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Impulsator® HC User Manual

Home Care TRUE-IPV® Therapy Ventilator EN


Dear Customer, Congratulations on the purchase of your Impulsator® HC! Your new TRUE-IPV® therapy device is portable, self-contained and easy to use. It allows you the freedom to go where you want to go while complying with the treatment plan prescribed by your doctor! To make sure you receive maximum benefit from TRUE-IPV® therapy and to ensure your safety, please read the enclosed Impulsator® HC User Manual. It contains important SAFETY and TECHNICAL DATA that should be kept handy for easy reference. Your safety and satisfaction are important to us! For assistance setting up or using the Impulsator® HC, or to report unexpected operation or events, please contact Percussionaire® or your local distributor. With proper care, the Impulsator® HC will reward you with long, trouble-free service life. Thank you for placing your trust with us! Sincerely, Percussionaire® Corporation © 2020 Percussionaire® Corporation ALL RIGHTS RESERVED 1st Edition First Printing August 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®. No part of this document may be copied, reproduced, transmitted, or stored in any electronic information system without the prior written consent of Percussionaire® Corporation. The devices and products contained in this manual may be covered by one or more patents. This manual was originally released and supplied in English. For a list of available translations, contact customerservice@percussionaire.com All ventilators should be operated and serviced only by trained professionals. Percussionaire® Corporation’s sole responsibility with respect to its ventilators, accessories, components, and software, and their use, is as stated in the warranty provided in the manuals. The information set forth herein is believed to be accurate; it is not a substitute for the exercise of professional judgment.

II


Table of Contents Chapter 1: Introduction........................................................................................................ 1 Three Components of TRUE-IPV®...................................................................... 2 Effects of TRUE-IPV®............................................................................................... 2 Chapter 2: Intended Use...................................................................................................... 3 Indications for Use.................................................................................................. 3 Patient Population.................................................................................................. 3 Absolute Contraindications................................................................................ 3 Relative Contraindications................................................................................... 3 Possible Adverse Reactions................................................................................. 3 Physiological Benefits of TRUE-IPV®................................................................. 3 Clinical Limitations/Restrictions........................................................................ 4 Document Symbols ............................................................................................... 4 Chapter 3: Setup...................................................................................................................... 5 Impulsator® HC Controller................................................................................... 5 Phasitron® P5-HC Breathing Circuit.................................................................. 6 Phasitron® P5-HC Diagram.......................................................................... 7 Configurations................................................................................................. 7 Connecting to the Impulsator® HC.......................................................... 8 Connecting the Tubing Harness to the Phasitron® P5-HC .............. 8 Removing Nebulizer Bowl........................................................................... 9. Adding Saline, Sterile Water, or Medication......................................... 9 Reattaching Nebulizer Bowl.....................................................................10 Phasitron® P5-HC Timestrip®....................................................................11 TRUE-IPV® In-Line Valve Setup.........................................................................12 Adding Phasitron® P5-HC to In-Line Valve..........................................12 Chapter 4: Impulsator® HC Controller Functions ....................................................13 Knob, Switch, and Connector...........................................................................13

III


Chapter 5: Impulsator® HC Pre-Use Check................................................................ 14 Chapter 6: General TRUE-IPV® Therapy Protocol for Adults.............................. 15 Chapter 7: Cleaning and Disinfection......................................................................... 16 Controller................................................................................................................ 16 Phasitron® P5-HC Breathing Circuit............................................................... 16 Disassembly of the Phasitron® P5-HC.................................................. 17 Cleaning and Disinfecting Solutions.................................................... 18 Phasitron® P5-HC Cleaning Process...................................................... 18 Phasitron® P5-HC Disinfection................................................................ 19 Disinfection Solution................................................................................. 19 Disinfection Procedure.............................................................................. 19 Dry Inside of Tubing................................................................................... 19 Phasitron® P5-HC Lubrication After Cleaning and Disinfection.....20 Reassembly of the Phasitron® P5-HC................................................... 20 Chapter 8: Technical Specifications.............................................................................. 22 Impulsator® HC..................................................................................................... 22 Phasitron® P5-HC.................................................................................................. 23 Chapter 9: Troubleshooting............................................................................................. 23 Chapter 10: Service, Maintenance, and Repair....................................................... 24 Service and Repair............................................................................................... 24 Maintenance.......................................................................................................... 24 Air Intake Filter Replacement.................................................................. 24 Cooling Fan Filter Replacement............................................................. 26 Fuse replacement........................................................................................ 26 Disposal of Equipment....................................................................................... 27 Chapter 11: Limited Warranty........................................................................................ 27

