System Instructions for Use.
Contents
1. i bralung Vibralung Acoustical Percussor Instructions for Use Yioratons Toons Mee me OO Indications for Use The Vibralung Acoustical Percussor is indicated as an airway secretion clearance device that creates vibrations in the airways and as a lung expansion device that applies Positive Expiratory Pressure PEP as a patient breathes through the device It may be used to promote bronchial drainage airway clearance and expectoration and to prevent or reverse atelectasis The Vibralung may be used simultaneously with aerosol drug delivery Patient Population Cystic Fibrosis COPD asthma and lung diseases with secretory problems patients with neuromuscular disease affecting the ability to effectively cough and patients with or at risk of developing atelectasis Anyone who is able to read and or follow verbal instructions Environment of Use Hospital and home Contraindications ACT or use of the Vibralung Acoustical Percussor especially with Positive Expiratory Pressure may be contraindicated in patients who have untreated air leaks tension pneumothorax bronchopleural fistula recent hemoptysis or pulmonary hemorrhage as it may exacerbate those conditions Prescribers should weigh the benefits against the risks in patients with these conditions Adverse Reactions If the patient complains of dry throat or mouth brought about by treatment with the Vibralung consider adding nebulization with normal saline2. Surge 1 kV line s to lines s Mains power quality should be that of a 1 kV line s to typical commercial or hospital environment IEC 61000 4 5 lines s 2 kV line s to earth 2 kV line s to earth Voltage dips short lt 5 U Mains power quality should be that of a interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz Magnetic field gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 cycles lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt S U gt 95 dip in Uz7 for 5 cycles Page 12 typical commercial or hospital environment If the user of the Vibralung Acoustical Percussor requires continued operation during power mains interruption it is recommended that the Vibralung Acoustical Percussor be powered from an uninterruptible power supply or a battery Note By design the Vibralung Acoustical Percussor cannot be powered by mains as it is powered by internal batteries and cannot be operated when the battery charger is connected Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment PARTS AND ACCESSORIES Pee DESCRIPTION PART NUMBER Vibralung Treatment Co
3. an exhalation filter is included in the exhalation pathway of the Circulaire II Hybrid to prevent medications and patient droplets from being emitted into the room and possibly inhaled by caregivers or other patients WARNING Do not connect or interface the Vibralung Acoustical Percussor to any airway clearance device or aerosol delivery system other than the Westmed Circulaire II or Circulaire Il Hybrid 3 aerosol drug delivery system and or Westmed Variable Expiratory Resistor for Positive Expiratory Pressure PEP because other devices have not been designed or ascertained to function properly with the inspiratory and exhalation gas flow pathways of the Vibralung Page TROUBLESHOOTING Patient develops difficulty breathing or other medical problem while using the device TCU does not power on Batteries not holding a charge after being recharged TCU unexpectedly shuts down in the middle of a treatment TCU powers on but does not respond or responds incorrectly to button selections TCU powers on and works as intended but fails to illuminate appropriate LED indicator s Patient complains of discomfort or interference with dental work or natural teeth during treatment with Vibralung Acoustical Percussor Patient has difficulty holding the HHT or holding it in the proper position REAT SOLUTION S Pause or discontinue the treatment and then teach and coach the patient on proper and effective cough t
4. patient may be instructed to perform an extended PEP maneuver by taking a deep breath and then exhaling slowly while maintaining an expiratory flowrate sufficient to keep the PEP manometer in the 10 to 20 cmH2O pressure range for 3 to 5 seconds This maneuver can be repeated 10 to 20 times or as often as desired for the patient Page 6 TREATMENT SETTINGS eoan A selected treatment setting with the Vibralung Acoustical Percussor takes up to 10 minutes depending upon the setting that has been selected and provided the session has not been paused at any time Five settings representing a designated sequence of frequency ranges have been programmed into the Treatment Control Unit as shown in the following table DESCRIPTION 1 minute Random Noise 7 minutes Low Frequency Tones 2 minutes Random Noise 10 minutes total M Medium 1 minute Random Noise 7 minutes Medium Frequency 5 600 Hz Tones 2 minutes Random Noise 10 minutes total H High 1 minute Random Noise 7 minutes High Frequency Tones 5 1 200 Hz 2 minutes Random Noise 10 minutes total Sn 2 minutes of Random Noise pam 5 minutes of Random Noise A treatment session may consist of the application of one or more settings depending upon the target area s of the lungs to which therapy should be directed patient preference and patient response to therapy In theory lower frequency tones are effective on larger wider airways while higher frequency tones are
