Sefam Ecostar Practitioner And Home Care Provider Manual

Brand: Sefam

Model: Ecostar

Type: Practitioner And Home Care Provider Manual

Sefam Ecostar is an easy-to-use medical device designed to provide respiratory support to patients with breathing difficulties. It features adjustable pressure settings to meet individual patient needs and a ramp feature for gradual pressure increase, making it comfortable to use. The device is equipped with an air inlet filter to ensure clean air delivery and has weekly and monthly maintenance schedules to keep it functioning optimally. With its compact design, Sefam Ecostar is suitable for home or travel use, offering reliable and convenient respiratory support.

2  EcoStar

Manufacturer:

Manufacturing and technical service location:

SEFAM

144 AV CHARLES DE GAULLE

92200 NEUILLY SUR SEINE

France

SEFAM

10 ALLEE PELLETIER DOISY

54600 VILLERS-LES-NANCY

FRANCE

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

www.Sefam-medical.com

Technical assistance:

E:mail: technicalservice@sefam-medical.com

EcoStar Table of Contents  3

TABLE OF CONTENTS

Before starting .................................................................................................................................. 4

Safety instructions ...................................................................................................................................... 4

Intended use ................................................................................................................................................. 5

Contraindications ........................................................................................................................................ 5

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

Accessing device settings ............................................................................................................... 6

Definitions ..................................................................................................................................................... 6

Setting ranges .............................................................................................................................................. 6

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

Device settings ............................................................................................................................................ 7

Description of symbols displayed on the screen ........................................................................................ 8

Settings ............................................................................................................................................................... 8

Adjustment of the pressure at the device outlet....................................................................................... 11

Choosing a pressure unit .............................................................................................................................. 11

Cleaning and Maintenance ............................................................................................................ 12

Weekly ......................................................................................................................................................... 12

Air inlet filter ..................................................................................................................................................... 12

Monthly ....................................................................................................................................................... 12

Device ............................................................................................................................................................... 12

Air inlet filter ..................................................................................................................................................... 12

Disinfecting the equipment ............................................................................................................ 13

Disinfecting the surface of the device ................................................................................................... 13

Products which must not be used ......................................................................................................... 13

Trouble-shooting ............................................................................................................................. 14

Device messages ...................................................................................................................................... 14

Error messages ......................................................................................................................................... 14

Technical characteristics ............................................................................................................... 16

Device performance.................................................................................................................................. 16

Conditions of use ...................................................................................................................................... 16

Electrical characteristics .......................................................................................................................... 16

Transport and storage conditions ......................................................................................................... 16

Physical characteristics ........................................................................................................................... 16

Symbols on the device ............................................................................................................................. 17

Disposing of the device at the end of its life ........................................................................................ 17

CE marking ................................................................................................................................................. 17

NF EN ISO 17510-1:2009 compliant features ...................................................................................... 18

Static pressure stability at 10 cmH

O ......................................................................................................... 18

Dynamic pressure stability............................................................................................................................ 18

Maximum flow ................................................................................................................................................ 19

Sound pressure level measured in accordance with NF EN ISO 17510-1:2009: ................................ 19

Sound power level measured in accordance with NF EN ISO 17510-1:2009: .................................... 19

Standards Compliance ............................................................................................................................. 19

Essential performance requirements for electromagnetic compatibility ....................................... 20

4  Before starting EcoStar

Before starting

This manual is intended for the use of the Practitioner and the Home care Service Provider. Under no

circumstances must it be supplied to the patient.

Safety instructions

WARNING

In this manual, this signals

a risk of injury or accident

to the patient.

 Please familiarize yourself with the safety

instructions in the patient manual.

 Refer to the patient manual for installing,

maintaining and storing the device.

 You must ensure that the patient receives the

manual intended for his use, as well as the

instructions for using the accessories.

 Only use authorized accessories as listed in this

manual.

 For proper maintenance and to prevent the risk

of damage, only qualified personnel are

authorized to service the device or carry out

approved modifications. The user assumes full

responsibility for any malfunction of the device

caused by maintenance performed by

unauthorized personnel.

 If you observe any anomaly in the device, do not

begin treatment.

 Never use the device without making sure that

the air inlet filter is installed.

