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Feellife AirICU Max+ User Manual

Medical mesh nebulizer
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User manual for
Medical Mesh Nebulizer
Model: AirICU Max+
Doc: LFS-EN-UM-25F
Issue date: Oct.25,2022
Rev.: A/0

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Summary of Contents for Feellife AirICU Max+

  • Page 1 User manual for Medical Mesh Nebulizer Model: AirICU Max+ Doc: LFS-EN-UM-25F Issue date: Oct.25,2022 Rev.: A/0...

  • Page 2: Table Of Contents

    Table of Contents 1. Intended Use and Indications for Use ................1 2. Working Principle ......................1 3. Contraindications .......................2 4. Important Safety Notes ......................2 5. Package Contents and Overview ..................2 6. Product Technical Parameters ................... 4 7. Installation and User Instructions ..................6 8.

  • Page 3: Intended Use And Indications For Use

     Thank you very much for purchasing this Medical Mesh Nebulizer.  Be sure to read this user manual carefully before using this device, so that you can use it safely and correctly.  Please keep this instruction for use in a place where convenient for reading at any time.

  • Page 4: Contraindications

    throat, trachea, bronchus, alveoli and other places, through the mucosa and other tissues absorption to achieve the purpose of treatment. 3. Contraindications None. 4. Important Safety Notes 1) For the type, dose, and regimen of the medication, be sure to follow the instructions of a doctor.
  • Page 5 Display Air flow sensor Previous step Medical Power Supply USB cable (Y-type) Stand-by Charging interface Support frame component Nebulizer mask(Adult and Child are Next steps for optional) Main unit Aerotank(With a mouthpiece) USB Interface Oxygen tube Mediation cup (10 mL max) USB cable (Linear type ) Mediation cup (10 mL max，Type PIN connector...

  • Page 6: Product Technical Parameters

    Nebulizer Mask (Child) 10 mL (max) Medication Cup MAICU Pro3 Medication Cup MAICU Pro4 10 mL (max)，Type of thread ф27.5mm Air Flow Sensor ICU A1 Length:67.3mm Note: There are 3 kinds of T-Piece and 2 kinds of Nebulizer Mask for you to choose.Please choose one which is suitable for the patient.
  • Page 7 Adapter: I/P: 100-240V~, 50/60Hz, 0.4A MAX O/P: 5.0V 2.5A Power source Main unit: I/P: 5.0V 2.5A 3.7V/1000 mAh, 3.7Wh rechargeable Li-ion battery Power consumption 3.7 Wh Low: 0.15-0.60 ml/min Middle: 0.25-0.80 ml/min Nebulization rate High: 0.35-0.90 ml/min MMAD ＜5 μm Medication cup 10 mL (max) capacity...

