SERVICE MANUAL - Sefam medicalsefam-medical.com/files/sefam/documents/Manuels Technique/EcoStar... · EcoStar Info/Auto Service Manual Service Manual Rev.3 4 8) Electrical design-Synopsis

SERVICE MANUAL

159MAT00-30.3

EcoStar™ Info

EcoStar™ Auto

Manufacturer:

SEFAM

144 AV CHARLES DE GAULLE

92200 NEUILLY SUR SEINE

FRANCE

Manufacturing plant :

SEFAM

10 ALLÉE PELLETIER DOISY

54600 VILLERS-LES-NANCY

FRANCE

TEL : +33 (0) 3 83 44 85 00

www.sefam-medical.com

http://www.sefam-medical.com

EcoStar Info/Auto Service Manual

Service Manual Rev.3 1

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.

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.

NOTE

Indicates points of particular interest for more efficient and convenient operation.

CAUTION

Means there is the possibility of damage to the EcoStarTM Info/Auto unit or other

property.

TECHNICAL BULLETINS

Please contact our technical agencies for Technical Bulletins related to your device.

REVISION LIST OF EcoStar TM Info et Auto Service Manual

Service Manual 159MAT00-30.3



Revision Description Date

01

02

03

Initial Release

modification comfort calibration, auto ON and Ramp

Modification the appellation of the French standards CEI by the Standards

English IEC.

2014-12

2015-10

2016-04

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

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

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.


I-3

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 )

Service Manual Rev.3


I-4

8) Dynamic Pressure Stability

( NF EN ISO 17510-1 : 2009 BB.2 and ISO 80601-2-70:2014 §201.12.1.102 )

Pressure (cmH2O) 4 8 12 16 20

Respiratory rate

(Resp./min) 10 15 20 10 15 20 10 15 20 10 15 20 10 15 20

Delta relative to

highest pressure

(cmH2O)

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

Delta relative to

lowest pressure

(cmH2O)

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

Delta relative to

dynamic pressure

(cmH2O) 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


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

Without humidifier and tubing 22mm diameter

Without humidifier and tubing 15mm diameter


Respiratory rate

(Resp./min) 10 15 20 10 15 20 10 15 20 10 15 20 10 15 20

Delta relative to

highest pressure

(cmH2O)

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

Delta relative to

lowest pressure

(cmH2O)

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

Delta relative to

dynamic pressure

(cmH2O) 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


Respiratory rate

(Resp./min) 10 15 20 10 15 20 10 15 20 10 15 20 10 15 20

Delta relative to

highest pressure

(cmH2O)

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

Delta relative to

lowest pressure

(cmH2O)

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

Delta relative to

dynamic pressure

(cmH2O) 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

With humidifier GKH2O and tubing 22mm diameter


I-5 Service Manual Rev.3

With humidifier GKH2O and tubing 15mm diameter


Respiratory rate

(Resp./min) 10 15 20 10 15 20 10 15 20 10 15 20 10 15 20

Delta relative to

highest pressure

(cmH2O)

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

Delta relative to

lowest pressure

(cmH2O)

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

Delta relative to

dynamic pressure

(cmH2O) 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


Respiratory rate

(Resp./min) 10 15 20 10 15 20 10 15 20 10 15 20 10 15 20

Delta relative to

highest pressure

(cmH2O)

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

Delta relative to

lowest pressure

(cmH2O)

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

Delta relative to

dynamic pressure

(cmH2O) 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

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


9) Maximal Flow rate and Pressure (NF EN ISO 17510-1 : 2009 CC.1 and ISO 80601-2-70:2014 §201.12.1.103 )

4 8 12 16 20 Test pressure (cmH2O)

Maximum flow (l/min) provoking

a pressure drop of 1 cmH2O at the

opening of the patient side

connection

Tubing 22 mm diameter > 130 180 180 170 150

Tubing 15 mm diameter 3.9 8.1 12.1 16 19.9 Pressure measurement (cmH

2O) at 40 l/min at the patient

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

CISPR 11

Group 1 The EcoStar™ Info or EcoStar™ Auto 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™ Info or EcoStar™ Auto device is suitable for use

in all establishments including residential establishments and tho-

se 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


I-8



Electromagnetic Immunity



Immunity test IEC 60601 test

level Compliance level

Recommended electromagnetic environ-

ment

Electro-static discharge

(ESD)

IEC 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, concrete or ceramic

tile. If the floor is covered with synthetic ma-

terial, the relative humidity should be at least

30%.

Electrical fast transient /

burst

IEC 61000-4-4

± 2 kV for power

supply lines

± 1 kV for input /

output lines

± 2 kV for power

supply lines

± 1 kV for input /

output lines

Mains power quality should be that of a typi-

cal commercial or hospital environment.

