SEFAM DreamStar Intro User Manual
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Also See for DreamStar Intro:
- User manual (54 pages) ,
- Patient manual (42 pages) ,
- Product manual (38 pages)
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Summary of Contents for SEFAM DreamStar Intro
- Page 1 DreamStar™ Product Range DreamStar™ Intro DreamStar™ Intro Evolve DreamStar™ Info DreamStar™ Info Evolve DreamStar™ Auto DreamStar™ Auto Evolve DreamStar™ is a brand registered by SEFAM.
- Page 2 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 2 DreamStar Intro, Info, Auto...
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Page 3: Table Of Contents
Surface disinfection of the device ....38 Water chamber disinfection procedure (if included) ............38 What should not be used ......39 Troubleshooting tips ..........40 Device Messages ..........40 Error Messages ..........40 DreamStar Intro, Info, Auto Table of contents 3... -
Page 4: Before You Start
The DreamStar™ product range devices are intended to treat patients suffering from Obstructive Sleep Apnea Syndrome (OSA) in patients over 30 kg (66 lbs.) and breathing spontaneously. They can be used in Home Healthcare Environment or in a sleep center. 4 Before you start DreamStar Intro, Info, Auto... -
Page 5: Contra-Indications
Patient Tubing, 15 mm diameter (except for Patient Tubing, 22 mm diameter DreamStar™ Intro/Intro Evolve) P/N M-261000-04 P/N M-261000-00 Swivel outlet elbow, 70° diameter 22 mm Carrying case P/N M-815505-00 P/N M-267010-00 DreamStar Intro, Info, Auto Before you start 5... - Page 6 WARNING: Use of cables, transducers and accessories other that those specified, may result in increased electromagnetic emissions or decreased electromagnetic immunity of the DreamStar™ product range devices and result in improper operation. 6 Before you start DreamStar Intro, Info, Auto...
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Page 7: Available Features
The DreamStar™ device has a patient reminder feature to help the patient remember key events such as filter and mask changes, device inspections, and memory card compliance data downloads on the memory card. This feature is described under “Reminders about key events”, on page 32. DreamStar Intro, Info, Auto Available Features 7... -
Page 8: Comfort Calibration
Ramp feature in CPAP mode 8 Available Features DreamStar Intro, Info, Auto... - Page 9 The table below lists the different cases of the indexed ramp operation in CPAP or Auto-CPAP mode. End of ramp / detection of events End of ramp / Max ramp time DreamStar Intro, Info, Auto Available Features 9...
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Page 10: Device Settings
A session is started after the device has been on for at least 5 minutes without interruption. Water chamber: chamber containing the water necessary for humidification. 10 Device Settings DreamStar Intro, Info, Auto... -
Page 11: Settings Ranges
(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. When the heat level is set at 0, the humidifier symbol is displayed without steam DreamStar Intro, Info, Auto Device Settings 11... - Page 12 Access to setting of comfort pressure for the patient (locked) (autorised) Access to setting of language for the patient (locked) (autorised) Ramp type Default Time ramp Indexed ramp Indexed ramp Ramp feature (T.Ramp) (I.Ramp) (I.Ramp) 12 Device Settings DreamStar Intro, Info, Auto...
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Page 13: Accessing The Device Menus
(see table entitled “Description of symbols displayed on the screen“). DreamStar Intro, Info, Auto Device Settings 13... - Page 14 For settings specific to the DreamStar™ Auto or DreamStar™ Auto Evolve device, see "How to set DreamStar™ Auto / Auto Evolve device", on page 23. The "General Information" menu for the devices is described on page 30. 14 Device Settings DreamStar Intro, Info, Auto...
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Page 15: How To Set Dreamstar™ Intro / Intro Evolve Device
1 cmH Press at the bottom of the page or to return to the page header. Press to move to the next page. DreamStar Intro, Info, Auto How to set DreamStar™ Intro / Intro Evolve device 15... -
Page 16: Service Menu
Press at the bottom of the page or to return to the page header. Press to move to the next page. 16 How to set DreamStar™ Intro / Intro Evolve device DreamStar Intro, Info, Auto... - Page 17 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. DreamStar Intro, Info, Auto How to set DreamStar™ Intro / Intro Evolve device 17...
- Page 18 Press at the bottom of the page or to return to the page header. Press to exit the menu. 18 How to set DreamStar™ Intro / Intro Evolve device DreamStar Intro, Info, Auto...