5. separate altogether Case components of the HHT become loose or separate altogether Interface cable between the TCU and HHT becomes damaged from the HHT or the mini plug becomes damaged Patient or caregiver unable to assemble parts i e parts do not seem to fit together or mate properly Variable Expiratory Resistor for PEP and or Circulaire Il Hybrid for aerosol therapy do not seem to fit properly Unable to attach non Westmed nebulizer or PEP device to the Vibralung Acoustical Percussor CARE CLEANING AND DISPOSAL EIR iG SOLUTION S Discontinue use immediately and contact Westmed Customer Service Retighten screws if all are present If some screws are missing contact Westmed Customer Service Discard faulty disposable unit and replace with a new HHT Discard faulty HHT and replace with a new HHT Refer to Instruction Manual to confirm proper parts Inspect parts for physical damage or deformation e g out of round rough edges Replace parts that have been damaged Refer to Instruction Manual to confirm proper Y adapter and orientation Inspect parts for physical damage or deformation e g out of round rough edges Replace parts that have been damaged Use only the Westmed Circulaire II or Circulaire II Hybrid for aerosol therapy and Westmed Variable Expiratory Resistor for PEP The TCU should undergo surface disinfection on a daily basis to minimize surface contamination Clean all
6. OR OPERATION READ THE FOLLOWING WARNINGS BEFORE ASSEMBLING OR OPERATING DEVICE e Federal law restricts this device to sale by or on the order of a physician e Read this Instructions for Use manual before use e Unskilled or untrained personnel should not operate or apply this device to patients e Use only as intended and described in this manual and supporting documentation e Use only on cooperative patients who can properly self administer following training e Use only with the supplied mouthpiece and accessory adapters e Be prepared to help patient with removal of secretions cough coaching suction as needed e The HHT Cone and related Y adapters are for single patient use multiple treatment sessions during single hospitalization and should be changed as directed Do not hold Hand Held Transducer up to your ear Hearing damage may result Foam ear plugs are provided to lessen the sound to which your ears are exposed Wear the ear plugs during each treatment e Do not connect or interface the Vibralung Acoustical Percussor to any airway clearance device or aerosol delivery system other than the Westmed Circulaire II or Circulaire II Hybrid aerosol drug delivery system and Westmed Variable Expiratory Resistor for Positive Expiratory Pressure PEP because other devices have not been designed or ascertained to function properly with the inspiratory and exhalation gas flow pathways of the Vibralung CAUTIONS e Do not open or at
7. emissions EMCI Report ETRB30430 IEC 61000 3 3 RF Emissions The Vibralung Acoustical Percussor is not suitable for interconnection with other equipment CISPR 14 1 RF Emissions NOTE 1 At 80 mHz and 800 mHz the separation distance for the higher frequency range applies The Vibralung Acoustical Percussor is not suitable for i NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by interconnection with other equipment absorption and reflection from structures objects and people CISPR 15 N A Not Applicable Manufacturer s Declaration Electromagnetic Immunity The Vibralung Acoustical Percussor is intended for use in the electromagnetic environment specified below The customer or user of the Vibralung Acoustical Percussor should assure that it is used in such an environment IEC 60601 l i lectromagn Immunity Test Compliance Level E etic Environment Guidance Electrostatic 6 kV contact Floors should be wood concrete or ceramic discharge ESD tile If floors are covered with synthetic material the relative humidity should be at least 30 6 kV contact 8kV air 1EC61000 4 2 8kV air Electrical fast transient burst 2 kV for power supply lines Mains power quality should be that ofa 2 kV for power typical commercial or hospital environment supply lines IEC 61000 4 4 1 kV for input output lines put P 1 kV for input output lines
