Related Manuals for SEFAM DreamStar Series
Summary of Contents for SEFAM DreamStar Series
- Page 1 DreamStar™ Product Range DreamStar™ Duo DreamStar™ Duo Evolve DreamStar™ DuoST DreamStar™ DuoST Evolve DreamStar™ is a brand registered by SEFAM.
- Page 2 Manufacturer: Manufacturing plant and technical agency: 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 As istance: E:mail : technicalservice@sefam-medical.com...
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Page 3: Table Of Contents
ABLE OF CONTENTS Before you start ............4 Technical characteristics ........39 Safety Precautions ........... 4 Device Performance ........39 Intended use ............4 Integrated Humidifier performance ..... 39 Contra-indications ..........5 Operating conditions for the device and List of authorised accessories ....... 5 humidifier ............ -
Page 4: Before You Start
Before you start This manual is intended for the Clinician and home care Provider. Under no circumstances should it be provided to the patient. Safety Precautions WARNING: This signals a risk of injury or accident to the patient. Pay attention to the Safety Precautions indicated in the Dreamstar™ Duo, Dreamstar™ DuoST (and their ... -
Page 5: Contra-Indications
Contra-indications Studies have shown that the use of positive pressure is contra-indicated in some patients affected by any of the following pre-existent pathologies: Severe bullous emphysema or emphysema previously complicated by pneumothorax. Pneumoencephalus, trauma or recent surgery with sequela of cranio-nasopharyngeal fistula. ... -
Page 6: Available Features
Available Features The device detects the patient’s respiratory cycles, and according to the patient's inspiratory and expiratory efforts, delivers a high-pressure inspiratory positive airway pressure (IPAP) and a low- pressure expiratory positive airway pressure (EPAP). The device can operate either in constant mode (CPAP), or in Bilevel mode, the DreamStar™ DuoST or DreamStar™... -
Page 7: Mask Unplugged Feature
Mask unplugged feature If the patient removes his mask, the device automatically switches to low power. The machine will restore normal power when the mask is reconnected or if the On/Off button or the ramp button is pressed. Otherwise, the device will stop after 30 minutes. Note: If the patient uses a resistive interface (full face mask with anti-asphyxia valve), a specific calibration of the pneumatic configuration must be carried out so that the DreamStar ™... -
Page 8: Device Settings
Device Settings The adjustment of the therapeutic pressure must be determined by the prescribing physician for each patient individually, with the configuration of the equipment to be used, including the accessories. The correct installation and positioning of the patient interface constitute a critical condition for the proper operation of the device. -
Page 9: Settings Ranges
Session: period during which data is recorded to memory between the time the device starts operation and the time the device goes into standby. A session is started after the device has been on for at least 5 minutes without interruption. - Page 10 The device is started by pressing the On/Off button . If the heated humidification feature is enabled on a device with a water chamber (Evolve configuration) and the heat level is set from 1 to 10, the heated humidifier begins operating automatically. The heated humidifier indicator then displays on the screen.
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Page 11: Accessing The Device Menus
Configuration of the devices depending on the accessories used: Pneumatic calibration Humidifier feature Accessory used Patient circuit (Settings menu) (Service menu) L. 1.80 m diam. 15 mm Ø15mm Cover L. 1.80 m diam. 22 mm Ø22mm Other SPECIFIC L. 1.80 m diam. 15 mm Ø15mm+HH Water chamber L. - Page 12 Description of symbols displayed on the screen Symbol Description Symbol Description Access to device information. Access to device settings. Provides access to the next page Provides access to the preceding available for display on the screen. page displayed on the screen. Allows the value of the parameter Allows the value of the parameter displayed on the screen to be...
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Page 13: Dreamstar™ Duo / Duo Evolve Settings
DreamStar™ Duo / Duo Evolve settings Accessing the Settings menu Refer to the "DreamStar™ Duo settings" section in the Patient Manual to know how to use the buttons and symbols displayed during the device setting procedure. Access of some settings is limited to the medical team only. For that, press the left control button and the right control button located on the front of the device simultaneously for 2 seconds. - Page 14 DreamStar™ Duo or DreamStar™ Duo Evolve The page displays: Press The page changes: Increase or decrease parameter value with the right or left as many times parameter settings button. as necessary to access the Then press to access the next desired menu parameter.
- Page 15 DreamStar™ Duo or DreamStar™ Duo Evolve The page displays: Press The page changes: Increase or decrease parameter value with the right or left as many times parameter settings button. as necessary to access the Then press to access the next desired menu parameter.
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Page 16: Service Menu
DreamStar™ Duo or DreamStar™ Duo Evolve Patient circuit options are: Ø15mm (15 mm in diameter patient tubing), Ø15mm+HH (15mm in diameter patient tubing with water chamber), Ø22mm (22mm in diameter patient tubing), Ø22mm+HH (22mm in diameter patient tubing with water chamber) and SPECIFIC (other configuration). Note If the SPECIFIC patient circuit option is selected, calibration must be launched. - Page 17 DreamStar™ Duo or DreamStar™ Duo Evolve 2. Setting the date The page displays: Press The page changes: Increase or decrease parameter value with the right or left as many times parameter settings button. as necessary to access the Then press to access the next...
