DreamStar™ Product Range51.15.206.121/files/sefam/documents/Manuels/DreamStar/English/1… ·...

Clinician and Home Care Provider User Manual

DreamStar™ Product Range

Upgradeable Humidifier Option

DreamStar™ Intro DreamStar™ Intro Evolve

DreamStar™ Info DreamStar™ Info Evolve

DreamStar™ Auto DreamStar™ Auto Evolve

DreamStar™ is a brand registered by SEFAM.

en GB – 2 DreamStar Intro, Info, Auto Clinician Manual

Manufacturer: Manufacturing plant and technical agency:

SEFAM

144 AV CHARLES DE GAULLE

92200 NEUILLY SUR SEINE

FRANCE

SEFAM

10 ALLEE PELLETIER DOISY

54600 VILLERS-LES-NANCY

FRANCE

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

www.sefam-medical.com

DreamStar Intro, Info, Auto Clinician Manual en GB – 3

Table of contents

Before you start ........................................... 4

Safety Precautions .............................................4

Recommended use ............................................4

Contra-indications .............................................5

List of authorised accessories ............................5

Available Features ........................................ 6

Heated Humidification feature available on Evolve

models ...............................................................6

Pressure Alter ....................................................6

Auto ON feature ................................................6

Mask unplugged feature ....................................6

Patient reminders ..............................................6

Comfort Calibration ...........................................7

Ramp feature .....................................................7

Time ramp ..........................................................7

Device Settings ............................................ 9

Definitions ..........................................................9

Settings Ranges ................................................10

Accessing the device menus ............................12

How to set DreamStar™ Intro / Intro Evolve

device .........................................................14

Accessing the Settings menu ...........................14

Settings menu ..................................................14

Service menu ...................................................15

How to set DreamStar™ Info / Info Evolve

device .........................................................18


Settings menu ..................................................18

Service menu ...................................................20

How to set DreamStar™ Auto / Auto Evolve

device .........................................................23


Settings menu ..................................................23

Service menu ...................................................26

Other settings and information ...................29

General Information menu ............................. 29

Setting the Heat level (if water chamber included)

......................................................................... 30

Reminders about key events ........................... 31

Specific calibration of the pneumatic

configuration ................................................... 32

Using a memory card ...................................... 32

Cleaning and Maintenance ......................... 34

Daily ................................................................. 34

Weekly............................................................. 34

Monthly ........................................................... 36

Material Disinfection .................................. 37

Surface disinfection of the device ................... 37

Water chamber disinfection procedure (if

included).......................................................... 37

What should not be used ................................ 38

Troubleshooting tips .................................. 39

Device Messages ............................................. 39

Error Messages ................................................ 39

Technical Specifications .............................. 42

DreamStar™ device Performance ................... 42

Integrated Humidifier performance ................ 42

Operating conditions for the device and

humidifier ........................................................ 42

Transportation and storage conditions ........... 43

Device electrical characteristics ...................... 43

Physical characteristics ................................... 43

CE marking ...................................................... 43

Symbols on the device .................................... 44

Standards Compliance ..................................... 44

Disposing of the device at the end of its life ... 45

NF EN ISO 17510-1:2007-compliant features . 46

Functional pneumatic block diagram .............. 49

Essential performance requirements for

electromagnetic compatibility ........................ 50


Before you start

This manual is intended for the Clinician and home care Provider. Under no

circumstances should it be provided to the patient.

Safety Precautions

WARNING This signals a risk of injury or accident to the patient.

• Pay attention to the Safety Precautions indicated in the DreamStar™ Patient Manual.

• Refer to the Patient Manual for all information relating to installation, maintenance and storage of the

device.

• Without exception, be sure to supply the patient with the Patient Manual and accessory use

instructions.

• Use only the accessories that the manufacturer has authorised for use with this device, as listed in

this manual.

• During treatment, only equipment included in the List of authorised accessories should be connected

to the device USB connector.

• To ensure that maintenance is performed correctly and to avoid any possibility of damage, only

qualified personnel are permitted to perform maintenance on the device and make authorised changes

to it. The user assumes full responsibility for any device malfunction that results from the device being

maintained by personnel other than personnel authorised.

• Never use the device without making sure that an air intake filter is installed.

• If you observe any anomaly in the device, do not begin treatment.

• The swivel outlet elbow, 70° 22 mm diameter, is an accessory intended for single patient use

In the following cases where the device is equipped with a water chamber:

• In case of heated humidification feature use, the cover must be removed and replaced by a water

chamber.

• When the heated humidification feature is enabled on a device equipped with a water chamber, the

patient must take, precautions to eliminate the risk of introducing water into the device and causing

irreversible damage to it. The device must be positioned on a stable horizontal surface and must not

be tilted.

• The water chamber should always be emptied before moving or transporting the device.

CAUTION This indicates that there is a possibility of material damage to this device or any other device.

• If the device is equipped with a cover where the water chamber should be, the heated humidification

feature must be disabled. Otherwise, the device may apply the heat setting. However, there would be

no risk as the device would not reach high temperatures. If you are unsure, check the Service menu

to confirm that the heated humidification feature is disabled.

• Since DreamStar™ devices are medical electrical devices, instructions concerning electromagnetic

compatibility indicated in this manual should be followed during installation.

• Like all medical electrical devices, DreamStar™ devices are vulnerable to interference from mobile and

portable RF communication equipment.

Recommended use

The DreamStar™ product range devices are intended to treat patients suffering from Obstructive Sleep

Apnea Syndrome (OSA) in patients over 30 kg (66 lbs.) and breathing spontaneously. They can be used at

home or in a sleep center.


Contra-indications

Studies have shown that the use of positive pressure is contra-indicated in some patients affected by any of

the following pre-existent pathologies:

• Severe bullous emphysema or emphysema previously complicated by pneumothorax.

• Pneumoencephalus, trauma or recent surgery with sequela of cranio-nasopharyngeal fistula.

• Decompensated cardiac insufficiency or hypotension, particularly in case of decreased blood volume or

cardiac arrhythmia.

• Dehydration.

• Massive epistaxis or history of massive epistaxis. Acute sinusitis, otitis media, or perforated tympanic

membrane.

• Tracheotomy.

In addition, because positive pressure is known to affect cardiac output in certain patients, patient arterial

pressure and heart rate should be closely monitored when starting treatment at an effective pressure. The

risks and benefits of treatment by Continuous Positive Airway Pressure (CPAP) must be weighed case by

case in such subjects. This evaluation should take into account the fact that the DreamStar™ device can be

set to deliver pressures up to 20 cmH2O and, under certain fault conditions, static pressures up to 30 cmH2O

are possible. The DreamStar™ device therefore should not be used if such pressure levels pose a risk to the

patient.

List of authorised accessories

Unless otherwise specified, all the DreamStar™ product range devices can be used with the following

optional accessories:

• Battery cable with lugs P/N M-214530-00

• RS232/mini USB 2 m cable (except for

DreamStar™ Intro) P/N M-214831-11

• Mini USB 2 m cable (except for DreamStar™

Intro) P/N M-214831-10

• Air intake filter (foam, reusable)

P/N M-314850-08 (x10);M-414840-06 (x96)

• Filter holder kit P/NM-314820-02

• Water chamber P/N M-315510-14

• Memory card P/N M-215530-00

• Software DreamStar™ Analyze

P/N M-215630-00

• Patient Tubing, 22 mm diameter

P/N M-261000-04

• Swivel outlet elbow, 70° diameter 22 mm

P/N M-267010-00

• Cigarette-lighter cable P/N M-214530-01

• RS 232/mini USB 15 m cable (except for

DreamStar™ Intro) P/N M-214831-12

• Power supply cord UK

P/N M-660601-40

• Optional high-efficiency filter (disposable)

P/N M-314850-09 (x10);M-414841-07 (x100)

• Device cover P/N M-315530-19

• 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 Tubing, 15 mm diameter (except for

DreamStar™ Intro/Intro Evolve)

P/N M-261000-00

• Carrying case P/N M-815505-00

WARNINGS

• Use only the accessories listed above or EN ISO 17510-2:2007-compliant accessories which are

approved for this device.

• Use only those accessories which can guarantee the patient’s treatment pressure and reduce re-

breathing of CO2. When a facial mask is necessary, always use a mask which is equipped with an anti-asphyxia valve.


Available Features

The DreamStar™ Intro and DreamStar™ Info devices operate in continuous mode (CPAP), i.e. the device

delivers a constant pressure level.