  • Page 8: Installation And User Instructions

    Figure 3. Add medicine liquid Step 1:Open the medication cover and add medicine (at least 2ml, less than 10ml). Step 2:Cover the lip of the medication cup. 7.2.2 Medication Cup（MAICU Pro4） Continuous infusion of liquid medication for aerosolization Syringe component（not supplied by feellife）...
  • Page 9 6) Use of the AirICU Max+ during the administration of volatile anesthetics may result in adverse effects on the constituent plastics. Do not use with volatile anesthetics unless known to be compatible. FEELLIFE have determined that, using anesthetic ventilators, the following volatile anesthetic agents are compatible under the stated conditions...
  • Page 10 ① Connection of Air Flow Sensor ② Air Flow Sensor is not connected Figure 5. Connection of T-Piece, Medication Cup ① Connection of Air Flow Sensor ② Air Flow Sensor is not connected Figure 6. Connection of USB Cable (two ways) 1) Keep the T-Piece on the horizontal line and insert the Medication Cup to T-Piece.
  • Page 11 Figure 7. Connecting the T-Piece to an adult breathing circuit 4) Air Flow Sensor can be connected just as the following graphic. Figure 8. Connecting the T-Piece to an adult breathing circuit (including Air Flow Sensor) 5) The Air Flow Sensor just can be used in 22 mm adult breathing circuits,do not support 15 mm and 10 mm pediatric breathing circuits.
  • Page 12 Air Inlet Air Inlet Air Outlet Figure 9. Connecting the T-Piece to a pediatric breathing circuit 7) The T-Piece can connect to 10 mm pediatric breathing circuits with the 10 mm Infant T- . This can be positioned approximately 30cm (12 in.) back from the patient Y,as Piece shown in Figure 10.
  • Page 13 ① Air Flow Sensor is not connected ② Connection of Air Flow Sensor Figure 11. T-Piece on dry side of humidifier Warning: 1) Please connect breathing hose with the Medication Cup Assembly.For more detailed information please refer to the user manual of the ventilator. 2) Where a standard equipment mount is available,use the Support Frame Component to support the main unit.
  • Page 14 10) The ventilator is not supplied by FEELLIFE. The image of the ventilator has been included for demonstration purposes. It is the responsibility of the clinician to determine if a ventilator is required and the type of ventilator selected for use (Viral/Bacterial) in conjunction with the AirICU Max+.
  • Page 15 Step 3 Use with the mouthpiece or the mask Step 4 Insert according to arrow Filter Note: The filter is not supplied by FEELLIFE. Step 5 Connect with USB cable Step 6 Power on Step 7 Inhalation...
  • Page 16 2) Aerotank Kits are for spontaneous and conscious breathing patients only. 3) The Aerotank Kits are non-sterile. 4) The filter is not supplied by FEELLIFE.The image of the filter has been included for demonstration purposes.It is the responsibility of the clinician to determine if a filter is required and the type of filter selected for use (Viral/Bacterial) in conjunction with the Aerotank.
  • Page 17 Instructions for Use for information including filter disposal. 7) For disposal of the Aerotank Kits,please refer to hospital or institutional protocol. 8) Aerotank Kits are designed to a single patient use. 9) Optimal aerosol delivery is achieved with valved mouthpiece or valved face mask (as supplied) with low/no oxygen flow.
  • Page 18 3）The main interface Mode selection: Cont.Mode and Br.Mode Nebulizer rate： L1-L2-L3 Default:L2 Time for working： 45min or 90 min 4）General setting Language: Time： Year/month/day/ho ur/minute Bluetooth： ON/OFF Sound： ON/OFF Record: Date, time, mode, level Record clearing System reset About this machine: M o d e l , s o f t w a r e Return versi on , websi te .
  • Page 19 Note: The device will automatically remember the last setting mode/gear/time, if you want to restore the factory settings, please click System Reset in the system settings. 2) Level There are three gears in total. This is the nebulization rate adjustment function. L1 is the minimum rate and L3 is the maximum rate.Adjust the value based on the patient situation.
  • Page 20 Note:To switch to Breath nebulization mode, operate in the system-mode selection before making sure the Air flow sensor is properly connected. 5）In standby mode, the screen will go off after 60 seconds, and the device will be shut down after 5 minutes. Caution: 1) Working time: Depending on the patient’s condition, we do not recommend the use time, please follow the advice of doctor.
  • Page 21 7.5.2 Open the application interface, click the device button.There are three log in methods: a. Wechat b. Apple ID c. Tourist identify 7.5.3 Connect the AirICU Max+ 1) Turn on the Bluetooth and log in. 2) Turn on the AirICU Max+. 3) Search for the device , select the device, enter the main interface.
  • Page 22 7.6 Automatic shutdown program 1) AirICU Max+ will have a short sound signal and automatically turn off when it reaches the maximum operating time.The maximum operating time is： • 45 min or 90 min Continuous nebulization mode • 45 min or 90 min Breath nebulization mode 7.7 Course of treatment Medicine cup assembly are used by a single patient.
  • Page 23 follow the advice of the doctor. 7.8 Finish nebulization 1) When finishing nebulization, long press power switch to power off(＞2 seconds). It will send a short signal and turn off. Pour out the residual liquid,do not reuse. (As shown below) Figure 13.
  • Page 24 ①Charging image ②Turn off when charging ③Turn on when charging Figure 13. Charging 2) Charging time It takes about 2 hours to charge 80% battery capacity and takes about 3 hours to charge 100% battery capacity. Caution 1) Only the last grid is left and shown as red. It is remind you to charge as soon as possible.