Lightning

IEC 61000-4-5

± 1 kV lines to lines

± 1 kV lines to lines



Voltage dips, short

interruptions and voltage

variations on power

supply input lines

IEC 61000-4-11

< 5% UT

(>95% dip in UT)

for 0.5 cycles

40% UT

(60% dip in UT)

for 5 cycles

70% UT

(30% dip in UT)

for 25 cycles

< 5% UT

(>95% dip in UT)

for 5 s

< 5% UT

(>95% dip in UT)

for 0.5 cycles

40% UT

(60% dip in UT)

for 5 cycles

70% UT

(30% dip in UT)

for 25 cycles

< 5% UT

(>95% dip in UT)

for 5 s



If the user of a EcoStar™ Info or EcoStar™

Auto device requires continued operation

during power outages, it is recommended that

the device be powered from an uninterrupti-

ble power supply or a battery.

Magnetic fields in the

Power Supply Frequencies

(50/60 Hz)

IEC 61000-4-8

3 A/m 3 A/m

Power frequency magnetic fields should be at

levels characteristic of a typical commercial

or hospital environment.

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



Electromagnetic Immunity - Conducted and radiated RF



Immunity test IEC 60601 test

level Compliance level

Recommended electromagnetic environ-

ment

Conducted RF

IEC 61000-4-6

3 V rms

150 kHz to 80

MHz

3 V rms

150 kHz to 80

MHz

Portable RF communications equipment

should not be used in proximity to any

part of a EcoStar™ Info or EcoStar™

Auto device including the cables.

Recommended separation distance:

d = 1.2√P

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.5

GHz

3 V/m d = 1.2√P 80 MHz to 800 MHz

d = 2.3√P 800 MHz to 2.5 GHz

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.

I-10



Rated maximum

output power of

transmitter

(W)

Separation distance according to frequency of transmitter (m)

150 kHz to 80 MHz

d = 1,2√P

80 MHz to 800 MHz

d = 1,2√P

800 MHz to 2.5 GHz

d = 2,3√P

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

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

1 1,2 1,2 2,3

10 3.8 3,8 7,3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d

in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is

the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance of the highest frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

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.

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-

meter displayed on the screen.

Symbol to decrease the value of the para-

meter displayed on the screen.

Information access button symbol.

Outlet symbol.

Device is protected against the penetra-

tion 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 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

of European Directive 93/42/EC on me-

dical devices.

Specific warning (see "Safety instruc-

tions" in the patient manual).

On the packaging, this symbol means

"Atmospheric Pressure Limit".

On the packaging, this symbol means

"relative humidity limit".

On the packaging, this symbol means:

temperature limit. Temperature range: -

20 ° C to + 60 ° C.

On the packaging: this symbol means

"Fragile", because the package must be

handled with care.

On the packaging: this symbol means

"Keep dry" because the package must be

protected against humidity and water.

I-12



Personal notes

II - THEORY OF OPERATION

Service Manual Rev.3 II-1


A. General description

1) General design-synopsis


Hidden button

Display

Information access

button On/Stand-by

or

Parameter settings

Ramp activation

or

Parameter settings

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.

Patient

EcoStar Info

or Auto

User

External

power module

DC power

Keyboard Display

Mask

Mains

Patient tube


7) Pneumatic diagrams

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.


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.

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.

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.



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.

Parameter Display Default

Operating mode CPAP

APAP

(Auto-CPAP)

APAP

(Auto-CPAP)

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

pressure

4 cmH2O 0,5 cmH2O

Ramp time 0 min 45 min 15 min 5 min

On EcoStar™ Auto device in Auto-CPAP mode:

Maximum pressure 4 cmH2O or mini-

mum pressure

20 cmH2O 20 cmH2O 0,5 cmH2O

Minimum pressure 4 cmH2O 20 cmH2O or maxi-

mum pressure

4 cmH2O 0,5 cmH2O

Comfort pressure 4 cmH2O 20 cmH2O or maxi-

mum pressure

4 cmH2O 0,5 cmH2O

Latency time 0 min 45 min 15 min 5 min

Maximum pressure on apnea

command Minimum pressure Maximum pressure 10 cmH2O 0,5 cmH2O

Parameter Display

Default

Pressure decrease speed (in Auto-CPAP

mode only) : Sd:F

(fast)

Sd:S

(slow)

Sd:S

(slow)

Operating mode on the EcoStar™ Auto:

NOTES

- As the device is equipped with a differential pressure sensor, the pressure compensation

for altitude is automatic.

- The default pressure unit is cmH2O.

Parameters adjustable on the devices:

Parameter adjustable on EcoStar™ Auto device:



Features available on the devices

Pneumatic configuration of the devices regarding the accessories used:

c) Accessing the menus:

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 .