The DreamStar™ Auto device operates in either constant mode (CPAP) or in automatic mode (Auto-CPAP),

i.e. the pressure fluctuates between a minimum pressure and a maximum pressure as a function of

respiratory events detected.

The first 5 minutes of operation of the device are not included in the ramp time or latency time. During this

time, depending on the device in question, compliance and AutoCPAP features are unavailable.

Heated Humidification feature available on Evolve models

The DreamStar™ Intro Evolve, DreamStar™ Info Evolve and DreamStar™ Auto Evolve devices can be

delivered either with a cover or with a water chamber. These devices are equipped with a heated

humidification feature which you can enable or disable.

The heated humidification function is enabled on the devices delivered with a water chamber and it is

disabled on the devices delivered with a cover.

If the device is equipped with a cover and if you want to use the heated humidification feature, it is

necessary to order a water chamber and to proceed as follows:

1. Remove the cover from the device and replace it with the water chamber by referring to the Patient

Manual.

2. Enable the heated humidification function by referring to Item 4 of the Service menu in the settings

procedure of the device concerned page 17, 21 or 27.

Pressure Alter

You can enable this feature which provides the option to the patient to change the prescribed pressure by ±

1 cmH2O.

Note: This feature is only available in CPAP mode.

Auto ON feature

Functionality allowing to automatically start the treatment without pressing the device On/Off button.

Mask unplugged feature

If the patient removes his mask, the device automatically switches to low power. The machine will restore

normal power when the mask is reconnected or if the On/Off button or the ramp button is

pressed. Otherwise, the device will stop after 30 minutes.

Note: If the patient uses a resistive interface (full face mask with anti-asphyxia valve), a specific

calibration of the pneumatic configuration must be carried out so that the DreamStar ™ unit

detects that the mask is unplugged.

Patient reminders

The DreamStar™ device has a patient reminder feature to help the patient remember key events such as

filter and mask changes, device inspections, and memory card compliance data downloads on the memory

card. This feature is described under “Reminders about key events”, on page 31.

DreamStar Intro, Info, Auto Clinician Manual

Comfort Calibration

Available on DreamStar™ Info / Info Evolve and DreamStar™ Auto / Auto Evolve , the (C.C.+) Comfort

Calibration feature is intended to increase the treatment pressure during inspiration and to decrease it

during expiration to make the patient's breathing more comfortable during the treatment. It can be enabled

continuously or during the ramp.

Ramp feature

Whatever the type of ramp used, the ramp feature can be stopped during device operation by pressing the

ramp button for 2 seconds. It can be reactivated by stopping and restarting the device.

The comfort pressure, the ramp time (only if the time ramp is selected and if comfort pressure < prescribed

pressure) and the maximum ramp time can be adjusted.

Time ramp

The Time Ramp feature (T.Ramp) allows

it is programmed (ramp time ≠ 0), it will be automatically activated at the beginning of the session at

comfort pressure.

In CPAP mode, the treatment begins at a

increases to treatment pressure.

In Auto-CPAP mode, the Ramp feature delays the commands

pressure is lower than the minimum pressure, the

pressure to the minimum pressure

Ramp feature in CPAP mode








pressure) and the maximum ramp time can be adjusted.

The Time Ramp feature (T.Ramp) allows for a gradual rise in pressure to help the patient go to sleep.

0), it will be automatically activated at the beginning of the session at

atment begins at a reduced pressure called comfort pressure

the Ramp feature delays the commands to raise or lower the pressure.

pressure is lower than the minimum pressure, the gradual rise in pressure will be made from the comfort

pressure to the minimum pressure during the ramp time.

Ramp feature in CPAP mode Ramp feature in AutoCPAP mode

en GB – 7







for a gradual rise in pressure to help the patient go to sleep. When

0), it will be automatically activated at the beginning of the session at

reduced pressure called comfort pressure, then the pressure

to raise or lower the pressure. If the comfort

rise in pressure will be made from the comfort

Ramp feature in AutoCPAP mode

en GB – 8

Indexed Ramp Available on DreamStar™ Info / Info Evolve and DreamStar™ Auto / Auto Evolve, the Indexed Ramp feature

(I.Ramp) allows to start the treatment

CPAP mode or the activation of the

which indicate that the patient is asleep.

If the end of the indexed ramp is not detected before the value of the set maximum ramp time, it will

automatically stop.

The table below lists the different cases of the

End of ramp / detection of events

CP

AP

mo

de

A

uto

-CP

AP

mo

de

C

om

fort

P.

< m

in P

. C

om

fort

P.

≥ m

in P

.


Available on DreamStar™ Info / Info Evolve and DreamStar™ Auto / Auto Evolve, the Indexed Ramp feature

treatment at the adjustable comfort pressure, then to have a

the Auto-CPAP as soon as the device starts to detect

that the patient is asleep.


rent cases of the indexed ramp operation in CPAP or Auto

detection of events End of ramp /


Available on DreamStar™ Info / Info Evolve and DreamStar™ Auto / Auto Evolve, the Indexed Ramp feature

to have a rise in pressure in

starts to detect respiratory events


or Auto-CPAP mode.

/ Max ramp time


Device Settings

The adjustment of the therapeutic pressure must be determined by the prescribing physician for each

patient individually, with the configuration of the equipment to be used, including the accessories. The

correct installation and positioning of the patient interface constitute a critical condition for the proper

operation of the device.

The most recent compliance data are recorded by session in the device memory within one year and 8

hours usage day, and they can be retrieved for analysis using DreamStar™ Analyze software.

The settings are accessible directly on all the devices. You can also adjust the settings of the DreamStar™

Info, DreamStar™ Info Evolve, DreamStar™ Auto and DreamStar™ Auto Evolve using the DreamStar™

Analyze software on a computer connected via a RS232 or Mini USB cable, or via a wireless connection

WARNING

Before changing the device settings, confirm that the device delivers sufficient airflow when it is in

operating mode. If it does not, stop immediately and contact the technical support.

Definitions

Comfort pressure: level of pressure produced by the device when the time ramp (T.Ramp) or the indexed

ramp (I.Ramp) starts up so that the patient can go to sleep comfortably.

When the DreamStar™ Auto / Auto Evolve device is in Auto-CPAP mode, the pressure

is adjusted to the comfort pressure or to the minimum pressure (if comfort pressure <

minimum pressure) when the device detects that there has been no respiratory cycle

for more than 2 minutes or when it detects a high pressure.

Compliance counter: total time during which the patient has effectively breathed in the mask (time

subtracted from the time when the mask was removed and the time with no

respiration).

Heating time: time needed for the device to reach the operating level required by the heated

humidification feature.

Hour counter: device operating time (ON/OFF).

IFL: Inspiratory Flow Limit.

Maximum pressure: maximum pressure that the DreamStar™ Auto / Auto Evolve can deliver in Auto-CPAP

mode.

Maximum pressure

on apnoea command:

maximum pressure on the DreamStar™ Auto / Auto Evolve in Auto-CPAP mode beyond

which no rise in pressure can be applied once a respiratory pause has been detected.

Maximum ramp

time:

Whatever the type of ramp used, this parameter accessible by the clinician and home

care provider only, allows a limit to be placed on the maximum value of ramp time

which can be set by the patient.

Minimum pressure: minimum pressure that the DreamStar™ Auto / Auto Evolve can deliver in Auto-CPAP

mode.

Prescribed pressure: level of pressure prescribed for the patient.

Ramp time: This is the time taken by the device in CPAP mode to reach the prescribed pressure

from the comfort pressure or to activate the Auto-CPAP feature when the time ramp is

enabled.

Session: period during which data is recorded to memory between the time the device starts

operation and the time the device goes into standby. A session is started after the

device has been on for at least 5 minutes without interruption.

Water chamber: chamber containing the water necessary for humidification.


Settings Ranges

For each parameter, the following table indicates the default value, the minimum and maximum values that

can be set on the devices.

