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2 EcoStar
Manufacturer:
Manufacturing and technical service location:
SEFAM
144 AV CHARLES DE GAULLE
92200 NEUILLY SUR SEINE
France
SEFAM
10 ALLEE PELLETIER DOISY
54600 VILLERS-LES-NANCY
FRANCE
TEL: +33 (0) 3 83 44 85 00
www.Sefam-medical.com
Technical assistance:
E:mail: technicalservice@sefam-medical.com
EcoStar Table of Contents 3
TABLE OF CONTENTS
Before starting .................................................................................................................................. 4
Safety instructions ...................................................................................................................................... 4
Intended use ................................................................................................................................................. 5
Contraindications ........................................................................................................................................ 5
List of authorised accessories .................................................................................................................. 5
Accessing device settings ............................................................................................................... 6
Definitions ..................................................................................................................................................... 6
Setting ranges .............................................................................................................................................. 6
Ramp feature ............................................................................................................................................... 7
Device settings ............................................................................................................................................ 7
Description of symbols displayed on the screen ........................................................................................ 8
Settings ............................................................................................................................................................... 8
Adjustment of the pressure at the device outlet....................................................................................... 11
Choosing a pressure unit .............................................................................................................................. 11
Cleaning and Maintenance ............................................................................................................ 12
Weekly ......................................................................................................................................................... 12
Air inlet filter ..................................................................................................................................................... 12
Monthly ....................................................................................................................................................... 12
Device ............................................................................................................................................................... 12
Air inlet filter ..................................................................................................................................................... 12
Disinfecting the equipment ............................................................................................................ 13
Disinfecting the surface of the device ................................................................................................... 13
Products which must not be used ......................................................................................................... 13
Trouble-shooting ............................................................................................................................. 14
Device messages ...................................................................................................................................... 14
Error messages ......................................................................................................................................... 14
Technical characteristics ............................................................................................................... 16
Device performance.................................................................................................................................. 16
Conditions of use ...................................................................................................................................... 16
Electrical characteristics .......................................................................................................................... 16
Transport and storage conditions ......................................................................................................... 16
Physical characteristics ........................................................................................................................... 16
Symbols on the device ............................................................................................................................. 17
Disposing of the device at the end of its life ........................................................................................ 17
CE marking ................................................................................................................................................. 17
NF EN ISO 17510-1:2009 compliant features ...................................................................................... 18
Static pressure stability at 10 cmH
2
O ......................................................................................................... 18
Dynamic pressure stability............................................................................................................................ 18
Maximum flow ................................................................................................................................................ 19
Sound pressure level measured in accordance with NF EN ISO 17510-1:2009: ................................ 19
Sound power level measured in accordance with NF EN ISO 17510-1:2009: .................................... 19
Standards Compliance ............................................................................................................................. 19
Essential performance requirements for electromagnetic compatibility ....................................... 20
4 Before starting EcoStar
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
WARNING
In this manual, this signals
a risk of injury or accident
to the patient.
Please familiarize yourself with the safety
instructions in the patient manual.
Refer to the patient manual for installing,
maintaining and storing the device.
You must ensure that the patient receives the
manual intended for his use, as well as the
instructions for using the accessories.
Only use authorized accessories as listed in this
manual.
For proper maintenance and to prevent the risk
of damage, only qualified personnel are
authorized to service the device or carry out
approved modifications. The user assumes full
responsibility for any malfunction of the device
caused by maintenance performed by
unauthorized personnel.
If you observe any anomaly in the device, do not
begin treatment.
Never use the device without making sure that
the air inlet filter is installed.
The patient should not use the device if it is near
or on top of a device other than the GoodKnight
H
2
O humidifier.
When using oxygen, the oxygen source should
be placed at more than one meter from the
device.
Do not introduce liquids or objects into the air
outlet.
Portable RF communications equipment
(including peripherals such as antenna cables
and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
EcoStar device, including cables specified by
the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
Use of this equipment adjacent to or stacked
with other equipment should be avoided
because it could result in improper operation. If
such use is necessary, this equipment and the
other equipment should be observed to verify
that they are operating normally.
CAUTION
In this manual, this
indicates that there is a
possibility of material
damage to this device
or any other device.
Since this is a medical electrical device,
please follow the installation instructions
contained in this manual concerning
electromagnetic compatibility.