  • Page 25: Cleaning And Disinfection

    continues and that the charging status turns off. 7) Power off the Main Unit. Reconnect the AC/DC adapter to the Main Unit. Press and hold the button for at least 2 seconds. Verify that aerosol is visible. 8) Turn the Main Unit off . 7.11 Software version WHQICU Max+ V1.0 8.

  • Page 26: Storage Conditions

    compound to disinfect. 3) The disinfectant residues should be cleaned thoroughly. 4) Do not immerse the Air Flow Sensor into the liquids,it may be damaged. 5) The Air Flow Sensor does not require disinfection. 9. Storage Conditions 1) The storage and transportation conditions of the products are detailed in the Product Technical Parameters section.

  • Page 27: Note & Warning

    mesh clogged with Take off the medicine cup, wash with warm water, medication. air dry. Re-assemble the medication cup correctly. The medication cup assembly Contact the manufacturer or the distributor for a new leakages. one. Residual medicine liquid in the It is a normal phenomenon.Clean the medication cup medication cup.
  • Page 28 • When the product is taken out from -20 ℃, it should be put in room temperature for 2 hours before use. • When the product is taken out from 55℃, it should be put in room temperature for 2 hours before use.

  • Page 29: Electromagnetic Compatibility

    • Use only with AirICU Max+ components, connectors and any accessories,which are specified by FEELLIFE in this instruction manual. • Federal (US) Law restricts this device to sale by or on the order of a physician.
  • Page 30 Medical devices manufactured by FEELLIFE HEALTH INC. conform to this IEC 60601- 1-2 standard for both immunity and emissions. Warning: 1) Only use the AirICU Max+ with components specified in the Instructions for Use. Use with components other than those specified in the Instructions for Use may result in increased emissions or decreased immunity.
  • Page 31 30 %. Mains power quality Electrical fast ±2kV for power ±2kV for power should be that of a transient/burst IEC supply lines ±1kV supply lines typical commercial or 61000-4-4 for Input/output lines hospital environment. ±0.5kV,±1kV line to Mains power quality Surge IEC line ±0.5kV,±1kV line to...

  • Page 32: Signs And Symbols

    transmitters, as determined by an electromagnetic site survey,*2) should be less than the compliance level in each frequency range.*3) Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations.

  • Page 33: After-Sales Service

    Date of manufacture General warning sign Refer to instructions for Manufacturer information Keep dry Non-sterile This way up Caution Temperature limit Fragile,handle with care Humidity limitation Type BF applied part Atmospheric pressure Keep away from sunlight limitation When this device life expires,the end users Degree of protection should discard this device...

  • Page 34: Configuration List

    Failure or damage caused by the dismantle movement of a non-our-company authorized maintainer. Failure or damage caused by accidental falling, pressing, dropping, immersion etc. If needed, we will provide circuit diagrams and component part lists to assist to user in parts repair. The Company reserves the right of final interpretation of the warranty card, which may be subject to change without prior Note.

  • Page 35: Manufacturer Information

    (with the store and address). Any repair service out of the scope of warranty will be charged accordingly. 17. Manufacturer information FEELLIFE HEALTH INC. Room 1903, Building A, No.9 Furong Road, Tantou Community, Songgang Subdistrict, Bao’an District, Shenzhen, 518104 Guangdong, P.R. China Tel: +86-755-66867080 E-mail:info@feellife.com...

  • Page 36: Fcc Warning

    FCC Warning This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

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