Operating mode on the DreamStar™ Auto or DreamStar™ Auto Evolve:

Parameter Display Default

Operating mode CPAP AUTO AUTO

Parameters that can be set on the devices in CPAP mode:

Parameter Minimum value Maximum value Default value Increment

Set pressure 4 cmH2O 20 cmH2O 8 cmH2O 0.5 cmH2O

Comfort pressure 4 cmH2O Prescribed

pressure

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

Heat level (if water chamber

included)

0 10 1 1

Device parameters that can be set on the DreamStar™ Auto or DreamStar™ Auto Evolve in Auto-CPAP

mode:

Parameter 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

Ramp time (if time ramp selected) 0 min Maximum ramp

time

15 min 5 min

Maximum ramp time 0 min 45 min 45 min 5 min

Heat level (if water chamber

included)

0 10 1 1

Parameter Display Default

Pressure decrease: SLOW FAST SLOW

The device is started by pressing the On/Off button . If the heated humidification feature is enabled on

a device with a water chamber (Evolve configuration) and the heat level is set from 1 to 10, the heated

humidifier begins operating automatically. The heated humidifier indicator then displays on the

screen. When the heat level is set at 0, the humidifier symbol is displayed without steam .


Note: When the heat level is set at 10,

hours use. The rate of water evaporation depends on several factors such as environment, leak

rate, patient's breathing pattern, etc.

Features available on all the devices:

Feature

Humidifier

Evolve configuration with water chamber*The Humidifier feature is inactive on a device

equipped with a cover).

Pressure Alter (in CPAP mode)

Mask reminder

Filter reminder

Service reminder

Memory card reminder

Features available on DreamStar™ Info / Info Evolve and Auto /Auto Evolve:

Comfort Calibration +

EXT. (for an external module connection)

Command on Inspiratory Flow LimitAuto/Auto Evolve in Auto-CPAP mode)

Auto ON

Access to setting of ramp time for the

Access to setting of comfort pressure for the

patient

Access to setting of language for the patient

Ramp feature


n the heat level is set at 10, the water chamber filled to the maximum fill line allows

. The rate of water evaporation depends on several factors such as environment, leak

breathing pattern, etc.

the devices:

Feature enabled

Feature disabled

Evolve configuration with water chamber* *The Humidifier feature is inactive on a device

Frequency

(increment of 1)

Frequency

(increment of 1)

Frequency

(increment of 1)

Frequency

(increment of 1)

Features available on DreamStar™ Info / Info Evolve and Auto /Auto Evolve:

(continuously)

(during the ramp)

connection)

Command on Inspiratory Flow Limit (on DreamStar™

CPAP mode)

for the patient

(autorised) (locked

Access to setting of comfort pressure for the

(autorised) (locked)

Access to setting of language for the patient

(autorised) (locked)

Ramp type

Time ramp

(T.Ramp)

Indexed ramp

(I.Ramp)

en GB – 11

filled to the maximum fill line allows at least 8

. The rate of water evaporation depends on several factors such as environment, leak

Feature disabled Default

0 0

0 0

0 0

0 0

locked)

locked)

(locked)

Default

Indexed ramp

(I.Ramp)

Indexed ramp

(I.Ramp)


Configuration of the devices depending on the accessories used:

Accessory used Patient circuit Pneumatic calibration

(Settings menu) Humidifier feature

(Service menu)

Cover

L. 1.80 m diam. 15 mm Ø15mm

L. 1.80 m diam. 22 mm Ø22mm

Other SPECIFIC

Water chamber

L. 1.80 m diam. 15 mm Ø15mm+HH

L. 1.80 m diam. 22 mm Ø22mm+HH

Other SPECIFIC

Note: As all DreamStar™ product range devices are equipped with a differential pressure sensor,

pressure compensation for altitude is automatic.

Accessing the device menus

The four buttons on the front of the device allow one to access the device settings menu, scroll through

different pages, or possibly modify the value of certain parameters within these pages.

The parameters are accessible when the machine is in standby or operating mode.

The parameters that are accessible are grouped on several screen pages indicating:

• device settings related to prescribed treatment

• general device settings, such as date and time

• Information about device servicing,

• patient reminders.

Description of a screen page

Each screen page includes:

• a first line or page header

• up to 4 parameter lines with associated values

• a final line showing the various symbols used for

such features as changing a parameter value,

moving about a page, or moving from page to page

(see table entitled “Description of symbols

displayed on the screen“).


Description of symbols displayed on the screen

Symbol Description

Access to device information.

Provides access to the next page

available for display on the screen.

Allows the value of the parameter

displayed on the screen to be raised.

The heated humidification feature is

enabled without heat or on a device

connected to a battery.

Parameters displayed on the screen

can be changed.

Feature enabled.

YES.

Time Ramp feature (T.Ramp).

C CPAP operating mode, on the

DreamStar™ Auto or DreamStar Auto

Evolve device.

Indicates that compliance is being

recorded.

Comfort calibration + feature enabled

on DreamStar™ Info / Auto (and

equivalent in Evolve configuration).

LEAK

Indicates the leak level (except on

DreamStar™ Intro / Intro Evolve).

Displays OK, +, ++, +++, ++++.

Memory card present.

The symbol blinks if the memory card

is not operational.

The device has detected an operating

error. The symbol displays alternately

with the error code.

For settings specific to the DreamStar™

DreamStar™ Intro / Intro Evolve devic


DreamStar™ Info / Info Evolve device


DreamStar™ Auto / Auto Evolve device

The "General Information" menu for the devices is described on page


Description of symbols displayed on the screen

Description Symbol

Access to device information. Access to device settings.

Provides access to the next page

available for display on the screen. Provides access to the

displayed on the screen.


displayed on the screen to be raised. Allows the value of the parameter

displayed on the screen to be lowered.

The heated humidification feature is

ithout 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.



are for information and cannot be

changed.

Feature disabled.

NO.

Time Ramp feature (T.Ramp).

Indexed Ramp feature (I.Ramp).

CPAP operating mode, on the

™ Auto or DreamStar Auto A Auto-CPAP operating mode, on the


Evolve device.

Indicates that compliance is being

The symbol blinks when one or several

patient reminders are about

Comfort calibration + feature enabled

on DreamStar™ Info / Auto (and

equivalent in Evolve configuration).

Selection of Settings menu or Service

menu.

Indicates the leak level (except on

DreamStar™ Intro / Intro Evolve).

+, ++, +++, ++++.

DD/MM/YYYY The dates displayed by the device are

in the format day/month/year.

Memory card present.

The symbol blinks if the memory card

Indicates that a battery is connected.

detected an operating

The symbol displays alternately

with the error code.

Indicates that a remote control is

connected.

DreamStar™ Intro or DreamStar™ Intro Evolve device, see "

device", on page 14.

DreamStar™ Info or DreamStar™ Info Evolve device


DreamStar™ Auto or DreamStar™ Auto Evolve device


menu for the devices is described on page 29.

en GB – 13

Description

Access to device settings.

Provides access to the preceding page



displayed on the screen to be lowered.

Heated humidification feature enabled

The symbol blinks if the heated

humidifier has a problem.


for information and cannot be

Feature disabled.

Indexed Ramp feature (I.Ramp).

CPAP operating mode, on the


Evolve device.

The symbol blinks when one or several

patient reminders are about to expire.

Selection of Settings menu or Service

The dates displayed by the device are

in the format day/month/year.

Indicates that a battery is connected.

Indicates that a remote control is

connected.

device, see "How to set




How to set DreamStar™ Intro / Intro Evolve device

Accessing the Settings menu

Refer to the "DreamStar™ Intro settings" section in the Patient Manual to know how to use the buttons and

symbols displayed during the device setting procedure.

Access of some settings is limited to the medical team only. For that, press the left control button and

the right control button located on the front of the device simultaneously for 2 seconds.

A page appears on the screen and allows you to choose the SETTINGS menu or the SERVICE menu.

Press the left control button to select the settings menu or the right control button to select the service

menu.

Notes:

• In the following screens, the values displayed are given by way of example.

• The symbol indicates that the Pressure Alter feature is enabled, and the symbol indicates that it is

disabled.

Settings menu

To access the Settings menu, press the left control button to select the symbol displayed at

the bottom left of the screen:

� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:

Increase or decrease the

parameter value with the right or left

parameter settings button.

Then press to access the next

menu parameter.

Prescribed P.: level of pressure prescribed for the patient.

Pressure Alter: feature that can be enabled to allow the patient to adjust the prescribed pressure ±1

cmH2O.

� Press at the bottom of the page or to return to the page header.

� Press to move to the next page.


DreamStar™ Intro or DreamStar™ Intro Evolve

� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:





menu parameter.

Comfort pressure: level of pressure produced by the device when the ramp feature starts up.

Max ramp time: maximum ramp time, set at a value from 0 to 45 minutes.

