dreamstar™ product range51.15.206.121/files/sefam/documents/manuels/dreamstar/english/1… ·...
TRANSCRIPT
Clinician and Home Care Provider User Manual
DreamStar™ Product Range
Upgradeable Humidifier Option
DreamStar™ Intro DreamStar™ Intro Evolve
DreamStar™ Info DreamStar™ Info Evolve
DreamStar™ Auto DreamStar™ Auto Evolve
DreamStar™ is a brand registered by SEFAM.
en GB – 2 DreamStar Intro, Info, Auto Clinician Manual
Manufacturer: Manufacturing plant and technical agency:
SEFAM
144 AV CHARLES DE GAULLE
92200 NEUILLY SUR SEINE
FRANCE
SEFAM
10 ALLEE PELLETIER DOISY
54600 VILLERS-LES-NANCY
FRANCE
TEL: +33 (0) 3 83 44 85 00
www.sefam-medical.com
DreamStar Intro, Info, Auto Clinician Manual en GB – 3
Table of contents
Before you start ........................................... 4
Safety Precautions .............................................4
Recommended use ............................................4
Contra-indications .............................................5
List of authorised accessories ............................5
Available Features ........................................ 6
Heated Humidification feature available on Evolve
models ...............................................................6
Pressure Alter ....................................................6
Auto ON feature ................................................6
Mask unplugged feature ....................................6
Patient reminders ..............................................6
Comfort Calibration ...........................................7
Ramp feature .....................................................7
Time ramp ..........................................................7
Device Settings ............................................ 9
Definitions ..........................................................9
Settings Ranges ................................................10
Accessing the device menus ............................12
How to set DreamStar™ Intro / Intro Evolve
device .........................................................14
Accessing the Settings menu ...........................14
Settings menu ..................................................14
Service menu ...................................................15
How to set DreamStar™ Info / Info Evolve
device .........................................................18
Accessing the Settings menu ...........................18
Settings menu ..................................................18
Service menu ...................................................20
How to set DreamStar™ Auto / Auto Evolve
device .........................................................23
Accessing the Settings menu ...........................23
Settings menu ..................................................23
Service menu ...................................................26
Other settings and information ...................29
General Information menu ............................. 29
Setting the Heat level (if water chamber included)
......................................................................... 30
Reminders about key events ........................... 31
Specific calibration of the pneumatic
configuration ................................................... 32
Using a memory card ...................................... 32
Cleaning and Maintenance ......................... 34
Daily ................................................................. 34
Weekly............................................................. 34
Monthly ........................................................... 36
Material Disinfection .................................. 37
Surface disinfection of the device ................... 37
Water chamber disinfection procedure (if
included).......................................................... 37
What should not be used ................................ 38
Troubleshooting tips .................................. 39
Device Messages ............................................. 39
Error Messages ................................................ 39
Technical Specifications .............................. 42
DreamStar™ device Performance ................... 42
Integrated Humidifier performance ................ 42
Operating conditions for the device and
humidifier ........................................................ 42
Transportation and storage conditions ........... 43
Device electrical characteristics ...................... 43
Physical characteristics ................................... 43
CE marking ...................................................... 43
Symbols on the device .................................... 44
Standards Compliance ..................................... 44
Disposing of the device at the end of its life ... 45
NF EN ISO 17510-1:2007-compliant features . 46
Functional pneumatic block diagram .............. 49
Essential performance requirements for
electromagnetic compatibility ........................ 50
en GB – 4 DreamStar Intro, Info, Auto Clinician Manual
Before you start
This manual is intended for the Clinician and home care Provider. Under no
circumstances should it be provided to the patient.
Safety Precautions
WARNING This signals a risk of injury or accident to the patient.
• Pay attention to the Safety Precautions indicated in the DreamStar™ Patient Manual.
• Refer to the Patient Manual for all information relating to installation, maintenance and storage of the
device.
• Without exception, be sure to supply the patient with the Patient Manual and accessory use
instructions.
• Use only the accessories that the manufacturer has authorised for use with this device, as listed in
this manual.
• During treatment, only equipment included in the List of authorised accessories should be connected
to the device USB connector.
• To ensure that maintenance is performed correctly and to avoid any possibility of damage, only
qualified personnel are permitted to perform maintenance on the device and make authorised changes
to it. The user assumes full responsibility for any device malfunction that results from the device being
maintained by personnel other than personnel authorised.
• Never use the device without making sure that an air intake filter is installed.
• If you observe any anomaly in the device, do not begin treatment.
• The swivel outlet elbow, 70° 22 mm diameter, is an accessory intended for single patient use
In the following cases where the device is equipped with a water chamber:
• In case of heated humidification feature use, the cover must be removed and replaced by a water
chamber.
• When the heated humidification feature is enabled on a device equipped with a water chamber, the
patient must take, precautions to eliminate the risk of introducing water into the device and causing
irreversible damage to it. The device must be positioned on a stable horizontal surface and must not
be tilted.
• The water chamber should always be emptied before moving or transporting the device.
CAUTION This indicates that there is a possibility of material damage to this device or any other device.
• If the device is equipped with a cover where the water chamber should be, the heated humidification
feature must be disabled. Otherwise, the device may apply the heat setting. However, there would be
no risk as the device would not reach high temperatures. If you are unsure, check the Service menu
to confirm that the heated humidification feature is disabled.
• Since DreamStar™ devices are medical electrical devices, instructions concerning electromagnetic
compatibility indicated in this manual should be followed during installation.
• Like all medical electrical devices, DreamStar™ devices are vulnerable to interference from mobile and
portable RF communication equipment.
Recommended use
The DreamStar™ product range devices are intended to treat patients suffering from Obstructive Sleep
Apnea Syndrome (OSA) in patients over 30 kg (66 lbs.) and breathing spontaneously. They can be used at
home or in a sleep center.
DreamStar Intro, Info, Auto Clinician Manual en GB – 5
Contra-indications
Studies have shown that the use of positive pressure is contra-indicated in some patients affected by any of
the following pre-existent pathologies:
• Severe bullous emphysema or emphysema previously complicated by pneumothorax.
• Pneumoencephalus, trauma or recent surgery with sequela of cranio-nasopharyngeal fistula.
• Decompensated cardiac insufficiency or hypotension, particularly in case of decreased blood volume or
cardiac arrhythmia.
• Dehydration.
• Massive epistaxis or history of massive epistaxis. Acute sinusitis, otitis media, or perforated tympanic
membrane.
• Tracheotomy.
In addition, because positive pressure is known to affect cardiac output in certain patients, patient arterial
pressure and heart rate should be closely monitored when starting treatment at an effective pressure. The
risks and benefits of treatment by Continuous Positive Airway Pressure (CPAP) must be weighed case by
case in such subjects. This evaluation should take into account the fact that the DreamStar™ device can be
set to deliver pressures up to 20 cmH2O and, under certain fault conditions, static pressures up to 30 cmH2O
are possible. The DreamStar™ device therefore should not be used if such pressure levels pose a risk to the
patient.
List of authorised accessories
Unless otherwise specified, all the DreamStar™ product range devices can be used with the following
optional accessories:
• Battery cable with lugs P/N M-214530-00
• RS232/mini USB 2 m cable (except for
DreamStar™ Intro) P/N M-214831-11
• Mini USB 2 m cable (except for DreamStar™
Intro) P/N M-214831-10
• Air intake filter (foam, reusable)
P/N M-314850-08 (x10);M-414840-06 (x96)
• Filter holder kit P/NM-314820-02
• Water chamber P/N M-315510-14
• Memory card P/N M-215530-00
• Software DreamStar™ Analyze
P/N M-215630-00
• Patient Tubing, 22 mm diameter
P/N M-261000-04
• Swivel outlet elbow, 70° diameter 22 mm
P/N M-267010-00
• Cigarette-lighter cable P/N M-214530-01
• RS 232/mini USB 15 m cable (except for
DreamStar™ Intro) P/N M-214831-12
• Power supply cord UK
P/N M-660601-40
• Optional high-efficiency filter (disposable)
P/N M-314850-09 (x10);M-414841-07 (x100)
• Device cover P/N M-315530-19
• Clinical kit P/N M-215630-01
• Memory card reader P/N M-214830-03
• KnightControl remote control (except for
DreamStar™ Intro) P/N M-114700-EU
• Patient Tubing, 15 mm diameter (except for
DreamStar™ Intro/Intro Evolve)
P/N M-261000-00
• Carrying case P/N M-815505-00
WARNINGS
• Use only the accessories listed above or EN ISO 17510-2:2007-compliant accessories which are
approved for this device.
• Use only those accessories which can guarantee the patient’s treatment pressure and reduce re-
breathing of CO2. When a facial mask is necessary, always use a mask which is equipped with an anti-asphyxia valve.
en GB – 6 DreamStar Intro, Info, Auto Clinician Manual
Available Features
The DreamStar™ Intro and DreamStar™ Info devices operate in continuous mode (CPAP), i.e. the device
delivers a constant pressure level.
The DreamStar™ Auto device operates in either constant mode (CPAP) or in automatic mode (Auto-CPAP),
i.e. the pressure fluctuates between a minimum pressure and a maximum pressure as a function of
respiratory events detected.
The first 5 minutes of operation of the device are not included in the ramp time or latency time. During this
time, depending on the device in question, compliance and AutoCPAP features are unavailable.
Heated Humidification feature available on Evolve models
The DreamStar™ Intro Evolve, DreamStar™ Info Evolve and DreamStar™ Auto Evolve devices can be
delivered either with a cover or with a water chamber. These devices are equipped with a heated
humidification feature which you can enable or disable.
The heated humidification function is enabled on the devices delivered with a water chamber and it is
disabled on the devices delivered with a cover.
If the device is equipped with a cover and if you want to use the heated humidification feature, it is
necessary to order a water chamber and to proceed as follows:
1. Remove the cover from the device and replace it with the water chamber by referring to the Patient
Manual.
2. Enable the heated humidification function by referring to Item 4 of the Service menu in the settings
procedure of the device concerned page 17, 21 or 27.
Pressure Alter
You can enable this feature which provides the option to the patient to change the prescribed pressure by ±
1 cmH2O.
Note: This feature is only available in CPAP mode.
Auto ON feature
Functionality allowing to automatically start the treatment without pressing the device On/Off button.
Mask unplugged feature
If the patient removes his mask, the device automatically switches to low power. The machine will restore
normal power when the mask is reconnected or if the On/Off button or the ramp button is
pressed. Otherwise, the device will stop after 30 minutes.
Note: If the patient uses a resistive interface (full face mask with anti-asphyxia valve), a specific
calibration of the pneumatic configuration must be carried out so that the DreamStar ™ unit
detects that the mask is unplugged.
Patient reminders
The DreamStar™ device has a patient reminder feature to help the patient remember key events such as
filter and mask changes, device inspections, and memory card compliance data downloads on the memory
card. This feature is described under “Reminders about key events”, on page 31.
