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Related Manuals for Percussionaire VDR-4 System
Summary of Contents for Percussionaire VDR-4 System
- Page 1 -4 System ® Volumetric Diffusive Respirator Operator’s Manual...
- Page 2 First Printing November 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®.
- Page 3 WARNING and CAUTIONS It is the user’s responsibility to follow the instructions given in this manual. Keep the operating instructions near the device to ensure correct operation. If the safety instructions are not followed, the patient may be at risk. WARNING A WARNING indicates the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device.
- Page 4 Patient Disconnect Test the operation of the VDR®-4 patient disconnect alarm when Protection doing pre-use check and pre-setup procedure. An increase in circuit resistance can prevent proper operations of some alarms. Speaking valves, heat moisture exchangers (HMEs), and filters create additional circuit resistance and may affect the performance of alarms chosen for circuit disconnect protection.
- Page 5 Maintenance Maintain and service the VDR®-4 device according to the recommendations provided in this manual. Use only Percussionaire® accessories designed specifically for use with the VDR®-4 device. Never attempt to modify the unit. Maintenance procedures must be complied with. Failure may result in injury to the patient or operator and could result in damage to the equipment.
- Page 6 Document Symbols Type BF Applied Part WARNING CAUTION Single Patient Use Read the manual Prescription Only before use CE marking Catalog Number Lot Number Manufacturer European Manufacture Date Representative Non-Sterile Not Made with STERILE LATEX Natural Rubber Latex Does Not Contain the Phthalate DEHP DIBP...
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Page 7: Table Of Contents
Table of Contents Chapter 1: Introduction ......................1 Volumetric Diffusive Respirator (VDR®) ..............1 Demand CPAP/PEEP ......................1 Inspiratory Time ........................1 Pulsatile Flow ........................1 Frequency..........................1 Manual Inspiration ......................1 Operation Pressure Control .................... 1 Phasitron® A50094-D Breathing Circuit Kit .............. 2 Chapter 2: Intended Use ...................... - Page 8 Monitron® II Waveform Analyzer Description of Controls ......16 Front Panel .........................16 Rear Panel ........................18 Visual Outputs ......................18 Waveform Display ....................18 Monitoring Parameters ....................19 Audible Outputs .......................20 Blended Gas/Air Connection ................20 Chapter 4: Alarms ........................21 Failsafe Sensitivity ...................... 21 Disconnect Alarm ...................... 21 Modifying Alarm Parameters .................
- Page 9 Neonatal Starting Guidelines ................38 Neonatal Patient VDR®-4 Strategies ..............39 Neonatal Patient Blood Gas Manipulation ............40 Wean ..........................41 Chapter 9: Cleaning and Disinfection ................42 Controller ........................42 Monitron® II ........................42 LCD Screen ......................42 Digital Multimeter (DM) or Manometer............. 43 Stand Assembly ......................
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Page 10: Chapter 1: Introduction
Chapter 1: Introduction This chapter provides an overview of the VDR®-4 device and High-Frequency Percussive Ventilation (HFPV). Volumetric Diffusive Respirator (VDR®) Designed specifically for hospital use, the Volumetric Diffusive Respirator unit (VDR®-4) is a flow-regulated and time-cycled ventilator which provides high-frequency percussive ventilation (HFPV). -
Page 11: Phasitron® A50094-D Breathing Circuit Kit
Phasitron® A50094-D Breathing Circuit Kit The patented Phasitron® uses a unique sliding venturi mechanism to protect the lung from overpressure. By automatically adjusting to the resistance of the lung, the Phasitron® precisely and safely delivers the optimal amount and pressure of air required by the alveolar space. -
Page 12: Chapter 2: Intended Use
Chapter 2: Intended Use Indications for Use The VDR®-4 is indicated for patients diagnosed with either respiratory failure or respiratory insufficiency requiring partial or full ventilator support in hospitals and for intra-hospital transport of these patients. Patient Population The VDR®-4 ventilator is for use on neonatal, pediatric, and adult patient populations. Absolute Contraindications •... -
Page 13: Chapter 3: System Description
Chapter 3: System Description Package Contents VDR®- 4 Monitron® II Phasitron® A50094-D VDR®-4 Description of Controls Tubing harness connections to the Phasitron®... -
Page 14: Front Panel
Front Panel Control Function Pulsatile Flowrate Determines the pulse amplitude delivered to the patient during inspiratory phase. Inspiratory Time Selects the time interval (adjustable from 0.5 seconds to approximately 10 seconds) in which the inspiratory amplitude (set with the pulsatile flowrate) is delivered. - Page 15 Control Function Convective Pressure Rise Adjusted to accelerate the pulsatile flowrate after 0.7-seconds delay and deliver a secondary, higher inspiratory amplitude during inspiratory phase. Pulse i:e Ratio Controls the pulse to interval (i:e) ratio of the high-frequency pulses delivered. Pulse Frequency Controls the rate of the high-frequency pulses delivered.
