Weinmann prisma20C User manual

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

2EN WM 100 TD
WM 67841c 03/2015
Table of contents
Table of contents
1 Introduction 5
1.1 Intended use ................................................................................. 5
1.2 Function ........................................................................................ 6
1.3 User qualifications ......................................................................... 7
1.4 Indications .................................................................................... 7
1.5 Contraindications .......................................................................... 9
1.6 Side effects ................................................................................. 10
2 Safety 11
2.1 Safety information ....................................................................... 11
2.2 General information .................................................................... 14
2.3 Warnings in this document .......................................................... 15
3 Product description 16
3.1 Therapy device overview .............................................................. 16
3.2 Display ........................................................................................ 17
3.3 Components ............................................................................... 23
3.4 Accessories ................................................................................. 24
3.5 Labels and symbols ..................................................................... 25
4 Preparation 30
4.1 Setting up the therapy device ...................................................... 30
4.2 Connecting components .............................................................. 30
4.3 Connecting optional accessories .................................................. 34
5 Operation 43
5.1 Navigating the menu ................................................................... 43
5.2 Switching on the therapy device .................................................. 43
5.3 Switching off the therapy device .................................................. 46
5.4 Starting the therapy .................................................................... 46
5.5 Ending the therapy ...................................................................... 48
5.6 Performing a mask test ................................................................ 49
5.7 Switching softSTART on/off ......................................................... 50
5.8 Setting the respiratory air humidifier ............................................ 51

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WM 100 TD EN 3
Table of contents
5.9 Setting the alarm ......................................................................... 54
5.10 Viewing therapy data and device information ............................... 56
5.11 Using the SD card ........................................................................ 58
6 Settings in the menu 62
6.1 Setting comfort parameters ......................................................... 62
6.2 Setting accessories parameters .................................................... 63
6.3 Setting time parameters .............................................................. 64
6.4 Setting device parameters ............................................................ 65
7 Hygienic preparation 66
7.1 General information .................................................................... 66
7.2 Cleaning intervals ........................................................................ 66
7.3 Hygienic preparation of the therapy device ................................... 67
7.4 Hygienic preparation of the respiration hose ................................ 69
7.5 Hygienic preparation of the respiratory air humidifier ................... 70
8 Function check 76
8.1 Intervals ...................................................................................... 76
8.2 Checking the therapy device ........................................................ 76
8.3 Checking the respiratory air humidifier ......................................... 77
9 Alarms and error messages 78
9.1 Alarms ........................................................................................ 78
9.2 Faults in the therapy device ......................................................... 80
9.3 Faults in the respiratory air humidifier .......................................... 81
9.4 Display messages ........................................................................ 81
10 Maintenance 83
11 Storage and disposal 84
11.1 Storage ....................................................................................... 84
11.2 Disposal ...................................................................................... 84
12 Appendix 85
12.1 Technical data ............................................................................. 85
12.2 Pressure volume curve ................................................................. 93
12.3 Pneumatic system diagram .......................................................... 93
12.4 Separation distances ................................................................... 94

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Table of contents
12.5 Scope of supply ........................................................................... 94
12.6 Warranty ..................................................................................... 99
12.7 Declaration of conformity ............................................................ 99

WM 67841c 03/2015
WM 100 TD EN 5
1 Introduction
1 Introduction
1.1 Intended use
1.1.1 WM 100 TD therapy devices
The WM 100 TD devices are pressure-controlled, non-invasive,
non-life-sustaining therapy devices for the treatment of sleep-
related respiratory disorders (SRRDs) 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.
1.1.2 WM 100 TH respiratory air humidifiers
The integrable respiratory air humidifiers WM 100 TH are used to
enrich the air flow created by the therapy device WM 100 TD with
moisture. The respiratory air humidifier WM 100 TH warms and
humidifies the respiratory air and thus prevents drying out of the
mucosae in the respiratory tract.
The WM 100 TH prismaAQUA respiratory air humidifier described
in these instructions for use can be used with WM 100 TD therapy
devices.
The WM 100 TH devices are used in clinical facilities and in
domestic situations. In domestic situations, the devices are also
taken on trips.

6EN WM 100 TD
WM 67841c 03/2015
1 Introduction
1.2 Function
1.2.1 WM 100 TD therapy devices
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
breathing 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, breathing flow signals, and respiratory events can be saved
and/or emitted as an analog output on a PSG system.
The therapy data are saved in the device and on an SD card for the
therapy control.
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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WM 100 TD EN 7
1 Introduction
1.2.2 WM 100 TH respiratory air humidifiers
The heatable respiratory air humidifier functions on the so-called
pass-over principle. The air coming from the therapy device is
routed across the surface of a preheated water reservoir. This
increases the relative humidity and the temperature of the air flow.
The humidifier level can be set individually using the buttons on the
therapy device.
The power of the element and consequently the temperature of
the water in the humidifier chamber is controlled electronically via
the therapy device.
The transparent window of the humidifier chamber makes it
possible to check the water level at any time.
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.

8EN WM 100 TD
WM 67841c 03/2015
1 Introduction
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,
• a 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,
• a 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,
• a poor CPAP compliance,
• central apneas,
• sleep-related or position-dependent hypoventilation (e.g.,
OHS),
• respiratory insufficiency,
• coprevalent respiratory insufficiency (e.g., COPD/overlap).