 The patient should not use the device if it is near

or on top of a device other than the GoodKnight

O humidifier.

 When using oxygen, the oxygen source should

be placed at more than one meter from the

device.

 Do not introduce liquids or objects into the air

outlet.

 Portable RF communications equipment

(including peripherals such as antenna cables

and external antennas) should be used no

closer than 30 cm (12 inches) to any part of the

EcoStar device, including cables specified by

the manufacturer. Otherwise, degradation of

the performance of this equipment could result.

 Use of this equipment adjacent to or stacked

with other equipment should be avoided

because it could result in improper operation. If

such use is necessary, this equipment and the

other equipment should be observed to verify

that they are operating normally.

CAUTION

In this manual, this

indicates that there is a

possibility of material

damage to this device

or any other device.

 Since this is a medical electrical device,

please follow the installation instructions

contained in this manual concerning

electromagnetic compatibility.

 Like all medical electrical devices, the device

is vulnerable to interference from mobile and

portable radiofrequency communication

equipment (cordless phones, WiFi) which

could be placed nearby.

 Addition of any accessory at the respiratory

circuit level or combination with other

medical devices may affect the performance

of the device. Check that the pneumatic

configuration selected is suitable.

 Never connect the device to a battery when it

is charging from the mains.

If the device is used with a GoodKnight H

heating humidifier:

 When using the humidifier's water chamber,

the patient must take precautions to

eliminate the risk of introducing water into

the machine, which can cause irreversible

damage. The device must be placed on a

stable horizontal surface and must not be

tilted.

 We recommend disconnecting the device

from the heating humidifier and emptying the

water chamber before moving or

transporting the assembly, to eliminate any

risk of introducing water into the device,

which could cause irreversible damage.

EcoStar Before starting  5

Intended use

The EcoStar device is a Positive Pressure device

indicated for the mask treatment of Sleep Apnea

Syndrome (SAS) in patients weighing more than

30 kg (66 lbs). It can be used at home or in a

sleep center. It is not suitable to be used in close

proximity to CT scanners, MRT devices, RF

surgical devices or in transportation vessels (on

land, sea or in the air).

The device can be used with the GoodKnight

O humidifier if a prescription for heated

humidification has been added to the patient's

treatment. The heated humidifier is designed to

heat and raise the humidity of the air delivered

to the patient through the Continuous Positive

Airway Pressure (CPAP) device.

Contraindications

Studies have shown that the use of positive

airway pressure is contraindicated for certain

patients with one of the following pre-existing

conditions:

 Severe bullous emphysema or emphysema

previously complicated by pneumothorax.

 Pneumoencephalus, trauma or recent

surgery with sequela of cranio-

nasopharyngeal fistula.

 Decompensated cardiac insufficiency or

hypotension, particularly in case of

decreased blood volume or cardiac

arrhythmia.

 Dehydration

 Massive epistaxis or history of massive

epistaxis.

 Acute sinusitis, otitis media, or perforated

tympanic membrane.

 Tracheotomy.

Moreover, as the effect of positive airway

pressure on cardiac output is clear for some

patients, close monitoring of the patient's blood

pressure and heart rate are recommended when

beginning treatment at the effective pressure.

The risks and benefits of continuous positive

airway pressure must be assessed on a case-

by-case basis for these patients.

List of authorized

accessories

Unless otherwise indicated, the EcoStar

device can be used with the following

optional accessories:

 Power supply

P/N M-413910-00

(EU plug)

 Air inlet filter

P/N M-415930-01

P/N M-415910-03

(plug except EU)

 GoodKnight H

P/N M-114600

 Carrying case

P/N M-214531-01

WARNINGS

 Use only those accessories authorized

according to the list above, or which comply

with standard EN ISO 17510-2:2007.

 Use only those accessories which can

guarantee treatment pressure and reduce re-

inhalation of CO

 When a facial mask is necessary, always use

a mask which is equipped with an anti-

asphyxia valve.

6  Accessing device settings EcoStar

Accessing device settings

The device operates in continuous mode, which

means that the pressure is set at a constant level

and no automatic change in pressure is possible.

The adjustment of the therapeutic pressure must

be determined by the prescribing physician for each

patient individually, with the configuration of the

equipment to be used, including the accessories.

