Starck Sefam S.Box Duo S User Manual
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Starck Sefam S.Box Duo S User Manual

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Summary of Contents for Starck Sefam S.Box Duo S

  • Page 1 S.Box™ Duo S.Box™ Duo...
  • Page 2 Manufacturer: Manufacturing and technical service location: 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 Technical assistance: E:mail: technicalservice@sefam-medical.com 2  Before you start S.Box Duo S and S.Box Duo ST...

  • Page 3: Table Of Contents

    ONTENTS Before you start ............................4 Safety guidelines ............................4 Recommended use ............................5 Contraindications............................5 Essential performance of the device ......................5 List of authorized accessories ........................6 Features of the device ........................... 7 Heated humidification ..........................7 Intelligent Start ............................... 7 Mask Fit &...

  • Page 4: Before You Start

    Before you start This user guide is intended for Physicians & Home Care Providers. Under no condition should it be given to patients. Safety guidelines It means that there is a possibility of danger risk of injuries or accident to WARNING: patient.

  • Page 5: Recommended Use

    Recommended use S.Box Duo S and S.Box Duo ST devices are designed for the Non-Invasive Ventilation of patients weighing more than 30 kg, suffering from a Ventilatory Disorder or Sleep Apnea Syndrome (SAS), but not dependent on respiratory assistance. They can be used mainly in Home Healthcare Environment or in a sleep center (hospital or clinics).They can travel easily and be used in airplane.

  • Page 6: List Of Authorized Accessories

    Ø 15 mm standard tube M-261000-05 ® S.Box Ø 22 mm standard tube M-261000-06 Travel accessories: ® S.Box carrying bag M-816405-00 S.Box by Starck carrying case M-816405-01 ® S.Box cigarette cable (24 VDC-5 m) M-216430-08 Machine data analysis: SEFAM Analyze Software M-215630-04 ® S.Box...

  • Page 7: Features Of The Device

    Features of the device S.Box Duo S and S.Box Duo ST devices are positive pressure generators used in the treatment of Ventilatory Disorders and Sleep Apnea Syndrome. These devices can operate in constant CPAP mode and in BPAP (bilevel) mode in which the pressure delivered changes with the inspiration and expiration of the patient.

  • Page 8: Ramp

    Ramp The time ramp feature allows for a gradual rise in pressure to help the patient go to sleep. When the ≠ Ramp feature is programmed, it starts automatically when the device is switched on (if OFF). Pressing the ramp button deactivates (and by pressing again reactivates) this function.

  • Page 9: Information And Settings

    Information and settings 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 are critical to the proper operation of the device.

  • Page 10: Settings Ranges

    Prescribed pressure: level of pressure prescribed for the patient in CPAP mode. Pressure rise time: set by the physician, time the device takes to rise from the expiratory pressure to the inspiratory pressure. Ramp time: time taken by the device to reach the prescribed pressure from the comfort pressure in CPAP mode or to reach expiratory and inspiratory pressures from the comfort pressure in BPAP (bilevel) mode.
  • Page 11 Minimum Maximum Value by Parameter Increment value value default In BPAP (bilevel) mode: Comfort pressure 3 cmH Expiratory pressure 4 cmH 0.5 cm H Inspiratory pressure Expiratory pressure 3 cmH 5 cmH 0.5 cm H or 20 cmH Inspiratory pressure 3 cmH 25 cmH 15 cmH...

  • Page 12: User Interface Description

    User interface description The two mechanical buttons on the top of the device are used to manage its operation:  Start / standby button : to switch the device on or off.  Ramp button : to disable or enable the ramp feature when the device is in use. If it is pressed simultaneously with the touch key , it also allows you to access your specific settings menu.
  • Page 13 Description of symbols displayed Symbol Meaning Symbol Meaning Status bar GSM mobile phone network status. Wi-Fi Communication activated. Flashes quickly during the Flashes quickly during the transmission. transmission. Airplane mode Oximeter connected USB connection active (Bluetooth Ramp active (T RAMP) disabled) Inspiratory pressure Operation mode...