Like all medical electrical devices, the device
is vulnerable to interference from mobile and
portable radiofrequency communication
equipment (cordless phones, WiFi) which
could be placed nearby.
Addition of any accessory at the respiratory
circuit level or combination with other
medical devices may affect the performance
of the device. Check that the pneumatic
configuration selected is suitable.
Never connect the device to a battery when it
is charging from the mains.
If the device is used with a GoodKnight H
2
O
heating humidifier:
When using the humidifier's water chamber,
the patient must take precautions to
eliminate the risk of introducing water into
the machine, which can cause irreversible
damage. The device must be placed on a
stable horizontal surface and must not be
tilted.
We recommend disconnecting the device
from the heating humidifier and emptying the
water chamber before moving or
transporting the assembly, to eliminate any
risk of introducing water into the device,
which could cause irreversible damage.
EcoStar Before starting 5
Intended use
The EcoStar device is a Positive Pressure device
indicated for the mask treatment of Sleep Apnea
Syndrome (SAS) in patients weighing more than
30 kg (66 lbs). It can be used at home or in a
sleep center. It is not suitable to be used in close
proximity to CT scanners, MRT devices, RF
surgical devices or in transportation vessels (on
land, sea or in the air).
The device can be used with the GoodKnight
H
2
O humidifier if a prescription for heated
humidification has been added to the patient's
treatment. The heated humidifier is designed to
heat and raise the humidity of the air delivered
to the patient through the Continuous Positive
Airway Pressure (CPAP) device.
Contraindications
Studies have shown that the use of positive
airway pressure is contraindicated for certain
patients with one of the following pre-existing
conditions:
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.
Moreover, as the effect of positive airway
pressure on cardiac output is clear for some
patients, close monitoring of the patient's blood
pressure and heart rate are recommended when
beginning treatment at the effective pressure.
The risks and benefits of continuous positive
airway pressure must be assessed on a case-
by-case basis for these patients.
List of authorized
accessories
Unless otherwise indicated, the EcoStar
device can be used with the following
optional accessories:
Power supply
P/N M-413910-00
(EU plug)
Air inlet filter
P/N M-415930-01
P/N M-415910-03
(plug except EU)
GoodKnight H
2
O
P/N M-114600
Carrying case
P/N M-214531-01
WARNINGS
Use only those accessories authorized
according to the list above, or which comply
with standard EN ISO 17510-2:2007.
Use only those accessories which can
guarantee treatment pressure and reduce re-
inhalation of CO
2
.
When a facial mask is necessary, always use
a mask which is equipped with an anti-
asphyxia valve.
6 Accessing device settings EcoStar
Accessing device settings
The device operates in continuous mode, which
means that the pressure is set at a constant level
and no automatic change in pressure is possible.
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.
WARNING
Before proceeding with device settings, check
that the device produces airflow when in
operating mode. If not, turn it off immediately
and contact technical support.
Definitions
Compliance
counter:
length of time during which the
patient actually breathed with the
mask (minus the periods when the
mask is removed and moments
when breathing does not occur).
Hour
counter:
time during which the machine was
in use (Start/Stop).
Pressure
level:
pressure applied at the end of ramp
time or at start-up if the ramp is
disabled (set at 0).
Comfort
pressure:
level of pressure produced by the
device when the ramp feature starts
up so that the patient can go to
sleep comfortably.
Prescribed
pressure:
level of pressure prescribed for the
patient.
CPAP:
Continuous Positive Airway
Pressure.
SAS:
Sleep Apnea Syndrome.
Ramp
time:
time the device takes to reach the
prescribed pressure when starting
from the comfort pressure.
Setting ranges
For each parameter, the following table shows the
minimum, maximum and default values which can
be set for the device:
Notes:
As the device is equipped with a
differential pressure sensor,
compensation in altitude is
automatic.
The default unit of pressure is
cmH
2
O
Parameter
Minimum
value
Maximum
value
Default
value
Step
Prescribed pressure
4 cm H
2
O
20 cm H
2
O
8 cm H
2
O
0.5 cm H
2
O
Comfort Pressure
4 cm H
2
O
Prescribed
pressure
4 cm H
2
O
0.5 cm H
2
O
Ramp time
0 min
30 min
0 min
5 min
EcoStar Ramp feature 7
Ramp feature
The Ramp feature allows for a gradual rise in pressure.
1. To start the ramp feature, press the
on/off button .
