SEFAM DreamStar Auto, DreamStar Info User Manual
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Clinician and Home Care Provider
User Manual
DreamStar™ Product Range
DreamStar™ Intro
DreamStar™ Info
DreamStar™ Auto
DreamStar™ is a brand registered by SEFAM.
Upgradeable Humidifier Option
DreamStar™ Intro Evolve
DreamStar™ Info Evolve
DreamStar™ Auto Evolve
Manufacturer:
SEFAM
144 AV CHARLES DE GAULLE
92200 NEUILLY SUR SEINE
FRANCE
Manufacturing plant and technical agency:
SEFAM
10 ALLEE PELLETIER DOISY
54600 VILLERS-LES-NANCY
FRANCE
TEL: +33 (0) 3 83 44 85 00 www.
sefam-medical.com
en GB – 2 DreamStar Intro, Info, Auto Clinician Manual
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
DreamStar Intro, Info, Auto Clinician Manual en GB – 3
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. en GB – 4 DreamStar Intro, Info, Auto Clinician Manual
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 cmH
2
O and, under certain fault conditions, static pressures up to 30 cmH
2
O 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 rebreathing of CO
2
. When a facial mask is necessary, always use a mask which is equipped with an antiasphyxia valve.
DreamStar Intro, Info, Auto Clinician Manual en GB – 5
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 cmH
2
O.
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 pressed. Otherwise, the device will stop after 30 minutes.
or the ramp button is
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. en GB – 6 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
Time ramp
for a gradual rise in pressure to help the patient go to sleep. When it is programmed (ramp time
≠
0), it will be automatically activated at the beginning of the session at comfort pressure. increases to treatment pressure.
Ramp feature in CPAP mode en GB – 7
Indexed Ramp
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 which indicate that the patient is asleep.
automatically stop. en GB – 8
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:
IFL: device operating time (ON/OFF).
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 ramp time: 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.
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:
Session:
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. 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.
DreamStar Intro, Info, Auto Clinician Manual en GB – 9
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
Operating mode CPAP
Display
AUTO
Default
AUTO
Parameters that can be set on the devices in CPAP mode:
Parameter Minimum value Maximum value Default value Increment
Set pressure
Comfort pressure
Ramp time
4 cmH
2
O
4 cmH
2
O
0 min
20 cmH
2
O
Prescribed pressure
Maximum ramp time
8 cmH
2
O
4 cmH
2
O
15 min
0.5 cmH
2
O
0.5 cmH
2
O
5 min
Maximum ramp time
Heat level (if water chamber included)
0 min
0
45 min
10
45 min
1
5 min
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 cmH
2
O 0.5 cmH
2
O 4 cmH
2
O Maximum set pressure
Minimum pressure Maximum pressure 10 cmH
2
O 0.5 cmH
2
O Maximum pressure on apnea command.
Maximum pressure 20 cmH
2
O 0.5 cmH
2
O
Minimum pressure
Ramp time (if time ramp selected)
Maximum ramp time
Heat level (if water chamber included)
4 cmH
2
O or minimum pressure
4 cmH
2
O
20 cmH
2
O
20 cmH
2
O or maximum pressure
0 min Maximum ramp time
0 min
0
45 min
10
4 cmH
2
O
15 min
45 min
1
0.5 cmH
5 min
5 min
1
2
O
Parameter
Pressure decrease: SLOW
Display
FAST
Default
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 . en GB – 10 DreamStar Intro, Info, Auto Clinician Manual
Note: When the heat level is set at 10, filled to the maximum fill line allows at least 8
. The rate of water evaporation depends on several factors such as environment, leak
Feature
Humidifier equipped with a cover ).
