Service Manual Cpap 2

SERVICE MANUAL
EcoStar™ Info
EcoStar™ Auto
159MAT00-30.3
Manufacturer: Manufacturing plant :
SEFAM SEFAM
144 AV CHARLES DE GAULLE 10 ALLÉE PELLETIER DOISY
92200 NEUILLY SUR SEINE 54600 VILLERS-LES-NANCY
FRANCE FRANCE
TEL : +33 (0) 3 83 44 85 00
www.sefam-medical.com
EcoStar Info/Auto Service Manual
PREFACE
This manual provides information necessary to service the EcoStarTM Info/Auto Respiratory System.
This information is intended for use by technicians or personnel qualified to repair and service
medical equipment.
TECHNICAL BULLETINS
Please contact our technical agencies for Technical Bulletins related to your device.
DEFINITION OF STATEMENTS
Statements in this manual preceded by the followings words are of special significance.
WARNING
Means there is the possibility of injury or death to yourself or others.
CAUTION
Means there is the possibility of damage to the EcoStarTM Info/Auto unit or other
property.
NOTE
Indicates points of particular interest for more efficient and convenient operation.
Service Manual Rev.3 1

REVISION LIST OF
EcoStar Info et Auto Service Manual
TM
Service Manual 159MAT00-30.3
Revision Description Date

01 Initial Release 2014-12
02 modification comfort calibration, auto ON and Ramp 2015-10
Modification the appellation of the French standards CEI by the Standards 2016-04
03 English IEC.
0459
Device in conformity with the requirements of Directive 93/42/EEC.
Risks pertaining to this medical equipment were assessed in accordance with the NF EN ISO 14971:2013
standard, specifically with reference to global residual risk.

CONTENTS
PREFACE 1
LIST OF REVISION 2
I - GENERAL INFORMATION I-1
A. Specifications I-2
1) Device Performances I-2
2) Electrical Specifications I-2
3) Storage and transport specifications I-3
4) Operating specifications I-3
5) Physical specifications I-3
6) Sound Levels I-3
7) Static pressure stability I-4
8) Dynamic pressure stability I-4
9) Maximum flow I-6
B. Using a Humidifier I-6
C. Standards Compliance I-7
D. Essential performance requirements for electromagnetic compatibility I-7

E. Autorized accessories I-10
F. Symbols I-10
II - THEORY OF OPERATION II-1
A. General description II-2

1) General design-Synopsis II-2
2) Keyboard II-2
3) Description II-3
4) Interactions between commands II-3
5) Temperature sensor II-3
6) Behaviour in case of main cut –off II-3
7) Pneumatic diagram II-3

8) Electrical design-Synopsis II-4

9) Means of pressure limitation II-5
10) settings access II-5
III - MAINTENANCE III-1
A. Performance verification and preventive maintenance III-3

1) General informations III-3
2) Control frequency and equipment required III-3
3) Annual pressure verification III-4
4) Pressure & Flow calibration _________________________________________ III-5
B. Dysassembly procedure III-10

1) Disassembly III-11
2) Assembly III-12
C. Trouble Shooting III-13
IV - SPARE PARTS IV-1

I - GENERAL INFORMATIONS
Service Manual Rev.3 I-1

A. SPECIFICATIONS
1) Device Performances
(See Note 1)
 Pressure adjustment range 4 to 20 cmH2O + 0,5cmH2O increments of
0,5 cmH2O (See Note 2)
 Maximum steady limiting pressure PLSmax = 30 cmH2O
at the patient connection port
under first fault condition:
 Flow range 0 to 150 l/min @ 4 to 20 cmH2O
( Lower pressure drop lower than 1cmH2O at a maximum flow rate of 150L/min ( 4 to
20cmH2O)
 Ramp (adjustable) 0 to 45min+ 1 minute adjustable in 5 minutes

increments
NOTE 1 : All the stated performances are for a 1.80-meter patient circuit, recommended
by the manufacturer.
NOTE 2 : The display can be in “hPa”. The pressure adjustment range is then between
3.9 hPa and 19.6 hPa. To select the unit refer to the Maintenance chapter.
2) Electrical specifications
 External Power Supply 100-240 VAC (-15%, +10%), 50-60 Hz
 DC Input 13 V
 Consumption 25 W max.
 CPAP consumption 0.750A @ 20cmH2O with 4 mm leak

3) Storage / Transport specifications

 Storage / Transport temperature -20° C to 60° C
 Storage / Transport humidity up to 95 % (non-condensing)
 Storage / Transport pressure 500 hPa to 1060 hPa (approximately up to
altitude of 2,400 m.)
4) Operating specifications
 Operating temperature +5° C to +40° C (5°C to 35°C with GKH2O)

