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flyp fn2000m User Manual

Pocket portable nebulizer
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Model fn2000m
Pocket Portable
Nebulizer
User Guide
USER: READ THIS GUIDE BEFORE OPERATING THIS DEVICE.
SAVE THIS GUIDE FOR FUTURE REFERENCE.

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Summary of Contents for flyp fn2000m

  • Page 1 Model fn2000m Pocket Portable Nebulizer User Guide USER: READ THIS GUIDE BEFORE OPERATING THIS DEVICE. SAVE THIS GUIDE FOR FUTURE REFERENCE.
  • Page 2 SYMBOLS The symbols that appear on the box and the Flyp™ nebulizer are described below: SYMBOL MEANING Caution +45ºC only DO NOT PLACE Consult instructions for use IN DISHWASHER -10ºC +45ºC only Keep dry DO NOT PLACE IN DISHWASHER DO NOT PLACE...
  • Page 3 Transient storage temperature limits -10˚C to 45˚C +45ºC only DO NOT PLACE (14˚F to 113˚F) IN DISHWASHER -10ºC Federal law (USA) restricts this device to sale only by or on the order of a physician or licensed DO NOT PLACE IN DISHWASHER practitioner.
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  • Page 5 Flyp™ nebulizer personal injury Before using your Flyp nebulizer for the first time, be aware of all warnings and safety information. Only use accessories approved by the manufacturer and referenced within this manual. If you do not fully understand all the warnings, safety precautions, and operating instructions, contact the Flyp customer service team at 844.FLYPNEB (359.7632) for...

  • Page 6: Table Of Contents

    Section 2: Safety Guidelines Safety Guidelines 10-15 Section 3: Product Description Features and Benefits 16-17 Section 4: Flyp™ at a Glance Names and Functions of Parts 18-20 Section 5: Using Flyp About Flyp’s Battery 21-23 Filling Medication Reservoir with Prescription...
  • Page 7 Section 6: Cleaning and Disinfecting Cleaning Parts 29-33 Disinfecting Parts 34-35 Section 7: Troubleshooting Troubleshooting 36-37 Section 8: Support Learning More Section 9: Information Technical Data Specifications 39-40 Aerosol Performance 41-42 Electromagnetic Compatibility 43-52 Disposal and Recycling Warranty Section 10: Replacement Parts and Accessories...

  • Page 8: Section 1: Introduction

    Flyp is intended for Guide’s contents. Flyp is intended use at home or a medical facility, for use by a single user. Flyp is not such as a hospital or doctor’s office. a life-saving device. Patients who are in severe respiratory distress,...
  • Page 9 Service life: are not breathing spontaneously should not use this device. The Flyp main unit has an expected service life of 36 months. In an emergency, call 911 *Note: The reservoir assembly immediately for medical (HypersonIQ™ Cartridge) should assistance. be replaced as needed, or every Caution: 3 months.

  • Page 10: Section 2: Safety Guidelines

    Direct exhaled medication away Failure to follow these instructions from others. could result in serious injury or If you are using Flyp to treat a damage to the device or other serious condition, a back-up property. Read all the safety...
  • Page 11 You should also be aware that Medical use: the USB Wall Charger presents a Flyp is intended solely to deliver potential choking hazard. prescribed medication to treat Cleaning: a respiratory condition. Using Flyp for any other purpose is...
  • Page 12 time and after each subsequent Battery: use (refer to pages 29-32). The battery is not replaceable. Don’t attempt to replace the The Main Unit should be cleaned battery yourself, as you may every day, but it should NEVER be damage it. Overheating and placed in water or washed in a injury could result.
  • Page 13 (EMC) standards. You should, not used or charged. Do not however, avoid operating it near store Flyp for long periods of time other electronic devices. without charging it periodically. If Flyp is not used or charged...
  • Page 14 Charger into the USB Port. heat and cold. Do not leave Check for obstructions in Flyp in a car if it will be subjected the USB Port. to significant heat or cold. •Do not expose the device to...
  • Page 15 53. positioned it correctly. Disposing of Flyp properly: If, after proper cleaning and charging, Flyp takes longer than 10 minutes to deliver either 1 unit-dose of medication or 3 mL of normal saline (0.9%), the HypersonIQ™ cartridge should...

  • Page 16: Section 3: Product Description

    Section 3: PRODUCT DESCRIPTION FEATURES AND BENEFITS Flyp is rechargeable with a USB Wall Charger, like a cell phone. There are no disposable Read this section to learn about batteries. Flyp’s features and benefits. Small and convenient: Flyp™ fits in your pocket.
  • Page 17 5 seconds to enter “clearing mode”. Fast and efficient: Operate the unit for 1-2 minutes or Flyp is designed to shut off until the reservoir is empty. automatically after 10 minutes to conserve battery life. After proper cleaning Flyp should...

