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Страница 2: ...location SEFAM 144 AV CHARLES DE GAULLE 92200 NEUILLY SUR SEINE FRANCE SEFAM 10 ALLEE PELLETIER DOISY 54600 VILLERS LES NANCY FRANCE TEL 33 0 3 83 44 85 00 www Sefam medical com Technical assistance T...
Страница 3: ...Troubleshooting tips 28 Device Messages 28 Error Messages 29 Technical characteristics 30 Performance of the device 30 Humidifier performance 30 Conditions of use 31 Transport and storing conditions 3...
Страница 4: ...ed with a heated humidifier The side cover must be removed and replaced by the humidifier that includes the heater plate and humidifier chamber Precaution must be taken by the patient while using the...
Страница 5: ...ydratation Tracheotomy Furthermore due to the fact that positive pressure affects the cardiac output in certain heart failure patients it is recommended that patient blood pressure and heart rate are...
Страница 6: ...orized accessories given in the list above or compliant with the standard EN ISO 17510 2 2007 Only connect the USB authorized cable to the USB connector The SEFAM S Box should not be used if connected...
Страница 7: ...tically at the first breathings in the mask without using the start standby button It can be activated or deactivated by following the instructions of paragraph 1 Setting menu page 19 Mask Fit Go Befo...
Страница 8: ...the latency or ramp time In the case where the Ramp pressure ramp start pressure is less than the minimum pressure a progressive increase in pressure will be done from the Ramp pressure to the minimum...
Страница 9: ...ent efficiency Definitions Bluetooth BLE Bluetooth Low Energy low power short range wireless communications technology for connecting devices Device hour counter device operating time Usage hour count...
Страница 10: ...ting power of the heated tube if installed OFF 05 AUTO with humid 01 without humid 01 Mask select theoretical leak in the mask at 12 0 cm H2O 20 l min Type A 60 l min 30 l min Type B 2 l min Ramp time...
Страница 11: ...Ramp T RAMP Time ramp OFF I RAMP I RAMP Intelligent ramp Locking access to a group of three settings by the patient Ramp pressure CC Intelligent Start LOCK locked access UNLOCK unlocked access UNLOCK...
Страница 12: ...rning the treatment of the patient the recorded compliance data the general settings of the device like the brightness and the time The display can also notify possible problems concerning the device...
Страница 13: ...vated Operation mode C CPAP A APAP Auto CPAP 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 Ca...
Страница 14: ...ramp button pressed then tapping the touch key permits to return to the previous display The standby screen is restored by tapping or after two minutes without tapping a key Press and hold the ramp bu...
Страница 15: ...and OFF or If you selected T RAMP Time ramp the displayed value on the right corresponds to the maximum ramp time You can decrease or increase the displayed value by tapping repeatedly the key or Poss...
Страница 16: ...S Intelligent Start You can activate ON or deactivate OFF this function by tapping the key or Possible settings ON and OFF Tap the touch key Circuit Select pneumatic calibration Tapping repeatedly the...
Страница 17: ...e of the mask by tapping the touch key or as many times as necessary Possible settings from 20 to 60 lpm by steps of 2 lpm Three possible types of masks A B and C refer to the corresponding list Tap t...
Страница 18: ...pping the touch key or Possible settings cm H2O and hPa Tap the touch key Offset of the pressure and flow sensor The touch key visible on the screen permits to run an automatic calculation of the offs...
Страница 19: ...its if you wish to restore the FACTORY configuration of the device CAUTION Restoring the FACTORY configuration erases all of the data recorded in the device and on the SD card as well as the pairing w...
Страница 20: ...standby mode see patient manual He she can also make the following adjustments using the touch keys displayed Tap Displayed parameter Adjusted by Available displays in standby or operating mode Heati...
Страница 21: ...entral Apneas Number of the last days of use for which the compliance has been higher than 4 hours per day when the number of the last days of use is more than 1 and within the limit of 30 days Access...
Страница 22: ...personnel only To optimize the performance of the device it is advisable to carry out a specific calibration depending on the pneumatic configuration 1 Make sure the unit is in standby mode If it is...
Страница 23: ...card in the memory card reader of your computer To retrieve the compliance data refer to the user manual of the SEFAM Analyze software CAUTION Use only authorized SD cards Settings update You can adju...
Страница 24: ...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 on the he...
Страница 25: ...h 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 chamber h...
Страница 26: ...humidifier chamber completely in the pre disinfectant solution diluted according to the instructions recommended by the manufacturer of the pre disinfectant o Likewise respect the recommended soaking...
Страница 27: ...nge 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 Do not use pre disinfecta...
Страница 28: ...This symbol flashes on screen The device has detected a malfunction of the S Box heated tube with ATC The device is operating without using the function of the heated tube Check the tube connections...
Страница 29: ...persists return the device to Technical Support service ER07 Turbine problem Unplug the device from all power supply Verify that there is no object in the air outlet Plug the machine in again If the...
Страница 30: ...determined under ATPD Ambient Temperature and Pressure Hygrometry conditions Time required for the device to warm from the minimum storage temperature between uses until it is ready for its intended u...
Страница 31: ...mum configuration SEFAM S Box with humidifier set to 10 and heated tube set to 05 RF emission type SEFAM S Box Bluetooth version 2 1 EDR Frequency band 2400 to 2483 5 MHz ISM band Maximum power 4 dBm...