 Operating humidity between 15 % and 95 % (non-condensing)
 Operating pressure 700 hPa to 1060 hPa (approximately up to
altitude of 2,400 m.)
5) Caractéristiques physiques
 Width 145 mm
 Height 79 mm
 Length 202 mm
 Weight 0,750 kg (without external power supply)
6) Sound Levels
Sound pressure level measured in accordance with NF EN ISO 17510-1:2009:
27,5dB(A) (without humidifier)
Sound pressure level measured in accordance with NF EN ISO 17510-1:2009:

29,5dB(A) (with humidifier GoodKnight H²O and tube diameter 15mm)
Sound power level measured in accordance with NF EN ISO 17510-1:2009:

35,5dB(A) (without humidifier)
Sound power level measured in accordance with NF EN ISO 17510-1:2009:

37,5dB(A) (with humidifier GoodKnight H²O and tube diameter 15mm )

7) Static Pressure Stability at 10cmH2O

( NF EN ISO 17510-1: 2009 BB.1 et ISO 80601-2-70:2014 §201.12.1.101 )
Without Humidifier
Pressure accuracy (cmH2O) : +/- 0,5 cmH2O
With Humidifier GKH2O
Pressure accuracy (cmH2O) : +/- 0,5 cmH2O
8) Dynamic Pressure Stability

( NF EN ISO 17510-1 : 2009 BB.2 and ISO 80601-2-70:2014 §201.12.1.102 )
Without humidifier and tubing 22mm diameter
Pressure (cmH2O) 4 8 12 16 20
Respiratory rate
10 15 20 10 15 20 10 15 20 10 15 20 10 15 20
(Resp./min)
Delta relative to
highest pressure 0.09 0.13 0.11 0.29 0.28 0.31 0.32 0.36 0.33 0.29 0.26 0.38 0.31 0.29 0.37
(cmH2O)
Delta relative to
lowest pressure 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
(cmH2O)
Delta relative to
dynamic pressure 0.03 0.03 0.03 0.05 0.06 0.07 0.07 0.07 0.09 0.10 0.11 0.14 0.12 0.13 0.29
(cmH2O)
Without humidifier and tubing 15mm diameter
Respiratory rate
10 15 20 10 15 20 10 15 20 10 15 20 10 15 20
(Resp./min)
Delta relative to
(cmH2O)
Delta relative to
lowest pressure 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
(cmH2O)
Delta relative to
(cmH2O)

With humidifier GKH2O and tubing 22mm diameter
Respiratory rate
10 15 20 10 15 20 10 15 20 10 15 20 10 15 20
(Resp./min)
Delta relative to
(cmH2O)
Delta relative to
lowest pressure 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
(cmH2O)
Delta relative to
dynamic pressure 0.04 0.06 0.06 0.08 0.15 0.13 0.10 0,16 0.24 0.15 0.23 0.25 0.16 0.29 0.33
(cmH2O)
With humidifier GKH2O and tubing 15mm diameter
Respiratory rate
10 15 20 10 15 20 10 15 20 10 15 20 10 15 20
(Resp./min)
Delta relative to
(cmH2O)
Delta relative to
lowest pressure 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
(cmH2O)
Delta relative to
(cmH2O)
With humidifier GKH2O, tubing 15mm diameter, and high-efficiency filter
Respiratory rate
10 15 20 10 15 20 10 15 20 10 15 20 10 15 20
(Resp./min)
Delta relative to
(cmH2O)
Delta relative to
lowest pressure 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
(cmH2O)
Delta relative to
(cmH2O)

9) Maximal Flow rate and Pressure

(NF EN ISO 17510-1 : 2009 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
opening of the patient side Tubing 22 mm diameter > 130 180 180 170 150
connection
Pressure measurement (cmH

2O) at 40 l/min at the patient Tubing 15 mm diameter 3.9 8.1 12.1 16 19.9
interface
B. USING A HUMIDIFIER
A heating or non-heating humidifier may be used with the EcoStar Info or Auto on the ex-
press condition that the following warnings are noted.
WARNING
You are strongly advised to read the manufacturer’s recommendations for the humidifier before
use.
WARNING
Using a humidifier can alter the performance of the the EcoStar™ Info or EcoStar™ Auto.
WARNING
The EcoStar™ Info or EcoStar™ Auto must always be placed above the humidifier. This posi-
tion minimizes the potential for water entering the Cpap device. Water can damage the device.