- Page 18 DreamStar™ Duo or DreamStar™ Duo Evolve Auto ON : functionality allowing to automatically start the treatment without pressing the device On/Off button. Humidifier: the heated humidification feature can be enabled or disabled (if water chamber included).. Ext. : the connection of an external module can be enabled or disabled. Notes: ...
- Page 19 DreamStar™ Duo or DreamStar™ Duo Evolve 6. Miscellaneous The page displays: Press The page changes: Increase or decrease parameter value with the right or left as many times parameter settings button. as necessary to access the Then press to access the next desired...
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Page 20: Dreamstar™ Duost / Duost Evolve Settings
DreamStar™ DuoST / DuoST Evolve settings Accessing the Settings menu Refer to the "DreamStar™ DuoST settings" section in the Patient Manual to know how to use the device buttons and symbols displayed during the setting procedure. Access of some settings is limited to the medical team only. For that, press the left control button and the right control button located on the front of the device simultaneously for 2 seconds. - Page 21 DreamStar™ DuoST or DreamStar™ DuoST Evolve The page displays: Press The page changes: Increase or decrease parameter value with the right or left as many times parameter settings button. as necessary to access the Then press to access the next desired menu parameter.
- Page 22 DreamStar™ DuoST or DreamStar™ DuoST Evolve The page displays: Press The page changes: Increase or decrease parameter value with the right or left as many times parameter settings button. as necessary to access the Then press to access the next desired menu parameter.
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Page 23: Service Menu
DreamStar™ DuoST or DreamStar™ DuoST Evolve Comfort pressure: level of pressure produced by the device when the ramp feature starts up. Max ramp time: maximum ramp time of from 0 to 45 minutes. Ramp time: set time to reach the inspiratory positive airway pressure (IPAP) and the expiratory positive airway pressure (EPAP) when starting from the comfort pressure. - Page 24 DreamStar™ DuoST or DreamStar™ DuoST Evolve Software version: version of the integrated device software. The version of the integrated device software can be viewed but not modified. Note: The time can be set only when the device is in standby. ...
- Page 25 DreamStar™ DuoST or DreamStar™ DuoST Evolve 4. Selection of features The page displays: Press The page changes:: With the right or left parameter settings button, enable as many times as necessary to disable the feature. access the desired Then press to access the next...
- Page 26 DreamStar™ DuoST or DreamStar™ DuoST Evolve CAUTION The reminder expiration date is recalculated when you change the frequency. Press at the bottom of the page or to return to the page header. Press to move to the next page. 6.
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Page 27: Other Settings And Information
Other Settings and Information General Information menu Press the left parameters settings button when the device is in stand-by to select the symbol on the screen: the General Information menu appears. The page displays: Hour counter: Device operating time. Total use: Total duration during which the patient was actually breathing in the mask. -
Page 28: Reminders About To Expire
Press at the bottom of the page or to return to the page header. Press to move to the next page. When the device starts, the heated humidifier automatically turns on. The patient can increase or decrease the heat level by moving the arrow at the bargraph with the right or left parameter settings button, as shown hereafter. -
Page 29: Specific Calibration Of The Pneumatic Configuration
Specific calibration of the pneumatic configuration CAUTION Since pressure performance depends on the pneumatic configuration selected, it is important to select the correct configuration. Special configurations should be set up by skilled personnel only. To optimise the performance of the device, it is advised to carry out a specific calibration based on the pneumatic configuration used. - Page 30 Updating Settings Devices may be set following the instructions provided by the DreamStar™ Analyze software and downloaded to the memory card. The machine settings will update automatically when the patient inserts the card into the device for the first time. Service card A memory card can be configured using DreamStar™...
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Page 31: Cleaning And Maintenance
Cleaning and Maintenance Please refer to the user instructions for your mask and tubing for details on their maintenance. WARNING Unplug the device from the power source and always detach the breathing circuit and the water chamber from the device before cleaning them. CAUTION ... - Page 32 Clean the various parts of the water chamber with warm water and mild detergent (for example 3 drops of dishwashing liquid diluted in water). Rinse well with water to eliminate any trace of detergent. Allow to dry naturally. ...