  • Page 18: Section 4: Flyp™ At A Glance

    Section 4: FLYP™ AT A GLANCE NAMES AND FUNCTIONS OF PARTS Read this section to learn the names and functions of the parts. If any items are missing, contact the store where you purchased Flyp. You may also contact Flyp...
  • Page 20 DRAW-STRING BAG USB WALL CHARGER Note: the Draw-String Bag is not intended to protect Flyp™. It is provided for convenience only.

  • Page 21: Section 5: Using Flyp

    Charging Flyp’s battery: use Flyp correctly. You can charge Flyp’s battery About Flyp’s battery: by connecting Flyp™ to a wall Flyp is charged through a USB outlet using the USB Wall Charger port, just as many cellular phones provided. Only use the charger and portable electronic media provided.
  • Page 22 To charge the battery with a wall outlet: 1. Open the USB Cover to reveal the USB Port. 2. Gently insert the USB Wall Charger’s Cord into the USB Port. 3. Insert the USB Wall Charger into a wall outlet. Connection via wall outlet...
  • Page 23 Yellow light blinking (plugged-in) Battery is charging Solid yellow and blue light Flyp is in clearing mode Blinking yellow and blue light HypersonIQ cartridge is not properly attached or there is no medication in the reservoir. Flyp™ will turn off in 5 seconds...

  • Page 24: Filling Medication Reservoir With Prescription

    FILLING MEDICATION RESERVOIR 2. Insert the medication ampule WITH MEDICATION into the Medication Reservoir. There is no need to remove the Squeeze to Medication Reservoir to fill it with empty medication. contents and fill reservoir. STEP 1 STEP 2...
  • Page 25 3. Close the Reservoir. Be careful Note: the Medication Reservoir’s maximum capacity is 6mL. not to touch any part of the Stopper that may come in contact with your medication. Then close the Reservoir Cover. STEP 3...

  • Page 26: Turning Flyp On And Off

    Gently raise the Mouthpiece using your index finger, revealing the On-Off Button and On-Off Indicator Light. To turn Flyp™ on, press the On-Off Button. The blue On-Off Indicator Light will light. Visually confirm that an aerosol mist is flowing from the Mouthpiece’s end.
  • Page 27 MOUTHPIECE ON/OFF BUTTON & INDICATOR LIGHT...

  • Page 28: Inhaling Prescribed Medication

    INHALING PRESCRIBED MEDICATION MOUTHPIECE Place the Mouthpiece between your lips. Inhale and breathe in a calm manner at a normal rate.

  • Page 29: Section 6: Cleaning And Disinfecting

    Section 6: CLEANING & DISINFECTING CLEANING PARTS Read this section to learn how to clean Flyp™, both before its first use and after each subsequent use. ALWAYS disconnect and unplug the USB Wall Charger before cleaning or disinfecting...
  • Page 30 Cleaning the Mouthpiece and Medication Reservoir: Remove the Mouthpiece by pulling on it gently. To remove the Medication Reservoir, take hold on each side and lift up.
  • Page 31 Prepare a solution of warm water Prepare a solution of warm water and mild liquid dishwashing soap. and mild dishwashing soap. Then Wash the Mouthpiece in the soap clean the Main Unit by wiping it solution. Rinse the Mouthpiece with gauze lightly moistened by and Medication Reservoir under the soap solution.
  • Page 32 5. Allow the aerosol mist to flow from not followed, the disk may become the raised Mouthpiece for 1-2 minutes blocked – impacting performance. or until empty. Please see troubleshooting on page 6. Power Flyp off by pressing the 36 in case of a suspected blockage.
  • Page 33 (or raised Mouthpiece for 1-2 minutes or until more frequently as-needed) basis is empty. recommended. 7. Power Flyp off by pressing the power 1. Check the HypersonIQ cartridge to button. make sure it is empty. 8. Remove HypersonIQ cartridge and 2.

  • Page 34: Disinfecting Parts

    OPTIONAL DISINFECTION Read this section to learn how to disinfect Flyp. Although disinfection is optional, it is recommended that you do it at the end of every day.
  • Page 35 Flyp. dry towel moistened with ethyl Step 2. Soak the mouthpiece and alcohol. cartridge in 70% ethyl alcohol for Step 2. Allow Flyp to sit for 5 10 minutes. Make sure both are minutes. completely submerged in the alcohol.

  • Page 36: Section 7: Troubleshooting

    Section 7: TROUBLESHOOTING TROUBLESHOOTING If these corrective actions do not return Flyp™ to full working order, read the next section, Most problems with the device “Support.” can be solved by following this advice. The following table describes possible troubles, their causes, and what corrective action to take.
  • Page 37 TROUBLE POSSIBLE CAUSE CORRECTIVE ACTION Charge Flyp using a USB port. The battery is low. Refer to pages 22-23. An air bubble Tap the back of the Main nebulization has formed in the Unit with your index finger rate is medication’s pathway.

  • Page 38: Section 8: Support

    Section 8: SUPPORT You can find more information about using Flyp™ on our website. To learn about service and support, and to view tutorials, go to: www.flypnebulier.com NOTES:...

