnetic interference. Do not operate the device if the
housing, cables or other equipment for electromagnetic shielding are damaged.
Do not operate the device in the immediate vicinity of other devices or in a stacked
arrangement, otherwise there may be malfunctions. If it is necessary to operate the
device in the immediate vicinity of other devices or in a stacked arrangement, keep all
the devices under observation to ensure that they are all operating properly.
Regularly check bacteria filter for increased resistance and blockages. If necessary:
Replace bacteria filter. Moistening with droplets or liquid can increase the resistance
of bacteria filters and thus change the therapeutic pressure delivered.
2.1.2 Energy supply
Operating the device outside the specified energy supply may injure the user and damage
the device.
Operate the device only at voltages from 100 V to 240 V.
Use the inverter for operation on voltages of 12 V DC or 24 V DC.

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2 Safety
Keep access to the power supply connector and the power supply free at all times.
2.1.3 Handling oxygen
Supplying oxygen without a special safety device can lead to fire and injure people.
Follow the Instructions for Use for the oxygen supply system.
Set up oxygen sources at a distance of over 1 m from the device.
The oxygen rate supplied in l/min may not exceed the set HFT flow rate (prisma
VENT40-C, prisma VENT50-C only).
At the end of therapy, shut off the oxygen supply and allow the device to run on briefly
to flush residual oxygen out of the device.
Specify oxygen dosage in agreement with a physician.
2.1.4 Transport
Water and dirt in the device may damage the device.
Do not transport or tilt the device with the humidifier full.
Only transport the device with the cover fitted.
Transport or store the device in the associated carrying bag.
2.2 General information
• The use of third-party articles may lead to incompatibility with the device. In such
cases, please be aware that any claim under warranty and liability will be void if
genuine replacement parts are not used.
• Have measures such as repairs, servicing, and maintenance work, as well as
modifications to the device, carried out exclusively by the manufacturer or by
specialists expressly so authorized by the manufacturer.
• Connect only the devices and modules permitted in accordance with these Instructions
for Use. The devices must meet the product standard applicable to them. Non-medical
equipment should be positioned out of the patient's vicinity.
• To prevent infection or bacterial contamination, follow the section about hygiene
treatment (see "6 Hygiene treatment", page 32).
• In the event of a power outage, all settings including alarm settings are retained.
• The use of accessories in the respiratory flow, such as bacteria filters, for example, may
make it necessary to reset device parameters. Be aware that pressure at the patient
connection opening may rise during expiration if you connect accessories.
• In the EU: As a user and/or patient, you must report any severe adverse events
occurring in connection with the product to the manufacturer and to the responsible
authorities.

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2 Safety
2.3 Warnings in this document
Warnings indicate information relevant to safety in front of a step which contains a
hazard to persons or objects.
There are three levels of warning depending on the degree of hazard:
Warning!
Indicates an unusually significant hazardous situation. If you
ignore this instruction, severe irreversible or fatal injuries may
result.
Caution!
Indicates a hazard. If you do not follow this instruction, mild
or moderate injuries may result
Notice!
Indicates a harmful situation. If you do not follow this
instruction, material damage may result.
Indicates useful information within procedures.

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3 Product description
3 Product description
3.1 Overview prisma VENT30, prisma VENT30-C, prisma VENT40,
prisma VENT40-C
1 Humidifier connection with cover 10 Strain relief for power supply cable
2 Control panel with display 11 Leakage circuit
3 System interface for connecting modules 12 Latching bores for connecting
modules
4 Handle
5 Release catch 13 SD card slot
6 Filter compartment with air filter and
pollen filter
14 Connection for tube heater
15 Device outlet port
7 Sealing plug 16 Power cord
8 O2 supply 17 SD card
1
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3 Product description
3.2 Overview prisma VENT50, prisma VENT50-C
9 Connection for power supply cable 18 O2 connector (option)
1 Humidifier connection with cover 11 Single circuit with valve
2 Control panel with display 12 Latching bores for connecting modules
3 System interface for connecting modules 13 SD card slot
4 Handle 14 Connection for tube heater, valve
control tube and pressure measuring
tube
5 Release catch
6 Filter compartment with air filter and
pollen filter 15 Device outlet port
7 Cooling air opening 16 Power cord
8 O2 supply 17 SD card
9 Connection for power supply cable 18 O2 connector
1
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12
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3 Product description
3.3 Operating states
•On: Therapy is running.
•Standby: Blower is off, but immediately operational if the on/off key is pressed briefly.
Settings can be made on the device when it is in standby mode.
•Off: The device is switched off. No settings can be made and the display remains dark.
3.4 Control panel
1 Alarm acknowledgment key - mutes an alarm for 2 minutes
2 LIAM key (only present on prisma VENT50 and prisma VENT50-C)
3 Dial for navigating in the menu
4 Function keys for switching between the System, softSTART/softSTOP,
Ventilation or Report menus and the Back function
5 Monitor key for switching between different screen views
6 Home key - switches the view back to the start screen, provides access to the
expert menu
7 Power supply indicator
8 On/off key
9 Humidifier key
10 Program key for selecting pre-configured programs
10 Strain relief for power supply cable
Enter
1
3
4
5
7
10
8
9
6
2

