Practitioner and

Home Care Provider manual

EcoStar™ Info

EcoStar™ Auto

EcoStar™ is a brand owned by SEFAM.

 Manufacturer: Manufacturing plant and technical agency:
SEFAM SEFAM
144 AV CHARLES DE GAULLE 10 ALLEE PELLETIER DOISY
92200 NEUILLY SUR SEINE 54600 VILLERS-LES-NANCY
FRANCE FRANCE
TEL : +33 (0) 3 83 44 85 00
www.sefam-medical.com

2 EcoStar Info, EcoStar Auto

Table of Contents

Before starting ............................................. 4 Monthly ........................................................... 18

Safety instructions .............................................4 Device ............................................................... 18
Intended use ......................................................4 Air intake filter .................................................. 18

Contraindications ...............................................5 Disinfecting the equipment ......................... 19

List of authorised accessories ............................5 Disinfecting the surface of the device ............. 19
Available features ........................................ 6 Products which must not be used ................... 19
Mask unplugged feature ....................................6 Trouble-shooting ........................................ 20
Comfort Calibration ...........................................6 Information messages ..................................... 20
Auto ON feature ................................................6 Error messages ................................................ 20
Time Ramp feature ............................................6
Technical characteristics ............................. 22
Indexed Ramp feature .......................................7
Device performance ........................................ 22
Accessing settings ........................................ 7 Conditions of use ............................................. 22
Definitions ..........................................................7 Electrical characteristics .................................. 22
Setting ranges ....................................................8 Transport and storage conditions ................... 22
Accessing the menus .........................................9 Physical characteristics.................................... 22
Description of a screen page .............................. 9 Symbols on the device .................................... 23
How to access settings ..................................... 10 Disposing of the device at the end of its life ... 23
Description of symbols displayed on the screen10
Standards Compliance ..................................... 24
Setting EcoStar™ Info device ...........................11
EC marking ...................................................... 24
Setting EcoStar™ Auto device ..........................13
ISO 17510-1:2009 and ISO 80601-2-70:2014
Setting the clock ..............................................16 compliant features .......................................... 25
Choosing a pressure unit .................................17 Static pressure stability at 10 cmH2O ............... 25
Adjustment of the pressure at the device Dynamic pressure stability ............................... 25
outlet ...............................................................17 Maximum flow and pressure ............................ 26
Specific calibration of the pneumatic Sound pressure and sound power levels ........... 26
configuration....................................................17 Essential performance requirements for
Cleaning and maintenance ..........................18 electromagnetic compatibility ........................ 27

Weekly .............................................................18
Air intake filter .................................................. 18

EcoStar Info, EcoStar Auto Table of Contents  3

Before starting
This manual is intended for the use of the Practitioner and the Home care Service
Provider. Under no circumstances must it be supplied to the patient.

Safety instructions
 Like all medical electrical devices, the
In this manual, this device is vulnerable to interference from
WARNING signals a risk of injury or mobile and portable radiofrequency
accident to the patient. communication equipment (cordless
 Please familiarize yourself with the safety phones, WiFi) which could be placed
instructions in the patient manual. nearby.
 Refer to the patient manual for installing,  Addition of any accessory at the respiratory
maintaining and storing the device. circuit level or combination with other
 You must ensure that the patient receives medical equipments may affect the
the manual intended for his use, as well performance of the device. Check that the
as the instructions for using the pneumatic configuration selected is
accessories. suitable.
 Only use the device with authorised  Never connect the device to a battery
accessories as listed in this manual. when it is charging from the mains.
 During treatment, only equipment
included in the list of authorised If the device is used with a GoodKnight H2O
accessories must be connected to the heating humidifier:
device USB connector. Do not use the  When using the humidifier's water
device if connected to a computer. chamber, the patient must take
 For proper maintenance and to prevent precautions to eliminate the risk of
the risk of damage, only qualified introducing water into the machine, which
personnel are authorized to service the could cause irreversible damage. The
device or carry out approved device must be placed on a stable
modifications. The user assumes full horizontal surface and must not be tilted.
responsibility for any malfunction of the  We recommend disconnecting the device
device caused by maintenance performed from the heating humidifier and emptying
by unauthorized personnel. the water chamber before moving or
 If you observe any anomaly in the device, transporting the assembly, to eliminate
do not begin treatment. any risk of introducing water into the
 Never use the device without making sure device, which could cause irreversible
that the air intake filter is installed. damage.
 The device should not be used if it is near
or on top of an equipment other than one
of the authorised accessories.
Intended use
 When using oxygen, the oxygen source The EcoStar™ Info and EcoStar™ Auto devices
should be placed at more than one meter are Positive Pressure devices indicated for the
from the device.
mask treatment of Obstructive Sleep Apnea and
 Do not introduce liquids or objects into the
air outlet.
Hypopnea Syndrome (OSAHS) in patients
weighing more than 30 kg (66 lbs). They can be
In this manual, this used at home or in a sleep center.
indicates that there is a
CAUTION possibility of material The device can be used with the GoodKnight H2O
damage to this device or humidifier if a prescription for heated
any other device. humidification has been added to the patient's
 Since this is a medical electrical device,
treatment. The heating humidifier is designed to
please follow the installation instructions heat and raise the humidity of the air delivered
contained in this manual concerning to the patient through the Continuous Positive
electromagnetic compatibility. Airway Pressure device.

