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M-155MAT00-00 Revision 8

SERVICE MANUAL

DreamStarTM series

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

PREFACE

This manual provides information necessary to service the DreamStarTM Respiratory System. This information is intended for use by technicians or personnel qualified to repair and service medical equipment. The information is not exhaustive and may not be applicable to future models.

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 DreamStarTM unit or other property.

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

Service Manual DreamStar series

DreamStarTM series Service Manual

1 Rev. 8

REVISION LIST OF DreamStarTM Service Manual

Revision Description Date

A

B

C

D

E

F

G

8

Initial Release.

Correction in maintenance

Addition of Spare parts Chapter Addition of some technical data

Addition of screws tightening torque values

Extension of intended use for DS Duo/DuoST (Refer to the Practitioner Manual for details)

Correction in maintenance

Cancellation current leakage and ground conti-

nuity testing.

modification for 3rd Edition

2011-09

2011-09

2012-01

2012-03

2012-07

2012-11

2014-01

2015-10

0459

Device in conformity with the requirements of Directive 93/42/EEC.

Risks pertaining to this medical equipment were assessed in accordance with the ISO 14971:2007 standard,

specifically with reference to global residual risk.



2

Manual M-155MAT00-00, revision 8.

Rev. 8

CONTENTS

PREFACE 2

REVISION LIST 3

I - GENERAL INFORMATION I-1

A. Specifications I-2

1) Device Performance I-2 2) Electrical specifications I-2 3) Physical specifications I-3 4) Environmental specifications I-3 5) Humidifier specifications I-3 6) Static pressure stability I-3 7) Dynamic pressure stability I-4 8) Maximal flow I-6 9) Acoustic performance I-6

10) Resistance of the system 1-7

B. Standards compliance I-7

C. Essential performance requirements for electromagnetic compatibility I-8

D. List of authorised accessories I-10

E. Symbols I-11

II - THEORY OF OPERATION II-1

A. GENERAL DESCRIPTION II-2

1) Pneumatic diagram II-2 2) Electrical design-Synopsis II-2 3) Electrical diagram II-4 4) Respiratory cycles detection II-5 5) Interaction between commands II-5 6) Means of pressures limitation II-6 7) Device description II-6 8) Meaning of symbols displayed on the screen II-9

B. DEVICE SETTINGS II-10

1) Setting ranges II-10 2) Service menu II-12



3 Rev. 8

III.-.SERVICE AND REPAIRS III-1

A. PERFORMANCE VERIFICATION AND PREVENTIVE MAINTENACE III-3

1) General information III-3 2) Frequency III-3 A-1) ANNUAL PRESSURE VERIFICATION III-4 A-2) PRESSURE & FLOW CALIBRATION III-5

A-3) HUMIDIFIER OPERATING III-9

B. DISASSEMBLY PROCEDURE III-10

1) Top housing III-11 2) Main board III-11 3) Blower chassy assembly III-12 4) Power supply board III-12 5) Heated humidifier board III-13 6) Heating plate III-13 7) Insulation foams III-14

C. PRECAUTION TO BE TAKEN DURING RE-ASSEMBLY III-15

D. SAFETY TESTING III-19

E. CONFIGURATION WITH FACTORY SETTINGS III-20

1) Default settings III-20 2) Default settings reinitializing III-21

F. ENTERING THE SERIAL NUMBER AND HOUR METER VALUES III-22

1) DreamStarTM Intro III-22 2) DreamStarTM Info / Auto / Duo / DuoST III-23

G. DISPLAY THE INFORMATION AND ERRORS STACK III-23

1) DreamStarTM Intro III-23 2) DreamStarTM Info / Auto / Duo / DuoST III-24

3) Error messages meaning III-25

IV.-.SPARE PARTS IV-1



4 Rev. 8


I - GENERAL INFORMATION

Service Manual DreamStar series I-1 Rev. 8


A. Specifications

1) Device Performance

Pressure adjustment range 4 to 20 cmH2O in increments of 0.5 cmH2O / CPAP and Auto PAP 3 to 25 cmH2O in increments of 0.5 cmH2O / Bilevel (see note 1)

Maximum achievable pressure 20 cmH2O / CPAP and Auto PAP. at the patient connection port 25 cmH2O / Bilevel (IPAP≠EPAP) under normal condition:

Maximum steady limiting pressure PLSmax = 30 cmH2O at the patient connection port under first fault condition:

Minimum steady limiting pressure PLSmin 0 cmH2O at the patient connection port under first fault condition:

Ramp (adjustable) 0 to 45 minutes Accuracy + 1 minute Increment 5 min

Backup frequency 0 or 4 BPM at 25BPM(DuoST) Accuracy + 1 BPM Increment 1 BPM

I/E ratio 1/4 to 1/0.5 Accuracy + 5% Increment 1/0.5

Air intake efficiency Foam (reusable), 90% effective for particles > 20 µm Optional high-efficiency filter, disposable fabric paper, 97% effective for particles > 3 µm

NOTE (1): Pressure can also be displayed in “hPa”. The pressure adjustment range in hPa is: 3.9hPa to

19.6hPa (CPAP/AutoPAP) or 2.9hPa to 24.5hPa (bilevel). To select the unit of measure-

ment, proceed to the service menu (Pressure unit).



2) Electrical specifications

Input voltage (auto-ranging): 100, 115, 120, 230 and 240VAC (-20%, +10%), 50/60 Hz

Maximum Consumption 90 VA Note that power consumption depends on the model. Models with heating humidifier (Evolve) are the highest-consumption devices.

Current consumption at 20cmH2O 130 mA eff on 230VAC with a Ø 4mm leak

Permitted DC input voltage: 13V (-20%, +25%)

Life duration of the battery cell DreamStar Intro: > 26 ans (based on typical cycle life) DreamStar Info/Auto/Duo: > 5 ans

The battery cell can be replaced only by the manufacturer. Send back the device to the manufacturer in order to perform this operation.