The correct installation and positioning of the

patient interface constitute a critical condition for

the proper operation of the device.

WARNING

Before proceeding with device settings, check

that the device produces airflow when in

operating mode. If not, turn it off immediately

and contact technical support.

Definitions

Compliance

counter:

length of time during which the

patient actually breathed with the

mask (minus the periods when the

mask is removed and moments

when breathing does not occur).

Hour

counter:

time during which the machine was

in use (Start/Stop).

Pressure

level:

pressure applied at the end of ramp

time or at start-up if the ramp is

disabled (set at 0).

Comfort

pressure:

level of pressure produced by the

device when the ramp feature starts

up so that the patient can go to

sleep comfortably.

Prescribed

pressure:

level of pressure prescribed for the

patient.

CPAP:

Continuous Positive Airway

Pressure.

SAS:

Sleep Apnea Syndrome.

Ramp

time:

time the device takes to reach the

prescribed pressure when starting

from the comfort pressure.

Setting ranges

For each parameter, the following table shows the

minimum, maximum and default values which can

be set for the device:

Notes:

 As the device is equipped with a

differential pressure sensor,

compensation in altitude is

automatic.

 The default unit of pressure is

cmH

Parameter

Minimum

value

Maximum

value

Default

value

Step

Prescribed pressure

4 cm H

20 cm H

8 cm H

0.5 cm H

Comfort Pressure

4 cm H

Prescribed

pressure

4 cm H

0.5 cm H

Ramp time

0 min

30 min

0 min

5 min

EcoStar Ramp feature  7

Ramp feature

The Ramp feature allows for a gradual rise in pressure.

1. To start the ramp feature, press the

on/off button .

The ramp indicator is displayed and

compliance recording begins.

The pressure level will gradually increase

from the comfort pressure to the level of

prescribed pressure.

Note:

If the ramp time is set at zero, the ramp

feature is disabled.

2. To turn the ramp feature off, press the

ramp button .

You can adjust the comfort pressure and the ramp time. Refer to "Settings" on page 8.

Device settings

The three buttons on the front of the device

allow access to the device settings and are

used to change the value of certain

parameters.

The parameters accessible on the screen

when the machine is in standby or operating

mode are:

 parameters of the device relating to

treatment

 the compliance data which has been

recorded.

Each screen of the practitioner settings menu

includes:

 an upper section indicating the value of

the parameter displayed

 a lower section with various symbols

indicating the device's operating mode or

the nature of the parameter displayed

(see table entitled "Description of symbols

displayed on the screen").

8  Description of symbols displayed on the screen EcoStar

Description of symbols displayed on the screen

Symbol

Description

Symbol

Description

Standby mode

Operating mode

Ramp feature

Pressure symbol

Time symbol

Compliance symbol

Adjustable parameter

Software version

Device message

Error message

Pressure sensor offset

Settings

In order to restrict access of certain settings to

the medical team, a hidden key has been

provided on the device. It is located under the

letters "Ec" of the name "EcoStar” and is

detectable to the touch as a hollow.

To access the device settings:

press the hidden key, then keeping it held

down, simultaneously press the information

access key for one second.

On the screen which appears:

 the symbol or the symbol shows if

the device is on standby or in use.

 the symbol indicates that the parameter

displayed can be modified. Raise the value

of the parameter by pressing the on/off

button or lower it using the ramp

button .

To access the next data:

press the information access button

again.

Note:

In the settings sequence below, the device is shown in operating mode and all the values displayed are

given by way of example.

EcoStar Settings  9

❶

This screen appears:

Press

simultaneously

the hidden key

and

for one second

Level of prescribed pressure

Increase or decrease the value displayed

using the button or the button.

❷

Press

Ramp time

Increase or decrease the value displayed

using the button or the button.

❸

Press

Comfort Pressure

This parameter is only adjustable if the

ramp time is greater than 0.

Increase or decrease the value displayed

using the button or the button.

For further information, refer to "Ramp

feature” on page 7.

❹

Press

Hour counter value (device operating

time).

The value displayed on the right below

represents the minutes. The hour meter

value cannot be changed.