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WM 100 TD EN 9
1 Introduction
The device has different pressure levels during inspiration and
expiration and a backup frequency for the treatment of central
events.
prisma30ST, prisma30ST-C
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.
prismaAQUA
Indications for the use of the respiratory air humidifier in
combination with the therapy device are dry upper airways and if
the respiratory air is felt to be too cold. prismaAQUA may only be
used in accordance with the recommendations of a physician.
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
• Decompensated pulmonary conditions
• Pneumothorax or pneumomediastinum
• Pneumocephalus
• Cranial trauma

10 EN WM 100 TD
WM 67841c 03/2015
1 Introduction
• 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
• Do not use the respiratory air humidifier on patients who have
undergone an airway bypass procedure.
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.
No side effects are known for the use of the respiratory air
humidifier.

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WM 100 TD EN 11
2 Safety
2 Safety
Please read these instructions carefully. They form part of the
devices described, and must be available at all times.
Use the unit for the designated purpose only (see "Intended use").
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
Warning 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 chapter "Technical data").
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.

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2 Safety
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, Weinmann, or an authorized dealer.
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 for increased resistance and blockages
regularly and remove them.
2.1.2 Power supply
Caution 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.
2.1.3 Transport
Notice Water in the device can cause material damages!
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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WM 100 TD EN 13
2 Safety
2.1.4 Therapy
Warning 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.
Risk of injury from burning oxygen!
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.
Caution 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.

14 EN WM 100 TD
WM 67841c 03/2015
2 Safety
2.2 General information
• Use of third-party products may lead to functional failures and
restricted fitness of purpose. 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 replacement parts recommended in the instructions
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 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 have modifications to the unit carried out by the
manufacturer, Weinmann, or by a technician expressly
authorized by Weinmann.
• Please observe the section on hygienic preparation in order to
avoid infection or bacterial contamination (see chapter
"Hygienic preparation").
• 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
chapter "Function check").

WM 67841c 03/2015
WM 100 TD EN 15
2 Safety
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.
Warnings consist of
• the warning symbol (pictogram),
• a signal word designating the hazard level,
• information about the hazard
• instructions for avoiding the hazard.
The warnings appear in three hazard levels depending on the
degree of danger:
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 hazardous situation. Failure to observe this warning
may lead to damage to equipment.
Designates useful information relating to a particular action.

16 EN WM 100 TD
WM 67841c 03/2015
3 Product description
3 Product description
3.1 Therapy device overview
3-1 Therapy device
12345
6
7
8
9
10
12
13 11
No. Designation Description
1 Cover Covers the humidifier connection when no respiratory air humidifier
is connected.
2 Unlocking button therapy
device
Makes it possible to remove the cover in order to connect the humid-
ifier prismaAQUA.
3 Display
Allows operation of the therapy device and the respiratory air humid-
ifier.
Displays settings and current values.
4 System interface Connects the therapy device with modules.
5 Handle Allows lifting and transporting of the therapy device.
6 Filter compartment in suc-
tion area
Houses the air filter and, where applicable, the pollen filter. The re-
spiratory air is sucked in here and the dust particles filtered out.
7 Voltage input Connects the therapy device to the power supply unit.
8 Mounting holes Accept a module and secure it to the therapy device.
9 SD card slot For inserting an SD card. The symbol in the display indicates the com-
munication between the SD card and the therapy device.

WM 67841c 03/2015
WM 100 TD EN 17
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 17).
Settings can be performed on the therapy device
(see "6Settings in the menu", page 62).
•Therapy mode (therapy in progress)
There is a therapy in progress (see "3.2.2Display in Therapy
mode", page 19).
You can perform the mask test and start the softSTART sleep
aid (see "5 Operation", page 43).
•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 the Standby
mode by pressing the on/off button .
10 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.
11 On/off button
Switches the therapy device on and off.
Switches the therapy device to standby mode.
Starts and stops the therapy.
12 Hose heating system con-
nection Electrical power supply connection for a heatable hose.
13 Device output Connection for the respiration hose, through which the patient is
supplied with respiratory air.
No. Designation Description

18 EN WM 100 TD
WM 67841c 03/2015
3 Product description
3.2.1 Display in Standby mode
(Start screen)
3-2 Start screen in Standby mode
1
2
3
4
5
No. Designation Description
1 Info menu button Provides access to the info menu.
2 Alarm with wake-up time Alarm is set.
Displays the set wake-up time.
3 Menu button Provides access to the settings menus.
4 Dimmer button Makes the display dark.
5 Time Displays the current time.

WM 67841c 03/2015
WM 100 TD EN 19
3 Product description
3.2.2 Display in Therapy mode
3-3 Start screen in Therapy mode
2
1
3
4
5
6
7
8
9
No. Designation Description
1 Time Displays the current time.
2 SD card symbol The SD card is inserted in the therapy device.
3 Info button Provides access to the info screen with detailed information
on the therapy currently in progress.
4 Alarm with wake-up time Alarm 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 switched 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 Displays the current respiration status.
7 Mask status symbol with leak
indicator Displays how well the respiratory mask is positioned.

20 EN WM 100 TD
WM 67841c 03/2015
3 Product description
3.2.3 Symbols on the display
8 Humidifier button for respiratory
air humidifier prismaAQUA
Displays 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 increasing/decreasing of humidifier level.
No. Designation Description
Symbol Designation Description
Device status symbols (shown on the top line of the display)
Filter symbols
Bacteria filter is connected and activated.
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 symbol Maintenance required (symbol only appears when
maintenance function is active).
USB symbol USB connection
CONNECT symbol prismaCONNECT module is connected
(Green symbol)
prisma2CLOUD symbol
(Gray symbol)
prisma2CLOUD module is connected
No connection to prisma2CLOUD module established.
(Green symbol)
PSG symbol
(Gray symbol)
prismaPSG module is connected
No connection to prismaPSG module established