Starck SEFAM S.Box Series User Manual
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Starck SEFAM S.Box Series User Manual

Physician and home care provider
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S.Box™
Physician and Home Care Provider
User Manual

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  • Page 1 S.Box™ Physician and Home Care Provider User Manual...
  • 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 ▪ SEFAM S.Box...

  • Page 3: Table Of Contents

    ABLE OF CONTENTS Product description ..........................4 Intended purpose ............................4 Indications ..............................4 Contra-indications ............................4 Warnings/ Precautions ..........................5 Potential undesirable side effects ......................6 Target patient groups ........................... 6 Intended users ............................... 7 Environment of use ............................7 Clinical benefits ..............................

  • Page 4: Product Description

    Product description Please read this manual carefully before using your SEFAM S.Box C to understand the usage constraints of the device. Intended purpose The S.Box C 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

    Warnings/ Precautions Means in this manual that there is a risk of danger of injury or accident WARNING: to yourself or others. ▪ Make sure you provide the patient with the patient manual and instructions for using the accessories. ▪ 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 C including cables specified by the manufacturer.

  • Page 6: Potential Undesirable Side Effects

    Do not add any products to the water in the humidifier chamber (essential oils, etc.). ▪ ▪ Always empty the humidifier chamber before moving or transporting the appliance. ▪ The humidifier must not be used with nitric oxide. This could cause the humidifier to malfunction, leading to a serious deterioration in health.

  • Page 7: Intended Users

    Intended users The various potential users of this device are: patients weighing over 30 kg, healthcare professionals and homecare providers. Patients can receive rapid training from healthcare professionals or homecare providers. This prior training is not essential, but reading this instruction manual is necessary for correct use of the device. Environment of use The SEFAM S.Box C is intended for use at home or in a care centre (hospital or clinic).

  • Page 8: Presentation Of The System

    Breeze Mask Zen M M-268030-13 S.Box ® carrying bag M-816405-00 Breeze Mask Zen L M-268040-13 SEFAM S.Box ® Starck M-216430-08 Breeze Mask Pillows M-268090-30 carrying case S.Box ® cigarette cable (24 VDC- Divers : 5 m) Machine data analysis: M-215630-04...

  • Page 9: Views Of The Device

    Views of the device Figure 1 – Vue de la face avant Figure 2 – Vue de la face arrière d'un appareil équipé d'un humidificateur Figure 3 – Vue de la face arrière d'un appareil Figure 4 – Vue de l'élément chauffant équipé...

  • Page 10: Meaning Of Symbols

    Meaning 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 paragraph "End-of-life devices.

  • Page 11: Installation

    Installation Standard installation The apparatus must be positioned on a flat and stable surface. It comes with a pre-mounted side cover and according to the chosen configuration, it can also be delivered with a heated humidifier that replaces the pre-mounted side cover. 1.

  • Page 12: Installation With Cigarette Lighter

    4. Connect the breathing tube: Connect the end of the flexible tube to the angled outlet connector on the back of the device (Mark 14 in Figure 2). If you have a S.Box heated tube with ATC, insert its power cable lead into the corresponding socket on the device (Mark 9 in Figure 2).

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

    Filling the humidifier chamber (if applicable) 1. Unplug the SEFAM S.Box C 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

    Device configuration 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 ▪...
  • Page 15 Meaning of symbols displayed Symbol Meaning Symbol Meaning Status bar Wi-Fi Communication activated. GSM mobile phone network status. Flashes quickly during the Flashes quickly during the transmission. transmission. Airplane mode Oximeter connected T RAMP: time ramp active Comfort Control Plus CC+ function activated I RAMP: intelligent ramp active SD card inserted...

  • Page 16: Available Features

    Touch key to access the settings Touch key to access information Multifunctional touch key Home touch key Available features Heated humidification This function allows to control the power supplied to the heater plate depending on the air flow, and to regulate the heating power to maintain the difference in temperature between the water and the air constant.

