Related Manuals for SEFAM nea
Summary of Contents for SEFAM nea
- Page 1 M-170DFU00-20 - V7 - Mise en activité le 01/08/2024 Patient Manual Manuel patient NEA Anglais 1 / 46...
- Page 2 TEL: +33 (0) 3 83 44 85 00 www.sefam-medical.com Technical assistance : Email: technicalservice@sefam-medical.com UK Authorised representative: SEFAM MEDICAL Ltd UNIT 6. BLACKTHORN WAY FIVE MILE BUSINESS PARK LN4 1BF LINCOLN UNITED KINGDOM www.sefam-medical.com ▪ Néa Manuel patient NEA Anglais 2 / 46...
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Page 3: Table Of Contents
Functional diagram of the internal pneumatic circuit ................. 41 Special characteristics according to the standard ISO 80601-2-74 ............42 EC Marking ..................................42 End of life disposal of the device ........................... 42 Néa Contents ▪ Manuel patient NEA Anglais 3 / 46... -
Page 4: Product Description
O, and under certain defect conditions, static pressures up to 40 O are possible. The device must not be used then, if such pressure level presents a risk to the patient. ▪ Product description Néa Manuel patient NEA Anglais 4 / 46... -
Page 5: Warnings/Precautions
▪ Equipment apnoea (Aflow); equipment hypopnoea (Hflow); and equipment apnoea hypopnoea index (AHLflow) are an estimate provided by sleep apnoea breathing therapy equipment and not diagnostic parameters. Néa Product description ▪ Manuel patient NEA Anglais 5 / 46... - Page 6 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…). ▪ Product description Néa Manuel patient NEA Anglais 6 / 46...
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Page 7: Potential Undesirable Side Effects
However, in case of failure the device has to be repaired by authorized persons who will use original parts only. Néa Product description ▪ Manuel patient NEA Anglais 7 / 46... -
Page 8: Presentation Of The System
Breeze Mask Facial + M Ø 22 mm standard tube Breeze Mask Facial + L Miscellaneous Sefam cigarette cable (24 VDC – max. Breeze Mask Facial Comfort S length 5 m) Breeze Mask Facial Comfort M Néa fine inlet filter... -
Page 9: Views Of The Device
Base used to heat the water contained in the tank - Tank cover Allows to close the tank - Tank (overmolded) Element to fill with water Meaning of symbols Néa Presentation of the system ▪ Manuel patient NEA Anglais 9 / 46... - Page 10 This symbol means "On prescription Device complies with the requirements of only". Regulation 2017/745 on medical devices This device may only be sold by a doctor or on a doctor's prescription. ▪ Presentation of the system Néa Manuel patient NEA Anglais 10 / 46...
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Page 11: Installation
(see paragraph “How to set the device”). The next time the device is switched on, the display lights up and the "Néa by Sefam " logo appears. Then, the standby screen appears a few seconds later, indicating the time. -
Page 12: Re-Installation Of The Side Cover
Installation with cigarette lighter (optional) The device can be powered by a cigarette lighter socket using the Sefam cigarette cable (24 VDC) (optional) designed for this purpose. To do this, replace step 4 of the standard installation by the following step: ▪... -
Page 13: Filling The Tank (If Applicable)
3. Replace the new filter(s) in the compartment, placing the fine filter first, followed by the air inlet filter. 4. Close the air inlet grid. Néa Installation ▪ Manuel patient NEA Anglais 13 / 46... -
Page 14: Device Configuration
Messages “Do not remove card” “Transfer in progress” Operation (Only for Néa Auto) SD card missing or incorrectly C : CPAP inserted A : APAP (Auto-CPAP) USB connection activated ▪ Device configuration Néa Manuel patient NEA Anglais 14 / 46... - Page 15 I Ramp (Intelligent ramp) Decrease Intelligent Start (optional) Changing the screen Comfort Control Plus (optional) Indicates the page of the slide Configuration Error Time Warning Yellow ON - OFF Néa Device configuration ▪ Manuel patient NEA Anglais 15 / 46...