4  Before starting EcoStar Info, EcoStar Auto

Contraindications List of authorised accessories
Studies have shown that the use of positive Unless otherwise indicated, the EcoStar™ Info or
airway pressure is contraindicated for certain EcoStar™ Auto device can be used with the following
patients with one of the following pre-existing optional accessories:
conditions:
 Severe bullous emphysema or emphysema  Air intake filter  Fine filter
P/N M-415930-01 P/N M-413950-04
previously complicated by pneumothorax.
 Pneumothorax.  Specific power supply  GoodKnight H2O
module heating humidifier
 Pneumoencephalus, trauma or recent
P/N M-413910-00 (EU P/N M-114600
surgery with sequela of cranio-
nasopharyngeal fistula. plug)
P/N M-415910-03 (no
 Decompensated cardiac insufficiency or EU plug)
hypotension, particularly in case of
 Patient Tubing, 22 mm  Patient Tubing, 15 mm
decreased blood volume or cardiac
diameter diameter
arrhythmia.
P/N M-261000-04 P/N M-261000-00
 Dehydration.
 Carrying case  Clinical kit
 Massive epistaxis or history of massive P/N M-214531-01 P/N M-215630-01
epistaxis, hemophilia.
 Battery cable /  DreamStar™ Analyze
 Acute sinusitis, otitis media, or perforated cigarette-lighter plug Software
tympanic membrane. P/N M-213930-03 P/N M-215630-00
 Tracheotomy.  RS232/mini USB 2 m  RS 232/mini USB 15 m
cable cable
P/N M-214831-11 P/N M-214831-12
Moreover, as the effect of positive airway
pressure on cardiac output is clear for some  Mini USB 2 m cable
patients, close monitoring of the patient's P/N M-214831-10
blood pressure and heart rate is
recommended when beginning treatment at
the effective pressure. The risks and benefits WARNINGS
of Continuous Positive Airway Pressure must  Use only the authorised accessories listed
be assessed on a case-by-case basis for these above or compliant with EN ISO 17510-
2:2007 standard.
patients.
 Use only those accessories which can
guarantee 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.

EcoStar Info, EcoStar Auto Before starting  5

Available features
The EcoStar™ Info device operates in continuous mode, i.e. the device delivers a constant pressure level.
The EcoStar™ Auto operates either in 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.

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 one of the three buttons of the device 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 device detects that the mask is
unplugged.

Comfort Calibration
The Comfort Calibration(CC) 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.

Auto ON feature
Functionality allowing to automatically start the treatment during the first breaths in the mask without
pressing the device button . It can be enabled or disabled.

Time Ramp feature

The time ramp feature allows for a gradual rise in pressure to help the patient fall asleep. When it is
programmed (ramp time  0), it will be automatically enabled at the beginning of the session at comfort
pressure.
In CPAP mode, the treatment begins at a reduced pressure called comfort pressure, then the pressure
increases to treatment pressure.
In Auto-CPAP mode, the time ramp feature delays the commands to raise or lower the pressure. If the
comfort 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 latency time.

6  Available features EcoStar Info, EcoStar Auto

Indexed Ramp feature
The indexed ramp feature allows to start the treatment at the adjustable comfort pressure, then to have a
rise in pressure in CPAP mode or the activation of the Auto-CPAP as soon as the device starts to detect
respiratory events which indicate that the patient is asleep.
If the end of the indexed ramp is not detected before the value of the maximum ramp time (45 minutes), it
will automatically stop.

Accessing 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 is recorded by session in the device memory within one year and 8 hours
usage day, and they can be retrieved for analysis by using DreamStar™ Analyze software.
The settings are accessible directly on the device and with the DreamStar™ Analyze software, by connecting
the machine to a computer via a RS232 / Mini USB cable.
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
Hour device operating time (ON/OFF). Compliance time during which the patient has
counter: counter: effectively breathed in the mask
(time subtracted from the time
when the mask was removed and
the time with no respiration).
FL: Inspiratory Flow Limitation with Prescribed level of pressure prescribed for the
EcoStar™ Auto device in Auto-CPAP pressure: patient.
mode.
Comfort level of pressure produced by the Maximum maximum pressure on the EcoStar™
pressure: device when the time ramp or the pressure on Auto beyond which no rise in
indexed ramp starts up so that the apnoea pressure can be applied once a
patient can go to sleep comfortably. command: respiratory pause has been
detected.
Maximum maximum pressure that the Minimum minimum pressure that the
pressure: EcoStar™ Auto can deliver in Auto- pressure: EcoStar™ Auto can deliver in Auto-
CPAP mode. CPAP mode.
Session: period during which data is recorded Ramp time: in CPAP mode, this is the time taken
to memory between the time the by the device to reach the prescribed
device starts operation and the time pressure from the comfort pressure.
it goes into standby.
Latency this is the time taken by the device
time: to activate the Auto-CPAP feature
when the ramp is enabled.

EcoStar Info, EcoStar Auto Accessing settings  7

Setting ranges
The following tables indicate the parameters
adjustable and the features available on the Notes:
EcoStar™ Info and EcoStar™ Auto devices, as
well as the pneumatic calibration regarding the  As the device is equipped with a differential
accessories used. pressure sensor, the pressure compensation
for altitude is automatic.
 The default pressure unit is cmH2O.