C. STANDARDS COMPLIANCE
Risks pertaining to this medical equipment were assessed in accordance with the NF EN ISO
14971: 2013 standard, specifically with reference to global residual risk. The EcoStar™ Info or
EcoStar™ Auto device complies with the following standards:
 IEC 60601-1:2005 + Amd1:2012: Medical electrical equipment. Part 1: General requirements

for basic safety and essential performance.
 IEC 60601-1-2:2007: Medical electrical equipment. Part 1: General requirements for safety. Col-
lateral standard: Electromagnetic compatibility – Requirements and tests.
 EN ISO 17510-1:2009: Sleep Apnoea Breathing Therapy.
 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 ba-
sic safety and essential performance of sleep apnoea breathing therapy equipment.
 Council Directive 93/42/EC concerning medical devices.
 European Parliament and Council Directive 2011/65/EU on the restriction of the use of certain
hazardous substances (RoHS) in electrical and electronic equipment.
 European Parliament and Council Directive 2012/19/EU on waste electrical and electronic equip-
ment (WEEE).
D. ESSENTIAL PERFORMANCE REQUIREMENTS FOR ELEC-

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

Electromagnetic Immunity
IEC 60601 test Recommended electromagnetic environ-

Immunity test Compliance level
level ment
Electro-static discharge Floors should be wood, concrete or ceramic

(ESD) ± 6 kV contact ± 6 kV contact tile. If the floor is covered with synthetic ma-
IEC 61000-4-2 ± 8 kV air ± 8 kV air terial, the relative humidity should be at least
30%.
Electrical fast transient /
burst ± 2 kV for power ± 2 kV for power Mains power quality should be that of a typi-
IEC 61000-4-4 supply lines supply lines cal commercial or hospital environment.
± 1 kV for input / ± 1 kV for input /
output lines output lines
Lightning Mains power quality should be that of a typi-

IEC 61000-4-5 ± 1 kV lines to lines ± 1 kV lines to lines cal commercial or hospital environment.
Voltage dips, short Mains power quality should be that of a typi-

interruptions and voltage < 5% UT < 5% UT cal commercial or hospital environment.
variations on power (>95% dip in UT) (>95% dip in UT) If the user of a EcoStar™ Info or EcoStar™
supply input lines for 0.5 cycles for 0.5 cycles Auto device requires continued operation
IEC 61000-4-11 40% UT 40% UT during power outages, it is recommended that
(60% dip in UT) (60% dip in UT) the device be powered from an uninterrupti-
for 5 cycles for 5 cycles ble 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
Magnetic fields in the Power frequency magnetic fields should be at

Power Supply Frequencies levels characteristic of a typical commercial
3 A/m 3 A/m
(50/60 Hz) or hospital environment.
IEC 61000-4-8
Note: UT is the AC mains voltage prior to application of the test level.

Electromagnetic Immunity - Conducted and radiated RF

IEC 60601 test Recommended electromagnetic environ-

Immunity test Compliance level
level ment
Portable RF communications equipment

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

Radiated RF 80 MHz to 2.5
IEC 61000-4-3 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).
Fields strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less
than the compliance level in each frequency rrangeb..
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 absorp-
tion 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 theore-
tically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electroma-
gnetic site survey should be consulted. If the measured field strength in the location in which the EcoStar™ In-
fo 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.

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.
E. AUTHORIZED ACCESSORIES
 EcoStar inlet air filter Ref. M-415930-01
 High-efficiency inlet air filter Ref. M-413950-04
 Specific power supply Ref. M-413910-00 (EU Plug) ; Ref. M-415910-03 (No EU Plug)
 GoodKnight H2O Heating humidifier Ref. M-114600
 Patient circuit 1,80 m 22 mm diameter Ref. M-261000-04
 Patient circuit 1,80 m 15 mm diameter Ref. M-261000-00
 Carrying case Ref. M-214531-01
 Clinical Kit Ref. M-215630-01
 Cigar lighter cable Ref. M-213930-03
 DreamStar™ Analyze software Ref. M-215630-00
 RS 232 / mini USB cable 2 m Ref. M-214831-11
 RS 232 / mini USB cable 15 m Ref. M-214831-12
 USB/Mini USB Cable 2 m (10 points) Ref. M-214831-10

Warning
The use of accessories and cables other than those specified, may increase the level of radiated
emissions or decrease the electromagnetic immunity of the EcoStar™ Info and EcoStar™ Auto
F. SYMBOLS
Symbole Description Symbole Description
On/Stand-by button symbol.

Ramp button symbol.
Symbol to increase the value of the para- Symbol to decrease the value of the para-
meter displayed on the screen. meter displayed on the screen.
Information access button symbol. Outlet symbol.
Device at the end of its life, separate

Device is protected against the penetra-
from household waste for disposal. For
tion of solid objects larger than 12 mm
further information, refer to "Disposing
and against falling drops of water.
of the device its life" (Patient Manual).
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 requirements

Specific warning (see "Safety instruc-
of European Directive 93/42/EC on me-
tions" in the patient manual).
dical devices.
On the packaging, this symbol means On the packaging, this symbol means
"Atmospheric Pressure Limit". "relative humidity limit".
On the packaging, this symbol means: On the packaging: this symbol means
temperature limit. Temperature range: - "Fragile", because the package must be
20 ° C to + 60 ° C. handled with care.
On the packaging: this symbol means

"Keep dry" because the package must be
protected against humidity and water.