DreamStar Intro, Info, Auto Clinician Manual
Comfort Calibration
Available on DreamStar™ Info / Info Evolve and DreamStar™ Auto / Auto Evolve , the (C.C.+) Comfort
Calibration feature is intended to increase the treatment pressure during inspiration and to decrease it
during expiration to make the patient's breathing more comfortable during the treatment. It can be enabled
continuously or during the ramp.
Ramp feature
Whatever the type of ramp used, the ramp feature can be stopped during device operation by pressing the
ramp button for 2 seconds. It can be reactivated by stopping and restarting the device.
The comfort pressure, the ramp time (only if the time ramp is selected and if comfort pressure < prescribed
pressure) and the maximum ramp time can be adjusted.
Time ramp
The Time Ramp feature (T.Ramp) allows
it is programmed (ramp time ≠ 0), it will be automatically activated at the beginning of the session at
comfort pressure.
In CPAP mode, the treatment begins at a
increases to treatment pressure.
In Auto-CPAP mode, the Ramp feature delays the commands
pressure is lower than the minimum pressure, the
pressure to the minimum pressure
Ramp feature in CPAP mode
DreamStar Intro, Info, Auto Clinician Manual
Available on DreamStar™ Info / Info Evolve and DreamStar™ Auto / Auto Evolve , the (C.C.+) Comfort
Calibration feature is intended to increase the treatment pressure during inspiration and to decrease it
during expiration to make the patient's breathing more comfortable during the treatment. It can be enabled
Whatever the type of ramp used, the ramp feature can be stopped during device operation by pressing the
ramp button for 2 seconds. It can be reactivated by stopping and restarting the device.
The comfort pressure, the ramp time (only if the time ramp is selected and if comfort pressure < prescribed
pressure) and the maximum ramp time can be adjusted.
The Time Ramp feature (T.Ramp) allows for a gradual rise in pressure to help the patient go to sleep.
0), it will be automatically activated at the beginning of the session at
atment begins at a reduced pressure called comfort pressure
the Ramp feature delays the commands to raise or lower the pressure.
pressure is lower than the minimum pressure, the gradual rise in pressure will be made from the comfort
pressure to the minimum pressure during the ramp time.
Ramp feature in CPAP mode Ramp feature in AutoCPAP mode
en GB – 7
Available on DreamStar™ Info / Info Evolve and DreamStar™ Auto / Auto Evolve , the (C.C.+) Comfort
Calibration feature is intended to increase the treatment pressure during inspiration and to decrease it
during expiration to make the patient's breathing more comfortable during the treatment. It can be enabled
Whatever the type of ramp used, the ramp feature can be stopped during device operation by pressing the
ramp button for 2 seconds. It can be reactivated by stopping and restarting the device.
The comfort pressure, the ramp time (only if the time ramp is selected and if comfort pressure < prescribed
for a gradual rise in pressure to help the patient go to sleep. When
0), it will be automatically activated at the beginning of the session at
reduced pressure called comfort pressure, then the pressure
to raise or lower the pressure. If the comfort
rise in pressure will be made from the comfort
Ramp feature in AutoCPAP mode
en GB – 8
Indexed Ramp Available on DreamStar™ Info / Info Evolve and DreamStar™ Auto / Auto Evolve, the Indexed Ramp feature
(I.Ramp) allows to start the treatment
CPAP mode or the activation of the
which indicate that the patient is asleep.
If the end of the indexed ramp is not detected before the value of the set maximum ramp time, it will
automatically stop.
The table below lists the different cases of the
End of ramp / detection of events
CP
AP
mo
de
A
uto
-CP
AP
mo
de
C
om
fort
P.
< m
in P
. C
om
fort
P.
≥ m
in P
.
DreamStar Intro, Info, Auto Clinician Manual
Available on DreamStar™ Info / Info Evolve and DreamStar™ Auto / Auto Evolve, the Indexed Ramp feature
treatment at the adjustable comfort pressure, then to have a
the Auto-CPAP as soon as the device starts to detect
that the patient is asleep.
If the end of the indexed ramp is not detected before the value of the set maximum ramp time, it will
rent cases of the indexed ramp operation in CPAP or Auto
detection of events End of ramp /
DreamStar Intro, Info, Auto Clinician Manual
Available on DreamStar™ Info / Info Evolve and DreamStar™ Auto / Auto Evolve, the Indexed Ramp feature
to have a rise in pressure in
starts to detect respiratory events
If the end of the indexed ramp is not detected before the value of the set maximum ramp time, it will
or Auto-CPAP mode.
/ Max ramp time
DreamStar Intro, Info, Auto Clinician Manual en GB – 9
Device Settings
The adjustment of the therapeutic pressure must be determined by the prescribing physician for each
patient individually, with the configuration of the equipment to be used, including the accessories. The
correct installation and positioning of the patient interface constitute a critical condition for the proper
operation of the device.
The most recent compliance data are recorded by session in the device memory within one year and 8
hours usage day, and they can be retrieved for analysis using DreamStar™ Analyze software.
The settings are accessible directly on all the devices. You can also adjust the settings of the DreamStar™
Info, DreamStar™ Info Evolve, DreamStar™ Auto and DreamStar™ Auto Evolve using the DreamStar™
Analyze software on a computer connected via a RS232 or Mini USB cable, or via a wireless connection
WARNING
Before changing the device settings, confirm that the device delivers sufficient airflow when it is in
operating mode. If it does not, stop immediately and contact the technical support.
Definitions
Comfort pressure: level of pressure produced by the device when the time ramp (T.Ramp) or the indexed
ramp (I.Ramp) starts up so that the patient can go to sleep comfortably.
When the DreamStar™ Auto / Auto Evolve device is in Auto-CPAP mode, the pressure
is adjusted to the comfort pressure or to the minimum pressure (if comfort pressure <
minimum pressure) when the device detects that there has been no respiratory cycle
for more than 2 minutes or when it detects a high pressure.
Compliance counter: total time during which the patient has effectively breathed in the mask (time
subtracted from the time when the mask was removed and the time with no
respiration).
Heating time: time needed for the device to reach the operating level required by the heated
humidification feature.
Hour counter: device operating time (ON/OFF).
IFL: Inspiratory Flow Limit.
Maximum pressure: maximum pressure that the DreamStar™ Auto / Auto Evolve can deliver in Auto-CPAP
mode.
Maximum pressure
on apnoea command:
maximum pressure on the DreamStar™ Auto / Auto Evolve in Auto-CPAP mode beyond
which no rise in pressure can be applied once a respiratory pause has been detected.
Maximum ramp
time:
Whatever the type of ramp used, this parameter accessible by the clinician and home
care provider only, allows a limit to be placed on the maximum value of ramp time
which can be set by the patient.
Minimum pressure: minimum pressure that the DreamStar™ Auto / Auto Evolve can deliver in Auto-CPAP
mode.
Prescribed pressure: level of pressure prescribed for the patient.
Ramp time: This is the time taken by the device in CPAP mode to reach the prescribed pressure
from the comfort pressure or to activate the Auto-CPAP feature when the time ramp is
enabled.
Session: period during which data is recorded to memory between the time the device starts
operation and the time the device goes into standby. A session is started after the
device has been on for at least 5 minutes without interruption.
Water chamber: chamber containing the water necessary for humidification.
en GB – 10 DreamStar Intro, Info, Auto Clinician Manual
Settings Ranges
For each parameter, the following table indicates the default value, the minimum and maximum values that
can be set on the devices.
Operating mode on the DreamStar™ Auto or DreamStar™ Auto Evolve:
Parameter Display Default
Operating mode CPAP AUTO AUTO
Parameters that can be set on the devices in CPAP mode:
Parameter Minimum value Maximum value Default value Increment
Set pressure 4 cmH2O 20 cmH2O 8 cmH2O 0.5 cmH2O
Comfort pressure 4 cmH2O Prescribed
pressure
4 cmH2O 0.5 cmH2O
Ramp time 0 min Maximum ramp
time
15 min 5 min
Maximum ramp time 0 min 45 min 45 min 5 min
Heat level (if water chamber
included)
0 10 1 1
Device parameters that can be set on the DreamStar™ Auto or DreamStar™ Auto Evolve in Auto-CPAP
mode:
Parameter Minimum value Maximum value Default value Increment
Comfort pressure 4 cmH2O Maximum set
pressure
4 cmH2O 0.5 cmH2O
Maximum pressure on apnea
command.
Minimum pressure Maximum pressure 10 cmH2O 0.5 cmH2O
Maximum pressure 4 cmH2O or
minimum pressure
20 cmH2O 20 cmH2O 0.5 cmH2O
Minimum pressure 4 cmH2O 20 cmH2O or
maximum pressure
4 cmH2O 0.5 cmH2O
Ramp time (if time ramp selected) 0 min Maximum ramp
time
15 min 5 min
Maximum ramp time 0 min 45 min 45 min 5 min
Heat level (if water chamber
included)
0 10 1 1
Parameter Display Default
Pressure decrease: SLOW FAST SLOW
The device is started by pressing the On/Off button . If the heated humidification feature is enabled on
a device with a water chamber (Evolve configuration) and the heat level is set from 1 to 10, the heated
humidifier begins operating automatically. The heated humidifier indicator then displays on the
screen. When the heat level is set at 0, the humidifier symbol is displayed without steam .
DreamStar Intro, Info, Auto Clinician Manual
Note: When the heat level is set at 10,
hours use. The rate of water evaporation depends on several factors such as environment, leak
rate, patient's breathing pattern, etc.
Features available on all the devices:
Feature
Humidifier
Evolve configuration with water chamber*The Humidifier feature is inactive on a device
equipped with a cover).
Pressure Alter (in CPAP mode)
Mask reminder
Filter reminder
Service reminder
Memory card reminder
Features available on DreamStar™ Info / Info Evolve and Auto /Auto Evolve:
Comfort Calibration +
EXT. (for an external module connection)
Command on Inspiratory Flow LimitAuto/Auto Evolve in Auto-CPAP mode)
Auto ON
Access to setting of ramp time for the
Access to setting of comfort pressure for the
patient
Access to setting of language for the patient
Ramp feature
DreamStar Intro, Info, Auto Clinician Manual
n the heat level is set at 10, the water chamber filled to the maximum fill line allows
. The rate of water evaporation depends on several factors such as environment, leak
breathing pattern, etc.
the devices:
Feature enabled
Feature disabled
Evolve configuration with water chamber* *The Humidifier feature is inactive on a device
Frequency
(increment of 1)
Frequency
(increment of 1)
Frequency
(increment of 1)
Frequency
(increment of 1)
Features available on DreamStar™ Info / Info Evolve and Auto /Auto Evolve:
(continuously)
(during the ramp)
connection)
Command on Inspiratory Flow Limit (on DreamStar™
CPAP mode)
for the patient
(autorised) (locked
Access to setting of comfort pressure for the
(autorised) (locked)
Access to setting of language for the patient
(autorised) (locked)
Ramp type
Time ramp
(T.Ramp)
Indexed ramp
(I.Ramp)
en GB – 11
filled to the maximum fill line allows at least 8
. The rate of water evaporation depends on several factors such as environment, leak
Feature disabled Default
0 0
0 0
0 0
0 0
locked)
locked)
(locked)
Default
Indexed ramp
(I.Ramp)
Indexed ramp
(I.Ramp)
en GB – 12 DreamStar Intro, Info, Auto Clinician Manual
Configuration of the devices depending on the accessories used:
Accessory used Patient circuit Pneumatic calibration
(Settings menu) Humidifier feature
(Service menu)
Cover
L. 1.80 m diam. 15 mm Ø15mm
L. 1.80 m diam. 22 mm Ø22mm
Other SPECIFIC
Water chamber
L. 1.80 m diam. 15 mm Ø15mm+HH
L. 1.80 m diam. 22 mm Ø22mm+HH
Other SPECIFIC
Note: As all DreamStar™ product range devices are equipped with a differential pressure sensor,
pressure compensation for altitude is automatic.