  • Page 17: Device Settings

    Ramp The ramp function makes it possible to gradually increase the pressure to help the patient fall asleep. If it is activated, it starts automatically when the device is switched on (if ≠ OFF). Pressing the ramp button deactivates (and reactivates by pressing again) this function. There are two types of ramp: T RAMP Time ramp: you can determine the ramp time ▪...
  • Page 18 WARNING: Before setting the device, confirm that the product delivers an air flow when it is in operation mode. Otherwise, stop the machine immediately and contact the technical support. Settings are accessible directly on the interface of the device, via a Bluetooth connection (tablets/cell phones apps), via a configured SD card or remotely through S.Box ®...
  • Page 19 Settings range The following tables indicate the operating mode of the device, the default value, the minimum and maximum values that can be set for each parameter, and the available functions. Adjustable parameters Minimum Maximum Value by Parameter Increment value value default Humidification level (if the...
  • Page 20 Activated Deactivated Feature By default feature feature T RAMP (Time ramp) Ramp I RAMP I RAMP (Intelligent ramp) Locking access to a group of three settings by the patient LOCK UNLOCK LOCK (Ramp start pressure, CC +, (locked access) (unlocked access) (locked access) Intelligent Start) Note:...
  • Page 21 How to set up the device The settings can be accessed using the touch buttons when the appliance is in standby or in use (depending on the settings). 1. Settings accessible to the patient The patient can access a settings menu of the device in standby mode (see patient manual). He/she can also make the following adjustments using the touch keys displayed: Displayed parameter: Adjusted by...
  • Page 22 The standby screen is restored by tapping or after two minutes without tapping a key. Pressure level ❶ Press and hold the You can decrease or increase the displayed ramp button then tap the touch key value by tapping repeatedly the key Possible settings: from 4 cm H O to for two seconds in...
  • Page 23 CC+ (Comfort Control Plus) ❹ Tap the touch key You can change or deactivate the selected function by tapping the key many times as necessary. Possible settings: during the ramp (R.1, R.2, R.3) ▪ during the entire treatment (1, 2, 3) ▪...
  • Page 24 Tap the touch key A progress bar indicates the status of the calibration until the specific calibration is effective and confirmed on the display. Refer to paragraph "6. Circuit Select: specific calibration of the pneumatic configuration". Mask select: theoretical leak in the mask ❼...
  • Page 25 Clock ❿ Tap the touch key The hour blinks on the display. You can set it by tapping the touch key many times as necessary. The minutes blink. Adjust the minutes the same way as the hour. Pressure unit ⓫ You can change the unit of the displayed Tap the touch key pressure by tapping the touch key...
  • Page 26 Tap the touch key 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 The touch key visible on the screen ⓭...
  • Page 27 Software version ⓰ 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. 3. Information menu The compliance information can be viewed but not modified. To access it, tap the touch key when the device is in standby mode.
  • Page 28 Accessing the compliance information report ❸ Tap the touch key The key allows displaying successively the compliance data recorded during the period of use. Average level of unintentional leakage in the ❹ mask during the period of use. Tap the touch key Possible displayed information: LK: OK, LK: NOK.
  • Page 29 ACI : Index of Apneas detected and classified ❽ as central during the period of use. Tap the touch key Number of the last days of use for which the ❾ compliance is higher than 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...
  • Page 30 Software version ⓬ Tap the touch key This is the version of the embedded software of the device. 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.
  • Page 31 Consecutively displayed information: Possible displays: SD: OK and SD : _ _ _. ❶ SD card status SPO: OK and SPO : _ _ _. ❷ Status of the oximeter 3150 when the device is in operation. ABD : XX and ABD : _ _ _. ❸...
  • Page 32 6. Circuit Select: specific calibration of the pneumatic configuration The specific calibration function of the pneumatic circuit permits to adjust the pressure delivered to the mask with a high level of accuracy by compensating for all the pneumatic resistances in the patient circuit.

  • Page 33: Utilisation

    Starting treatment 1. The patient puts on his mask. If the Intelligent Start feature has been activated, the device will start during your first breaths in the mask. You can also hold down the start / standby button to begin treatment. Recording of compliance data and of treatment effectiveness begins immediately in the device memory and on the SD card when present.

  • Page 34: Use When Oxygen Is Added (Optional)

    Use when oxygen is added (optional) WARNING ▪ The oxygen source should be placed at least one metre from the appliance. Do not smoke in the presence of oxygen. ▪ Do not inject oxygen through the device's air inlet. ▪ ▪...
  • Page 35 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. The symbol blinks slowly in the status bar on the screen and the display changes: an animation appears at the top, showing three blocks that move towards the right until the data storage is complete.