❺

Press

Value of the compliance counter (time

during which the patient actually breathed

with the mask). The value displayed on

the right below represents the minutes.

This counter can only be reset to zero. To

do this, press the hidden key, then keeping

it held down, press the button or the

button.

10  Settings EcoStar

❻

This screen appears:

Press

Built-in pressure sensor offset.

This value can be adjustable between 0 and 255.

Increase or decrease the value displayed using

the button or the button. For further

information, refer to "Adjustment of the pressure

at the device outlet" on page 11.

❼

Press

Software version included with the EcoStar

device.

To exit the parameter settings menu, press the information access button again.

The display will indicate the operating status of the machine as shown below:

The machine is in standby

mode.

The device is running.

Note:

Exit from the parameter setting menu takes place automatically when you do not press any key for 30

seconds.

CAUTION

If, when in use, a problem with the memorized settings is detected, the device stops and displays the message

Er 1.

Press (the device displays the blinking message "dEF"), then the button.

The machine is then automatically reset to the default values and you can set the desired

parameters again.

EcoStar Adjustment of the pressure at the device outlet  11

Adjustment of the pressure at the

device outlet

1. Connect the spiral tubing to the device

outlet and the free nozzle of the tubing

to a plug equipped with a 4 mm leak

and a pressure point.

2. Then connect the pressure point to a

manometer and adjust the pressure

order to 12 cmH

3. Access the settings for the pressure

sensor offset as shown in "Settings" on

page 8 of this manual, and adjust the

value using the button or the

button until the pressure reads

12.0 cmH

O on the manometer.

4. Then, press the button while

holding down the hidden key. The

pressure sensor offset setting is

automatically memorized.

Choosing a pressure unit

You can select hPa instead of cmH2O as

the default pressure unit displayed on the

device, and vice versa.

To select the pressure unit, hold the hidden

key and the button simultaneously

pressed while you connect the device to the

power supply source (electrical outlet). The

machine displays the unit selected until you

release the hidden key and the

button.

Repeat to change the unit displayed.

12  Cleaning and Maintenance EcoStar

Cleaning and Maintenance

WARNING

Always unplug the device from the electrical source and disconnect the respiratory circuit from the

device before cleaning.

CAUTION

 Do not let water come into contact with the device.

 Use appropriate materials for cleaning: do not use harsh detergents, abrasive sponges or brushes with

hard bristles.

Weekly

Air inlet filter

 Remove the filter at the rear of the device.

 Wash the filter with warm water and mild

detergent (for example 1 drop of

dishwashing liquid on the filter).

 Rinse well to eliminate any trace of

detergent.

 Dry the filter:

o Press dry in a clean, absorbent cloth

o Allow to dry completely away from

sunlight.

 Once dry, reinstall the filter at the rear of

the device. Do not use a filter which is not

completely dry.

Monthly

Device

 Clean the device exterior regularly by

using a damp cloth or paper towel

moistened with a little water and a

drop of gentle detergent.

 Remove detergent residue by repeating

this step with a clean cloth or paper

towel, slightly moistened with just

water.

 Wipe the entire device with a dry cloth

or paper towel.

Air inlet filter

Change the filter whenever it is damaged

or soiled.

WARNINGS

 Do not use detergent sprays. Chemical

product residue could enter the air outlet,

the filter's foam or the device interior,

causing airway irritation.

 Never use the device without making sure

that an air inlet filter is installed.

Note:

Please refer to the instructions for your mask, the heating humidifier and the respiratory circuit for more

information about the care and maintenance of these items.

EcoStar Disinfecting the equipment  13

Disinfecting the equipment

Please refer to the instructions for the chemical products used to comply with the correct strength

and quantity of the products, contact time, and personal protective equipment needed.

Disinfecting the surface of

the device

A detergent-disinfectant is used to

disinfect the exterior of the machine.

 If using a spray or foam detergent-

disinfectant:

o Spray the product onto a

disposable cleaning pad made of

a non-woven material.

o Wipe the exterior of the device

and allow to dry.

 If using detergent-disinfectant wipes:

o Wipe the exterior of the device

and allow to dry.

Products which must not be

used

 Never use abrasive or highly alkaline

cleaning products, acetone, benzene or

leaded gasoline to clean the device.