Pressure Alter
(in CPAP mode)
Mask reminder
Filter reminder
Service reminder
Memory card reminder
Feature enabled
Frequency
(increment of 1)
Frequency
(increment of 1)
Frequency
(increment of 1)
Frequency
(increment of 1)
0
0
0
0
Default
0
0
0
0
Comfort Calibration + patient
Ramp feature
(continuously)
Command on Inspiratory Flow Limit (on DreamStar™
CPAP mode)
Auto ON
(during the ramp)
(autorised)
(autorised)
(autorised)
Ramp type
Time ramp
(T.Ramp)
(locked) locked) locked)
Default
Indexed ramp
(I.Ramp) en GB – 11
Configuration of the devices depending on the accessories used:
Accessory used Patient circuit
Pneumatic calibration
(Settings menu)
Humidifier feature
(Service menu)
L. 1.80 m diam. 15 mm Ø15mm
Cover L. 1.80 m diam. 22 mm Ø22mm
Other SPECIFIC
L. 1.80 m diam. 15 mm Ø15mm+HH
Water chamber 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“). en GB – 12 DreamStar Intro, Info, Auto Clinician Manual
Symbol Symbol with heat.
Description can be changed.
Feature enabled.
YES.
C
Evolve device. recorded.
LEAK changed.
NO.
A menu.
DD/MM/YYYY is not operational.
For settings specific to the DreamStar™ or DreamStar™ Intro Evolve device, see "How to set
For settings specific to the DreamStar™ or DreamStar™ Info Evolve device, see "How to set
For settings specific to the DreamStar™ or DreamStar™ Auto Evolve device, see "How to set en GB – 13
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. and Access of some settings is limited to the medical team only. For that, press the left control button 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 disabled.
symbol indicates that the Pressure Alter feature is enabled, and the symbol indicates that it is
Settings menu
To access the Settings menu, press the left control button the bottom left of the screen: to select the symbol displayed at
The page displays: Press The page changes: as many times as necessary to access the desired parameter setting.
Increase parameter value with the right or left parameter settings button.
Then press
or decrease menu parameter.
the
to access the next
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 cmH
2
O.
Press to return to the page header.
Press
at the bottom of the page or
to move to the next page.
en GB – 14 DreamStar Intro, Info, Auto Clinician Manual
DreamStar™ Intro or DreamStar™ Intro Evolve
The page displays: Press The page changes: as many times as necessary to access the desired parameter setting.
Increase parameter value with the right or left parameter settings button.
Then press
or decrease menu parameter.
the
to access the next
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 the bottom right of the screen:
to select the symbol displayed at
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 menu parameter.
to access the next
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.
to move to the next page. Press
DreamStar Intro, Info, Auto Clinician Manual en GB – 15
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.
Press at the bottom of the page or
The page changes:
Increase or decrease the parameter value with the right or left parameter settings button.
Then press menu parameter.
to access the next
to return to the page header.
Press to move to the next page.
3) Patient reminders
The page displays: Press The page changes: as many times as necessary to access the desired parameter setting.
Increase parameter value with the right or left parameter settings button.
Then press
or decrease menu parameter.
the
to access the next
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. en GB – 16 DreamStar Intro, Info, Auto Clinician Manual
DreamStar™ Intro or DreamStar™ Intro Evolve
4) Other features
The page displays: Press The page changes: as many times as necessary to access the desired parameter setting.
Pressure offset: offset of the pressure sensor.
Increase or decrease the parameter value with the right or left parameter settings button.
Then press menu parameter.
to access the next
Pressure unit: the unit of measurement used for the displayed pressure can be changed from cmH
2
O to hPa, and vice versa.
Humidifier: the heated humidification feature can be enabled included).
or disabled (if water chamber
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.
DreamStar Intro, Info, Auto Clinician Manual en GB – 17
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. and Access of some settings is limited to the medical team only. For that, press the left control button 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 disabled.
symbol indicates that the Pressure Alter feature is enabled, and the symbol indicates that it is
Settings menu
To access the Settings menu, press the left control button the bottom left of the screen: to select the symbol displayed at
The page displays: Press The page changes: as many times as necessary to access the desired parameter setting.
Increase the parameter value with the right or left parameter settings button.
