Lowenstein Medical prisma20C User manual

Sleep therapy devices
prisma20C prisma25S-C
prisma20A prisma25ST
prismaCR prismaLAB
prisma25S prisma30ST
EN Instructions for use for devices of type WM 100 TD

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WM 67841f 01/2019
Contents
Contents
1 Introduction 4
1.1 Intended use ............................................................................................. 4
1.2 Function ................................................................................................... 4
1.3 User qualifications ..................................................................................... 5
1.4 Indications ................................................................................................ 5
1.5 Contraindications ...................................................................................... 6
1.6 Side effects ............................................................................................... 6
2 Safety 7
2.1 Safety information .................................................................................... 7
2.2 General information ................................................................................ 10
2.3 Warnings in this document ..................................................................... 11
3 Product description 12
3.1 Therapy device overview ......................................................................... 12
3.2 Display .................................................................................................... 13
3.3 Accessories ............................................................................................. 18
4 Preparation 19
4.1 Setting up the therapy device .................................................................. 19
4.2 Connecting up the power supply ............................................................ 19
5 Operation 23
5.1 Navigating the menu .............................................................................. 23
5.2 Switching on the therapy device ............................................................. 23
5.3 Switching off the therapy device ............................................................. 25
5.4 Starting the therapy ................................................................................ 25
5.5 Ending the therapy ................................................................................. 26
5.6 Performing a mask test ........................................................................... 27
5.7 Switching softSTART on/off ..................................................................... 28
5.8 Setting the respiratory air humidifier ....................................................... 29
5.9 Setting the alarm .................................................................................... 31
5.10 Viewing therapy data and device information ......................................... 32
5.11 Using the SD card .................................................................................. 35

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Contents
6 Settings in the menu 38
6.1 Setting comfort parameters .................................................................... 38
6.2 Setting accessories parameters ................................................................ 39
6.3 Setting time parameters .......................................................................... 40
6.4 Setting device parameters ....................................................................... 40
7 Hygienic preparation 42
7.1 General information ................................................................................ 42
7.2 Cleaning intervals ................................................................................... 42
7.3 Hygienic preparation of the therapy device ............................................. 43
7.4 Hygienic preparation of the respiration hose ........................................... 45
8 Function check 46
8.1 Intervals .................................................................................................. 46
8.2 Checking the therapy device ................................................................... 46
9 Alarms and error messages 47
9.1 Alarms .................................................................................................... 47
9.2 Faults in the therapy device ..................................................................... 49
9.3 Display messages .................................................................................... 50
10 Maintenance 51
11 Transport and storage 51
12 Disposal 51
13 Appendix 52
13.1 Technical Data ....................................................................................... 52
13.2 Emission of electromagnetic interference ............................................... 61
13.3 Electromagnetic interference immunity .................................................. 61
13.4 Electromagnetic interference immunity for ME equipment and
ME systems .............................................................................................63
13.5 Labels and symbols ................................................................................ 64
13.6 Scope of supply ...................................................................................... 66
13.7 Warranty ................................................................................................ 67
13.8 Declaration of conformity ....................................................................... 67

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WM 67841f 01/2019
1 Introduction
1 Introduction
1.1 Intended use
The WM 100 TD devices are pressure-controlled, non-invasive, non-life-sustaining
therapy devices for the treatment of sleep disordered breathing (SDB) or intermittent
treatment of respiratory insufficiency by means of a mask.
The devices can be used on persons weighing above 30 kg. The CPAP mode can be
used on persons above the age of 3 years. The device may only be used on the
instruction of a physician.
The WM 100 TD devices are used in clinical facilities and in domestic situations. In
domestic situations, the devices are also taken on trips.
1.2 Function
The fan in the therapy device sucks ambient air in through a filter, compresses it, and
routes it to the device outlet.
From here, the air flows through the hose system and the mask to the patient. The
exhalation system in front of the mask, or optionally integrated in the mask, prevents
CO2-enriched exhaled air from collecting in the hose system.
The therapy device determines and analyzes the pressure and respiratory flow signal.
This allows respiratory events to be recognized.
The device can function with one pressure level (CPAP) or with two or three pressure
levels (BiLevel or inspiratory pressure, expiratory pressure, and end-expiratory
pressure). Depending on the version employed, the pressure levels can be set
automatically by the device within preset limits, or they can be set manually.
Depending on the mode, the pressure can be continually applied at one level, or
triggered by the patient, or applied with time controls. Pressure signals, respiratory
flow signals, and respiratory events can be saved and/or can be output in analog form
on a PSG system.
The therapy data are saved in the device and on an SD card for therapy monitoring.
The device is operated via an On/Off button and a touchscreen.
The device can be remotely controlled using the prismaTS therapy software.
In the case of a power failure, the settings are retained and the therapy is continued
once the power supply is restored.

