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 Before you start 

S.Box Duo S and S.Box Duo ST 

Before you start 

 

Please  read  this manual  carefully  before  using  your  S.Box  Duo  S  or  S.Box  Duo  ST  to  understand  the 
usage constraints of the device. 

Safety guidelines  

WARNING: 

Means in this manual that there is a risk of danger of injury or accident to 
yourself or others. 

 

The S.Box Duo S and S.Box Duo ST can only be used on prescription. Under no circumstances should you 
change the prescribed settings without the agreement of your healthcare professional. 

 

Use the device only for the prescribed use as indicated in this manual. The advices given in this manual do 
not replace the instructions of your healthcare professional. 

 

This device is not intended to provide assistance to vital functions.  

 

The  device  should  be  used  only  with  the  circuits,  masks,  fittings  and  accessories  recommended  by  a 
physician  or  provided  by  your  Home  Care  Provider.  Make  sure  that  you  have  the  user  guide  for  each 
accessory and read them carefully. 

 

Contact  your  Home  Care  Provider  if  you  think  that  the  device  or  any  of  its  accessories  is  damaged, 
malfunctioning or has a defect. 

 

Do  not  attempt  to  open  or  modify  the  device  (risk  of  electric  shock).  The  maintenance  of  this  device  is 
entirely the responsibility of qualified personnel.  Please contact your  Home Care  Provider,  for  any problem 
detected. 

 

Any  serious  incident  that  occurs  in  relation  to  use  of  the  S.Box  Duo  S  or  S.Box  Duo  ST  must  be 
communicated to the manufacturer and a competent authority of the Member State of your location. 

 

Place the device on a stable horizontal surface and in a clean and dry environment. Do not use the device if it 
is adjacent to another electrical/electronic device or over another appliance. 

 

Use only the power supply provided with the device. 

 

If necessary,  the  device  can be  disconnected from  the  power supply by unplugging the  power  cord.  Make 
sure the power cord is easily accessible. 

 

If the device is connected to a multi-socket outlet, do not connect the system to any other multi-socket outlet 
or extension cable. 

 

Be careful not to accidentally or intentionally block the air outlet or any opening of the device or the breathing 
circuit. Do not cover the device or place it too close to a wall. Do not put any liquid or any object into the air 
outlet of the device, as they may be propelled into the tube. 

 

Keep  the  device  and  its  power  supply  away  from  all  sources  of  water  /  liquids.  Use  the  device  and  its 
accessories only if they are dry and in a good working condition. 

 

Keep the power cord away from a hot surface. 

 

If oxygen enrichment is required, follow the safety instructions carefully, concerning the use of oxygen. 

 

Do  not  use  the  device,  particularly  the  heated  humidifier,  in  the  presence  of  flammable  gases,  flammable 
anesthetic agents, which may be independent or mixed with other gases, as there is a risk of explosion, or 
fire. 

 

While the machine is operational and the mask is applied on the face, make sure the unit produces an air-
flow.  If  it  does  not,  remove  the  mask  immediately  and  stop  using  the  device.  Contact  your  Home  Care 
Provider, to inform this. 

 

Never  block  the  exhalation  vents  on  the  mask  which  allows  continuous  exhaust  of  air,  which  minimizes 
rebreathing of carbon dioxide. While the device is operational, the generated air-flow pushes out the exhaled 
air through the vent-holes of the mask. On the other hand, while the device is not operational, there will not be 
enough fresh air produced in the mask, and the exhaled air may be rebreathed, which can cause suffocation 
and/or any adverse effect on health in a few minutes. 

 

If the device has a malfunction and the patient is equipped with a nasal mask, the resistance of the device is 
low enough to allow the patient to exhale through the machine, and alternatively the patient can simply open 
his/her mouth to breathe in and out. If the patient is equipped with a face mask, the mask should have an 
anti-asphyxia valve, for safety of the patient in case of malfunction of the device. 

 

Remove the mask immediately in case of power outage or malfunction of the device. 

Содержание Sefam S.Box Duo S

Страница 1: ...S Box Duo S S Box Duo ST...

Страница 2: ...r S Box Duo S or your S Box Duo ST 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 professio...

Страница 3: ...ures 12 Using an SD card 13 Transporting the device 14 Information and settings 15 User interface description 15 How to set the device 17 Using the device with oxygen enrichment optional 28 Installati...

Страница 4: ...ected to a multi socket outlet do not connect the system to any other multi socket outlet or extension cable Be careful not to accidentally or intentionally block the air outlet or any opening of the...

Страница 5: ...ning of the upper airways The performance of the device may alter if a heated humidifier is installed There is a risk of air leak when the humidifier chamber or side cover is not attached properly whi...

Страница 6: ...ehydratation Tracheotomy Adverse effects If any of the following symptoms appear while using the device which may in certain cases require temporary cessation of treatment please contact your healthca...

Страница 7: ...midifier chamber or side cover intended for unlocking the side cover or the humidifier chamber and removing it from the machine It also identifies the model of the device or 5 SD card slot Slot for in...

Страница 8: ...is symbol indicates the maximum water level which should not be exceeded in the chamber On the humidifier chamber this symbol indicates that it is necessary to open the chamber and remove its cover be...

Страница 9: ...Box modem S Box Wi Fi module or PolyLink system into the accessory slot mark 10 in Figure 4 we herefor refer to the corresponding instructions in the installation and usage procedure 3 Then place the...

