Lowenstein Medical prisma VENT30 User manual

prisma VENT30
prisma VENT30-C
prisma VENT40
prisma VENT50
Ventilators
EN Instructions for Use for devices of type WM 110 TD and WM 120 TD

2| EN
WM 68131d 10/2017
Contents
Contents
1 Introduction 4
1.1 Intended use ............................................................................................. 4
1.2 Description of function ............................................................................. 4
1.3 User qualifications ..................................................................................... 4
1.4 Indications ................................................................................................ 5
1.5 Contraindications ...................................................................................... 5
1.6 Side effects ............................................................................................... 5
2 Safety 6
2.1 Safety information .................................................................................... 6
2.2 General information .................................................................................. 7
2.3 Warnings in this document ....................................................................... 7
3 Product description 8
3.1 Overview .................................................................................................. 8
3.2 Operating states ..................................................................................... 10
3.3 Control panel .......................................................................................... 11
3.4 Symbols in the display ............................................................................. 11
3.5 Accessories ............................................................................................. 14
4 Preparation and operation 15
4.1 Set up the device .................................................................................... 15
4.2 Connect the breathing tube .................................................................... 16
4.3 Before first use ........................................................................................ 18
4.4 Start therapy ........................................................................................... 18
4.5 End therapy/switch off device ................................................................. 19
4.6 Set humidifier ......................................................................................... 19
4.7 Select a preconfigured program .............................................................. 19
4.8 LIAM (prisma VENT50 only) ..................................................................... 20
4.9 Switching softSTART on and off .............................................................. 20
4.10 Use SD card (optional) ............................................................................ 21
4.11 Use battery (optional) ............................................................................. 22
5 Settings in the menus 23

WM 68131d 10/2017
EN | 3
Contents
5.1 Navigating in the device .......................................................................... 23
5.2 Menu structure ....................................................................................... 23
5.3 System menu (device settings) ................................................................. 24
5.4 Ventilation menu (ventilation settings) .................................................... 25
5.5 softSTART/softSTOP menu ...................................................................... 25
5.6 Report menu (usage data) ....................................................................... 26
6 Hygiene treatment 27
6.1 General information ................................................................................ 27
6.2 Cleaning intervals ................................................................................... 27
6.3 Hygiene treatment for device .................................................................. 28
6.4 Hygiene treatment for breathing tube ..................................................... 30
7 Function check 30
8 Alarms and faults 32
8.1 Sequence for display of alarms ................................................................ 32
8.2 Deactivating physiological alarms ............................................................ 32
8.3 Muting alarms ........................................................................................ 32
8.4 Physiological alarms ................................................................................ 32
8.5 Technical alarms ..................................................................................... 34
8.6 Troubleshooting ...................................................................................... 38
9 Servicing 39
10 Storage 39
11 Disposal 39
12 Appendix 40
12.1 Technical data ........................................................................................ 40
12.2 Markings and symbols ............................................................................ 47
12.3 Scope of supply ...................................................................................... 50
12.4 Accessories and replacement parts ......................................................... 50
12.5 Warranty ................................................................................................ 50
12.6 Declaration of conformity ....................................................................... 51

4| EN
WM 68131d 10/2017
1 Introduction
1 Introduction
1.1 Intended use
WM 110 TD
Device WM 110 TD 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.
WM 120 TD
Device WM 120 TD 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.
A blower takes in ambient air through a filter and pumps it to the patient at therapy
pressure through the breathing tube 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 breathing tube with leakage ventilation and a
breathing tube with patient valve (prisma VENT50 only). On the breathing tube with a
patient valve (prisma VENT50 only), 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.
Therapy data are saved on the SD card and can be evaluated using PC software.
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.

WM 68131d 10/2017
EN | 5
1 Introduction
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.
1.4 Indications
Obstructive ventilation disorders (e.g. COPD), restrictive ventilation disorders (e.g.
scolioses, deformities of the thorax), neurological, muscular, and neuromuscular
disorders (e.g. pareses of the diaphragm), central respiratory regulation disorders,
obstructive sleep apnea syndrome (OSAS), obesity hypoventilation syndrome (OHS).
1.5 Contraindications
The following contraindications are known - in the individual case, responsibility for
deciding whether to use the device rests with the attending physician. Threatening
situations have not ever been observed.
Cardiac decompensation, severe cardiac arrhythmias, severe hypotension, especially in
combination with intravascular volume depletion, severe epistaxis, high risk of
barotrauma, pneumothorax or pneumomediastinum, pneumoencephalus, head
injury, status following brain surgery and following surgical procedures on the
hypophysis or middle or inner ear, acute inflammation of the nasal sinuses (sinusitis),
middle ear infection (otitis media) or perforated eardrum, 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 sinuses,
irritated mucous membrane in the eyes, gastrointestinal insufflation of air
("bloating"), nosebleeds, reduced auditory capacity, muscular atrophy in the case of
long-term ventilation.
These are general side effects not attributable specifically to use of devices of type
WM 110 TD/WM 120 TD.