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Page 33: Monthly
Monthly Device Clean the outside of the unit using a damp tissue (cloth, paper towel) with a little water and one drop of mild detergent. Eliminate any trace of detergent in repeating this operation with a new tissue (cloth, paper towel) ... -
Page 34: Material Disinfection
Material Disinfection Refer to the instructions for use of the chemicals used to respect dilutions and quantities of products, contact time, wearing of personal protective equipment. Surface disinfection of the device Disinfection of the outside of the machine is carried out using disinfectant detergent product. ... -
Page 35: What Should Not Be Used
What should not be used Never use abrasive cleaners or highly alkaline, acetone, benzene, leaded gasoline to clean the device. Do not use any support like sponge- with scraper or stiff brush. Never use any pre-disinfecting or disinfecting product containing aldehydes and/or its derivatives: ... -
Page 36: Troubleshooting Tips
Troubleshooting tips Device Messages Message Description Corrective action MASK UNPLUGGED is The mask is Check the connections between the mask, displayed on the screen. disconnected. the patient circuit and the device. This message disappears when the patient breaths in the mask well reconnected or when the On/Off button or the ramp button... - Page 37 Code Description Corrective action Er 03 Program stack Unplug the machine from all electrical power. Plug it in again. overflow If the error recurs, return the machine to a technical service centre. Er 04 High pressure. Unplug the device from all sources of electrical power. Plug it in again and turn on.
- Page 38 Code Description Corrective action Er 102 Humidifier The device is operating without employing the heated current too high. humidification feature. Unplug the device from all sources of electrical power. Plug it in again and turn on. If the error persists, contact Technical Support. Er 103 Humidifier The device is operating without employing the heated...
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Page 39: Technical Characteristics
Technical characteristics Device Performance Device pressure range: 4 cmH O to 20 cmH O in CPAP mode 3 cmH O to 25 cmH O in Bilevel mode Accuracy: ± 0.5 cmH Increment: 0.5 cmH Maximum steady limiting pressure at the patient- side connection aperture in single fault condition: = 30 cmH Minimum steady limiting pressure at the patient-... -
Page 40: Operating Conditions For The Device And Humidifier
Operating conditions for the device and humidifier Pressure range: 730 hPa to 1060 hPa Temperature: +5 °C to + 40 °C (41 ºF to 104 ºF) without humidifier +5° C to + 35 °C (41 ºF to 95 ºF) with humidifier Relative humidity: between 10% and 95% without condensation 0 ... -
Page 41: Symbols On The Device
Symbols on the device Symbol Description Symbol Description Symbol of Ramp and selection Symbol of On/Off button. button. Symbol of Left control button. Symbol of Right control button. Waste device to be eliminated separately from the household Device protected against solid waste. -
Page 42: Standards Compliance
Standards Compliance Risks pertaining to this medical equipment were assessed in accordance with the ISO 14971:2007 standard, specifically with reference to global residual risk. The DreamStar™ product range device complies with the following standards. CEI 60601-1:2005 + AC1:2006 + AC2:2007 + Amd1:2012: Medical electrical equipment. Part 1: ... -
Page 43: Features
NF EN ISO 17510-1:2007-compliant features Static pressure stability at 10 cmH2O (Long-term accuracy according to ISO 17510-1:2007, Appendix BB.1) Without humidifier With humidifier Pressure accuracy +/- 0.5 cmH +/- 0.5 cmH Dynamic pressure stability (Short-term accuracy according to ISO 17510-1:2007, Appendix BB.2) Test pressure (cmH Respiratory Respiratory... - Page 44 Test pressure (cmH Respiratory Respiratory Respiratory Respiratory Respiratory Without humidifier rate rate rate rate rate Resp./min Resp./min Resp./min Resp./min Resp./min Tubing 22 mm diameter: Delta relative to highest pressure 0.10 0.18 0.23 0.15 0.23 0.28 0.18 0.29 0.31 0.22 0.32 0.36 0.24 0.33 0.34 (cmH Delta relative to lowest pressure...
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Page 45: Functional Pneumatic Block Diagram
Functional pneumatic block diagram DreamStar Duo, DuoST Technical characteristics 45... -
Page 46: Essential Performance Requirements For Electromagnetic Compatibility
Essential performance requirements for electromagnetic compatibility During the electromagnetic compatibility tests, the device saved its settings and the values of the inspiratory and expiratory pressures delivered remained at the set pressure ± 0.5 cm H The device was occasionally disturbed and it recovered a normal operation after disruption. Electromagnetic emissions DreamStar™... - Page 47 Electromagnetic Immunity ° (continued) Magnetic fields in the Power Supply Power frequency magnetic fields should be at Frequencies 3 A/m 3 A/m levels characteristic of a typical location in a (50/60 Hz) typical commercial or hospital environment. IEC 61000-4-8 Note: is the AC mains voltage prior to application of the test level Electromagnetic Immunity - conducted and radiated RF DreamStar™...
- Page 48 Recommended separation distance between portable and mobile RF communications equipment and a device from the DreamStar™ product range The DreamStar™ product range are designed to be used in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of a device from the DreamStar™ product range can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device from the DreamStar™...
- Page 50 Manufacturer: Manufacturing plant: SEFAM SEFAM 144 AV CHARLES DE GAULLE 10 ALLEE PELLETIER DOISY 92200 NEUILLY SUR SEINE 54600 VILLERS-LES-NANCY FRANCE FRANCE : M-155DFU00-70 Version 10 2020-02...
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