SEFAM EcoStar Info Practitioner And Home Care Provider Manual
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SEFAM EcoStar Info Practitioner And Home Care Provider Manual

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Practitioner and
Home Care Provider manual
EcoStar Info
EcoStar Auto

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Summary of Contents for SEFAM EcoStar Info

  • Page 1 Practitioner and Home Care Provider manual EcoStar Info EcoStar Auto...
  • Page 2 Manufacturing plant and technical agency: SEFAM SEFAM 144 AV CHARLES DE GAULLE 10 ALLEE PELLETIER DOISY 92200 NEUILLY SUR SEINE 54600 VILLERS-LES-NANCY FRANCE FRANCE TEL : +33 (0) 3 83 44 85 00 www.sefam-medical.com 2  EcoStar Info, EcoStar Auto...

  • Page 3: Table Of Contents

    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 ..................

  • Page 4: Before Starting

    Intended use The EcoStar Info and EcoStar Auto devices are Positive Pressure devices indicated for the mask treatment of Obstructive Sleep Apnea and Hypopnea Syndrome (OSAHS) in patients weighing more than 30 kg (66 lbs). They can be used at home or in a sleep center.

  • Page 5: Contraindications

    List of authorised accessories Studies have shown that the use of positive airway pressure is contraindicated for certain Unless otherwise indicated, the EcoStar Info or patients with one of the following pre-existing EcoStar Auto device can be used with the following conditions: optional accessories: ...

  • Page 6: Available Features

    Available features The EcoStar Info device operates in continuous mode, i.e. the device delivers a constant pressure level. The EcoStar Auto operates either in 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.

  • Page 7: Indexed Ramp Feature

    Latency this is the time taken by the device time: to activate the Auto-CPAP feature when the ramp is enabled. EcoStar Info, EcoStar Auto Accessing settings  7...

  • Page 8: Setting Ranges

    Parameters adjustable on the devices: Minimum Maximum Default Parameter Increment value value value On EcoStar Info and EcoStar Auto devices in CPAP mode: Pressure level 4 cmH 20 cmH 8 cmH 0.5 cmH Comfort pressure 4 cmH prescribed 4 cmH 0.5 cmH...

  • Page 9: Accessing The Menus

     parameter displayed (see table entitled compliance counter data. "Description of symbols displayed on the screen"). EcoStar Info, EcoStar Auto Accessing settings  9...

  • Page 10: How To Access Settings

    Information message Error message Pressure sensor offset Note : The EcoStar Info or EcoStar Auto device is shown in operating mode and all the values displayed are given by way of example. 10  Accessing settings EcoStar Info, EcoStar Auto...

  • Page 11: Setting Ecostar Info Device

    Press This screen appears: Comfort Calibration You can enable (1) the feature either continuously, or during the ramp ( ), or disable it (0) pressing the button EcoStar Info, EcoStar Auto Setting EcoStar Info device  11...
  • Page 12 The connection can be enabled (1) or disabled (0) by pressing the button Press This screen appears: Software version included with the EcoStar Info device. The version can be viewed but not modified. Press the information access button again to exit the parameter settings menu.

  • Page 13: Setting Ecostar Auto Device

    Increase or decrease the pressure value displayed using the button Press This screen appears: Ramp You can select the time ramp (tr) or the indexed ramp (ir) pressing the button EcoStar Info, EcoStar Auto Setting EcoStar Auto device  13...
  • Page 14 17. Press This screen appears: Command Inspiratory Flow Limitation, available in APAP mode only. The command can be enabled (1) or disabled (0) pressing the button 14  Setting EcoStar Auto device EcoStar Info, EcoStar Auto...
  • Page 15 The connection can be enabled (1) or disabled (0) by pressing the button Press This screen appears: Software version included with the EcoStar Auto device. The version can be viewed but not modified. EcoStar Info, EcoStar Auto Setting EcoStar Auto device  15...

  • Page 16: Setting The Clock

    The symbol of minute min blinks in turn. You can set the minutes by following the same procedure as for the hour. Press the information access button to exit the menu. 16  Setting the clock EcoStar Info, EcoStar Auto...