Personal notes

II - THEORY OF OPERATION
Service Manual Rev.3 II-1

A. General description
1) General design-synopsis
User
Mask
Keyboard Display
DC power External
Patient EcoStar Info Mains
power module
or Auto
Patient tube
2) View of control panel

In order to restrict access of certain settings to the medical team, a hidden button has been provi-
ded on the device. It is located under the letters "Ec" of the name "EcoStar™ Info or EcoStar™
Auto” and is detectable to the touch as a hollow.
Hidden button Ramp activation

or
Parameter settings
Display
Information access On/Stand-by

button or
Parameter settings

3) Description
- The general architecture of the device is based on the use of a blower (pressurized air
generator) and a microcontroller board.
- Some functions are hardware-controlled, some are software-controlled and others are a mixture
of hardware and software.
- The EcoStar™ Info and EcoStar™ Auto devices are Positive Pressure devices indicated for the
treatment of Obstructive Sleep Apnea and Hypopnea Syndrome (OSAHS) in patients weighing
more than 30 kg (66 lbs). They can be used at home or in a sleep center.
- The EcoStar is based on a blower technology that is specifically designed for this range of
Cpap systems. This design provides optimum performances in terms of size, consumption, noise
and stability.
- In order to guarantee these optimum performances some parameters are preset in the circuit
board during the manufacturing process.
4) Interaction between commands:

- The interactions between commands are described in the practitioner manuals. Ask your repre-
sentative in order to get the reference of the practitioner manual .
5) Temperature Sensor:
- The stator of the blower is fitted with a temperature sensor which will protect the system against
the overheating of the blower in the eventuality of a problem.
- The EcoStar™ Info and EcoStar™ will stop working if the temperature goes above 95°C during
10 seconds.
6) Behavior of the devices when mains failure happens:

- The device stops working. As soon as the mains resumes, the unit starts up with the same set-
tings as the ones prior the shutdown.
7) Pneumatic diagrams

8) Electrical design synopsis

9) Means of pressure limitation

The limitation of the pressure is managed by the system of pressure production (blower motor
driver)
10) Settings access
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 acces-
sories. The correct installation and positioning of the patient interface constitute a critical condi-
tion 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 per day usage, 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.
a) Definitions:
Hour counter: Device operating time (ON/OFF).

Compliance counter : Time during which the patient breathed effectively in the mask (time re-
duced from the time when the mask was removed and the time with no respiration).
FL: Inspiratory Flow Limitation with EcoStar™ Auto device in Auto-CPAP mode.
Comfort pressure : Level of pressure produced by the device when the ramp starts up so that the
patient can go to sleep comfortably.
Prescribed pressure : Level of pressure prescribed for the patient.
Maximum pressure: Maximum pressure that the EcoStar™ Auto can deliver in Auto-CPAP mo-
de.
Maximum pressure on apnoea command : Maximum pressure on the EcoStar™ Auto beyond
which no rise in pressure can be applied once a respiratory pause has been detected.
Minimum pressure : Minimum pressure that the EcoStar™ Auto can deliver in Auto-CPAP mo-
de.
Session : Period during which data is recorded to memory between the time the device starts ope-
ration and the time it goes into standby.
Ramp time : In CPAP mode, this is the time taken by the device to reach the prescribed pressure
from the comfort pressure.
Latency time : This is the time taken by the device to activate the Auto-CPAP feature when the
ramp is enabled.

b) Setting ranges:
The following tables indicate the adjustable parameters and the features available on the
EcoStar™ Info and EcoStar™ Auto devices, as well as the pneumatic calibration regarding the
accessories used.
NOTES
- As the device is equipped with a differential 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:
Parameter Minimum value Maximum value Default value Increment
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 mini- 20 cmH2O 20 cmH2O 0,5 cmH2O
mum pressure
Minimum pressure 4 cmH2O 20 cmH2O or maxi- 4 cmH2O 0,5 cmH2O
mum pressure
Comfort pressure 4 cmH2O 20 cmH2O or maxi- 4 cmH2O 0,5 cmH2O

mum pressure
Latency time 0 min 45 min 15 min 5 min
Maximum pressure on apnea

Minimum pressure Maximum pressure 10 cmH2O 0,5 cmH2O
command
Parameter adjustable on EcoStar™ Auto device:

Display
Parameter Default
Pressure decrease speed (in Auto-CPAP Sd:F Sd:S Sd:S

mode only) :
(fast) (slow) (slow)

Features available on the devices

Feature Feature enabled Feature disabled Default
CC:1 CC:0 CC:1
Comfort Calibration (Continuously or during the
ramp) (during the ramp)
External module connection rS:1 rS:0 rS:1
Command on Inspiratory Flow Limita- FL:1 FL:0 FL:1
tion (in Auto-CPAP mode only)
Auto ON Ao:1 Ao:0 Ao:1
Ramp type Default
Ramp feature Time ramp Indexed ramp Indexed ramp (ir)

(tr) (ir)
Pneumatic configuration of the devices regarding the accessories used:
Display calibration pneumatic

With GKH2O heated
Accessory used Without humidifier
humidifier
Tubing 1.80 m long 22 mm diameter (standard configura-
CP:22 CP:HH 22
tion 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 basent)
c) Accessing the menus:

In order to restrict access of certain set-
tings to the medical team, a hidden but-
ton has been provided on the device. It
is located under the letters "Ec" of the Hydden button
same "EcoStar™” and is detectable to
the touch as a hollow.
Moreover, the three buttons shown on-

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:

- 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 »)
The parameters accessible on the screen when the machine is in standby or operating mode are:
- Parameters of the device relating to treatment
- Compliance data counter .

