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DreamStar Duo, DuoST 

Technical characteristics 

 47 

 

Electromagnetic Immunity 

(continued)

° 

Magnetic fields in the 
Power 

Supply 

Frequencies  
(50/60 Hz) 
IEC 61000-4-8 
 

3 A/m 

3 A/m 

Power  frequency  magnetic  fields  should  be  at 
levels  characteristic  of  a  typical  location  in  a 
typical commercial or hospital environment. 

Note: 

U

is the AC mains voltage prior to application of the test level 

Electromagnetic Immunity - conducted and radiated RF

 

DreamStar™ product range devices are intended for use in the electromagnetic environment specified 
below. The customer or the user of the device from DreamStar™ product range should assure that it is 
used in such an environment. 

Immunity test 

IEC 60601  

test level  

Compliance level 

Recommended electromagnetic environment 

Conducted RF 
IEC 61000-4-6 
 

3 Vrms 
150 kHz to  
80 MHz 
 

3 Vrms 
150 kHz to  
80 MHz 
 

Portable  and  mobile  RF  communications 
equipment  should  not  be  used  in  proximity  to 
any  part  of  the  device  from  the  DreamStar™ 
product range, including cables. 
 
Recommended separation distance: 
d = 1.2√P  

Radiated RF 
IEC 61000-4-3 
 

3 V/m 
80 MHz to 2.5 GHz 

3 V/m  

d = 1.2√P 80 MHz to 800 MHz 
d = 2.3√P 800 MHz to 2.5 GHz 

Where 

P

  is  the  maximum  output  power  rating  of  the  transmitter  in  watts  (W)  according  to  the  transmitter 

manufacturer and 

d

 is the recommended separation distance in meters (m). 

Fields  strengths  from  fixed  RF  transmitters,  as  determined  by  an  electromagnetic  site  survey

a

,  should  be  less 

than the compliance level in each frequency range

b

Interference may occur in the vicinity of equipment marked with the following symbol: 

 

 

NOTE 1: 

At 80 MHz and 800 MHz, the highest frequency range applies

 

NOTE 2: 

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption 

and reflection from structures, objects, and people. 

 

 a)

 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land 

mobile  radios,  amateur  radio,  AM and FM  radio broadcast and TV broadcast cannot be  predicted theoretically 
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site 
survey should be considered. If the measured field strength in the location in which a device from  DreamStar™ 
product range is used exceeds the applicable RF compliance level above, the device from  DreamStar™ product 
range should be observed to verify normal operation. If abnormal performance is observed, additional measures 
may be necessary, such as reorienting or relocating the device from DreamStar™ product range. 

(b)

 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V / m. 

 

 
 

Summary of Contents for DreamStar Duo

Page 1: ...DreamStar is a brand registered by SEFAM DreamStar Product Range DreamStar Duo DreamStar Duo Evolve DreamStar DuoST DreamStar DuoST Evolve...

Page 2: ...and technical agency 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...

Page 3: ...e Heat level if water chamber included 27 Reminders about to expire 28 Specific calibration of the pneumatic configuration 29 Using a memory card 29 Cleaning and Maintenance 31 Daily 31 Weekly 31 Mont...

Page 4: ...se of heated humidification feature use the cover must be removed and replaced by a water chamber When the heated humidification feature is enabled on a device equipped with a water chamber the patien...

Page 5: ...ent List of authorised accessories Unless otherwise specified all the DreamStar product range devices can be used with the following optional accessories Battery cable with lugs P N M 214530 00 RS232...

Page 6: ...it is disabled on the devices delivered with a cover If the device is equipped with a cover and if you want to use the heated humidification feature it is necessary to order a water chamber and to pro...

Page 7: ...led comfort pressure then the pressure increases to treatment pressure In Bilevel mode the pressure is reduced to the comfort pressure and then raised to the inspiratory positive airway pressure IPAP...