IV


Chapter 1: Introduction Designed specifically for non-continuous home use, the Impulsator® HC is a pressurelimited, flow-interrupted, and time-cycled ventilator which delivers TRUE-IPV® therapy, a modality of mechanical ventilation, “Intrapulmonary Percussive Ventilation.” The Impulsator® HC delivers high-frequency percussive pulses between 110-500 cycles per minute. These high-frequency percussive pulses ramify throughout the airways and alveolar ducts, augmenting diffusive ventilation in the gas exchange regions of the lungs, allowing improved FRC, CO2 removal, airway clearance, and lung recruitment. The Impulsator® HC system also supplies a dense aerosol mist that is delivered into the lungs during therapeutic percussion, serving to reduce the adhesive and cohesive forces of retained airway secretions.

Impulsator® HC Control Functions

Percussion Control Knob

Therapy Selection Switch

Percussion Determines frequency of delivered breaths from easy to hard. Therapy Selection Switch Determines mode: percussion with nebulization or nebulization only.

Power Switch

Power Cord

1


The Impulsator® HC device requires a Phasitron® P5-HC breathing circuit for TRUE-IPV® therapy. WARNING: Due to the therapeutic nature of these devices, they do not have alarms. When using the Impulsator® HC for invasive therapy, the patient MUST be under continuous observation by a clinician or trained care provider. Three Components of Intrapulmonary Percussive Ventilation (IPV®) ThreeThe Components of TRUE-IPV®

70

• Diffusion O2

• Convection CO2

• Perfusion Vesicular Peristalsis

60 50 40

cmH2O hPa 30 20 10 0

Frequency = 300 Frequency = 150 Frequency = 100 Percussive Mechanical Percussive Convective Percussive Perfusion Mixing Diffusion Ventilation With Diffusion Vesicular Peristalsis f=300 f=150 f=100

Percussive Mechanical Mixing Diffusion

Percussive Convective Ventilation with Diffusion

Percussive Perfusion Vesicular Peristalsis

Effects of TRUE-IPV®

Ventilation & Oxygenation Mobilization of Airway Secretions

Lung Recruitment

TRUE-IPV® provides a percussive, subtidal gas exchange within the respiratory bronchioles with associated alveolar recruitment, maintaining a minimal mean intrathoracic expiratory pressure increase for peripheral lung stabilization. This allows for mechanical ventilation to provide for peripheral lung recruitment while minimizing the potential for induced barotrauma.

2


Chapter 2: Intended Use Indications for Use The Impulsator® HC is indicated for mobilization of secretions and raising of endobronchial secretions, bronchodilation, reducing mucosal edema, and the resolution of diffuse patchy atelectasis in most patient populations.

Patient Population The Impulsator® HC ventilator is for use on patient populations from pediatric through adult.

Absolute Contraindications • Untreated tension pneumothorax

• Untrained or unskilled operator

Relative Contraindications • History of pneumothorax

• Lack of patient cooperation

• Recent pneumonectomy

• Vomiting

• Pulmonary hemorrhage

• Pulmonary air leak (without functioning chest tube)

• Myocardial infarction

Possible Adverse Reactions • Decreased cardiac output

• Increased intracranial pressure

• Pneumothorax

• Increased air trapping

• Hyper-oxygenation

• Pulmonary air leak

• Pulmonary hemorrhage

• Hyperventilation

• Gastric distension

Physiological Benefits of TRUE-IPV® • Recruitment of atelectatic lung

• Mechanical bronchodilation

• Improved FRC

• May Improve breathing pattern

• Decreased work of breathing

• Increased secretion mobilization

3


Clinical Limitations/Restrictions Use of the ImpulsatorÂŽ HC is limited to patients, caregivers, respiratory therapists/clinicians who have received proper training and who have read and understand this manual. WARNING: When used on a patient with an artificial airway (i.e., endotracheal or tracheostomy tube), a trained caregiver must be present so that a one-to-one relationship exists. These devices enhance secretion clearance. Patients must be assessed pre- and post- treatment for a reduced vital capacity/FRC or the need for assistance in clearing airway secretions. NOTE: A WARNING icon indicates a risk of injury to patient or operator. A CAUTION icon indicates a risk of equipment damage.