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Page 16: Top Panel
Control Function Failsafe Sensitivity Limits a maximum sustained pressure over a defined time. If the failsafe pressure rise system is activated, a pneumatic alert is activated by a partial pressure release. A counterclockwise control knob rotation increases the sensitivity by decreasing the time required to activate the alert. - Page 17 Control Function Operating Pressure Control Controls the peak operating pressure of the entire control unit. This control at maximum output will only provide pressure slightly less than that of the institution. The optimal source gas pressure is 50 psi/3.4 bar. Operating Pressure Gauge A pressure regulator serves to control the 50 psi/3.4 bar sources of air and oxygen supplies,...
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Page 18: Digital Multimeter (Dm)
Digital Multimeter (DM) The Digital Multimeter (DM) has six different operating modes: POST, Wake, Active, Report, Sleep, and Fault. Power-On Self-Test (POST) Mode When batteries are installed in the Digital Multimeter (DM), the 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 POST. -
Page 19: Wake Mode
Wake Mode To wake up the DM, ensure the VDR®-4 ventilator pressure is greater than 2.5 cmH₂O/hPa at the Phasitron® patient delivery port for more than 1 second. The DM remains on for the first 15 seconds, showing the bar-graph timer. If usage is stopped within 12 seconds, the DM enters Report mode. - Page 20 Dynamic Pressure Mean Airway Pressure (AIP) and (AEP) Bar graph measuring pulse amplitude Pulse Frequency Rate (0-50 cmH O/hPa) Increments Usage Timer 2.5-3 cmH O/hPa Pulsating Bar Graph The pulsating bar graph on the left side displays pulse amplitude calculated as average peak maximum pressure sample in last 5 seconds minus minimum pressure sample in last 5 seconds.
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Page 21: Report Mode
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. The alternating page display continues for 5 minutes, or until usage resumes and the DM enters Active mode. -
Page 22: Sleep Mode
NOTE: If System Failure screen is displayed, remove batteries for 30 seconds. Replace batteries (note that positive terminals face same direction) and wait 30 seconds until the screen turns off. If POST check runs correctly, DM may be used. If System Failure screen recurs, contact an authorized Percussionaire® service center. -
Page 23: Fault Detection
Fault Detection The DM has both hardware and software fault detection. This is a dedicated hardware “watchdog” that runs on an independent clock source and can continue to operate even if the main microprocessor’s clock fails or the microcontroller pauses in any way. The independent fault detection is reset each time a valid pressure reading (free of hardware and software errors) is obtained. -
Page 24: Manometer (Proximal Airway Pressure Gauge)
Manometer (Proximal Airway Pressure Gauge) Airway pressure manometer with range from 0 to 120 cmH₂O is installed in the top panel of the VDR®-4. The manometer reads a selected mode of proximal airway pressure. A switch labeled Integrated Manometer selects the mode of display. When the integrated manometer switch is in the "off"... -
Page 25: Monitron® Ii Waveform Analyzer Description Of Controls
Monitron® II Waveform Analyzer Description of Controls NOTE: Waveform and numbers for display only Front Panel Control Function Freeze On/Off Switch The Freeze switch is a push button located on the front panel. The normal position of the freeze mode is “OFF. ” With the freeze mode “ON, ” information that is displayed on the LCD will be frozen for observation. - Page 26 Control Function Low Alarm Adjust The Low Alarm is adjusted by pressing the buttons to move the “green” low alarm limit line up and down. The up and down arrows are pushed repeatedly until the desired low alarm limit is achieved. Sweep Rate Sweep Rate determines the rate that new data is displayed on the LCD.