Accessing the device menus
The four buttons on the front of the device allow one to access the device settings menu, scroll through
different pages, or possibly modify the value of certain parameters within these pages.
The parameters are accessible when the machine is in standby or operating mode.
The parameters that are accessible are grouped on several screen pages indicating:
• device settings related to prescribed treatment
• general device settings, such as date and time
• Information about device servicing,
• patient reminders.
Description of a screen page
Each screen page includes:
• a first line or page header
• up to 4 parameter lines with associated values
• a final line showing the various symbols used for
such features as changing a parameter value,
moving about a page, or moving from page to page
(see table entitled “Description of symbols
displayed on the screen“).
DreamStar Intro, Info, Auto Clinician Manual
Description of symbols displayed on the screen
Symbol Description
Access to device information.
Provides access to the next page
available for display on the screen.
Allows the value of the parameter
displayed on the screen to be raised.
The heated humidification feature is
enabled without heat or on a device
connected to a battery.
Parameters displayed on the screen
can be changed.
Feature enabled.
YES.
Time Ramp feature (T.Ramp).
C CPAP operating mode, on the
DreamStar™ Auto or DreamStar Auto
Evolve device.
Indicates that compliance is being
recorded.
Comfort calibration + feature enabled
on DreamStar™ Info / Auto (and
equivalent in Evolve configuration).
LEAK
Indicates the leak level (except on
DreamStar™ Intro / Intro Evolve).
Displays OK, +, ++, +++, ++++.
Memory card present.
The symbol blinks if the memory card
is not operational.
The device has detected an operating
error. The symbol displays alternately
with the error code.
For settings specific to the DreamStar™
DreamStar™ Intro / Intro Evolve devic
For settings specific to the DreamStar™
DreamStar™ Info / Info Evolve device
For settings specific to the DreamStar™
DreamStar™ Auto / Auto Evolve device
The "General Information" menu for the devices is described on page
DreamStar Intro, Info, Auto Clinician Manual
Description of symbols displayed on the screen
Description Symbol
Access to device information. Access to device settings.
Provides access to the next page
available for display on the screen. Provides access to the
displayed on the screen.
Allows the value of the parameter
displayed on the screen to be raised. Allows the value of the parameter
displayed on the screen to be lowered.
The heated humidification feature is
ithout heat or on a device
connected to a battery.
Heated humidification feature enabled
with heat.
The symbol blinks if the heated
humidifier has a problem.
Parameters displayed on the screen
Parameters displayed on the screen
are for information and cannot be
changed.
Feature disabled.
NO.
Time Ramp feature (T.Ramp).
Indexed Ramp feature (I.Ramp).
CPAP operating mode, on the
™ Auto or DreamStar Auto A Auto-CPAP operating mode, on the
DreamStar™ Auto or DreamStar Auto
Evolve device.
Indicates that compliance is being
The symbol blinks when one or several
patient reminders are about
Comfort calibration + feature enabled
on DreamStar™ Info / Auto (and
equivalent in Evolve configuration).
Selection of Settings menu or Service
menu.
Indicates the leak level (except on
DreamStar™ Intro / Intro Evolve).
+, ++, +++, ++++.
DD/MM/YYYY The dates displayed by the device are
in the format day/month/year.
Memory card present.
The symbol blinks if the memory card
Indicates that a battery is connected.
detected an operating
The symbol displays alternately
with the error code.
Indicates that a remote control is
connected.
DreamStar™ Intro or DreamStar™ Intro Evolve device, see "
device", on page 14.
DreamStar™ Info or DreamStar™ Info Evolve device
device", on page 17.
DreamStar™ Auto or DreamStar™ Auto Evolve device
device", on page 22.
menu for the devices is described on page 29.
en GB – 13
Description
Access to device settings.
Provides access to the preceding page
displayed on the screen.
Allows the value of the parameter
displayed on the screen to be lowered.
Heated humidification feature enabled
The symbol blinks if the heated
humidifier has a problem.
Parameters displayed on the screen
for information and cannot be
Feature disabled.
Indexed Ramp feature (I.Ramp).
CPAP operating mode, on the
DreamStar™ Auto or DreamStar Auto
Evolve device.
The symbol blinks when one or several
patient reminders are about to expire.
Selection of Settings menu or Service
The dates displayed by the device are
in the format day/month/year.
Indicates that a battery is connected.
Indicates that a remote control is
connected.
device, see "How to set
device, see "How to set
device, see "How to set
en GB – 14 DreamStar Intro, Info, Auto Clinician Manual
How to set DreamStar™ Intro / Intro Evolve device
Accessing the Settings menu
Refer to the "DreamStar™ Intro settings" section in the Patient Manual to know how to use the buttons and
symbols displayed during the device setting procedure.
Access of some settings is limited to the medical team only. For that, press the left control button and
the right control button located on the front of the device simultaneously for 2 seconds.
A page appears on the screen and allows you to choose the SETTINGS menu or the SERVICE menu.
Press the left control button to select the settings menu or the right control button to select the service
menu.
Notes:
• In the following screens, the values displayed are given by way of example.
• The symbol indicates that the Pressure Alter feature is enabled, and the symbol indicates that it is
disabled.
Settings menu
To access the Settings menu, press the left control button to select the symbol displayed at
the bottom left of the screen:
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
Prescribed P.: level of pressure prescribed for the patient.
Pressure Alter: feature that can be enabled to allow the patient to adjust the prescribed pressure ±1
cmH2O.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
DreamStar Intro, Info, Auto Clinician Manual en GB – 15
DreamStar™ Intro or DreamStar™ Intro Evolve
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
Comfort pressure: level of pressure produced by the device when the ramp feature starts up.
Max ramp time: maximum ramp time, set at a value from 0 to 45 minutes.
Ramp time: time the device takes to reach the prescribed pressure when starting from the comfort
pressure.
� Press at the bottom of the page or to return to the page header.
� Press to exit the menu.
Note : The DreamStar™ Intro device was calibrated at the factory for a 22 mm in diameter tubing and
cannot be used with a 15 mm in diameter tubing.
Service menu
To access the Service menu, press the left control button to select the symbol displayed at
the bottom right of the screen:
1) Selecting the language and setting the clock
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
The language can be selected by
successive presses on the left or right
parameters settings button.
Then press to access the next
parameter. Increase or decrease
the parameter value with the
right or left parameter settings button.
Then press to access the next
menu parameter.
Software version: Version of the integrated device software. The version of the integrated device software
can be viewed but not modified.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
en GB – 16 DreamStar Intro, Info, Auto Clinician Manual
DreamStar™ Intro or DreamStar™ Intro Evolve
2) Setting the date � � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
3) Patient reminders
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
For each type of reminder, you can set the frequency with which the device will set a reminder activation
date for the patient. The date will appear in the relevant menu (see Patient Manual for further information).
Filter: reminder how often the filter should be changed
Mask: reminder how often the mask should be changed.
Service: reminder how often the device pressure should be checked.
Memory card: reminder how often the patient should download data to the memory card and return the
card to the home care provider or physician.
CAUTION
The reminder expiration date is recalculated when you change the frequency.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
DreamStar Intro, Info, Auto Clinician Manual en GB – 17
DreamStar™ Intro or DreamStar™ Intro Evolve
4) Other features
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
Pressure offset: offset of the pressure sensor.
Pressure unit: the unit of measurement used for the displayed pressure can be changed from cmH2O to hPa,
and vice versa.
Humidifier: the heated humidification feature can be enabled or disabled (if water chamber
included).
Note : If you have changed the value of the pressure offset or the status of the heated humidification
feature, a confirmation message appears when you press the On/Off button. Press the right
control button to confirm the change or the left control button to cancel.
� Press at the bottom of the page or to return to the page header.
� Press to exit the menu.
en GB – 18 DreamStar Intro, Info, Auto Clinician Manual
How to set DreamStar™ Info / Info Evolve device
Accessing the Settings menu
Refer to the "DreamStar™ Info settings" section in the Patient Manual to know how to use the buttons and
symbols displayed during the device setting procedure.
Access of some settings is limited to the medical team only. For that, press the left control button and
the right control button located on the front of the device simultaneously for 2 seconds.
A page appears on the screen and allows you to choose the SETTINGS menu or the SERVICE menu.
Press the left control button to select the settings menu or the right control button to select the service
menu.
Notes:
• In the following screens, the values displayed are given by way of example.
• The symbol indicates that the Pressure Alter feature is enabled, and the symbol indicates that it is
disabled.
Settings menu
To access the Settings menu, press the left control button to select the symbol displayed at
the bottom left of the screen:
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
Prescribed P.: Level of pressure prescribed.
Pressure Alter: Feature that can be enabled to allow the patient to adjust the prescribed pressure ± 1
cmH2O.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
DreamStar Intro, Info, Auto Clinician Manual en GB – 19
DreamStar™ Info or DreamStar™ Info Evolve
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
Select the ramp type with the right or
left parameter settings button.
Comfort pressure: level of pressure produced by the device when the ramp feature starts up.
Ramp type : Time Ramp (T.Ramp) or Indexed Ramp (I.Ramp).
Max ramp time: maximum ramp time of from 0 to 45 minutes.
Ramp time: time the device takes to reach the prescribed pressure when starting from the comfort
pressure. This parameter is displayed only when the time ramp (T.Ramp) is selected.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
Calibrating the device
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
With the right or left parameter settings
button, you can select the activation or
disactivation status of the Comfort
Calibration + feature.
The and symbols show that
it is enabled during the ramp.
Then press to access the next
menu parameter.
C.C.+ : Comfort Calibration + feature. This feature can be enabled either continuously or during the ramp
only, or it can be disabled.
Patient circuit options are: Ø15mm (15 mm in diameter patient tubing), Ø15mm+HH (15mm in diameter
patient tubing with water chamber), Ø22mm (22mm in diameter patient tubing), Ø22mm+HH (22mm in
diameter patient tubing with water chamber) and SPECIFIC (other configuration).