Then press
or decrease menu parameter.
to access the next
Prescribed P.: Level of pressure prescribed.
Pressure Alter: Feature that can be enabled to allow the patient to adjust the prescribed pressure
±
1 cmH
2
O.
Press at the bottom of the page or to return to the page header.
Press to move to the next page. en GB – 18 DreamStar Intro, Info, Auto Clinician Manual
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 menu parameter.
to access the next
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 menu parameter.
to access the next
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.
DreamStar Intro, Info, Auto Clinician Manual en GB – 19
DreamStar™ Info or DreamStar™ Info Evolve
Service menu
To access the Service menu, press the left control button the bottom right of the screen:
to select the symbol displayed at
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 menu parameter.
to access the next
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 The page changes: as many times as necessary to access the desired parameter setting.
Note: The date can be set only when the device is in standby.
Press at the bottom of the page or
Increase parameter value with the right or left parameter settings button.
Then press
to return to the page header.
or decrease menu parameter.
the
to access the next
Press to move to the next page. en GB – 20 DreamStar Intro, Info, Auto Clinician Manual
3) Access to the settings for the patient
The page displays: The page changes: button, lock or unlock for the setting.
to access the next
This menu gives you the possibility to allow or not the patient to select himself the language and / or set the
Press
Press to move to the next page.
4) Selection of features
The page displays:
to return to the page header.
The page changes:: feature.
or disable the
to access the next
Auto ON : 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 firmation message appears when 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 to return to the page header.
Press to move to the next page.
en GB – 21
DreamStar™ Info or DreamStar™ Info Evolve
5) Patient reminders
The page displays: Press The page changes: as many times as necessary to access the desired parameter setting.
Increase parameter value with the right or left parameter settings button.
Then press
or decrease menu parameter.
the
to access the next
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 The page changes:
Increase or decrease parameter value with the right or left parameter settings button.
the as many times as necessary to access the desired parameter setting.
Pressure offset: offset of the pressure sensor.
Then press menu parameter.
to access the next
Pressure unit: the unit of measurement used for the displayed pressure can be changed from cmH
2
O to hPa, and vice versa.
Press at the bottom of the page or to return to the page header.
Press to exit the menu. en GB – 22 DreamStar Intro, Info, Auto Clinician Manual
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. and Access of some settings is limited to the medical team only. For that, press the left control button 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 disabled.
symbol indicates that the Pressure Alter feature is enabled, and the symbol indicates that it is
Settings menu
To access the Settings menu, press the left control button the bottom left of the screen: to select the symbol displayed at
In CPAP mode
The page displays: Press The page changes: Press the right or left parameter settings button to select the operating mode. as many times as necessary to access the desired parameter setting.
Then press menu parameter.
to access the next
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 cmH
2
O.
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 – 23
The page displays: The page changes: Increase or decrease the
to access the next
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 reach the prescribed pressure when starting from the comfort
This parameter is displayed only when the time ramp (T.Ramp) is selected.
Press to return to the page header.
Press
In Auto-CPAP mode
The page displays: The page changes: mode.
to access the next
Increase or decrease the
Mode: device operating mode.
Min. Pressure: minimum pressure deliverable by the device.
Max. Pressure: maximum pressure deliverable by the device.
Press to return to the page header.
Press to move to the next page.
The page displays: The page changes:
Increase or decrease the
to access the next en GB – 24
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 menu parameter.
to access the next
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 menu parameter.
to access the next
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.
DreamStar Intro, Info, Auto Clinician Manual en GB – 25
DreamStar™ Auto or DreamStar™ Auto Evolve
Press
to exit the menu.
Service menu
To access the Service menu, press the left control button the bottom right of the screen:
to select the symbol displayed at
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 menu parameter.
to access the next
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 The page changes: as many times as necessary to access the desired parameter setting.
Note: The date can be set only when the device is in standby.
Press at the bottom of the page or
Increase parameter value with the right or left parameter settings button.