  • Page 39: Section 9: Information

    Section 9: INFORMATION TECHNICAL DATA SPECIFICATIONS Technical Specifications: Indications for use: Length: 119 mm The Flyp™ nebulizer, for use by Width: 54 mm adolescent and adult patients, is Depth: 27 mm intended to aerosolize healthcare Weight: 102 g provider-prescribed solutions...
  • Page 40 Adolescent to adult (+41°F to +104°F) Method of operation: Humidity: up to 95% RH Piezoelectric/Ultrasonic Storage conditions: Power source: Temperature range: -10°C to Lithium-ion battery (rechargeable) +45°C (14°F to +113°F) Weight: Humidity: up to 93% RH Flyp: 102 g (with battery)

  • Page 41: Aerosol Performance

    Aerosol Performance Albuterol Ipratropium Cromolyn sulfate bromide sodium MMAD (μ) 2.31 +/- 0.10 2.17 +/- 0.05 2.26 +/- 0.11 (geometric standard 1.60 +/- 0.07 1.48 +/- 0.03 1.54 +/- 0.06 deviation) Total delivered dose (μ) 1038.8 +/- 127.3 230.8 +/- 19.3 958.4 +/- 129.0 Total respirable dose (μ) 921.6 +/- 70.3...
  • Page 42 Aerosol Performance Albuterol Ipratropium Cromolyn sulfate bromide sodium Coarse particle dose (μ) 69.2 +/- 36.1 7.4 +/- 3.8 85.7 +/- 37.2 Fine particle dose (μ) 969.7 +/- 74.2 223.4 +/- 16.3 872.7 +/- 80.9 Extra fine particle dose (μ) 374.9 +/- 42.0 89.8 +/- 6.7 356.7 +/- 47.4 Coarse fraction (>4.7μ)

  • Page 43: Electromagnetic Compatibility

    ELECTROMAGNETIC Medical Electrical Equipment needs special precautions COMPATIBILITY regarding EMC and needs to be installed and put into With the increased number service according to the EMC of electronic devices, such information provided in this as computers and cellular User Guide. phones, medical devices in use may be susceptible to Portable and Mobile RF...
  • Page 44 parts for internal components, may result in increased emissions or decreased immunity of the equipment or system. The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it...
  • Page 45 Guidance and Manufacturer’s Declaration - Emissions The Flyp™ fn2000m is intended for use in the electromagnetic environment specified below. The customer or user of the Flyp fn2000m should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment – Guidance Radiated...
  • Page 46 Guidance and Manufacturer’s Declaration - Emissions The Flyp™ fn2000m is intended for use in the electromagnetic environment specified below. The customer or user of the Flyp fn2000m should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment – Guidance...
  • Page 47 Guidance and Manufacturer’s Declaration – Immunity The Flyp fn2000m is intended for use in the electromagnetic environment specified below. The customer or user of the Flyp fn2000m should ensure that it is used in such an environment. IEC 60601 Compliance...
  • Page 48 Guidance and Manufacturer’s Declaration – Immunity The Flyp™ fn2000m is intended for use in the electromagnetic environment specified below. The customer or user of the Flyp fn2000m should ensure that it is used in such an environment. IEC 60601 Compliance...
  • Page 49 IEC 60601 Compliance Electromagnetic Immunity Test Test Level Level Environment Guidance Power frequency Power magnetic fields Frequency should be at levels 50/60Hz 30 A/m 30 A/m characteristic of a Magnetic Field: typical location in a IEC61000-4-8 typical commercial or hospital environment.
  • Page 50 Guidance and Manufacturer’s Declaration – Immunity The Flyp™ fn2000m is intended for use in the electromagnetic environment specified below. The customer or user of the Flyp fn2000m should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level 3 Vrms 0.15-80 MHz...
  • Page 51 Electromagnetic Environment – Guidance Portable and mobile communications equipment should be separated from the Flyp fn2000m by no less than the distances calculated/listed below: D=(3.5/V1)(Sqrt P) where P is the max. power in watts and D is the recommended separation distance in meters.
  • Page 52 Recommended Separation Distances for the Flyp fn2000m The Flyp™ fn2000m is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the Flyp fn2000m can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the Flyp fn2000m as recommended below, according to the maximum output power of the communications equipment.

  • Page 53: Disposal And Recycling

    DISPOSAL & RECYCLING WARRANTY The Flyp main unit is warrantied for a period of thirty-six (36) months from Your Flyp must be disposed of the date of purchase against defects properly, according to local laws in manufacturing. All warranties and regulations. Because this...

  • Page 54: Section 10: Replacement Parts And Accessories

    Section 10: REPLACEMENT PARTS AND ACCESSORIES PART REORDER NUMBER Mouthpiece MP-1000 HypersonIQ Replacement Head hs2000m USB Wall Charger DC-1000 Mask Adapter MA-2000 Draw-String Bag AIR-4000 User Guide AIR-5000 Cleaning Kit CS-2000...
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  • Page 56 CONVEXITY SCIENTIFIC INC. 418 Meadow Street Fairfield, CT, 06824 (844) 359-7632 v2.8...

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