8. external surfaces of the TCU with a pre moistened germicidal wipe product such as Clorox Disinfecting Wipes Be sure to allow the appropriate contact time as specified by the product s instructions Ensure that moisture does not enter the case of the TCU at the seams or at the two electrical jacks The control buttons on the faceplate are sealed against moisture entry The HHT should undergo cleaning and disinfection on a daily basis to remove possible accumulation of secretions and to minimize surface contamination To clean the HHT first remove the Y adapter mouthpiece variable expiratory resistor and screw on cone Wash these parts with soap and warm water rinse with sterile water then disinfect by soaking in a solution of 1 part household bleach and 50 parts water for 3 minutes Spread all parts on a clean paper towel to air dry Also remove the Circulaire if present and clean it according to its instructions Do not immerse the handle or speaker part of the HHT in any liquid Clean the outside surface of the HHT and the transducer diaphragm with a pre moistened germicidal wipe product such as Clorox Disinfecting Wipes Allow the appropriate contact time as specified by the product s instructions Allow to dry before reassembling and using The disposable HHT and all associated plastic parts may be discarded into the usual waste stream in accord with local regulations The TCU contains a lithium ion battery pack which in most states can
9. Hand held Transducer HHT and the bottom jack is for connecting the Battery Charger Seven user selectable buttons contain LEDs that illuminate when pressed The buttons also make a clicking feeling to provide tactile feedback when they are pressed These buttons enable the user to select from 5 control settings as shown in the legend below as well as a Start Pause function and Power On Off Additionally two LED indicators Charging and Low Battery illuminate as needed to show the status of the internal battery Note The TCU will not operate while the Battery Charger is plugged into it Button Label Action Control button to select Low frequency setting 5 200 Hz Control button to select Medium frequency setting 5 600 Hz Control button to select High frequency setting 5 1 200 Hz Sas Control buttons to select either a 2 or 5 minute period of Random Noise ajaja Control button to Start Pause or Resume a treatment session L4 Pause Control button to turn the TCU on or off C Power Page 5 OPERATING INSTRUCTIONS Peni Refer to physician s prescription or caregivers instructions for appropriate settings for the Vibralung Acoustical Percussor Regardless of which Y adapter is used operation of the Vibralung Acoustic Percussor is the same The patient should hold the device in one or both hands while inserting the mouthpiece into the mouth and breathing nor
10. airing the Vibralung Acoustical Percussor TCU replacing its internal batteries or replacing the entire TCU e To initiate a service request please contact the Westmed Customer Service Department and request a Returned Goods Authorization RGA Number prior to returning the device s for service e Place the RGA Number on the outside of the shipping package when returning goods to Westmed e Any device received by Westmed without an RGA Number will be returned to sender e When packaging for return please perform disinfection on the TCU according to the Care and Cleaning Instructions on page 9 then place it in a plastic bag and surround with packaging peanuts bubble wrap or crushed paper for additional protection Westmed Inc Customer Service 5580 South Nogales Highway Tucson AZ 85706 3333 800 975 7987 Page 13 Safety and Informational Symbols The manufacturer is Westmed Inc WARNING Failure to abide by the WARNING information may result in serious injury and can be life threatening Direct Current A device described herein operates on direct current electrical power Storage and transport temperature range 25 C to 70 C Class Il Equipment according to IEC 61140 For further information scan this QR code with your smart phone or tablet for the comprehensive Online User Manual or browse to www westmedinc com VL_Manual E E EE E E FEV WVUY When Your Care Is Critical Westme This document contai
11. be disposed of via normal waste management procedures If in doubt please check your local regulations Westmed recommends cleaning and disinfection at the end of each treatment day Page 9 TECHNICAL SPECIFICATIONS Vibralung Device Name Design Type Electro acoustic Configuration 2 piece Treatment Control Unit Hand held Transducer FDA Classification Type Il Percussor Powered Electric Vibralung Acoustical Percussor FDA Classification IEC Classification IEC Compliance a TREATMENT CONTROL UNIT TCU Part Number 9500 x5 x 1 inches 10 8 x 13 3 x 3 2 cm HWD Intended Usage Period Minimum Lifespan Battery Type amp Cell Quantity 3 6 VDC Li ion 3 cells Battery Charger Transformer Class Il UL Listed 120 VAC 60 Hz Input 15 VDC 1 6A 24A Output Manufacturer Sceptre Power P N PXX1516AWPLOS Battery Lifespan Battery Charge Capacity Transformer AC Plug Type 2 conductor Transducer Output Jack Pole mounting slide supplied attached to rear of TCU One pole mounting bracket supplied with each TCU Atmospheric Pressure Temperature Storage amp Transport 13 F to 158 F 25 C to 70 C Temperature Conditions for Use Humidity Storage amp Transport Humidity Conditions for Use Explosive Atmosphere Use Outdoor Wet Area Use Not intended EMI RF Susceptibility EMI RF Emissions Low non existent complies with IEC 60601 1 2 Proprietary in EPROM Signal Generator Low Fre
