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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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.