Document Symbols Type BF Applied Part

WARNING CAUTION

D

Read the manual i before use

C CE marking

Prescription Only

h

Catalog Number Lot Number

M

Manufacturer

g

N

Manufacture Date

y European Representative

Non-Sterile

NON STERILE

PHT

4

Single Patient Use

DEHP DIBP DBP BBP

Does Not Contain the Phthalate Plasticizers DEHP, DIBP, DBP, or BBP

LATEX

Not Made with Natural Rubber Latex Disposal


Chapter 3: Setup Impulsator® HC Controller Place the Impulsator® HC controller on the table or floor, in a place with good unrestricted airflow. Make sure the controller is away from curtains, sheets, bedspreads, or anything that might block the vents and airflow. The device should be at least 8 inches from the wall. Insert the Phasitron® P5-HC platform bracket into the housing slot bracket. (Pull paper out from the housing slot bracket first.)

Remove the power cord from the compartment of the carrying case. Plug the power cord into a wall electrical outlet.

5


Phasitron® P5-HC Breathing Circuit

The patented Phasitron® P5-HC uses a unique venturi as a “clutch” mechanism to protect the lung from overpressure. By automatically adjusting to the resistance of the lung, the Phasitron® P5-HC precisely and safely delivers the optimal amount and pressure of air required by the alveolar space. When lung resistance is low, as in a compliant lung, all the pulsed air from the Impulsator® HC enters the mouth of the venturi. Each air pulse draws up to four times as much additional air into the venturi tube. This low-pressure entrained air automatically fills the available space in the lung. The Phasitron® P5-HC continuously and instantaneously adjusts to keep a gentle and safe air pressure, even in a compromised lung. NOTE: TRUE-IPV® therapy can only be achieved using the Phasitron® P5-HC.

6


Phasitron® P5-HC Diagram

Exhalation Port

Corrugated Tubing Safety Valve Entrainment Port Spring O-ring

Venturi Cap

Patient Port Phasitron® P5-HC Housing Nebulizer Cap

Mouthpiece Diaphragm

Nebulizer Bowl

Baffle

WARNING: Only use Percussionaire® parts and accessories Type BF D Single patient use

Configurations Phasitron® P5-HC kit can be used with or without a mouthpiece or standard mask (as shown below). Connection sizes: 15 mm ID or 22 mm OD.

Phasitron® P5-HC without mouthpiece or mask

Phasitron® P5-HC with mouthpiece (included)

Phasitron® P5-HC with face mask (sold separately) 7


Connecting to the Impulsator® HC YELLOW CLEAR

GREEN

Connect the tubing harness to the Impulsator® HC controller device matching the color-coded connectors and sockets.

Biphasic Controller Insert the clear and yellow connectors of the harness into the color-matching sockets in the top control panel of the Impulsator® HC device.

Connecting the Tubing Harness to the Phasitron® P5-HC

Connect yellow tubing quick-connect fitting to nebulizer bowl.

YELLOW

Connect the clear tubing quick-connect fitting to the cap at the rear of the Phasitron® P5-HC body. WHITE/CLEAR

8


Removing Nebulizer Bowl

Nebulizer bowl can be removed by rotating bowl towards rear of PhasitronÂŽ P5-HC. Rotate gently past the stop and nebulizer bowl will release.

Adding Saline, Sterile Water, or Medication

Twist clockwise to open nebulizer bowl. Add prescribed amount.

Reverse to close.

9


Reattaching Nebulizer Bowl

Reattach nebulizer bowl by aligning the notch. Insert the nebulizer housing into the PhasitronÂŽ P5-HC body, then rotate to lock.

CAUTION: Ensure yellow nebulizer tubing is not bent. This may cause undue stress on connector.