  • Page 14: How To Set The Device

    How to set the device 1. Setting menu The adjustment of the treatment parameters is accessible by the touch keys displayed on the screen. Access to some of them is restricted to the medical professional (in standby mode only). To do this, press and maintain the ramp button , then tap the touch key for two seconds when it is shown on the display.
  • Page 15 Views of the display: Expiratory pressure (low pressure for expiration). Tap the touch key You can decrease or increase the displayed value by tapping repeatedly the key Possible settings: from 3 cm H O to the inspiratory pressure or 20 cmH Backup frequency available on S.Box Duo ST ❸...
  • Page 16 Views of the display: ❼ expiratory sensitivity (sensitivity Tap the touch key detecting the beginning of the breathing expiratory phase). You can decrease or increase the displayed value by tapping repeatedly the key Possible settings: 1 to 10 (1 the most sensitive and 10 the least sensitive)..
  • Page 17 Views of the display: Circuit Select: specific calibration ⓫ Tap the touch key Tapping repeatedly the touch key you can choose the pneumatic calibration adapted to the pneumatic circuit (tube and mask) of the patient. Possible settings:  15 (tube 15 mm in diameter) ...
  • Page 18 Views of the display: ⓮ Choosing the format of time display Tap the touch key The time display is set to 24 hours by default. You can select another format by tapping the Possible Settings: 24H and 12H. Clock ⓯ Tap the touch key The hour blinks on the display.
  • Page 19 Views of the display: The offset of the flow sensor comes after. Unchangeable value: from 1450 to 5450 (default value 3450). If a offset problem occurs on the flow sensor, the value is no longer displayed. Delete of data ⓳ Tap the touch key The touch key visible on the screen...
  • Page 20 View of the display: Software version Tap the touch key This is the version of the embedded software of the device. It can be read but not written. to exit the menu. 2. Settings accessible to the patient The can make the following adjustments using the touch keys displayed on the S.Box Duo S or S.Box Duo ST: Displayed parameter: Adjusted by...
  • Page 21 3. Information menu The touch key gives access to the compliance information recorded in the device during the last 24-hour periods stored (within the limit of 30 days), then to the technical information about the device (see patient manual). Information displayed successively: ❶...
  • Page 22 4. Status menu This menu is accessible when the device is in operation and when a PolyLink system or an oximeter 3150 has been installed and paired (see the S.Box Duo S or S.Box Duo ST patient manual). Information displayed successively: Possible displays: SD: OK and SD : _ _ _.
  • Page 23 6. Circuit Select: specific calibration of the pneumatic configuration The specific calibration feature of the pneumatic circuit allows adjusting the pressure delivered to the mask with a high level of accuracy by compensating for all the pneumatic resistances in the patient circuit.

  • Page 24: Using The Sd Card

    Using the SD card The SD card permits to store the most recent compliance data or to update the device settings. Backing up the data 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.

  • Page 25: Cleaning And Maintenance

    Cleaning and maintenance Make sure that the patient follows carefully the instructions given in this chapter. The patient should refer to the user guide for instructions on maintenance for the mask, the breathing tube, the S.Box heated tube with ATC and the communicating accessory. WARNING: Unplug the device from the power supply.

  • Page 26: Monthly

    Washable filter  Remove the air intake grid.  Pull the filter towards you to remove it.  Wash the filter with lukewarm water and a mild detergent (e.g. using a drop of dishwashing liquid diluted in water).  Rinse thoroughly to remove any trace of detergent. ...

  • Page 27: Disinfection Instructions

    Disinfection instructions Please refer to the instructions for use of the chemicals you use in order to comply with dilution and quantity of products, contact time and wearing of personal protective equipment. Disinfecting the surface of the device Disinfecting the outside of the device is done with disinfectant detergents. ...

  • Page 28: Warnings

    Warnings  Never use abrasive or strong alkaline cleaners, acetone, benzene, leaded gasoline to clean the device.  Do not use a type of sponge with a scraper or a hard bristle brush.  Never use any pre-disinfectant or disinfectant products containing Aldehydes and/or its derivatives: Formaldehyde, Glutaraldehyde, etc.

  • Page 29: Troubleshooting Tips

    Troubleshooting tips Displayed messages Message on the Possible cause Proposed solution display The mask is Check the connection between the mask, the disconnected. breathing tube and the device. This message disappears once you breathe into your properly reconnected mask or press the button.

  • Page 30: Error Messages

    Error Messages Code Description Corrective action ER01 Problem with Reset the default settings by pressing the ramp button for 2 patient settings. seconds, then scroll up touch key . The message will blink. Tap scroll up touch key to confirm. The device is now set to default values.

  • Page 31: Technical Characteristics

    Technical characteristics Performance of the device Pressure range: 4 cmH O to 20 cmH O in CPAP mode 3 cmH O to 25 cmH O in BPAP (bilevel) mode Device adjustable in 0.5 cmH O step Accuracy: ± 0.5 cmH Maximum steady limiting pressure at the patient- side connection aperture in single fault condition: = 40 cmH...

  • Page 32: Humidifier Performance

    Humidifier performance Humidification rate: > 12mg H O/l at the maximum setting for a leakage rate < 60 l/min. Heating time: 45 minutes Pressure drop depending on flow: 1.3 cm H O at 1 l/sec Humidifier chamber compliance: 11 ml / kPa (humidifier chamber empty) 8 ml / kPa (humidifier chamber full) Maximum operating pressure: 20 cm H...