Page 8: ...t can go to sleep comfortably Compliance counter total time during which the patient has effectively breathed in the mask time subtracted from the time when the mask was removed and the time with no r...

Page 9: ...cmH2O 0 5 cmH2O Ramp time 0 min Maximum ramp time 0 min 5 min Maximum ramp time 0 min 45 min 0 min 5 min Heat level if water chamber included 0 10 1 1 Parameters that can be set on the devices in Bi L...

Page 10: ...r evaporation depends on several factors such as environment leak rate patient s breathing pattern etc Features available on all devices Feature Feature enabled Feature disabled Default Humidifier Evo...

Page 11: ...ccess the device settings menu scroll through different pages or possibly modify the value of certain parameters within these pages The parameters are accessible only when the machine is in standby or...

Page 12: ...recorded C CPAP operating mode B Bilevel operating mode two pressure levels Vt Estimated tidal volume The values displayed are estimates They are provided for purposes of determining trends only Pati...

Page 13: ...s the values displayed are given by way of example The symbol indicates that the Pressure Alter feature is enabled and the symbol indicates that it is disabled Settings menu To access the Settings men...

Page 14: ...m of the page or to return to the page header Press to move to the next page In Bilevel mode The page displays Press as many times as necessary to access the desired parameter setting The page changes...

Page 15: ...of the page or to return to the page header Press to move to the next page The page displays Press as many times as necessary to access the desired parameter setting The page changes Increase or decr...

Page 16: ...page header Press to exit the menu Service menu To access the Service menu press the left control button to select the symbol displayed at the bottom right of the screen 1 Selecting the language and s...

Page 17: ...age displays Press as many times as necessary to access the desired parameter setting The page changes With the right or left parameter settings button lock or unlock the access to the parameter setti...

Page 18: ...t the bottom of the page or to return to the page header Press to move to the next page 5 Patient reminders The page displays Press as many times as necessary to access the desired parameter setting T...

Page 19: ...The page changes Increase or decrease the parameter value with the right or left parameter settings button Then press to access the next menu parameter Pressure offset offset of the pressure sensor Pr...

Page 20: ...creens the values displayed are given by way of example The symbol indicates that the Pressure Alter feature is enabled and the symbol indicates that it is disabled Settings menu To access the Setting...

Page 21: ...ottom of the page or to return to the page header Press to move to the next page In Bilevel mode The page displays Press as many times as necessary to access the desired parameter setting The page cha...

Page 22: ...e backup frequency the inspiratory positive airway pressure IPAP the expiratory positive airway pressure EPAP and the I E ratio Press at the bottom of the page or to return to the page header Press to...

Page 23: ...water chamber 22mm 22mm in diameter patient tubing 22mm HH 22mm in diameter patient tubing with water chamber and SPECIFIC other configuration Note If the SPECIFIC patient circuit option is selected...

Page 24: ...left parameter settings button Then press to access the next menu parameter Note The date can be set only when the device is in standby Press at the bottom of the page or to return to the page header...

Page 25: ...d humidification feature the pneumatic configuration is automatically reset to the default value If a specific calibration of the pneumatic configuration was in use it will be replaced with a default...

Page 26: ...s The page displays Press as many times as necessary to access the desired parameter setting The page changes Increase or decrease the parameter value with the right or left parameter settings button...

Page 27: ...ing in the mask Average Freq Average frequency measured during the session Average leak Indicates the average leak displaying OK or The session date and time are displayed in the upper right of the sc...

Page 28: ...ar product range When one or several reminders are about to expire the information access symbol in the lower left of the screen changes to the blinking envelope symbol the device being in standby hou...

Page 29: ...libration 5 Allow the device to calibrate itself taking care not to touch the pneumatic circuit 6 If calibration completes correctly the message CALIBRATION CORRECT will appear on the screen Press the...

Page 30: ...for the first time Service card A memory card can be configured using DreamStar Analyze software as a service card to set a number of devices to the same default values for example language time zone...

