12.7Declaration of conformity ............................................................ 99
4EN WM 100 TD
WM 67841c 03/2015
1Introduction
1.1Intended use
1.1.1WM 100 TD therapy devices
The WM 100 TD devices are pressure-controlled, non-invasive,
non-life-sustaining therapy devices for the treatment of sleeprelated 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 Introduction
1.1.2WM 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.
WM 67841c 03/2015
WM 100 TDEN 5
1 Introduction
1.2Function
1.2.1WM 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 CO
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.
-enriched exhaled
2
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.
WM 67841c 03/2015
6ENWM 100 TD
1 Introduction
1.2.2WM 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.
1.3User 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.
1.4Indications
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.
WM 67841c 03/2015
WM 100 TDEN 7
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.,
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.
1.5Contraindications
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
WM 67841c 03/2015
•Cranial trauma
WM 100 TDEN 9
1 Introduction
•Status following brain surgery or surgical intervention on the
pituitary gland or the middle/inner ear
•Do not use the respiratory air humidifier on patients who have
undergone an airway bypass procedure.
1.6Side 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.
10ENWM 100 TD
WM 67841c 03/2015
2Safety
2.1Safety information
2.1.1Safe use of the therapy device, components,
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.
and accessories
WarningRisk 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.
WM 67841c 03/2015
WM 100 TDEN 11
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.
2.1.2Power supply
CautionRisk 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.
2.1.3Transport
NoticeWater 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
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.
12ENWM 100 TD
humidifier is filled.
WM 67841c 03/2015
2 Safety
2.1.4Therapy
WarningThe 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.
CautionPrevented 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.
WM 67841c 03/2015
WM 100 TDEN 13
2 Safety
2.2General 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").
14ENWM 100 TD
WM 67841c 03/2015
2.3Warnings 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.
2 Safety
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.
WM 67841c 03/2015
WM 100 TDEN 15
3 Product description
1
2
3
4
5
6
7
8
9
10
12
13
11
3Product description
3.1Therapy device overview
3-1 Therapy device
No.DesignationDescription
1 Cover
Unlocking button therapy
2
device
Covers the humidifier connection when no respiratory air humidifier
is connected.
Makes it possible to remove the cover in order to connect the humidifier prismaAQUA.
Allows operation of the therapy device and the respiratory air humid-
3 Display
ifier.
Displays settings and current values.
4 System interfaceConnects the therapy device with modules.
5 HandleAllows lifting and transporting of the therapy device.
Filter compartment in suc-
6
tion area
Houses the air filter and, where applicable, the pollen filter. The respiratory air is sucked in here and the dust particles filtered out.
7 Voltage inputConnects the therapy device to the power supply unit.
8 Mounting holesAccept 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 communication between the SD card and the therapy device.
16ENWM 100 TD
WM 67841c 03/2015
No.DesignationDescription
Used for point-to-point connection with a PC on which prismaTS is
10 Micro USB port
11 On/off button
installed. Allows settings to be changed on the therapy device and
data to be exported.
Switches the therapy device on and off.
Switches the therapy device to standby mode.
Starts and stops the therapy.
3 Product description
12
13 Device output
Hose heating system connection
3.2Display
Electrical power supply connection for a heatable hose.
Connection for the respiration hose, through which the patient is
supplied with respiratory air.
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 "3.2Display", page 17).
Settings can be performed on the therapy device
(see "6Settings in the menu", page 62).
WM 67841c 03/2015
•Therapy mode (therapy in progress)
There is a therapy in progress (see "3.2.2Display 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 .
WM 100 TDEN 17
3 Product description
1
2
3
4
5
3.2.1Display in Standby mode
(Start screen)
3-2 Start screen in Standby mode
No.DesignationDescription
1 Info menu buttonProvides access to the info menu.
2 Alarm with wake-up time
Alarm is set.
Displays the set wake-up time.
3 Menu buttonProvides access to the settings menus.
4 Dimmer buttonMakes the display dark.
5 TimeDisplays the current time.
18ENWM 100 TD
WM 67841c 03/2015
3.2.2Display in Therapy mode
2
1
3
4
5
6
7
8
9
3 Product description
3-3 Start screen in Therapy mode
No.DesignationDescription
1 TimeDisplays the current time.
2 SD card symbolThe SD card is inserted in the therapy device.
3 Info button
4 Alarm with wake-up time
Provides access to the info screen with detailed information
on the therapy currently in progress.