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Page 19: How To Set Dreamstar™ Info / Info Evolve Device19
1 cmH Press at the bottom of the page or to return to the page header. Press to move to the next page. DreamStar Intro, Info, Auto How to set DreamStar™ Info / Info Evolve device 19... - Page 20 "Specific calibration of the pneumatic configuration" paragraph, on page 33. Press at the bottom of the page or to return to the page header. Press to exit the menu. 20 How to set DreamStar™ Info / Info Evolve device DreamStar Intro, Info, Auto...
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Page 21: Service Menu
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. Press to move to the next page. DreamStar Intro, Info, Auto How to set DreamStar™ Info / Info Evolve device 21... - Page 22 Press at the bottom of the page or to return to the page header. Press to move to the next page. 22 How to set DreamStar™ Info / Info Evolve device DreamStar Intro, Info, Auto...
- Page 23 Press at the bottom of the page or to return to the page header. Press to exit the menu. DreamStar Intro, Info, Auto How to set DreamStar™ Info / Info Evolve device 23...
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Page 24: How To Set Dreamstar™ Auto / Auto Evolve Device
1 cmH Press at the bottom of the page or to return to the page header. Press to move to the next page. 24 How to set DreamStar™ Auto / Auto Evolve device DreamStar Intro, Info, Auto... - Page 25 Then press to access the next desired menu parameter. parameter setting. DreamStar Intro, Info, Auto How to set DreamStar™ Auto / Auto Evolve device 25...
- Page 26 If no calibration is PRESENT, the calibration goes back to the default calibration. See "Specific calibration of the pneumatic configuration" paragraph, on page 33. 26 How to set DreamStar™ Auto / Auto Evolve device DreamStar Intro, Info, Auto...
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Page 27: Service Menu
Then press to access the next desired menu parameter. parameter setting. Note: The date can be set only when the device is in standby. DreamStar Intro, Info, Auto How to set DreamStar™ Auto / Auto Evolve device 27... - Page 28 Press at the bottom of the page or to return to the page header. Press to move to the next page. 28 How to set DreamStar™ Auto / Auto Evolve device DreamStar Intro, Info, Auto...
- Page 29 Press at the bottom of the page or to return to the page header. Press to exit the menu. DreamStar Intro, Info, Auto How to set DreamStar™ Auto / Auto Evolve device 29...
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Page 30: Other Settings And Information
The Session page is only available if the device is in standby and if at least one session was recorded. Press the On/Off button to exit the menu. 30 Other settings and information DreamStar Intro, Info, Auto... -
Page 31: Setting The Heat Level (If Water Chamber Included)
Press at the bottom of the page or to return to the page header. Press to move to the next page. DreamStar Intro, Info, Auto Other settings and information 31... -
Page 32: Reminders About Key Events
If you respond yes, the event reminder disappears from the display. Press at the bottom of the page or to return to the page header. Press to exit the menu. 32 Other settings and information DreamStar Intro, Info, Auto... -
Page 33: Specific Calibration Of The Pneumatic Configuration
To do this, insert the memory card into the card reader supplied with the software, then connect the reader to a USB port on your computer. To retrieve the compliance data, consult the DreamStar™ Analyze software user manual. CAUTION Use approved memory cards only. DreamStar Intro, Info, Auto Other settings and information 33... - Page 34 "service card", consult the DreamStar™ Analyze software user manual. To be able to use the service card with the device, hold down the ramp button pressed while inserting the card. 34 Other settings and information DreamStar Intro, Info, Auto...
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Page 35: Cleaning And Maintenance
Keep the clip held down while gently pulling the tubing towards you to extract it from the upper part. ① ② Grip zone Inner tubing Upper part Gasket Base Center tab DreamStar Intro, Info, Auto Cleaning and Maintenance 35... - Page 36 Once dry, place the filter into the filter holder, then the assembly at the back of the device. Do not use a filter which is not completely dry. Reinstall the cover or the water chamber. 36 Cleaning and Maintenance DreamStar Intro, Info, Auto...