Operating mode on the EcoStar™ Auto:

Parameter Display Default

Operating mode CPAP APAP APAP
(Auto-CPAP) (Auto-CPAP)

Parameters adjustable on the devices:

Minimum Maximum Default

Parameter Increment
value value value

On EcoStar™ Info and EcoStar™ Auto devices in CPAP mode:

Pressure level 4 cmH2O 20 cmH2O 8 cmH2O 0.5 cmH2O

Comfort pressure 4 cmH2O prescribed 4 cmH2O 0.5 cmH2O

pressure
Ramp time 0 min 45 min 15 min 5 min

On EcoStar™ Auto device in Auto-CPAP mode:

Maximum pressure 4 cmH2O or 20 cmH2O 20 cmH2O 0.5 cmH2O

minimum
pressure
Minimum pressure 4 cmH2O 20 cmH2O or 4 cmH2O 0.5 cmH2O
maximum
pressure
Comfort pressure 4 cmH2O 20 cmH2O or 4 cmH2O 0.5 cmH2O
maximum
pressure

Latency time 0 min 45 min 15 min 5 min

Maximum pressure on apnea minimum maximum 10 cmH2O 0.5 cmH2O

command pressure pressure

Parameter adjustable on EcoStar™ Auto device:

Parameter Display Default

Pressure decrease speed (in Auto-CPAP mode only) : Sd:F Sd:S Sd:S
(fast) (slow) (slow)

8  Setting ranges EcoStar Info, EcoStar Auto

Features available on the devices:

Feature Feature
Feature Default
enabled disabled
Comfort Calibration CC:1 CC:0 CC:1
(continuously or (during the
during the ramp ) ramp )
External module connection rS:1 rS:0 rS:1
Command on Inspiratory Flow Limitation (in Auto-CPAP FL:1 FL:0 FL:1
mode only)
Auto ON Ao:1 Ao:0 Ao:1

Ramp type Default

Ramp feature Time ramp Indexed ramp Indexed
(tr) (ir) ramp (ir)

Pneumatic configuration of the devices regarding the accessories used:

Display calibration pneumatique

Accessory used Without humidifier With GKH2O heated
humidifier
Tubing 1.80 m long 22 mm diameter (standard
CP:22 CP:HH 22
configuration set by default)
Tubing 1.80 m long 15 mm diameter CP:15 CP:HH 15
CP:SP
(specific calibration present)
Other (specific)
CP:--
(specific calibration absent)

Accessing the menus

In order to restrict access of certain settings to the
medical team, a hidden key has been provided on the
device. It is located under the letters "Ec" of the name
"EcoStar™” and is detectable to the touch as a hollow.

Moreover, the three buttons shown at the user interface

allow access to the device settings and are used to
change the value of certain parameters.

Description of a screen page

Each screen of the practitioner settings menu includes: The parameters accessible on the screen
 an upper section indicating the value of the when the machine is in standby or
parameter displayed operating mode are:
 parameters of the device relating to
 a lower section with various symbols indicating the
treatment
device's operating mode or the nature of the
parameter displayed (see table entitled  compliance counter data.
"Description of symbols displayed on the screen").

EcoStar Info, EcoStar Auto Accessing settings  9

How to access settings

To access the device settings: press the hidden key, then simultaneously the
information access button for one second.

On the screen which appears:  the symbol or the symbol shows if the
device is in standby or in operation.

 the symbol indicates that the parameter

displayed can be modified. Raise the parameter

value pressing the on/off button or lower it

using the ramp button .

To access the next data:

press the information access button again.

To return to the previous data: press the hidden key.

Note:
Exit from the parameter setting menu takes place automatically when you do not press any key for 30
seconds.

Description of symbols displayed on the screen

Symbol Description Symbol Description

Standby mode Operating mode

Ramp feature Pressure symbol

Time symbol Compliance symbol

Adjustable parameter Software version

Information message Error message

Pressure sensor offset

Note :
The EcoStar™ Info or EcoStar™ Auto device is shown in operating mode and all the values displayed
are given by way of example.

10  Accessing settings EcoStar Info, EcoStar Auto

Setting EcoStar™ Info device

Press This screen appears:

simultaneously Pressure level
the hidden key
Increase or decrease the value displayed pressing
and the button or .
for one second.

Press This screen appears:

Ramp
You can select the time ramp (tr) or the indexed
ramp (ir) pressing the button or .

Press This screen appears:

Ramp time when the time ramp tr is selected,
otherwise this parameter is not displayed.
Increase or decrease the value displayed pressing
the button or .

Press This screen appears:

Comfort pressure
Increase or decrease the value displayed pressing
the button or .

Press This screen appears:

Auto ON
You can enable (1) or disable (0) the feature
pressing the button or .

Press This screen appears:

Comfort Calibration
You can enable (1) the feature either continuously,
or during the ramp ( ), or disable it (0) pressing
the button or .

EcoStar Info, EcoStar Auto Accessing settings  11

 Press This screen appears: Pneumatic Calibration

Using the button or , you can select a

configuration 22 (tubing 22 mm diameter, standard),
15 (tubing 15 mm diameter), HH (humidifier), SP
(specific present) or -- (specific absent).
The value on the right below represents the diameter
of the tubing used with the heated humidifier.
For specific calibration, refer to "Specific calibration of
the pneumatic configuration" page 17.