10


Phasitron® P5-HC Timestrip® Using the Phasitron® Timestrip® It is very important to replace your Phasitron® P5-HC kit every 6 months for the most effective treatments. Timestrip® is a visual indicator that makes it easy for you to remember when to replace your Phasitron® P5-HC. Activating Timestrip® Firmly squeeze the bubble between your finger and thumb. You may need to squeeze it more than once to ensure all the liquid has been emptied from the bubble. Verifying Timestrip® A red line will appear on the Timestrip® within 1 to 2 minutes, indicating activation. If you do not see the red line after 3 minutes, press the bubble again. Bubble

NOTE: The Timestrip® is only supplied with the Phasitron® P5-HC home care kit.

Attach Timestrip to Phasitron® P5-HC Storage Bag Remove the adhesive tab on the back of the Timestrip® and attach the Timestrip® to the front of your Phasitron® P5-HC storage bag. NOTE: Do not attach Timestrip® to your Phasitron® P5-HC! When the red bar reaches 6 months, it is time to replace your Phasitron® P5-HC breathing circuit kit. Contact your home healthcare provider to order your new Phasitron® P5-HC kit. Timestrip® does not monitor the condition of the Phasitron® P5-HC kit. Timestrip® only records the passage of time after it is activated. If activated at the time of first using the Phasitron® P5-HC, it serves as a reminder that the kit needs to be replaced. The liquid inside the Timestrip® is not toxic. If tampered with, the Timestrip® may leak and will not function properly. WARNING: The Timestrip® may present a choking hazard to small children. Adult supervision is required. WARNING: If the liquid inside the Timestrip® contacts skin, wash with soap and water. If the liquid contacts eyes, rinse immediately with water for 15 minutes. If irritation develops, seek medical attention. Timestrip® is a registered trademark of Timestrip® Plc.

11


TRUE-IPV® In-Line Valve Setup WARNING: In-line valve setup and use are for respiratory clinicians/therapists only.

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. WARNING: Ensure TRUE-IPV® In-Line Valve is inserted into inspiratory side of ventilator circuit.

Adding Phasitron® P5-HC to In-Line Valve Install provided blue cap (color may vary) onto the Phasitron® P5-HC expiratory port. Port must be occluded for proper use and treatment. The cap is provided with TRUE-IPV® In-Line Valve kit.

Installation of TRUE-IPV® In-Line Valve with Phasitron® P5-HC

Press blue cap over Phasitron® P5-HC expiratory port. Blue cap supplied with In-Line Valve kit.

12

Fill nebulizer with 15 to 20 cc normal saline or prescribed medication. Aerosol consumption approximately .3 cc per minute. WARNING: Blue cap must be removed when giving a direct treatment, either by mouth, mask, or directly connected to endotracheal tube.


Chapter 4: Impulsator速 HC Controller Functions Knob, Switch, and Connector Knob, Switch, Connector

Function

The ON/OFF power switch turns the Impulsator速 HC controller ON and OFF.

The air intake filter is found on the top right corner of the Impulsator速 HC controller face. Replace the filter every 6 months.

The Therapy Selection switch determines therapy: percussion with nebulization or nebulization only.

The Phasitron速 P5-HC white quick-connect fitting connects to the silver PHAS. fitting. The nebulizer yellow quick-connect fitting connects to the yellow NEB. fitting.

The PERCUSSION control knob determines frequency of delivered breaths, from easy to hard.

13


Chapter 5: Impulsator® HC Pre-Use Check Regularly perform this test before using the Impulsator® HC TRUE-IPV® device. If the Impulsator® HC has been stored in conditions outside the operational conditions outlined in the Technical Specifications section of this manual, allow the unit to acclimate for 2 hours prior to using. 1.

Check that the Impulsator® HC is clean on the outside and that the power cord is in good condition.

2.

Place the Impulsator® HC on a sturdy table, keeping the device at least 8 inches from the wall. Alternately, place on the floor away from curtains, at least 8 inches from the wall.

3.

Plug the power cord into the wall electrical outlet.

4.

Connect the Phasitron® P5-HC breathing circuit according to the instructions in this manual (refer to page 8).

5.

Place the blue cap over end of Phasitron® patient port.

6. Place PERCUSSION control knob with arrow at 12:00. 7.

Turn the POWER switch to the ON position and listen for the compressor.

