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Guidance and Manufacturer’s Declaration - Emissions
The FLYP™ pe1200m is intended for use in the electromagnetic 

environment specified below. The customer or user of the  

FLYP pe1200m 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. 

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  

will be used.

Содержание pe1200m

Страница 1: ...USER READ THIS GUIDE BEFORE OPERATING THIS DEVICE SAVE THIS GUIDE FOR FUTURE REFERENCE Portable Vibrating Mesh Nebulizer User Guide Model pe1200m ...

Страница 2: ...device to sale by or on the order of 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 45ºC only DO NOT PLACE IN DISHWASHER nly DO NOT PLACE IN DISHWASHER 10ºC 45ºC only DO NOT PLACE IN DISHWASHER 10ºC 45ºC only DO NOT PLA...

Страница 3: ... first time please read this User Guide and clean the parts Be aware of all warnings and safety information Only use accessories approved by Convexity and referenced within this manual If you do not fully understand all the warnings safety precautions and operating instructions contact Convexity for technical support ALWAYS KEEP THIS USER GUIDE HANDY This page left blank intentionally ...

Страница 4: ...ng Medication Reservoir with Prescription 24 26 Turning FLYP ON and OFF 26 27 Inhaling Prescribed Medication 28 Section 6 Cleaning and Disinfecting Cleaning Parts 29 32 Disinfecting Parts 33 35 Section 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 ...

Страница 5: ...ctor 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 saving device Patients who are in severe respiratory distress who are unconscious or who are not breathing spontaneously should not use this device In an emergency call 911 immediately for...

Страница 6: ...eatening situation NEVER rely on a nebulizer Call 911 immediately for emergency medical assistance Use by others For single patient use only If others use it infection may spread Medical use FLYP is intended solely to deliver prescribed medication to treat a respiratory condition Using FLYP for any other purpose is dangerous and neither the distributor manufacturer nor their affiliates can be held...

Страница 7: ...hen fire and even an explosion could result NEVER immerse the battery in water as this may cause the battery to rupture Electronic device FLYP complies with all applicable electromagnetic compatibility EMC standards You should however avoid operating it near other electronic devices If you are not going to use the unit for a long period of time disconnect the USB Wall Charger Charging FLYP contain...

Страница 8: ...evice 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 heat or cold If the USB Wall Charger and USB Port don t join with reasonable ease they probably don t match Make sure that you are using the USB Wall Charger provided and that you have positioned it correctly Disposing of FLYP properly If after pro...

Страница 9: ...he battery can power an entire day s medical needs which should not exceed 3 treatments Simple FLYP is designed for easy operation and delivers all medications approved for use with general purpose nebulizers Silent FLYP operates almost silently so it will not disturb children Fast and efficient FLYP delivers 1 unit dose in approximately 7 minutes It is designed to shut off automatically after 10 ...

Страница 10: ...s of the parts If any items are missing contact the store where you purchased FLYP You may also contact Convexity Section 4 FLYP AT A GLANCE RESERVOIR COVER LATCH MEDICATION RESERVOIR STOPPER USB COVER USB PORT BEHIND COVER MOUTHPIECE ON OFF BUTTON ON OFF INDICATOR LIGHT NEBULIZER DISK ...

Страница 11: ...ular phones and portable electronic media devices are charged FLYP has an internal battery that you cannot replace If your battery must be replaced Section 5 USING FLYP contact Convexity Scientific at P O Box 297 Westport CT 06880 203 557 6254 For best results use FLYP fully charged Daily users should charge the device fully between uses Do not allow the battery to remain unused or uncharged for a...

Страница 12: ...USB Wall Charger i nto a wall outlet Understanding battery states When FLYP isn t connected to a power source the On Off Indicator Light has three possible states When FLYP is connected to a power source the On Off Indicator Light has two possible states Light Signal Status No Light Go Neb is Off Blue Light Go Neb is On Blue Light Blinking Battery is Low Light Signal Status Yellow Light Blinking B...

Страница 13: ...ESERVOIR COVER STEP 2 3 Carefully insert your medication ampule fully into the Medication Reservoir Then squeeze the entire contents in being careful not to spill any 4 Once the medication is in the Medication Reservoir reinsert the Stopper using your fingers Be careful not to touch any part of the Stopper that may come in contact with your medication Then close the Reservoir Cover STOPPER AMPULE ...