  • Page 33: Physical Characteristics

    RF emission type (PolyLink): Bluetooth Smart (BLE 4.1) Frequency band: 2402 to 2480 MHz (ISM band) Maximum power: 5.3 dBm RF emission type (optional S.Box modem): HSDPA, WCDMA, EDGE, UMTS Frequency band: 850 MHz, 1900 MHz (for US version) 900 MHz, 2100 MHz (for European version) 800 MHz, 850 MHz, 2100 MHz (for Japanese version) Maximum power:...

  • Page 34: Definition Of Symbols

    Definition of symbols Symbol Description Symbol Description Start / standby button. Ramp button. Device is in accordance with the Device can no longer be used, requirements European dispose separately from household directive 93/42 /EC on medical garbage. See "End of life disposal of devices.

  • Page 35: Regulatory Requirements

    Regulatory Requirements Risks concerning this medical device are evaluated according to the ISO 14971:2019 standard, specifically with regard to global residual risk. The S.Box Duo S or S.Box Duo ST complies with the following Directives and standards:  Directive 93/42/CEE of the European Parliament and of the Council concerning medical devices, modified by the European Directive 2007/47/CE.

  • Page 36: Electromagnetic Compatibility

    Electromagnetic Compatibility Electromagnetic environment guidance Electromagnetic emissions Conformity The device uses RF energy only for its internal function. Therefore, its RF emissions are very RF emissions CISPR 11 Group 1 Class B low and are not likely to cause any interference in nearby electronic equipment.

  • Page 37: Special Characteristics According To The Standard Iso 80601-2-70:2015

    Special characteristics according to the standard ISO 80601-2-70:2015 Sound pressure level measured according to ISO 80601-2-70:2015 With side cover: NOISE EMISSION VALUES DECLARED DISSOCIATED In accordance with ISO 4871 A-weighted sound power level, L (Reference 1pW), in decibels 33.5 Uncertainty K in decibels A-weighted emission sound pressure level, L (Reference 20μPa) at...
  • Page 38 With side cover: Static pressure stability at 10 cm H (Long-term accuracy according to ISO 80601-2-70:2015 §201.12.1.101) Without humidifier With humidifier Pressure accuracy: +/- 0.5 cm H +/- 0.5 cm H Dynamic pressure stability (Short-term accuracy according to ISO 80601-2-70:2015 and ISO 80601-2-79:2018) In CPAP mode Test pressure (cm H ITHOUT...
  • Page 39 Test Pressure (cm H Respiratory freq. Respiratory freq. Respiratory freq. Respiratory freq. Respiratory freq. HUMIDIFIER breaths/min breaths/min breaths/min breaths/min breaths/min 22 mm diameter tube: Most positive 0.08 0.14 0.18 0.22 0.26 0.32 0.24 0.29 0.32 0.20 0.24 0.28 0.16 0.21 0.26 pressure difference (cm H Most negative...
  • Page 40 In BPAP (bilevel) mode Test Pressure (cm H Expiratory P. 3 Expiratory P. 6 Expiratory P. 12 Expiratory P. 17 Expiratory P. 20 Inspiratory P. 7 Inspiratory P. 10 Inspiratory P. 16 Inspiratory P. 21 Inspiratory P. 25 ITHOUT Respiratory Respiratory Respiratory Respiratory...
  • Page 41 Test Pressure (cm H Expiratory P. 3 Expiratory P. 6 Expiratory P. 12 Expiratory P. 17 Expiratory P. 20 Inspiratory P. 7 Inspiratory P. 10 Inspiratory P. 16 Inspiratory P. 21 Inspiratory P. 25 Respiratory Respiratory Respiratory Respiratory Respiratory HUMIDIFIER freq.
  • Page 42 Maximum flow and pressure (According to ISO 80601-2-70:2015 and ISO 80601-2-79:2018) Test pressure (cm H ITHOUT HUMIDIFIER Maximum flow (lpm) 22 mm diameter tube >124 >150 causing a pressure drop of 1 cm H O at the patient 15 mm diameter tube >130 >150 port...

  • Page 43: Functional Diagram Of The Internal Pneumatic Circuit

    Functional diagram of the internal pneumatic circuit Device with side cover Device with humidifier S.Box Duo S and S.Box Duo ST Technical characteristics  43...
  • Page 44 44  Technical characteristics S.Box Duo S and S.Box Duo ST...
  • Page 46 Contact of your Home Care Provider 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-164DFU03-90 Version 2 2021-08...

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