Feature Feature enabled Feature disabled Default

Comfort Calibration CC:1

(Continuously or during the ramp)

CC:0 CC:1

(during the ramp)

External module connection rS:1 rS:0 rS:1

Command on Inspiratory Flow Limita-

tion (in Auto-CPAP mode only) FL:1 FL:0 FL:1

Auto ON Ao:1 Ao:0 Ao:1

Display calibration pneumatic

Accessory used Without humidifier With GKH2O heated

humidifier

Tubing 1.80 m long 22 mm diameter (standard configura-tion set by default)

CP:22 CP:HH 22

Tubing 1.80 m long 15 mm diameter CP:15 CP:HH 15

Other (specific)

CP:SP

(specific calibration present)

CP:--

(specific calibration basent)

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

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.

Hydden button

Ramp type Default

Ramp feature Time ramp

(tr)

Indexed ramp

(ir)

Indexed ramp (ir)



How to access setting

To access the device settings:

On the screen which ap-

pears:

Description of symbols displayed on the screen

press the hidden button, then simultaneously the information access button

for one second.

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 .

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

To access the next data:

press the information access button again.

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

NOTE : The EcoStar™ Info or EcoStar™ Auto device is shown in operating

mode and all the values displayed are given as example.

NOTE : Exit from the parameter setting menu happens automatically if you do

not press any key for 30 seconds.



D) Setting EcoStar™ Info device

Press

simultaneously

the hidden key and

for one second.

This screen appears:

Pressure level

Increase or decrease the value displayed pressing the

button or the button.

3 4 Press


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

pressing the button or .

5 6 Press


Ramp time when the time ramp tr is selected, otherwise

this parameter is not displayed.


button or .

7 8 Press


Comfort pressure


button or .

9 10 Press


Auto ON

You can enable (1) or disable (0) the feature pressing the

button or .

11 12 Press


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

Press


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

played on the right below represents the minutes.

17 18

Press


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


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

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 Press

simultaneously

the hidden button and

for one second


Device operating mode.

If CPAP is displayed, the device delivers a constant

pressure level.

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 Press


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 Press


Ramp

You can select the time ramp (tr) or the indexed ramp

(ir) pressing the button or .

7 8

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


button or .



9 10

Press


Comfort pressure

Increase or decrease the value displayed using the button

or .

11 12

Press


Auto ON

You can enable (1) or disable (0) the feature pressing the

button or .

13 14

Press


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


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

Press


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

Press


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 Press


Maximum pressure on apnea command, available in

APAP mode only.

Increase or decrease the value displayed pressing the but-

ton or .

23 24

Press


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

played on the right below represents the minutes.

25 26

Press


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


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

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


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.



F) Setting the clock

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

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.

1 2

Press

for 2 seconds,

then keeping it hold

down, press

.


Once the buttons are released, the symbol of

adjustment appears under the hour and the letter h blinks. You can change the time

displayed by using the or but-

ton.

3 4

Press


The symbol of minute min blinks in turn. You

can set the minutes by following the same pro-

cedure as for the hour.

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.



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 cmH2O.

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.


Service Manual Rev.3 III-1

III - MAINTENANCE



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: 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.

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

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.

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.


III-3 Service Manual Rev.3

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:

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:

Alt F9 Control

Alt S Control or



a) Preparation for testing

Connect the device as shown below:

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.

Test kit

With Ø 4 mm leak

(including coupling)

Patient circuit

Pressure controller

(example of device)



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



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)

Patient circuit

Calibrated output



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:



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.


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 baffle

foam

Top Housing Internal Frame

Assembly

Bottom cover



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

Error messages

Message displayed Possible cause Solution

In 1 The mask is disconnec-

ted.

Check the connections between the mask, the tubing, 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 min-

utes.

Message displayed Description Solution

Er 1 Patient settings pro-

blem.

Reinitialize the default settings by holding down the informa-

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-

re.

Unplug the device from all sources of electrical power. Allow it

to cool and plug it in again according to the instructions in the

patient manual.


Er 3 Program battery over-

flow.

Unplug the machine from all electrical power. Plug it in 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.




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



Er 10 Machine parameter pro-

blem.

Unplug the device from all sources of electrical power. Plug it



Er 11 High current consump-

tion.




Er 12 Device memory is emp-

ty.


in again.


Er 13 I²C bus communication

error.



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-1

IV - SPARE PARTS

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


Service Manual Rev.3 IV-2


Service Manual Rev.3 IV-3

Manufacturer : SEFAM 144 AV CHARLES DE GAULLE 92200 NEUILLY SUR SEINE FRANCE

Manufacturing plant and technical agency : SEFAM 10 ALLEE PELLETIER DOISY 54600 VILLERS-LES-NANCY FRANCE TEL: 33 (0) 3 83 44 85 00 www.sefam-medical.com


http://www.sefam-medical.com

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SERVICE MANUAL - Sefam medicalsefam-medical.com/files/sefam/documents/Manuels Technique/EcoStar... · EcoStar Info/Auto Service Manual Service Manual Rev.3 4 8) Electrical design-Synopsis