Alarm is set.
Displays the set wake-up time.
Switches the softSTART function on or off.
Displays the time remaining.
5 softSTART button
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 symbolDisplays the current respiration status.
7
Mask status symbol with leak
indicator
Displays how well the respiratory mask is positioned.
WM 67841c 03/2015
WM 100 TDEN 19
3 Product description
No.DesignationDescription
Displays that the respiratory air humidifier is connected and
8
Humidifier button for respiratory
air humidifier prismaAQUA
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.
3.2.3Symbols on the display
SymbolDesignationDescription
Device status symbols (shown on the top line of the display)
Bacteria filter is connected and activated.
If this symbol is displayed even though you are not
Filter symbols
Maintenance symbol
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 symbolUSB connection
CONNECT symbolprismaCONNECT module is connected
(Green symbol)
prisma2CLOUD module is connected
prisma2CLOUD symbol
(Gray symbol)
No connection to prisma2CLOUD module established.
(Green symbol)
prismaPSG module is connected
PSG symbol
No connection to prismaPSG module established
(Gray symbol)
WM 67841c 03/2015
20ENWM 100 TD
SymbolDesignationDescription
3 Product description
(Green symbol)
Network symbol
(Gray symbol)
SD card symbol
Symbols on the rest of the display
Respiratory air humidifier
symbol
Network connection available.
No network connection available.
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.
Respiratory air humidifier is connected and empty of
water.
Alarm symbol
Alarm is set.
If no alarm symbol is shown: the alarm is switched off.
Displays the respiration status:
•Arrow pointing upward: inhalation
•Arrow pointing downward: exhalation
Respiration status symbol
•Green arrow, spontaneous respiration
•Orange arrow, assisted breathing
Apnea
Mask position is good, no leaks.
Mask status symbol with
leak indicator symbol
Mask is not well positioned, considerable leaks, the
efficacy of the therapy is not guaranteed.
Hose diameter symbolSpecifies the diameter of the hose in mm.
WM 67841c 03/2015
WM 100 TDEN 21
3 Product description
SymbolDesignationDescription
Specifies the menu level that you are currently in:
Menu level symbol
The more green dots, the deeper you are in the menu
structure.
Alarm window
Alarm symbolLow-priority alarm triggered.
Alarm pause symbolAlarm paused for 2 minutes.
(Black symbol)
Mute symbol
(Orange symbol)
Indicates that the acoustic signal for an alarm can be
muted.
Acoustic signal for alarm is muted.
22ENWM 100 TD
WM 67841c 03/2015
3.3Components
1
2
3
4
5
6
3 Product description
3-4 Components
No.DesignationDescription
1 Respiratory maskSupplies the respiratory air to the patient.
2
Power supply unit with
connection cable
Supplies power to the device.
Connects the power supply unit to the therapy device.
3 Power supply cableConnects the power supply unit to the power socket.
4 SD cardRecords therapy data.
5
Respiration hose with
19-22 mm diameter
6 Exhalation system
Connects the therapy device to the respiratory mask.
If the mask does not feature an integrated expiratory system, the
exhaled air escapes here during the therapy.
WM 67841c 03/2015
WM 100 TDEN 23
3 Product description
3
2
7
8
5
4
6
910
11
12
1
3.4Accessories
3-5 Accessories
No.DesignationDescription
Respiration hose with 15 mm
1
diameter
Connects the therapy device to the respiratory mask.
Filters the suctioned respiratory air and prevents the ingress of fine
2 Pollen filter (white filter)
dust particles, pollen and fungal spores. Recommended for patients
with allergies.