6| EN
WM 68131d 10/2017
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 "7 Function check", page 30).
Only operate device within the specified ambient conditions (see "12.1 Technical
data", page 40).
Do not use the device in an MRT 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 breathing tubes with an internal diameter of Ø 15 mm or more.
Do not use antistatic or electrically-conductive tubes.
The device is subject to special precautions with regard to EMC (electromagnetic
compatibility). Maintain the recommended safety distances between the device and
equipment that emits HF radiation (e.g. cell phones) (e.g. cell phones) (see "12.1.4
Safety distances", page 46).
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 DC adapter for operation on voltages of 12 V or 24 V.
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.
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.
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.

WM 68131d 10/2017
EN | 7
2 Safety
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 27).
• 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 exhalation if you connect accessories.
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.

8| EN
WM 68131d 10/2017
3 Product description
3 Product description
3.1 Overview
3.1.1 prisma VENT30, prisma VENT30-C, prisma VENT40
1 Humidifier connection with cover
2 Control panel with display
3 System interface for connecting modules
4 Handle
5 Release catch
6 Filter compartment with air filter and pollen filter
7 Cooling air opening (prisma VENT50 only)/Sealing plug
8 O2supply (option)
1
34
8
10
11
12
13
16
14
5
15
2
9
6
18
17
7

WM 68131d 10/2017
EN | 9
3 Product description
9 Connection for power supply cable
10 Strain relief for power supply cable
11 Breathing tube with connection for breathing mask
12 Latching bores for connecting modules
13 SD card slot
14 Connection for tube heater
15 Device outlet port
16 Power cord
17 SD card
18 O2connector (option)
3.1.2 prisma VENT50
1 Humidifier connection with cover
1
34
8
10
11
12
13
16
14
5
15
2
9
6
7
18
17

10 | EN
WM 68131d 10/2017
3 Product description
2 Control panel with display
3 System interface for connecting modules
4 Handle
5 Release catch
6 Filter compartment with air filter and pollen filter
7 Cooling air opening
8 O2supply
9 Connection for power supply cable
10 Strain relief for power supply cable
11 Breathing tube with active valve
12 Latching bores for connecting modules
13 SD card slot
14 Connection for tube heater, valve control tube and pressure measuring tube
15 Device outlet port
16 Power cord
17 SD card
18 O2connector
3.2 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.

WM 68131d 10/2017
EN | 11
3 Product description
3.3 Control panel
1 Alarm acknowledgment key - mutes an alarm for 2 minutes
2 LIAM key (only present on prisma VENT50)
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 area
7 Power supply indicator
8 On/off key
9 Humidifier key
10 Program key for selecting pre-configured programs
3.4 Symbols in the display
SYMBOL DESCRIPTION
Device in patient mode. Expert area disabled.
Device in expert mode (device enabled)
Breathing tube with leakage ventilation connected (prisma VENT50
only).
Breathing tube with patient valve connected (prisma VENT50 only).
Enter
1
3
4
5
7
10
8
9
6
2

12 | EN
WM 68131d 10/2017
3 Product description
Set tube diameter 15 mm (prisma VENT30, prisma VENT30-C, prisma
VENT40 only)
Set tube diameter 22 mm (prisma VENT30, prisma VENT30-C, prisma
VENT40 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)
Bacteria filter connected and activated (prisma VENT30, prisma
VENT30-C, prisma VENT40 only)
Pulse rate (if pulsoximetry sensor connected)
SpO2sensor 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
AirTrap Control switched on.
LIAM activated.
SYMBOL DESCRIPTION
+ L

WM 68131d 10/2017
EN | 13
3 Product description
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
SYMBOL DESCRIPTION

14 | EN
WM 68131d 10/2017
3 Product description
3.5 Accessories
1 Humidifier
2 Inverter
3 Breathing tube with 15 mm/22 mm diameter
4 Communication module prismaCONNECT module - links the device and a PC or
the PSG module.
5 SpO2and nurse call module prisma CHECK - links the device to a call system and
determines SpO2and pulse frequency data.
6 prismaPSG - converts digital device signals into analog data. Is used in sleep
laboratories.
7 Heatable tube 15 mm/22 mm
Follow the Instructions for Use for the accessories. Here you will find further
information about operation and combining accessories with the device.
3
2
5
1
6
7
4

WM 68131d 10/2017
EN | 15
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 device in the protective bag (prismaBAG advanced).