Press This screen appears:

Hour counter (device operating time). The value

displayed on the right below represents the minutes.

Press This screen appears:

Compliance counter (time during which the patient

actually breathed with the device). The value
displayed on the right below represents the minutes.

Press This screen appears: Built-in pressure sensor

Increase or decrease the value displayed using the
button or .
Refer to "Adjustment of the pressure at the device
outlet" page 17.

Press This screen appears:

Selection of RS232 connection for an external
module (for example a modem)
The connection can be enabled (1) or disabled (0) by
pressing the button or .

Press This screen appears:

Software version included with the EcoStar™ Info

device. The version can be viewed but not modified.

Press the information access button again to exit the parameter settings menu.

12  Setting EcoStar™ Info device EcoStar Info, EcoStar Auto

Setting EcoStar™ Auto device

Press This screen appears:

simultaneously Device operating mode.
the hidden key
If CPAP is displayed, the device delivers a constant
and pressure level.
for one second

If APAP is displayed, the device operates in

automatic mode (Auto-CPAP), and most of +the
parameters are adjustable.

To change from one mode to the other, press the

button or .

Press This screen appears:

Device pressure level.

In CPAP mode, you can set the pressure level.

In APAP mode, you can set the maximum pressure

and the minimum pressure which can be viewed
successively by pressing each time the information
access button.

Maximum pressure

Minimum pressure

Increase or decrease the pressure value displayed

using the button or .

Press This screen appears:

Ramp
You can select the time ramp (tr) or the indexed
ramp (ir) pressing the button or .

EcoStar Info, EcoStar Auto Accessing settings  13

 Press This screen appears: Ramp time (in CPAP mode) or latency time (in
APAP mode) when the time ramp tr is selected,
otherwise this parameter is not displayed
Increase or decrease the value displayed pressing
the button or .

Press This screen appears:

Comfort pressure
Increase or decrease the value displayed using the
button or .

Press This screen appears:

Auto ON
You can enable (1) or disable (0) the feature
pressing the button or .

Press This screen appears:

Comfort Calibration
You can enable (1) the feature either continuously,
or during the ramp ( ), or disable it (0) pressing the
button or .

Press This screen appears: Pneumatic Calibration

Using the button or , you can select a

configuration 22 (tubing 22 mm diameter,
standard), 15 (tubing 15 mm diameter), HH
(humidifier), SP (specific present) or -- (specific
absent).
The value displayed on the right below represents
the diameter of the patient tubing used with the
heated humidifier.
For specific calibration, refer to "Specific calibration
of the pneumatic configuration" page 17.

Press This screen appears:

Command on Inspiratory Flow Limitation,
available in APAP mode only.
The command can be enabled (1) or disabled (0)
pressing the button or .

14  Setting EcoStar™ Auto device EcoStar Info, EcoStar Auto

 Press This screen appears:
Pressure decrease speed, available in APAP mode
only.
You can set the speed - slow (S) or fast (F) - by
pressing the button or .

Press This screen appears:

Maximum pressure on apnea command,
available in APAP mode only.
Increase or decrease the value displayed pressing
the button or .

Press This screen appears:

Hour counter (device operating time). The value

displayed on the right below represents the
minutes.

Press This screen appears:

Compliance counter (time during which the
patient actually breathed with the mask). The
value displayed on the right below represents the
minutes.

Press This screen appears: Built-in pressure sensor offset.

Increase or decrease the value displayed using the
button or .
Refer to "Adjustment of the pressure at the
device outlet" page 17.

Press This screen appears:

Selection of RS232 connection for an external
module (for example a modem)
The connection can be enabled (1) or disabled (0)
by pressing the button or .

Press This screen appears:

Software version included with the EcoStar™

Auto device. The version can be viewed but not
modified.

EcoStar Info, EcoStar Auto Accessing settings  15

Press the information access button again to exit the parameter settings menu.

The display will show the status of your device as shown hereafter:

The device is in standby. The device is in operation.

CAUTION
If, when in use, a problem with the memorized settings is detected, the device stops and displays the
message Er 1.

Press for 1 second (the device displays the blinking message dEF), then the button .
The machine is then automatically reset to the default values and you can set the desired parameters again.

Setting the clock

You can set the time only when the device is in standby.

Press This screen appears:

Once the buttons are released, the
for 2 seconds, symbol of adjustment appears under
the hour and the letter h blinks. You can
then keeping it hold
change the time displayed by using the
down, press
button or .
.

Press This screen appears:

The symbol of minute min blinks in turn.

You can set the minutes by following the
same procedure as for the hour.

Press the information access button to exit the menu.