3) Physical specifications

Dimensions (L x W x H): 200 x 230 x 120 mm approximately with reservoir

Weight: 1,5 kg approximately fitted with an empty reservoir. 1,4 Kg approximately fitted with a cover

Maximum water capacity 300 ml

Operational gas volume 811 ml

4) Environmental specifications

Storage / Transportation temperature -20° C to 60° C (-4°F to 140°F)

Storage / Transportation humidity up to 95 % (non-condensing)

Storage / Transportation pressure 500 hPa to 1060 hPa

Operating temperature +5° C to +40° C without humidifier

+5°C to +35°C with humidifier

Operating humidity between 10 % and 95 % (non-condensing)

Operating relative pressure 730 hPa to 1060 hPa (approximately up to an altitude of 2700m / 9,000ft)

5) Humidifier specifications

Humidification rate: 10 mg H2O/s minimum at maximum setting with a 60 L/min maximum leak flow.

Heating time ≤45 minutes

Pressure drop depending on flow 0.59 cmH2O with 1l/sec

Reservoir compliance 14.2 ml/kPa (empty reservoir)

12.2 ml/kPa (filled reservoir)

Maximum air delivery temperature 43°C (at the patient’s tube outlet)



7)Dynamic pressure stability

(Short term accuracy in accordance with ISO 17510-1 :2007, annex BB.2)

a) DreamStarTM Intro

Without humidifier

Test pressure (cmH2O) 3 7 11 16 20

Respiratory F. cycle/minute





10 15 20 10 15 20 10 15 20 10 15 20 10 15 20

Maximum posi-tive deviation

(cmH2O) 0.35 0.37 0.30 0.33 0.37 0.41 0.32 0.33 0.39 0.29 0.33 0.38 0.30 0.30 0.36

Maximum negative devia-

tion (cmH2O) -0.11 -0.05 0.11 0.01 0.04 0.12 0.12 0.15 0.23 0.23 0.24 0.30 0.34 0.35 0.38

Dynamic pres-sure deviation

(cmH2O) 0.07 0.06 0.09 0.07 0.12 0.12 0.15 0.13 0.19 0.18 0.20 0.24 0.20 0.25 0.36


6) Static pressure stability at 10cmH2O (Long term accuracy in accordance with ISO 17510-1 :2007, annex BB.1)


b) DreamStarTM Info / Auto / Duo / DuoST

Without Humidifier With Humidifier

Pressure accuracy +/- 0.6 cmH2O +/- 0.6 cmH2O

Without Humidifier With Humidifier

Pressure accuracy +/- 0.5 cmH2O +/- 0.5 cmH2O



Without humidifier







10 15 20 10 15 20 10 15 20 10 15 20 10 15 20


(cmH2O) 0.10 0.18 0.23 0.15 0.23 0.28 0.18 0.29 0.31 0.22 0.32 0.36 0.24 0.33 0.34


tion (cmH2O) 0.13 0.14 0.20 0.16 0.18 0.23 0.23 0.22 0.28 0.30 0.28 0.35 0.38 0.35 0.41


(cmH2O) 0.06 0.05 0.06 0.08 0.12 0.11 0.11 0.16 0.16 0.19 0.21 0.22 0.20 0.24 0.26


With humidifier







10 15 20 10 15 20 10 15 20 10 15 20 10 15 20


(cmH2O) 0.35 0.39 0.43 0.33 0.37 0.43 0.31 0.34 0.39 0.30 0.34 0.38 0.31 0.30 0.23


tion (cmH2O) 0.00 0.08 0.21 0.15 0.24 0.34 0.30 0.39 0.49 0.44 0.53 0.62 0.56 0.71 0.99


(cmH2O) 0.07 0.10 0.10 0.13 0.14 0.17 0.20 0.26 0.35 0.25 0.39 0.27 0.35 0.43 0.41


Without humidifier

Test pressure (cmH2O)

4 8 12 16 20

Maximum Flow rate (l/min) at which the pressure measurement drop reaches 1cmH2O (at the pa-

tient’s tube outlet)

>130 160 160 160 160

With humidifier


4 8 12 16 20



80 80 80 80 80

8) Maximal Flow

(In accordance with ISO 17510-1 :2007, annex BB.2 )



Without humidifier


4 8 12 16 20



>130 200 200 200 200

With humidifier


4 8 12 16 20



>130 180 180 180 180


With humidifier







10 15 20 10 15 20 10 15 20 10 15 20 10 15 20


(cmH2O) 0.12 0.18 0.23 0.18 0.21 0.28 0.23 0.25 0.30 0.27 0.28 0.34 0.30 0.35 0.37


tion (cmH2O) 0.13 0.15 0.23 0.18 0.22 0.28 0.25 0.28 0.30 0.35 0.38 0.41 0.44 0.46 0.41


(cmH2O) 0.06 0.06 0.08 0.14 0.17 0.19 0.19 0.24 0.23 0.28 0.30 0.35 0.34 0.41 0.32


Acoustic power level measured according to NF EN ISO 17510: 2009:

NOTE : Measurements were performed with a 22 mm diameter tube.

Values are determined in the ATPD conditions (Ambient Temperature and Pressure, Dry)

10) Resistance of the system for an air flow of 60LPM

With humidifier: 1.9cmH2O Without humidifier: 1.6cmH2O

Acoustic power level (DUO/DUOST)

Acoustic power level (INTRO/INFO/AUTO)

With or without humidifier 39 dBa 38 dBa


B. Standards compliance

9) Acoustic performance

Acoustic pressure level measured according to NF EN ISO 17510: 2002:

Acoustic pressure level measured according to NF EN ISO 17510: 2009:

Acoustic pressure level (DUO/DUOST

Acoustic pressure level (INTRO/INFO/AUTO)


Acoustic pressure level (DUO/DUOST)

Acoustic pressure level (INTRO/INFO/AUTO)


Risks pertaining to this medical equipment were assessed in accordance with the ISO 14971:2007 standard, specifically with

reference to global residual risk.