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Page 16: Features Of The Device
(and by pressing again reactivates) this function. There are two types of ramp: ▪ T RAMP (programmable ramp ): you can determine the ramp time ▪ I RAMP (intelligent ramp): the ramp time is automatically determined by the device. ▪ Device configuration Néa Manuel patient NEA Anglais 16 / 46... -
Page 17: How To Set The Device
You can decrease or increase the displayed value of the humidification level. Possible settings: (the color of the logo • OFF (no humidification), differs according to • 01 to 10 the heating level) Néa Device configuration ▪ Manuel patient NEA Anglais 17 / 46... - Page 18 Tap the touch key Possible setting: • ON (blue) then • OFF (black) Comfort Control Plus: (optional) Tap the touch key Possible setting: • ON (blue) then • OFF (black) ▪ Device configuration Néa Manuel patient NEA Anglais 18 / 46...
- Page 19 Time zone selection: Use the 2 keys to select the time zone. Language selection: Tap the touch key Use the 2 keys to select a language. then Néa Device configuration ▪ Manuel patient NEA Anglais 19 / 46...
- Page 20 Note: IAH = IAH flow Tap the touch to go to the next screen Polylink information (optional): Only with Polylink and device in the treatment process. ▪ Device configuration Néa Manuel patient NEA Anglais 20 / 46...
- Page 21 (optional) Activated connectivity (optional) to exit the menu. WARNING : ▪ IAH=IAHflow is an estimate provided by sleep apnoea breathing therapy equipment and not diagnostic parameters Néa Device configuration ▪ Manuel patient NEA Anglais 21 / 46...
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Page 22: Use
When using oxygen with this device, the oxygen supply must comply with local regulations for medical oxygen and the oxygen adapter used must comply with ISO 80369-1:2018. ▪ Scrupulously follow the instructions for starting and stopping treatment. ▪ Use Néa Manuel patient NEA Anglais 22 / 46... -
Page 23: Use Of The Sd Card
Once the data has been saved, you can send the memory card to your service provider or healthcare professional so that they can retrieve the compliance data and analyse it. Néa Use ▪ Manuel patient NEA Anglais 23 / 46... -
Page 24: Settings Update
(4-3-2, 4-3-2, etc ). This stage may last a few minutes, particularly when using for the first time or when changing network (for example when moving the module to another geographical location). ▪ Use Néa Manuel patient NEA Anglais 24 / 46... - Page 25 PolyLink search and check that the PolyLink is working. Once the PolyLink has been detected, its serial number will appear. CAUTION : Make sure that the PolyLink's serial number matches the one you want to pair. Néa Use ▪ Manuel patient NEA Anglais 25 / 46...
- Page 26 Confirm pairing from the Néa device interface. Connecting to the Wi-Fi network for the first time You can connect to the local network using the Sefam Access Lite application. Connection via Sefam Access Lite Make sure that the symbol is present in the status bar of the Néa device, indicating that Bluetooth communication is active.
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Page 27: Cybersecurity
(see paragraph " How to The device does not set the device "). deliver correct pressure on the display. selected ramp Contact your Home Care Provider. does not suit you. Néa Cybersecurity ▪ Manuel patient NEA Anglais 27 / 46... - Page 28 Set the humidification level between 01 and 10 (see appear to heat the level is set on OFF. paragraph " How to set the device "). water. ▪ In case of problems Néa Manuel patient NEA Anglais 28 / 46...
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Page 29: Device Messages
Disconnect the Néa device from the power supply. Plug it in again. Communication module If the problem persists, contact your Home Care software problem. Provider. Néa In case of problems ▪ Manuel patient NEA Anglais 29 / 46... - Page 30 Keep the Néa device away from sources of module seems Excessive electromagnetic interference such as halogen lights, mobile phones, disturbed and is not interference. etc. working properly. ▪ In case of problems Néa Manuel patient NEA Anglais 30 / 46...