The ramp indicator is displayed and
compliance recording begins.
The pressure level will gradually increase
from the comfort pressure to the level of
prescribed pressure.
Note:
If the ramp time is set at zero, the ramp
feature is disabled.
2. To turn the ramp feature off, press the
ramp button .
You can adjust the comfort pressure and the ramp time. Refer to "Settings" on page 8.
Device settings
The three buttons on the front of the device
allow access to the device settings and are
used to change the value of certain
parameters.
The parameters accessible on the screen
when the machine is in standby or operating
mode are:
parameters of the device relating to
treatment
the compliance data which has been
recorded.
Each screen of the practitioner settings menu
includes:
an upper section indicating the value of
the parameter displayed
a lower section with various symbols
indicating the device's operating mode or
the nature of the parameter displayed
(see table entitled "Description of symbols
displayed on the screen").
8 Description of symbols displayed on the screen EcoStar
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
Device message
Error message
Pressure sensor offset
Settings
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.
To access the device settings:
press the hidden key, then keeping it held
down, simultaneously press the information
access key for one second.
On the screen which appears:
the symbol or the symbol shows if
the device is on standby or in use.
the symbol indicates that the parameter
displayed can be modified. Raise the value
of the parameter by pressing the on/off
button or lower it using the ramp
button .
To access the next data:
press the information access button
again.
Note:
In the settings sequence below, the device is shown in operating mode and all the values displayed are
given by way of example.
EcoStar Settings 9
❶
This screen appears:
Press
simultaneously
the hidden key
and
for one second
Level of prescribed pressure
Increase or decrease the value displayed
using the button or the button.
❷
Press
Ramp time
Increase or decrease the value displayed
using the button or the button.
❸
Press
Comfort Pressure
This parameter is only adjustable if the
ramp time is greater than 0.
Increase or decrease the value displayed
using the button or the button.
For further information, refer to "Ramp
feature” on page 7.
❹
Press
Hour counter value (device operating
time).
The value displayed on the right below
represents the minutes. The hour meter
value cannot be changed.
❺
Press
Value of the compliance counter (time
during which the patient actually breathed
with the mask). The value displayed on
the right below represents the minutes.
This counter can only be reset to zero. To
do this, press the hidden key, then keeping
it held down, press the button or the
button.
10 Settings EcoStar
❻
This screen appears:
Press
Built-in pressure sensor offset.
This value can be adjustable between 0 and 255.
Increase or decrease the value displayed using
the button or the button. For further
information, refer to "Adjustment of the pressure
at the device outlet" on page 11.
❼
Press
Software version included with the EcoStar
device.
To exit the parameter settings menu, press the information access button again.
The display will indicate the operating status of the machine as shown below:
The machine is in standby
mode.
The device is running.
Note:
Exit from the parameter setting menu takes place automatically when you do not press any key for 30
seconds.
CAUTION
If, when in use, a problem with the memorized settings is detected, the device stops and displays the message
Er 1.
Press (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.
EcoStar Adjustment of the pressure at the device outlet 11
Adjustment of the pressure at the
device outlet
1. Connect the spiral tubing to the device
outlet and the free nozzle of the tubing
to a plug equipped with a 4 mm leak
and a pressure point.
2. Then connect the pressure point to a
manometer and adjust the pressure
order to 12 cmH
2
O.
3. Access the settings for the pressure
sensor offset as shown in "Settings" on
page 8 of this manual, and adjust the
value using the button or the
button until the pressure reads
12.0 cmH
2
O on the manometer.
4. Then, press the button while
holding down the hidden key. The
pressure sensor offset setting is
automatically memorized.
Choosing a pressure unit
You can select hPa instead of cmH2O as
the default pressure unit displayed on the
device, and vice versa.
To select the pressure unit, hold the hidden
key and the button simultaneously
pressed while you connect the device to the
power supply source (electrical outlet). The
machine displays the unit selected until you
release the hidden key and the
button.
Repeat to change the unit displayed.
12 Cleaning and Maintenance EcoStar
Cleaning and Maintenance
WARNING
Always unplug the device from the electrical source and disconnect the respiratory circuit from the
device before cleaning.
CAUTION
Do not let water come into contact with the device.
Use appropriate materials for cleaning: do not use harsh detergents, abrasive sponges or brushes with
hard bristles.
Weekly
Air inlet filter
Remove the filter at the rear of the device.