Page 31: ...if included Empty the water chamber and rinse it with clean water Leave to drip dry out of direct sunlight Weekly Water chamber if included Disassemble the water chamber o Remove the water chamber fr...

Page 32: ...in a dishwasher at 60 C maximum for 2 hours To prevent growth of micro organisms do not allow water in the chamber to stagnate Washable filter Pull the filter holder towards you to remove it Remove th...

Page 33: ...y are torn or soiled or when the device displays a reminder to do so Water chamber if included After the water chamber has been disassembled and cleaned you can let it soak for 15 minutes in a solutio...

Page 34: ...cording to the instructions recommended by the pre disinfecting product manufacturer o Also follow the recommended soaking time and if necessary brush using a soft brush o Rinse all the parts of the c...

Page 35: ...sponge with scraper or stiff brush Never use any pre disinfecting or disinfecting product containing aldehydes and or its derivatives formaldehyde glutaraldehyde etc Do not use any pre disinfecting or...

Page 36: ...ys LEAK OK If the error persists contact Technical Support The symbol blinks alternately with the error code at the centre of the display The device has detected an operating error See table entitled...

Page 37: ...or Unplug the machine from all electrical power Plug it in again If the error recurs return the machine to a technical service centre Er 10 Machine settings problem Unplug the machine from all electri...

Page 38: ...all sources of electrical power Plug it in again and turn on If the error persists contact Technical Support Er 104 Lack of communi cation from the humidifier to the device The device is operating wit...

Page 39: ...years System resistance for an air flow of 60 l min at the patient side connection aperture in power supply fault condition 1 6 cm H2O without humidifier 1 9 cm H2O with humidifier Patient side connec...

Page 40: ...Input voltage auto ranging 100 240 VAC 15 10 at 50 or 60Hz Maximum power consumption 100 VA at maximum setting Current consumed at 20cmH2O with a 4mm leak 130 mA eff at 230 VAC DC power supply 13 V V...

Page 41: ...Class II device Type BF device DC power supply Recording and play back Refer to the user manual Specific warning Device complies with the requirements of European Directive 93 42 EC on medical device...

Page 42: ...ded use of non invasive ventilation with non dependent patients EN ISO 8185 2009 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems Directive...

Page 43: ...0 13 0 15 0 23 0 18 0 22 0 28 0 25 0 28 0 30 0 35 0 38 0 41 0 44 0 46 0 41 Delta relative to dynamic pressure cmH2O 0 06 0 06 0 08 0 14 0 17 0 19 0 19 0 24 0 23 0 28 0 30 0 35 0 34 0 41 0 32 Tubing 1...

Page 44: ...to lowest pressure cmH2O 0 12 0 16 0 21 0 04 0 05 0 04 0 20 0 15 0 13 0 14 0 03 0 06 0 14 0 01 0 02 Delta relative to dynamic pressure cmH2O 0 06 0 09 0 09 0 09 0 19 0 17 0 20 0 22 0 30 0 38 0 39 0 4...

Page 45: ...DreamStar Duo DuoST Technical characteristics 45 Functional pneumatic block diagram...

Page 46: ...for use in the electromagnetic environment specified below The customer or the user of a device from DreamStar product range should assure that it is used in such an environment Immunity test Test le...

Page 47: ...W according to the transmitter manufacturer and d is the recommended separation distance in meters m Fields strengths from fixed RF transmitters as determined by an electromagnetic site survey a shoul...

Page 48: ...d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended se...

Page 49: ......

Page 50: ...Manufacturer Manufacturing plant SEFAM 144 AV CHARLES DE GAULLE 92200 NEUILLY SUR SEINE FRANCE SEFAM 10 ALLEE PELLETIER DOISY 54600 VILLERS LES NANCY FRANCE M 155DFU00 70 Version 10 2020 02...

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