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First Printing February 2020 Percussionaire® is a registered trademark of Percussionaire Corporation. This work is the sole property of Percussionaire® Corporation. The information in this manual is confidential and may not be disclosed to third parties without the prior written consent of Percussionaire®.
Chapter 1: Introduction This chapter provides an overview of the IPV®-1C device and TRUE-IPV® therapy. Intrapulmonary Percussive Ventilation (IPV®) Designed specifically for non-continuous institutional/hospital use, the IPV®-1C is a pressure-limited, flow-interrupted and time-cycled ventilator which provides IPV® therapy, a modality of mechanical ventilation, “Intrapulmonary Percussive Ventilation”. The IPV®-1C provides high frequency percussive pulses between 100-300 cycles per minute.
Three Components of TRUE-IPV® The Three Components of Intrapulmonary Percussive Ventilation (IPV®) • Diffusion • Perfusion Vesicular • Convection Peristalsis Frequency = 300 Frequency = 150 Frequency = 100 Percussive Mechanical Percussive Convective Percussive Perfusion Mixing Diffusion Ventilation With Diffusion Vesicular Peristalsis f=300 f=150...
Chapter 2: Intended Use Indications for Use The IPV ® -1C is indicated for mobilization of secretions, lung expansion therapy, and the treatment and prevention of pulmonary atelectasis. It can also provide supplemental oxygen when used with compressed oxygen. Patient Population IPV®-1C is for use on pediatric and adult patient populations.
Clinical Limitations/Restrictions Use of the IPV®-1C is limited to individuals who have received proper training. For invasive applications or patients supported by Continuous Mandatory Ventilation (CMV). WARNING: Due to the therapeutic nature of these devices, they do not have alarms. Consequently, the patient MUST be under continuous observation by a clinician.
IPV® is not indicated. NOTE: For use only with Percussionaire® TRUE-IPV® ventilator devices. Compatible with all Percussionaire® single patient Phasitrons. The IPV® In-Line Valve is indicated for patient populations from pediatrics to adults, for whom IPV® therapy has been prescribed.
Chapter 4: Setup Controller and Stand Phasitron® 5 holder bracket DISS supplied oxygen hose for incoming gas between 50 - 80 psi (345 - 551 kPa) normally supplied to USA devices Pole and stand assembly...
Rear Panel Blended Gas/Air Connection The IPV®-1C can be connected to hospital single gas source or blended gas. Single or double air/oxygen gas connections available. Current Gas/Air Connectors Available: DISS NIST European AFNOR French UNIFOR Italian German Scandinavian British Pole Mount Supplied rear mounting bracket for Adjustable pole mount to attach pole mounting the IPV®-1C device...
Phasitron®5 Breathing Circuit Setup The patented Phasitron® 5 uses a unique venturi as a “clutch” mechanism to protect the lung from over pressure. By automatically adjusting to the resistance of the lung, the Phasitron® 5 precisely and safely delivers the optimal amount and flow of air required by the alveolar space.
Housing Nebulizer Cap Mouthpiece Diaphragm Nebulizer Bowl Baffle CAUTION: Only use Percussionaire® parts and accessories Type BF Single patient use Configurations Phasitron® 5 kit can be used with or without a mouthpiece or standard mask (as shown below). Connection sizes, 15mm ID or 22mm OD.
Connecting to the IPV®-1C Connect red, clear, and yellow tubing connectors to IPV®-1C controller device. WARNING: Green remote bulkhead is vented, NOT USED YELLOW do not obstruct CLEAR Connect the Tubing Harness to Phasitron® 5 Connect yellow tubing quick-connect fitting to nebulizer bowl.
Adding Saline Solution or Medication Twist clockwise to open nebulizer bowl. Add saline and/or prescribed medication. Reverse to close. CAUTION: Ensure yellow nebulizer tubing is not bent. This may cause undue stress on connector. CAUTION: Do not bend nebulizer bowl while holding the tubing. This may cause undue stress on the red line conical connector.