16  Setting the clock EcoStar Info, EcoStar Auto

Choosing a pressure unit Adjustment of the pressure at
You can select hPa instead of cmH2O as the device outlet
the default pressure unit displayed on the 1. Connect the spiral tubing to the device outlet and
device, and vice versa. the free nozzle of the tubing to a plug equipped
with a 4 mm leak and a pressure point.
To select the pressure unit, hold the 2. Then connect the pressure point to a manometer
and adjust the pressure to 12 cmH2O.
hidden key and the button
simultaneously pressed while you connect 3. Access the setting of the pressure sensor offset
as shown in "Settings" paragraph of the device
the device to the power supply source
(electrical outlet). concerned. Adjust the value using the button
The machine displays the unit selected
or until the pressure 12.0 cmH2O is
until you release the hidden key and the
read on the manometer.
button .
4. Then, press the button while holding down
the hidden key. The pressure sensor offset
Repeat to change the unit displayed.
setting is automatically memorized.

Specific calibration of the pneumatic configuration

CAUTION
Since pressure performance depends on the pneumatic configuration selected, it is important to select the
correct configuration. Specific configurations should be set up by skilled personnel only.

To optimise the performance of the device, it is advised to carry out a specific calibration based on the
pneumatic configuration used. If Comfort Calibration is enabled (1), disable it (0) and follow the procedure
hereafter:

1. Confirm that the device is in standby. If it is operating, 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 screen page of the Settings menu related to “Pneumatic Calibration” by following the
settings procedure for the device concerned.
4. Select the specific patient circuit CP:SP or CP:--:

specific calibration already present specific calibration absent

5. Press the hidden key and hold it down until launch of calibration taking care not to touch the pneumatic
circuit.

EcoStar Info, EcoStar Auto Accessing settings  17

Cleaning and maintenance
Check with the patient that he complies with the following instructions for cleaning and maintenance
below.

WARNING
Monthly
Unplug the device from the electrical source
and always disconnect the respiratory circuit
from the device before cleaning.
Device
 Clean the device exterior regularly by using
CAUTION a damp cloth or paper towel moistened
with a little water and a drop of gentle
 Do not let water come into contact
detergent.
with the device.
 Use appropriate material for cleaning: do  Remove detergent residue by repeating
not use harsh detergent, abrasive this step with a clean cloth or paper towel,
sponges or brushes with hard bristles. slightly moistened with just water.
 Wipe the entire device with a dry cloth or
paper towel.
Weekly
Air intake filter
Air intake filter Change the air intake filter whenever it is
 Remove the filter at the rear of the device. damaged or soiled.
 Wash the filter with warm water and mild The fine filter, which is optional, cannot be
detergent (for example 1 drop of washed; it must be changed once a month at
dishwashing liquid on the filter). least, or more often if it is visibly clogged.

 Rinse well to eliminate any trace of

detergent. WARNINGS
 Dry the filter:  Do not use detergent sprays. Chemical
product residue could enter the air outlet,
the filter's foam or the device interior,
o Dry the filter by pressing in a causing airway irritation.
clean, absorbent cloth  Never use the device without making sure
o Allow to dry completely away from that an air intake filter is installed.
sunlight.

 Once dry, reinstall the filter at the rear of

the device. Do not use a filter which is not
completely dry.

Note:
The patient must refer to the instructions for the mask, the heating humidifier and the respiratory circuit
for more information about the care and maintenance of these items.

18  Weekly EcoStar Info, EcoStar Auto

Disinfecting the equipment
Please refer to the instructions for the chemical products used to comply with the correct strength and
quantity of the products, contact time, and personal protective equipment needed.

Disinfecting the surface of

the device Products which must not be
A detergent-disinfectant is used to disinfect the used
exterior of the machine.
 Never use abrasive or highly alkaline
cleaning products, acetone, benzene or
 If using a spray or foam detergent- leaded gasoline to clean the device.
disinfectant:
 Do not use materials such as abrasive
sponges or stiff-bristled brushes.
o Spray the product onto a  Never use any pre-disinfecting or
disposable cleaning pad made of a disinfecting product containing aldehydes
non-woven material. and/or its derivatives: formaldehyde,
o Wipe the exterior of the device and glutaraldehyde, etc.
allow it to dry.  Do not use any pre-disinfecting or
disinfecting product which is not effective
on Mycobacterium tuberculosis (BK).
 If using detergent-disinfectant wipes:
 Never disinfect the internal circuit of air
flow using a disinfecting product or with an
o Wipe the exterior of the device and Airway Surface Disinfection System (DSVA).
allow it to dry.

EcoStar Info, EcoStar Auto Disinfecting the equipment  19

Trouble-shooting
Information messages
Message displayed Possible cause Solution

In 1 The mask is Check the connections between the mask, the tubing,
disconnected. and the device. This message disappears when you
breathe in your mask well reconnected or when one of
the three buttons of the device is pressed. Otherwise,
the device will stop after 30 minutes.

Error messages
Message displayed Description Solution

Er 1 Patient settings Reinitialize the default settings by holding down the

problem.
information access 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, return the machine to the technical
support.

Er 2 High motor Unplug the device from all sources of electrical power.
temperature. Allow it to cool and plug it in again according to the
instructions in the patient manual.
If the error persists, return the machine to the technical
support.

Er 3 Program battery Unplug the machine from all electrical power. Plug it in
overflow. again.
If the error recurs, return the machine to the technical
support.

Er 4 High pressure. Unplug the machine from all electrical power. Plug it in
again.
If the error recurs, return the machine to the technical
support.

Er 6 CheckSum code error. Unplug the device from all sources of electrical power.
Plug it in again and turn it on.
If the error persists, return the machine to the technical
support.