DreamStar™ devices comply with the following standards:

CEI 60601-1:2005 + AC1:2006 + AC2:2007 + Amd1:2012: Medical electrical equipment. Part 1: General requirements for basic safety and essential performance.

CEI 60 601-1-2:2007: Medical electrical equipment. Part 1: General requirements for safety. Collateral stan-dard: Electromagnetic compatibility – Requirements and tests.

EN ISO 17510-1:2009: Sleep Apnoea Breathing Therapy Devices.

EN ISO 8185:2009: Respiratory tract humidifiers for medical use -- Particular requirements for respiratory hu-midification systems.

Directive 93/42/EC of the Council concerning medical devices.

Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS).

Directive 2012/19/EU of the European Parliament and of the Council on waste electrical and electronic equipment (WEEE).



C. Essential performance requirements for electromagnetic compatibility

During the electromagnetic compatibility tests, the device saved its settings and the value of the pressure delivered re-mained at the set pressure ± 0.5 cm H2O.

The device was occasionally disturbed and it recovered a normal operation after disruption.

Electromagnetic emissions

DreamStar™ product range devices are intended for use in the electromagnetic environment specified below. The customer or the user of a device from DreamStar™ product range should ensure that it is used in such an environment.

Emission test Conformity Recommended electromagnetic environment

RF emissions CISPR 11

Group 1 DreamStar™ product range devices uses RF energy only for its internal operations. Therefore its RF emissions are very low and cannot be assumed to interfere with nearby electronic equipment.

RF emissions CISPR 11

Class B DreamStar™ product range devices are suitable for use in all establish-ments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings

used for domestic purposes

Harmonic emissions CEI 61000-3-2

Class A

Voltage fluctuations / flicker emissions CEI 61000-3-3

Complies

Electromagnetic Immunity

DreamStar™ product range devices are intended for use in the electromagnetic environment specified below. The customer or the user of a device from DreamStar™ product range should assure that it is used in such an environment.

Immunity test CEI 60601 test level Compliance level Recommended electromagnetic environment

Electro-static discharge (ESD) CEI 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient / burst CEI 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 typical commercial or hospital environment.

Lightning CEI 61000-4-5

± 1 kV lines to lines

± 1 kV lines to lines

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines CEI 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

Mains power quality should be that of a typical commercial or hospital environment. If the user of the device from DreamStar™ product range requires continued operation during power mains, it is recommended that the device from DreamStar™ product range be powered from an uninterruptible power supply or a battery.

Magnetic fields in the

Power Supply Frequencies (50/60 Hz)

CEI 61000-4-8

3 A/m 3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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



Electromagnetic Immunity - Conducted and radiated RF

DreamStar™ product range devices are intended for use in the electromagnetic environment specified below. The customer or the user of the device from DreamStar™ product range should assure that it is used in such an environment.

Immunity test CEI 60601 test level Compliance level Recommended electromagnetic environment

Conducted RF

CEI 61000-4-6

3 V rms

150 kHz to 80 MHz

3 V rms

150 kHz to 80 MHz

Portable and mobile RF communications equipment should not be used in proximity to any part of the de-vice from the DreamStar™ product range, including cables.

Recommended separation distance:

d = 1.2√P

Radiated RF

CEI 61000-4-3

3 V/m

80 MHz to 2.5 GHz

3 V/m

d = 1.2√P 80 MHz to 800 MHz

d = 2.3√P 800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Fields strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.

Interference may occur in the vicinity of equipment marked with the following symbol:

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

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which a device from DreamStar™ product range is used exceeds the applicable RF compliance level above, the device from DreamStar™ product range should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device from DreamStar™ product range.

(b) Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3 V / m.



D. List of authorised accessories

Recommended separation distance between portable and mobile RF communications equipment and a de-vice from the DreamStar™ product range

The DreamStar™ product range are designed to be used in an electromagnetic environment in which radiated RF distur-bances are controlled. The customer or user of a device from the DreamStar™ product range can help prevent electro-magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device from the DreamStar™ product range as recommended below, according to the maximum power of the communications equipment.

Rated maximum output power of

transmitter

(W)

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 out-put 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.

Battery cable 3A ring term P/N M-214530-00

RS232/mini USB cable 2 m (except for DreamStar™ Intro) P/N M-214831-11

USB/Mini USB cable 2 m (except for DreamStar™ Intro) P/N M-214831-10

Inlet air filter (foam, reusable) P/N M-314850-08 (x10);M-414840-06 (x96)

Filter holder kit P/NM-314820-02

DreamStar™ water reservoir P/N M-315510-14

Memory card DreamStar™ P/N M-215530-00

DreamStar™ Analyze Software P/N M-215630-00

Patient circuit,1.80 m, ø 22 mm P/N M-261000-04

Outlet swivel elbow, 70° ø 22 mm P/N M-267010-00

Cigarette-lighter cable 3A P/N M-214530-01

RS 232/mini USB cable 15 m (except for DreamStar™ Intro) P/N M-214831-12

Power cord 2 poles - UK P/N M-660601-40

Optional high-efficiency filter (disposable) P/N M-314850-09 (x10);M-414841-07 (x100)

Rear cover DreamStar™ P/N M-315530-19

DreamStar™ Analyze Clinical kit P/N M-215630-01

Memory card reader P/N M-214830-03

KnightControl remote control (except for DreamStar™ Intro) P/N M-114700-EU

Patient circuit,1.80 m, ø 15 mm (except for DreamStar™ Intro/Intro Evolve) P/N M-261000-00

Carrying case DreamStar™ P/N M-815505-00


SYMBOL Description SYMBOL Description

On / Off.

Ramp and selection button.

Left control button.

Right control button.

Device protected against solid objects up to 50 mm (e.g. accidental touch by person hands) and against vertically falling drops of water (e.g. condensation).

Waste device to be eliminated separately from the household waste. For further information refer the paragraph “waste device elimination” of the Patient Manual.

Class 2 device.

Type BF device.

DC power supply.

Consult instructions before using this device.

0459

Device complies with the require-ments of European directive 93/42/EC on medical devices.