How to access setting

press the hidden button, then simultaneously the information access button
To access the device settings:
for one second.
the symbol or the symbol shows if the device is in standby or in operation.

On the screen which ap-
pears:
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 button.
Description of symbols displayed on the screen
NOTE : Exit from the parameter setting menu happens automatically if you do
not press any key for 30 seconds.
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 as example.

D) Setting EcoStar™ Info device

Press
simultaneously This screen appears:
Pressure level
the hidden key and
Increase or decrease the value displayed pressing the
button or the button.

for one second.
3 4
Press This screen appears:
Ramp
You can select the time ramp (tr) or the indexed ramp (ir)
pressing the button or .
5 6
Press This screen appears: Ramp time when the time ramp tr is selected, otherwise
this parameter is not displayed.
button or .
7 8
Comfort pressure
button or .
9 10
Auto ON
You can enable (1) or disable (0) the feature pressing the
button or .
11 12
Press This screen appears: Comfort Calibration
You can enable (1) the feature either continuously, or
during the ramp ( ), or disable it (0) pressing the but-
ton or .
13 14
Press This screen appears: Pneumatic Calibration
Using the button or , you can select a con-

figuration 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".

15 16
Hour counter (device operating time). The value dis-

played on the right below represents the minutes.
17 18

Compliance counter (time during which the patient
actually breathed with the device). The value displayed
on the right below represents the minutes.
19 20
Press This screen appears: Built-in pressure sensor

Increase or decrease the value displayed using the but-
ton or .
Refer to "
Adjustment of the pressure at the device outlet".
21 22
This screen appears:
Press Selection of RS232 connection for an external mod-
ule (for example a modem)
The connection can be enabled (1) or disabled (0) by

23 24
Press
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.

E) Setting EcoStar™ Auto device

1 2
simultaneously
the hidden button and Device operating mode.
If CPAP is displayed, the device delivers a constant

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 the button.

3 4
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 the button.

5 6
Ramp
You can select the time ramp (tr) or the indexed ramp
(ir) pressing the button or .
7 8
Ramp time (in CPAP mode) or latency time (in APAP
mode) when the time ramp tr is selected, otherwise this
parameter is not displayed
button or .

9 10
Comfort pressure
Increase or decrease the value displayed using the button
or .
11 12
Auto ON
You can enable (1) or disable (0) the feature pressing the
button or .
13 14
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 .
15 16
Press This screen appears: Pneumatic Calibration
Using the button or , you can select a con-

figuration 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 hu-
midifier.
For specific calibration, refer to "Specific calibration of
the pneumatic configuration".
17 18
Command on Inspiratory Flow Limitation, available in
APAP mode only.
The command can be enabled (1) or disabled (0) pressing
the button or .
19 20
Pressure decrease speed, available in APAP mode only.
You can set the speed - slow (S) or fast (F) - by pressing
the button or .

21 22
Maximum pressure on apnea command, available in
APAP mode only.
Increase or decrease the value displayed pressing the but-
ton or .
23 24
Press This screen appears: Hour counter (device operating time). The value dis-
played on the right below represents the minutes.
25 26
Compliance counter (time during which the patient actu-

ally breathed with the mask). The value displayed on the
right below represents the minutes.
27 28
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".
29 30
This screen appears: Selection of RS232 connection for an external module
Press
(for example a modem)
The connection can be enabled (1) or disabled (0) by

31 32
Press
Software version included with the EcoStar™ Auto

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

Warning
If, when in use, a problem with the memorized settings is detected, the device stops and displays the mes-
sage Er 1.
Press for 1 second (the device displays the blinking message dEF), then press the but-
ton.
The machine is then automatically reset to the default values and you can set the desired parameters
again.
F) Setting the clock
You can set the time only when the device is in standby.
1 2
Once the buttons are released, the symbol of
adjustment appears under the hour and

for 2 seconds,
the letter h blinks. You can change the time
then keeping it hold
down, press
displayed by using the or but-
ton.
.
3 4
The symbol of minute min blinks in turn. You

can set the minutes by following the same pro-
cedure as for the hour.
Press the information access button to exit the menu.
G) 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.