Note: If the SPECIFIC patient circuit option is selected, calibration must be launched. Press the ramp
button to enable calibration. If no calibration is PRESENT, the calibration goes back to the default
calibration. See "Specific calibration of the pneumatic configuration" paragraph, on page 32.
� Press at the bottom of the page or to return to the page header.
� Press to exit the menu.
en GB – 20 DreamStar Intro, Info, Auto Clinician Manual
DreamStar™ Info or DreamStar™ Info Evolve
Service menu
To access the Service menu, press the left control button to select the symbol displayed at
the bottom right of the screen:
1) Selecting the language and setting the clock
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
The language can be selected by
successive presses on the left or right
parameters settings button.
Then press to access the next
parameter. Increase or decrease
the parameter value with the
right or left parameter settings button.
Then press to access the next
menu parameter.
Software version: version of the integrated device software. The version of the integrated device software
can be viewed but not modified.
Note: The time can be set only when the device is in standby.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
2) Setting the date
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
Note: The date can be set only when the device is in standby.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
DreamStar Intro, Info, Auto Clinician Manual
3) Access to the settings for the patient
� �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
This menu gives you the possibility to allow or not the patient to select himself the language and / or set the
ramp time and / or pressure comfort.
� Press at the bottom of the page or
� Press to move to the next page.
4) Selection of features
� �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
Auto ON : functionality allowing to automatically start the treatment without pressing the device On/Off
button.
Humidifier: the heated humidification feature can be enabled or disabled (if water chamber included).
Ext. : the connection of an external module can be enabled or disabled.
Notes:
• If you have changed the status of the heated humidification feature, a con
you press the On/Off button. Press the right control button to confirm the change or the left control button to
cancel.
• When enabling/disabling the heated humidification feature, the pneumatic configuration is automatically
reset to the default value. If a specific calibration of the pneumatic configuration was in use, it will be replaced
with a default configuration.
� Press at the bottom of the page or
� Press to move to the next page.
DreamStar Intro, Info, Auto Clinician Manual
DreamStar™ Info or DreamStar™ Info Evolve
Access to the settings for the patient
� �
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
With the right or left parameter settings
button, lock
patient the
setting.
Then press
menu parameter.
This menu gives you the possibility to allow or not the patient to select himself the language and / or set the
ramp time and / or pressure comfort.
at the bottom of the page or to return to the page header.
to move to the next page.
� �
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes::
With the right or left parameter settings
button, enable
feature.
Then press
menu parameter.
allowing to automatically start the treatment without pressing the device On/Off
the heated humidification feature can be enabled or disabled (if water chamber included).
the connection of an external module can be enabled or disabled.
If you have changed the status of the heated humidification feature, a confirmation message appears when
button. Press the right control button to confirm the change or the left control button to
When enabling/disabling the heated humidification feature, the pneumatic configuration is automatically
reset to the default value. If a specific calibration of the pneumatic configuration was in use, it will be replaced
at the bottom of the page or to return to the page header.
to move to the next page.
en GB – 21
DreamStar™ Info or DreamStar™ Info Evolve
�
With the right or left parameter settings
button, lock or unlock for the
the access to the parameter
Then press to access the next
menu parameter.
This menu gives you the possibility to allow or not the patient to select himself the language and / or set the
�
right or left parameter settings
button, enable or disable the
Then press to access the next
menu parameter.
allowing to automatically start the treatment without pressing the device On/Off
the heated humidification feature can be enabled or disabled (if water chamber included).
firmation message appears when
button. Press the right control button to confirm the change or the left control button to
When enabling/disabling the heated humidification feature, the pneumatic configuration is automatically
reset to the default value. If a specific calibration of the pneumatic configuration was in use, it will be replaced
en GB – 22 DreamStar Intro, Info, Auto Clinician Manual
DreamStar™ Info or DreamStar™ Info Evolve
5) Patient reminders
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
For each type of reminder, you can set the frequency with which the device will set a reminder activation
date for the patient. The date will appear in the relevant menu (see Patient Manual for further information).
Filter: reminder how often the filter should be changed.
Mask: reminder how often the mask should be changed.
Service: reminder how often the device pressure should be checked.
Memory card: reminder how often the patient should download data to the memory card and return the
card to the home care provider or physician.
CAUTION
The reminder expiration date is recalculated when you change the frequency.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
6) Miscellaneous
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
Pressure offset: offset of the pressure sensor.
Pressure unit: the unit of measurement used for the displayed pressure can be changed from cmH2O to hPa,
and vice versa.
� Press at the bottom of the page or to return to the page header.
� Press to exit the menu.
DreamStar Intro, Info, Auto Clinician Manual en GB – 23
How to set DreamStar™ Auto / Auto Evolve device
Accessing the Settings menu
Refer to the "DreamStar™ Auto settings" section in the Patient Manual to know how to use the buttons and
symbols displayed during the device setting procedure.
Access of some settings is limited to the medical team only. For that, press the left control button and
the right control button located on the front of the device simultaneously for 2 seconds.
A page appears on the screen and allows you to choose the SETTINGS menu or the SERVICE menu.
Press the left control button to select the settings menu or the right control button to select the service
menu.
Notes:
• In the following screens, the values displayed are given by way of example.
• The symbol indicates that the Pressure Alter feature is enabled, and the symbol indicates that it is
disabled.
Settings menu
To access the Settings menu, press the left control button to select the symbol displayed at
the bottom left of the screen:
In CPAP mode
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Press the right or left parameter
settings button to select the operating
mode.
Then press to access the next
menu parameter.
Increase or decrease the
parameter value with the right or left
parameter settings button.
Mode: device operating mode.
Prescribed P.: level of pressure prescribed.
Pressure Alter: feature that can be enabled to allow the patient to adjust the prescribed pressure ± 1
cmH2O.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
en GB – 24
� �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
Comfort pressure: level of pressure produced by the device when the ramp feature starts up.
Ramp type : Time Ramp (T.Ramp) or Indexed Ramp (I.Ramp).
Max ramp time: maximum ramp time
Ramp time: time the device takes to
pressure. This parameter is displayed only when the time ramp (T.Ramp) is selected.
� Press at the bottom of the page or
� Press to move to the next page.
In Auto-CPAP mode
� �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
Mode: device operating mode.
Min. Pressure: minimum pressure deliverable by the device.
Max. Pressure: maximum pressure deliverable by the device.
� Press at the bottom of the page or
� Press to move to the next page.
� �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
DreamStar Intro, Info, Auto Clinician Manual
DreamStar™ Auto or DreamStar™ Aut
� �
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase
parameter value with the right or left
parameter settings button.
Then press
menu parameter.
Select the ramp type with the right or
left parameter settings
level of pressure produced by the device when the ramp feature starts up.
Time Ramp (T.Ramp) or Indexed Ramp (I.Ramp).
maximum ramp time set from 0 to 45 minutes.
time the device takes to reach the prescribed pressure when starting from the comfort
This parameter is displayed only when the time ramp (T.Ramp) is selected.
at the bottom of the page or to return to the page header.
to move to the next page.
� �
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Press the right or left parameter
settings button to select the operating
mode.
Then press
menu parameter.
Increase
parameter value with the right or left
parameter settings button.
pressure deliverable by the device.
pressure deliverable by the device.
at the bottom of the page or to return to the page header.
to move to the next page.
� �
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase
parameter value with the right or left
parameter settings button.
Then press
menu parameter.
DreamStar Intro, Info, Auto Clinician Manual
DreamStar™ Auto or DreamStar™ Auto Evolve
�
or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
Select the ramp type with the right or
left parameter settings button.
level of pressure produced by the device when the ramp feature starts up.
reach the prescribed pressure when starting from the comfort
This parameter is displayed only when the time ramp (T.Ramp) is selected.
�
Press the right or left parameter
settings button to select the operating
Then press to access the next
menu parameter.
or decrease the
parameter value with the right or left
parameter settings button.
�
or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
DreamStar Intro, Info, Auto Clinician Manual en GB – 25
DreamStar™ Auto or DreamStar™ Auto Evolve
Command on IFL: command on Inspiratory Flow Limit.
Pressure decrease: Pressure decrease speed.
Max. P. on Apnoea: Maximum pressure on apnoea command.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
Select the ramp type with the right or
left parameter settings button.
Comfort pressure: Level of pressure produced by the device when the ramp feature starts up.
Ramp type : Time Ramp (T.Ramp) or Indexed Ramp (I.Ramp).
Max ramp time: maximum ramp time set from 0 to 45 minutes.
Ramp time: time the device takes to activate the Auto-CPAP feature. This parameter is displayed only when
the time ramp (T.Ramp) is selected.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
Calibrating the device
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
With the right or left parameter settings
button, you can select the activation or
disactivation status of the Comfort
Calibration + feature.
The and symbols show that
it is enabled during the ramp.
Then press to access the next
menu parameter.
C.C.+ : Comfort Calibration + feature. This feature can be enabled either continuously or during the ramp
only, or it can be disabled.
Patient circuit options are: Ø15mm (15 mm in diameter patient tubing), Ø15mm+HH (15mm in diameter
patient tubing with water chamber), Ø22mm (22mm in diameter patient tubing), Ø22mm+HH (22mm in
diameter patient tubing with water chamber) and SPECIFIC (other configuration).
Note: If the SPECIFIC patient circuit option is selected, calibration must be launched. Press the ramp
button to enable calibration. If no calibration is PRESENT, the calibration goes back to the default
calibration. See "Specific calibration of the pneumatic configuration" paragraph, on page 32.
� Press at the bottom of the page or to return to the page header.
en GB – 26 DreamStar Intro, Info, Auto Clinician Manual
DreamStar™ Auto or DreamStar™ Auto Evolve
� Press to exit the menu.
Service menu
To access the Service menu, press the left control button to select the symbol displayed at
the bottom right of the screen:
1) Selecting the language and setting the clock
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
The language can be selected by
successive presses on the left or right
parameters settings button.
Then press to access the next
parameter. Increase or decrease
the parameter value with the
right or left parameter settings button.
Then press to access the next
menu parameter.
Software version: version of the integrated device software. The version of the integrated device software
can be viewed but not modified.
Note: The time can be set only when the device is in standby.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
2) Setting the date
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
Note: The date can be set only when the device is in standby.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
DreamStar Intro, Info, Auto Clinician Manual
3) Access to the settings for the patient
� �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
This menu gives you the possibility to allow or not the patient to select himself the language and / or set the
ramp time and / or pressure comfort.
� Press at the bottom of the page or
� Press to move to the next page.
3) Selection of features
� �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
Auto ON : functionality allowing to automatically start the treatment without pressing the device On/Off
button.
Humidifier: the heated humidification feature can be enabled or disabled (if water chamber included)..
Ext. : the connection of an external module can be enabled or
Notes:
• If you have changed the status of the heated humidification feature, a confirmation message appears when
you press the On/Off button. Press the right control button to confirm the change or the left control button to
cancel.
• When enabling/disabling the heated humidification feature, the pneumatic configuration is automatically
reset to the default value. If a specific calibration of the pneumatic configuration was in use, it will be replaced
with a default configuration.