Страница 14: ...hpiece 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 than 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 MOUTH...

Страница 15: ...rvoir Cover 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 Cleaning the Mouthpiece and Medication Reservoir Remove the Mouthpiece by tugging on it gently To remove the Medication Reservoir STEP 1 LATCH MEDICATION RESERVOIR RESERVOIR COVER ...

Страница 16: ...piece and storing it NEVER place the Main Unit or USB Wall Charger in water or hold them under running water The lithium ion battery inside the Main Unit may be dangerous when wet Prepare a solution of warm water and mild liquid dishwashing soap Wash the Mouthpiece and Medication Reservoir in the soap solution Rinse the Mouthpiece and Medication Reservoir under running tap water These are the only...

Страница 17: ...ation from drying there If these steps are not followed the 4 5 micron holes on the Nebulizer Disk may become clogged and it may not perform properly DISINFECTING PARTS 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 Disinfecting the Mouthpiece and Medication Reservoir 1 Remove the Mouthpiece and Medication...

Страница 18: ...ce for 10 minutes 7 Unplug the Stopper and remove the Medication Reservoir 8 Shake excess distilled water from the Medication Reservoir 9 Let the Medication Reservoir dry on a clean dry towel 10 Let the Main Unit dry on a clean dry towel 11 Allow the Main Unit to dry fully before using it again Disinfecting the Main Unit s exterior Before disinfecting the Main Unit s exterior make sure the USB Cov...

Страница 19: ...sing a USB port Refer to pages 22 23 An air bubble has formed in the medication s pathway Tap the back of the Main Unit with your index finger until normal flow resumes The Nebulizer Disk has become clogged with medication Nebulize distilled water for 1 minute Refer to pages 29 32 The On Off Indicator Light is on but there is no mist The Medication Reservoir is not correctly inserted Remove the Me...

Страница 20: ...s Length 119 mm Width 54 mm Depth 27 mm Weight 102 g with battery Section 9 INFORMATION LENGTH WIDTH DEPTH 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 su...

Страница 21: ... 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 Albuterol sulfate Ipratropium bromide Cromolyn sodium MMAD μ 2 31 0 10 2 17 0 05 2 26 0 11 GSD geometric standard deviation 1 60 0 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 Respira...

Страница 22: ...ds to be installed and put into service according to the EMC information provided in this User Guide Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment The use of accessories transducers and or cables other than those specified with the exception of those sold by the manufacturer as replacement ELECTROMAGNETIC COMPATIBILITY With the increased number of electron...

Страница 23: ...ssions 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 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 ...

Страница 24: ...al commercial or hospital environment Surges IEC61000 4 5 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 Emissions Test Compliance Electromagnetic Environment Guidance Harmonics IEC61000 3 2 Not Applicable The FLYP pe1200m is suitable for use in all establishments including domestic and those direct...

Страница 25: ... 50 Hz Single phase at 0 0 UT 250 300 cycle for 50 Hz and 60 Hz 0 UT 0 5 cycle at 0 45 90 135 180 225 270 and 315 0 UT 1 cycle 70 UT 25 cycles for 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 pe1200m requires continued charging during mains power interruptions it is recommen...

Страница 26: ...lated listed below Guidance and Manufacturer s Declaration Immunity The FLYP pel200m is intended for use in the electromagnetic environment specified below The customer or user of the FLYP pel200m should ensure that it is used in such an environment D 3 5 V1 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 recomme...

Страница 27: ...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 166667 1 166667 2 333333 10 3 689324 3 689324 7 378648 100 11 66667 11 66667 23 33333 DISPOSAL RECYCLING Your FLYP must be disposed of properly according to local laws and regulations Because this product contains a battery the pro...

Страница 28: ...10 REPLACEMENT PARTS AND ACCESSORIES PART REORDER NUMBER Mouthpiece Medication Reservoir USB Wall Charger Draw String Bag User Guide AIR 1000 AIR 2000 AIR 3000 AIR 4000 AIR 5000 This page left blank intentionally ...

Страница 29: ...CONVEXITY SCIENTIFIC INC P O Box 297 Westport CT 06880 203 557 6254 v35 ...

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