Then press
to return to the page header.
or decrease menu parameter.
the
to access the next
Press to move to the next page. en GB – 26 DreamStar Intro, Info, Auto Clinician Manual
The page displays: The page changes:
or unlock the patient.
to access the next
This menu gives you the possibility to allow or not the patient to select himself the language and / or set the
Press
Press to move to the next page.
3) Selection of features
The page displays:
to return to the page header.
The page changes:: feature.
or disable the
to access the next
Auto ON : 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.
• 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 with a default configuration.
Press to return to the page header.
Press to move to the next page.
en GB – 27
DreamStar™ Auto or DreamStar™ Auto Evolve
5) Patient reminders
The page displays: Press The page changes: as many times as necessary to access the desired parameter setting.
Increase or decrease the parameter value with the right or left parameter settings button.
Then press menu parameter.
to access the next
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 The page changes: as many times as necessary to access the desired parameter setting.
Increase parameter value with the right or left parameter settings button.
Then press
or decrease menu parameter.
the
to access the next
Pressure offset: offset of the pressure sensor.
Pressure unit: the unit of measurement used for the displayed pressure can be changed from cmH
2
O to hPa, and vice versa.
Press at the bottom of the page or to return to the page header.
Press
to exit the menu. en GB – 28 DreamStar Intro, Info, Auto Clinician Manual
Press the left
General Information menu appears.
The page displays:
Hour counter: Device operating time.
Total use: Total duration during which the patient was actually breathing in the
Tot. Session Nbr.: Number of start/stop sessions in the device memory.
Press first and then simultaneously
The values on the total use and total sessions counters will return to zero.
or cancel this change using the right or
Press to move to the next page.
The last session is displayed: Date: Date of the last On/Off session.
Total duration: Total duration of the last session.
Usage duration: which the patient was actually breathing in the
Average pressure: Average pressure delivered during the session.
Notes:
• 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.
Press the On/Off button en GB – 29
Press the left
The page displays:
Hour counter: Device operating time.
Total use: Total duration during which the patient was actually breathing in the
Tot. Session Nbr.: Number of start/stop sessions in the device memory.
Press to move to the next page.
The last session is displayed:
Date: Date and start hour of the last On/Off session.
Usage duration: was actually breathing in the
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.
Press the right control button
Press the On/Off button
to access the next page.
When the device is in stand-by :
Press The page displays: Press to select the setting
Press
Press
The page changes:
to return to the page header. en GB – 30
or decrease
the parameter value
patient can increase or decrease the heat level by moving button, as shown hereafter.
Note: When the device is battery powered, the heated humidification feature cannot be used-and the
Indicates that the humidifier is not functioning because it is under battery power.
When one or several reminders are about to expire, the information access symbol in the lower left 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: Press The page changes: as many times as necessary to access the desired reminder.
Answer YES or NO
with the right or left parameter settings button.
Press to access the next reminder.
Note: If you respond yes, the event reminder disappears from the display.
Press to return to the page header.
Press to exit the menu. en GB – 31
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. en GB – 32 DreamStar Intro, Info, Auto Clinician Manual
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.
DreamStar Intro, Info, Auto Clinician Manual en GB – 33
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
CAUTION
•
Use for the cleaning material intended for this purpose.
•
Do not use strong detergent, abrasive sponge or st
Daily
1.
Empty the water chamber and rinse it with clean water.
2.
Leave to drip dry out of direct sunlight.
Weekly
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 ( A from the locking system ( B ).
2 : the clip held down while gently pulling the tubing towards you to extract it from the upper part.
Grip zone
Inner tubing
Center tab
Upper part
Gasket
Base
A
B en GB – 34
Clean the various parts of the water chamber
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 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).
• 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
Filter holder Filter holder Filter
Filter holder
•
Wash the filter and the filter holder with warm water and mild detergent (for example one drop of
•
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
•
Reinstall the cover or the water chamber.
en GB – 35
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. en GB – 36 DreamStar Intro, Info, Auto Clinician Manual
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.