3 Heatable hoseAvoids condensation in the respiration hose.
4 InverterEnables operation of the device via a DC power socket (12 V / 24 V).
Respiratory air humidifier prismaAQUA
5 Top of humidifierSeals the respiratory air humidifier.
6 Humidifier insertPrevents water from escaping.
7 Base of humidifierHolds the water for humidifying the respiratory air.
8 Lower recessFor opening the respiratory air humidifier.
9 InputConnects the therapy device to the respiratory air humidifier.
WM 67841c 03/2015
24ENWM 100 TD
3 Product description
1
2
3
4
5
6
89
7
No.DesignationDescription
10 OutputConnects the respiratory air humidifier to the device output.
11 ElementHeats the water in the respiratory air humidifier.
12 Upper recessFor lifting and transporting the respiratory air humidifier.
3.5Labels and symbols
3.5.1Labels on the therapy device
3-6 Labels on the therapy device
No.SymbolDescription
Type plate on the right side of the therapy device
SNSerial number of the therapy device
1
Year of manufacture
Labels and symbols on the therapy device
2 , 8 Consult instructions for use
3 Device inlet: inlet for room air at ambient temperature
WM 67841c 03/2015
WM 100 TDEN 25
3 Product description
No.SymbolDescription
4 Follow the instructions for use.
5 Slot for SD card
6 USB port
7 On/off: Indicates the on/off button
9
Device output: Outlet for room air at 4 hPa to 30 hPa (depending on type
of device)
Type plate on the underside of the therapy device
TYPE: WM 100 TD Type designation of the therapy device
37V
IP21
37 V DC
Degree of protection against solid foreign bodies. The device is protected
against dripping water.
Degree of protection against electric shock: Protection class II device
Do not dispose of device in household waste.
Suitable for use in airplanes. Complies with RTCA/DO-160G chapter 21,
Category M.
26ENWM 100 TD
Type BF applied part
Manufacturer
CE mark (confirms that the product complies with the applicable
European directives)
WM 67841c 03/2015
3 Product description
1
2
3.5.2Labels on the respiratory air humidifier
r
3-7 Labels on the respiratory air humidifier
No.SymbolDescription
1Fill with water.
2Respiratory air humidifier is heated. Do not touch the element.
Labels and symbols on the underside
Do not dispose of device in household waste.
CE mark (confirms that the product complies with the applicable European
directives).
32 V DC32 V direct current
Type BF applied part
IP22
>PC<Material designation: Polycarbonate
WM 67841c 03/2015
IP protection class: Degree of protection against solid foreign bodies. The
device is protected against dripping water.
WM 100 TDEN 27
3 Product description
No.SymbolDescription
Date of manufacture (month/year)
Type: WM100TH Type designation: Device of type WM 100 TH
Consult instructions for use.
SNSerial Number
3.5.3Labels on the type plate of the power supply
unit
SymbolDescription
Input: 100-240 V,
50-400 Hz, 1.5 A
Output: 37 V
2.43 A
Input voltage: 100-240 V, 50-400 Hz, 1.5 A
Output voltage 37 V DC 2.43 A
GOST-R certification (confirms that the product complies with the applicable
Russian directives)
China RoHS label (confirms that the product does not emit toxic substances for
the number of years indicated)
PSE mark (confirms that the product complies with the applicable Japanese
directives)
Only intended for indoor use.
Degree of protection against electric shock: Protection class II device
Do not dispose of device in household waste.
CE mark (confirms that the product complies with the applicable European
directives)
28ENWM 100 TD
WM 67841c 03/2015
SymbolDescription
25
%
%
3
1
3 Product description
IP21
IP protection class: Degree of protection against solid foreign bodies. The device
is protected against dripping water.
3.5.4Labels on the therapy device packaging
SymbolDescription
Permissible storage temperature: -25°C to +70°C
Permissible storage humidity: 15% to 93% relative humidity
3.5.5Labels on the respiration hose packaging
SymbolDescription
For use on one patient only!
WM 67841c 03/2015
WM 100 TDEN 29
4 Preparation
4Preparation
4.1Setting up the therapy device
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.
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.
ResultThe therapy device is set up properly.
4.2Connecting components
4.2.1Connecting up the power supply
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 Weinmann.
30ENWM 100 TD
WM 67841c 03/2015
Loading...
+ 70 hidden pages
You need points to download manuals.
1 point = 1 manual.
You can buy points or you can get point for every manual you upload.