� Press at the bottom of the page or
� Press to move to the next page.
DreamStar Intro, Info, Auto Clinician Manual
DreamStar™ Auto or DreamStar™ Aut
Access to the settings for the patient
� �
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
With the right or left parameter settings
button, lock
access to the parameter setting for the
patient.
Then press
menu parameter.
This menu gives you the possibility to allow or not the patient to select himself the language and / or set the
ramp time and / or pressure comfort.
at the bottom of the page or to return to the page header.
to move to the next page.
� �
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes::
With the right or left parameter settings
button, enable
feature.
Then press
menu parameter.
allowing to automatically start the treatment without pressing the device On/Off
the heated humidification feature can be enabled or disabled (if water chamber included)..
the connection of an external module can be enabled or disabled.
If you have changed the status of the heated humidification feature, a confirmation message appears when
you press the On/Off button. Press the right control button to confirm the change or the left control button to
g/disabling the heated humidification feature, the pneumatic configuration is automatically
reset to the default value. If a specific calibration of the pneumatic configuration was in use, it will be replaced
bottom of the page or to return to the page header.
to move to the next page.
en GB – 27
DreamStar™ Auto or DreamStar™ Auto Evolve
�
With the right or left parameter settings
button, lock or unlock the
access to the parameter setting for the
Then press to access the next
menu parameter.
This menu gives you the possibility to allow or not the patient to select himself the language and / or set the
�
With the right or left parameter settings
button, enable or disable the
Then press to access the next
menu parameter.
allowing to automatically start the treatment without pressing the device On/Off
the heated humidification feature can be enabled or disabled (if water chamber included)..
If you have changed the status of the heated humidification feature, a confirmation message appears when
you press the On/Off button. Press the right control button to confirm the change or the left control button to
g/disabling the heated humidification feature, the pneumatic configuration is automatically
reset to the default value. If a specific calibration of the pneumatic configuration was in use, it will be replaced
en GB – 28 DreamStar Intro, Info, Auto Clinician Manual
DreamStar™ Auto or DreamStar™ Auto Evolve
5) Patient reminders
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
For each type of reminder, you can set the frequency with which the device will set a reminder activation
date for the patient. The date will appear in the relevant menu (see Patient Manual for further information).
Filter: reminder how often the filter should be changed.
Mask: reminder how often the mask should be changed.
Service: reminder how often the device pressure should be checked.
Memory card: reminder how often the patient should download data to the memory card and return the
card to the home care provider or physician.
CAUTION
The reminder expiration date is recalculated when you change the frequency.
� Press at the bottom of the page or to return to the page header.
� Press to move to the next page.
6) Miscellaneous
� � � �
The page displays:
Press
as many times as
necessary to
access the
desired
parameter
setting.
The page changes:
Increase or decrease the
parameter value with the right or left
parameter settings button.
Then press to access the next
menu parameter.
Pressure offset: offset of the pressure sensor.
Pressure unit: the unit of measurement used for the displayed pressure can be changed from cmH2O to hPa,
and vice versa.
� Press at the bottom of the page or to return to the page header.
� Press to exit the menu.
DreamStar Intro, Info, Auto Clinician Manual
Other settings and information
General Information menu
For the DreamStar™ Intro
Press the left parameters settings button to select the
General Information menu appears.
�
The page displays:
Hour counter:
Total use:
mask.
Tot. Session Nbr.:
This page allows you to reset the total use
simultaneously and hold for 2 seconds.
The values on the total use and total sessions counters will return to zero.
Press the control button to accept
left control but
� Press to move to the next page.
�
The last session is
displayed:
Date:
Total duration:
Usage duration:
mask.
Average pressure:
Notes:
• The total use and total sessions number can be reset to zero only when the device is in standby.
• The Session page is only available if the device is in standby and if at least one session was recorded.
� Press the On/Off button to exit the menu.
DreamStar Intro, Info, Auto Clinician Manual
and information
menu
Intro or DreamStar™ Intro Evolve
parameters settings button to select the symbol on the
General Information menu appears.
Hour counter: Device operating time.
Total use: Total duration during which the patient was actually breathing in the
mask.
Tot. Session Nbr.: Number of start/stop sessions in the device memory.
This page allows you to reset the total use and total sessions number to zero. Press first
and hold for 2 seconds.
The values on the total use and total sessions counters will return to zero.
Press the control button to accept or cancel
left control button.
to move to the next page.
Date: Date of the last On/Off session.
Total duration: Total duration of the last session.
Usage duration: duration during which the patient was actually breathing in the
mask.
Average pressure: Average pressure delivered during the session.
he total use and total sessions number can be reset to zero only when the device is in standby.
available if the device is in standby and if at least one session was recorded.
to exit the menu.
en GB – 29
symbol on the standby screen: the
Total duration during which the patient was actually breathing in the
Number of start/stop sessions in the device memory.
Press first and then
The values on the total use and total sessions counters will return to zero.
this change using the right or
which the patient was actually breathing in the
Average pressure delivered during the session.
he total use and total sessions number can be reset to zero only when the device is in standby.
available if the device is in standby and if at least one session was recorded.
en GB – 30
For the DreamStar™ Info /
Press the left parameters settings button to select the
General Information menu appears.
�
The page displays:
Hour counter:
Total use:
mask.
Tot. Session Nbr.:
� Press to move to the next page.
�
The last session is
displayed:
Date:
Usage duration:
mask.
Average pressure:
Average leak:
A.H. index:
The session date and
The pages for the last 5 sessions can be displayed, from the most current to the oldest.
� Press the right control button
� Press the On/Off button to exit the menu.
Setting the Heat level
When the device is in stand-by :
� �
Press
The page displays:
� Press at the bottom of the page or
� Press to move to the next page.
DreamStar Intro, Info, Auto Clinician Manual
/ Info Evolve and DreamStar™ Auto
parameters settings button to select the symbol on the
General Information menu appears.
Hour counter: Device operating time.
Total use: Total duration during which the patient was actually breathing in the
mask.
Tot. Session Nbr.: Number of start/stop sessions in the device memory.
to move to the next page.
Date: Date and start hour of the last On/Off session.
Usage duration: duration during which the patient was actually breathing in the
mask.
Average pressure: Average pressure delivered during the session.
Average leak: Indicates the average leak, displaying OK, +, ++, +++, or ++++.
A.H. index: Index of obstructive apneas and hypopnoeas.
The session date and time are displayed in the upper right of the screen.
The pages for the last 5 sessions can be displayed, from the most current to the oldest.
to access the next page.
to exit the menu.
eat level (if water chamber included)
� �
Press
to select the
setting
The page changes:
Increase
with the right or left
parameter settings button.
at the bottom of the page or to return to the page header.
to move to the next page.
DreamStar Intro, Info, Auto Clinician Manual
Auto / Auto Evolve
symbol on the standby screen: the
Total duration during which the patient was actually breathing in the
Number of start/stop sessions in the device memory.
was actually breathing in the
Average pressure delivered during the session.
Indicates the average leak, displaying OK, +, ++, +++, or ++++.
Index of obstructive apneas and hypopnoeas.
time are displayed in the upper right of the screen.
The pages for the last 5 sessions can be displayed, from the most current to the oldest.
�
Increase or decrease
the parameter value
with the right or left
parameter settings button.
DreamStar Intro, Info, Auto Clinician Manual
When the device starts, the heated humidifier automatically turns on. The
decrease the heat level by moving
button, as shown hereafter.
Note: When the device is battery
following screen is displayed after the settings button has been pressed:
Reminders about key events
This function is identical on all devices in the
When one or several reminders are about to expire, the information access symbol
of the screen changes to the blinking envelope s
operating (pressure displayed)..
Pressing the button located opposite the symbol brings up a window with a list of the reminders involved, as
the following example shows.
� �
Press
The page displays:
Note: If you respond yes, the event reminder disappears from the display.
� Press at the bottom of the page or
�Press to exit the menu.
DreamStar Intro, Info, Auto Clinician Manual
When the device starts, the heated humidifier automatically turns on. The patient can increase
the heat level by moving the arrow at the bargraph with the right or left parameter settings
When the device is battery-powered, the heated humidification feature cannot be used
following screen is displayed after the settings button has been pressed:
Reminders about key events
is identical on all devices in the DreamStar™ product range.
When one or several reminders are about to expire, the information access symbol
of the screen changes to the blinking envelope symbol , the device being in standby (hour displayed) or
Pressing the button located opposite the symbol brings up a window with a list of the reminders involved, as
� �
Press
as many times
as necessary to
access the
desired
reminder.
The page changes:
If you respond yes, the event reminder disappears from the display.
at the bottom of the page or to return to the page header.
Indicates that the humidifier is not
functioning because it is under battery
power.
en GB – 31
patient can increase or
the right or left parameter settings
powered, the heated humidification feature cannot be used-and the
When one or several reminders are about to expire, the information access symbol in the lower left
the device being in standby (hour displayed) or
Pressing the button located opposite the symbol brings up a window with a list of the reminders involved, as
�
Answer YES or NO
with the right or left
parameter settings button.
Press to access the
next reminder.
en GB – 32 DreamStar Intro, Info, Auto Clinician Manual
Specific calibration of the pneumatic configuration
CAUTION
Since pressure performance depends on the pneumatic configuration selected, it is important to select the
correct configuration. Special configurations should be set up by skilled personnel only.
To optimise the performance of the DreamStar™ Info/Auto device (or equivalent in Evolve configuration), it
is advised to carry out a specific calibration based on the pneumatic configuration used. Set the Comfort
Calibration + on OFF and follow the procedure hereafter:
1. Confirm that the device is in standby. If it is running, stop it by holding down the On/Off button
for several seconds.
2. Set up the desired pneumatic configuration (humidifier, patient circuit, etc.) with the patient interface.
Take care to keep the patient circuit straight and the air outlet unobstructed.
3. Bring up the “Calibration” page of the Settings menu by following the settings procedure for the device
concerned.
4. Select the SPECIFIC patient circuit, enable and launch calibration.
5. Let the device calibrate itself taking care not to touch the pneumatic circuit.
6. If calibration completes correctly, the message “CALIBRATION CORRECT” will appear on the screen.
Press the right control button to confirm and exit the menu. If the message “CALIBRATION ERROR”
appears, relaunch automatic calibration or select the standard configuration.
Using a memory card
The memory card captures the most recent compliance data in the DreamStar™ product range device
memory. It also allows you to update the machine settings.
Data Backup The patient can use the external memory card to download the most recent compliance data in the device
memory by following the instructions you will provide him (see Patient Manual).
Once the data is downloaded, the patient will forward you the memory card and you will then be able to
retrieve the compliance data and analyze it using DreamStar™ Analyze software.
To do this, insert the memory card into the card reader supplied with the software, then connect the reader to
a USB port on your computer. To retrieve the compliance data, consult the DreamStar™ Analyze software user
manual.
CAUTION
Use approved memory cards only.