12. echniques Assist patient where possible Suction patient if indicated Pause or discontinue the treatment and then assess the patient if the battery charger is plugged in to the TCU disconnect it The TCU will not function when the battery charger is connected to it Connect the HHT to the TCU Ifthe problem persists contact Westmed Customer Service Always use the charger supplied with the Vibralung Acoustic Percussor The batteries in the TCU will hold their charge for 500 charge recharge cycles If the TCU has not been in use long enough to have been charged about 500 times contact Westmed Customer Service Charge the TCU s internal battery Restart the TCU If the problem persists contact Westmed Customer Service Restart the TCU and insure that the HHT is connected to it if the problem persists contact Westmed Customer Service Restart the TCU lf the problem persists contact Westmed Customer Service Consider removing dental work during treatment with the Vibralung Encourage patient to not clamp down on plastic mouthpiece with teeth The HHT is ergonomically designed to be easily held without fatigue by most patients for periods of up to 10 minutes Patient must not be lying recumbent Reposition patient to at least a 30 head up position continued next page Page 8 TROUBLESHOOTING PROBLEM TCU becomes very hot to the touch Case components of the TCU case become loose or
13. effective on smaller thinner airways Therapeutic benefit s may not necessarily be rendered on the first treatment or even the first few treatments It may require an indeterminate number of treatment sessions 2 to 4 times daily before benefits become apparent SIMULTANEOUS AEROSOL THERAPY The Circulaire II Hybrid aerosol delivery system may be used with the Vibralung Acoustical Percussor if wetting agents or inhalation medications are prescribed The Circulaire II Hybrid is the only nebulizer system approved for use with the Vibralung Acoustical Percussor The Vibralung includes an Aerosol Y adapter that allows connecting the Circulaire II Hybrid to the HHT as shown in the bottom figure on page 4 The Circulaire II Hybrid when attached to the Vibralung Acoustical Percussor with the Aerosol Y adapter provides a direct pathway for inhalation and exhalation The Aerosol Y adapter provides a direct pathway for the sound waves to travel through to enter the mouth and the lung In this manner the acoustical energy remains coupled to the patient s lungs during inhalation and exhalation while the aerosol treatment is taking place Further PEP therapy can also be administered by way of the Circulaire II Hybrid which has a Variable Expiratory Resistor on the exhalation port Finally because many of the patients who may benefit from airway clearance therapy and aerosol therapy with the Vibralung Acoustical Percussor also have pulmonary infections
14. es One box holds the reusable Treatment Control Unit A Pole mount Bracket B and Battery Charger C The other box holds the disposable Hand held Transducer assembly D plus Standard Y adapter mouthpiece and Variable Expiratory Resistor E plus an Aerosol Y adapter F that can be used for aerosol delivery You should have all the following parts images not to scale Screw on Cone Treatment Control Pole mount Bracket Unit TCU pole not included Battery Charger Mouthpiece Variable Expiratory Resistor for 8 A ato Valve purple cap Hand held Transducer HHT A cable not shown emerges from the bottom of the handle for connecting the HHT to the TCU Standard Y adapter Aerosol Y adapter PREPARING THE TCU FOR FIRST USE Follow these steps to charge test and set up the Treatment Control Unit TCU for the first time 1 Remove the TCU A Pole mount Bracket B and Battery Charger C from their shipping box 2 Mount the TCU on any pole between and 1 inch in diameter using the supplied Pole mount Bracket as shown in the figure above Alternately simply set the TCU on a flat surface 3 Plug the Battery Charger into a standard 120 volt electrical outlet and plug the end of the battery charger cable into the bottom jack on the left side of the TCU The Battery Charger plug will not fit in the top jack on the left side of the TCU All 9 Light Emitting Diodes LEDs should flash 3 times quickly and then the C