20  Trouble-shooting EcoStar Info, EcoStar Auto

 Message displayed Description Solution

Er 7 Turbine problem. Unplug the device from all sources of electrical power.
Check that there is no foreign object in the air outlet. Plug
in the machine again and turn it on.
If the error persists, return the machine to the technical
support.

Er 8 Voltage problem. Unplug the device from all sources of electrical power.
Plug it in again and turn it on.
If the error persists, return the machine to the technical
support.

Er 10 Machine parameter Unplug the device from all sources of electrical power.
problem. Plug it in again and turn it on.
If the error persists, return the machine to the technical
support.

Er 11 High current Unplug the device from all sources of electrical power.
consumption. Plug it in again and turn it on.
If the error persists, return the machine to the technical
support.

Er 12 Device memory is Unplug the device from all sources of electrical power.
empty. Plug it in again.
If the error persists, return the machine to the technical
support.

Er 13 I²C bus Unplug the device from all sources of electrical power.
communication error. Plug it in again and turn it on.
If the error persists, return the machine to the technical
support

Note:
When an error is detected, the device goes into standby mode and access to the different menus is
impossible.

EcoStar Info, EcoStar Auto Trouble-shooting  21

Technical characteristics
Device performance
Device pressure range: 4 cmH2O to 20 cmH2O  0.5 cmH2O
device adjustable in increments of 0.5 cmH2O

Maximum pressure at the patient-side connection

port under single fault condition: 30 cmH2O

Ramp duration : 0 to 45 minutes  1 minute

device adjustable in increments of 5 minutes

Patient-side connection aperture: Conical connector of 22 mm diameter

Sound pressure level measured in accordance with

NF EN ISO 17510-1:2009 and ISO 80601-2-70:2014 27,5 dB(A) without humidifier
§201.9.6.2.1.101 standards: 29,5 dB(A) with GoodKnight H2O humidifier

Conditions of use Electrical characteristics

Absolute pressure
700 hPa to 1060 hPa Maximum power
range:
consumption: 25 W

+5°C to +40°C
Input voltage: 13 V
(+41 °F to +104 °F)
Temperature : +5°C to +35°C with Current consumption
GKH2O humidifier at 20 cmH2O with a
(+41 °F to 95°F) 4 mm leak: 0.750 A

Relative humidity: between 10 % and 95 %

without condensation

Altitude range: 0  2.400 m approx.

(7.900 ft approx.)

Transport and storage conditions Physical characteristics

Dimensions (D x W x H): 202 x 145 x 79 mm approx.
without power supply
Relative pressure range: 500 hPa to 1060 hPa
module
(11.0 x 5.5 x 13.8 ins approx.)

Weight: 0. 750 kg without power

Temperature : -20°C à +60°C
supply module
(-4 °F to +140 °F)
(1.65 lbs approx.)

Relative humidity: up to 95% without

condensation

22  Technical characteristics EcoStar Info, EcoStar Auto

Symbols on the device
Symbol Description Symbol Description

On/off button symbol. Ramp button symbol.

Symbol for raising the value of the Symbol for lowering the value of the
parameter displayed on the screen. parameter displayed on the screen.

Information access button symbol. Outlet symbol.

Device at the end of its life, separate

Device is protected against the
from household waste for disposal.
penetration of solid objects larger
For further information, refer to
than 12 mm and against falling drops
"Disposing of the device at the end of
of water.
its life".

Class II device. BF-type device.

Direct current power supply. Direct current.

Refer to the user manual. Recording and play back.

Device complies with the

Specific warning (see "Safety
requirements of European Directive
instructions" in the patient manual).
93/42/EC on medical devices.

Keep dry.

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").
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.

EcoStar Info, EcoStar Auto Technical characteristics  23

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.
The EcoStar™ Info or EcoStar™ Auto device complies with the following standards:

 CEI 60601-1:2005 + Amd1:2012: Medical electrical  Council Directive 93/42/EC concerning

equipment. Part 1: General requirements for basic medical devices.
safety and essential performance.
 European Parliament and Council Directive
 CEI 60601-1-2:2007: Medical electrical equipment. 2011/65/EU on the restriction of the use of
Part 1: General requirements for safety. Collateral certain hazardous substances (RoHS) in
standard: Electromagnetic compatibility – electrical and electronic equipment.
Requirements and tests.  European Parliament and Council Directive
 EN ISO 17510-1:2009: Sleep Apnoea Breathing 2012/19/EU on waste electrical and
Therapy. electronic equipment (WEEE).

 EN ISO 5356-1:2005: Anaesthetic and respiratory

equipment - Conical connectors.
 ISO 80601-2-70:2014: Medical Electrical Equipment -
Part 2-70: Particular requirements for basic safety
and essential performance of sleep apnoea breathing
therapy equipment.