Recording and play back.

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.

E. Symbols


WARNING

The use of accessories and cables other than those specified, may result in increased emissions

or decreased immunity of the DreamStar™ product range devices.


Service Manual DreamStar series I-12

Personal notes

Rev. 8


II - THEORY OF OPERATION

Service Manual DreamStar series II-1 Rev. 8


A. GENERAL DESCRIPTION

1) Pneumatic diagram

2) Electrical design-Synopsis


(1) Flow sensor: DreamStarTM Info / Auto / Duo / DuoST.

VMOT(13V) 5V

AC/DC

Insulation

4KV

DC

ST7FMC2R7T6

Keyboard Display

ADC

FLASH

48 Kw

BEMF

Driver mo-tor

PWM

GPIO

I²C RAM

1536w

Heating humidifier

Pressure transducer

Pressure interface

RTC Bat.

VMOT(13V)

Memory card

UART

Tx Rx

SPI Serial memory

Mains

Isolation Barrier 4kV

Blower

Blower interface

Current measu-rement

Temperature measurement



TMS320F2812



ADC

VMOT(13V) +5V

AC/DC

Insulation

4kV

Mains DC

Keyboard

Display LCD

Blower interface

Current measu-rement

FLASH

128kw

PWM

RAM

18kw

Heating humidifier.

Insulation 4kV

Data pro-cessing

RTC Backup battery

VMOT(13V)

Memory card Pressure

and flow sensors

Data bus

SRAM 1M-word.

(data)

GPIO

UART

USB Interface

RS232 Interface

EEPROM serial 4ko

GPIO

+3,3V

I2C n°1

I2C n°2

Management of power backup

Mini USB connector

10pts

Blower

Temperature measurement

Address bus


3) Electrical diagram General block diagram a) DreamStarTM Intro

Air

Input

Power Supply

AC/DC

85 – 264 VAC

5Vcc & 13Vcc /45W

Protection

&

Filtering

Motor Driver

Blower

Electronic

Supply

DC

Regulation

3,3V & 1.9V

Patient

Device Envelope

Supply selector

AC/DC

Supply

AC

Isolation

Barrier

4kV

Heating

Humidifier

Memory

card

Service Manual DreamStar series II-4

Behavior of the DreamStar devices when mains power supply failure happens: The device stops functioning. As soon as the mains power supply resumes, the unit starts up with the same settings as the ones prior the shut down.

Rev. 8



Power Supply

AC/DC

85 – 264 VAC

5Vcc & 13Vcc /45W

Serial Link

Interface

Protection

&

Filtering

Motor Driver

Blower

Electronic

Serial Link

to PC

Supply

DC

Regulation

3,3V & 1,9V

Patient

Air

Input

Device Envelope

Supply Selector

AC/DC

Supply

AC

Isolation

Barrier

4kV

Heating

Humidifier

Memory

card

Service Manual DreamStar series II-5

4) Respiratory cycles detections

In the BiLevel mode the DreamStar Duo/DuoST tracks patient breathing cycles by using an elec-tronic flow meter that analyze the patient flow signal and, in response to the patient’s inspiratory and expiratory efforts, provide two levels of pressure: -IPAP (Inpiratory Positive Airway Pressure) -EPAP (Expiratory Positive Airway Pressure)

5) Interaction between commands

The interactions between commands are describes in the practitioner manuals. Ask to your repre-sentative in order to get the reference of the practitioner manual corresponding to your language.

Rev. 8


7) Device description

Front view

4

2

1

3

5

7

6

Right view Rear view without tank

9

8 10

11


6) Means of pressure limitation The limitation of the pressure is managed by the system of pressure production (blower motor driver)


1-Display

Allows viewing the information.

Displayed pressure

When working the delivered pressure is displayed rounded at + 0.5cmH2O and filtered with a 0,07Hz low pass filter (CPAP and Auto CPAP) and 1,87Hz (Bi-Level)

Displayer Tidal volume

Displayed values are estimations. There are provided for trends purpose only.

2-Left control button

This allows the selection of the symbol displayed at the lower left of the display.

3-Right control button

This allows the selection of the symbol displayed at the lower right of the display.

4-Ramp button

Provides access to ramp functions. It is also used to select the next parameter in the dis-played menu during the device-settings.

5-On/off button

Turns the blower on or off. It is also used to exit the device-setting menus.

6-Power port

This is where the removable power cord is connected.

7-External battery port

This allows the device to be powered by an external battery or a cigarette-lighter power ca-ble.


15

14

12

15

12

13

Rear view of a cover equipped device Rear view of a water chamber equipped device



8-Air intake filters

Prevent dust in the airflow from entering the device.

9-Heating element (Evolve)

The heated humidifier base, used to heat the water chamber.

10-Memory card connector

Connector into which you can slide the memory card.

11-Serial cable/USB connector

Available on DreamStarTM Info, Auto, Duo and DuoST devices.

12-Outlet connector (indicated by )

Air outlet to which the tubing is connected.

13-Water chamber (if applicable)

Water chamber in case of humidification, with marking to show the maximum fill level.

14-Cover (if applicable)

15-Air inlet (indicated by )



8) Meaning of symbols displayed on the screen

Symbol Description Symbol Description

The heated humidification feature is activated without heat or on a device connected to a battery.

Heated humidification feature enabled with heat. The symbol blinks if the heated humidifier has a problem.

Access to device information.

Access to device settings.

Parameters displayed on the screen can be changed.

Parameters displayed on the screen are for information and cannot be changed.

Feature enabled.

Feature disabled.

YES. NO.

Provides access to the next page avail-able for display on the screen.

Provides access to the preceding page displayed on the screen.

Allows the value of the parameter dis-played on the screen to be raised.

Allows the value of the parameter dis-played on the screen to be lowered.

Ramp feature in CPAP mode. The sym-bol blinks when the ramp feature is selected but still disabled.

In Auto-CPAP mode, wait time. The symbol blinks before the Auto-CPAP is activated.