Ramp time: time the device takes to reach the prescribed pressure when starting from the comfort

pressure.


� Press to exit the menu.

Note : The DreamStar™ Intro device was calibrated at the factory for a 22 mm in diameter tubing and

cannot be used with a 15 mm in diameter tubing.

Service menu

To access the Service menu, press the left control button to select the symbol displayed at

the bottom right of the screen:

1) Selecting the language and setting the clock

� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:

The language can be selected by

successive presses on the left or right

parameters settings button.


parameter. Increase or decrease

the parameter value with the

right or left parameter settings button.


menu parameter.

Software version: Version of the integrated device software. The version of the integrated device software

can be viewed but not modified.





2) Setting the date � � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:





menu parameter.



3) Patient reminders

� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:





menu parameter.

For each type of reminder, you can set the frequency with which the device will set a reminder activation

date for the patient. The date will appear in the relevant menu (see Patient Manual for further information).

Filter: reminder how often the filter should be changed

Mask: reminder how often the mask should be changed.

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

Memory card: reminder how often the patient should download data to the memory card and return the

card to the home care provider or physician.

CAUTION

The reminder expiration date is recalculated when you change the frequency.





4) Other features

� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:





menu parameter.

Pressure offset: offset of the pressure sensor.

Pressure unit: the unit of measurement used for the displayed pressure can be changed from cmH2O to hPa,

and vice versa.

Humidifier: the heated humidification feature can be enabled or disabled (if water chamber

included).

Note : If you have changed the value of the pressure offset or the status of the heated humidification

feature, a confirmation message appears when you press the On/Off button. Press the right

control button to confirm the change or the left control button to cancel.




How to set DreamStar™ Info / Info Evolve device


Refer to the "DreamStar™ Info settings" section in the Patient Manual to know how to use the buttons and






menu.

Notes:



disabled.

Settings menu



� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:





menu parameter.

Prescribed P.: Level of pressure prescribed.

Pressure Alter: Feature that can be enabled to allow the patient to adjust the prescribed pressure ± 1

cmH2O.




DreamStar™ Info or DreamStar™ Info Evolve

� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:





menu parameter.

Select the ramp type with the right or

left parameter settings button.


Ramp type : Time Ramp (T.Ramp) or Indexed Ramp (I.Ramp).

Max ramp time: maximum ramp time of from 0 to 45 minutes.

Ramp time: time the device takes to reach the prescribed pressure when starting from the comfort

pressure. This parameter is displayed only when the time ramp (T.Ramp) is selected.



Calibrating the device

� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:

With the right or left parameter settings

button, you can select the activation or

disactivation status of the Comfort

Calibration + feature.

The and symbols show that

it is enabled during the ramp.


menu parameter.

C.C.+ : Comfort Calibration + feature. This feature can be enabled either continuously or during the ramp

only, or it can be disabled.

Patient circuit options are: Ø15mm (15 mm in diameter patient tubing), Ø15mm+HH (15mm in diameter

patient tubing with water chamber), Ø22mm (22mm in diameter patient tubing), Ø22mm+HH (22mm in

diameter patient tubing with water chamber) and SPECIFIC (other configuration).

Note: If the SPECIFIC patient circuit option is selected, calibration must be launched. Press the ramp

button to enable calibration. If no calibration is PRESENT, the calibration goes back to the default

calibration. See "Specific calibration of the pneumatic configuration" paragraph, on page 32.





Service menu




� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:









menu parameter.

Software version: version of the integrated device software. The version of the integrated device software


Note: The time can be set only when the device is in standby.



2) Setting the date

� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:





menu parameter.

Note: The date can be set only when the device is in standby.




3) Access to the settings for the patient

� �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

This menu gives you the possibility to allow or not the patient to select himself the language and / or set the

ramp time and / or pressure comfort.

� Press at the bottom of the page or


4) Selection of features

� �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

Auto ON : functionality allowing to automatically start the treatment without pressing the device On/Off

button.

Humidifier: the heated humidification feature can be enabled or disabled (if water chamber included).

Ext. : the connection of an external module can be enabled or disabled.

Notes:

• If you have changed the status of the heated humidification feature, a con

you press the On/Off button. Press the right control button to confirm the change or the left control button to

cancel.

• When enabling/disabling the heated humidification feature, 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.





Access to the settings for the patient

� �

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:


button, lock

patient the

setting.

Then press

menu parameter.



at the bottom of the page or to return to the page header.

to move to the next page.

� �

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes::


button, enable

feature.

Then press

menu parameter.

allowing to automatically start the treatment without pressing the device On/Off

the heated humidification feature can be enabled or disabled (if water chamber included).

the connection of an external module can be enabled or disabled.

If you have changed the status of the heated humidification feature, a confirmation message appears when

button. Press the right control button to confirm the change or the left control button to

When enabling/disabling the heated humidification feature, the pneumatic configuration is automatically




en GB – 21


�


button, lock or unlock for the

the access to the parameter


menu parameter.


�

right or left parameter settings

button, enable or disable the


menu parameter.


the heated humidification feature can be enabled or disabled (if water chamber included).

firmation message appears when

button. Press the right control button to confirm the change or the left control button to

When enabling/disabling the heated humidification feature, the pneumatic configuration is automatically





� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:





menu parameter.



Filter: reminder how often the filter should be changed.





CAUTION




6) Miscellaneous

� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:





menu parameter.



and vice versa.




How to set DreamStar™ Auto / Auto Evolve device


Refer to the "DreamStar™ Auto settings" section in the Patient Manual to know how to use the buttons and






menu.

Notes:



disabled.

Settings menu



In CPAP mode

� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:

Press the right or left parameter

settings button to select the operating

mode.


menu parameter.




Mode: device operating mode.

Prescribed P.: level of pressure prescribed.

Pressure Alter: feature that can be enabled to allow the patient to adjust the prescribed pressure ± 1

cmH2O.



en GB – 24

� �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.



Max ramp time: maximum ramp time

Ramp time: time the device takes to

pressure. This parameter is displayed only when the time ramp (T.Ramp) is selected.



In Auto-CPAP mode

� �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

Mode: device operating mode.

Min. Pressure: minimum pressure deliverable by the device.

Max. Pressure: maximum pressure deliverable by the device.



� �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.


DreamStar™ Auto or DreamStar™ Aut

� �

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:

Increase



Then press

menu parameter.


left parameter settings

level of pressure produced by the device when the ramp feature starts up.

Time Ramp (T.Ramp) or Indexed Ramp (I.Ramp).

maximum ramp time set from 0 to 45 minutes.

time the device takes to reach the prescribed pressure when starting from the comfort

This parameter is displayed only when the time ramp (T.Ramp) is selected.



� �

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:



mode.

Then press

menu parameter.

Increase



pressure deliverable by the device.

pressure deliverable by the device.



� �

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:

Increase



Then press

menu parameter.


DreamStar™ Auto or DreamStar™ Auto Evolve

�

or decrease the




menu parameter.



level of pressure produced by the device when the ramp feature starts up.

reach the prescribed pressure when starting from the comfort

This parameter is displayed only when the time ramp (T.Ramp) is selected.

�




menu parameter.

or decrease the



�

or decrease the




menu parameter.



Command on IFL: command on Inspiratory Flow Limit.

Pressure decrease: Pressure decrease speed.

Max. P. on Apnoea: Maximum pressure on apnoea command.



� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:





menu parameter.



Comfort pressure: Level of pressure produced by the device when the ramp feature starts up.


Max ramp time: maximum ramp time set from 0 to 45 minutes.

Ramp time: time the device takes to activate the Auto-CPAP feature. This parameter is displayed only when

the time ramp (T.Ramp) is selected.



Calibrating the device

� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:


button, you can select the activation or

disactivation status of the Comfort

Calibration + feature.

The and symbols show that

it is enabled during the ramp.


menu parameter.

C.C.+ : Comfort Calibration + feature. This feature can be enabled either continuously or during the ramp

only, or it can be disabled.

Patient circuit options are: Ø15mm (15 mm in diameter patient tubing), Ø15mm+HH (15mm in diameter

patient tubing with water chamber), Ø22mm (22mm in diameter patient tubing), Ø22mm+HH (22mm in

diameter patient tubing with water chamber) and SPECIFIC (other configuration).

Note: If the SPECIFIC patient circuit option is selected, calibration must be launched. Press the ramp

button to enable calibration. If no calibration is PRESENT, the calibration goes back to the default

calibration. See "Specific calibration of the pneumatic configuration" paragraph, on page 32.