EC marking
EcoStar™ Info : 2015
EcoStar™ Auto : 2015

24  Technical characteristics EcoStar Info, EcoStar Auto

ISO 17510-1:2009 and ISO 80601-2-70:2014 compliant features

Static pressure stability at 10 cmH2O

(Long-term accuracy according to ISO 17510-1:2009, Appendix BB.1 and ISO 80601-2-70:2014 §201.12.1.101)

Without humidifier With GoodKnight H2O humidifier

Pressure accuracy (cmH2O):  0.5 cmH2O  0.5 cmH2O

Dynamic pressure stability

(Short-term accuracy according to ISO 17510-1:2009, Appendix BB.2 and ISO 80601-2-70:2014 §201.12.1.102)

Test pressure (cmH2O)

4 8 12 16 20
Without humidifier Respiratory rate Respiratory rate Respiratory rate Respiratory rate Respiratory rate
Resp./min Resp./min Resp./min Resp./min 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

0,09 0,13 0,11 0,29 0,36 0,31 0,32 0,36 0,33 0,29 0,26 0,38 0,31 0,29 0,37
pressure (cmH2O)
Delta relative to lowest
0,16 0,19 0,30 0,06 0,05 0,20 0,12 0,14 0,27 0,25 0,32 0,32 0,33 0,39 0,43
pressure (cmH2O)
Delta relative to dynamic
0,03 0,03 0,03 0,05 0,06 0,07 0,07 0,09 0,09 0,10 0,11 0,14 0,12 0,13 0,29
pressure (cmH2O)

Tubing 15 mm diameter:

Delta relative to highest

0.05 0.10 0.17 0.22 0.27 0.38 0.24 0.29 0.40 0.21 0.26 0.37 0.16 0.23 0.34
pressure (cmH2O)
Delta relative to lowest
0.24 0.30 0.40 0.17 0.24 0.30 0.25 0.30 0.37 0.40 0.45 0.51 0.56 0.60 0.67
pressure (cmH2O)
Delta relative to dynamic
0.04 0.06 0.05 0.07 0.09 0.13 0.11 0.13 0.17 0.15 0.19 0.18 0.23 0.24 0.24
pressure (cmH2O)

EcoStar Info, EcoStar Auto Technical characteristics  25

 Test pressure (cmH2O)
4 8 12 16 20
With GoodKnight H2O
humidifier Respiratory rate Respiratory rate Respiratory rate Respiratory rate Respiratory rate
Resp./min Resp./min Resp./min Resp./min 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
0.13 0.14 0.21 0.35 0.37 0.40 0.38 0.38 0.47 0.35 0.35 0.46 0.29 0.34 0.44
pressure (cmH2O)
Delta relative to lowest
0.13 0.21 0.27 0.05 0.14 0.25 0.12 0.21 0.26 0.27 0.35 0.41 0.43 0.50 0.56
pressure (cmH2O)
Delta relative to dynamic
0.04 0.06 0.06 0.08 0.15 0.13 0.10 0.16 0.20 0.15 0.23 0.25 0.16 0.29 0.33
pressure (cmH2O)

Tubing 15 mm diameter:
Delta relative to highest
0.09 0.16 0.32 0.34 0.43 0.63 0.36 0.52 0.71 0.32 0.51 0.75 0.31 0.52 0.77
pressure (cmH2O)
Delta relative to lowest
0.26 0.31 0.35 0.17 0.23 0.26 0.25 0.25 0.32 0.40 0.40 0.48 0.53 0.56 0.61
pressure (cmH2O)
Delta relative to dynamic
0.06 0.08 0.08 0.13 0.14 0.15 0.16 0.22 0.23 0.22 0.24 0.33 0.23 0.35 0.31
pressure (cmH2O)

Tubing 15 mm diameter and high-efficiency filter:

Delta relative to highest
0.11 0.18 0.43 0.22 0.30 0.52 0.23 0.31 0.49 0.17 0.31 0.42 0.12 0.26 0.36
pressure (cmH2O)
Delta relative to lowest
0.32 0.42 0.53 0.28 0.36 0.47 0.42 0.50 0.60 0.61 0.64 0.81 0.79 0.83 0.98
pressure (cmH2O)
Delta relative to dynamic
0.07 0.10 0.09 0.11 0.15 0.13 0.15 0.19 0.24 0.20 0.26 0.26 0.30 0.32 0.31
pressure (cmH2O)

Maximum flow and pressure

(According to ISO 17510-1:2009, Appendix CC.1 and ISO 80601-2-70:2014 §201.12.1.103)

Test pressure (cmH2O)

4 8 12 16 20
Maximum flow (l/min) provoking
a pressure drop of 1 cmH2O at the
Tubing 22 mm diameter >130 180 180 170 150
opening of the patient side
connection
Pressure measurement (cmH2O)
at 40 l/min at the patient Tubing 22 mm diameter 3.9 8,1 12,1 16,0 19,9
interface

Sound pressure and sound power levels

(according to ISO 17510-1:2009 and et ISO 80601-2-70:2014 §201.9.6.2.1.101)
With GoodKnight H2O humidifier
Without humidifier
and tubing 15 mm diameter
Sound pressure level 27.5 dB(A) 29.5 dB(A)

Sound power level 35.5 dB(A) 37.5 dB(A)

26  Technical characteristics EcoStar Info, EcoStar Auto

Essential performance requirements for electromagnetic compatibility
The EcoStar™ Info or EcoStar™ Auto device generates an over pressure and regulates it to make the patient
sleep properly. The device saves its settings and the value of the pressure delivered remains at the set pressure
± 0.5 cmH2O.

Electromagnetic emissions

The EcoStar™ Info or EcoStar™ Auto device is designed for use in the electromagnetic environment specified
below. The customer or the user of the device should ensure that it is used in such an environment.