DreamStar Intro, Info, Auto Clinician Manual en GB – 37
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). en GB – 38 DreamStar Intro, Info, Auto Clinician Manual
Troubleshooting tips
Device Messages
Message
MASK UNPLUGGED is displayed on the screen.
LEAK : ++ (or +++ or ++++ ) is displayed on the screen.
The symbol blinks alternately with the error code at the centre of the display.
The symbol blinks alternately with the error code at the centre of the heat level page.
Description
Large leak detected.
The device detects a high level of leak.
The device has detected an operating error.
The device has detected a humidifier operating error.
Corrective action
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.
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.
See table entitled, “Error Messages”.
See errors 100-105 in the table entitled, “Error
Messages”.
Error Messages
Code Description Corrective action
Er 01
Er 02
Patient settings problem.
High motor temperature.
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.
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)
Er 04 High pressure.
Unplug the machine from all electrical power. Plug it in again.
If the error recurs, return the machine to a technical service centre.
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.
DreamStar Intro, Info, Auto Clinician Manual en GB – 39
Code Description Corrective action
Er 07
Er 08
Turbine problem.
Voltage 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.
Unplug the device from all sources of electrical power. Plug it in again and turn on.
If the error persists, contact Technical Support.
Unplug the machine from all electrical power. Plug it in again.
If the error recurs, return the machine to a technical service centre.
Er 09 Language CheckSum error (on DreamStar™
Info / Info Evolve and
DreamStar™ Auto /
Auto Evolve).
Er 10 Machine settings problem.
Er 11
Er 12
High current consumption.
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.
Unplug the device from all sources of electrical power. Plug it in again and turn on.
If the error persists, contact Technical Support.
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
Er 14
I²C bus communication error.
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.
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. en GB – 40 DreamStar Intro, Info, Auto Clinician Manual
Code Description
Er 103 Humidifier current too low.
Er 104 Lack of communication from the humidifier to the device.
Er 105 Communication problem between the humidifier and the device.
Corrective action
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.
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.
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
Technical Specifications
DreamStar™ device Performance
Device pressure range:
Maximum steady limiting pressure at the patient connection port under single fault condition:
Maximum pressure that can be set:
Ramp duration:
Sound pressure level measured in accordance with
NF EN ISO 17510-1 : 2002:
Sound pressure level measured in accordance with NF EN ISO 17510-1:2007:
Battery life of mainboard:
Patient-side connection aperture:
Air intake filter efficiency:
4 cmH
2
O to 20 cmH
2
O
Device adjustable in increments of 0.5 cmH
2
O
30 cmH
2
O
20 cmH
2
O
0 to 45 minutes
±
1 minute
Device adjustable in increments of 5 minutes.
26 dBA with humidifier
30 dBA without humidifier
30 dBA with humidifier
33 dBA without humidifier
5 years
Conical connector 22 mm diameter.
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:
Heating time:
Pressure loss as a function of flow:
Compliance of the water chamber :
Maximum service pressure:
Maximum gas temperature delivered from patient tubing:
> 10 mg H
2
O/l at the maximum setting for a leak flow
< 60 l/min
< 45 minutes
0.59 cmH
2
O at 1 l/sec
0.73 cmH
2
O at 1 l/sec with swivel outlet elbow
14.2 ml/kPa (chamber empty)
12.2 ml/kPa (chamber full)
20 cmH
2
O
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:
Relative humidity:
Altitude range:
+5 °C to + 40 °C (41 ºF to 104 ºF) without humidifier
+5° C to + 35 °C (41 ºF to 95 ºF) with humidifier between 10% and 95% without condensation
0
−
2 700 m (0
−
9,000 ft) approximately en GB – 42 DreamStar Intro, Info, Auto Clinician Manual
Transportation and storage conditions
Pressure range:
Temperature:
Relative humidity:
500 hPa to 1060 hPa
-20°C to +60°C (-4 °F to +140 °F)
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):
Maximum power consumption:
100 - 240 VAC (-15%, +10%), at 50 or 60Hz
100VA at maximum setting.*
Current consumed at 20cmH
2
O with a 4mm leak:
DC power supply (13 V)
130 mA eff. at 230 VAC
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):
Carrying case Dimensions (D x W x H):
Weight:
Operational volume (minimal gas volume in water chamber):
Useful volume of water chamber:
Maximum liquid fill level:
200 x 230 x 120 mm (7.8 x 9.0 x 4.7 in) approximately with water chamber
260 x 350 x 150 mm (10.2 x 13.7 x 5.9 in) approximately
1.5 kg (3.3 lbs) approximately with water chamber
1.4 kg (3.1 lbs) approximately with cover
811 ml
300 ml
Indicated on water chamber
CE marking
DreamStar™ Intro, DreamStar™ Intro Evolve : 2011
DreamStar™ Info, DreamStar™ Info Evolve : 2011
DreamStar™ Auto, DreamStar™ Auto Evolve : 2011.