 Do not use materials such as abrasive

sponges or stiff-bristled brushes.

 Never use any pre-disinfecting or

disinfecting product containing

aldehydes and/or its derivatives:

formaldehyde, glutaraldehyde, etc.

 Do not use any pre-disinfecting or

disinfecting product which is not

effective on Mycobacterium tuberculosis

(BK).

 Never disinfect the internal circuit of air

flow using a disinfecting product or with

an Airway Surface Disinfection System

(DSVA).

14  Trouble-shooting EcoStar

Trouble-shooting

Device messages

Message

displayed

Possible cause

Solution proposed

In 01

The mask is disconnected.

Check the connections between the mask, the

patient circuit, and the device. This message

disappears as soon as the mask is well

connected.

In 02

The device has detected

excess pressure for more

than 10 seconds.

Contact the technical department.

In 03

Reduction of the power

supply voltage.

Check the connections between the power supply

module, the device and the power outlet. Unplug

the power supply module, then reconnect it to the

power outlet. If the problem persists, contact your

home care provider.

Check the battery and replace it if necessary. If

the message persists, contact your home care

provider.

Error messages

Message

displayed

Possible cause

Solution proposed

Er 01

Problem with the settings.

Contact the technical department.

Er 02

High turbine temperature.

Unplug the device from all sources of electrical

power. Allow it cool and plug it in again according

to the instructions in the patient manual.

If the error persists, return the machine to the

technical department.

Er 06

CheckSum code error.

Unplug the device from all sources of electrical

power. Plug it in again.

If the error persists, return the machine to the

technical department.

EcoStar Trouble-shooting  15

Message

displayed

Description

Solution proposed

Er 07

Problem with the turbine.

Unplug the device from all sources of electrical

power. Check that there are no foreign bodies in

the air outlet. Plug the device in again.

If the error persists, return the machine to the

technical department.

Er 10

Motor power limit has been

exceeded.

Unplug the device from all sources of electrical

power. Plug it in again.

If the error persists, return the machine to the

technical department.

Er 11

Overconsumption of power

by the motor.

Unplug the device from all sources of electrical

power. Plug it in again.

If the error persists, return the machine to the

technical department.

Er 12

Device memory is empty.

Unplug the device from all sources of electrical

power. Plug it in again.

If the error persists, return the machine to the

technical department.

Er 13

Error in the speed table.

Unplug the device from all sources of electrical

power. Plug it in again.

If the error persists, return the machine to the

technical department.

Er 14

Problem with the motor

control.

Unplug the device from all sources of electrical

power. Plug it in again.

If the error persists, return the machine to the

technical department.

Er 15

CheckSum error in the

memory.

Unplug the device from all sources of electrical

power. Plug it in again.

If the error persists, return the machine to the

technical department.

Er 16

I²C communication error.

Unplug the device from all sources of electrical

power. Plug it in again.

If the error persists, return the machine to the

technical department.

EcoStar CPAP System is not designed to be repaired. A faulty EcoStar will be replaced with a new

one.

16  Technical characteristics EcoStar

Technical characteristics

Device performance

Device pressure range:

4 cm H

O to 20 cm H

O  1 cmH2O

device adjustable in increments of 0.5 cm H

Maximum pressure at the patient-side connection

port under single fault condition:

30 cmH

Ramp time:

0 to 30 minutes  1 minute

device adjustable in increments of 5 minutes

Patient-side connection aperture:

Conical connection of 22mm diameter

Sound pressure level measured in accordance with

NF EN ISO 17510-1: 2002:

27 dB(A)

Sound pressure level measured in accordance with

NF EN ISO 17510-1: 2009:

29 dB(A)

Conditions of use

Electrical characteristics

Absolute pressure

range:

700 hPa to 1060 hPa

Maximum power

consumption:

20 W

Temperature:

+5°C to +40°C

(+41 °F to +104 °F)

Input voltage:

13 V

+5°C to +35°C

(41 °F to 95°F) with

GKH

O humidifier

Current consumed

at 20 cmH

O with a

4mm leak:

0.750 A

Relative humidity:

between 10% and 95%

without condensation

Altitude range:

0  2,400 m approx.