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Page 27: Rear Panel
Rear Panel Control Function Power Switch The Power Switch has two positions, “ON” and “OFF. ” Signal Output The Monitron® II is fitted with a 25-pin “D” connector and a 9-pin connector on the back panel. Both of these connectors are non-functional and should be covered when not in use. -
Page 28: Monitoring Parameters
Monitoring Parameters Control Function Ratio between I time and E time The ratio between pulse and interval for the high frequency “Convective “ rate from the I time and E time in cycles per minute Inspiration time or T-high in seconds Expiration time or T-low in seconds High-frequency rate in cycles per minute Mean airway pressure in cmH... -
Page 29: Audible Outputs
Control Function Clock Alarm status Low Alarm Level Low Alarm will display as a green line on the LCD at the set pressure level. High Alarm Level High Alarm will display as a red line on the LCD at the set pressure level. The Proximal Airway Pressure (pulse amplitude) signal is collected from the red tubing connection on the Phasitron Tee. -
Page 30: Chapter 4: Alarms
Chapter 4: Alarms Failsafe Sensitivity The Failsafe alarm is an obstruction alert intended to protect the patient from a high-pressure situation. This alert should be considered as the highest level of alert that requires immediate and urgent attention because ventilation of the patient is significantly reduced. -
Page 31: Modifying Alarm Parameters
Modifying Alarm Parameters NOTE: RESET High and Low alarms after any change in programming. High Alarm Adjust The High Alarm is adjusted by pressing the arrow buttons on the front panel to move the “red” high alarm up and down. The up and down arrows are pushed repeatedly until the desired high alarm is achieved. -
Page 32: Alarm Activity
Alarm Activity High-Amplitude Pressure Alarm Event – visual and audible indicators Low-Amplitude Pressure Alarm Event – visual and audible indicators Patient-Disconnect Alarm Event – audible indicator Blender Gas Supply – audible indicator Alarm Summary Table High-Amplitude Visible: When amplitude exceeds set level, high alarm Pressure Alarm Event will display as a red line on the LCD at the appropriate pressure level. -
Page 33: Chapter 5: Setup
Chapter 5: Setup Typical VDR®-4 Configuration Roll Stand and VDR®-4 Assembly The VDR®-4 is mounted on a standard ventilator stand and is set up for two e-cylinders to be mounted to provide for transportation of the patient while receiving mechanical ventilation with the VDR®-4. -
Page 34: Phasitron® A50094-D Breathing Circuit
Phasitron® A50094-D Breathing Circuit NOTE: 0.5 L bag supplied for neonatal patients only. This is not a test lung. NOTE: A heated wire circuit is required. Connecting to the VDR®-4 Place heater chamber onto heater. Insert nebulizer into mounting hook, normally installed near heater. - Page 35 Connect nebulizer to heater chamber using unheated, fresh gas, blue corrugated tubing (see Fig. 2, A and Fig. 3, C). Connect blue heated-wire tubing to heater (Fig. 2, B). Fig. 2 Insert 4-way manifold 22 mm port into nebulizer with flapper gate placed upright (Fig.
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Page 36: Adding Sterile Inhalation Water
Remove wye from heated-wire circuit and attach white corrugated tubing to the clear expiration port valve on the Phasitron® (Fig. 4, H). Fig. 4 Connect blue corrugated heated-wire tubing to blue Phasitron® entrainment port (Fig. 4, I). Connect red tubing quick-connect fitting to middle tee connected to Phasitron®... -
Page 37: Digital Multimeter (Dm) Setup
Digital Multimeter (DM) Setup To ensure correct atmospheric pressure calibration at startup, remove batteries, wait 30 seconds, and reinstall. Allow 15 seconds for Power-On Self-Test. When screen goes blank, the DM can be installed into the VDR®-4. Side view of DM Install batteries into DM USB serial port only used for firmware upgrades... -
Page 38: Chapter 6: Pre-Use Check
Chapter 6: Pre-Use Check Blender Pre-Use Check Check blender with FiO₂ analyzer at 21% and 100% FiO₂ per department policy with O₂ analyzer before initializing mechanical ventilation. Pre-Use Check Connect hospital air supply hose to VDR®-4. Listen for blender alarm, then disconnect air hose. - Page 39 Set inspiratory time and expiratory time to: • 2.0 seconds to get a convective rate of ~15 (adult/large peds) • 1.5 seconds to get a convective rate of ~20 (small peds) • 1.0 second to get a convective rate of ~30 (neonatal) Set oscillatory CPAP/PEEP to AEP of 5 cmH₂O as read on DM or manometer.
