Lowenstein Medical prismaLINE User manual

Sleep therapy devices
from firmware 5.05
prismaLINE
EN Additional information for experts for WM 100 TD devices

2EN WM 100 TD
LMT 68411 05/2020
Table of contents
Table of contents
1 Introduction 4
1.1 User qualifications ......................................................................... 4
2 Safety 5
2.1 Safety information ......................................................................... 5
2.2 General information ...................................................................... 7
3 Product description 8
3.1 Display in the expert sector ............................................................ 8
3.2 Symbols on the display ................................................................ 10
3.3 Components ............................................................................... 12
3.4 Accessories ................................................................................. 13
4 Preparation 14
4.1 Connecting up a bacteria filter ..................................................... 14
5 Settings in the expert sector 15
5.1 Menu structure in the expert sector ............................................. 15
5.2 Navigating in the expert sector .................................................... 16
5.3 Settings in the expert settings menus ........................................... 23
6 Description of the modes 33
6.1 CPAP mode ................................................................................. 33
6.2 APAP mode ................................................................................. 34
6.3 AcSV mode ................................................................................. 35
6.4 S mode ....................................................................................... 38
6.5 autoS mode ................................................................................ 40
6.6 autoS/T mode .............................................................................. 41
6.7 S/T mode .................................................................................... 44
6.8 T mode ....................................................................................... 47
6.9 HFT mode (prisma30ST-HFT only) ................................................ 48
7 Advanced BiLevel modes in prisma30ST-C,
prisma30ST and prisma30ST-HFT 49
7.1 aPCV mode ................................................................................. 49
7.2 S mode ....................................................................................... 52

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Table of contents
WM 100 TD EN 3
7.3 S/T mode .................................................................................... 54
7.4 T mode ....................................................................................... 58
7.5 autoS/T mode .............................................................................. 60
8 Particularities with prismaLAB 64
9 Hygienic preparation 65
9.1 General information .................................................................... 65
9.2 Intervals without a patient change ............................................... 65
9.3 Intervals with a patient change .................................................... 66
9.4 Replacing the bacteria filter ......................................................... 66

4EN WM 100 TD
LMT 68411 05/2020
1 Introduction
1 Introduction
This document is intended as supplementary material for experts
(hospital personnel and authorized dealers) and contains
additional information about the prismaLINE sleep therapy devices.
1.1 User qualifications
As an expert (this includes hospital personnel and authorized
dealers) you can completely operate the therapy device and the
respiratory air humidifier. The maintenance work that you can do
yourself is described in this Additional information for experts.
Always perform all the operating steps in accordance with this
additional information.
Please note:
This document does not replace complete instructions for use.
The following information can be found in the instructions for use
for patients:
• Safety instructions for the safe handling of the device
• Description of the device
• Connecting up and operating the device
• Hygienic preparation
• Function check
• Troubleshooting
• Maintenance
• Storage and disposal
• Technical Data
• SCOPE of supply
• Accessories
• Warranty

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2 Safety
WM 100 TD EN 5
2 Safety
This chapter provides supplementary safety information for
experts. Whenever using the therapy device, you should always
also observe the safety information in the instructions for use for
patients.
2.1 Safety information
2.1.1 Using the therapy device on the patient
Warning Risk of injury for patients with impaired cardiac function!
For patients with impaired cardiac function, cardiac output can be
decreased during the therapy.
⇒Perform a blood pressure test when setting the device for the
first time:
• Measure the blood pressure before performing
overpressure therapy
• Measure the blood pressure after 20 minutes of therapy
with the expected medium pressure (e.g., 7 cmH2O)
• Measure the blood pressure after 20 minutes of therapy
with maximum pressure (e.g., 15 cmH2O)
A notable drop in blood pressure during the therapy or
indisposition (dizziness, etc.) is an indication of decreased
cardiac output. In this case, stop the therapy immediately. The
patient is not suited to the therapy.
2.1.2 Safe use of the therapy device, components,
and accessories
Warning Risk of injury from electrical shock!
If the USB connection is connected, the PC can cause a higher
leakage current. The therapy device cannot detect a USB cable
connected to a switched-off PC and an increased leakage current.
⇒Do not connect a USB cable to a switched-off PC when
operating the therapy device.