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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". In contrast, a "patient" is the person receiving the therapy. Always perform all
the operating steps in accordance with these instructions for use.
1.4 Indications
prisma20C
CPAP therapy device for the treatment of patients with obstructive sleep apnea with
a constant pressure requirement.
prisma20A
APAP therapy device for the treatment of patients with obstructive sleep apnea with
a variable pressure requirement. The therapy pressure adjusts automatically to suit the
patient's pressure requirement.
prismaCR
Therapy device for the treatment of patients with periodic breathing or Cheyne-Stokes
respiration (e.g., in cases of heart failure) as well as with central, mixed, or complex
sleep apnea. The therapy device adjusts the ventilation automatically and continually
to the changing requirements of the patient.
prisma25S
BiLevel therapy device for the treatment of patients with obstructive, mixed, or
complex sleep apnea, and a high and/or fluctuating pressure requirement, poor CPAP
compliance The device has different pressure levels during inspiration and expiration.
prisma25S-C
BiLevel therapy device for the treatment of patients with obstructive, mixed, or
complex sleep apnea and a high pressure requirement, poor CPAP compliance The
device has different pressure levels during inspiration and expiration.
prisma25ST
BiLevel therapy device for the treatment of patients with obstructive, mixed, or
complex sleep apnea and a high and/or fluctuating pressure requirement, poor CPAP
compliance, central apneas, sleep-related or position-dependent hypoventilation (e.g.,
OHS), respiratory insufficiency, coprevalent respiratory insufficiency (e.g., COPD/
overlap). The device has different pressure levels during inspiration and expiration and
a backup frequency for the treatment of central events.

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1 Introduction
prisma30ST
BiLevel therapy device for the treatment of patients with obstructive, mixed, or
complex sleep apnea and/or chronically reduced respiratory drive (e.g., sleep-related
or position-dependent hypoventilation or chronically stable OHS), respiratory
insufficiency, e.g., COPD.
1.5 Contraindications
The following contraindications are known – the physician in charge is responsible for
deciding whether to use the therapy device in each individual case.
Acute cardiac decompensation, severe arrhythmia, severe hypotension, particularly in
combination with intravascular volume depletion, severe epistaxis, high risk of a
barotrauma, severe chronic/decompensated pulmonary conditions, pneumothorax or
pneumomediastinum, pneumocephalus, cranial trauma, status following brain surgery
or surgical intervention on the pituitary gland or the middle/inner ear, acute sinus
infection (sinusitis), middle ear infection (otitis media) or perforated eardrum,
dehydration.
prismaCR
Symptomatic chronic systolic heart failure (NYHA 2-4) with reduced left ventricular
ejection fraction (LVEF 45%) and moderate to severe predominant central sleep
apnea (AHI 15/h, CAHI/AHI 50% and CAI 10/h)
1.6 Side effects
The following undesirable side effects may occur when using the therapy device for
short or long periods of time: pressure marks from the respiratory mask and the
forehead cushion on the face, flush of the facial skin, nasal congestion, dry nose,
morning xerostomia (dry mouth), sensation of pressure in the sinuses, irritated
conjunctiva, gastrointestinal air insufflation ("bloating"), epistaxis.
These side effects are general side effects associated with therapy using a sleep
therapy device and are not specially linked to the use of WM 100 TD devices.