15. harging and Power LEDs should stay on during the charging process 4 Leave the Battery Charger plugged in and connected to the TCU until the TCU s internal batteries are fully charged which should take no more than 4 hours The Charging LED will go out and the Power LED will flash when the unit is fully charged 5 Disconnect the Battery Charger after batteries are charged as the TCU will not operate while the charger is connected 6 After charging is completed and the charger is disconnected from the TCU perform a Power On Self Test POST to verify that the TCU software and processor is operating properly Turn the TCU on by pressing the Power control button once The POST will occur immediately as shown by all 9 LEDs flashing 3 times If the TCU passes the POST the Pause and Power LEDs will remain illuminated If other LEDs are illuminated or if no LEDs are illuminated the TCU failed the POST and should not be used Contact Westmed Customer Service see page 10 7 The Treatment Control Unit TCU is now ready for use Repeat these steps every time the battery needs to be recharged as indicated by the Low Battery LED Page 3 HHT ASSEMBLY WITHOUT AEROSOL Vibralung The assembled Vibralung Acoustical Percussor Hand held Transducer HHT is shown below This assembly uses the Standard Y adapter E Connect the long end of the Standard Y adapter to the cone The mouthpiece should be at the other end and the Variable Expiratory Resistor
16. ically terminated session or repeat a session with the same settings or start a different session with different settings repeat steps 1 and 2 above and select the appropriate settings 4 Treatment To take the treatment the patient should place the mouthpiece in his or her mouth and seal their lips around it just tightly enough to maintain a comfortable seal The teeth may rest gently on the mouthpiece but the patient should be cautioned to not bite down or chew on the soft plastic mouthpiece 5 Patient Position Avoid recumbent patient positioning while using the Vibralung Acoustical Percussor Patient should be sitting upright or at no more than a 30 recumbent angle to facilitate coughing and expectoration 6 Breathing Pattern The patient should breathe normally during the treatment As with any breathing treatment hyperventilation or excessively deep or fast breathing may result in dizziness or light headedness The treatment may be paused at any time and resumed if the patient needs to rest 7 Positive Expiratory Pressure PEP Therapy Adjust the Variable Expiratory Resistor to apply PEP during resting breathing Minimal PEP is applied when the orifice is wide open 60 and maximal PEP when the orifice is at the minimal position 10 An optional PEP manometer is available so that PEP levels can be monitored Minimal PEP levels will be observed during quiet tidal breathing due to relatively low respiratory flowrates If desired the
17. if it is not already being done If the patient complains of sore mouth jaw or teeth brought about by using the Vibralung device the healthcare practitioner should assess the patient If the patient complains of dizziness or light headedness assess the patient for possible hyperventilation while using the device If the patient appears to be hyperventilating pause the treatment and coach the patient to alter their breathing pattern appropriately Any other adverse reactions should be fully assessed before continuing therapy with the Vibralung Acoustical Percussor Westmed 4 E EE E E FEV WV Y When Your Care Is Critical Westmed Inc 5580 S Nogales Highway Tucson AZ 85706 800 975 7987 www westmedinc com Vibralung Acoustical Percussor ibralung_ Instructions for Use DEVICE DESCRIPTION The Vibralung Acoustical Percussor is used for airway clearance therapy and helps patients with lung disease to clear mucus and phlegm from their lungs through the use of sound waves The patient simply breathes through a mouthpiece attached to the Hand Held Transducer or HHT while holding on to the handle The HHT is connected to a small battery operated electronic box called the Treatment Control Unit or TCU The TCU generates the sound waves and controls the treatment See the pictures and instructions inside this pamphlet before operating WARNINGS PATIENT INJURY OR INEFFECTIVE THERAPY CAN RESULT FROM IMPROPER ASSEMBLY
