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EcoStar Info, EcoStar Auto

Table of Contents

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Table of Contents

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

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

Intended use .............................................................................................................................................. 4

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

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

Available features ......................................................................................................................... 6

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

Comfort Calibration.................................................................................................................................... 6

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

Time Ramp feature .................................................................................................................................... 6

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

Accessing settings ......................................................................................................................... 7

Definitions .................................................................................................................................................. 7

Setting ranges ............................................................................................................................................ 8

Accessing the menus .................................................................................................................................. 9

Description of a screen page ......................................................................................................................... 9

How to access settings ................................................................................................................................ 10

Description of symbols displayed on the screen .......................................................................................... 10

Setting EcoStar Info device ...................................................................................................................... 11

Setting EcoStar Auto device ..................................................................................................................... 13

Setting the clock ....................................................................................................................................... 16

Choosing a pressure unit .......................................................................................................................... 17

Adjustment of the pressure at the device outlet ..................................................................................... 17

Specific calibration of the pneumatic configuration ................................................................................ 17

Cleaning and maintenance .......................................................................................................... 18

Weekly ..................................................................................................................................................... 18

Air intake filter ............................................................................................................................................. 18

Monthly .................................................................................................................................................... 18

Device .......................................................................................................................................................... 18

Air intake filter ............................................................................................................................................. 18

Disinfecting the equipment ......................................................................................................... 19

Disinfecting the surface of the device ...................................................................................................... 19

Products which must not be used ............................................................................................................ 19

Trouble-shooting......................................................................................................................... 20

Information messages .............................................................................................................................. 20

Error messages ......................................................................................................................................... 20

Technical characteristics .............................................................................................................. 22

Device performance ................................................................................................................................. 22

Conditions of use ..................................................................................................................................... 22

Electrical characteristics ........................................................................................................................... 22

Transport and storage conditions ............................................................................................................ 22

Physical characteristics ............................................................................................................................ 22

Symbols on the device ............................................................................................................................. 23

Disposing of the device at the end of its life ............................................................................................ 23

Standards Compliance ............................................................................................................................. 24

EC marking ............................................................................................................................................... 24

ISO 17510-1:2009 and ISO 80601-2-70:2014 compliant features ........................................................... 25

Static pressure stability at 10 cmH

O .......................................................................................................... 25

Dynamic pressure stability........................................................................................................................... 25

Maximum flow and pressure ....................................................................................................................... 26

Sound pressure and sound power levels ...................................................................................................... 26

Essential performance requirements for electromagnetic compatibility ................................................ 27

Содержание EcoStar Auto

Страница 1: ...Practitioner and Home Care Provider manual EcoStar Info EcoStar Auto ...

Страница 2: ...uto 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 ...

Страница 3: ...ion of the pneumatic configuration 17 Cleaning and maintenance 18 Weekly 18 Air intake filter 18 Monthly 18 Device 18 Air intake filter 18 Disinfecting the equipment 19 Disinfecting the surface of the device 19 Products which must not be used 19 Trouble shooting 20 Information messages 20 Error messages 20 Technical characteristics 22 Device performance 22 Conditions of use 22 Electrical character...

Страница 4: ...ity 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...

Страница 5: ... Continuous Positive Airway Pressure must be assessed on a case by case basis for these patients List of authorised accessories Unless otherwise indicated the EcoStar Info or EcoStar Auto device can be used with the following optional accessories Air intake filter P N M 415930 01 Fine filter P N M 413950 04 Specific power supply module P N M 413910 00 EU plug P N M 415910 03 no EU plug GoodKnight ...

Страница 6: ... Calibration The Comfort Calibration CC 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 Auto ON feature Functionality allowing to automatically start the treatment during the first breaths in the mask without pressing...

Страница 7: ...ng 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 Hour counter device operating time ON OFF Compliance counter 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 F...

Страница 8: ...m value Maximum value Default value Increment On EcoStar Info and EcoStar Auto devices in CPAP mode Pressure level 4 cmH2O 20 cmH2O 8 cmH2O 0 5 cmH2O Comfort pressure 4 cmH2O prescribed pressure 4 cmH2O 0 5 cmH2O Ramp time 0 min 45 min 15 min 5 min On EcoStar Auto device in Auto CPAP mode Maximum pressure 4 cmH2O or minimum pressure 20 cmH2O 20 cmH2O 0 5 cmH2O Minimum pressure 4 cmH2O 20 cmH2O or ...

Страница 9: ...ific CP SP specific calibration present CP specific calibration absent Accessing the menus 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 Moreover the three buttons shown at the user interface allow access to the device settings and are...

Страница 10: ...p button To access the next data press the information access button again To return to the previous data press the hidden key Note Exit from the parameter setting menu takes place automatically when you do not press any key for 30 seconds Description of symbols displayed on the screen Symbol Description Symbol Description Standby mode Operating mode Ramp feature Pressure symbol Time symbol Compli...

Страница 11: ...tton or Press This screen appears Ramp time when the time ramp tr is selected otherwise this parameter is not displayed Increase or decrease the value displayed pressing the button or Press This screen appears Comfort pressure Increase or decrease the value displayed pressing the button or Press This screen appears Auto ON You can enable 1 or disable 0 the feature pressing the button or Press This...

Страница 12: ...ght below represents the minutes Press This screen appears Compliance counter time during which the patient actually breathed with the device The value displayed on the right below represents the minutes Press This screen appears Built in pressure sensor Increase or decrease the value displayed using the button or Refer to Adjustment of the pressure at the device outlet page 17 Press This screen a...