Страница 32: ...e is in accordance with the requirements of the European directive 93 42 EC on medical devices Device can no longer be used dispose separately from household garbage See End of life disposal of the de...
Страница 33: ...ment WEEE Federal Aviation Administration RTCA DO 160G section 21 category M IEC 60601 1 2005 AC1 2006 AC2 2007 Amd1 2012 Medical electrical equipment Part 1 General requirements for basic safety and...
Страница 34: ...rruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s...
Страница 35: ...min Respiratory freq breaths min Respiratory freq breaths min 10 15 20 10 15 20 10 15 20 10 15 20 10 15 20 22 mm diameter tube Most positive pressure difference cm H2O 0 17 0 23 0 28 0 27 0 27 0 37 0...
Страница 36: ...05 0 05 0 06 0 06 0 04 0 05 0 08 0 06 0 08 0 09 15 mm diameter tube and fine filter Most positive pressure difference cm H2O 0 02 0 08 0 14 0 03 0 02 0 12 0 04 0 02 0 12 0 01 0 05 0 17 0 01 0 18 0 18...
Страница 37: ...9 12 0 16 1 20 1 15 mm diameter tube 3 9 8 0 12 0 16 0 20 0 WITH HUMIDIFIER Pressure measure cm H2O at 40 l min at the patient interface 22 mm diameter tube 3 8 8 0 12 0 16 0 20 0 15 mm diameter tube...
Страница 38: ...settings 3 Ramp button Enables or disables the ramp function when the unit is operating 4 Button to unlock humidifier chamber or side cover To unlock and remove the humidifier chamber or the side cove...
Страница 39: ...air a leakage current testing will be required The technical department must ensure that no external material stays inside the device and that all the repairs have been carried out in accordance with...
Страница 40: ...e cover away from the machine Fig 1 Fig 2 If you have a humidifier unlock the heater by pushing the latch to the right as indicated by fig 1 Remove the heating element by sliding it outwards fig 1 If...
Страница 41: ...ves tabs and capacitors Unlock the connector of the display ribbon on the main board Fig 1 and remove the display ribbon from the connector Fig 2 Unscrew the screw that holds the front panel display w...
Страница 42: ...ver Dislodge the connectors from the rear panel and remove the connector s board Disconnect the turbine layer 1 and the accessory connector 2 slide the connector upwards and remove it Unscrew the 3 sc...
Страница 43: ...crew the screw holding the rear panel Fig 1 remove the rear panel and the elbow seal from its location Fig 2 Fig 1 Fig 2 Unscrew with a screwdriver equipped with a T6 tip and remove the upper frame ch...
Страница 44: ...om cover by gently lifting the tank outlet seal elbow tube Remove the humidifier cable from the rib Fig 1 Slide the humidifier connector to the right to unlock 1 and remove the humidifier cable from t...
Страница 45: ...bottom cover Assembly instructions Prepare the bottom cover Insert the humidifier connector in the opening of the bottom cover 1 and then slide it to the left to lock 2 Fig 1 Place the humidifier cab...
Страница 46: ...ntenance Sefam S Box Place the tank inlet seal on the bottom cover with the bevel facing down 1 Check that the two seals are correctly positioned The holes of the bottom cover must be covered by the s...
Страница 47: ...et seal 1 while lifting the tank outlet seal 2 Check that the Humidifier cable is in the notch provided on the turbine chassis Assemble the cable on the pressure flow sensor Place the pressure flow se...
Страница 48: ...lace the top turbine chassis shell by passing the turbine cable through the shell cutout Screw with a T6 tip equipped screwdriver until it locks do not force Check that the holding clip is in position...
Страница 49: ...umidifier cables to the main board sensor cable passing in front of the humidifier cable Place the main board on the bottom cover Align the back of the main board with the rear cover while positioning...
Страница 50: ...r 1 and slide it up to lock 2 Connect the turbine cable to the connector on the main board 3 Check that the turbine cable and accessory cable pass behind their guides Screw the 3 screws with a T6 tip...
Страница 51: ...r board with a T6 tip equipped screwdriver until it locks Place and slide down the front panel display on the bottom cover and engage the notch in its position Screw the front panel display with a T6...
Страница 52: ...d Place the IP protection carefully on the capacitor Fig 1 Slide the IP protection tabs between the edge of the main board and the bottom cover Fig 2 Place the top cover check that it is inserted into...
Страница 53: ...cover you have to hear a click of locking mechanism For units equipped with a humidifier insert the heating element by sliding it inward and lock it by pushing the latch to the left as indicated by Fi...
Страница 54: ...w to set the device set the pressure to 12cmH2O Select 22mm or 15mm pneumatic calibration following the tube used see 7 circuit select Connect the patient tube to the S Box air outlet and connect the...
Страница 55: ...mber M 216430 16 S Box Humidifier chamber base part M 316470 01 Display S Box Ext M 316490 01 Main board S Box Ext M 316450 01 Internal frame ASSY S Box Ext M 316490 03 Flow sensor S Box Ext M 315940...
Страница 56: ...Manufacturer Manufacturing plant SEFAM 144 AV CHARLES DE GAULLE 92200 NEUILLY SUR SEINE FRANCE SEFAM 10 ALL E PELLETIER DOISY 54600 VILLERS LES NANCY FRANCE M 164MAT00 10 Version 1 2018 01...