  • Page 36: In Case Of Problems

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

  • Page 37: Error Messages

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

  • Page 38: Cleaning And Maintenance

    Cleaning and Maintenance Make sure that the patient follows the instructions given in this chapter. For more details on how to maintain the accessories, refer to the instructions for use for the mask, breathing circuit, heated tube and communicating accessory used. WARNING: Unplug the device from the power supply.
  • Page 39 Notes: • Do not leave stagnant water in the chamber in order to prevent the development of micro-organisms. 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).

  • Page 40: Disinfection Instructions

    ▪ Never use concentrated bleach higher than 0.1%. For example: pour 200 ml of bleach to 2.6% in 5 liters of cold water. ▪ The tank is the only part of the gas pathways running through the humidifier that can become contaminated with body fluids or contaminated substances carried by expired gases, both normal and single-fault condition.
  • Page 41 • 41 SEFAM S.Box Cleaning and Maintenance...
  • Page 42 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 43: Transport Of The Device

    Transport of the device Unplug the power module and disconnect all accessories from the device. Store the device and accessories in the carry bag. Device with heated humidifier If your device is equipped with a humidifier, press the button to unlock the humidifier chamber and at the same time, pull the chamber using the integrated handle.

  • Page 44: Technical Characteristics

    Technical characteristics Performance of the device Pressure range: 4 to 20 cm H Adjustable by steps of 0.5 cmH Maximum pressure at the patient-side connection 40 cm H port in single fault condition: Maximum adjustable pressure: 20 cm H 0 to 45 minutes  1 minute Duration of ramp: Adjustable in 5 minute steps Sound pressure level measured according to...

  • Page 45: Conditions Of Use

    Conditions of use Pressure range: 700 hPa to 1060 hPa Temperature: +5°C to +40°C (+41°F to +104°F) with side cover +5°C to +35°C (+41°F to +95°F) with humidifier Relative humidity: Between 15 % and 90 % without condensation Altitude range: Approximately 0 −...

  • Page 46: Physical Characteristics

    Power supply Power supply class II: Input voltage: 100 – 240 VAC, 50 - 60 Hz MDS-090BAS24 A (outlet depending on the Power supply provided: country) Input current: 2 - 1 A Output voltage: 24 V WARNING: ▪ Use only the plug-in power supply provided with the device ▪...
  • Page 47 Compliance Electromagnetic Immunity Test level Electromagnetic environment guidance level Electro-static discharge Floors should be wood, concrete or ± 6 kV contact ± 6 kV contact (ESD) IEC 61000-4-2 ceramic tile. If floors are covered with synthetic material, the relative humidity ±...

  • Page 48: Special Characteristics According To The Standard Iso 80601-2-70

    Special characteristics according to the standard ISO 80601-2-70 Sound pressure level measured according to ISO 80601-2-70 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 49 Static pressure stability at 10 cm H ISO 80601-2-70 (Long-term accuracy according to ITHOUT SIDE COVER ITH HUMIDIFIER Pressure accuracy: +/- 0.5 cm H +/- 0.5 cm H Dynamic pressure stability (Short-term accuracy according to ISO 80601-2-70) Test pressure (cm H ITHOUT Respiratory freq.
  • Page 50 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 0.20 0.25 0.32 0.29 0.32 0.39 0.34 0.40 0.50 0.42 0.49 0.60 0.52 0.61 0.70 pressure difference (cm H Most negative...

  • Page 51: Functional Diagram Of The Internal Pneumatic Circuit

    Test pressure (cm H ITHOUT HUMIDIFIER Pressure measure (cm H O) at 22 mm diameter tube 12.0 16.1 20.1 40 l/min at the patient interface 15 mm diameter tube 12.0 16.0 20.0 ITH HUMIDIFIER 22 mm diameter tube 12.0 16.0 20.0 Pressure measure (cm H O) at...

  • Page 52: Ce Marking

    CE marking Date of CE marking of SEFAM S.Box C: 2021 End-of-life disposal of the device In accordance with European Directive 2012/19/EU, this appliance constitutes electrical and electronic equipment whose waste must be collected and treated separately from household waste. Recycling electrical equipment preserves natural resources and avoids any risk of pollution.
  • Page 53 • 53 SEFAM S.Box End-of-life disposal of the device...
  • Page 54 54 • End-of-life disposal of the device SEFAM S.Box...
  • Page 56 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-164DFU05-80-Version 6 2023-09...

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