18. mally throughout the treatment 1 Power To power on the TCU disconnect it from the charger plug the HHT into it and then press the Power On Off button e The LEDs embedded in the Power and Start Pause buttons illuminate e The Low Battery LED illuminates if the battery is in need of recharging e The Unit is in Pause mode upon powering on 2 Mode Selection To select and activate a setting rower e Press one of the 5 setting buttons in the top row L M H R2 or R5 The LED embedded in the selected setting button illuminates P I e Press the Pause button to activate the device and emit sound at the selected setting Pause The LED embedded in the Pause button extinguishes e Unless stopped or paused the unit will operate at the selected setting for 10 minute and then terminate e Press the Pause button at any time while activated to pause the session The LED embedded in the Pause button illuminates e Press the Pause button while paused to resume the session N The LED embedded in the Pause button extinguishes i Charging amp Low Battery LEDs e f a paused session is not resumed within 2 minutes by pressing the Pause button again the session automatically terminates Important If a different treatment mode is desired before the currently selected mode has terminated it is necessary to power the TCU off then power it on again and select the desired mode 3 Resume Terminate Repeat To resume an automat
19. ns Instructions for Use CAUTION Failure to abide by the CAUTION information may result in moderate injury and or property or product damage Alternating Current A device described herein operates on direct current electrical power Storage and transport humidity range 0 to 93 RH When used on a package insert or label indicates the manufacturer s Reference number Copyright 2013 Westmed Inc All rights reserved Vibralung and Vibralung Acoustical Percussor are registered trademarks of VibraLung Inc Circulaire is a registered trademark of Westmed Inc Circulaire II Hybrid is a trademark of Westmed Inc PN 71944 Rev 01 Page 14 Von ibralung For indoor use only Type BF Mouthpiece Type BF applied part according to EN 60601 1 Power supply meets Level V requirements Storage and transport atmospheric pressure range 70 kPa to 106 kPa When used ona package insert or label indicates the Lot Number Westmed Inc 5580 S Nogales Highway Tucson AZ 85706 800 975 7987 www westmedinc com
20. ntrol Unit hospital model with Battery Charger Pole mount Bracket and Instructions for Use single unit Vibralung Patient Kit not included Vibralung Patient Kit Hand held Transducer Cone Standard Y adapter Aerosol Y adapter Disposable Ear Plugs Mouthpiece and PEP Resistor 9600 9600 10 disposable hospital model single unit or package of 10 Vibralung Battery Charger Instructions for Use single unit Bracket Pole mounting Instructions for Use single unit Circulaire Il Hybrid High Efficiency Aerosol Drug Delivery System with Reusable VixOne Variable Expiratory Resistor and Bacterial Viral Expiratory Filter case of 10 Circulaire Il Hybrid High Efficiency Aerosol Drug Delivery System with Reusable VixOne and Variable Expiratory Resistor case of 10 Circulaire l Hybrid High Efficiency Aerosol Drug Delivery System with Reusable VixOne Variable Expiratory Resistor Bacterial Viral Expiratory Filter and PEP Manometer case of 10 SERVICE e For any unexpected change in normal operation suspected malfunction or failure of the device contact the Westmed Customer Service Department at the telephone number below e Prior to considering service be sure to review the Troubleshooting section above e Only the Treatment Control Unit TCU can be serviced There are no serviceable parts in the disposable Hand held Transducer HHT e Westmed Inc is the only authorized service center available for diagnosing or rep
21. quency Tones Range 5to200Hz S Medium Frequency Tones Range 5 to 600 Hz High Frequency Tones Range 5 to 1 200 Hz Random Noise Range 5 to 1 200 Hz continued next page Page 10 TECHNICAL SPECIFICATIONS Vibralung HAND HELD TRANSDUCER HHT Part Number Dimensions Interface Cable to Control Unit Interface Cable Plug Type Weight Weight with Standard Y adapter Patient Interface Intended Patient Population By Age 7 5 x 3 75 x 3 5 inches 19 x 9 5 x 8 9 cm HWD 4 to 4 5 feet 1 22 to 1 37 M 2 conductor mini phone plug 3 5 mm 0 51 pounds 233 grams 0 56 pounds 256 grams Plastic Mouthpiece Contains No Latex Anyone who is able to read and or understand the instructions may use the Vibralung Acoustical Percussor Materials Hand held Case ABS plastic White off white Contains No Latex Polypropylene Translucent Clear Contains No Latex Mouthpiece Low Density Polyethylene LDPE Translucent Clear Y adapters High Density Polyethylene HDPE Translucent Clear Speaker Diameter 3 inches 7 6 cm Speaker Magnet Material Speaker Magnetic Field Minimum Lifespan Intended Usage Period Mechanical Deadspace Standard Y adapter Mechanical Deadspace Aerosol Y Inspiratory Flow Resistance lt 3 gauss 0 3 mTesla 1 inch Single patient use Disposable 39 mL expressed as potential rebreathed volume 53 mL expressed as potential rebreathed volume lt 2 cmH20 L sec Positive Expira