Страница 10: ...h key or any button the hibernation mode screen appears The touch key home permits to return the screen from hibernation to standby screen to turn off the display from the standby screen Standby scree...

Страница 11: ...rk Fill the chamber only with water at room temperature do not use hot or chilled water It is recommended to use distilled water Do not add any product to the water in the chamber essential oils etc D...

Страница 12: ...by tapping the touch button Adjust your mask in case of undesired leak Tap to return to the standby screen Mask unplugged If you remove your mask the device automatically reduces the flow The machine...

Страница 13: ...peration can be performed only once 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 powe...

Страница 14: ...the opening clip upwards to release the upper part of the chamber then put it aside Empty the water Then unlock the heater plate by pushing the latch to the right and remove it Pack it with the humidi...

Страница 15: ...tion When the device is in operation information appears on the touch screen in front and you may be able to adjust certain settings The available parameters are settings for your treatment general se...

Страница 16: ...rogress Settings values units and symbols displayed Numbers or letters Pressure unit hecto Pascal or cm H2O Flow unit liter per minute Time unit hour and minute Caution the device detected an error or...

Страница 17: ...ly possible if your device is equipped with a S Box heated tube with ATC Tap to return to the standby or operation screen 2 Humidification level if humidifier installed Tap the touch key in standby or...

Страница 18: ...bled by your Home Care Provider By tapping the key or as many times as necessary you can decrease or increase the value displayed or disable the ramp feature in selecting Possible settings OFF and fro...

Страница 19: ...device via a Bluetooth connection to make adjustments via tablet smartphone applications refer to the corresponding instructions for use If your device is equipped with a communicating accessory S Bo...

Страница 20: ...rmanent Then you go back to the WPS screen and you can resume the settings menu C BLE communication BLE Bluetooth Low Energy or Tap the touch key You can disable OFF or enable ON the communication by...

Страница 21: ...e The device searches for the BLE module and the display blinks alternately with six dashes as long as no module is associated Once detected the last six digits of the Bluetooth address of the PolyLin...

Страница 22: ...allows leaving the menu Information concerning a period of use A period of 24 hour use is set from noon to the next noon Views of the display Tap the touch key in standby mode Accessing a period of us...

Страница 23: ...iance value time during which you have been breathing in the mask during the period of use Tap the touch key Average breath rate delivered during the period of use Tap the touch key Number of the last...

Страница 24: ...fication number of six digits specific to the patient is automatically assigned by the device Tap the touch key Software version This is the version of the embedded software of the device It can be re...

Страница 25: ...e previous display leaves the current menu Tap the touch button when the device is in operation SD card status Possible displays SD OK and SD _ _ _ If SD _ _ _ is displayed check that the SD card is p...

Страница 26: ...position sensor Possible displays POS lying on back POS lying on stomach POS lying on right side POS lying on left side POS standing POS sensor inverted If POS is displayed check that the PolyLink sy...

Страница 27: ...of the machine at the first pairing View of the display Tap the touch key Enable pairing or Refuse to pair The display disappears after 30 seconds 9 Airplane mode In an airplane or in public places su...

Страница 28: ...ygen must not exceed 8 l min CAUTION At a fixed oxygen flow the concentration of inhaled oxygen varies depending on the settings of pressure your breathing pattern type of mask and leakage rate This a...

Страница 29: ...e install the humidifier chamber once it is dry o Fill the bottom part of the humidifier chamber then press down on the upper part to close the chamber and lock it o Place the humidifier chamber back...

Страница 30: ...ce a month or more if it is visibly dirty Change filters as soon as they are torn or stained It is recommended to change the washable filter every 6 months Humidifier if installed Once the humidifier...

Страница 31: ...eaction to mask components Adjust the headgear Contact your doctor or Home Care Provider to try different sizes Stop using the mask Contact your doctor or the Home Care Provider Dryness or irritated e...

Страница 32: ...humidifier does not appear to heat the water The humidification level is set on OFF Set the humidification level between 01 and 10 see section How to set the device page 16 Water droplets appear in th...

Страница 33: ...l power sources Plug it in again and turn it on If the problem persists contact your Home Care Provider This symbol flashes on screen The device detected a malfunction of the heated tube Check the tub...

Страница 34: ...ameter Expected life of the device 5 years for a typical use of 8 hours a day Air inlet filters Optional high efficiency filter Disposable fabric HEPA filter which is 90 effective for particles 3 micr...

Страница 35: ...20 Maximum power consumption 75 W during a mask disconnection Current consumption at 20 cmH2O with a 4 mm leak 0 42 A minimum configuration S Box Duo S or S Box Duo ST only 1 99 A maximum configuratio...

Страница 36: ...2021 Date of CE marking of S Box Duo ST 2021 Regulatory Requirements Risks concerning this medical device are evaluated according to the ISO 14971 2019 standard specifically with regard to global resi...

Страница 37: ...t humidifiers for medical use Particular requirements for respiratory humidification systems ISO 80601 2 79 2018 Medical electrical equipment Part 2 79 Particular requirements for basic safety and ess...

Страница 38: ...38 Technical characteristics S Box Duo S and S Box Duo ST...

Страница 39: ......

Страница 40: ...Manufacturing plant SEFAM 144 AV CHARLES DE GAULLE 92200 NEUILLY SUR SEINE FRANCE SEFAM 10 ALLEE PELLETIER DOISY 54600 VILLERS LES NANCY FRANCE M 164DFU03 80 Version 2 2021 08 Contact of your Home Ca...

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