Service menu




� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:









menu parameter.

Software version: version of the integrated device software. The version of the integrated device software


Note: The time can be set only when the device is in standby.



2) Setting the date

� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:





menu parameter.

Note: The date can be set only when the device is in standby.




3) Access to the settings for the patient

� �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.





3) Selection of features

� �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

Auto ON : functionality allowing to automatically start the treatment without pressing the device On/Off

button.

Humidifier: the heated humidification feature can be enabled or disabled (if water chamber included)..

Ext. : the connection of an external module can be enabled or

Notes:

• If you have changed the status of the heated humidification feature, a confirmation message appears when


cancel.

• When enabling/disabling the heated humidification feature, the pneumatic configuration is automatically


with a default configuration.




DreamStar™ Auto or DreamStar™ Aut

Access to the settings for the patient

� �

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:


button, lock

access to the parameter setting for the

patient.

Then press

menu parameter.





� �

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes::


button, enable

feature.

Then press

menu parameter.


the heated humidification feature can be enabled or disabled (if water chamber included)..

the connection of an external module can be enabled or disabled.



g/disabling the heated humidification feature, the pneumatic configuration is automatically


bottom of the page or to return to the page header.


en GB – 27


�


button, lock or unlock the

access to the parameter setting for the


menu parameter.


�


button, enable or disable the


menu parameter.


the heated humidification feature can be enabled or disabled (if water chamber included)..



g/disabling the heated humidification feature, the pneumatic configuration is automatically





� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:





menu parameter.



Filter: reminder how often the filter should be changed.





CAUTION




6) Miscellaneous

� � � �

The page displays:

Press

as many times as

necessary to

access the

desired

parameter

setting.

The page changes:





menu parameter.



and vice versa.




Other settings and information

General Information menu

For the DreamStar™ Intro

Press the left parameters settings button to select the

General Information menu appears.

�

The page displays:

Hour counter:

Total use:

mask.

Tot. Session Nbr.:

This page allows you to reset the total use

simultaneously and hold for 2 seconds.

The values on the total use and total sessions counters will return to zero.

Press the control button to accept

left control but


�

The last session is

displayed:

Date:

Total duration:

Usage duration:

mask.

Average pressure:

Notes:

• The total use and total sessions number can be reset to zero only when the device is in standby.

• The Session page is only available if the device is in standby and if at least one session was recorded.

� Press the On/Off button to exit the menu.


and information

menu

Intro or DreamStar™ Intro Evolve

parameters settings button to select the symbol on the


Hour counter: Device operating time.

Total use: Total duration during which the patient was actually breathing in the

mask.

Tot. Session Nbr.: Number of start/stop sessions in the device memory.

This page allows you to reset the total use and total sessions number to zero. Press first

and hold for 2 seconds.


Press the control button to accept or cancel

left control button.


Date: Date of the last On/Off session.

Total duration: Total duration of the last session.

Usage duration: duration during which the patient was actually breathing in the

mask.

Average pressure: Average pressure delivered during the session.

he total use and total sessions number can be reset to zero only when the device is in standby.

available if the device is in standby and if at least one session was recorded.

to exit the menu.

en GB – 29

symbol on the standby screen: the

Total duration during which the patient was actually breathing in the

Number of start/stop sessions in the device memory.

Press first and then


this change using the right or

which the patient was actually breathing in the

Average pressure delivered during the session.

he total use and total sessions number can be reset to zero only when the device is in standby.

available if the device is in standby and if at least one session was recorded.

en GB – 30

For the DreamStar™ Info /

Press the left parameters settings button to select the


�

The page displays:

Hour counter:

Total use:

mask.

Tot. Session Nbr.:


�

The last session is

displayed:

Date:

Usage duration:

mask.

Average pressure:

Average leak:

A.H. index:

The session date and

The pages for the last 5 sessions can be displayed, from the most current to the oldest.

� Press the right control button

� Press the On/Off button to exit the menu.

Setting the Heat level

When the device is in stand-by :

� �

Press

The page displays:




/ Info Evolve and DreamStar™ Auto

parameters settings button to select the symbol on the


Hour counter: Device operating time.

Total use: Total duration during which the patient was actually breathing in the

mask.

Tot. Session Nbr.: Number of start/stop sessions in the device memory.


Date: Date and start hour of the last On/Off session.

Usage duration: duration during which the patient was actually breathing in the

mask.

Average pressure: Average pressure delivered during the session.

Average leak: Indicates the average leak, displaying OK, +, ++, +++, or ++++.

A.H. index: Index of obstructive apneas and hypopnoeas.

The session date and time are displayed in the upper right of the screen.


to access the next page.

to exit the menu.

eat level (if water chamber included)

� �

Press

to select the

setting

The page changes:

Increase

with the right or left





Auto / Auto Evolve

symbol on the standby screen: the

Total duration during which the patient was actually breathing in the

Number of start/stop sessions in the device memory.

was actually breathing in the

Average pressure delivered during the session.

Indicates the average leak, displaying OK, +, ++, +++, or ++++.

Index of obstructive apneas and hypopnoeas.

time are displayed in the upper right of the screen.


�

Increase or decrease

the parameter value




When the device starts, the heated humidifier automatically turns on. The

decrease the heat level by moving

button, as shown hereafter.

Note: When the device is battery

following screen is displayed after the settings button has been pressed:

Reminders about key events

This function is identical on all devices in the

When one or several reminders are about to expire, the information access symbol

of the screen changes to the blinking envelope s

operating (pressure displayed)..

Pressing the button located opposite the symbol brings up a window with a list of the reminders involved, as

the following example shows.

� �

Press

The page displays:

Note: If you respond yes, the event reminder disappears from the display.


�Press to exit the menu.


When the device starts, the heated humidifier automatically turns on. The patient can increase

the heat level by moving the arrow at the bargraph with the right or left parameter settings

When the device is battery-powered, the heated humidification feature cannot be used

following screen is displayed after the settings button has been pressed:

Reminders about key events

is identical on all devices in the DreamStar™ product range.

When one or several reminders are about to expire, the information access symbol

of the screen changes to the blinking envelope symbol , the device being in standby (hour displayed) or


� �

Press

as many times

as necessary to

access the

desired

reminder.

The page changes:

If you respond yes, the event reminder disappears from the display.


Indicates that the humidifier is not

functioning because it is under battery

power.

en GB – 31

patient can increase or

the right or left parameter settings

powered, the heated humidification feature cannot be used-and the

When one or several reminders are about to expire, the information access symbol in the lower left

the device being in standby (hour displayed) or


�

Answer YES or NO



Press to access the

next reminder.


Specific calibration of the pneumatic configuration

CAUTION

Since pressure performance depends on the pneumatic configuration selected, it is important to select the

correct configuration. Special configurations should be set up by skilled personnel only.

To optimise the performance of the DreamStar™ Info/Auto device (or equivalent in Evolve configuration), it

is advised to carry out a specific calibration based on the pneumatic configuration used. Set the Comfort

Calibration + on OFF and follow the procedure hereafter:

1. Confirm that the device is in standby. If it is running, stop it by holding down the On/Off button

for several seconds.

2. Set up the desired pneumatic configuration (humidifier, patient circuit, etc.) with the patient interface.

Take care to keep the patient circuit straight and the air outlet unobstructed.

3. Bring up the “Calibration” page of the Settings menu by following the settings procedure for the device

concerned.

4. Select the SPECIFIC patient circuit, enable and launch calibration.

5. Let the device calibrate itself taking care not to touch the pneumatic circuit.

6. If calibration completes correctly, the message “CALIBRATION CORRECT” will appear on the screen.

Press the right control button to confirm and exit the menu. If the message “CALIBRATION ERROR”

appears, relaunch automatic calibration or select the standard configuration.

Using a memory card

The memory card captures the most recent compliance data in the DreamStar™ product range device

memory. It also allows you to update the machine settings.

Data Backup The patient can use the external memory card to download the most recent compliance data in the device

memory by following the instructions you will provide him (see Patient Manual).

Once the data is downloaded, the patient will forward you the memory card and you will then be able to

retrieve the compliance data and analyze it using DreamStar™ Analyze software.

To do this, insert the memory card into the card reader supplied with the software, then connect the reader to

a USB port on your computer. To retrieve the compliance data, consult the DreamStar™ Analyze software user

manual.