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2 Safety
2 Safety
Please read these instructions for use carefully. They form part of the devices
described, and must be available at all times.
Use the unit for the designated purpose only (see "1.1 Intended use", page 4).
For your own safety and that of your patients, and in accordance with the
requirements of Directive 93/42/EEC, please observe the following safety instructions.
2.1 Safety information
2.1.1 Safe use of the therapy device, components, and accessories
Risk of injury due to device or component malfunction!
A damaged device or damaged components may result in injury to the patient, user
or bystanders.
⇒Only operate the device and components if they are externally undamaged.
⇒Only operate the device and components if the function check has been
successfully completed.
⇒Only operate the device if the display is functional.
Risk of injury if the device is operated outside the prescribed ambient
conditions!
Use of the device outside the prescribed ambient conditions can result in failure to
comply with tolerances, device failures, and injury to the patient.
⇒Only operate the device within the prescribed ambient conditions
(see "13.1 Technical Data", page 52).
Risk of injury if disposable items are reused!
Disposable items are only intended to be used once. Reused disposable items may be
contaminated and/or not function correctly and thus cause patient injury.
⇒Do not reuse disposable items.
Risk of infection when reusing therapy device!
When the therapy device is used by multiple patients, infections may be passed on to
the next patient.
⇒Use a bacteria filter
⇒When the device is used without a bacteria filter: Have the device hygienically
prepared by the manufacturer or an authorized dealer.

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2 Safety
2.1.2 Power supply
2.1.3 Transport
Treatment prevented due to increased resistance when bacteria filters are
used!
Misting or moistening can increase the resistance of the bacteria filters, thereby
modifying the output of the therapy pressure.
⇒Check bacteria filters regularly for increased resistance and blockages and rectify
these.
Risk of injury due to inaccessible power plug!
An obstructed power plug cannot be pulled out in an emergency and can thus result
in injury.
⇒Keep the power plug and power supply accessible at all times.
Risk of injury and material damage as a result of insufficient power supply!
Operation of the device outside the specified power supply range can injure the user
and damage the device.
⇒Only operate the device with the supplied power supply unit at voltages from
100V to 240 V.
⇒Use the DC adapter for operation at voltages from 12 V or 24 V.
Water in the device can cause material damage!
If the device is tilted severely, the residual water from the respiratory air humidifier can
enter the device and damage it.
⇒Do not transport or tilt the device when the respiratory air humidifier is filled.
Dirt in the device can cause material damage!
Dirt entering the device during transport can damage the device.
⇒Only transport the device with the cover in position.
⇒Transport the device in the corresponding transport bag.

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2 Safety
2.1.4 Therapy
The use of oxygen in combination with flammable substances poses a fire
hazard!
Oxygen in combination with flammable substances can result in spontaneous
explosions. In cases of insufficient ventilation, oxygen in the surrounding area (e.g.,
clothes, hair, bedclothes) can become enriched and cause fires and thus injuries to the
patient, user, and others in the immediate vicinity.
⇒Do not smoke.
⇒Do not use naked flames.
⇒Ensure sufficient ventilation.
⇒Use an oxygen safety valve.
⇒Keep the device and screwed unions free from oil and grease.
⇒Always replace splashguards immediately after use.
The use of oxygen in combination with flammable substances poses a fire
hazard!
Supplying oxygen without special safety equipment can cause fires and injure people.
⇒Always use an oxygen safety valve.
⇒Observe the instructions for use for the oxygen safety valve and the oxygen
supply unit.
⇒Set up oxygen sources more than 1 m from the device.
Prevented therapy and material damage due to dirt in the device or
respiratory air humidifier!
Dirt entering the device can impair the success of the therapy and damage the device.
⇒Use the gray air filter.
⇒If necessary, use the white pollen filter (optional accessory).
Risk of injury if the patient connection opening becomes hot when uses a
hose heating system!
In combination with the device, the hose heating system generates a somewhat higher
temperature at the patient connection opening.
⇒Observe the instructions for use for the hose heating system.

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2 Safety
2.2 General information
• Use of third-party products may lead to functional failures and restricted usability.
Biocompatibility may also be compromised. Please note that in these cases, any claim
under warranty and liability will be void if neither the accessories nor original spare
parts recommended in the instructions for use are used.
• Repairs, servicing, and maintenance should only be carried out by the manufacturer or
by a technician expressly authorized by the manufacturer.
• Only connect up the devices and modules permitted in accordance with these
instructions for use. The devices must satisfy their respective product standard.
Position non-medical devices outside of the patient's immediate vicinity.
• 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 4) 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.
• Only operate device within the specified ambient conditions (see "13.1 Technical
Data", page 52).
• The operator is responsible for ensuring the compatibility of the therapy device and all
the connected components and accessories prior to the application with the patient.
• Only use accessory parts from the manufacturer. Third-party electrical connecting
cables, in particular, may cause the device to malfunction.
• Only have modifications to the unit carried out by the manufacturer or by a technician
expressly authorized by the manufacturer.
• Please observe the chapter on hygienic preparation in order to avoid infection or
bacterial contamination (see "7 Hygienic preparation", page 42).