C CPAP operating mode. A Auto CPAP operating mode DreamS-tarTM Auto.

B Bilevel operating mode (two pressure levels) DreamStarTM Duo/Duo ST.

Comfort calibration feature enabled DreamStarTM Info / DreamStarTM Auto.

Vt

Estimated tidal volume DreamStarTM Duo/Duo ST. The values displayed are estimates. They are provided for pur-poses of determining trends only.

Respiratory cycle detection indicator DreamStarTM Duo ST.

Indicates that compliance is being re-corded.

The symbol blinks when one or several patient reminders are about to expire.

Memory card present. The symbol blinks if the memory card is not operational.

Indicates that a remote control is con-nected.

A battery is connected to the device.

The device has detected an operating error. The symbol displays alternately with the error code.

DD/MM/YYYY The date format displayed by the de-vice is day/month/year.

MM/DD/YYYY

In “ENGLISH US”, the date format dis-played by the device is month/day/year.



B. DEVICE SETTINGS

1) Settings ranges For each parameter, the following table indicates the minimum, maximum and default values that can be set. In CPAP mode:

In AutoCPAP mode:

Parameters Minimun

value

Maximum

value

Default

value Increment

Pressure 4 cmH2O 20 cmH2O 8 cmH2O 0.5 cmH2O

Comfort pressure 4 cmH2O Prescribed pres-sure

4 cmH2O 0.5 cmH2O

Ramp time 0 min Maximum ramp time

15 min 5 min

Maximum ramp time 0 min 45 min 45 min 5 min

Humidification level 0 10 1 1

Parameters Minimum value Maximum value Default value Increment

Comfort pressure 4 cmH2O Maximum set pressure 4 cmH2O 0.5 cmH2O

Maximum pressure on apnea command.

Minimum pressure Maximum pressure 10 cmH2O 0.5 cmH2O

Maximum pressure 4 cmH2O or minimum

pressure 20 cmH2O 20 cmH2O 0,5 cmH2O

Minimum pressure 4 cmH2O 20 cmH2O or maximum

pressure 4 cmH2O 0.5 cmH2O

Latency time 0 min Maximum ramp time 15 min 5 min

Maximum latency time 0 min 45 min 45 min 5 min

Humidification level 0 10 1 1

Pressure decrease: (available in AutoCPAP mode only)

SLOW FAST SLOW N/A



In Bi-level mode:

In addition, the following table shows the parameters that can be enabled or disabled and the corresponding symbols displayed on the screen.

Parameters Minimun

value

Maximum value Default

value

Increment

Comfort pressure 3 cmH2O EPAP 4 cmH2O 0.5 cmH2O

Expiratory positive airway pressure (EPAP)

3 cmH2O IPAP or 20 cmH2O 5 cmH2O 0.5 cmH2O

Inspiratory positive airway pressure (IPAP)

EPAP or 3 cmH2O

25 cmH2O 15 cmH2O 0.5 cmH2O

Ramp time 0 min Maximum ramp time 0 min 5 min

Maximum ramp time 0 min 45 min 0 min 5 min

Pressure rise time: 1 (approx. 200 ms for 10 cmH2O)

5 (approx. 600 ms for 10 cmH2O)

3 (approx. 400 ms for 10 cmH2O)

1

Inspiratory sensitivity: 1 10 5 1

Expiratory sensitivity: 1 10 5 1

Backup frequency DuoST only

0 or 4 BPM 25 BPM 10 BPM 1 BPM

I/E ratio (backup frequency ≠ 0) DuoST only

1/4 1/0.5 1/2.0 1/0.5

Humidification level: 0 10 1 1

Display

Features Feature

enabled Feature disabled

Humidifier

Pressure Alter (available on the CPAP mode only)

EXT. (Bluetooth connection)

(not available on DreamStarTM Intro)

Auto ON

(not available on DreamStarTM Intro)

Reminders Frequency (increments of 1 month) 0



2) Service menu Press the left control button and the right control button simultaneously for a few seconds. This causes a page to appear on the screen offering a choice between the Clinical Settings Menu and the Service Menu. The service menu is then selected by pressing the right control button.

a) Selecting the language and clock settings

Press to select hour or minute.

The version of the integrated device software can be viewed but not modified.

Once the settings are made, select the page header by using or , then press to access the next page.

Press to select the language.

Press the right control button as many times as necessary until the de-sired language is displayed.

The time can be set by the patient or home care provider in increments of 1 based on a 24-hour clock. Press the right control button to raise the hour or minute setting and the left control button to lower it.

SERVICE

SOFTWARE VERSION XXXXXX

LANGUAGE ENGLISH US

HOUR 12

MINUTE 59

SERVICE


LANGUAGE ENGLISH US

HOUR 12

MINUTE 59

SERVICE


LANGUAGE ENGLISH US

HOUR 12

MINUTE 59



Press to select the parameter to be modified.

Press the right control button to raise the value and the left control but-ton to lower it.

c) Patient reminders

For each type of reminder, the home care provider can set the frequency with which the device will set a re-minder activation date for the patient. This frequency can be set in increments of 1 month, and the date will ap-pear in the relevant menu (see Patient Manual for further information).

Once the settings are made, select the page header by using or , then press to access the next page.

Note: Setting the date can be done only if the unit is on stand by mode

SERVICE

DATE 01

MONTH 1

YEAR 2011

SERVICE

DATE 01

MONTH 1

YEAR 2011

Filter: Recalls how often the filter should be changed

Mask: Recalls how often the mask should be changed.

Service: Recalls how often the device pressure should be checked.

Memory card: Recalls how often the patient should download data to the memory card and return the card to their home care provider.

Reminders can be increased using or decreased using .

CAUTION

The reminder expiration date is recalculated each time the frequency is modified

The frequency of each reminder can be adjusted in increments of 1 month from the current date. When a reminder is disabled, the duration value displayed is 0.

Once the settings are made, select the page header by using or , then press to ac-cess the next page.