CAUTION

Use approved memory cards only.


Updating Settings Devices may be set following the instructions provided by the DreamStar™ Analyze software and downloaded

to the memory card. The machine settings will update automatically when the patient inserts the card into the

device for the first time.

Service card A memory card can be configured using DreamStar™ Analyze software as a "service card" to set a number of

devices to the same default values (for example, language, time zone, patient reminders). This allows you to

set the specific treatment parameters for a given type of device. To configure a "service card", consult the

DreamStar™ Analyze software user manual. To be able to use the service card with the device, hold down

the ramp button pressed while inserting the card.

en GB – 34

Cleaning and Maintenance

Please refer to the user instructions for your mask and tubing for details on their maintenance.

WARNING

Unplug the device from the power source and always detach the breathing circuit and the water chamber

from the device before cleaning them.

CAUTION

• Use for the cleaning material intended for this purpose.

• Do not use strong detergent, abrasive sponge or st

Daily

Water chamber (if included) 1. Empty the water chamber and rinse it with clean water.

2. Leave to drip dry out of direct sunlight.

Weekly

Water chamber (if included)� Disassemble the water chamber.

o Remove the water chamber from the device.

o Unlock the cover by pressing the centre tab and rotating it backwards

o Separate the upper part from the base of the water chamber.

o Empty any water remaining in the chamber.

o To remove the inner tubing

1 : Gently press the clip (

2 : Keep the clip held down while gently pulling the tubing towards you

upper part.

�

Inner tubing

Center tab


Cleaning and Maintenance



from the device before cleaning them.

Use for the cleaning material intended for this purpose.

Do not use strong detergent, abrasive sponge or stiff brush.

Water chamber (if included) Empty the water chamber and rinse it with clean water.

Leave to drip dry out of direct sunlight.

Water chamber (if included) Disassemble the water chamber.

Remove the water chamber from the device.

Unlock the cover by pressing the centre tab and rotating it backwards �

Separate the upper part from the base of the water chamber.

Empty any water remaining in the chamber.

To remove the inner tubing �:

press the clip (A) to release the tubing from the locking system (

the clip held down while gently pulling the tubing towards you

�

A

B Base

Gasket

Grip zone

Upper part




�.

from the locking system (B).

the clip held down while gently pulling the tubing towards you to extract it from the


� Clean the various parts of the water chamber

detergent (for example 3 drops of dishwashing liquid diluted in water).

� Rinse well with water to eliminate any trace of detergent.

� Allow to dry naturally.

� Once dry, reassemble the water chamber

o Insert the inner tubing into the holes and ensure it is clipped.

o Place the upper part on the water chamber base

forward. Lock the water chamber by pushing on the grip zone.

o Fill the water chamber befo

Notes:

• The different parts of the water chamber may also be washed in a dishwasher (at 60°C maximum for 2 hours).

• To prevent growth of micro-organisms, do not allow water in the chamber to stagnate.

Washable filter:

• Pull the filter holder � towards you to remove it

• Remove the filter from the filter holder

�

• Wash the filter and the filter holder with warm water and mild

dishwashing liquid on the filter and the filter holder, then rub…)

• Rinse well to eliminate any trace of detergent.

• Allow to dry:

o Pad the filter dry using a clean absorbent towel, then allow it to dry thoroughly naturally.

o Allow the filter holder to dry naturally.

• Once dry, place the filter into the filter holder, then the assembly at the back of the device. Do not use

a filter which is not completely dry.

• Reinstall the cover or the water chamber.

Filter holder


Clean the various parts of the water chamber � with warm water and mild

detergent (for example 3 drops of dishwashing liquid diluted in water).

Rinse well with water to eliminate any trace of detergent.

Once dry, reassemble the water chamber

Insert the inner tubing into the holes and ensure it is clipped.

Place the upper part on the water chamber base � and tilt it

Lock the water chamber by pushing on the grip zone.

Fill the water chamber before replacing it into the device.

The different parts of the water chamber may also be washed in a dishwasher (at 60°C maximum for 2 hours).

organisms, do not allow water in the chamber to stagnate.

towards you to remove it �.

Remove the filter from the filter holder �.

�

Wash the filter and the filter holder with warm water and mild detergent (for example one drop of

dishwashing liquid on the filter and the filter holder, then rub…)

Rinse well to eliminate any trace of detergent.

Pad the filter dry using a clean absorbent towel, then allow it to dry thoroughly naturally.

Allow the filter holder to dry naturally.

Once dry, place the filter into the filter holder, then the assembly at the back of the device. Do not use

a filter which is not completely dry.

Reinstall the cover or the water chamber.

Filter holder

en GB – 35

�

�

The different parts of the water chamber may also be washed in a dishwasher (at 60°C maximum for 2 hours).

organisms, do not allow water in the chamber to stagnate.

�

detergent (for example one drop of

Pad the filter dry using a clean absorbent towel, then allow it to dry thoroughly naturally.

Once dry, place the filter into the filter holder, then the assembly at the back of the device. Do not use

Filter

holder

Filter


Monthly

Device

• Clean the outside of the unit using a damp tissue (cloth, paper towel) with a little water and one drop of

mild detergent.

• Eliminate any trace of detergent in repeating this operation with a new tissue (cloth, paper towel)

moistened with water only.

• Wipe the device thoroughly using a dry tissue (cloth, paper towel).

Air intake filters:

• The high-efficiency filter, which is offered as an option, cannot be washed. It must be changed once a

month or more frequently if visibly dirty.

• Change the filters systematically, as soon as they are torn or soiled or when the device displays a

reminder to do so.

Water chamber (if included):

• After the water chamber has been disassembled and cleaned, you can let it soak for 15 minutes in a

solution of 1 part white vinegar to 9 parts water.

• Rinse well with water to eliminate any trace of vinegar.

• Allow to dry naturally.

WARNINGS

• Do not use spray detergent. Harmful product residue could enter the air outlet, the air intake filter, or

the device interior, causing airway irritation.

• Never use bleach at a concentration higher than 0.1%. For example: pour 200 ml of 2,6 % bleach into

5 liters of cold water.

• Never use the device without making sure that an air intake filter is installed.

• Check that the heating element is completely dry before reconnecting the device to the power supply.


Material Disinfection

Refer to the instructions for use of the chemicals used to respect dilutions and quantities of products,

contact time, wearing of personal protective equipment.

Surface disinfection of the device

Disinfection of the outside of the machine is carried out using disinfectant detergent product.

• If using spray or disinfectant detergent foam:

o Pulverize the product on a single use non-woven support.

o Wipe the outside of the device with this support and let dry.

• If using disinfectant detergent towels:

o Wipe the outside of the device and let dry.

Water chamber disinfection procedure (if included)

• Disassemble the chamber completely.

• Pre-disinfection:

o Completely immerse the parts of the chamber in the pre-disinfecting solution diluted according

to the instructions recommended by the pre-disinfecting product manufacturer.

o Also, follow the recommended soaking time and if necessary, brush using a soft brush.

o Rinse all the parts of the chamber thoroughly and copiously with running water.

• Cleaning:

o Prepare a dip tank containing water and a mild detergent (for example using 5 to 10 ml of

dishwashing liquid diluted in 5 l of water).

o Clean the chamber parts in the detergent solution, and if necessary, brush using a soft brush

o Rinse the different parts of the chamber thoroughly and copiously with running water.

o Remove excess water by shaking slightly.

• Disinfection:

o Prepare a new dip tank containing water and a disinfecting product.

o Follow the same steps as the pre-disinfection.

• Drying :

o Allow to dry naturally.

• Storage :

o Reassemble the water chamber.

o Keep the disinfected and dried water chamber in a single use clean bag, sealed until a new use.

Note : Discard the water chamber if showing any damage and replace it with a new one.


What should not be used

• Never use abrasive cleaners or highly alkaline, acetone, benzene, leaded gasoline to clean the device.

• Do not use any support like sponge- with scraper or stiff brush.

• Never use any pre-disinfecting or disinfecting product containing aldehydes and/or its derivatives:

formaldehyde, glutaraldehyde, etc.

• Do not use any pre-disinfecting or disinfecting product not active on the Mycobacterium tuberculosis

(BK).

• Never disinfect the internal circuit of air flow using disinfecting product or with a Airway Surface

Disinfection System (DSVA).


Troubleshooting tips

Device Messages

Message Description Corrective action

MASK UNPLUGGED is


Large leak

detected.

