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Immunity Test

IEC 60601 Test Level

Compliance Level

Conducted RF:

IEC61000-4-4

Radiated RF:

IEC61000-4-3

3 Vrms 0.15-80 MHz

6 Vrms in ISM and

Amateur radio bands

10 V/m

80 MHz - 2.7 GHz

1 kHz @ 80% AM

3 Vrms 0.15-80 MHz

6 Vrms in ISM and

Amateur radio bands

10 V/m

80 MHz - 2.7 GHz

1 kHz @ 80% AM

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.

Содержание fn2000m

Страница 1: ...USER READ THIS GUIDE BEFORE OPERATING THIS DEVICE SAVE THIS GUIDE FOR FUTURE REFERENCE Pocket Portable Nebulizer User Guide Model fn2000m ...

Страница 2: ...he Flyp nebulizer are described below SYMBOL MEANING Caution Consult instructions for use Keep dry Do not place in dishwasher 45ºC only DO NOT PLACE IN DISHWASHER nly DO NOT PLACE IN DISHWASHER SYMBOLS 10ºC 45ºC only DO NOT PLACE IN DISHWASHER ...

Страница 3: ...f a physician or licensed practitioner Type BF applied part IP22 Protected against insertion of fingers and will not become damaged or unsafe during a test in which it is exposed to vertically dripping water when held at an angle Bluetooth enabled technology 10ºC 45ºC only DO NOT PLACE IN DISHWASHER C only DO NOT PLACE IN DISHWASHER ...

Страница 4: ...4 This page left blank intentionally ...

Страница 5: ...ulizer 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 technical support ALWAYS KEEP THIS USER GUIDE HANDY ...

Страница 6: ...delines 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 24 25 Turning Flyp ON and OFF 26 27 Inhaling Prescribed Medication 28 ...

Страница 7: ...ion 7 Troubleshooting Troubleshooting 36 37 Section 8 Support Learning More 38 Section 9 Information Technical Data 39 Specifications 39 40 Aerosol Performance 41 42 Electromagnetic Compatibility 43 52 Disposal and Recycling 53 Warranty 53 Section 10 Replacement Parts and Accessories 54 ...

Страница 8: ... or doctor s office Intended user Flyp nebulizer for use by adolescent and adult patients should only be used by a patient under the supervision of a qualified medical expert such as a doctor nurse or respiratory therapist The user or their actively assisting caregiver should be capable of understanding all of the User Guide s contents Flyp is intended for use by a single user Flyp is not a life s...

Страница 9: ...r licensed practitioner Precautions All warnings and cautions described in the User Guide should be observed Service life The Flyp main unit has an expected service life of 36 months Note The reservoir assembly HypersonIQ Cartridge should be replaced as needed or every 3 months Note Charge only with Flyp provided charger EC 60601 1 DO NOT Alter or modify this device The mouthpiece of this device i...

Страница 10: ...in serious injury or damage to the device or other property Read all the safety information below before using the device Medical device Flyp is a medical device available only by prescription and for prescribed medications Be sure to follow a qualified medical expert s instructions Direct exhaled medication away from others If you are using Flyp to treat a serious condition a back up device is re...

Страница 11: ...rpose is dangerous and neither the distributor manufacturer nor their affiliates can be held liable for any damage or injury caused by improper use or misuse Supervision required Adult supervision is required when the device is used by children and the infirm If someone swallows small pieces such as the Stopper consult a doctor immediately You should also be aware that the USB Wall Charger present...

Страница 12: ...er area immediately wipe it off with gauze Battery The battery is not replaceable Don t attempt to replace the battery yourself as you may damage it Overheating and injury could result The lithium ion battery should be replaced only by the manufacturer and it must be recycled or disposed of separately from household waste NEVER incinerate the battery Incineration may cause the battery to rupture I...

Страница 13: ...e Flyp only with the USB Wall Charger provided NEVER use the device when it is charging Battery life should exceed 500 charge cycles All batteries deteriorate over time if they are not used or charged Do not store Flyp for long periods of time without charging it periodically If Flyp is not used or charged for a long period of time the battery may create a hazardous condition Proper handling Flyp ...

Страница 14: ... the USB Port Check for obstructions in the USB Port If you re concerned about dirtying Flyp you can carry it in the Draw String Bag NEVER unscrew or open the Main Unit Do not disassemble repair or modify Flyp You may injure yourself or render the device ineffective Keep the device away from heated surfaces and extreme heat and cold Do not leave Flyp in a car if it will be subjected to significant...

Страница 15: ... 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 be cleaned or replaced Consult Troubleshooting on pages 36 37 to see if corrective steps can be taken For information about the proper disposal of Flyp including other important regulatory compliance information see Dispos...

Страница 16: ...ontrol unit compressor mask hose or cup And Flyp s convenient Draw String Bag makes it easy to carry with you Flyp is rechargeable with a USB Wall Charger like a cell phone There are no disposable batteries Simple Flyp is designed for easy operation and delivers all medications approved for use with general purpose nebulizers Section 3 PRODUCT DESCRIPTION ...