8. Ensure THERAPY SELECTION switch is in the Bi-PHASIC IPV® position. 9.

Increase percussion by rotating PERCUSSION control knob counterclockwise (left).

10.

Slowly rotate the PERCUSSION control knob clockwise until the knob stops. Do not force.

11.

If all steps are performed and function as described, this completes the pre-use check.

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Chapter 6: General TRUE-IPV® Therapy Protocol for Adults WARNING: Never run the Impulsator® HC without liquid in the nebulizer during your treatment. This is required for airway hydration. 1.

Place your Impulsator® HC at least 8 inches from the wall on a sturdy table. Alternatively, place the Impulsator® HC on the floor away from curtains and blankets.

2. 3.

Insert male end of power cord into wall electrical outlet. Add prescribed medications into nebulizer bowl as prescribed by your physician, to a total of 7-10 cc. If no medications are prescribed, use normal saline or sterile water. Do not exceed the 20 cc line.

4. Connect the Phasitron® P5-HC kit as indicated on package insert or Connecting the Tubing Harness to the Phasitron® P5-HC section. 5. Sit in an upright, comfortable position. Alternatively, you may lay down with your head and shoulders elevated. (Gravitational position is not a factor in TRUE-IPV® therapy.) 6.

Rotate the PERCUSSION control knob to 12:00 position.

7.

Turn the POWER switch to the ON position. The POWER switch is located on the front panel.

8.

Start your TRUE-IPV® therapy by moving the THERAPY SELECTION switch to the UP position (BI-PHASIC).

9. 10.

Rotate the PERCUSSION control knob full counterclockwise (left) to the EASY position.

11.

Place your lips firmly around the mouthpiece of the Phasitron® P5-HC with the nebulizer in an upright position.

12.

When using the mouthpiece, inhale and exhale through the programmed pulses. Let your breathing become comfortable (natural).

If this is your first treatment, observe and feel the pulses on your hand before either connecting to the airway or breathing through the mouthpiece. This will help you get used to the sensations.

NOTE: Try to keep your lips and cheeks tight to prevent nasal air venting. This may take some practice.

For patients who cannot use a mouthpiece, a mask may be required to administer therapy.

13.

Gradually start rotating the PERCUSSION control knob clockwise, moving the arrow towards the 12:00 index position (average). The goal is to gradually increase the percussive amplitude to average as breathing with TRUE-IPV® pulsed percussion becomes more comfortable.

15


14.

Increase the amplitude by rolling the BI-PHASIC wheel away from the machine.

NOTE: If air is leaking out from your nose or mouthpiece, it may indicate that you are increasing the pulsed air amplitude too fast. Only increase percussive amplitude as you can comfortably accommodate (no air leaks from nose or mouthpiece). 15.

Take normal breaths through the pulses whenever you desire. Observe your chest oscillation (shaking) when exhaling. The objective is to achieve a 15-to-20-minute TRUE-IPV® breathing treatment.

NOTE: Those patients with artificial airways use a similar process. While cheek fatigue is less of a consideration, you may need pauses during your treatment.

16.

Increase and decrease percussion frequency to raise bronchial secretions by rolling the biphasic wheel away from the machine every 30 seconds during treatment to create an intrapulmonary percussive effect that will help clear your airway and move secretions.

During your treatment, briefly rotate the PERCUSSION control knob from EASY to HARD, back and forth numerous times, and then back to the 12:00 index (average) position. This will help raise secretions from your bronchial airways.

NOTE: Keep tissues handy for expectorated (coughed up) secretions.

17.

When treatment is complete, the Impulsator® controller should be turned OFF. The Phasitron® P5-HC should be rinsed, cleaned, and stored in the supplied bag until the next treatment.

Chapter 7: Cleaning and Disinfection Controller Clean the controller according to home care/institutional protocols. Always clean between patients, and when visibly soiled. Clean the controller with a clean, lint-free cloth or paper towel moistened with the cleaner. Use only approved cleaners.

CAUTION: Do not spray any cleaning solution directly onto the device.

CAUTION: Do not immerse or allow liquids to access the device.

