Starck Sefam S.Box Patient Manual
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Starck Sefam S.Box Patient Manual

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Summary of Contents for Starck Sefam S.Box

  • Page 1 Patient Manual...
  • Page 2 ▪ Easily monitor the evolution of the effectiveness of your treatment and other parameters of your health and well-being, ▪ Share this data with your healthcare professionals, ▪ Get access to information about your S. Box. With SEFAM Access Lite, engage in your treatment ! www.Sefam-medical.com ▪ SEFAM S.Box...

  • Page 3: Table Of Contents

    Transporting and storage conditions ...................... 39 Electrical characteristics ..........................39 Physical characteristics ..........................40 Functional diagram of the internal pneumatic circuit ................40 CE marking ............................41 End-of-life disposal of the device ...................... 41 • 3 SEFAM S.Box Product description...

  • Page 4: Product Description

    Product description Please read this manual carefully before using your SEFAM S.Box to understand the usage constraints of the device. Intended purpose The S.Box is Positive Pressure devices connected by a flexible tube to a mask worn by the patient suffering from obstructive sleep apneas and hypopneas during sleep.

  • Page 5: Warnings/ Precautions

    Portable RF communications devices (including peripherals such as antenna cables and external antennas) should not be used closer than 30 cm (12 inches) to any part of the SEFAM S.Box including cables specified by the manufacturer. Otherwise, the performance of these devices may be impaired.

  • Page 6: Potential Undesirable Side Effects

    Target patient groups S.Box and its accessories may only be used for the treatment of obstructive sleep apnea-hypopnea syndrome (OSAHS) in patient over 30 kg and with spontaneously breathing. 6 • Product description SEFAM S.Box...

  • Page 7: Intended Users

    Environment of use The SEFAM S.Box is intended for use at home or in a care centre (hospital or clinic). It is designed to travel easily and can be used on aircraft (see " Transport of the device " paragraph).

  • Page 8: Presentation Of The System

    Presentation of the system Components of the system The SEFAM S.Box comes with the following components: ▪ S.Box SD card ▪ Side cover Inlet air filter Patient manual ▪ ▪ S.Box power supply S.Box carrying bag ▪ ▪ Flexible tube ▪...
  • Page 9 Base of the heated humidifier used to heat the water in the humidifier chamber. Humidifier chamber (if included): Humidifier chamber in which the maximum water level is indicated. Side cover (if included): Angled outlet connector: Swivel connector for connecting the tube. • 9 SEFAM S.Box Presentation of the system...

  • Page 10: Meaning Of Symbols

    On the packaging, this symbol Refer to the user manual. means "Temperature limit". Air flow input. Do not clog. Air flow output. Do not clog. Pay attention to the electrical connections. 10 • Presentation of the system SEFAM S.Box...

  • Page 11: Installation

    B) Lock the heater plate by pushing the latch to the left as indicated by C) Place the base of the humidifier chamber on the heater plate and push the humidifier chamber against the device until you hear a "click". • 11 SEFAM S.Box Installation...

  • Page 12: Installation With Cigarette Lighter

    Use only the 24 V cigarette lighter cable recommended with the device. ▪ Assure the conformity of the voltage supplied by the cigarette lighter socket. ▪ Do not use the device with a 12 V or 13 V battery of a light vehicle. 12 • Installation SEFAM S.Box...

  • Page 13: Filling The Humidifier Chamber (If Applicable)

    Filling the humidifier chamber (if applicable) 1. Unplug the SEFAM S.Box device from the power supply or the electrical power grid. 2. To separate the humidifier chamber from the device, press the button to unlock the humidifier chamber (mark 4 in Figure 1) and at the same time, pull the humidifier chamber away from the device using the integrated handle.

  • Page 14: Device Configuration

    The backlight of the display comes on when your hand approaches the display (Wave & Go feature) or • when you tap the touch area or push one of the two operating buttons on the device. Displays illustrated in this manual are just used as examples. • 14 • Device configuration SEFAM S.Box...
  • Page 15 Touch key to adjust the S.Box Touch key to adjust the heated heated tube with ATC setting humidifier setting Touch key to access the settings Touch key to access information Multifunctional touch key Home touch key • 15 SEFAM S.Box Device configuration...

  • Page 16: Available Features

    The symbol is displayed in the status bar. The ramp starts automatically when the apparatus is switched on (if the ramp time is not zero). It can be deactivated by pressing the ramp button 16 • Device configuration SEFAM S.Box...