TRUE-IPV® In-Line Valve Setup Patient connection wye Phasitron® port connection Pediatric to Adult Recommended to install as close to the patient wye as allowable Insert TRUE-IPV® In-line Valve into inspiratory limb of ventilator circuit. WARNING: Ensure Pressure Relief valve is closed. WARNING: Allow ventilator to cycle with valve in place.
Percussionaire® Digital Multimeter (PDM) Setup NOTE: Remove the PDM from the IPV®-1C device, to access battery pull tabs, by turning the PDM counterclockwise. Pull up to remove both tabs NOTE: To ensure correct atmospheric pressure calibration at start up, remove batteries, wait 30 seconds and re-install.
Chapter 5: Controller Functions Knob, Switch and Button Knob, Switch, Button Function The Percussion control knob adjusts frequency of PERCUSSION pulses at a fixed i:e ratio. Controls the rate of high frequency volumes delivered. Ranges from 100 up to above 300 cycles per minute.
Percussionaire® Digital Multimeter (PDM) The PDM has six different operating modes: POST, Wake, Active, Report, Sleep and Fault. Power-On Self-Test (POST) Mode When batteries are installed in a system, the PDM software displays the software revision, battery voltage, total usage time and serial number for 15 seconds. This Start- Up mode allows the software to perform additional tests on the hardware that are part of the Power-On Self-Test.
Wake Mode To wake up the PDM, ensure the ventilator pressure is greater than 2.5 cmH₂O or 2 hPa at the Phasitron®5 patient delivery port for more than 1 second. The PDM remains on for the first 15 seconds, showing the Bar-Graph timer. If usage is stopped within 12 seconds, the PDM enters Report mode.
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The Pulsating Bar Graph on the left side displays Pulse Amplitude calculated as average peak amplitude pressure sample in last 5 seconds, minus amplitude pressure sample in last 5 seconds. The Bar Graph is a visual representation better reflecting AIP and AEP values and represents an estimate of airway pressure.
Mean Airway Pulse Amplitude Pressure Pulse Frequency Rate Usage Timer EUR Therapy: IPV®-1C, display Report Mode The Session Timer and the Total Usage Timer (A) are displayed for 2 seconds, followed by the System Information page (B) for 2 seconds, alternating. Alternating page display continues for 5 minutes or until usage resumes and the PDM enters Active mode.
Display screens when the IPV®-1C is switched off. EUR Therapy: IPV®-1C US IPV: IPV®-1C NOTE: When the IPV®-1C is turned off, the measurements will drop to zeros after a few seconds. Sleep Mode In Sleep mode the LCD is off, but the Blank screen, indicating microcontroller continues to sample and PDM Sleep mode...
(note that positive terminals face same direction) and wait 30 seconds until the screen turns off. If POST check runs correctly, PDM may be used. If System Failure screen recurs, contact an authorized Percussionaire® service center. Fault Logging The software keeps track of several types of hardware and data faults. All faults are logged in the microcontroller’s memory and are retained even if the batteries are...
Chapter 6: Pre-Use Check Connect a Siemens style 1-liter ventilator test lung to the Phasitron®5. (1) Connect the Phasitron®5 tubing connectors to the IPV®-1C using the red, clear and yellow connections. (2) Rotate the OPERATIONAL PRESSURE knob full counterclockwise to the stop (OFF) position. Connect the IPV®-1C to gas source supply.
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Occlude green port and observe that pulsations stop. Remove occlusion from green port. Press the MANUAL INSP button and observe pressure increase over 40 cmH₂O. NOTE: If using the “EUR” multimeter, MAP is in a different position on display. Rotate the MASTER switch to the “OFF” position. Disconnect gas source supply.
Chapter 7: General TRUE-IPV® Therapy Protocol for Adults Connect IPV®-1C to 50-80 psi (3.5-5.5 BAR) gas power source. Master switch is “OFF”. Patient should be in an upright, comfortable armchair or lying with head and shoulders elevated by pillows. NOTE: Patient’s gravitational position is not a factor with TRUE-IPV®. Auscultate patient for breath sounds, heart and respiratory rate or follow institution guidelines.