Phasitron® P5-HC Breathing Circuit It is not necessary to clean the Phasitron® P5-HC after each use; however rinsing with sterile water is advised. Cleaning instructions are for single patient, multiple uses. Before starting cleaning process, wash hands thoroughly with soap and water or use an alcohol-based hand sanitizer. When disassembling the Phasitron® P5-HC, visually inspect the exterior of all parts, including tubing, for corrosion, discoloration, pitting, and missing O-rings.

16


Disassembly of the Phasitron® P5-HC Disconnect tubing from controller device and Phasitron® P5-HC.

1. Rotate nebulizer bowl towards rear of Phasitron® P5-HC, moving gently past the stop to release.

2. Gently lift nebulizer cap and bowl to separate from Phasitron® P5-HC.

3. Holding the nebulizer cap, twist the nebulizer bowl to remove bowl from cap. Discard any unused medication in accordance with hospital/institutional protocol.

4. Twist white cap on the rear of Phasitron® P5-HC to remove.

5. Remove cap.

6. Remove sliding venturi and spring from Phasitron® P5-HC body.

17


Cleaning and Disinfecting Solutions The Phasitron® P5-HC breathing circuit has been tested for biocompatibility with the following cleaning solutions:

Chemical Class

Active Ingredient

Bleach Alcohol Peroxide Benzyl Ammonium Chloride Phenolic Quaternary Ammonium Chloride

5.25% Sodium hypochlorite 70% Isopropyl alcohol 3% Hydrogen peroxide N-alkyl dimethyl ethyl benzyl ammonium chlorides N-alkyl dimethyl benzyl ammonium chloride Ortho-phenylphenol Ortho-benzyl-para-chlorophenol Didecyl dimethyl ammonium chloride Alkyl dimethyl benzyl ammonium chloride

Phasitron® P5-HC Cleaning Process 1.

Thoroughly rinse each of the disassembled parts (except for tubing harness) under warm running tap water for approximately 10 seconds.

2. Use fragrance-free liquid soap added to a clean bowl or basin with warm water.

CAUTION: Do NOT use “white” liquid dish soaps or antibacterial liquid dish soap as they may contain additives harmful to parts of the Phasitron® P5-HC kit.

3.

Hand wash all parts of the Phasitron® P5-HC kit and accessories in the warm soapy water.

4.

Rinse all parts thoroughly using sterile water.

5.

Gently shake all parts to remove as much water as possible, then dry with a clean lint-free cloth or paper towel. Alternatively, place on a clean, lint-free cloth or paper towel and allow to air dry completely.

6.

Use a clean, damp cloth to wipe the exterior of the tubing harness with an approved alcohol-based cleaner.

7.

Inspect prior to reassembly for any remaining soil or damaged parts. Repeat cleaning steps if needed.

8.

Reassemble the Phasitron® P5-HC and place in the supplied bag until next use.

9.

Do not disinfect the Phasitron® P5-HC for reuse with more than one patient.

CAUTION: Use of cleaning methods not outlined in these Instructions for Use may damage the Phasitron® P5-HC and accessories. WARNING: The Phasitron® P5-HC breathing circuit is for a SINGLE patient, multiple uses.

18


Phasitron® P5-HC Disinfection Disinfection Solution: Use standard household bleach (sodium hypochlorite 5.25%) for disinfection. Mix solution of 1-part household bleach and 8-parts water. Example: 8 ounces of bleach to 64 ounces of water, or 250 ml bleach to 2 liters of water.

Disinfection Procedure: 1.

Wear disposable gloves.

2.

Pour bleach solution into an airtight container large enough to hold 64 ounces or 2 liters.

3.

Completely immerse all the Phasitron® P5-HC parts, including mouthpiece and mask, into bleach solution.

4.

Let soak for 30 minutes minimum. Do not exceed 1 hour.

5.

Rinse off cold-disinfection solution using sterile water or filtered water (less than or equal to 0.2-micron filter). Do not use tap water.

6.

Gently shake all parts to remove as much water as possible.

7.

Dry with a clean, lint-free cloth. Place on clean, lint-free cloth or paper towel and allow to air dry completely.

8.

Insert all parts into sealable plastic bag and store in a dry, clean location.

