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S.Box Duo S and S.Box Duo ST 

Before you start 

 5 

 

Do not leave unnecessary lengths of the tube on the bed because they could wrap around your head or neck. 

 

Keep the device away from children and pets. 

 

The Health Industry Manufacturers Association (HIMA) recommends maintaining a minimum separation of 
15  cm  between  a  cordless  phone  and  a  pacemaker  in  order  to  avoid  possible  interference  with  the 
pacemaker. The Bluetooth communication in the S.Box Duo S or S.Box Duo ST device must be considered as 
a wireless phone. 

If your device is equipped with a heated humidifier: 

 

Precautions should be taken while using a heated humidifier to prevent a risk of water entering the machine, 
causing irreversible damage. Place the device on a horizontal and stable surface and be careful not to tilt it 
when reservoir is filled with water. 

 

The heated humidifier as well as the bottom of the humidifier chamber has a plate that can be very hot when 
in operation. Avoid touching these parts. 

 

The  humidifier  chamber  must be  cleaned before  its first use  or  after  any technical intervention,  as well as  
regularly in time, following a procedure described in the paragraph "Cleaning and Maintenance" on page 29. 

 

Always detach the humidifier chamber and empty it, before moving or transporting the device. 

 

Fill the humidifier chamber  with water  keeping it far  away from the  device  to  prevent water  spilling on  the 
device. 

 

Do not add any type  of liquid in the water, used in the chamber (e.g. essential oils, or aerosol medications 
etc). 

 

Do not use the device if a leak is detected in the humidifier chamber, e.g. due to a deterioration of the gasket, 
or a crack due to fall of the chamber. 

 

The heated humidifier should not be used when room temperature is above 35°C, because the temperature 
of air delivered to the patient may exceed 43°C. This can cause irritation or burning 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,  which  may 
cause a variation in the applied pressure versus the prescribed pressure. 

CAUTION: 

In this manual it means that there is the possibility of material  damage 
to this device or any other. 

 

Place the device in a way that nobody can bump into it or trips over the power cord 

 

If the apparatus is placed on the floor, ensure that it is in a place free from dust, bedding, clothing or other 
objects that may obstruct the air intake. 

 

After storing or transporting the device, ensure it is used in compliance with the conditions of use specified in 
this manual. 

 

Like  all  medical  electrical  devices,  the  device  is  vulnerable  to  interference  from  mobile  and  portable 
radiofrequency communication equipment (mobile phones, Wi-Fi…). 

 

The device has to be controlled to check the proper  operation, whenever it is located near to a AM, FM  or 
broadcast antennas. 

When traveling 

When traveling with your device, refer to the instructions of "Transporting the device" page 14 and in 
case of  airline  travel,  contact  your  Home Care  Provider to  prepare  the trip.  It is  advised to  bring  the 
patient manual along with you to facilitate the formalities of registration and security in airports. 
You can take with you, as hand luggage, the device and its accessories packed in their travel bag, but it 
is  recommended  to  protect  them  inside  a  rigid  suitcase  if  they  are  in  the  checked  luggage 
compartment.  
If  you  travel  to  a  country  where  the  voltage  is  different  from  the  voltage  usually  used,  it  may  be 
necessary to take another power cord or an adapter to connect your device to the electrical outlets in 
this country. 

Recommended use 

The 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.  

Summary of Contents for Sefam S.Box Duo S

Page 1: ...S Box Duo S S Box Duo ST...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 39: ......

Page 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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