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2 Safety
• The operator is responsible for ensuring that the therapy pressure setting is specified
individually for each patient according to the device configuration, including
accessories, that is to be used.
• The operator is required to regularly assess the effectiveness of the therapy settings.
• Also observe the respective instructions for use for the therapy device, the
components, and the accessories.
• Always carry out a function check before using the unit (see "8 Function check", page
46).
• Keep the therapy device and accessories out of the reach of children and pets. Keep
the therapy device in its transport case when not in use and when it is being
transported.
2.3 Warnings in this document
Warnings are used to flag up safety-relevant information.
You will find a warning preceding any action that entails a hazard for persons or
equipment.
Danger!
Designates an extremely dangerous situation. Failure to
observe this warning will lead to serious, irreversible injury, or
death.
Warning!
Designates an extremely dangerous situation. Failure to
observe this warning may lead to serious, irreversible, or fatal
injury.
Caution!
Designates a dangerous situation. Failure to observe this
warning may lead to minor or moderately serious injury.
Notice!
Indicates a harmful situation. Failure to observe this warning
may lead to damage to equipment.
Designates useful information relating to a particular action.

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3 Product description
3 Product description
3.1 Therapy device overview
NO. DESIGNATION DESCRIPTION
1 Cover Covers the humidifier connection when no respiratory air
humidifier is connected.
2 Unlocking button
therapy device
Allows the cover to be removed for connecting the
humidifier.
3 Display
Allows operation of the therapy device and the respiratory
air humidifier.
Displays settings and current values.
4 System interface Connects the therapy device to modules.
5 Handle Allows lifting and transporting of the therapy device.
6 SD card Records therapy data.
7 Filter compartment in
the suction area
Houses the air filter and, where applicable, the pollen
filter. The respiratory air is sucked in here and the dust
particles are filtered out.
8 Power input Connects the therapy device to the power supply unit.
9 Power supply unit with
connection cable
Supplies power to the device. Connects the power supply
unit to the therapy device.
123
45
6
7
8
9
10
12
14
11
13
17
15
16

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3 Product description
3.2 Display
The information shown on the display depends on the current status of the therapy
device:
•Standby mode (no therapy in progress)
The therapy device operating hours since therapy began are shown for the first
30seconds. Then the device switches to the start screen automatically.
The start screen shows the clock and the wake-up time if the alarm clock is set.
(see "3.2 Display", page 13).
Settings can be performed on the therapy device (see "6 Settings in the menu",
page 38).
•Therapy mode (therapy in progress)
Therapy is in progress (see "3.2.2 Display in Therapy mode", page 15).
You can perform the mask test and start the softSTART sleep aid
(see "5 Operation", page 23).
•Energy-saving mode
The therapy device is supplied with a very low level of power; nothing is shown on
the display. You can return to Standby mode by pressing the On/Off button .
10 Mounting holes For attaching and securing a module to the therapy
device.
11 Power supply cable Connects the power supply unit to the power socket.
12 SD card slot
For inserting an SD card. The symbol on the display indi-
cates the communication between the SD card and the
therapy device.
13 Micro USB port
Used for point-to-point connection with a PC on which
prismaTS is installed. Allows settings to be changed on the
therapy device and data to be exported.
14 On/Off button
Switches the therapy device on and off.
Switches the therapy device to standby mode.
Starts and stops the therapy.
15 Respiration hose Connects the therapy device to the respiratory mask.
16 Hose heating system
connection Electrical power supply connection for a heatable hose.
17 Device outlet Connection for the respiratory hose, through which the
patient is supplied with respiratory air.
NO. DESIGNATION DESCRIPTION

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3 Product description
3.2.1 Display in Standby mode (Start screen)
NO. DESIGNATION DESCRIPTION
1 Info menu button Provides access to the info menu.
2 Alarm clock with
wake-up time
Alarm clock is set.
Displays the set wake-up time.
3 Menu button Provides access to the settings menus.
4 Dimmer button Dims the display.
5 Time Displays the current time.
1
2
3
4
5