Check the connections between the mask, the

patient circuit and the device. This message

disappears when the patient breaths in the mask

well reconnected or when the On/Off button

or the ramp button is pressed.

LEAK : ++ (or +++ or ++++) is


The device detects

a high level of leak.

Adjust the mask, mask cushion and/or harness until

you have a good mask-fit. The leak level must

decrease until the screen displays LEAK : OK.

If the error persists, contact Technical Support.

The symbol blinks

alternately with the error code

at the centre of the display.

The device has

detected an

operating error.

See table entitled, “Error Messages”.

The symbol blinks

alternately with the error code

at the centre of the heat level

page.

The device has

detected a

humidifier

operating error.

See errors 100-105 in the table entitled, “Error

Messages”.

Error Messages

Code Description Corrective action

Er 01 Patient settings

problem.

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 values and can be

reset to the desired values.


Er 02 High motor

temperature.

Unplug the device from all sources of electrical power. Ensure air intake

filter is clean. Allow it to cool and plug it in again carefully following the use

instructions.


Er 03 Program battery

overflow (on

DreamStar™ Info/Info

Evolve and

DreamStar™

Auto/Auto Evolve)

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

If the error recurs, return the machine to a technical service centre.

Er 04 High pressure. Unplug the device from all sources of electrical power. Plug it in again and

turn on.


Er 06 CheckSum code error. Unplug the device from all sources of electrical power. Plug it in again and

turn on.




Er 07 Turbine problem. Unplug the device from all sources of electrical power. Check that there is

no foreign object or signs of water in the air outlet. Plug in the machine

again and turn on.


Er 08 Voltage problem. Unplug the device from all sources of electrical power. Plug it in again and

turn on.


Er 09 Language CheckSum

error (on DreamStar™

Info / Info Evolve and

DreamStar™ Auto /

Auto Evolve).

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

If the error recurs, return the machine to a technical service centre.

Er 10 Machine settings

problem.

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

turn on.


Er 11 High current

consumption.


turn on.


Er 12 Device memory is

empty.


turn on.


Er 13 I²C bus communication

error.


turn on.


Er 14 SPI bus communication

error. (on DreamStar™

Intro / Intro Evolve).


turn on.


Er 100 Bad humidifier setting. The device is operating without employing the heated humidification

feature.


turn on.


Er 101 Humidifier

temperature problem.

The device is operating without employing the heated humidification

feature.


turn on.


Er 102 Humidifier current too

high.


feature.


turn on.




Er 103 Humidifier current too

low.


feature.


turn on.


Er 104 Lack of communication

from the humidifier to

the device.


feature.


turn on.


Er 105 Communication

problem between the

humidifier and the

device.


feature.


turn on.



Technical Specifications

DreamStar™ device Performance

Device pressure range: 4 cmH2O to 20 cmH2O

Device adjustable in increments of 0.5 cmH2O

Maximum steady limiting pressure at the patient

connection port under single fault condition:

30 cmH2O

Maximum pressure that can be set: 20 cmH2O

Ramp duration: 0 to 45 minutes ± 1 minute

Device adjustable in increments of 5 minutes.

Sound pressure level measured in accordance with

NF EN ISO 17510-1 : 2002:

26 dBA with humidifier

30 dBA without humidifier

Sound pressure level measured in accordance

with NF EN ISO 17510-1:2007:

30 dBA with humidifier

33 dBA without humidifier

Battery life of mainboard: 5 years

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

Air intake filter efficiency: Optional high-efficiency filter.

Disposable fabric HEPA paper, which is 90% effective

for particles > 3 microns.

High Density Foam (reusable) and is 90% effective with

particles > 20 microns.

Values determined under ATPD (Ambient Temperature and Pressure, Dry) conditions.

Integrated Humidifier performance

Humidification rate: > 10 mg H2O/l at the maximum setting for a leak flow

< 60 l/min

Heating time: < 45 minutes

Pressure loss as a function of flow: 0.59 cmH2O at 1 l/sec

0.73 cmH2O at 1 l/sec with swivel outlet elbow

Compliance of the water chamber : 14.2 ml/kPa (chamber empty)

12.2 ml/kPa (chamber full)

Maximum service pressure: 20 cmH2O

Maximum gas temperature delivered from patient

tubing:

43°C (109.4°F)

Values determined under ATPD (Ambient Temperature and Pressure, Dry) conditions.

Operating conditions for the device and humidifier

Pressure range: 730 hPa to 1060 hPa

Temperature: +5 °C to + 40 °C (41 ºF to 104 ºF) without humidifier

+5° C to + 35 °C (41 ºF to 95 ºF) with humidifier

Relative humidity: between 10% and 95% without condensation

Altitude range: 0 − 2 700 m (0−9,000 ft) approximately


Transportation and storage conditions

Pressure range: 500 hPa to 1060 hPa

Temperature: -20°C to +60°C (-4 °F to +140 °F)

Relative humidity: Up to 95% without condensation

Device electrical characteristics

Universal internal electrical power with the detachable electrical power cord (which varies by country).

Input voltage (auto-ranging): 100 - 240 VAC (-15%, +10%), at 50 or 60Hz

Maximum power consumption: 100VA at maximum setting.*

Current consumed at 20cmH2O with a 4mm leak: 130 mA eff. at 230 VAC

DC power supply (13 V) Voltage range allowed: 13V (-15%, +25%).

*Power consumption is based on the type of model. The DreamStar™ Auto™ Evolve with heated humidification

enabled is the highest-consumption device.

Physical characteristics

Dimensions (D x W x H): 200 x 230 x 120 mm (7.8 x 9.0 x 4.7 in) approximately

with water chamber

Carrying case Dimensions (D x W x H): 260 x 350 x 150 mm (10.2 x 13.7 x 5.9 in)

approximately

Weight: 1.5 kg (3.3 lbs) approximately with water chamber

1.4 kg (3.1 lbs) approximately with cover

Operational volume (minimal gas volume in water

chamber):

811 ml

Useful volume of water chamber: 300 ml

Maximum liquid fill level: Indicated on water chamber

CE marking

DreamStar™ Intro, DreamStar™ Intro Evolve : 2011

DreamStar™ Info, DreamStar™ Info Evolve : 2011

DreamStar™ Auto, DreamStar™ Auto Evolve : 2011.

en GB – 44

Symbols on the device

Symbol Description

Symbol of On/Off button.

Symbol of Left control button.

Device protected against solid objects

up to 12 mm and against vertically

falling drops of water.

Class II device.

DC power supply.

Refer to the user manual.

Device complies with the requirements

of European Directive 93/42/EC on

medical devices.

On packaging: this icon means “Storage

temperature limit”.

Temperature range:

(-4 °F to +140 °F)

On packaging: this icon means “Fragile”,

as the package needs to be handled

with care.

Standards Compliance

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

specifically with reference to global residual risk.

DreamStar™ devices comply with the following standards:

• CEI 60601-1:2005 + AC1:2006 + AC2:2007 + Amd1:20

requirements for basic safety and essential performance.

• CEI 60 601-1-2:2007: Medical electrical equipment. Part 1: General requirements for safety.

standard: Electromagnetic compatibility

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

• EN ISO 8185:2009: Respiratory tract humidifiers for medical use

respiratory humidification systems.

• Directive 93/42/EC of the Council concerning

• 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).

DreamStar Intro, Info, Auto

Symbols on the device

Symbol Description

button.

Symbol of Ramp and selection button.

Symbol of Left control button.

Symbol of Right control button.

Device protected against solid objects

up to 12 mm and against vertically

falling drops of water.

Waste device to be eliminated

separately from the household waste.

For further information, refer to the

paragraph "Disposing of the device at

the end of its life

Type BF device.

Recording and play back.

Refer to the user manual.

Specific warning.

Device complies with the requirements

Directive 93/42/EC on

On packaging this symbols means,

"atmospheric pressure limit".

On packaging: this icon means “Storage

Temperature range: -20°C to +60°C


"relative humidity limit ".

On packaging: this icon means “Fragile”,

as the package needs to be handled

On packaging: this icon means “Keep

dry”, as the package needs to be

protected against moisture and water.

Standards Compliance

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

specifically with reference to global residual risk.

comply with the following standards:

+ AC1:2006 + AC2:2007 + Amd1:2012: Medical electrical equipment. Part 1: General

requirements for basic safety and essential performance.