(7,900 ft approx.)

Transport and storage conditions

Physical characteristics

Relative pressure

range:

500 hPa to 1060 hPa

Dimensions

(D x W x H):

202 x 145 x 79 mm

approx.

(7.9 x 5.7 x 3.1 in

approx.), without power

supply module

Temperature:

-20°C to +60°C

(-4 °F to +140 °F)

Relative humidity:

up to 95% without

condensation

Weight:

0.644 kg approximately

(1.4 lbs approx.), without

power supply module

EcoStar Technical characteristics  17

Symbols on the device

Symbol

Description

Symbol

Description

On/off button symbol.

Ramp button symbol.

Symbol for raising the value of the

parameter displayed on the screen.

Symbol for lowering the value of

the parameter displayed on the

screen.

Information access button symbol.

Outlet symbol.

Device is protected against the

penetration of solid objects larger

than 12 mm and against falling

drops of water.

Device at the end of its life,

separate from household waste for

disposal.

For further information, refer to

"Disposing of the device at the end

of its life".

Class II device.

BF-type device.

Direct current power supply.

Direct current.

Refer to the user manual.

Specific warning (see "Safety

instructions" in the patient manual).

Device complies with the

requirements of European Directive

93/42/EC on medical devices.

Keep dry.

Disposing of the device at the end of its life

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

equipment as defined in Directive 2012/19/EU, and must be collected and processed separately

from household waste for disposal as indicated by the symbol of the crossed out garbage bin (see

"Symbols on the device").

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

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

CE marking

EcoStar : 2013.

18  Technical characteristics EcoStar

NF EN ISO 17510-1:2009 compliant features

Static pressure stability at 10 cmH

(Long-term accuracy according to ISO 17510-1:2009, Appendix BB.1)

Without humidifier

With GoodKnight H

humidifier

Pressure accuracy (cmH

O):

- 0.02 /- 0.37

- 0.37 / - 0.74

Dynamic pressure stability

(Short-term accuracy according to ISO 17510-1:2009, Appendix BB.2)

Test pressure (cmH

Respiratory

rate

Resp./min

Respiratory

rate

Resp./min

Respiratory

rate

Resp./min

Respiratory

rate

Resp./min

Respiratory

rate

Resp./min

Without humidifier :

Delta relative to

highest pressure

(cmH

0.05

0.03

0.07

0.08

0.12

0.09

0.11

0.14

0.26

0.31

0.32

0.30

0.31

Delta relative to

lowest pressure

(cmH

0.23

0.32

0.40

0.31

0.36

0.41

0.40

0.44

0.49

0.38

0.41

0.46

0.48

0.51

Delta relative to

dynamic pressure

(cmH

0.07

0.06

0.07

0.09

0.12

0.15

0.16

0.20

0.33

0.32

0.42

0.36

0.32

0.37

With GoodKnight H

O humidifier :

Delta relative to

highest pressure

(cmH

0.2

0.19

0.31

0.32

0.33

0.35

0.48

0.52

0.54

0.65

0.73

0.82

0.86

0.95

1.00

Delta relative to

lowest pressure

(cmH

0.31

0.5

0.79

0.35

0.54

0.82

0.35

0.54

0.75

0.3

0.51

0.73

0.24

0.43

0.69

Delta relative to

dynamic pressure

(cmH

0.08

0.1

0.09

0.1

0.11

0.13

0.14

0.16

0.24

0.18

0.32

0.3

0.23

0.28

0.35

EcoStar Technical characteristics  19

Maximum flow

(According to ISO 17510-1:2009, Appendix CC.1)

Test pressure (cmH

Without humidifier :

Maximum flow (l/min) provoking a

pressure drop of 1 cmH

O at the

opening of the patient side connection

> 105.0

> 159.0

167.0

144.0

132

With GoodKnight H

O humidifier :

Maximum flow (l/min) provoking a

pressure drop of 1 cmH

O at the

opening of the patient side connection

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

26 dB(A)

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

34 dB(A)

Standards Compliance

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

standard, specifically with reference to global residual risk.

The EcoStar device complies with the following directives and standards:

 IEC 60601-1:2005 + Amd1:2012: Medical

electrical equipment. Part 1: General

requirements for basic safety and essential

performance.