  • Page 17: Device Settings

    Possible displays: LK:OK, LK:NOK. in standby mode. In case of undesired leak (LK:NOK), re- adjust your mask. to return to the standby screen. The display will turn off automatically after two minutes without tapping a key. • 17 SEFAM S.Box Device configuration...
  • Page 18 Possible settings: ▪ from 4 cm H O to the pressure set in CPAP mode. ▪ from 4 cm H O to the maximum pressure set in APAP (Auto-CPAP) mode. 18 • Device configuration SEFAM S.Box...
  • Page 19 Nonin pulse oximeter on the SD card ▪ to recover compliance data recorded in the device via a Bluetooth connection ▪ to make adjustments via tablet / smartphone applications (refer to the corresponding instructions for use). • 19 SEFAM S.Box Device configuration...
  • Page 20 The symbol blinks slowly at the top of the screen. Only when the Wi-Fi module is installed inside the SEFAM S.Box device and the Wi-Fi connection activated, you can access the WPS automatic configuration which allows connecting to the local network.
  • Page 21 Once detected, the last six digits of the Bluetooth address of the PolyLink system flash alternately with BLE. You can disable the communication by tapping the key • 21 SEFAM S.Box Device configuration...
  • Page 22 A period of 24-hour use is set from noon to the next noon. Accessing a period of use ❶ Tap the touch key This screen appears only if at least two periods of 24-hour use have been recorded in the device. in standby mode. 22 • Device configuration SEFAM S.Box...
  • Page 23 24-hour use. Usage hour counter: time during which you ❺ have been breathing in the mask during the Tap the touch key period of use. • 23 SEFAM S.Box Device configuration...
  • Page 24 4 hours per day Tap the touch key (within the limit of 30 days) This screen appears only if the number of 24- hour periods recorded in the device is more than 01. 24 • Device configuration SEFAM S.Box...
  • Page 25 It can be read but not modified. Total usage hour counter ⓭ Tap the touch key This counter calculates the total time during which you have been breathing into the mask. • 25 SEFAM S.Box Device configuration...
  • Page 26 Possible displays: SPO: OK and SPO: _ _ _. button If SPO: _ _ _ is displayed, check that the oximeter sensor has been properly installed and the communication with the oximeter is correct. 26 • Device configuration SEFAM S.Box...
  • Page 27 Possible displays: BAT : X (X = 0 to 100) If the displayed value is slow, recharge the internal battery using the USB charger (see the procedure for installation of the PolyLink system). • 27 SEFAM S.Box Device configuration...
  • Page 28 When you are using SEFAM Access application on a Bluetooth enabled device (such as a Smartphone or a tablet) and you connect it to the SEFAM S.Box in standby mode via Bluetooth wireless communication, a message appears on the display of the machine at the first pairing:...

  • Page 29: Use

    After a power failure, the appliance will recover the same parameters and operating mode as the ones before the power failure occured (start / standby). Stopping treatment 1. Remove the mask. 2. Hold down the start / standby button to switch off the device. If it is installed, the heated humidifier stops simultaneously. • 29 SEFAM S.Box...

  • Page 30: Use When Oxygen Is Added (Optional)

    If the data is recorded within the device, the data backup starts automatically when you insert the memory card into the machine, turn on the power and stop treatment. The symbol blinks slowly in the status bar on the screen and the display changes: an animation appears at the top, showing three 30 • SEFAM S.Box...
  • Page 31 Once the recording is finished, switch off the apparatus by holding down the start / standby button . Wait for the symbol to stop blinking on the screen (up to 2 minutes) and remove the card. • 31 SEFAM S.Box...

  • Page 32: In Case Of Problems

    The device seems to Too much electro- Keep the device away from sources of interference be disturbed and not magnetic such as halogen lamps, mobile phones, etc. functioning properly. disturbance. 32 • In case of problems SEFAM S.Box...
  • Page 33 ATC "). The humidifier does humidification Set the humidification level between 01 and 10 not appear to heat level is set on OFF. (see paragraph "2. Humidification level "). the water. • 33 SEFAM S.Box In case of problems...

  • Page 34: Device Messages

    Disconnect the power supply from the mains. Plug it in operating error. again and turn on the device. If the error persists, contact your Home Care Provider. The error code blinks. (XX = 2 figures). 34 • In case of problems SEFAM S.Box...

  • Page 35: Cleaning And Maintenance

    Fill the bottom part of the humidifier chamber, then press down on the upper part to close the chamber and lock it. Place the humidifier chamber back on the heater plate, hinge side towards the inside of the machine, and push it against the device until you hear a "click". • 35 SEFAM S.Box Cleaning and Maintenance...

  • Page 36: Monthly

    ▪ Never use concentrated bleach higher than 0.1%. For example: pour 200 ml of bleach to 2.6% in 5 liters of cold water. 36 • Cleaning and Maintenance SEFAM S.Box...

  • Page 37: Transport Of The Device

    If you are travelling to a country where the voltage is different from that normally used, it may be necessary to bring a different power cord or an adapter to connect your appliance to the electrical sockets in that country. • 37 SEFAM S.Box Transport of the device...

  • Page 38: Technical Characteristics

    Maximum operating pressure: 20 cm H Maximum gas temperature coming from the 43°C breathing tube: (109°F) The humidification rate includes a measurement uncertainty of 2.7%. Values determined under ATPD (Ambient Temperature and Pressure, Hygrometry) conditions. 38 • Technical characteristics SEFAM S.Box...

  • Page 39: Conditions Of Use

    Maximum power consumption: 75 W during a mask disconnection Current consumption at 20 cmH O with a 0.42 A (minimum configuration: SEFAM S.Box 4-mm leak: only) 1.99 A (maximum configuration: SEFAM S.Box with humidifier set to 10 and heated tube set to RF emission type (SEFAM S.Box...

  • Page 40: Physical Characteristics

    730 ml in the humidifier chamber): Usable volume of water in humidifier chamber 350 ml Maximum liquid level: Indicated by on humidifier chamber Functional diagram of the internal pneumatic circuit Device with side cover 40 • Technical characteristics SEFAM S.Box...

  • Page 41: Ce Marking

    Recycling electrical equipment preserves natural resources and avoids any risk of pollution. To this end, SEFAM fulfils its obligations relating to the end-of-life of SEFAM S.Box devices by financing Recylum's recycling channel dedicated to WEEE Pro, which takes them back free of charge (more information on www.recylum.com).
  • Page 42 42 • End-of-life disposal of the device SEFAM S.Box...
  • Page 44 Coordonnées de votre Prestataire de Santé A Domicile Fabricant : Site de fabrication : SEFAM SEFAM 144 AV CHARLES DE GAULLE 10 ALLEE PELLETIER DOISY 92200 NEUILLY SUR SEINE 54600 VILLERS-LES-NANCY FRANCE FRANCE : M-164DFU00-20-Version 13 2023-09...

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