Dry Inside of Tubing Dry the inside of the tubing with air from the controller device. Connect each tube, one at a time, to the yellow connector on the controller device. Turn on device and run for two minutes at a time to remove moisture. Hang tubing to air dry. WARNING: Do not steam clean the controller or circuit. Injury or equipment damage could occur. WARNING: Do not expose the unit to excessive moisture. Injury or equipment damage could occur. CAUTION: Do not use harsh cleansers, solvents, or detergents. Equipment damage could occur. WARNING: Percussionaire® makes no claims regarding the efficacy of the listed chemicals or processes as a means for controlling infection.

19


Phasitron® P5-HC Lubrication After Cleaning and Disinfection Lubrication is needed only after cleaning and/or disinfection of your Phasitron® P5-HC breathing circuit. quick-connect fitting

Wash hands thoroughly with soap and water or use and alcohol-based hand sanitizer before reassembly and lubrication. Lightly coat each quick-connect fitting O-ring with the Percussionaire® lubricant Lubetube, supplied with the Impulsator® device. CAUTION: Only use Percussionaire® approved lubricant.

Reassembly of the Phasitron® P5-HC

CAUTION: Do NOT lubricate diaphragm.

Visually inspect O-rings on sliding venturi for cracks and damage. CAUTION: Do NOT lubricate sliding venturi O-ring. O-ring

O-ring Visually inspect O-rings on nebulizer cap for cracks and damage. CAUTION: Do NOT lubricate nebulizer cap O-ring.

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Reassembly of the Phasitron® P5-HC (continued)

Insert venturi and spring into Phasitron® P5-HC body.

Screw white cap onto rear of the Phasitron® P5-HC body until stop.

Holding the ring of the nebulizer cap, insert and twist nebulizer bowl until it locks.

Add mouthpiece, mask, and corrugated tubing to the Phasitron® P5-HC as needed.

By aligning the notch, insert the nebulizer housing into the Phasitron® P5-HC body, then rotate to lock.

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Chapter 8: Technical Specifications Impulsator® HC

Size

45.7 cm W x 45.7 cm H x 27.9 cm D (18" W x 18" H x 11" D )

Mass

6.8 kg (15 lb)

Operating Range

5°C to 40°C (41°F to 104°F) Humidity <93% non-condensing

Storage and Transport

-25°C to 60°C (-13°F to -140°F) Humidity <93% non-condensing

Power Input

120V 60Hz or 220v 50Hz

Run Time Intermittent for 15-to-20-minute treatments CAUTION: Do not exceed 20 minutes. Aerosol Flow Pulse Interval Ratio

12 litres per minute Average ratio 1:2.5

Airway Pressure

No display

Pulse Frequency

No display

Session Usage Time

No display

Percussion Frequency

110-500 pulses per minute, no display

Air intake filters: Black foam B12450, White felt B12585 Filters Cooling fan filter: B13091 Accessories Phasitron® P5-HC kit Mouthpiece 10-pack PRT-B20018 Timestrip® PRT-B20020 Lubrication Lubetube A50060 Required Maintenance

22

Every 3 years from date of manufacture


Phasitron® P5-HC

Size

13.5 mm x 17 mm (5 ¼" x 6 ¾" )

Mass

123 g (0.27 lb)

Operating Range

Temp., 0°C to 49°C (32°F to 120°F) Relative humidity range, 15% to < 90% non-condensing

Storage and Transport Range

Temp., -40°C to 60°C (-40°F to 140°F)

Rate Range

0-999 pulses per minute

Pressure Range

0-150 cmH₂O/hPa

Aerosol Flow

.3 cc per minute

Safety Valve Release

30-50 cmH₂O/hPa

Disposal

Recycle according to local laws

Service Life

6 months or 540 uses, whichever is less

Shelf Life

2 years from date of manufacture

Chapter 9: Troubleshooting Problem

Examine

Repair

Impulsator® HC will not turn on.

Unit is not connected to an approved power source.

Plug unit into an approved power source.

Loose wire or poor grounding

Service required

Fuse not functioning properly.

Check Fuse.

PERCUSSION knob is not set at 12:00.

Rotate PERCUSSION knob to 12:00.

Capacitor failure

Service required

Impulsator® HC has delayed startup.

Compressor failure Phasitron® P5-HC breathing circuit will not function.

Rotate PERCUSSION knob to 12:00. PERCUSSION knob is not set at 12:00. If no flow, service is required. Remove white quick connector from Phasitron® P5-HC. Check for pulse flow while device is running.