DreamStar Intro, Info, Auto Clinician Manual en GB – 43
Symbol Description
Class II device.
DC power supply. medical devices. temperature limit”.
(-4 °F to +140 °F) with care.
Symbol Description pertaining to this medical equipment were assessed in accordance with the ISO 14971:2007 standard,
•
CEI 60601-1:2005 + AC1:2006 + AC2:2007 + Amd1:20 Medical electrical equipment. Part 1: General
•
2:2007: Medical electrical equipment. Part 1: General requirements for safety. Collateral
•
EN ISO 17510-1:2009: Sleep Apnoea Breathing Therapy Devices.
•
EN ISO 8185:2009: Respiratory tract humidifiers for medical use Particular requirements for
•
Directive 93/42/EC of the Council concerning
• 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 equipment (WEEE).
en GB – 44
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.
DreamStar Intro, Info, Auto Clinician Manual en GB – 45
NF EN ISO 17510-1:2007-compliant features
Using the DreamStar™ Intro and DreamStar™ Intro Evolve
Static pressure stability at 10 cmH
2
O
(Long-term accuracy according to ISO 17510-1:2007, Appendix BB.1)
Pressure accuracy
Without humidifier
+/- 0,6 cmH
2
O
With humidifier
+/- 0,6 cmH
2
O
Dynamic pressure stability
(Short-term accuracy according to ISO 17510-1:2007, Appendix BB.2)
With tubing 22 mm diameter
4
Respiratory rate
Resp./min
8
Respiratory rate
Resp./min
Test pressure (cmH
2
O)
12
Respiratory rate
Resp./min
16
Respiratory rate
Resp./min
20
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 (cmH
2
O)
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 (cmH
2
O)
Delta relative to dynamic pressure (cmH
2
O)
-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
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 (cmH
2
O)
Delta relative to lowest pressure (cmH
2
O)
Delta relative to dynamic pressure (cmH
2
O)
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
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
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)
4 8
Test pressure (cmH
2
O)
12 16
Maximum flow (l/min) provoking a pressure drop of 1 cmH
2
O at the opening of the patient side connection
Without humidifier
With humidifier
>130
80
160
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
160
80
160
80
20
160
80 en GB – 46 DreamStar Intro, Info, Auto Clinician Manual
Using the DreamStar™ Info, DreamStar™ Auto, DreamStar™ Info Evolve and
DreamStar™ Auto Evolve
Static pressure stability at 10 cmH
2
O
(Long-term accuracy according to ISO 17510-1:2007, Appendix BB.1)
Pressure accuracy
Without humidifier
+/- 0.5 cmH
2
O
With humidifier
+/- 0.5 cmH
2
O
Dynamic pressure stability
(Short-term accuracy according to ISO 17510-1:2007, Appendix BB.2)
With humidifier
Tubing 22 mm diameter:
4 8
Test pressure (cmH
2
O)
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
Delta relative to highest pressure (cmH
2
O)
Delta relative to lowest pressure (cmH
2
O)
Delta relative to dynamic pressure (cmH
2
O)
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
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
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 (cmH
2
O)
Delta relative to lowest pressure (cmH
2
O)
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
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 (cmH
2
O)
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 (cmH
2
O)
Delta relative to lowest pressure (cmH
2
O)
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
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 (cmH
2
O)
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
DreamStar Intro, Info, Auto Clinician Manual en GB – 47
Without humidifier
Tubing 22 mm diameter:
4
Respiratory rate
Resp./min
8
Respiratory rate
Resp./min
Test pressure (cmH
2
O)
12
Respiratory rate
Resp./min
16
Respiratory rate
Resp./min
20
Respiratory rate
Resp./min
