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-159DFU00-30 Version 7
2019-01
Page 1: ......
Page 2: ...l 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 ...
Page 3: ... 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 fe...
Page 4: ... 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 CA...
Page 5: ...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 p...
Page 6: ...ts 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 pat...
Page 7: ...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 practit...
Page 8: ...tters 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 pa...
Page 9: ...han 0 Increase or decrease the value displayed using the button or the button For further information refer to Ramp feature on page 7 Press Hour counter value device operating time The value displayed on the right below represents the minutes The hour meter value cannot be changed Press Value of the compliance counter time during which the patient actually breathed with the mask The value displaye...
Page 10: ...u 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 messag...
Page 11: ... and adjust the value using the button or the button until the pressure reads 12 0 cmH2O 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 k...
Page 12: ...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 c...
Page 13: ...r 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 containi...
Page 14: ...dule 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...
Page 15: ...vice 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 ...
Page 16: ...7510 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 GKH2O humidifier Current consumed at 20 cmH2O 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 appro...
Page 17: ... 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 e...
Page 18: ... 10 15 20 10 15 20 Without humidifier Delta relative to highest pressure cmH2O 0 05 0 03 0 07 0 07 0 08 0 12 0 09 0 11 0 14 0 26 0 26 0 31 0 32 0 30 0 31 Delta relative to lowest pressure cmH2O 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 46 0 48 0 51 Delta relative to dynamic pressure cmH2O 0 07 0 06 0 07 0 09 0 12 0 15 0 16 0 20 0 20 0 33 0 32 0 42 0 36 0 32 0 37 With GoodKnight...
Page 19: ...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 8060...
Page 20: ... 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 dischar...
Page 21: ...rdance with EN 60601 1 2 2015 table 9 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 survey a should be less than the conformity level in each frequency range b Interference may occur in the...
Page 22: ...on b 18 Hz 2 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT UMTS LTE Band 1 3 4 25 Pulse modulation b 217 Hz 2 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 28 5240 5100 5800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 9 5500 5785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL the distance between the transmitting anten...
Page 23: ...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 o...
Page 24: ...24 Technical characteristics EcoStar ...
Page 25: ......
Page 26: ...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 159DFU00 30 Version 7 2019 01 ...