Wash the filter with warm water and mild
detergent (for example 1 drop of
dishwashing liquid on the filter).
Rinse well to eliminate any trace of
detergent.
Dry the filter:
o Press dry in a clean, absorbent cloth
o Allow to dry completely away from
sunlight.
Once dry, reinstall the filter at the rear of
the device. Do not use a filter which is not
completely dry.
Monthly
Device
Clean the device exterior regularly by
using a damp cloth or paper towel
moistened with a little water and a
drop of gentle detergent.
Remove detergent residue by repeating
this step with a clean cloth or paper
towel, slightly moistened with just
water.
Wipe the entire device with a dry cloth
or paper towel.
Air inlet filter
Change the filter whenever it is damaged
or soiled.
WARNINGS
Do not use detergent sprays. Chemical
product residue could enter the air outlet,
the filter's foam or the device interior,
causing airway irritation.
Never use the device without making sure
that an air inlet filter is installed.
Note:
Please refer to the instructions for your mask, the heating humidifier and the respiratory circuit for more
information about the care and maintenance of these items.
EcoStar Disinfecting the equipment 13
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
A detergent-disinfectant is used to
disinfect the exterior of the machine.
If using a spray or foam detergent-
disinfectant:
o Spray the product onto a
disposable cleaning pad made of
a non-woven material.
o Wipe the exterior of the device
and allow to dry.
If using detergent-disinfectant wipes:
o Wipe the exterior of the device
and allow to dry.
Products which must not be
used
Never use abrasive or highly alkaline
cleaning products, acetone, benzene or
leaded gasoline to clean the device.
Do not use materials such as abrasive
sponges or stiff-bristled brushes.
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 which is not
effective on Mycobacterium tuberculosis
(BK).
Never disinfect the internal circuit of air
flow using a disinfecting product or with
an Airway Surface Disinfection System
(DSVA).
14 Trouble-shooting EcoStar
Trouble-shooting
Device messages
Message
displayed
Possible cause
Solution proposed
In 01
The mask is disconnected.
Check the connections between the mask, the
patient circuit, and the device. This message
disappears as soon as the mask is well
connected.
In 02
The device has detected
excess pressure for more
than 10 seconds.
Contact the technical department.
In 03
Reduction of the power
supply voltage.
Check the connections between the power supply
module, the device and the power outlet. Unplug
the power supply module, then reconnect it to the
power outlet. If the problem persists, contact your
home care provider.
Check the battery and replace it if necessary. If
the message persists, contact your home care
provider.
Error messages
Message
displayed
Possible cause
Solution proposed
Er 01
Problem with the settings.
Contact the technical department.
Er 02
High turbine temperature.
Unplug the device from all sources of electrical
power. Allow it cool and plug it in again according
to the instructions in the patient manual.
If the error persists, return the machine to the
technical department.
Er 06
CheckSum code error.
Unplug the device from all sources of electrical
power. Plug it in again.
If the error persists, return the machine to the
technical department.
EcoStar Trouble-shooting 15
Message
displayed
Description
Solution proposed
Er 07
Problem with the turbine.
Unplug the device from all sources of electrical
power. Check that there are no foreign bodies in
the air outlet. Plug the device in again.
If the error persists, return the machine to the
technical department.
Er 10
Motor power limit has been
exceeded.
Unplug the device from all sources of electrical
power. Plug it in again.
If the error persists, return the machine to the
technical department.
Er 11
Overconsumption of power
by the motor.
Unplug the device from all sources of electrical
power. Plug it in again.
If the error persists, return the machine to the
technical department.
Er 12
Device memory is empty.
Unplug the device from all sources of electrical
power. Plug it in again.
If the error persists, return the machine to the
technical department.
Er 13
Error in the speed table.
Unplug the device from all sources of electrical
power. Plug it in again.
If the error persists, return the machine to the
technical department.
Er 14
Problem with the motor
control.
Unplug the device from all sources of electrical
power. Plug it in again.
If the error persists, return the machine to the
technical department.
Er 15
CheckSum error in the
memory.
Unplug the device from all sources of electrical
power. Plug it in again.
If the error persists, return the machine to the
technical department.
Er 16
I²C communication error.
Unplug the device from all sources of electrical
power. Plug it in again.
If the error persists, return the machine to the
technical department.
EcoStar CPAP System is not designed to be repaired. A faulty EcoStar will be replaced with a new
one.