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Page 40: Alarm Check
Alarm Check Routine alarm checks should be performed before use with each new patient. If the alarms do not function as described in this manual, contact your distributor. Settings To check alarms, set the VDR®-4 to the following settings: Operating pressure 40 psig FiO₂... -
Page 41: Monitron® Ii Waveform Analyzer Alarm System
Monitron® II Waveform Analyzer Alarm System: With VDR®-4 functioning, adjust red line with HIGH ALARM selection arrow to 50 cmH₂O. Adjust green line with LOW ALARM selection arrow to 8 cmH₂O. During inspiratory phase, squeeze the test lung so that a pressure of > 50 cmH₂O registers on the screen. -
Page 42: Chapter 7: Patient Management
Chapter 7: PATIENT MANAGEMENT Therapeutic Objectives Managing patients on high-frequency percussive ventilation is similar to managing patients on a CMV. Oxygenation - adjustments will be made to increase mean airway pressure if oxygenation is the primary concern. Ventilation - adjustments that increase minute volume will be made when CO elimination is the primary concern. -
Page 43: Chapter 8: Clinical Guidelines
Chapter 8: Clinical Guidelines Color-Coded Control Knobs Specific meanings: Green Green knobs are for the selection of Inspiratory and Expiratory Flowrates. The yellow knob is for Demand CPAP/PEEP. Yellow Demand CPAP/PEEP is used for a spontaneously breathing patient with high inspiratory or respiratory rate demand or, with the VDR®-4 master switch in the “off”... -
Page 44: Adjusting Settings
Adjusting Settings Wait for recruitment or effect of updated control setting changes. It is important to allow time for the changes to take effect. After a period of ventilatory stabilization, check SPO or blood-gas determinations to determine oxygenation. Determine Period The black Inspiratory Time control knob determines of Oscillatory the period of oscillatory equilibrium, providing for... -
Page 45: Adult Patient Starting Guidelines
Adult Patient Starting Guidelines NOTE: These are merely suggested guidelines based on clinical consensus. Operating Pressure (psi) 40-42 Pulsatile Flowrate cmH AIP 28-32 (Max 40-46) Alternately, adjust pulsatile flowrate to match mean airway pressure (MAP) on current ventilator. Convective Rate (bpm) I time (seconds) E time (seconds) Oscillatory CPAP/PEEP (cmH... -
Page 46: Adult Patient Blood Gas Manipulation
Adult Patient Blood Gas Manipulation NOTE: These are merely suggested guidelines based on clinical consensus. Decrease CO only Increase Oxygenation Increase PaO with PaCO in Range Lower PaCO a.FIO if at low levels a. Pulsatile flow by a. Pulsatile flow by 2 cmH O up to 2 cmH... -
Page 47: Pediatric Starting Guidelines
Pediatric Starting Guidelines NOTE: These are merely suggested guidelines based on clinical consensus. Pediatrics Pediatrics Pediatrics <10 kg 10-20 kg >20 kg Operating Pressure (psi) Pulse Frequency Rate (cycles per minute) Convective Rate (bpm) I time (seconds) E time (seconds) Oscillatory PEEP (AEP) 6-10 8-10... -
Page 48: Neonatal Patient Vdr®-4 Strategies
Neonatal Patient VDR®-4 Strategies NOTE: These are merely suggested guidelines based on clinical consensus. PRDS Meconium Asp. / PPHN Lung Protective Strategies & Reduce PIE/Air Leak a. HFV Rate 450 to 500 a. HFV Rate 600 cycles per a. HFV Rate 500 to 600. minute Target 600 rate when b. -
Page 49: Neonatal Patient Blood Gas Manipulation
Neonatal Patient Blood Gas Manipulation NOTE: These are merely suggested guidelines based on clinical consensus. Increase PaO Increase Oxygenation Decrease CO only Lower PaCO with PaCO in Range a. FIO2 if at low levels a. Pulsatile flow by a. -
Page 50: Wean
Wean NOTE: These are merely suggested guidelines based on clinical consensus. Gradually reduce FiO to under 30%. Gradually reduce green CONVECTIVE PRESSURE RISE to “OFF” (clockwise). Gradually reduce green PULSATILE FLOWRATE. Watch inspiratory amplitude reduction rate during weaning to maintain acceptable blood gases. -