Страница 17: ...0 minutes to conserve battery life After proper cleaning Flyp should not take longer than 10 minutes to deliver 3 mL of normal saline 0 9 Self clearing function To active this mode press and hold power button for 5 seconds to enter clearing mode Operate the unit for 1 2 minutes or until the reservoir is empty ...

Страница 18: ...TS 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 nebulizer customer service at 1 844 FLYPNEB Section 4 FLYP AT A GLANCE ...

Страница 19: ...19 ...

Страница 20: ...20 USB WALL CHARGER DRAW STRING BAG Note the Draw String Bag is not intended to protect Flyp It is provided for convenience only ...

Страница 21: ...media devices are charged Flyp has an internal battery that you cannot replace If your battery must be replaced Section 5 Using Flyp contact Flyp nebulizer customer service at 1 844 FLYPNEB Charging Flyp s battery You can charge Flyp s battery by connecting Flyp to a wall outlet using the USB Wall Charger provided Only use the charger provided NEVER use the device while it is charging ...

Страница 22: ...n via wall outlet 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 ...

Страница 23: ...s fully charged 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 Note the indicator lights are hemispheric Left is yellow right is blue ...

Страница 24: ...RESERVOIR WITH MEDICATION There is no need to remove the Medication Reservoir to fill it with medication STEP 1 2 Insert the medication ampule into the Medication Reservoir STEP 2 Squeeze to empty contents and fill reservoir ...

Страница 25: ...Close the Reservoir Be careful not to touch any part of the Stopper that may come in contact with your medication Then close the Reservoir Cover Note the Medication Reservoir s maximum capacity is 6mL STEP 3 ...

Страница 26: ...cator 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 To turn Flyp off press the On Off Button again The blue On Off Indicator Light will no longer be lit Flyp will automatically turn off after 10 minutes ...

Страница 27: ...27 MOUTHPIECE ON OFF BUTTON INDICATOR LIGHT ...

Страница 28: ...28 INHALING PRESCRIBED MEDICATION Place the Mouthpiece between your lips Inhale and breathe in a calm manner at a normal rate MOUTHPIECE ...

Страница 29: ...EANING 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 ...

Страница 30: ...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 ...

Страница 31: ...nder running water The lithium ion battery inside the Main Unit may be dangerous when wet DEEP CLEANING Prepare a solution of warm water and mild liquid dishwashing soap Wash the Mouthpiece in the soap solution Rinse the Mouthpiece and Medication Reservoir under running tap water These are the only parts that can be submerged in water Shake off excess water and dry on clean dry towel NEVER rinse t...

Страница 32: ... to flow from the raised Mouthpiece for 1 2 minutes or until empty 6 Power Flyp off by pressing the power button 7 Remove HypsersonIQ cartridge and shake out excess water 8 Let the main unit cartridge and mouthpiece dry on a clean dry towel 9 Allow the interior to dry fully prior to using again It is important to clean the HypersonIQ disk after each use in order to prevent the buildup of residual ...

Страница 33: ... vinegar or Flyp cleaning solution Close the stopper 4 Gently raise the Mouthpiece with your index finger 5 Press and hold the power button for 5 seconds Flyp will enter a cleaning mode indicated by Blue AND yellow lights Flyp will produce a pulsing aerosol 6 Allow the aerosol mist to flow from the raised Mouthpiece for 1 2 minutes or until empty 7 Power Flyp off by pressing the power button 8 Rem...

Страница 34: ...34 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 ...

Страница 35: ... alcohol Step 3 Remove mouthpiece and cartridge from the alcohol bath and rinse under running water Step 4 Let dry on a clean dry towel DISINFECTING THE MAIN UNIT S EXTERIOR Step 1 Wipe exterior with clean dry towel moistened with ethyl alcohol Step 2 Allow Flyp to sit for 5 minutes Step 3 Moisten with a clean dry towel with water and wipe exterior to remove the ethyl alcohol Step 4 Let dry on a c...

Страница 36: ...be solved by following this advice The following table describes possible troubles their causes and what corrective action to take Section 7 TROUBLESHOOTING If these corrective actions do not return Flyp to full working order read the next section Support ...

Страница 37: ...until normal flow resumes The Nebulizer Disk has become clogged with medication See deep cleaning instructions Refer to page 33 The On Off Indicator Light is on but there is no mist The Medication Reservoir is not correctly inserted Remove the Medication Reservoir and install it correctly The Medication Reservoir is not filled Fill with medication Refer to pages 24 25 Check that Flyp has been prop...

Страница 38: ...38 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 Section 8 SUPPORT ...

Страница 39: ... SPECIFICATIONS Indications for use The Flyp nebulizer for use by adolescent and adult patients is intended to aerosolize healthcare provider prescribed solutions for inhalation that are approved for use with a general purpose nebulizer Flyp is intended for use at home or a medical facility such as a hospital or doctor s office ...