REMINDER

FILTER 0 MONTH

0 MONTH MASK

SERVICE 0 MONTH

MEMORY CARD 0 MONTH

REMINDER

FILTER 1 MONTH

MASK 0 MONTH

SERVICE 0 MONTH

0 MONTH MEMORY CARD



d) Pressure sensor offset, pressure unit, Heating humidifier function (EVOLVE) and external wireless module.

Note: When enabling/disabling the heating humidifier function, the pneumatic configuration is automatically reset to the default value. If a specific calibration of the pneumatic configuration was in use, it will be replaced with a default configuration

Press to select the parameter to be modified

Pressure offset: Offset of the pressure sensor.

Pressure unit: The pressure measurement can be displayed in cmH20 or hPa.

Humidifier: The heated humidification feature can be enabled or disabled. (EVOLVE devices only)

Ext.: Allows the connection of an external module. (not available on DreamStarTM Intro)

SERVICE

PRESSURE OFFSET XXXX

cmH2O PRESSURE UNIT

HUMIDIFIER

EXT.

The pressure sensor offset value can be increased or decreased using or . This adjustment must be done only during the calibration procedures.

Refer to the chapter “Service and Repairs” section “Calibration”.

SERVICE


cmH2O PRESSURE UNIT

HUMIDIFIER

EXT.

The pressure unit of measure can be displayed in either cmH2O or hPa. Use

or to select the unit.

SERVICE


cmH2O PRESSURE UNIT

HUMIDIFIER

EXT.

The heating humidification feature can be enabled or disabled. Use either or to change its status.

SERVICE


cmH2O PRESSURE UNIT

HUMIDIFIER

EXT.

The external module communication feature can be enabled or disabled. Use ei-ther or to change its status.

SERVICE


cmH2O PRESSURE UNIT

HUMIDIFIER

EXT.


III - SERVICE AND REPAIRS

Service Manual DreamStar series III-1 Rev. 8


This section describes how to service devices from the DreamStarTM range. It includes instructions where applicable, for removal, disassembly, calibration, re-assembly and installation.

WARNING: ELECTRICAL HAZARD

The DreamStarTM Cpap 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: PERFORMANCE VERIFICATION

After a component has been serviced, the unit must be calibrated and the overall sys-tem 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 static sensitive devices. To prevent IC damage, follow the standard safety pro-cedures :

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 described in the clinician and home care provider user manual.



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 (if applicable), Humidifier operating (if applicable).

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 calibra-tion shell,

A calibrated output M-BH0210,

PC computer with DreamStarTM Analyze, A safety tester, A test base for current leakage test.



A-1) ANNUAL PRESSURE VERIFICATION (Intro/Info/Auto/Duo) - Recommended but not mandatory

The pressure accuracy test can be performed from the CPAP keyboard. 1.Connect the patient circuit to the air outlet on the DreamStar™ product range device 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/off button to start up the device, set the device in CPAP mode, then connect the pressure tap to a reference pressure gauge. Adjust the pressure setting to 12 cmH2O and the ramp time to 0.

3.Wait for 1 minute

4.Check the pressure displayed on the pressure controller. The value must be 12 cmH2O +/-0,6 (Intro) or +/- 0,5 (Info/Auto/Duo)

If the pressure is not correct, you can adjust it :

-Access to the setting of the offset pressure (Menu Service) -Adjust the value by using the right control button and the left control button until the pressure on the pressure gauge reads 12 cmH2O (+/- 0,2), taking care to block the 4 mm leak. -Press the ramp button or on/off button - A message will appear on the screen asking for confirmation of the setting. Press the right control button to confirm.



A-2) PRESSURE & FLOW SENSORS VERIFICATION AND CALIBRATION (Info/Auto/Duo) - After servicing only

Open DreamStarTM Analyze, Click on the direct link connection icon,

When the connection screen shows up, click on the following combination of keys on your computer key-board:

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

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.

Direct link cable

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, 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 section A.4 “Service menu access”,

Select Calibrations then click on OK,

The calibration screen shows up:

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. -Block the 4mm leak and adjust the pressure gain to read 12.0 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:

Direct link cable

Flow controller (example of device)

Patient circuit

Calibrated output



-Observe the warm up step, ramp=0 and pressure =12 cmH2O. -Adjust the Flow Gain to match the value measured by the device with the value measured by the flow meter,

-Click on OK to enter the values then click on OK to confirm when the following message appears:

A-3 HUMIDIFIER OPERATING

a) Test set-up Connect the device on the mains (AC power), Equip the patient outlet with a Ø 4 mm leak.

b) Verification

TEST#1 -Let the water chamber empty, -Set the humidifier level to 0, -Turn the device on and allow it to operate for 5 minutes, -Turn off the device, -Remove the water tank,

Verify that the heating plate does not heat and stays “cold” and check that the Humidifier symbol does

not blink.

TEST#2 -Let the water chamber empty, -Set the humidifier level to 10, -Turn the device on and allow it to operate for 5 minutes, -Turn off the device, -Remove the water tank,

Verify that the heating plate is hot and check that the Humidifier symbol does not blink.



B. DISASSEMBLY PROCEDURE

WARNING: ASSEMBLY PRECAUTIONS

After each repair, a current leakage testing 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 ac-cordance with the service manual. It is the responsibility of the technical department to ensure that all these procedures have been performed in order that the device remains in conformance 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 operation checked according to the “Performance Verification” section, before the unit is returned to service.

CAUTION

Circuit boards contain complementary metal-oxide semiconductor (CMOS) integrated cir-cuits (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.

WARNING: ELECTRICAL HAZARD

The DreamStarTM Cpap System is electrically powered. To prevent serious injury or death, follow standard safety procedures. Ensure that power has been disconnected from the unit before ser-

vicing any component.



1) Top housing Remove the reservoir (if applicable) or the cover, Remove the four screws holding the top housing, (Tightening torque value for re-assembling: 0,75N.m +/-

0,08N.m) Remove the top housing.