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2 Safety
Risk of injury due to incorrect alarm presets!
The use of different alarm presets for the same or similar devices
can put the patient at risk.
⇒Check the alarm presets again for each patient.
2.1.3 Safe handling of oxygen
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.
⇒Keep the device and screwed unions free from oil and grease.
⇒Always replace splashguards immediately after use.
Risk of fire when oxygen supply unit is used without special
safety equipment!
Supplying oxygen without special safety equipment can cause
fires and injure people.
⇒Observe the instructions for use for oxygen supply unit.
⇒Set up oxygen sources more than 1 m from the device.
⇒Only switch off the oxygen supply at the end of therapy.
Allow the device to run on briefly to flush residual oxygen out
of the device.
Risk of poisoning from concentration of oxygen which is too
high during ventilation!
Highly concentrated oxygen can poison the patient if
administered for too long and depending on the age of the
patient.
⇒Do not ventilate the patient for too long with highly
concentrated oxygen.
⇒Adapt the oxygen flow to suit the patient's age.
⇒The prescribed flow must only be set by the physician or
specialist dealer.

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WM 100 TD EN 7
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 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 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 device carried out by the
manufacturer or by a technician expressly authorized by the
manufacturer.
• 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.
• Please observe the chapter on hygienic preparation in order to
avoid infection or bacterial contamination (see chapter
"Hygienic preparation").
• Also observe the respective instructions for use of the device,
the components, and the accessories.
• Always carry out a function check before using the unit (see
chapter "Function check" of the instructions for use).

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3 Product description
3 Product description
This section describes the elements which are important for experts
on the display and the components and accessories which are used
for applications in clinical areas.
A complete description of the whole therapy device and the
respiratory air humidifier can be found in the instructions for use
for patients.
3.1 Display in the expert sector
3-1 Display in expert sector (screen in BILevel S/T mode in Therapy
device mode)
Please note that the screens may differ slightly depending on the
set ventilation mode and device mode.
2
13
4
5
6
7
8
10
11
12
13
14
15
16
9
No. Designation Description
1 PSG symbol prismaCONNECT module is connected, prismaPSG module is
not connected.
2 CONNECT symbol prismaCONNECT module is plugged in.
3 Network symbol Network connection available.

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WM 100 TD EN 9
4 Mask test button Starts the mask test and stops it prematurely.
Shows the remaining time in seconds.
5
softSTART button
for prisma30ST, prisma30ST-C,
prismaLAB only: softSTART/
softSTOP button
Switches the softSTART on and off.
Shows the set/remaining softSTART time in minutes.
In addition for prisma30ST, prisma30ST-C, prismaLAB:
Switches off the current softSTOP. Shows the remaining
softSTOP time in minutes.
6 Lock button Exits the settings menus and locks the parameter setting
function.
7 Menu button Offers access to the settings menus (only available after login
(see 5.2.1, p. 16)).
8VTdisplay
Displays the tidal volume. Please note that if an oxygen
supply unit is used, the supplied quantity of oxygen is not
taken into consideration.
9 Hose diameter display Displays the set diameter of the respiration hose used.
10 Info fields Display the set therapy parameters. (They can be changed
here following login).
11 Respiration status symbol Indicates the current respiration status.
12 Mask status symbol with leak
indicator
Displays how well the respiratory mask is positioned and the
extent of any leak.
13 Actual pressure display Shows the actual pressure.
14 rAMV display/MV display Shows the relative or absolute respiratory minute volume
(not available in CPAP or APAP mode).
15 Ventilation mode display Displays the set ventilation mode.
Allows selection of another ventilation mode.
16 Expert sector symbol Shows that the expert sector is open and it is possible to set
the parameters.
Not
visible in
image
Ti display Shows the inspiration duration.
Te display Shows the expiration duration.
Ti/T display Shows the relative duration of inspiration.
I/E display Shows the ratio of inspiration to expiration.
Ti status Shows whether triggering of breathing was spontaneous or
mandatory at Ti min or Ti max.
No. Designation Description