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3 Product description
3.2.2 Display in Therapy mode
NO. DESIGNATION DESCRIPTION
1 Time Displays the current time.
2 SD card symbol The SD card is in the therapy device.
3 Info button Provides access to the info screen with detailed
information on the therapy currently in progress.
4 Alarm clock with wake-up
time
Alarm clock is set.
Displays the set wake-up time.
5 softSTART button
Switches the softSTART function on or off.
Displays the time remaining.
If the softSTART is off, the set softSTART period is
displayed.
If there is no softSTART button, the physician or
authorized dealer has disabled this function.
6 Respiration status symbol Indicates the current respiration status.
7 Mask status symbol with
leak indicator
Indicates how well the respiratory mask is
positioned.
8 Humidifier button for
respiratory air humidifier
Indicates that the respiratory air humidifier is
connected and switched on.
Shows the set humidifier level of the respiratory air
humidifier.
9 Function buttons for the
respiratory air humidifier
Allow the humidifier level to be increased/
decreased.
21
3
4
5
6
7
8
9

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3 Product description
3.2.3 Symbols on the display
SYMBOL DESCRIPTION
Bacteria filter is connected and active.
If this symbol is displayed even though you are not using a bacteria filter,
contact your authorized dealer.
Air filter replacement required. (Symbol only appears if the authorized
dealer has activated the reminder to change the air filter)
Maintenance required (symbol only appears when maintenance
function is active).
USB port
prismaCONNECT module is plugged in
Module prismaPSG is connected (Green symbol)
No connection to prismaPSG module established (Gray symbol)
Network connection available (Green symbol)
No network connection available (Gray symbol)
SD card in SD card slot.
Symbol flashes: Data is being saved to the SD card or read off
the SD card.
Respiratory air humidifier is connected and switched off.
Respiratory air humidifier is connected and switched on.
The set humidifier level is displayed.
The choice of humidifier levels 1-7 can be limited by the physician.
Respiratory air humidifier is connected and empty of water.

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3 Product description
Alarm clock is set.
If no alarm clock symbol is shown: The alarm clock is off.
Displays the respiration status:
• Arrow pointing upward: inhalation
• Arrow pointing downward: exhalation
• Green arrow, spontaneous respiration
• Orange arrow, assisted breathing
Apnea
Mask position is good, no leaks
Mask is not well positioned, considerable leaks, the efficacy of the
therapy is not guaranteed
Indicates the diameter of the hose in mm.
Indicates which menu level you are currently in:
The more green dots, the deeper you are in the menu structure.
Alarm window
Low-priority alarm triggered.
Alarm paused for 2 minutes.
Indicates that the acoustic signal for an alarm can be muted (Black
symbol)
Acoustic signal for alarm is muted (Orange symbol)
SYMBOL DESCRIPTION

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3 Product description
3.3 Accessories
NO. DESIGNATION DESCRIPTION
1 Respiratory air humidifier Humidifies the respiratory air
2 Pollen filter Filters the suctioned respiratory air and prevents the
ingress of fine dust particles, pollen and fungal spores.
3 Inverter Enables operation of the device via a DC power socket
(12 V/24 V)
4 Respiratory hose with
15 mm diameter Connects the therapy device to the respiratory mask.
5 Communication module Creates a connection between the therapy device and a
PC or the PSG module
6 SpO2and nurse call
module
Connects the therapy device with a call system and
acquires SPO2and pulse frequency data.
7 PSG module Converts digital signals from the therapy device into
analog data. Is used in sleep laboratories.
8 Heatable hose Avoids condensation in the respiration hose.
3
7
5
4
6
8
2
1

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4 Preparation
4 Preparation
4.1 Setting up the therapy device
1. Place the therapy device on a flat surface (e.g., a bedside table).
2. Leave the suction area of the therapy device uncovered.
3. Keep the power plug and power socket accessible at all times.
4. Pull the protective foil off the device.
4.2 Connecting up the power supply
Material damage due to overheating!
Temperatures which are too high can cause the therapy device to overheat and
damage the device.
⇒The therapy device and power supply unit must not be covered with textiles
(e.g., bedclothes).
⇒Do not operate the therapy device close to heating systems.
⇒Do not expose the therapy device to direct sunlight.
⇒Do not operate the therapy device in the transport bag.
Risk of injury due to electric shock when connecting an incorrect power
supply unit to the line power!
The power supply unit contains a safety device to prevent electric shock. The use of a
non-original power supply unit may result in injury to the user and the patient.
⇒Only operate the device on line power using the power supply unit
recommended by the manufacturer.

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4 Preparation
1. Connect the power supply cable with the power supply unit.
2. Insert the free connector of the power supply unit's connection cable into the
power supply port on the therapy device. When doing so, pay attention to the
alignment of the connector.