2) Main board Remove the screw holding the main board, (Tightening torque value for re-assembling: mini 0,35N.m ;

maxi 0,40N.m) Disconnect the pressure and flow sensors tubes (if applicable) from the output port, Remove the main board by carefully pulling it. The main board is connected to the power supply board

and the heated humidifier board (if applicable), Remove the two strengthening wedges,

DreamStarTM Intro DreamStarTM Info / Auto / Duo / DuoST


Main board

Pressure tube

Heating Humidifier board (if applicable)

Flow sensor tubes

Holding screw

DreamStarTM Intro DreamStarTM Info / Auto / Duo / DuoST

Power supply board connectors

humidifier board connectors


Disconnect the blower connector.

3) Blower chassis assembly

Lift up the whole blower chassis assembly.

4) Power supply board

Disconnect the heating humidifier board connector (if applicable), Lift up the power supply board.

Blower connector


Lift up

Heating humidifier board connector

Lift up


5) Heated Humidifier board Disconnect the heating plate connector, Free the board from the retaining tabs and lift it up.

6) Heating plate

Remove the two screws holding the rear housing, (Tightening torque value for re-assembling: 0,75N.m +/- 0,08N.m)

Remove the rear housing, Remove the heating plate. The heating plate is blocked by two hooks.

Heating plate connector

Retaining tab

hooks

thermostat Temperature probe



7) Insulation foams

Place the rectangular foam first as indicated on picture1, Be careful not to obstruct the airway with the foam, Place the semi circular foam as indicated on picture 2.

Two internal insulation foams. Caution: the air intake foams are not symmetrically shaped, be sure to observe their position in order not to obstruct the airway.


airway


C. PRECAUTION TO BE TAKEN DURING RE-ASSEMBLY

Make sure that the two springs are positioned on their slots.

Make sure that the heating plate cable goes through the cable way.

Make sure that the humidifier board cable is positioned in the cable way.

Cable way

springs

Cable way




Make sure that the groove of the seal gasket is correctly placed.

Make sure to connect the pressure and flow tubes (if applicable) as shown below: Place the humidifier strengthening wedge a shown bellow:

Retaining spring

Red line

Blue line

Pressure tube

Pressure tube


On humidifier boards, the two optocouplers can be damaged when improperly placing the parts.

Place the power board strengthening wedge a shown bellow:



On power supply boards, components R59,C25,Q102 and R104 can be damaged when improperly placing the strengthening wedge ; be careful with this operation

Do not forget to replace the screw on the main board.

Make sure that the top chassis blower insulation foam is correctly positioned on the chassis blower.


Top chassis blower

insulation foam


D. SAFETY TESTING

WARNING

The electrical safety tests must be carried out after each time the device has been opened and/or after each part replacement.

CAUTION

Don’t forget to remove the protection film of the heating plate if a new part was installed.

WARNING

After each repair, a current leakage testing will be required. The technical department must ensure that any external material stays with 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 ensure that all these pro-cedures have been performed in order that the device stays in conformance with the general electrical

safety standard for medical equipment IEC 60601-1.


Make sure that the pressure tube is correctly placed (Info/Auto/Duo/DuoST).


E. CONFIGURATION WITH FACTORY SETTING

1) Default settings

Default settings will be reinitialized after a “device setup” (if applicable, see paragraph 2.c), or in case of error 1 (see paragraph 2.b). INTRO:

INFO:

AUTO:

Pressure alter No

Pressure 8 cm H2O

Maximum ramp time 45 min

Ramp time 15 min

Comfort pressure 6 cm H2O

Heated humidifier function Disabled

Pressure alter No

Pressure 8 cm H2O


Ramp time 15 min



Mode: Auto

Maximum pressure (AUTO CPAP) 20 cm H2O

Minimum pressure (AUTO CPAP) 4 cm H2O

Prescribed pressure (CPAP) 8 cmH2O

Pressure alter (CPAP) No

Maximum ramp (CPAP) or latency (AUTO) time 45 min

Ramp (CPAP) or latency (AUTO) time 15 min


Command on IFL yes

Pressure decrease speed fast

Maximum pressure on apnoea command 10 cm H2O




DUO and DUOST:

DUO ST:

Production parameters:

2) Default settings reinitializing

a) Compliance resetting Refer to the Clinician and home care provider user Manual.

b) Error message 01 If an error 01 message is displayed (Bad memory settings) you can reinitialize the default settings by holding down both the ramp and right control button for 2 seconds. The blinking “DEF?” message will appear. Accept by pressing the on/off button. The device is now set to the default values and can be reset to the desired values.

If the problem persists contact your local technical manufacturer representative.

Mode: BILEVEL

IPAP (BILEVEL) 15 cm H2O

EPAP (BILEVEL) 5 cm H2O

Prescribed pressure (CPAP) 8 cmH2O

Pressure alter (CPAP) No


Ramp time 15 min


Inspiratory sensitivity 5

Expiratory sensitivity 5

Rise Time 3


Backup frequency 10 BPM

I/E ratio 1 /2.0

Reminders OFF

Unit cmH2O

Contrast 5

Humidifier level 1



c) Device setup Connect the device to a computer and access the service menu of DreamStarTM Analyze as described in

section A.4 “Service menu access”, Select “device setup” then click on OK and follow the steps.

F. ENTERING THE SERIAL NUMBER AND HOUR METER VALUES

1) DreamStarTM Intro

-The unit is in standby mode. Simultaneously depress and for 2 seconds, -The “MENU SELECTION” screen appears:

-Simultaneously depress and for 2 seconds:

CAUTION

The serial number recorded in the device must match the one printed on the base of the device.

The manufacturer is not responsible for any fraudulent use that might result from modification of the serial number.

SERVICE

SN

A B 5 5 1 2 3 A B C

HOUR COUNTER

0 0 0 1 2 3 h 4 5 min

SERVICE

SN

A B 5 5 1 2 3 A B C

HOUR COUNTER

0 0 0 1 2 3 h 4 5 min

2

Press to select the character to be mo-dified then press either

or to change its value

Press to exit then

press to confirm the changes once the confirmation screen shows up.