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3 Product description
3.2 Symbols on the display
Symbol Designation Description
Device status symbols (shown on the top line of the display)
Access symbol
The expert sector is open and the parameters can be
set.
The expert sector is open and the settings are locked.
It is not possible to set parameters.
Bacteria filter symbol Bacteria filter is connected and active.
Filter change symbol
Air filter replacement required. (Symbol only appears if
you have activated the reminder to change the air
filter).
Maintenance symbol Maintenance required (symbol only appears when
maintenance function is active).
Connect symbol prismaCONNECT module is plugged in.
(Green symbol)
prisma2CLOUD symbol
(Gray symbol)
prisma2CLOUD module is plugged in
No connection to prisma2CLOUD module established.
(Green symbol)
PSG symbol
(Gray symbol)
prismaPSG module is plugged in.
No connection to prismaPSG module established.
(Green symbol)
Network symbol
(Gray symbol)
Network connection available.
No network connection available.

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SD card symbol SD card in SD card slot.
Symbol flashes: Data is being saved to the SD card.
Symbols on the rest of the display
(Gray symbol)
Respiratory air humidifier
symbol
(Green symbol)
(Green symbol)
(Orange symbol)
Respiratory air humidifier is connected and switched
off. Smart AQUA Control climate control is activated.
The last set humidifier level is displayed.
Respiratory air humidifier is connected and switched
on. Smart AQUA Control climate control is
deactivated. The currently set humidifier level is
displayed.
Humidifier is connected and switched on. Smart AQUA
Control climate control is activated. The humidifier
level currently set is shown.
Respiratory air humidifier is connected and empty of
water.
Respiration status symbol
Displays the respiration status (in the expert sector):
• S=Spontaneous
• T=timed
• Arrow pointing upward: Inspiration
• Arrow pointing downward: Expiration
Displays the status in the vertical text next to the
arrow:
• min=inspiration extended to Ti min
• max=inspiration ended by Ti max
• max=inspiration ended by Ti timed
Apnea in the expert sector
Mask status symbol with
leak indicator symbol
Mask position is good, no leaks
Mask is not well positioned, considerable leaks, the
efficacy of the therapy is not guaranteed
Hose diameter symbol Indicates the diameter of the hose in mm.
Symbol Designation Description

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3 Product description
3.3 Components
3-2 Additional components in clinical areas
Menu level symbol
Shows the menu level that you are currently in:
The more green dots, the deeper you are in the menu
structure.
Alarm window
Alarm symbol Low-priority alarm triggered.
Alarm pause symbol Alarm 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.
Symbol Designation Description
2
13
No. Designation Description
1 prismaCONNECT module Creates the connection between the therapy device and PC and
between the therapy device and prismaPSG module.
2 PSG connection cable Connects the therapy device to the prismaPSG module.
3 prismaPSG module Used to convert digital signals from the therapy device into analog
data.

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3.4 Accessories
3-3 Additional accessories in clinical areas
1
No. Designation Description
1 Bacteria filter Protects the patient against contaminations and infections, if the
therapy device is used by more than one patient.

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4 Preparation
4 Preparation
4.1 Connecting up a bacteria filter
A bacteria filter prevents against renewed infection of the patient
in cases of infectious diseases and prevents contaminations or
infections being passed on to the next patient when changing
between patients.
1. Insert the bacteria filter between the device outlet and the
respiration hose.
2. Switch on the therapy device.
3. Set in the menu that a bacteria filter is being used (see "5.3.1
Setting therapy parameters", page 24).
Result The bacteria filter is connected.
The bacteria filter symbol is shown on the therapy device
display.
The other preparation and setup steps for the therapy device and
the components and accessories can be taken from the
instructions for use for patients.