16 Technical characteristics EcoStar
Technical characteristics
Device performance
Device pressure range:
4 cm H
2
O to 20 cm H
2
O 1 cmH2O
device adjustable in increments of 0.5 cm H
2
O
Maximum pressure at the patient-side connection
port under single fault condition:
30 cmH
2
O
Ramp time:
0 to 30 minutes 1 minute
device adjustable in increments of 5 minutes
Patient-side connection aperture:
Conical connection of 22mm diameter
Sound pressure level measured in accordance with
NF EN ISO 17510-1: 2002:
27 dB(A)
Sound pressure level measured in accordance with
NF EN ISO 17510-1: 2009:
29 dB(A)
Conditions of use
Electrical characteristics
Absolute pressure
range:
700 hPa to 1060 hPa
Maximum power
consumption:
20 W
Temperature:
+5°C to +40°C
(+41 °F to +104 °F)
Input voltage:
13 V
+5°C to +35°C
(41 °F to 95°F) with
GKH
2
O humidifier
Current consumed
at 20 cmH
2
O with a
4mm 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
Relative pressure
range:
500 hPa to 1060 hPa
Dimensions
(D x W x H):
202 x 145 x 79 mm
approx.
(7.9 x 5.7 x 3.1 in
approx.), without power
supply module
Temperature:
-20°C to +60°C
(-4 °F to +140 °F)
Relative humidity:
up to 95% without
condensation
Weight:
0.644 kg approximately
(1.4 lbs approx.), without
power supply module
EcoStar Technical characteristics 17
Symbols on the device
Symbol
Description
Symbol
Description
On/off button symbol.
Ramp button symbol.
Symbol for raising the value of the
parameter displayed on the screen.
Symbol for lowering the value of
the parameter displayed on the
screen.
Information access button symbol.
Outlet symbol.
Device is protected against the
penetration of solid objects larger
than 12 mm and against falling
drops of water.
Device at the end of its life,
separate from household waste for
disposal.
For further information, refer to
"Disposing of the device at the end
of its life".
Class II device.
BF-type device.
Direct current power supply.
Direct current.
Refer to the user manual.
Specific warning (see "Safety
instructions" in the patient manual).
Device complies with the
requirements of European Directive
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.
CE marking
EcoStar : 2013.
18 Technical characteristics EcoStar
NF EN ISO 17510-1:2009 compliant features
Static pressure stability at 10 cmH
2
O
(Long-term accuracy according to ISO 17510-1:2009, Appendix BB.1)
Without humidifier
With GoodKnight H
2
O
humidifier
Pressure accuracy (cmH
2
O):
- 0.02 /- 0.37
- 0.37 / - 0.74
Dynamic pressure stability
(Short-term accuracy according to ISO 17510-1:2009, Appendix BB.2)
Test pressure (cmH
2
O)
4
8
12
16
20
Respiratory
rate
Resp./min
Respiratory
rate
Resp./min
Respiratory
rate
Resp./min
Respiratory
rate
Resp./min
Respiratory
rate
Resp./min
10
15
20
10
15
20
10
15
20
10
15
20
10
15
20
Without humidifier :
Delta relative to
highest pressure
(cmH
2
O)
0.05
0.03
0.07
0.07
0.08
0.12
0.09
0.11
0.14
0.26
0.26
0.31
0.32
0.30
0.31
Delta relative to
lowest pressure
(cmH
2
O)
0.23
0.32
0.40
0.31
0.36
0.41
0.40
0.44
0.49
0.38
0.41
0.46
0.46
0.48
0.51
Delta relative to
dynamic pressure
(cmH
2
O)
0.07
0.06
0.07
0.09
0.12
0.15
0.16
0.20
0.20
0.33
0.32
0.42
0.36
0.32
0.37
With GoodKnight H
2
O humidifier :
Delta relative to
highest pressure
(cmH
2
O)
0.2
0.19
0.31
0.32
0.33
0.35
0.48
0.52
0.54
0.65
0.73
0.82
0.86
0.95
1.00
Delta relative to
lowest pressure
(cmH
2
O)
0.31
0.5
0.79
0.35
0.54
0.82
0.35
0.54
0.75
0.3
0.51
0.73
0.24
0.43
0.69
Delta relative to
dynamic pressure
(cmH
2
O)
0.08
0.1
0.09
0.1
0.11
0.13
0.14
0.16
0.24
0.18
0.32
0.3
0.23
0.28
0.35
EcoStar Technical characteristics 19
Maximum flow
(According to ISO 17510-1:2009, Appendix CC.1)
Test pressure (cmH
2
O)
4
8
12
16
20
Without humidifier :
Maximum flow (l/min) provoking a
pressure drop of 1 cmH
2
O at the
opening of the patient side connection
> 105.0
> 159.0
167.0
144.0
132
With GoodKnight H
2
O humidifier :
Maximum flow (l/min) provoking a
pressure drop of 1 cmH
2
O at the
opening of the patient side connection
48
47
45
44
43
Sound pressure level measured in accordance with NF EN ISO 17510-1:2009:
26 dB(A)
Sound power level measured in accordance with NF EN ISO 17510-1:2009:
34 dB(A)
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 device complies with the following directives and standards:
IEC 60601-1:2005 + Amd1:2012: Medical
electrical equipment. Part 1: General
requirements for basic safety and essential
performance.