H) Ajustment of the pressure at the device outlet
 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.
 Then connect the pressure point to a manometer and adjust the pressure to 12 cmH 2O.
 Access the setting of the pressure sensor offset as shown in "Settings" paragraph of the device concerned. Adjust
the value using the button or the button until the pressure 12.0 cmH2O is read on the manome-
ter.
 Then, press the button while holding down the hidden key. The pressure sensor offset setting is auto-
matically memorized.
I) Specific calibration of the pneumatic configuration
Warning
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 con-
figuration used. If Comfort Calibration is enabled (1), disable it (0) and follow the procedure hereafter:
 Confirm that the device is in standby. If it is operating, stop it by holding down the On / Standby button
for several seconds.
 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.
 Bring up the screen page of the Settings menu related to “Pneumatic Calibration” by following the settings pro-
cedure for the device concerned.
 Select the specific patient circuit CP:SP or CP:--:
specific calibration already present specific calibration absent
 Press the hidden key and hold it down until launch of calibration taking care not to touch the pneumatic circuit.

III - MAINTENANCE
Service Manual Rev.3 III-1

This section describes how to service devices from the EcoStar™ Info and EcoStar™ . It in-
cludes instructions where applicable, for removal, disassembly, calibration, re-assembly and
installation.
WARNING: ELECTRICAL HAZARD
The EcoStar™ Info and EcoStar™ System is electrically powered. To prevent

serious injury or death, follow standard safety procedures. Ensure that
power has been disconnected from the unit before servicing any component.
WARNING: CLEANING AND DISINFECTION

Prior to any operation, follow the cleaning and disinfection instructions de-
scribed in the clinician and home care provider user manual.
WARNING: PERFORMANCE VERIFICATION

After a component has been serviced, the unit must be calibrated and the overall
system operation checked according to the “Performance Verification” of this
chapter, before the unit is returned to service.
WARNING: SPARE PARTS

It is absolutely forbidden to use spare parts not provided by the manufacturer of
the Cpap system.
It is absolutely forbidden to repair the sub-assembly. The complete sub-assembly
must be changed.
CAUTION
Circuit boards contain complementary metal-oxide semiconductor (CMOS) integrated
circuits (ICs) which are electrostatic sensitive devices. To prevent IC damage, follow
the standard safety procedures :
 handle circuit boards by edges only  wear a grounded wrist strap
 work on a grounded conductive mat  store circuit board in a conductive
plastic bag

A. PERFORMANCE VERIFICATION AND PREVENTIVE MAINTENANCE

1) General information
The performance verification should be carried out for any one of the following reasons :
 to determine the cause of operational failure,

 to check the overall operation of the device after repair or replacement of a component,
 to check that the device is operating within specification.
2) Frequency and required equipment
a) Performance verification
 Annually (recommended but not mandatory)
During this verification, the pressure accuracy could be checked
Required equipment
 A calibrated pressure meter 0-30 cm H2O

 A Ø 22 mm patient tube
 A test kit (consists of a coupling and a stopper with a 4 mm diameter leak)
b) Performance verification after repair

During this verification, the following parameters will be tested :
 Pressure accuracy
 Flow measurement chain
Required equipment
 A calibrated pressure meter 0-30 cm H2O
 A Ø 22 mm patient tube
 A test kit (consists of a coupling and a stopper with a 4 mm diameter leak) or a cali-
bration shell
 A calibrated output M-BH0210
 PC computer with DreamStarTM Analyze

3) ANNUAL PRESSURE VERIFICATION (Info/Auto) - Recommended but not manda-

tory
The pressure accuracy test can be performed from the CPAP keyboard.
1.Connect the patient circuit to the air outlet on the EcoStar™ Info and EcoStar™ and connect the free end
piece of the patient tubing to a connector equipped with a 4 mm vent hole and a pressure tap.
2. Press the on/Standby button to start up the device, set the device in CPAP mode, then connect the pressure
tap to a calibrated pressure meter. Adjust the pressure setting to 12 cmH2O and the ramp time to 0. (The pneu-
matic configuration must be conformed to the utilized components).
3.Wait 1 minute.
4.Check the pressure displayed on the pressure controller. The value must be 12 cmH2O +/-0,5
If the pressure is not correct, you have to adjust it :
-Access the setting of the offset pressure (refer § « setting acess » of EcoStar™ Info and EcoStar™
Auto)
-Increase or decrease the displayed value by using the buttons or till the value 12cmH2O
(+/-0.2) be displayed on the pressure meter, taking care to block the 4 mm leak.
-Press the button and the hidden button at the same time. The adjustment of the sensure pressu-
re is automatically recorded.