DreamStar Intro, Info, Auto Clinician Manual en GB – 33
Updating Settings Devices may be set following the instructions provided by the DreamStar™ Analyze software and downloaded
to the memory card. The machine settings will update automatically when the patient inserts the card into the
device for the first time.
Service card A memory card can be configured using DreamStar™ Analyze software as a "service card" to set a number of
devices to the same default values (for example, language, time zone, patient reminders). This allows you to
set the specific treatment parameters for a given type of device. To configure a "service card", consult the
DreamStar™ Analyze software user manual. To be able to use the service card with the device, hold down
the ramp button pressed while inserting the card.
en GB – 34
Cleaning and Maintenance
Please refer to the user instructions for your mask and tubing for details on their maintenance.
WARNING
Unplug the device from the power source and always detach the breathing circuit and the water chamber
from the device before cleaning them.
CAUTION
• Use for the cleaning material intended for this purpose.
• Do not use strong detergent, abrasive sponge or st
Daily
Water chamber (if included) 1. Empty the water chamber and rinse it with clean water.
2. Leave to drip dry out of direct sunlight.
Weekly
Water chamber (if included)� Disassemble the water chamber.
o Remove the water chamber from the device.
o Unlock the cover by pressing the centre tab and rotating it backwards
o Separate the upper part from the base of the water chamber.
o Empty any water remaining in the chamber.
o To remove the inner tubing
1 : Gently press the clip (
2 : Keep the clip held down while gently pulling the tubing towards you
upper part.
�
Inner tubing
Center tab
DreamStar Intro, Info, Auto Clinician Manual
Cleaning and Maintenance
Please refer to the user instructions for your mask and tubing for details on their maintenance.
Unplug the device from the power source and always detach the breathing circuit and the water chamber
from the device before cleaning them.
Use for the cleaning material intended for this purpose.
Do not use strong detergent, abrasive sponge or stiff brush.
Water chamber (if included) Empty the water chamber and rinse it with clean water.
Leave to drip dry out of direct sunlight.
Water chamber (if included) Disassemble the water chamber.
Remove the water chamber from the device.
Unlock the cover by pressing the centre tab and rotating it backwards �
Separate the upper part from the base of the water chamber.
Empty any water remaining in the chamber.
To remove the inner tubing �:
press the clip (A) to release the tubing from the locking system (
the clip held down while gently pulling the tubing towards you
�
A
B Base
Gasket
Grip zone
Upper part
DreamStar Intro, Info, Auto Clinician Manual
Please refer to the user instructions for your mask and tubing for details on their maintenance.
Unplug the device from the power source and always detach the breathing circuit and the water chamber
�.
from the locking system (B).
the clip held down while gently pulling the tubing towards you to extract it from the
DreamStar Intro, Info, Auto Clinician Manual
� Clean the various parts of the water chamber
detergent (for example 3 drops of dishwashing liquid diluted in water).
� Rinse well with water to eliminate any trace of detergent.
� Allow to dry naturally.
� Once dry, reassemble the water chamber
o Insert the inner tubing into the holes and ensure it is clipped.
o Place the upper part on the water chamber base
forward. Lock the water chamber by pushing on the grip zone.
o Fill the water chamber befo
Notes:
• The different parts of the water chamber may also be washed in a dishwasher (at 60°C maximum for 2 hours).
• To prevent growth of micro-organisms, do not allow water in the chamber to stagnate.
Washable filter:
• Pull the filter holder � towards you to remove it
• Remove the filter from the filter holder
�
• Wash the filter and the filter holder with warm water and mild
dishwashing liquid on the filter and the filter holder, then rub…)
• Rinse well to eliminate any trace of detergent.
• Allow to dry:
o Pad the filter dry using a clean absorbent towel, then allow it to dry thoroughly naturally.
o Allow the filter holder to dry naturally.
• Once dry, place the filter into the filter holder, then the assembly at the back of the device. Do not use
a filter which is not completely dry.
• Reinstall the cover or the water chamber.
Filter holder
DreamStar Intro, Info, Auto Clinician Manual
Clean the various parts of the water chamber � with warm water and mild
detergent (for example 3 drops of dishwashing liquid diluted in water).
Rinse well with water to eliminate any trace of detergent.
Once dry, reassemble the water chamber
Insert the inner tubing into the holes and ensure it is clipped.
Place the upper part on the water chamber base � and tilt it
Lock the water chamber by pushing on the grip zone.
Fill the water chamber before replacing it into the device.
The different parts of the water chamber may also be washed in a dishwasher (at 60°C maximum for 2 hours).
organisms, do not allow water in the chamber to stagnate.
towards you to remove it �.
Remove the filter from the filter holder �.
�
Wash the filter and the filter holder with warm water and mild detergent (for example one drop of
dishwashing liquid on the filter and the filter holder, then rub…)
Rinse well to eliminate any trace of detergent.
Pad the filter dry using a clean absorbent towel, then allow it to dry thoroughly naturally.
Allow the filter holder to dry naturally.
Once dry, place the filter into the filter holder, then the assembly at the back of the device. Do not use
a filter which is not completely dry.
Reinstall the cover or the water chamber.
Filter holder
en GB – 35
�
�
The different parts of the water chamber may also be washed in a dishwasher (at 60°C maximum for 2 hours).
organisms, do not allow water in the chamber to stagnate.
�
detergent (for example one drop of
Pad the filter dry using a clean absorbent towel, then allow it to dry thoroughly naturally.
Once dry, place the filter into the filter holder, then the assembly at the back of the device. Do not use
Filter
holder
Filter
en GB – 36 DreamStar Intro, Info, Auto Clinician Manual
Monthly
Device
• Clean the outside of the unit using a damp tissue (cloth, paper towel) with a little water and one drop of
mild detergent.
• Eliminate any trace of detergent in repeating this operation with a new tissue (cloth, paper towel)
moistened with water only.
• Wipe the device thoroughly using a dry tissue (cloth, paper towel).
Air intake filters:
• The high-efficiency filter, which is offered as an option, cannot be washed. It must be changed once a
month or more frequently if visibly dirty.
• Change the filters systematically, as soon as they are torn or soiled or when the device displays a
reminder to do so.
Water chamber (if included):
• After the water chamber has been disassembled and cleaned, you can let it soak for 15 minutes in a
solution of 1 part white vinegar to 9 parts water.
• Rinse well with water to eliminate any trace of vinegar.
• Allow to dry naturally.
WARNINGS
• Do not use spray detergent. Harmful product residue could enter the air outlet, the air intake filter, or
the device interior, causing airway irritation.
• Never use bleach at a concentration higher than 0.1%. For example: pour 200 ml of 2,6 % bleach into
5 liters of cold water.
• Never use the device without making sure that an air intake filter is installed.
• Check that the heating element is completely dry before reconnecting the device to the power supply.
DreamStar Intro, Info, Auto Clinician Manual en GB – 37
Material Disinfection
Refer to the instructions for use of the chemicals used to respect dilutions and quantities of products,
contact time, wearing of personal protective equipment.
Surface disinfection of the device
Disinfection of the outside of the machine is carried out using disinfectant detergent product.
• If using spray or disinfectant detergent foam:
o Pulverize the product on a single use non-woven support.
o Wipe the outside of the device with this support and let dry.
• If using disinfectant detergent towels:
o Wipe the outside of the device and let dry.
Water chamber disinfection procedure (if included)
• Disassemble the chamber completely.
• Pre-disinfection:
o Completely immerse the parts of the chamber in the pre-disinfecting solution diluted according
to the instructions recommended by the pre-disinfecting product manufacturer.
o Also, follow the recommended soaking time and if necessary, brush using a soft brush.
o Rinse all the parts of the chamber thoroughly and copiously with running water.
• Cleaning:
o Prepare a dip tank containing water and a mild detergent (for example using 5 to 10 ml of
dishwashing liquid diluted in 5 l of water).
o Clean the chamber parts in the detergent solution, and if necessary, brush using a soft brush
o Rinse the different parts of the chamber thoroughly and copiously with running water.
o Remove excess water by shaking slightly.
• Disinfection:
o Prepare a new dip tank containing water and a disinfecting product.
o Follow the same steps as the pre-disinfection.
• Drying :
o Allow to dry naturally.
• Storage :
o Reassemble the water chamber.
o Keep the disinfected and dried water chamber in a single use clean bag, sealed until a new use.
Note : Discard the water chamber if showing any damage and replace it with a new one.
en GB – 38 DreamStar Intro, Info, Auto Clinician Manual
What should not be used
• Never use abrasive cleaners or highly alkaline, acetone, benzene, leaded gasoline to clean the device.
• Do not use any support like sponge- with scraper or stiff brush.
• Never use any pre-disinfecting or disinfecting product containing aldehydes and/or its derivatives:
formaldehyde, glutaraldehyde, etc.
• Do not use any pre-disinfecting or disinfecting product not active on the Mycobacterium tuberculosis
(BK).
• Never disinfect the internal circuit of air flow using disinfecting product or with a Airway Surface
Disinfection System (DSVA).
DreamStar Intro, Info, Auto Clinician Manual en GB – 39
Troubleshooting tips
Device Messages
Message Description Corrective action
MASK UNPLUGGED is
displayed on the screen.
Large leak
detected.
Check the connections between the mask, the
patient circuit and the device. This message
disappears when the patient breaths in the mask
well reconnected or when the On/Off button
or the ramp button is pressed.
LEAK : ++ (or +++ or ++++) is
displayed on the screen.
The device detects
a high level of leak.
Adjust the mask, mask cushion and/or harness until
you have a good mask-fit. The leak level must
decrease until the screen displays LEAK : OK.
If the error persists, contact Technical Support.
The symbol blinks
alternately with the error code
at the centre of the display.
The device has
detected an
operating error.
See table entitled, “Error Messages”.
The symbol blinks
alternately with the error code
at the centre of the heat level
page.
The device has
detected a
humidifier
operating error.
See errors 100-105 in the table entitled, “Error
Messages”.
Error Messages
Code Description Corrective action
Er 01 Patient settings
problem.
Reinitialize the default settings by holding down the right control button
for 2 seconds. The blinking “DEF?” message will appear. Accept by pressing
the On/Off button. The device is now set to the default values and can be
reset to the desired values.
If the error persists, contact Technical Support.
Er 02 High motor
temperature.
Unplug the device from all sources of electrical power. Ensure air intake
filter is clean. Allow it to cool and plug it in again carefully following the use
instructions.
If the error persists, contact Technical Support.
Er 03 Program battery
overflow (on
DreamStar™ Info/Info
Evolve and
DreamStar™
Auto/Auto Evolve)
Unplug the machine from all electrical power. Plug it in again.
If the error recurs, return the machine to a technical service centre.
Er 04 High pressure. Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
Er 06 CheckSum code error. Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
en GB – 40 DreamStar Intro, Info, Auto Clinician Manual
Code Description Corrective action
Er 07 Turbine problem. Unplug the device from all sources of electrical power. Check that there is
no foreign object or signs of water in the air outlet. Plug in the machine
again and turn on.