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Page 31: Error Messages
Internal memory error Notes : • When an error is detected, the device goes in standby mode (except for special cases) making access to different menus impossible. Néa In case of problems ▪ Manuel patient NEA Anglais 31 / 46... -
Page 32: Cleaning And Maintenance
Place the tank back on the hot plate, hinge side towards the inside of the device, and push it against the device until you hear a "click". Notes: ▪ Do not leave stagnant water in the tank in order to prevent the development of micro-organisms. ▪ Cleaning and maintenance Néa Manuel patient NEA Anglais 32 / 46... -
Page 33: Monthly
The reservoir is the only part of the gas pathways passing through the humidifier that is likely to ▪ be contaminated by bodily fluids or contaminated substances carried by exhaled gases, both under normal conditions and in the event of a first fault. Néa Cleaning and maintenance ▪ Manuel patient NEA Anglais 33 / 46... -
Page 34: Transport Of The Device
WARNING: The heated humidifier ‘Néa H2O’ is not intended to be used as a transit-operable humidifier ▪ ▪ Transport of the device Néa Manuel patient NEA Anglais 34 / 46... -
Page 35: Technical Characteristics
Setting 1 (min) Setting 10 (max) >4 >10 >4 >10 Humidifier performance meets ISO 80601-2-74 : 2021 performance > 10 mg/L tested at 15°C to 35°C and relative humidity > 15% Néa Technical characteristics ▪ Manuel patient NEA Anglais 35 / 46... -
Page 36: Conditions Of Use
Input voltage: 100 – 240 VAC, 50 - 60 Hz Power supply provided: MDS-090BAS24 A (outlet depending on the country) Input current: 2 - 1 A Output voltage: 24 V ▪ Technical characteristics Néa Manuel patient NEA Anglais 36 / 46... -
Page 37: Physical Characteristics
27 V/m 380-390 MHz PM 18 Hz Recommended separation distance wireless communication equipment d = 0.3 m 28 V/m 430-470 MHz FM ± 5 KHz sinus IEC 61000-4-3 1 KHz Néa Technical characteristics ▪ Manuel patient NEA Anglais 37 / 46... - Page 38 Due to the presence of a wireless transceiver in Néa, the radiated RF electromagnetic field immunity tests are performed between 80MHz and 6000 MHz rather than between 80 MHz and 2700 MHz. ▪ Technical characteristics Néa Manuel patient NEA Anglais 38 / 46...
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Page 39: Special Characteristics According To The Standard Iso 80601-2-70:2020
The accuracy quoted for static pressure already includes the system uncertainties from the test equipment, i.e. ±0,75% of reading or ±0,1cmH ▪ Technical characteristics Néa Manuel patient NEA Anglais 39 / 46... - Page 40 The most unfavourable configuration for the passage of respiratory gases is the configuration with a 15 mm breathing tube and an optional fine filter, with or without a humidifier. ▪ Technical characteristics Néa Manuel patient NEA Anglais 40 / 46...
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Page 41: Functional Diagram Of The Internal Pneumatic Circuit
Device with side cover Device with humidifier Pneumatic diagram ISO 80601-2-70 CPAP Device N° Function PPC Device Filter and air inlet Blower Humidifier (optional) Air outlet Applied parts (Accessories) 1.80m tube Mask Néa Technical characteristics ▪ Manuel patient NEA Anglais 41 / 46... -
Page 42: Special Characteristics According To The Standard Iso 80601-2-74
Recycling electrical equipment preserves natural resources and avoids any risk of pollution. To this end, SEFAM fulfills its obligations regarding the end-of-life of the Néa device by financing Recylum's recycling channel dedicated to WEEE Pro, which takes them back free of charge (more information on www.recylum.com). - Page 43 M-170DFU00-20 - V7 - Mise en activité le 01/08/2024 Manuel patient NEA Anglais 43 / 46...
- Page 44 Contact details for your Home Healthcare Provider Manufacturer : Manufacturing site : SEFAM SEFAM 144 AV CHARLES DE GAULLE 10 ALLEE PELLETIER DOISY 92200 NEUILLY-SUR-SEINE 54600 VILLERS-LES-NANCY FRANCE FRANCE : M-170DFU00-20-Version 7 2024-07 Manuel patient NEA Anglais 44 / 46...
- Page 45 Utilisateurs en diffusion : ALLIAUME Mélanie - AR e-mail Historique du document : M-170DFU00-20 version 7 : Manuel patient NEA Anglais Validé le 01/08/2024 Mise en activité le 01/08/2024 Nature des modifications : DM3586 : Ajout Erreur 15. et prise en compte des suggestions M-170DFU00-20 version 6 : Manuel patient NEA Anglais Validé...
- Page 46 12 V or 13 V battery in a light vehicle." . Corrected names of accessories. Mise en archive le 01/08/2024 M-170DFU00-20 version 5 : Manuel patient NEA Anglais Validé le 07/05/2024 Mise en activité le 07/05/2024 Nature des modifications : DM3576 : Mise en conformité...
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