Page 51: Chapter 9: Cleaning And Disinfection
Chapter 9: Cleaning and Disinfection Controller NOTE: All single-patient use components and Phasitron® are not intended for cleaning, sterilization, or re-use. Replace single-patient use components regularly, following your healthcare institution’s protocol. Before cleaning any part of the VDR®-4, disconnect external power sources. Do not spray any cleaning solution directly onto the controller. -
Page 52: Digital Multimeter (Dm) Or Manometer
Dry the assembly thoroughly after cleaning. WARNING: Percussionaire® makes no claims regarding the efficacy of the listed chemicals or processes as a means for controlling infection. Consult your hospital’s infection control officer or epidemiologist. -
Page 53: Phasitron® Breathing Circuit Kit
Phasitron® Breathing Circuit Kit Cleaning and Disinfecting Solutions The Phasitron® breathing circuit has been tested for biocompatibility with the following cleaning and disinfecting 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... -
Page 54: Chapter 10: Troubleshooting
Chapter 10: Troubleshooting VDR®-4 Problem Check Solution Frequencies of percussions Check if unit has been Unit must be sent to abused, fallen, etc. authorized service center. do not change as frequency Contact your distributor. control knob is rotated. Check last calibration or functional check performed. -
Page 55: Monitron® Ii Waveform Analyzer
Monitron® II Waveform Analyzer Problem Check Action With waveform “ON,” Check to see if unit is If problem is not resolved connected to an approved after completing all the no readings appear on power source. checks, contact your the LCD screen. distributor. -
Page 56: Digital Multimeter (Dm)
Digital Multimeter (DM) Problem Check Action Service error screen Batteries Remove batteries and wait 30 seconds. Replace batteries and watch the screen until the text disappears before putting DM back into the device. Not turning on Red sample line is connected, DM reads pressure from the no blockage in the sample line, patient to wake up. -
Page 57: Chapter 11: Service And Repair
A device which has not received a mandated full service for a period of 10 years, whether in use during that period or not, will not be serviced. Repair To repair a Percussionaire® VDR®-4, contact Percussionaire® Service Department or the distributor. -
Page 58: Disposal Of Equipment
Disposal of Equipment At the end of useful life of a unit, disposal should be in accordance with local, state, federal, and international laws. Shipping and Packaging To ship the VDR®-4 to a factory service center, contact: 800-850-7205 or (208) 263-2549 and request a Return Authorization (RA) number. -
Page 59: Chapter 12: Limited Warranty
(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®... -
Page 60: Chapter 13: Technical Specifications
Chapter 13: Technical Specifications VDR®-4 Phasitron® Kit A50094-D Liquid Consumption 1 cc per minute Percussion Frequency 50-900 pulses per minute Pulse/Interval Ratio Adjustable Operating Range Temp., 0°C to 49°C (32°F to 120°F) Storage and Temp., -20°C to 60°C (-4°F to 140°F) Transport Range Humidity <... -
Page 61: Monitron® Ii Waveform Analyzer
Batteries the event of AC power failure. In the event of battery failure or malfunction, batteries can only be replaced by a Percussionaire®- authorized service center. W x H x D 33 cm x 20.3 cm x 23.4 cm (13" x 8" x 9.2") -
Page 62: Digital Multimeter (Dm)
Digital Multimeter (DM) Size 73 mm (2.87 inch) diameter Mass 165 g (0.36 lb) Operating Range Temperature -20°C to 60°C (-4°F to 140°F), Humidity <93% non-condensing Temperature -20°C to 60°C (-4°F to 140°F) Storage and Transport Range Humidity < 93% non-condensing Display 128 x 64-pixel FSTN chip-on-glass LCD with reflector Fault Detection... - Page 63 This page intentionally left blank...
- Page 64 130 McGhee Road, Suite 109, Sandpoint, Idaho 83864 USA percussionaire.com +1.208.263.2549 P20078 Rev A...