2:2007: Medical electrical equipment. Part 1: General requirements for safety.

standard: Electromagnetic compatibility – Requirements and tests.

: Sleep Apnoea Breathing Therapy Devices.

: Respiratory tract humidifiers for medical use -- Particular requirements for

respiratory humidification systems.

of the Council concerning medical devices.

of the European Parliament and of the Council on the restriction of the use of

certain hazardous substances in electrical and electronic equipment (RoHS).

of the European Parliament and of the Council on waste electrical and electronic


Symbol of Ramp and selection button.

Right control button.

Waste device to be eliminated

separately from the household waste.

For further information, refer to the

Disposing of the device at

the end of its life", page 45.

Type BF device.

Recording and play back.

Specific warning.


"atmospheric pressure limit".


"relative humidity limit ".

On packaging: this icon means “Keep

dry”, as the package needs to be

protected against moisture and water.

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

Medical electrical equipment. Part 1: General

2:2007: Medical electrical equipment. Part 1: General requirements for safety. Collateral

Particular requirements for

of the European Parliament and of the Council on the restriction of the use of

of the European Parliament and of the Council on waste electrical and electronic


Disposing of the device at the end of its life

In European Union this device has to be considered as an electrical and electronic piece of equipment as

defined in Directive 2012/19/EU, and must be collected and processed separately from household waste for

disposal as indicated by the symbol of the crossed out garbage bin (see "Symbols on the device" page 44).

In other countries, this device must be processed following local regulation.

Unsuitable disposal of the device at the end of its life could harm the environment.


NF EN ISO 17510-1:2007-compliant features

Using the DreamStar™ Intro and DreamStar™ Intro Evolve

Static pressure stability at 10 cmH2O

(Long-term accuracy according to ISO 17510-1:2007, Appendix BB.1)

Without humidifier With humidifier

Pressure accuracy +/- 0,6 cmH2O +/- 0,6 cmH2O

Dynamic pressure stability

(Short-term accuracy according to ISO 17510-1:2007, Appendix BB.2)

With tubing 22 mm

diameter

Test pressure (cmH2O)

4 8 12 16 20

Respiratory rate

Resp./min

Respiratory rate

Resp./min

Respiratory rate

Resp./min

Respiratory rate

Resp./min

Respiratory rate

Resp./min 10 15 20 10 15 20 10 15 20 10 15 20 10 15 20

Without humidifier:

Delta relative to highest

pressure (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

Delta relative to lowest

pressure (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

Delta relative to dynamic

pressure (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

With humidifier:


pressure (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


pressure (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


pressure (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

Maximum flow

(According to ISO 17510-1:2007, Appendix CC.1)


4 8 12 16 20 Maximum flow (l/min)

provoking a pressure

drop of 1 cmH2O at the

opening of the patient

side connection

Without humidifier >130 160 160 160 160

With humidifier 80 80 80 80 80

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

30 dBA with humidifier, 33 dBA without humidifier

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



Using the DreamStar™ Info, DreamStar™ Auto, DreamStar™ Info Evolve and

DreamStar™ Auto Evolve

Static pressure stability at 10 cmH2O

(Long-term accuracy according to ISO 17510-1:2007, Appendix BB.1)

Without humidifier With humidifier

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

Dynamic pressure stability

(Short-term accuracy according to ISO 17510-1:2007, Appendix BB.2)

With humidifier


4 8 12 16 20

Respiratory rate

Resp./min

Respiratory rate

Resp./min

Respiratory rate

Resp./min

Respiratory rate

Resp./min

Respiratory rate

Resp./min 10 15 20 10 15 20 10 15 20 10 15 20 10 15 20

Tubing 22 mm diameter:


pressure (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


pressure (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


pressure (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



pressure (cmH2O) 0.22 0.29 0.37 0.55 0.54 0.74 0.70 0.73 0.90 0.81 0.83 1.01 0.92 1.02 1.13


pressure (cmH2O) 0.08 0.17 0.29 -0.19 0.04 0.02 -0.26 -0.14 -0.07 -0.29 -0.15 -0.07 -0.32 -0.22 -0.08


pressure (cmH2O) 0.05 0.05 0.05 0.05 0.09 0.08 0.07 0.12 0.13 0.07 0.14 0.15 0.11 0.16 0.15

Tubing 15 mm diameter and high-efficiency filter:


pressure (cmH2O) 0.25 0.28 0.39 0.59 0.67 0.75 0.74 0.83 0.92 0.83 0.90 1.05 0.89 0.99 1.14


pressure (cmH2O) 0.05 0.04 0.26 -0.27 -0.13 0.01 -0.30 -0.22 -0.06 -0.31 -0.20 -0.08 -0.28 -0.25 -0.08


pressure (cmH2O) 0.04 0.04 0.06 0.06 0.07 0.09 0.08 0.11 0.12 0.09 0.12 0.15 0.13 0.15 0.16


Without humidifier


4 8 12 16 20

Respiratory rate

Resp./min

Respiratory rate

Resp./min

Respiratory rate

Resp./min

Respiratory rate

Resp./min

Respiratory rate

Resp./min 10 15 20 10 15 20 10 15 20 10 15 20 10 15 20



pressure (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


pressure (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


pressure (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



pressure (cmH2O) 0.18 0.27 0.39 0.49 0.50 0.79 0.71 0.66 0.98 0.79 0.80 1.02 0.92 0.89 1.12


pressure (cmH2O) 0.12 0.16 0.21 0.04 -0.05 -0.04 -0.20 -0.15 -0.13 -0.14 -0.03 -0.06 -0.14 0.01 -0.02


pressure (cmH2O) 0.06 0.09 0.09 0.09 0.19 0.17 0.20 0.22 0.30 0.38 0.39 0.47 0.34 0.53 0.59

Maximum flow

(According to ISO 17510-1:2007, Appendix CC.1)


4 8 12 16 20

With humidifier:

Maximum flow (l/min)

provoking a pressure drop of

1 cmH2O at the opening of the

patient side connection

Tubing 22 mm diameter >130 180 180 180 180


Tubing 15 mm diameter

and high-efficiency filter >120 160 150 140 120

Without humidifier:

Maximum flow (l/min)

provoking a pressure drop of

1 cmH2O at the opening of the

patient side connection



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


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



Functional pneumatic block diagram

* except DreamStar™ Intro or DreamStar™ Intro Evolve


Essential performance requirements for electromagnetic

compatibility

During the electromagnetic compatibility tests, the device saved its settings and the value of the pressure

delivered remained 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

establishments including domestic establishments and those

directly connected to the public low-voltage power supply

network that supplies buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations

/ flicker emissions

IEC 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 Test level

IEC 60601 Compliance level Recommended electromagnetic environment

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 floors are covered with synthetic

material, 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

typical commercial or hospital environment.

Surge

IEC 61000-4-5

± 1 kV lines / lines

± 2 kV lines/earth

± 1 kV lines / lines

± 2 kV lines/earth Mains power quality should be that of a


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

Mains power quality should be that of a


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.


Electromagnetic Immunity (continued)°

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 location in a


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 IEC 60601

test level Compliance level Recommended electromagnetic environment

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80

MHz

3 Vrms

150 kHz to 80

MHz

Portable and mobile RF communications

equipment should not be used in

proximity to any part of the device from

the DreamStar™ product range, including

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

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 150 kHz to 80 MHz, field strengths should be less than 3 V / m.


Recommended separation distance between portable and mobile RF communications equipment and a

device from the DreamStar™ product range

The DreamStar™ product range are designed to be used in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or user of a device from the DreamStar™ product range can help prevent

electromagnetic 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 output power rating of the transmitter in watts (W) according to the transmitter

manufacturer.

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

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

absorption and reflection from structures, objects, and people.

Compliant cables

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.

Ref.: M-214831-10

Mini USB 2 m cable (except with DreamStar™ Intro)

6.5 ft (2m)

Ref.: M-214831-11

RS 232/mini USB 2 m cable (except with DreamStar™

Intro)

6.5 ft (2m)

Ref.: M-214831-12

RS 232/mini USB 15 m cable (except with

DreamStar™ Intro)

50 ft (15m)

Manufacturer: Manufacturing plant:

0459

SEFAM

144 AV CHARLES DE GAULLE

92200 NEUILLY SUR SEINE

FRANCE

SEFAM

10 ALLEE PELLETIER DOISY

54600 VILLERS-LES-NANCY

FRANCE

: M-155DFU00-60 Revision 8

2015-11

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