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The Phasitron® 5 can be rinsed, cleaned and stored in the supplied bag as per hospital infection control policy until the next treatment. NOTE: The Phasitron® 5 is for a SINGLE patient only, to be used multiple times. NOTE: Percussionaire® recommends cleaning per your institution’s approved practice.
Administering TRUE-IPV® Therapy with In-Line Valve When administering TRUE-IPV® Therapy with an In-Line Valve, a pressure control (PC) mode is recommended or follow your institutional protocol. Mean Airway Pressures (MAP) will increase slightly with the administration of TRUE-IPV® In-line therapy with the ventilator. The clinician must be aware of this effect and monitor the patient closely for any adverse side effects.
Ensure the IPV®-1C is “OFF” and connected to a 50 psi/3.2 bar gas source. Turn incoming air/gas pressure regulator on IPV® device counterclockwise to the stop. Turn IPV®-1C “ON”. Adjust pressure regulator clockwise, to a starting drive pressure, Pediatric 20 psi/1.4 bar, Adult 30 psi/2.1 bar with a percussive rate of approximately 200 cycles per minute.
WARNING: The cell used in this device may present a risk of fire or chemical burn hazard if mistreated. Do not recharge, disassemble, heat above 100°C (212°F) or incinerate. Replace cell with a CR123A only, or Percussionaire part PRT-B13350. Use of another cell may present a risk of fire or explosion.
Phasitron®5 Breathing Circuit Follow hospital/institutional guidelines for cleaning and storage between treatments. It is not necessary to clean the Phasitron®5 after each use; however rinsing with sterile water is advised. When disassembling the Phasitron®5, visually inspect the exterior of all parts, including tubing, for corrosion, discoloration, pitting, and missing O-rings. CAUTION Do not immerse the tubing harness.
4. Twist white cap on the rear of the Phasitron®5 to remove. 5. Remove cap. 6. Remove sliding venturi with spring from Phasitron®5 body. Cleaning Phasitron®5 Thoroughly rinse each of the disassembled parts (except for tubing harness and filter) under warm running tap water for approximately 10 seconds.
Cleaning and Disinfecting Solutions The Phasistron® 5 breathing circuit has been tested for biocompatibility with the following cleaning solutions: Chemical Class Active Ingredient Bleach 5.25% Sodium hypochlorite Alcohol 70% Isopropyl alcohol Peroxide 3% Hydrogen peroxide Benzyl Ammonium N-alkyl dimethyl ethyl benzyl ammonium chlorides Chloride N-alkyl dimethyl benzyl ammonium chloride Phenolic...
CAUTION: If you notice any unexplained changes in the performance of the device, if the device is making unusual sounds, or if the device is dropped or damaged in any way, discontinue use and contact an authorized Percussionaire® service center.
Chapter 10: Technical Specifications IPV®-1C Specifications Dimensions (W x H x D) 17cm x 24.13cm x 24.13cm (6.7" x 9.5" x 9.5") Weight 1.99 kg (4.4 lbs) Operating Range 0°C to 49°C (32°F to 120°F) Humidity < 93% non-condensing Storage and Transport -20°C to 60°C (-4°F to 140°F) Humidity <...
Recycle according to local laws Service Life 6 months or 540 uses whichever is less Shelf Life 2 years from date of manufacture Percussionaire® Digital Multimeter (PDM) Specifications Size 73 mm (2.87 inch) diameter Mass 165 g (0.36 lb) Temp -20° C to 60° C (-4° F to 140° F)
(proof of delivery will be required). If the product fails to perform in accordance with the product specifications, Percussionaire® will repair or replace – at its option – the defective material or part. Percussionaire® will pay customary freight charges to and from Percussionaire® or an authorized Percussionaire® service center.
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