Emission test Conformity Recommended electromagnetic environment

RF emissions The EcoStar™ Info or EcoStar™ Auto device uses RF energy only
CISPR 11 for its internal operation. Therefore its RF emissions are very low
Group 1
and cannot be assumed to interfere with nearby electronic
equipment.
RF emissions
Class B
CISPR 11
The EcoStar™ Info or EcoStar™ Auto device is suitable for use in
Harmonic emissions
Class A all establishments including residential establishments and those
CEI 61000-3-2
directly connected to the public low-voltage power supply
Voltage fluctuations / network which supplies residential buildings.
flicker emissions Complies
CEI 61000-3-3

Electromagnetic Immunity

The EcoStar™ Info or EcoStar™ Auto device is designed for use in the electromagnetic environment specified
below. The customer or the user of the device should ensure that it is used in such an environment.

Immunity test CEI 60601 test level Compliance level Recommended electromagnetic environment

Electro-static discharge Floors should be wood, concrete or ceramic tile. If

± 6 kV contact ± 6 kV contact
(ESD) the floor is covered with synthetic material, the
± 8 kV air ± 8 kV air relative humidity should be at least 30%.
CEI 61000-4-2
Electrical fast transient / ± 2 kV for power ± 2 kV for power Mains power quality should be that of a typical
burst supply lines supply lines commercial or hospital environment.
CEI 61000-4-4 ± 1 kV for input / ± 1 kV for input /
output lines output lines
Lightning ± 1 kV lines to lines ± 1 kV lines to lines Mains power quality should be that of a typical
CEI 61000-4-5 commercial or hospital environment.
Voltage dips, short < 5% UT < 5% UT Mains power quality should be that of a typical
interruptions and voltage (>95% dip in UT) (>95% dip in UT) commercial or hospital environment.
variations on power for 0.5 cycles for 0.5 cycles If the user of a EcoStar™ Info or EcoStar™ Auto
supply input lines 40% UT 40% UT device requires continued operation during power
CEI 61000-4-11 (60% dip in UT) (60% dip in UT) outages, it is recommended that the device be
for 5 cycles for 5 cycles powered from an uninterruptible power supply or a
battery.
70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
< 5% UT < 5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 s for 5 s

EcoStar Info, EcoStar Auto Technical characteristics  27

 Electromagnetic Immunity (continued)

Magnetic fields in the

Power frequency magnetic fields should be at
Power Supply
3 A/m 3 A/m levels characteristic of a typical commercial or
Frequencies (50/60 Hz)
hospital environment.
CEI 61000-4-8

Note: UT is the AC mains voltage prior to application of the test level.

Electromagnetic Immunity - Conducted and radiated RF

The EcoStar™ Info or EcoStar™ Auto device is designed for use in the electromagnetic environment specified
below. The customer or the user of the device should ensure that it is used in such an environment.

Immunity test CEI 60601 test level Compliance level Recommended electromagnetic environment

Portable RF communications equipment should

not be used in proximity to any part of a
EcoStar™ Info or EcoStar™ Auto device including
Conducted RF 3 V rms 3 V rms the cables.
CEI 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz
Recommended separation distance:
d = 1.2P
Radiated RF 3 V/m 3 V/m d = 1.2P 80 MHz to 800 MHz
CEI 61000-4-3 80 MHz to 2.5 GHz
d = 2.3P 800 MHz to 2.5 GHz

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).
a
Fields strengths from fixed RF transmitters, as determined by an electromagnetic site survey , should be less than the
b
compliance level in each frequency range .
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 wireless (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcasts cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be consulted. If the measured field strength in the location in which the EcoStar™ Info or EcoStar™ Auto device
is to be used exceeds the applicable RF compliance level shown above, the device should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the EcoStar™ Info or EcoStar™ Auto device.
(b)
Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3 V / m.

28  Technical characteristics EcoStar Info, EcoStar Auto

 Recommended separation distance between portable and mobile RF communication equipment and a
EcoStar™ Info or EcoStar™ Auto device

EcoStar™ Info and EcoStar™ Auto devices are designed to be used in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or user of the EcoStar™ Info or EcoStar™ Auto device
can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and this device as recommended below, according to the
maximum power of the communications equipment.

Rated maximum Separation distance according to frequency of transmitter (m)

output power of
transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
(W) d = 1.2P d = 1.2P 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

CAUTION
The use of accessories and cables other than those specified, may result in increased emissions or decreased
immunity of the EcoStar™ Info and EcoStar™ Auto devices.

P/N: M-214831-10 2 m (6.5 ft)

Mini USB 2 m cable

P/N: M-214831-11 2 m (6.5 ft)

RS 232/mini USB 2 m cable

P/N: M-214831-12 15 m (50 ft)

RS 232/mini USB 15 m cable

EcoStar Info, EcoStar Auto Technical characteristics  29

30  Technical characteristics EcoStar Info, EcoStar Auto
 Manufacturer: Manufacturing plant:
SEFAM SEFAM
144 AV CHARLES DE GAULLE 10 ALLEE PELLETIER DOISY
0459
92200 NEUILLY SUR SEINE 54600 VILLERS-LES-NANCY
FRANCE FRANCE

: M-159DFU01-90 Revision 4
2015-08