If the error persists, contact Technical Support.
Er 08 Voltage problem. Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
Er 09 Language CheckSum
error (on DreamStar™
Info / Info Evolve and
DreamStar™ Auto /
Auto Evolve).
Unplug the machine from all electrical power. Plug it in again.
If the error recurs, return the machine to a technical service centre.
Er 10 Machine settings
problem.
Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
Er 11 High current
consumption.
Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
Er 12 Device memory is
empty.
Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
Er 13 I²C bus communication
error.
Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
Er 14 SPI bus communication
error. (on DreamStar™
Intro / Intro Evolve).
Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
Er 100 Bad humidifier setting. The device is operating without employing the heated humidification
feature.
Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
Er 101 Humidifier
temperature problem.
The device is operating without employing the heated humidification
feature.
Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
Er 102 Humidifier current too
high.
The device is operating without employing the heated humidification
feature.
Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
DreamStar Intro, Info, Auto Clinician Manual en GB – 41
Code Description Corrective action
Er 103 Humidifier current too
low.
The device is operating without employing the heated humidification
feature.
Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
Er 104 Lack of communication
from the humidifier to
the device.
The device is operating without employing the heated humidification
feature.
Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
Er 105 Communication
problem between the
humidifier and the
device.
The device is operating without employing the heated humidification
feature.
Unplug the device from all sources of electrical power. Plug it in again and
turn on.
If the error persists, contact Technical Support.
en GB – 42 DreamStar Intro, Info, Auto Clinician Manual
Technical Specifications
DreamStar™ device Performance
Device pressure range: 4 cmH2O to 20 cmH2O
Device adjustable in increments of 0.5 cmH2O
Maximum steady limiting pressure at the patient
connection port under single fault condition:
30 cmH2O
Maximum pressure that can be set: 20 cmH2O
Ramp duration: 0 to 45 minutes ± 1 minute
Device adjustable in increments of 5 minutes.
Sound pressure level measured in accordance with
NF EN ISO 17510-1 : 2002:
26 dBA with humidifier
30 dBA without humidifier
Sound pressure level measured in accordance
with NF EN ISO 17510-1:2007:
30 dBA with humidifier
33 dBA without humidifier
Battery life of mainboard: 5 years
Patient-side connection aperture: Conical connector 22 mm diameter.
Air intake filter efficiency: Optional high-efficiency filter.
Disposable fabric HEPA paper, which is 90% effective
for particles > 3 microns.
High Density Foam (reusable) and is 90% effective with
particles > 20 microns.
Values determined under ATPD (Ambient Temperature and Pressure, Dry) conditions.
Integrated Humidifier performance
Humidification rate: > 10 mg H2O/l at the maximum setting for a leak flow
< 60 l/min
Heating time: < 45 minutes
Pressure loss as a function of flow: 0.59 cmH2O at 1 l/sec
0.73 cmH2O at 1 l/sec with swivel outlet elbow
Compliance of the water chamber : 14.2 ml/kPa (chamber empty)
12.2 ml/kPa (chamber full)
Maximum service pressure: 20 cmH2O
Maximum gas temperature delivered from patient
tubing:
43°C (109.4°F)
Values determined under ATPD (Ambient Temperature and Pressure, Dry) conditions.
Operating conditions for the device and humidifier
Pressure range: 730 hPa to 1060 hPa
Temperature: +5 °C to + 40 °C (41 ºF to 104 ºF) without humidifier
+5° C to + 35 °C (41 ºF to 95 ºF) with humidifier
Relative humidity: between 10% and 95% without condensation
Altitude range: 0 − 2 700 m (0−9,000 ft) approximately
DreamStar Intro, Info, Auto Clinician Manual en GB – 43
Transportation and storage conditions
Pressure range: 500 hPa to 1060 hPa
Temperature: -20°C to +60°C (-4 °F to +140 °F)
Relative humidity: Up to 95% without condensation
Device electrical characteristics
Universal internal electrical power with the detachable electrical power cord (which varies by country).
Input voltage (auto-ranging): 100 - 240 VAC (-15%, +10%), at 50 or 60Hz
Maximum power consumption: 100VA at maximum setting.*
Current consumed at 20cmH2O with a 4mm leak: 130 mA eff. at 230 VAC
DC power supply (13 V) Voltage range allowed: 13V (-15%, +25%).
*Power consumption is based on the type of model. The DreamStar™ Auto™ Evolve with heated humidification
enabled is the highest-consumption device.
Physical characteristics
Dimensions (D x W x H): 200 x 230 x 120 mm (7.8 x 9.0 x 4.7 in) approximately
with water chamber
Carrying case Dimensions (D x W x H): 260 x 350 x 150 mm (10.2 x 13.7 x 5.9 in)
approximately
Weight: 1.5 kg (3.3 lbs) approximately with water chamber
1.4 kg (3.1 lbs) approximately with cover
Operational volume (minimal gas volume in water
chamber):
811 ml
Useful volume of water chamber: 300 ml
Maximum liquid fill level: Indicated on water chamber
CE marking
DreamStar™ Intro, DreamStar™ Intro Evolve : 2011
DreamStar™ Info, DreamStar™ Info Evolve : 2011
DreamStar™ Auto, DreamStar™ Auto Evolve : 2011.
en GB – 44
Symbols on the device
Symbol Description
Symbol of On/Off button.
Symbol of Left control button.
Device protected against solid objects
up to 12 mm and against vertically
falling drops of water.
Class II device.
DC power supply.
Refer to the user manual.
Device complies with the requirements
of European Directive 93/42/EC on
medical devices.
On packaging: this icon means “Storage
temperature limit”.
Temperature range:
(-4 °F to +140 °F)
On packaging: this icon means “Fragile”,
as the package needs to be handled
with care.
Standards Compliance
Risks pertaining to this medical equipment were assessed in accordance with the ISO 14971:2007 standard,
specifically with reference to global residual risk.
DreamStar™ devices comply with the following standards:
• CEI 60601-1:2005 + AC1:2006 + AC2:2007 + Amd1:20
requirements for basic safety and essential performance.
• CEI 60 601-1-2:2007: Medical electrical equipment. Part 1: General requirements for safety.
standard: Electromagnetic compatibility
• EN ISO 17510-1:2009: Sleep Apnoea Breathing Therapy Devices.
• EN ISO 8185:2009: Respiratory tract humidifiers for medical use
respiratory humidification systems.
• Directive 93/42/EC of the Council concerning
• Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of
certain hazardous substances in electrical and electronic equipment (RoHS).
• Directive 2012/19/EU of the European Parliament and of the Council on waste electrical and electronic
equipment (WEEE).
DreamStar Intro, Info, Auto
Symbols on the device
Symbol Description
button.
Symbol of Ramp and selection button.
Symbol of Left control button.
Symbol of Right control button.
Device protected against solid objects
up to 12 mm and against vertically
falling drops of water.
Waste device to be eliminated
separately from the household waste.
For further information, refer to the
paragraph "Disposing of the device at
the end of its life
Type BF device.
Recording and play back.
Refer to the user manual.
Specific warning.
Device complies with the requirements
Directive 93/42/EC on
On packaging this symbols means,
"atmospheric pressure limit".
On packaging: this icon means “Storage
Temperature range: -20°C to +60°C
On packaging this symbols means,
"relative humidity limit ".
On packaging: this icon means “Fragile”,
as the package needs to be handled
On packaging: this icon means “Keep
dry”, as the package needs to be
protected against moisture and water.
Standards Compliance
pertaining to this medical equipment were assessed in accordance with the ISO 14971:2007 standard,
specifically with reference to global residual risk.
comply with the following standards:
+ AC1:2006 + AC2:2007 + Amd1:2012: Medical electrical equipment. Part 1: General
requirements for basic safety and essential performance.
2:2007: Medical electrical equipment. Part 1: General requirements for safety.
standard: Electromagnetic compatibility – Requirements and tests.
: Sleep Apnoea Breathing Therapy Devices.
: Respiratory tract humidifiers for medical use -- Particular requirements for
respiratory humidification systems.
of the Council concerning medical devices.
of the European Parliament and of the Council on the restriction of the use of
certain hazardous substances in electrical and electronic equipment (RoHS).
of the European Parliament and of the Council on waste electrical and electronic
DreamStar Intro, Info, Auto Clinician Manual
Symbol of Ramp and selection button.
Right control button.
Waste device to be eliminated
separately from the household waste.
For further information, refer to the
Disposing of the device at
the end of its life", page 45.
Type BF device.
Recording and play back.
Specific warning.
On packaging this symbols means,
"atmospheric pressure limit".
On packaging this symbols means,
"relative humidity limit ".
On packaging: this icon means “Keep
dry”, as the package needs to be
protected against moisture and water.
pertaining to this medical equipment were assessed in accordance with the ISO 14971:2007 standard,
Medical electrical equipment. Part 1: General
2:2007: Medical electrical equipment. Part 1: General requirements for safety. Collateral
Particular requirements for
of the European Parliament and of the Council on the restriction of the use of
of the European Parliament and of the Council on waste electrical and electronic
DreamStar Intro, Info, Auto Clinician Manual en GB – 45
Disposing of the device at the end of its life
In European Union this device has to be considered as an electrical and electronic piece of equipment as
defined in Directive 2012/19/EU, and must be collected and processed separately from household waste for
disposal as indicated by the symbol of the crossed out garbage bin (see "Symbols on the device" page 44).
In other countries, this device must be processed following local regulation.