Страница 13: ...meters are adjustable To change from one mode to the other press the button or Press This screen appears Device pressure level In CPAP mode you can set the pressure level In APAP mode you can set the maximum pressure and the minimum pressure which can be viewed successively by pressing each time the information access button Maximum pressure Minimum pressure Increase or decrease the pressure value...

Страница 14: ...omfort Calibration You can enable 1 the feature either continuously or during the ramp or disable it 0 pressing the button or Press This screen appears Pneumatic Calibration Using the button or you can select a configuration 22 tubing 22 mm diameter standard 15 tubing 15 mm diameter HH humidifier SP specific present or specific absent The value displayed on the right below represents the diameter ...

Страница 15: ...ts the minutes Press This screen appears Compliance counter time during which the patient actually breathed with the mask The value displayed on the right below represents the minutes Press This screen appears Built in pressure sensor offset Increase or decrease the value displayed using the button or Refer to Adjustment of the pressure at the device outlet page 17 Press This screen appears Select...

Страница 16: ...e dEF then the button The machine is then automatically reset to the default values and you can set the desired parameters again Setting the clock You can set the time only when the device is in standby Press for 2 seconds then keeping it hold down press This screen appears Once the buttons are released the symbol of adjustment appears under the hour and the letter h blinks You can change the time...

Страница 17: ...ure sensor offset setting is automatically memorized Specific calibration of the pneumatic configuration CAUTION Since pressure performance depends on the pneumatic configuration selected it is important to select the correct configuration Specific configurations should be set up by skilled personnel only To optimise the performance of the device it is advised to carry out a specific calibration b...

Страница 18: ...install 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 o...

Страница 19: ...xterior of the device and allow it to dry If using detergent disinfectant wipes o Wipe the exterior of the device and allow it 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 prod...

Страница 20: ...ice is now set to the default values and can be reset to the desired values If the error persists return the machine to the technical support Er 2 High motor temperature Unplug the device from all sources of electrical power Allow it to cool and plug it in again according to the instructions in the patient manual If the error persists return the machine to the technical support Er 3 Program batter...

Страница 21: ...f electrical power Plug it in again and turn it on If the error persists return the machine to the technical support Er 11 High current consumption Unplug the device from all sources of electrical power Plug it in again and turn it on If the error persists return the machine to the technical support Er 12 Device memory is empty Unplug the device from all sources of electrical power Plug it in agai...

Страница 22: ...umidifier 29 5 dB A with GoodKnight H2O humidifier Conditions of use Electrical characteristics Absolute pressure range 700 hPa to 1060 hPa Maximum power consumption 25 W Temperature 5 C to 40 C 41 F to 104 F Input voltage 13 V 5 C to 35 C with GKH2O humidifier 41 F to 95 F Current consumption at 20 cmH2O with a 4 mm leak 0 750 A Relative humidity between 10 and 95 without condensation Altitude ra...

Страница 23: ... its life Class II device BF type device Direct current power supply Direct current Refer to the user manual Recording and play back Device complies with the requirements of European Directive 93 42 EC on medical devices Specific warning see Safety instructions in the patient manual Keep dry Disposing of the device at the end of its life In European Union this device has to be considered as an ele...

Страница 24: ...0601 1 2 2007 Medical electrical equipment Part 1 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests EN ISO 17510 1 2009 Sleep Apnoea Breathing Therapy EN ISO 5356 1 2005 Anaesthetic and respiratory equipment Conical connectors Council Directive 93 42 EC concerning medical devices European Parliament and Council Directive 2011 65 EU on the rest...

Страница 25: ...te 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 Delta relative to highest pressure cmH2O 0 09 0 13 0 11 0 29 0 36 0 31 0 32 0 36 0 33 0 29 0 26 0 38 0 31 0 29 0 37 Delta relative to lowest pressure cmH2O 0 16 0 19 0 30 0 06 0 05 0 20 0 12 0 14 0 27 0 25 0 32 0 32 0 33 0 39 0 43 Delta relative to dynamic pressure cmH2O 0 03 0 03 0 03 0 05 0 0...

Страница 26: ...pressure cmH2O 0 06 0 08 0 08 0 13 0 14 0 15 0 16 0 22 0 23 0 22 0 24 0 33 0 23 0 35 0 31 Tubing 15 mm diameter and high efficiency filter Delta relative to highest pressure cmH2O 0 11 0 18 0 43 0 22 0 30 0 52 0 23 0 31 0 49 0 17 0 31 0 42 0 12 0 26 0 36 Delta relative to lowest pressure cmH2O 0 32 0 42 0 53 0 28 0 36 0 47 0 42 0 50 0 60 0 61 0 64 0 81 0 79 0 83 0 98 Delta relative to dynamic pres...

Страница 27: ...ce is designed for use in the electromagnetic environment specified below The customer or the user of the device should ensure that it is used in such an environment Immunity test IEC 60601 test level 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 the f...

Страница 28: ...smitter manufacturer and d is the recommended separation distance in meters m Fields strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b 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 Thes...

Страница 29: ... 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 transmitt...

Страница 30: ...30 Technical characteristics EcoStar Info EcoStar Auto ...

Страница 31: ......

Страница 32: ...Manufacturer Manufacturing plant SEFAM 144 AV CHARLES DE GAULLE 92200 NEUILLY SUR SEINE FRANCE SEFAM 10 ALLEE PELLETIER DOISY 54600 VILLERS LES NANCY FRANCE M 159DFU01 90 Revision 5 2016 06 ...

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