10 15 20 10 15 20 10 15 20 10 15 20 10 15 20
Delta relative to highest pressure (cmH
2
O)
Delta relative to lowest pressure (cmH
2
O)
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
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 (cmH
2
O)
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 (cmH
2
O)
Delta relative to lowest pressure (cmH
2
O)
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
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 (cmH
2
O)
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)
4 8
Test pressure (cmH
2
O)
12 16 20
With humidifier
:
Tubing 22 mm diameter >130
Maximum flow (l/min) provoking a pressure drop of
1 cmH
2
O at the opening of the patient side connection
Tubing 15 mm diameter >120
Tubing 15 mm diameter and high-efficiency filter
>120
Without humidifier
:
Maximum flow (l/min) provoking a pressure drop of
1 cmH
2
O at the opening of the patient side connection
Tubing 22 mm diameter
>130
Tubing 15 mm diameter >120
180
160
160
200
170
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
180
160
150
200
170 en GB – 48
180
150
140
200
150
180
130
120
200
150
DreamStar Intro, Info, Auto Clinician Manual
Functional pneumatic block diagram
* except DreamStar™ Intro or DreamStar™ Intro Evolve
DreamStar Intro, Info, Auto Clinician Manual en GB – 49
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 H
2
O.
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
Harmonic emissions
IEC 61000-3-2
Class B
Class A
Voltage fluctuations
/ flicker emissions
IEC 61000-3-3
Complies
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.
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 environment.
DreamStar™ product range should assure that it is used in such an
Immunity test
Electro-static discharge (ESD)
IEC 61000-4-2
Electrical transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5 fast
Test level
IEC 60601
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for input / output lines
± 1 kV lines / lines
± 2 kV lines/earth
Compliance level
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for input / output lines
± 1 kV lines / lines
± 2 kV lines/earth
Recommended electromagnetic environment
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment.
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% U
T
(>95% dip in U
T
) for 0.5 cycles
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
< 5% U
T
(>95% dip in U
T
) for 5 s en GB – 50
< 5% U
T
(>95% dip in U
T
) for 0.5 cycles
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
< 5% U
T
(>95% dip in U
T
) 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
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: U
T 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
Conducted RF
IEC 61000-4-6
IEC 60601 test level
3 Vrms
150 kHz to 80
MHz
Compliance level
3 Vrms
150 kHz to 80
MHz
Recommended electromagnetic environment
Portable and mobile RF communications equipment should not be used in proximity to any part of the device from the DreamStar™ cables. product range, including
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 survey a
, should be less than the compliance level in each frequency range b
.
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.
DreamStar Intro, Info, Auto Clinician Manual en GB – 51
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)
0.01
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz d = 1.2√P
0.12
80 MHz to 800 MHz d = 1.2√P
0.12
800 MHz to 2.5 GHz d = 2.3√P
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) en GB – 52 DreamStar Intro, Info, Auto Clinician Manual
0459
Manufacturer:
SEFAM
144 AV CHARLES DE GAULLE
92200 NEUILLY SUR SEINE
FRANCE
Manufacturing plant:
SEFAM
10 ALLEE PELLETIER DOISY
54600 VILLERS-LES-NANCY
FRANCE
: M-155DFU00-60 Revision 8
2015-11

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