4) PRESSURE & FLOW SENSORS VERIFICATION AND CALIBRATION (- After servicing

only)
 Run DreamStarTM Analyze software,

 Connect the EcoStar™ Info or EcoStar™ Auto to the computer
 Click on the direct link connection icon
 When the connection screen shows up, click on the following combination of keys on your computer keyboard:
Control Alt F9
or Control Alt S
 A password is required. The password is given to technicians who have been trained by the manufacturer or a
person accredited by the manufacturer.
 The service menu screen shows up allowing you to access the service options:
Service Manual Rev.3

III-5
a) Preparation for testing
Connect the device as shown below:
Pressure controller
(example of device)
Test kit
With Ø 4 mm leak Patient circuit
(including coupling)
CAUTION: WARM UP STEP

Allow to warm up for 30 minutes at 12cm H2O with a Ø 4 mm leak before carrying out the
performance verification and/or the calibration procedure.
CAUTION
The Ø 4 mm leak must be blocked during the calibration only, not during the warm up.

b) Pressure verification
 Select the appropriate pneumatic configuration in the settings menu
 Select the pressure = 12 cmH2O
 Observe the warm up step of 30 minutes
 Check that the pressure meter measures a pressure of 12 cmH2O + 0.5.
If calibration is required, complete the calibration procedure.
c) Calibration
 Connect the device to a computer and access the service menu of DreamStarTM Analyze as described in sec-
tion A.4 “Service menu access”
 Select Calibrations then click on OK
 The calibration screen shows up:
d) Offsets
The calibration of the two OFFSETS (Pressure and Flow) is automatic.
The calibration must be done when the device is in Standby mode.
 Observe the warm up step, ramp=0 and pressure =12 cmH2O.

 Turn the blower OFF and wait until it is totally stopped
 Click on “Default”. This allows to start the calibration with standard value
NOTE: Do not click again on “Default” during all the others steps of the calibration
 Click on “Automatic Offsets”, then confirm the changes when asked to

III-7
 Pressure gain
 Observe the warm up step, ramp=0 and pressure =12 cmH2O

 Adjust the pressure to 20cmH2O
 Block the 4mm leak and adjust the pressure gain to read 20.0 cmH2O +/-0.1 on the pressure meter.
 Flow gain
 Connect the patient side of the patient tube to a flow meter equipped with a calibrated output:
Flow controller (example of device)
Calibrated output
Patient circuit

III-8
 Observe the warm up step, ramp=0 and pressure =12 cmH2O.

 Adjust the pressure to 20cmH2O
 Adjust the Flow Gain to match the value measured by the device with the value measured by the flow me-
ter.
 Click on OK to enter the values then click on OK to confirm when the following message appears:

III-9
B. DISASSEMBLY PROCEDURE
WARNING: ELECTRICAL HAZARD
The EcoStar™ Info and EcoStar™ Auto System is electrically powered. To prevent serious
injury or death, follow standard safety procedures. Ensure that power has been discon-
nected from the unit before servicing any component.
WARNING: ASSEMBLY PRECAUTIONS
After each repair, a current leakage test will be required. The technical department must ensure
that no external material stays inside the device and that all the repairs have been carried out in
accordance with the service manual. It is the responsibility of the technical department to en-
sure that all these procedures have been performed in order that the device remains in confor-
mance with the general electrical safety standard for medical equipment IEC 60601-1.
WARNING: PERFORMANCE VERIFICATION
After a component has been replaced, the unit must be calibrated and the overall system op-
eration passed the “Performance Verification” check, before it’s reused.
CAUTION
Circuit boards contain complementary metal-oxide semiconductor (CMOS) inte-
grated circuits (ICs) which are static sensitive devices. To prevent IC damage, follow
the standard safety procedures :
 handle circuit boards by edges only,  wear a grounded wrist strap,
 work on a grounded conductive mat,  store circuit board in a conductive
plastic bag.

III-10
1) Disassembly
Required equipment:
A Torx T10 screwdriver

A grounded wrist strap
A grounded conductive mat
 Remove the four screws located under the device (Screws tightening torque value for re-
assembling: 0,75N.m +/- 0,08N.m)
 Remove the top housing
 Remove the internal frame assembly
 Remove the internal baffle foam
Internal Frame Bottom cover

Top Housing Assembly
Internal baffle
foam

2) ASSEMBLY
Internal baffle foam positioning on the internal frame assembly

 Position the internal baffle foam under the new internal frame assembly (The baffle foam must follow
the edges of the internal frame assembly).
 The baffle foam should extend slightly beyond the frame only to the location of the flow tubes.
The baffle should extend slightly

beyond the frame only to the loca-
tion of the flow tubes.
Internal frame assembly positioning

 Insert the frame (with the baffle foam) in the bottom cover
 The assembly frame must be inserted from left to right (facing the device)
 Place the top housing on the bottom cover and the assembled frame (Be careful, not to pinch the sili-
con tubes) and screwed the four cover screws (Screws tightening torque value for re-assembling:
0,75N.m +/- 0,08N.m)

C. Trouble Shooting
Information messages
Message displayed Possible cause Solution
In 1 The mask is disconnec- Check the connections between the mask, the tubing, and the
ted. 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 min-
utes.
Error messages
Message displayed Description Solution
Er 1 Patient settings pro- Reinitialize the default settings by holding down the informa-
blem.
tion 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 temperatu- Unplug the device from all sources of electrical power. Allow it
re. to cool and plug it in again according to the instructions in the
patient manual.
Er 3 Program battery over- Unplug the machine from all electrical power. Plug it in again.
flow.
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.