2) DreamStarTM Info / Auto / Duo / DuoST

Connect the device to a computer and access the service menu of DreamStarTM Analyze as described in section A.4 “service menu access”,

Select “Serial number and time counter”:

Enter the new serial number and the hour counter:

Click on OK to exit and confirm the changes once the confirmation screens shows up.

G. DISPLAY THE INFORMATION AND ERRORS STACK

1) DreamStarTM Intro Open DreamStarTM Analyze, Download the information from the device using a memory card (refer to the clinician and home care pro-

vider user manual), Open the patient file (refer to DreamStarTM Analyze user manual), Click on the following combination of keys on your computer:

Errors are displayed in two categories: Humidifier errors and device errors.

Alt F9 Control

Alt S Control or



2) DreamStarTM Info / Auto / Duo / DuoST

Connect the device to a computer and access the service menu of DreamStarTM Analyze as described in section A.4 “Service menu access”,

Select “Informations and errors Stack”:

Information and errors are displayed in three categories: Information, Humidifier errors and device errors.



3) Error messages meaning

Code Description & Possible cause Corrective action

Er 01 Patient settings problem.

Main board faulty

-Reinitialize the default settings by holding down the right control button for 2 seconds. The blinking “DEF?” message will appear. Accept by pressing the on/off button. The device is now set to the default setting values and can be reset to the desired values.

-Change the main board.

If the problem persists, contact the local technical manufac-turer representative.

Er 02 High motor temperature

The blower is damaged

-Unplug the device from all sources of electrical power. En-sure air intake filter is clean. Allow it to cool and plug in again carefully following the use instructions.

-Change the blower chassis assembly.


Er 03 Program stack overflow (DreamStarTM Info / Auto / Duo / DuoST)

Main board faulty

-Unplug the device from all sources of electrical power. Plug it in again and turn on.



Er 04

High pressure detected. Unit incorrectly calibrated Pressure sensor or main board faulty

-Unplug the device from all sources of electrical power. Plug in again and turn on.

-Perform pressure calibration.

-Change the electronic main board.


Er 06 CheckSum code error.

Main board faulty




Er 07 The blower stops working

Blower damaged

Main board faulty


-Change the Blower chassis assembly.






Er 08 Voltage problem detected

Main board faulty

Power board faulty



-Change the power board.


Er 09 Language CheckSum error (DreamStarTM Info / Auto / Duo / DuoST)

Main board faulty




Er 10 Machine settings problem

Main board faulty .

Reinitialize the default settings by holding down the right con-trol button for 2 seconds. The blinking “DEF?” message will appear. Accept by pressing the on/off button and making sure the patient outlet is unobstructed. The device restores its de-fault motor parameters. Perform sensors calibration.



Er 11 High current consumption

Blower damaged

Main board faulty


-Change the blower chassis assembly.






Er 12 Device memory is empty

Main board faulty

Reinitialize the default settings by holding down the right control button for 2 seconds. The blinking “DEF?” message will appear. Accept by pressing the on/off button and making sure the patient outlet is unobstructed. The device restores its default motor parameters. Perform sensors calibration.



Er 13 I2C bus communication error

Main board faulty




Er 14 SPI bus communication error

(DreamStarTM Intro)

Main board faulty







Er 100/105 Communication problem be-tween the humidifier and the device.

Main board faulty

Humidifier board faulty



-Change the humidifier board.


Er 101 Problem with heating element (CTN damaged).

Heating element damaged


-Change the heating element.


Er 102 Humidifier current too high.

Heating element faulty




Er 103 Humidifier current too low

Heating element faulty.




Er 104 The unit is connected on bat-tery

Lack of communication from the humidifier to the device.

Humidifier board faulty

Main board faulty

-If the device is connected to a battery, the heated humidifi-cation function cannot be used.


-Change the humidifier board.





Service Manual DreamStar series III-29

Personal notes

Rev. 8


IV - SPARE PARTS

Service Manual DreamStar series IV-1 Rev. 8


Part # Description

M-314820-02 Filter holder + filter DreamStar

M-315520-14 Heating element DreamStar

M-314850-02 Kit Chassis blower DreamStar Intro

M-314850-03 Kit Chassis blower DreamStar Info/Auto/Duo

M-314850-10 Coupler between air output and reservoir (qty=5)

M-315590-14 Electronic Power board DreamStar

M-315590-06 Electronic Main board DreamStar Intro

M-315590-07 Electronic Main board DreamStar Info

M-315590-08 Electronic Main board DreamStar Auto

M-315590-09 Electronic Main board DreamStar Duo

M-315590-10 Electronic Main board DreamStar DuoST

M-314890-12 Electronic humidifier board DreamStar

M-314850-11 Foams set (circle + square) (qty=5x 2 foams)

M-315530-29 Top housing Auto

M-315530-30 Top housing Duo

M-315530-31 Top housing Duo ST

M-315530-28 Top housing Info

M-315530-27 Top housing Intro

M-315540-00 Bottom housing Intro

M-315540-01 Bottom housing Intro Evolve

M-315540-02 Bottom housing Info/Auto/Duo

M-315540-03 Bottom housing Info/Auto/Duo Evolve

M-711903-00 Screw WN1452 K30X16 (one screw)

M-314820-04 Set of 10 springs (guidance for heating element)

M-314850-07 Set of internal “versilic” tubes ( 2*5 tubes)

M-314810-02 Tool for current leak measurement

M-315530-07 Rear “housing”



Part # Description

M-414840-06 Air input filters (qty = 96)

M-314850-08 Air input filters (qty = 10)

M-414841-07 Fine filters (optional) (qty=100)

M-314850-09 Fine filters (optional) (qty=10)

M-315530-19 Cpap cover

M-315510-14 Reservoir

M-660601-04 Power cord Europe

M-660601-37 Power cord India

M-660601-40 Power cord UK

M-660601-41 Power cord Australia

M-660600-39 Power cord US

M-660601-46 Power cord ZA




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