Страница 40: ... of operation Piezoelectric Ultrasonic Power source Lithium ion battery rechargeable Weight Flyp 102 g with battery Dimensions 27 x 119 x 54 mm Main Unit Sound level 35 dBA at 1 meter Operating conditions Temperature range 5 C to 40 C 41 F to 104 F Humidity up to 95 RH Storage conditions Temperature range 10 C to 45 C 14 F to 113 F Humidity up to 93 RH ...

Страница 41: ... 07 1 48 0 03 1 54 0 06 Total delivered dose μ 1038 8 127 3 230 8 19 3 958 4 129 0 Total respirable dose μ 921 6 70 3 209 4 14 9 857 7 84 4 Respirable fraction mass 0 4 4 7μ 87 8 90 3 88 1 Aerosol Performance All data shown at a 95 confidence level Medications were tested 3 times each on 3 devices for a total of 27 sample data points ...

Страница 42: ...4 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 6 7 3 1 8 9 Fine fraction 4 7μ 92 4 96 3 89 7 Extra fine fraction 1 0μ 35 7 38 7 36 6 All data shown at a 95 confidence level Medications were tested 3 times each on 3 devices for a total of 27 sample data points Aerosol Performance ...

Страница 43: ... other than those specified with the exception of those sold by the manufacturer as replacement ELECTROMAGNETIC COMPATIBILITY With the increased number of electronic devices such as computers and cellular phones medical devices in use may be susceptible to electromagnetic interference This interference may result in incorrect operation of the medical device and create a potentially unsafe situatio...

Страница 44: ...unity 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 will be used ...

Страница 45: ...ified 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 Emissions CISPR 11 Class B Conducted Emissions CISPR 11 Class B EMC Tables The following tables are provided in accordance with IEC 60601 1 2 2014 ed 4 0 ...

Страница 46: ...ge power supply network that supplies buildings used for domestic purposes Flicker IEC61000 3 3 Not Applicable 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 EMC Tables The following tables are provided in accordanc...

Страница 47: ...1000 4 2 8kV Contact 2KV 4kV 8kV 15kV Air 8kV Contact 2KV 4kV 8kV 15kV Air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be 30 EFT IEC61000 4 4 0 5 KV L1 and L2 1 KV L1 and L2 0 5 KV L1 and L2 1 KV L1 and L2 Mains power quality should be that of a typical commercial or hospital environment Surges IEC61000 4 5 0 5 KV L1 and...

Страница 48: ...50 Hz Single phase at 0 0 UT 250 300 cycle for 50 Hz and 60 Hz Mains power quality should be that of a typical commercial or hospital environment If the user of the Flyp fn2000m requires continued charging during mains power interruptions it is recommended that the Flyp fn2000m be powered from an uninterruptible power supply or battery Guidance and Manufacturer s Declaration Immunity The Flyp fn20...

Страница 49: ...ce Level Electromagnetic Environment Guidance Power Frequency 50 60Hz Magnetic Field IEC61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment ...

Страница 50: ...ands 10 V m 80 MHz 2 7 GHz 1 kHz 80 AM 3 Vrms 0 15 80 MHz 6 Vrms in ISM and Amateur radio bands 10 V m 80 MHz 2 7 GHz 1 kHz 80 AM 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 ...

Страница 51: ...Sqrt P 150kHz to 80 MHz D 3 5 E1 Sqrt P 80 to 800 MHz D 7 E1 Sqrt P 800 MHz to 2 5 GHz where P is the max power in watts and D is the recommended separation distance in meters Field strengths from fixed transmitters as determined by an electromagnetic site survey should be less than the compliance levels V1 and E1 Interference may occur in the vicinity of equipment containing a transmitter ...

Страница 52: ...um 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 Max Output Power Watts Separation m 150kHz to 80MHz D 3 5 V1 Sqrt P Separation m 80 to 800MHz D 3 5 E1 Sqrt P Separation m 800MHz to 2 5GHz D 7 E1 Sqrt P 0 01 0 116667 0 116667 0 233333 0 1 0 368932 0 368932 0 737865 1 1...

Страница 53: ...n about recycling options WARRANTY The Flyp main unit is warrantied for a period of thirty six 36 months from the date of purchase against defects in manufacturing All warranties are based on typical usage and following care instructions We will at our option repair or replace without charge your device Repair or replacement is our only responsibility and your only remedy under the warranty Hypers...

Страница 54: ...PLACEMENT PARTS AND ACCESSORIES PART REORDER NUMBER Mouthpiece HypersonIQ Replacement Head USB Wall Charger Mask Adapter Draw String Bag User Guide Cleaning Kit MP 1000 hs2000m DC 1000 MA 2000 AIR 4000 AIR 5000 CS 2000 ...

Страница 55: ...This page left blank intentionally ...

Страница 56: ...CONVEXITY SCIENTIFIC INC 418 Meadow Street Fairfield CT 06824 844 359 7632 v2 8 ...

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