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3 Product description
3.5 Symbols in the display
SYMBOL DESCRIPTION
Device in patient mode. Expert menu locked.
Device in expert mode (device enabled)
Leakage circuit connected (prisma VENT50 and prisma VENT50-C
only).
Single circuit with valve connected (prisma VENT50 and prisma
VENT50-C only).
Device on standby. The blower is off.
Air filter change required (only if filter function is activated).
Servicing required (only if servicing function is activated).
Humidifier connected but not active (gray symbol)
Humidifier switched on (green symbol)
Humidifier empty (orange symbol)
Pulse rate (if pulsoximetry sensor connected)
SpO2 sensor connected
prismaCONNECT module module connected
prisma CHECK module connected
prismaPSG module connected
Network connection present.
SD card inserted (flashes green if data are currently being written to
the card).
Indicates respiratory status:
• Arrow pointing upward: Inspiration
• Arrow pointing downward: Exhalation
• S: Spontaneous breath
• T: Mandatory breath
Target volume switched on

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3 Product description
AirTrap Control switched on.
LIAM activated (prisma VENT50 and prisma VENT50-C only).
5 segments green: Battery capacity above 85 %
4 segments green: Battery capacity above 65 %
3 segments green: Battery capacity above 45 %
2 segments green: Battery capacity above 25 %
1 segment orange: Battery capacity below 25 %
1 segment red: Battery capacity below 10 %
0 segments: Battery capacity below 5 %
Battery fault
Low-priority alarm triggered.
Medium-priority alarm triggered.
High-priority alarm triggered.
All physiological alarms have been deactivated.
Acoustic signal for alarm paused.
Acoustic signal for alarm deactivated.
softSTART started with remaining time quoted in min:sec
softSTOP started with remaining time for the ramp quoted in min:sec
Mask fits well, no leaks.
Mask does not fit adequately, severe leak, therapy efficacy is not
guaranteed.
SYMBOL DESCRIPTION
+ L

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4 Preparation and operation
4 Preparation and operation
4.1 Set up the device
1. Connect the power cord to the therapy device and the power supply socket.
Material damage from overheating!
Excessive temperatures may lead to the device overheating and damage the device.
Do not cover device and power supply unit with textiles (e.g. bedclothes).
Do not operate device in the vicinity of a radiator.
Do not expose device to direct sunlight.
Do not operate the device in the carrying bag (prismaBAG advanced).
Alternatively, you can connect the power cord to the inverter in order to use a direct
voltage electricity supply (12 V DC or 24 V DC) in accordance with ISO 80601-2-80.

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4 Preparation and operation
4.2 Connecting circuit
Risk of injury from incompatible accessory parts!
The use of accessories not intended for the ventilator described may put the patient
at risk.
Only use accessory parts intended for use with the ventilator described.
Risk of asphyxia if non-invasive or invasive patient/ventilator interfaces
without an exhalation system are used!
If non-invasive or 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 non-invasive or invasive patient/ventilator interfaces with an external
exhalation system if there is no integrated exhalation system.
Follow the Instructions for Use for the exhalation system.
Risk of injury if circuit is routed incorrectly!
An incorrectly routed circuit may injure the patient.
Never wrap the circuit around the neck.
Do not crush the circuit.

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4 Preparation and operation
4.2.1 Connecting leakage circuit
1. Push leakage circuit onto the device outlet port.
2. Connect the non-invasive or invasive patient/ventilator interface to the leakage
circuit (see instructions for use for the patient/ventilator interface).
4.2.2 Connecting single circuit with valve (prisma VENT50 and prisma
VENT50-C only)
Risk of injury from re-inhaling CO2!
If the patient valve is covered, exhaled air can no longer be routed away and the
patient will be put at risk from CO2 re-inhalation.
Always keep the patient valve free.

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4 Preparation and operation
1. Push the free end of single circuit with valve 1 onto the device outlet port.
2. Connect valve control tube 2 to connection .
3. Connect pressure measuring tube 3 to connection .
4. Connect patient/ventilator interface (e.g. mask) to patient valve 4.
The device can also be operated with valve ventilation without pressure being
measured at the patient. In this case, the connection for the pressure measuring tube
is unused (perform tube test).
3
1
2
4
P

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4 Preparation and operation
4.2.3 Connect patient circuit for mouthpiece ventilation (prisma VENT50 and
prisma VENT50-C only)
1. Push circuit for mouthpiece ventilation 1 onto the device outlet port.
2. Connect mouthpiece 2 to the circuit for mouthpiece ventilation (see instructions
for use for the patient/ventilator interface).
As an alternative to the leakage circuit, it is also possible to use a single circuit with
valve for mouthpiece ventilation.
1
2