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5 Settings in the expert sector
WM 100 TD EN 15
5 Settings in the expert sector
As an expert, you can view all the parameters and values for a
patient and change the settings to set the therapy device up
optimally for the therapy of the respective patient in the expert
sector.
The patient sector is described in the instructions for use for
patients.
5.1 Menu structure in the expert sector
5-1 Menu structure in the expert sector
Alongside the screens for the currently active ventilation mode, the
expert sector is divided into an info menu and a settings menu.
•IntheInfo menu, you can view information about the therapy
quality (compliance, leaks, AHI, pressure statistics in ventilation
modes with automatic pressure adaptation, and volume and
frequency parameters) within a selectable period of time and
general information about the device and network.
• You can set the parameters in the Settings menu.
Expert info menu
Menu
Ventilation mode*
Menu
Ventilation mode*
Patient sector Expert sector
Login: Press for a long time
Start screen
Patient info menu
*The Ventilation mode menu corresponds to the currently active mode.
Expert settings menu
Patient settings menu
Locking the
settings menus
Logout
V

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5 Settings in the expert sector
The values and setting options shown on the display depend on
the mode the therapy device is in at that time:
•Standby mode (no therapy in progress)
•Therapy mode (therapy in progress)
5.2 Navigating in the expert sector
You configure all the settings in the menu via the display. Press the
required field directly on the display.
5.2.1 Opening and exiting the expert sector
Requirement The therapy device is in the Standby or Therapy mode.
1. Hold down the info button for > 4 seconds.
2. To confirm the login, press Login.
The symbol appears in the top left of the display. The
expert sector is opened and you can set the parameters.
3. Press the lock button to prevent unauthorized access to
the setting options. (In the case of the device versions
prisma20A and prisma20C, the settings can only be locked by
leaving the expert sector.)
The symbol appears in the top left of the display.
The expert sector is opened and the settings are locked. It is not
possible to set parameters.
4. To exit the expert sector, press the Logout button .
5. To confirm the logout, press Logout.
The patient sector is now opened.

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WM 100 TD EN 17
5.2.2 Navigating in the expert sector
5.2.3 Viewing the therapy data and device
information in the expert info menu
In the expert info menu, you can view information about the
therapy quality (compliance, leaks, AHI, pressure statistics in
ventilation modes with automatic pressure adaptation, and
volume and frequency parameters) within a selectable period of
time, and general information about the device and network.
Button Function
Button Go back a screen
Button Go forward a screen
Set the exact value
using the and
buttons.
Select values:
• If the parameter can have exactly 2 possible values
(e.g., on/off): Press the button.
The value changes to the other one.
• If the parameter can have several different values,
press the button and select the value from the
overview.
• If the parameter can have a range of different
values, press the approximate value on the scale.
Use the button
to open the list,
select the setting
from the overview.
Select the setting from the list
Button Confirm values
Button Reject values
Home button Go back to start screen (Standby or Therapy mode)

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5 Settings in the expert sector
Requirement • The therapy device is in Standby mode.
• The expert sector is opened (see "5.2.1 Opening and exiting
the expert sector", page 16).
1. Press the info button .
2. If necessary: To view therapy data from a night other than the
previous night, select the desired date in the list .
3. If necessary: To view a longer period of time, navigate to the
second screen .
4. Select the required period.
5. Navigate back with the arrow key.

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5 Settings in the expert sector
WM 100 TD EN 19
6. Press the respective field to see more detailed information.
7. In some modes, there are also additional pages displaying the
required pressures and statistical parameters on respiratory
rate and volume. If present: Use to navigate to the second
and third screens.
8. To view the device information, navigate using the arrow keys
and and press the Device field.
The content of the fields and the additional information vary in the
different device versions.

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5 Settings in the expert sector
9. To exit the info menu, press the Home button .
Result The therapy data and device information are called up.
Abbreviation Description
DV Device version
SN Serial number
HW Hardware version
FW Firmware version
PM Only relevant for service technicians
MC Only relevant for service technicians
SID System identification of the device.
N1
Therapy hours without artifacts or open mask.
This counter is reset when therapy data in the device are
deleted or the device is reset to the factory settings.
N2
Therapy hours with respiratory air humidifier (without
artifacts or open mask).
This counter is reset when therapy data in the device are
deleted or the device is reset to the factory settings.
N3
Patient operating hours: Period of use including artifacts and
open mask.
This counter is reset when therapy data in the device are
deleted or the device is reset to the factory settings.
N4 Fan running time. Determines the age of the device and
cannot be reset.
FU
Date of first therapy. In combination with the current counter
readings you can use this to determine the compliance, for
example, the daily usage. This is especially important when
therapy data in the device have been deleted since the last
compliance check. In this case, you can see the date of the
first therapy after the data were deleted and can reconstruct
the compliance as of this date.