Message displayed Description Solution
Er 7 Turbine problem. Unplug the device from all sources of electrical power. Check
that there is no extraneous object in the air outlet. Plug in the
machine again and turn it on.
Er 8 Voltage problem. Unplug the device from all sources of electrical power. Plug it
in again and turn it on.
Er 10 Machine parameter pro- Unplug the device from all sources of electrical power. Plug it
blem. in again and turn it on.
Er 11 High current consump- Unplug the device from all sources of electrical power. Plug it
tion. in again and turn it on.
Er 12 Device memory is emp- Unplug the device from all sources of electrical power. Plug it
ty. in again.
Er 13 I²C bus communication Unplug the device from all sources of electrical power. Plug it
error. 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 switch to standby mode and access to the
different menus is impossible.

Personal Notes:

IV - SPARE PARTS
Service Manual Rev.3 IV-1

Reference Description
M-315930-01 Top Housing EcoStar Info
M-315930-02 Top Housing EcoStar Auto
M-315940-02 Bottom Cover EcoStar
M-315950-02 Internal Frame Assembly EcoStar Info (Equiped with a blower and the
electronic main board factory set )
M-315950-03 Internal Frame Assembly EcoStar Auto (Equiped with a blower and the
electronic main board factory set )
M-315920-01 Internal baffle foam EcoStar
M-413910-00 External power supply Europe
M-711902-00 Torx T10 screws
M-315940-01 Inlet Air Filter EcoStar (qty=50)
M-315965-01 EcoStar Info Keyboard
M-315965-02 EcoStar Auto Keyboard


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

Service Manual Cpap 2

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SERVICE MANUAL

Service Manual Rev.3 1

Service Manual 159MAT00-30.3

Revision Description Date

02 modification comfort calibration, auto ON and Ramp 2015-10

Service Manual Rev.3 2

I - GENERAL INFORMATION I-1

B. Using a Humidifier I-6

C. Standards Compliance I-7

D. Essential performance requirements for electromagnetic compatibility I-7

II - THEORY OF OPERATION II-1

A. General description II-2

Service Manual Rev.3 3

8) Electrical design-Synopsis II-4

III - MAINTENANCE III-1

A. Performance verification and preventive maintenance III-3

B. Dysassembly procedure III-10

C. Trouble Shooting III-13

IV - SPARE PARTS IV-1

Service Manual Rev.3 4

Service Manual Rev.3 I-1

 Ramp (adjustable) 0 to 45min+ 1 minute adjustable in 5 minutes

 CPAP consumption 0.750A @ 20cmH2O with 4 mm leak

Service Manual Rev.3 I-2

3) Storage / Transport specifications

 Operating temperature +5° C to +40° C (5°C to 35°C with GKH2O)

Sound pressure level measured in accordance with NF EN ISO 17510-1:2009:

Sound power level measured in accordance with NF EN ISO 17510-1:2009:

Sound power level measured in accordance with NF EN ISO 17510-1:2009:

Service Manual Rev.3 I-3

7) Static Pressure Stability at 10cmH2O

8) Dynamic Pressure Stability

Without humidifier and tubing 22mm diameter

Without humidifier and tubing 15mm diameter

Service Manual Rev.3 I-4

With humidifier GKH2O and tubing 22mm diameter

With humidifier GKH2O and tubing 15mm diameter

With humidifier GKH2O, tubing 15mm diameter, and high-efficiency filter

Service Manual Rev.3 I-5

9) Maximal Flow rate and Pressure

Test pressure (cmH2O) 4 8 12 16 20

Maximum flow (l/min) provoking

Pressure measurement (cmH

Service Manual Rev.3 I-6

 IEC 60601-1:2005 + Amd1:2012: Medical electrical equipment. Part 1: General requirements

D. ESSENTIAL PERFORMANCE REQUIREMENTS FOR ELEC-

Emission test Conformity Recommended electromagnetic environment

Service Manual Rev.3 I-7

IEC 60601 test Recommended electromagnetic environ-

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

Lightning Mains power quality should be that of a typi-

Voltage dips, short Mains power quality should be that of a typi-

Magnetic fields in the Power frequency magnetic fields should be at

Service Manual Rev.3 I-8

Electromagnetic Immunity - Conducted and radiated RF

IEC 60601 test Recommended electromagnetic environ-

Portable RF communications equipment

3 V/m 3 V/m d = 1.2√P 80 MHz to 800 MHz

Service Manual Rev.3 I-9

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

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3