  • Page 17: Choosing A Pressure Unit

    4. Select the specific patient circuit CP:SP or CP:--: specific calibration already present specific calibration absent 5. Press the hidden key and hold it down until launch of calibration taking care not to touch the pneumatic circuit. EcoStar Info, EcoStar Auto Accessing settings  17...

  • Page 18: Cleaning And Maintenance

    Note: The patient must refer to the instructions for the mask, the heating humidifier and the respiratory circuit for more information about the care and maintenance of these items. 18  Cleaning and maintenance EcoStar Info, EcoStar Auto...

  • Page 19: Disinfecting The Equipment

    Never disinfect the internal circuit of air  If using detergent-disinfectant wipes: flow using a disinfecting product or with an Airway Surface Disinfection System (DSVA). o Wipe the exterior of the device and allow it to dry. EcoStar Info, EcoStar Auto Disinfecting the equipment  19...

  • Page 20: Trouble-Shooting

    CheckSum code error. Unplug the device from all sources of electrical power. Er 6 Plug it in again and turn it on. If the error persists, return the machine to the technical support. 20  Trouble-shooting EcoStar Info, EcoStar Auto...
  • Page 21 Plug it in again and turn it on. If the error persists, return the machine to the technical support Note: When an error is detected, the device goes into standby mode and access to the different menus is impossible. EcoStar Info, EcoStar Auto Trouble-shooting  21...

  • Page 22: Technical Characteristics

    (7.9 x 5.7 x 3.1 in approx.) Weight: 0.750 kg without power Temperature : -20°C à +60°C supply module (-4 °F to +140 °F) (1.65 lbs approx.) Relative humidity: up to 95% without condensation 22  Technical characteristics EcoStar Info, EcoStar Auto...

  • Page 23: Symbols On The Device

    (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. EcoStar Info, EcoStar Auto Technical characteristics  23...

  • Page 24: Standards Compliance

    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 Info or EcoStar Auto device complies with the following standards:   IEC 60601-1:2005 + Amd1:2012: Medical...

  • Page 25: Iso 17510-1:2009 And Iso 80601-2-70:2014 Compliant Features

    0.25 0.30 0.37 0.40 0.45 0.51 0.56 0.60 0.67 pressure (cmH Delta relative to dynamic 0.04 0.06 0.05 0.07 0.09 0.13 0.11 0.13 0.17 0.15 0.19 0.18 0.23 0.24 0.24 pressure (cmH EcoStar Info, EcoStar Auto Technical characteristics  25...

  • Page 26: Maximum Flow And Pressure

    (according to ISO 17510-1:2009 and et ISO 80601-2-70:2014 §201.9.6.2.1.101) With GoodKnight H O humidifier Without humidifier and tubing 15 mm diameter Sound pressure level 27.5 dB(A) 29.5 dB(A) Sound power level 35.5 dB(A) 37.5 dB(A) 26  Technical characteristics EcoStar Info, EcoStar Auto...

  • Page 27: Essential Performance Requirements For Electromagnetic Compatibility

    Essential performance requirements for electromagnetic compatibility The EcoStar Info or EcoStar Auto device generates an over pressure and regulates it to make the patient sleep properly. The device saves its settings and the value of the pressure delivered remains at the set pressure ±...
  • Page 28 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be consulted. If the measured field strength in the location in which the EcoStar Info or EcoStar Auto device is to be used exceeds the applicable RF compliance level shown above, the device should be observed to verify normal operation.
  • Page 29 EcoStar Info and EcoStar Auto devices are designed to be used in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the EcoStar Info or EcoStar Auto device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended below, according to the maximum power of the communications equipment.
  • Page 30 30  Technical characteristics EcoStar Info, EcoStar Auto...
  • Page 32 Manufacturer: Manufacturing plant: SEFAM SEFAM 144 AV CHARLES DE GAULLE 10 ALLEE PELLETIER DOISY 92200 NEUILLY SUR SEINE 54600 VILLERS-LES-NANCY FRANCE FRANCE : M-159DFU01-90 Revision 5 2016-06...

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