Nebulizer is not aerosolizing properly.

Check to see if nebulizer baffle is in place.

Replace Phasitron® P5-HC.

Check yellow line for gas flow while device is running.

If no gas flow, service is required.

Check if unit has been damaged (dropped, fallen, etc.).

Service required

No change when frequency control knob is rotated.

Check last calibration or functional check performed.

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Chapter 10: Service, Maintenance, and Repair Service and Repair Percussionaire® recommends an annual Preventive Maintenance (PM) for each device. An annual PM consists of a thorough cleaning, functional evaluation, and, if necessary, recalibration. A mandated service is required every 3 years from the date of manufacture and/or not later than 4 years. The service includes all new elastomeric components, recalibration, functional evaluation, conformance certification and a one-year warranty on all parts replaced. A device that has not received its required service, whether in use during that period or not, may be considered beyond economic repair. Service by an unauthorized individual or repair maintenance facility will cause the immediate expiration of the clinical readiness of the device. Return the device to Percussionaire® or an authorized service center for repair, required service, or annual preventive maintenance.

Maintenance Use the Phasitron® Timestrip® as your guideline for replacing filters. When the Timestrip® indicates it is necessary to replace your Phasitron® P5-HC breathing circuit, you should also check and replace filters. (Refer to Timestrip® section for information).

Air Intake Filter Replacement Check, clean, and/or change filters every 6 months (more often in dusty environments).

To replace air intake filter, remove cap by pressing small flat blade screwdriver into slot and prying up. Lift cap and then remove.

24


Air Intake Filter Replacement (Continued)

Remove grey/black filter from inside top cap.

E FILTERS ANG CH ERY 6 MONTHS EV

Remove white filter with screwdriver. R POWE ON

N ECTIO P Y SEL THERA HASIC IPV BI-P

I LIZAT NEBU

NLY ON O

OFF

E FILTERS ANG CH ERY 6 MONTHS EV

Filters removed. R POWE ON

N ECTIO P Y SEL THERA HASIC IPV BI-P

I LIZAT NEBU

NLY ON O

OFF

E FILTERS ANG CH ERY 6 MONTHS EV

Install white filter first. Insert grey/black filter into the cap. Align and reinstall cap. R POWE ON

N ECTIO P Y SEL THERA HASIC IPV BI-P

ION LIZAT NEBU

ONLY

OFF

25


Cooling Fan Filter Replacement

Lay unit on its face. Locate Allen retention screws. Insert 5/64 Allen tool and turn counterclockwise to open. Remove guard and filter. Rinse filter with plain running water. Allow to air dry.

Replace filter and filter guard. Listen for â&#x20AC;&#x153;snap.â&#x20AC;? Replace retention screw.

Fuse Replacement Locate fuse holder above power cord attachment. Remove fuse by pushing holder in and turning to the left (counterclockwise), or open with a screwdriver. Fuse holder will release.

Pull to remove fuse. Grasp fuse and cap. Separate by pulling apart. Insert new fuse and reverse steps above to replace in holder.

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Disposal of Equipment At the end of useful life of a unit, disposal should be in accordance with local, state, federal, and international laws.

Chapter 11: Limited Warranty Percussionaire® warrants that the Impulsator® HC shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of one year from the date of first use (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. This warranty does not cover damage caused by non-approved cleaning or sterilization, accident, misuse, abuse, alteration, and other defects not related to material or workmanship. Percussionaire® disclaims all liability for economic loss, loss of profits, overhead, or consequential damages which may be claimed to arise from any sale or use of this product. NOTE: In the event that the operation of a Percussionaire® product is in any way adversely affected by using components other than those designed, manufactured, or approved by Percussionaire® Corporation, Percussionaire® shall not be liable under this warranty with respect to such product.

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M 130 McGhee Road, Suite 109, Sandpoint, Idaho 83864 USA

 percussionaire.com

 +1.208.263.2549

P20048 Rev A

Profile for Percussionaire

Impulsator HC Manual  

Instruction manual for the IPV-HC (Home Care) Bi-Phasic Impulsator.

Impulsator HC Manual  

Instruction manual for the IPV-HC (Home Care) Bi-Phasic Impulsator.

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