22. r of the Vibralung Acoustical Percussor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF equipment transmitters and the Vibralung Acoustical Percussor as recommended below according to the maximum output power of the Electromagnetic Environment Guidance communications equipment Separation Distance According to Frequency of Transmitter Meters M Feet Ft 80 mHz to 800 mHz The Vibralung Acoustical Percussor uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The Vibralung Acoustical Percussor must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected Rated maximum output power of transmitter 150 kHz to 80 mHz CISPR 11 800 mHz to 2 5 GHz RF Emissions j CISPR 11 RF Emissions pO onmom onmo ozm osr omman osmim omman swam smin zemaan namas nemzan asssrsm For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power of the transmitter in watts W according to the transmitter manufacturer CISPR 11 Harmonic Emissions IEC 61000 3 2 Voltage fluctuations flicker
23. should be on the tail of the Y The outlet port of the cone should be at the 3 o clock position as you are facing it and the assembly should be aligned as shown in the user s view below Cone Inspiratory Valve AA Housing a purple 2 o Mouthpiece m a Standard Y adapter Ergonomic Handle Variable Expiratory Resistor for PEP User s View 3 o clock alignment HHT ASSEMBLY WITH AEROSOL If simultaneous aerosol therapy is required obtain and attach the Circulaire II Hybrid aerosol delivery system as shown below Remove the Standard Y adapter E replace with the Aerosol Y adapter F and transfer the mouthpiece to the Aerosol Y adapter Insert the Circulaire II Hybrid aerosol delivery system on to the tail of the Aerosol Y adapter as shown The outlet port of the cone should be at the 3 o clock position as you are facing it and the assembly should be aligned as shown in the Bird s Eye View below servoir Ball Aerosol Y adapter Variable Expiratory Resistor for PEP Nebulizer Bird s Eye View Operate the nebulizer with oxygen or compressed air Adjust the opening of the Variable Expiratory Resistor to apply PEP See the Circulaire II or Circulaire II Hybrid package insert for further instructions for use Page 4 BUTTONS AND SETTINGS ON THE TCU Vibralung The TCU has 2 electrical jacks on the left side panel The top jack is for connecting the TCU to the
24. tempt to disassemble either the TCU or the HHT There are no user serviceable parts inside Internal batteries are not user serviceable The TCU must be returned to Westmed for service The HHT is disposable and if it is damaged it should be discarded and replaced e Do not over tighten the Cone onto the HHT Ensure the outlet port of the Cone is properly aligned and the outlet port on the Cone should be aligned to the 3 o clock position See inset diagrams on page 4 e Do not use the TCU and HHT in extremely moist and humid environments such as a shower or outside during rain e Do not immerse the TCU or the HHT in liquid or allow liquid to seep into the case e Do not attempt to disinfect either the HHC or the TCU with boiling water steam baby bottle sterilizers dishwashers or microwave ovens e Use only the Battery Charger that is supplied with the TCU Use of a different charger may damage the batteries and or the electronics e Do not operate the Vibralung Acoustical Percussor in potentially explosive highly flammable or oxygen enriched atmospheres such as an operating room during use of flammable anesthetics or in an oxygen tent croup tent head hood or incubator with oxygen flowing e Do not use the Vibralung Acoustical Percussor with a facemask of any kind because of the uncertainty of coupling the acoustic energy to the airways Page 2 INCLUDED PARTS raan The Vibralung Acoustical Percussor is supplied in two box
25. tory Pressure PEP Yes via supplied Variable Expiratory Resistor VER Yes via optional VER with Manometer 0 9 to 4 0 cmMH20 representative test bench measurement 0 7 to 2 4 cmMH20 representative test bench measurement Monitoring During adult tidal breathing pattern During pediatric tidal breathing Aerosol Delivery Yes via Circulaire I Hybrid aerosol delivery device Sound Pressure Levels Maximum 1 inch from Mouthpiece 104 dbA represents therapeutic level Maximum 1 inch from Expiratory Port 100 dbA represents ambient noise level Ingress Protection Protected against solid objects over 12 5 mm Protected against falling drops of water if the e g hands large tools etc case is disposed up to 15 degrees from vertical Ingress of Solid Objects Ingress of Liquids Page 11 ELECTROMAGNETIC EMISSIONS AND ENVIRONMENT ibralung Manufacturer s Declaration Electromagnetic Emissions Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Vibralung Acoustical Percussor The Vibralung Acoustical Percussor is intended for use in the electromagnetic environment specified below The customer or user of the Vibralung Acoustical Percussor should assure that it is used in such an environment RF Emissions The Vibralung Acoustical Percussor is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or use
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