16 | EN
WM 68131d 10/2017
4 Preparation and operation
4.2 Connect the breathing tube
4.2.1 Connect breathing tube with leakage ventilation
1. Push breathing tube onto the device outlet port.
2. Connect the non-invasive or invasive patient/ventilator interface to the breathing
tube (see Instructions for Use for the patient/ventilator interface).
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, CO2concentration 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 breathing tube routed incorrectly!
An incorrectly routed breathing tube may injure the patient.
Never wrap the breathing tube around the neck.
Do not crush the breathing tube.

WM 68131d 10/2017
EN | 17
4 Preparation and operation
4.2.2 Connect breathing tube with patient valve (prisma VENT50 only)
1. Push the free end of breathing tube 1onto the device outlet port.
2. Connect valve control tube 2to connection .
3. Connect pressure measuring tube 3to connection .
4. Connect patient/ventilator interface (e.g. mask) to patient valve 4.
Risk of injury if patient valve is covered!
If the patient valve is covered, exhaled air can no longer be taken away and the patient
will be put at risk.
Always keep the patient valve free.
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

18 | EN
WM 68131d 10/2017
4 Preparation and operation
4.2.3 Connect patient circuit for mouthpiece ventilation
1. Push the free end of breathing tube 1onto the device outlet port.
2. Connect mouthpiece 2to the breathing tube (see Instructions for Use for the
patient/ventilator interface).
4.3 Before first use
The device must be configured before being used for the first time. If your specialist
dealer has not yet done so, you must set language and time on the device.
If the device is equipped with an internal battery, leave the device connected to the
power supply for at least 8 hours.
4.4 Start therapy
Requirement
• Device is set up and connected (see "4.1 Set up the device", page 15).
• Patient/ventilator interface is connected (see Instructions for Use for patient/
ventilator interface)
1. If the display is dark: Press on/off key briefly.
The device switches to standby.
As an alternative to leakage ventilation, it is also possible to use a breathing tube with
patient valve for mouthpiece ventilation.
1
2

WM 68131d 10/2017
EN | 19
4 Preparation and operation
2. Press on/off key briefly.
or
If the Autostart function is activated: Breathe into the patient/ventilator interface.
Therapy starts.
If the softSTART function is activated in the selected program, therapy
automatically starts with softSTART.
4.5 End therapy/switch off device
1. Press and hold on/off key until the End therapy display disappears.
The device switches to standby.
If the softSTOP function is activated, ventilation pressures and background
frequency are continuously reduced. Remaining time is displayed in the button bar
in minutes and seconds .
Once the set softSTOP time has expired, the device continues running at an EPAP
of 4 hPa and a background frequency of 5 bpm until it is switched to standby with
a brief press of the on/off key .
To interrupt softSTOP, briefly press the softSTART/softSTOP key (center function
key 4).
2. To switch off the device completely, press the on/off key until the message
Shutting down device is no longer displayed and the display goes out.
4.6 Set humidifier
Requirement
Humidifier is connected and filled with water (see Instructions for Use for humidifier)
1. To switch the humidifier on or off, press humidifier key briefly.
2. To adjust humidifier stage, press and hold humidifier key .
4.7 Select a preconfigured program
Your physician can store up to three preconfigured programs in the device. If you need
different ventilation settings during the day compared to during the night, for
example, you can change the program.
For more information on Autostart: See "5 Settings in the menus", page 23.
The humidifier stage suitable for you depends on room temperature and humidity.
If you have dry airways in the morning, heating output is set too low. If
condensation has formed in the breathing tube in the morning, heating output is
set too high.

20 | EN
WM 68131d 10/2017
4 Preparation and operation
1. Press the Program key .
2. Select and confirm the program using the dial.
4.8 LIAM (prisma VENT50 only)
LIAM (Lung Insufflation Assist Maneuver) supports the cough process or sigh
ventilation.
Requirement
• Therapy is running,
• LIAM has been enabled by the physician.
1. Press the LIAM key .
The device switches to LIAM mode and the process is started to synchronize with
the next inspiration.
2. To interrupt LIAM: Press the LIAM key again.
The process is canceled. The device switches back to the set ventilation mode.
4.9 Switching softSTART on and off
The softSTART function makes it easier to get used to ventilation pressure when falling
asleep. A pressure and optionally also a pressure difference which deviate from those
prescribed are set. The therapy device sets this softSTART pressure when it is switched
on. After that, pressures gradually rise to therapy level within the specified time.
This function is suitable for patients who find elevated pressures unpleasant when
awake and are unable to fall asleep.
Requirement
• The softSTART function is activated by the physician or the specialist dealer.
• softSTART is supported by the selected ventilation mode (S, S/T, autoS/T, T, aPCV,
PSV or PCV).
• A breathing tube with leakage ventilation is used.
• A softSTART time is set.
Risk of injury from the use of incorrect ventilation programs
Use of ventilation programs which have not been configured for an individual can lead
to incorrect therapy and put the patient at risk.
Only use ventilation programs if they have been configured for the patient in
question.