Unsuitable disposal of the device at the end of its life could harm the environment.
en GB – 46 DreamStar Intro, Info, Auto Clinician Manual
NF EN ISO 17510-1:2007-compliant features
Using the DreamStar™ Intro and DreamStar™ Intro Evolve
Static pressure stability at 10 cmH2O
(Long-term accuracy according to ISO 17510-1:2007, Appendix BB.1)
Without humidifier With humidifier
Pressure accuracy +/- 0,6 cmH2O +/- 0,6 cmH2O
Dynamic pressure stability
(Short-term accuracy according to ISO 17510-1:2007, Appendix BB.2)
With tubing 22 mm
diameter
Test pressure (cmH2O)
4 8 12 16 20
Respiratory rate
Resp./min
Respiratory rate
Resp./min
Respiratory rate
Resp./min
Respiratory rate
Resp./min
Respiratory rate
Resp./min 10 15 20 10 15 20 10 15 20 10 15 20 10 15 20
Without humidifier:
Delta relative to highest
pressure (cmH2O) 0.35 0.37 0.30 0.33 0.37 0.41 0.32 0.33 0.39 0.29 0.33 0.38 0.30 0.30 0.36
Delta relative to lowest
pressure (cmH2O) -0.11 -0.05 0.11 0.01 0.04 0.12 0.12 0.15 0.23 0.23 0.24 0.30 0.34 0.35 0.38
Delta relative to dynamic
pressure (cmH2O) 0.07 0.06 0.09 0.07 0.12 0.12 0.15 0.13 0.19 0.18 0.20 0.24 0.20 0.25 0.36
With humidifier:
Delta relative to highest
pressure (cmH2O) 0.35 0.39 0.43 0.33 0.37 0.43 0.31 0.34 0.39 0.30 0.34 0.38 0.31 0.30 0.23
Delta relative to lowest
pressure (cmH2O) 0.00 0.08 0.21 0.15 0.24 0.34 0.30 0.39 0.49 0.44 0.53 0.62 0.56 0.71 0.99
Delta relative to dynamic
pressure (cmH2O) 0.07 0.10 0.10 0.13 0.14 0.17 0.20 0.26 0.35 0.25 0.39 0.27 0.35 0.43 0.41
Maximum flow
(According to ISO 17510-1:2007, Appendix CC.1)
Test pressure (cmH2O)
4 8 12 16 20 Maximum flow (l/min)
provoking a pressure
drop of 1 cmH2O at the
opening of the patient
side connection
Without humidifier >130 160 160 160 160
With humidifier 80 80 80 80 80
Sound pressure measured in accordance with ISO 17510-1:2009:
30 dBA with humidifier, 33 dBA without humidifier
Sound power measured in accordance with ISO 17510-1:2009:
38 dBA with humidifier, 41 dBA without humidifier
DreamStar Intro, Info, Auto Clinician Manual en GB – 47
Using the DreamStar™ Info, DreamStar™ Auto, DreamStar™ Info Evolve and
DreamStar™ Auto Evolve
Static pressure stability at 10 cmH2O
(Long-term accuracy according to ISO 17510-1:2007, Appendix BB.1)
Without humidifier With humidifier
Pressure accuracy +/- 0.5 cmH2O +/- 0.5 cmH2O
Dynamic pressure stability
(Short-term accuracy according to ISO 17510-1:2007, Appendix BB.2)
With humidifier
Test pressure (cmH2O)
4 8 12 16 20
Respiratory rate
Resp./min
Respiratory rate
Resp./min
Respiratory rate
Resp./min
Respiratory rate
Resp./min
Respiratory rate
Resp./min 10 15 20 10 15 20 10 15 20 10 15 20 10 15 20
Tubing 22 mm diameter:
Delta relative to highest
pressure (cmH2O)
0.12 0.18 0.23 0.18 0.21 0.28 0.23 0.25 0.30 0.27 0.28 0.34 0.30 0.35 0.37
Delta relative to lowest
pressure (cmH2O)
0.13 0.15 0.23 0.18 0.22 0.28 0.25 0.28 0.30 0.35 0.38 0.41 0.44 0.46 0.41
Delta relative to dynamic
pressure (cmH2O)
0.06 0.06 0.08 0.14 0.17 0.19 0.19 0.24 0.23 0.28 0.30 0.35 0.34 0.41 0.32
Tubing 15 mm diameter:
Delta relative to highest
pressure (cmH2O) 0.22 0.29 0.37 0.55 0.54 0.74 0.70 0.73 0.90 0.81 0.83 1.01 0.92 1.02 1.13
Delta relative to lowest
pressure (cmH2O) 0.08 0.17 0.29 -0.19 0.04 0.02 -0.26 -0.14 -0.07 -0.29 -0.15 -0.07 -0.32 -0.22 -0.08
Delta relative to dynamic
pressure (cmH2O) 0.05 0.05 0.05 0.05 0.09 0.08 0.07 0.12 0.13 0.07 0.14 0.15 0.11 0.16 0.15
Tubing 15 mm diameter and high-efficiency filter:
Delta relative to highest
pressure (cmH2O) 0.25 0.28 0.39 0.59 0.67 0.75 0.74 0.83 0.92 0.83 0.90 1.05 0.89 0.99 1.14
Delta relative to lowest
pressure (cmH2O) 0.05 0.04 0.26 -0.27 -0.13 0.01 -0.30 -0.22 -0.06 -0.31 -0.20 -0.08 -0.28 -0.25 -0.08
Delta relative to dynamic
pressure (cmH2O) 0.04 0.04 0.06 0.06 0.07 0.09 0.08 0.11 0.12 0.09 0.12 0.15 0.13 0.15 0.16
en GB – 48 DreamStar Intro, Info, Auto Clinician Manual
Without humidifier
Test pressure (cmH2O)
4 8 12 16 20
Respiratory rate
Resp./min
Respiratory rate
Resp./min
Respiratory rate
Resp./min
Respiratory rate
Resp./min
Respiratory rate
Resp./min 10 15 20 10 15 20 10 15 20 10 15 20 10 15 20
Tubing 22 mm diameter:
Delta relative to highest
pressure (cmH2O) 0.10 0.18 0.23 0.15 0.23 0.28 0.18 0.29 0.31 0.22 0.32 0.36 0.24 0.33 0.34
Delta relative to lowest
pressure (cmH2O) 0.13 0.14 0.20 0.16 0.18 0.23 0.23 0.22 0.28 0.30 0.28 0.35 0.38 0.35 0.41
Delta relative to dynamic
pressure (cmH2O) 0.06 0.05 0.06 0.08 0.12 0.11 0.11 0.16 0.16 0.19 0.21 0.22 0.20 0.24 0.26
Tubing 15 mm diameter:
Delta relative to highest
pressure (cmH2O) 0.18 0.27 0.39 0.49 0.50 0.79 0.71 0.66 0.98 0.79 0.80 1.02 0.92 0.89 1.12
Delta relative to lowest
pressure (cmH2O) 0.12 0.16 0.21 0.04 -0.05 -0.04 -0.20 -0.15 -0.13 -0.14 -0.03 -0.06 -0.14 0.01 -0.02
Delta relative to dynamic
pressure (cmH2O) 0.06 0.09 0.09 0.09 0.19 0.17 0.20 0.22 0.30 0.38 0.39 0.47 0.34 0.53 0.59
Maximum flow
(According to ISO 17510-1:2007, Appendix CC.1)
Test pressure (cmH2O)
4 8 12 16 20
With humidifier:
Maximum flow (l/min)
provoking a pressure drop of
1 cmH2O at the opening of the
patient side connection
Tubing 22 mm diameter >130 180 180 180 180
Tubing 15 mm diameter >120 160 160 150 130
Tubing 15 mm diameter
and high-efficiency filter >120 160 150 140 120
Without humidifier:
Maximum flow (l/min)
provoking a pressure drop of
1 cmH2O at the opening of the
patient side connection
Tubing 22 mm diameter >130 200 200 200 200
Tubing 15 mm diameter >120 170 170 150 150
Sound pressure measured in accordance with ISO 17510-1:2009:
30 dBA with humidifier, 33 dBA without humidifier
Sound power measured in accordance with ISO 17510-1:2009:
38 dBA with humidifier, 41 dBA without humidifier
DreamStar Intro, Info, Auto Clinician Manual en GB – 49
Functional pneumatic block diagram
* except DreamStar™ Intro or DreamStar™ Intro Evolve
en GB – 50 DreamStar Intro, Info, Auto Clinician Manual
Essential performance requirements for electromagnetic
compatibility
During the electromagnetic compatibility tests, the device saved its settings and the value of the pressure
delivered remained at the set pressure ± 0.5 cm H2O.
The device was occasionally disturbed and it recovered a normal operation after disruption.
Electromagnetic emissions
DreamStar™ product range devices are intended for use in the electromagnetic environment specified below.
The customer or the user of a device from DreamStar™ product range should ensure that it is used in such an
environment.
Emission test Conformity Recommended electromagnetic environment
RF emissions
CISPR 11 Group 1
DreamStar™ product range devices uses RF energy only for
its internal operations. Therefore its RF emissions are very
low and cannot be assumed to interfere with nearby
electronic equipment.
RF emissions
CISPR 11 Class B
DreamStar™ product range devices are suitable for use in all
establishments including domestic establishments and those
directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations
/ flicker emissions
IEC 61000-3-3
Complies
Electromagnetic Immunity
DreamStar™ product range devices are intended for use in the electromagnetic environment specified below. The
customer or the user of a device from DreamStar™ product range should assure that it is used in such an
environment.
Immunity test Test level
IEC 60601 Compliance level Recommended electromagnetic environment
Electro-static
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input /
output lines
± 2 kV for power
supply lines
± 1 kV for input /
output lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV lines / lines
± 2 kV lines/earth
± 1 kV lines / lines
± 2 kV lines/earth Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
< 5% UT
(>95% dip in UT)
for 0.5 cycles
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(>95% dip in UT)
for 5 s
< 5% UT
(>95% dip in UT)
for 0.5 cycles
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(>95% dip in UT)
for 5 s
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the device from DreamStar™
product range requires continued operation
during power mains, it is recommended that
the device from DreamStar™ product range
be powered from an uninterruptible power
supply or a battery.
DreamStar Intro, Info, Auto Clinician Manual en GB – 51
Electromagnetic Immunity (continued)°
Magnetic fields in
the Power Supply
Frequencies (50/60
Hz)
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Note: UT is the AC mains voltage prior to application of the test level
Electromagnetic Immunity - conducted and radiated RF
DreamStar™ product range devices are intended for use in the electromagnetic environment specified below. The
customer or the user of the device from DreamStar™ product range should assure that it is used in such an
environment.
Immunity test IEC 60601
test level Compliance level Recommended electromagnetic environment
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80
MHz
3 Vrms
150 kHz to 80
MHz
Portable and mobile RF communications
equipment should not be used in
proximity to any part of the device from
the DreamStar™ product range, including
cables.
Recommended separation distance :
d = 1.2√P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance in meters (m).
Fields strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less
than the compliance level in each frequency rangeb.
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the highest frequency range applies
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which a
device from DreamStar™ product range is used exceeds the applicable RF compliance level above, the device
from DreamStar™ product range should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the device from
DreamStar™ product range. (b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V / m.
en GB – 52 DreamStar Intro, Info, Auto Clinician Manual
Recommended separation distance between portable and mobile RF communications equipment and a
device from the DreamStar™ product range
The DreamStar™ product range are designed to be used in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or user of a device from the DreamStar™ product range can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the device from the DreamStar™ product range as recommended below, according to
the maximum power of the communications equipment.
Rated maximum
output power of
transmitter
(W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2.5 GHz
d = 2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance of the highest frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
Compliant cables
Warning
The use of accessories and cables other than those specified, may result in increased emissions or decreased immunity
of the DreamStar™ product range devices.
Ref.: M-214831-10
Mini USB 2 m cable (except with DreamStar™ Intro)
6.5 ft (2m)
Ref.: M-214831-11
RS 232/mini USB 2 m cable (except with DreamStar™
Intro)
6.5 ft (2m)
Ref.: M-214831-12
RS 232/mini USB 15 m cable (except with
DreamStar™ Intro)
50 ft (15m)
Manufacturer: Manufacturing plant:
0459
SEFAM
144 AV CHARLES DE GAULLE
92200 NEUILLY SUR SEINE
FRANCE
SEFAM
10 ALLEE PELLETIER DOISY
54600 VILLERS-LES-NANCY
FRANCE
: M-155DFU00-60 Revision 8
2015-11