IEC 60601-1-2:2014: Medical electrical
equipment – Part 1-2: General requirements
for basic safety and essential performance –
Collateral Standard: Electromagnetic
disturbances – Requirements and tests.
ISO 80601-2-70-1:2015: Medical electrical
equipment -- Part 2-70: Particular
requirements for basic safety and essential
performance of sleep apnea breathing
therapy equipment.
NF EN ISO 5356-1:2005 : Anaesthetic and
respiratory equipment. Conical connectors.
Council Directive 93/42/EC concerning
medical equipment.
European Parliament and Council Directive
2011/65/EC on the restriction of the use of
certain hazardous substances (RoHS) in
electrical and electronic equipment.
European Parliament and Council Directive
2012/19/EC on waste electrical and
electronic equipment (WEEE).
20 Technical characteristics EcoStar
Essential performance requirements for electromagnetic
compatibility
The EcoStar device generates an over pressure and regulates it to make the patient sleep properly.
The device retains its settings and the value of the delivered pressure remains that of the set
pressure + /-0.5cm H
2
O.
If the Essential performance is lost or degraded, the delivered pressure could be different of the set
pressure. It is widely recognized that a patient will be resume breathing after the 5 seconds
interruption or that the patient will reset the device (without experiencing a hazard) when he notices
the display has stalled.
Electromagnetic emissions
The EcoStar device is designed for use in the electromagnetic environment specified below. The
customer or the user of an EcoStar device should ensure that it is used in such an environment.
Emission test
Conformity
Recommended electro-magnetic environment
RF emissions
CISPR 11
Group 1
The EcoStar device uses RF energy only for its internal
operation. Therefore its RF emissions are very low and
cannot be assumed to interfere with nearby electronic
equipment.
RF emissions
CISPR 11
Class B
The EcoStar device is suitable for use in all
establishments including residential establishments and
those directly connected to the public low-voltage power
supply network which supplies residential buildings.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations
/ flicker emissions
IEC 61000-3-3
Complies
Electromagnetic Immunity
The EcoStar device is designed for use in the electromagnetic environment specified below. The
customer or the user of an EcoStar device should ensure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Conformity level
Recommended electro-magnetic environment
Electro-static
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 2 kV air, ± 4 kV
air, ± 8 kV air,
± 15 kV air
± 8 kV contact
± 2 kV air, ± 4 kV
air, ± 8 kV air,
± 15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV
100kHz repetition
frequency
± 2 kV
100kHz repetition
frequency
Mains power quality should be that of a
typical commercial or hospital
environment.
Lightning
IEC 61000-4-5
± 0,5 kV, ± 1 kV
lines to lines
± 0,5 kV, ± 1 kV
lines to lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
< 5% UT
(>95% dip in UT) for
0.5 cycles
0% UT
for 1 cycle
70% UT
(30% dip in UT) for
25 cycles
< 5% UT
(>95% dip in UT) for
5 s
< 5% UT
(>95% dip in UT) for
0.5 cycles
0% UT
for 1 cycle
70% UT
(30% dip in UT) for
25 cycles
< 5% UT
(>95% dip in UT) for
5 s
Mains power quality should be that of a
typical commercial or hospital
environment.
If the user of an EcoStar device requires
continued operation during power
outages, it is recommended that the
EcoStar device be powered from an
uninterruptible power supply or a battery.
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