 IEC 60601-1-2:2014: Medical electrical

equipment – Part 1-2: General requirements

for basic safety and essential performance –

Collateral Standard: Electromagnetic

disturbances – Requirements and tests.

 ISO 80601-2-70-1:2015: Medical electrical

equipment -- Part 2-70: Particular

requirements for basic safety and essential

performance of sleep apnea breathing

therapy equipment.

 NF EN ISO 5356-1:2005 : Anaesthetic and

respiratory equipment. Conical connectors.

 Council Directive 93/42/EC concerning

medical equipment.

 European Parliament and Council Directive

2011/65/EC on the restriction of the use of

certain hazardous substances (RoHS) in

electrical and electronic equipment.

 European Parliament and Council Directive

2012/19/EC on waste electrical and

electronic equipment (WEEE).

20  Technical characteristics EcoStar

Essential performance requirements for electromagnetic

compatibility

The EcoStar device generates an over pressure and regulates it to make the patient sleep properly.

The device retains its settings and the value of the delivered pressure remains that of the set

pressure + /-0.5cm H

If the Essential performance is lost or degraded, the delivered pressure could be different of the set

pressure. It is widely recognized that a patient will be resume breathing after the 5 seconds

interruption or that the patient will reset the device (without experiencing a hazard) when he notices

the display has stalled.

Electromagnetic emissions

The EcoStar device is designed for use in the electromagnetic environment specified below. The

customer or the user of an EcoStar device should ensure that it is used in such an environment.

Emission test

Conformity

Recommended electro-magnetic environment

RF emissions

CISPR 11

Group 1

The EcoStar device uses RF energy only for its internal

operation. Therefore its RF emissions are very low and

cannot be assumed to interfere with nearby electronic

equipment.

RF emissions

CISPR 11

Class B

The EcoStar device is suitable for use in all

establishments including residential establishments and

those directly connected to the public low-voltage power

supply network which supplies residential buildings.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations

/ flicker emissions

IEC 61000-3-3

Complies

Electromagnetic Immunity

The EcoStar device is designed for use in the electromagnetic environment specified below. The

customer or the user of an EcoStar device should ensure that it is used in such an environment.

Immunity test

IEC 60601 test

level

Conformity level

Recommended electro-magnetic environment

Electro-static

discharge (ESD)

IEC 61000-4-2

± 8 kV contact

± 2 kV air, ± 4 kV

air, ± 8 kV air,

± 15 kV air

± 8 kV contact

± 2 kV air, ± 4 kV

air, ± 8 kV air,

± 15 kV air

Floors should be wood, concrete or

ceramic tile. If floors are covered with

synthetic material, the relative humidity

should be at least 30%.

Electrical fast

transient/burst

IEC 61000-4-4

± 2 kV

100kHz repetition

frequency

± 2 kV

100kHz repetition

frequency

Mains power quality should be that of a

typical commercial or hospital

environment.

Lightning

IEC 61000-4-5

± 0,5 kV, ± 1 kV

lines to lines

± 0,5 kV, ± 1 kV

lines to lines

Mains power quality should be that of a

typical commercial or hospital

environment.

Voltage dips, short

interruptions and

voltage variations on

power supply input

lines

IEC 61000-4-11

< 5% UT

(>95% dip in UT) for

0.5 cycles

0% UT

for 1 cycle

70% UT

(30% dip in UT) for

25 cycles

< 5% UT

(>95% dip in UT) for

5 s

< 5% UT

(>95% dip in UT) for

0.5 cycles

0% UT

for 1 cycle

70% UT

(30% dip in UT) for

25 cycles

< 5% UT

(>95% dip in UT) for

5 s

Mains power quality should be that of a

typical commercial or hospital

environment.

If the user of an EcoStar device requires

continued operation during power

outages, it is recommended that the

EcoStar device be powered from an

uninterruptible power supply or a battery.

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Sefam Ecostar Practitioner And Home Care Provider Manual

Brand: Sefam

Model: Ecostar

Type: Practitioner And Home Care Provider Manual

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Sefam Ecostar Practitioner And Home Care Provider Manual

Sefam Ecostar Practitioner And Home Care Provider Manual

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