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Page 37: Monthly
Never use the device without making sure that an air intake filter is installed. Check that the heating element is completely dry before reconnecting the device to the power supply. DreamStar Intro, Info, Auto Cleaning and Maintenance 37... -
Page 38: Material Disinfection
Keep the disinfected and dried water chamber in a single use clean bag, sealed until a new use. Note : Discard the water chamber if showing any damage and replace it with a new one. 38 Material Disinfection DreamStar Intro, Info, Auto... -
Page 39: What Should Not Be Used
Do not use any pre-disinfecting or disinfecting product not active on the Mycobacterium tuberculosis (BK). Never disinfect the internal circuit of air flow using disinfecting product or with a Airway Surface Disinfection System (DSVA). DreamStar Intro, Info, Auto Material Disinfection 39... -
Page 40: Troubleshooting Tips
Unplug the machine from all electrical power. Plug it in again. overflow (on If the error recurs, return the machine to a technical service DreamStar™ Info / centre. Info Evolve and DreamStar™ Auto / Auto Evolve) 40 Troubleshooting tips DreamStar Intro, Info, Auto... - Page 41 SPI bus Unplug the device from all sources of electrical power. Plug communication error. it in again and turn on. (on DreamStar™ Intro / If the error persists, contact Technical Support. Intro Evolve). DreamStar Intro, Info, Auto Troubleshooting tips 41...
- Page 42 Unplug the device from all sources of electrical power. device. Plug it in again and turn on. If the error persists, contact Technical Support. 42 Troubleshooting tips DreamStar Intro, Info, Auto...
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Page 43: Technical Specifications
+5° C to + 35 °C (41 ºF to 95 ºF) with humidifier Relative humidity: between 10% and 95% without condensation Altitude range: 0 2 700 m (09,000 ft) approximately DreamStar Intro, Info, Auto Technical Specifications 43... -
Page 44: Transportation And Storage Conditions
300 ml Maximum liquid fill level: Indicated on water chamber CE marking DreamStar™ Intro, DreamStar™ Intro Evolve : 2011 DreamStar™ Info, DreamStar™ Info Evolve : 2011 DreamStar™ Auto, DreamStar™ Auto Evolve : 2011. 44 Technical Specifications DreamStar Intro, Info, Auto... -
Page 45: Symbols On The Device
safety and essential performance of sleep apnea breathing therapy equipment ISO 80601-2-74:2017: Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment DreamStar Intro, Info, Auto Technical Specifications 45... -
Page 46: Disposing Of The Device At The End Of Its Life46
(see "Symbols on the device" page 45). In other countries, this device must be processed following local regulation. Unsuitable disposal of the device at the end of its life could harm the environment. 46 Technical Specifications DreamStar Intro, Info, Auto... -
Page 47: Iso 80601-2-70:2015-Compliant Features
Sound pressure measured in accordance with ISO 80601-2-70:2015: 30 dBA with humidifier, 33 dBA without humidifier Sound power measured in accordance with ISO 80601-2-70:2015: 38 dBA with humidifier, 41 dBA without humidifier DreamStar Intro, Info, Auto Technical Specifications 47... - Page 48 0.05 0.04 0.26 -0.27 -0.13 0.01 -0.30 -0.22 -0.06 -0.31 -0.20 -0.08 -0.28 -0.25 -0.08 lowest pressure (cmH Delta relative to 0.04 0.04 0.06 0.06 0.07 0.09 0.08 0.11 0.12 0.09 0.12 0.15 0.13 0.15 0.16 dynamic pressure (cmH 48 Technical Specifications DreamStar Intro, Info, Auto...
- Page 49 Sound pressure measured in accordance with ISO 80601-2-70:2015: 30 dBA with humidifier, 33 dBA without humidifier Sound power measured in accordance with ISO 80601-2-70:2015: 38 dBA with humidifier, 41 dBA without humidifier DreamStar Intro, Info, Auto Technical Specifications 49...
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Page 50: Functional Pneumatic Block Diagram
Functional pneumatic block diagram * except DreamStar™ Intro or DreamStar™ Intro Evolve 50 Technical Specifications DreamStar Intro, Info, Auto... -
Page 51: Electromagnetic Compatibility
80 MHz to from 80 MHz to 800 MHz 6 GHz 6 GHz from 800 MHz to 2,5 GHz Note: is the AC mains voltage prior to application of the test level. DreamStar Intro, Info, Auto Technical Specifications 51... - Page 52 52 Technical Specifications DreamStar Intro, Info, Auto...
- Page 54 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-155DFU00-60 Version 10 2021-01...
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