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Sentec IPV 1 Instruction Manual

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IPV® 1 System
Instruction Manual

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Summary of Contents for Sentec IPV 1

  • Page 1 IPV® 1 System Instruction Manual...
  • Page 2 The contents of this document may not be reproduced in any form or communicated to any third party without the prior written consent of Sentec. While every effort is made to ensure the correctness of the information provided in this document, Sentec assumes no responsibility for errors or omissions.

  • Page 3: Table Of Contents

    Table of Contents 1. Introduction..............................1 About This Instruction Manual ......................1 Related Documents and Resources ....................1 Glossary of Symbols ..........................2 Safety Information ..........................4 Y Warnings ............................5 Y Precautions ..........................6 Technical Assistance ..........................7 2. Indications for Use/Intended Purpose ..................7 Intended Patient Population ......................7 Intended Use Environment ......................7 Intended User Profile .........................7 Indications for Use ..........................7...
  • Page 4 8. Prepare for Patient-Airway Connection .................27 9. Administer IPV® Therapy .......................27 10. Cleaning and Maintenance Protocol ..................29 Digital Display ...........................29 Roll Stand Assembly ........................29 Breathing Circuit - Phasitron® 5 UC ..................30 Breathing Circuit - Phasitron® 5 UC - Cleaning Process ...........31 11.

  • Page 5: Introduction

    • Symbol definitions • Safety information, including warnings and cautions • Technical assistance information Related Documents and Resources The current version of this manual, specifications, clinical studies, and additional information is available at: customerservice.uk@sentec.com IPV® 1 System Instruction Manual 1...

  • Page 6: Glossary Of Symbols

    Glossary of Symbols The table below summarizes symbols that may be used on the IPV® 1 (including all its related parts), on the packaging, and in the associated documentation. These symbols indicate information essential for proper use; the order of their appearance is not prioritized.
  • Page 7 Symbol Name Description Atmospheric pressure Indicates the atmospheric pressure limits limitation to which the medical device can be safely exposed. Single patient - Indicates a medical device that may be multiple use used multiple times (multiple procedures) on a single patient. Mandatory action: refer Indicates that the instruction manual must to Instruction manual...

  • Page 8: Safety Information

    Glossary of Symbols, continued Symbol Name Description General Caution - Indication that caution is Caution necessary when operating or cleaning the device to avoid undesirable circumstances. Class 9 - UN3091 Lithium metal batteries contained in or packed with the equipment, but not attached to the source.

  • Page 9: Y Warnings

    Do not recharge, disassemble, heat above 100°C (212°F), or incinerate. Replace cell with type recognized CR123A only, or Sentec Part #B13350. Use of another cell may present a risk of fire or explosion. Carefully follow assembly instructions outlined in this instruction manual.

  • Page 10: Y Precautions

    • Care should be taken to appropriately suction secretions as they mobilize into the upper airways. • Use only genuine Sentec parts and accessories. Cleaning and IPV® 1 Controller: Disinfection • Clean as required. Do not spray any liquid directly onto the device.

  • Page 11: Technical Assistance

    The IPV® 1 System is intended to be used by healthcare professionals (including respiratory technicians), clinically trained in Airway Clearance Therapy and trained on the Sentec IPV® systems. Indications for Use The IPV® 1 System is used where Airway Clearance Therapy (ACT) is indicated. ACT is indicated for mobilization of secretions, lung expansion therapy, and the treatment and prevention of pulmonary atelectasis.

  • Page 12: Expected Clinical Benefits Of Ipv

    Expected Clinical Benefits of IPV® The IPV® 1 System is a form of IPV® used for ACT. During operation, the system provides a continuous, dense aerosol mist to reduce the adhesive and cohesive forces of retained airway secretions. IPV® is used in many respiratory conditions where the following clinical and/or physiological benefits are desired: •...

  • Page 13: Principles Of Operation

    3. Principles of Operation The IPV®1 device operates pneumatically, independent of electrical energy, delivering variable-frequency and variable-amplitude oscillatory ventilation to patients via a breathing circuit. This circuit includes the Phasitron® 5 UC, which utilizes a sliding venturi assembly to convey kinetic energy from the IPV® 1 and dynamically entrain additional oxygen or air as necessary, adjusting to the patient’s compliance and resistance.

  • Page 14: Description

    4. Description The IPV® 1 System consists of devices which provide Intrapulmonary Percussive Ventilation (IPV®), a form of Airway Clearance Therapy (ACT). The IPV® therapy system is designed specifically for noncontinuous institutional/ hospital/physician’s office use and provides high-frequency percussive flow that works around obstructions, recruits the lungs, breaks up and loosens secretions and mucus plugs, and enables the expiratory flow necessary to move those secretions outward.

  • Page 15: Front Panel

    Front Panel 1. Digital Display 2. AMPLITUDE Adjustment Knob 3. GAS SOURCE Selector Knob 4. Breathing Circuit Connector 5. FREQUENCY Adjustment Knob 6. Phasitron® 5 UC Holder Control Functions Control Functions FREQUENCY determines the rate of high-frequency percussive pulses delivered to the patient. AMPLITUDE determines the pressure delivered to the patient.

  • Page 16: Back Panel

    Control Functions, continued Digital Display reads and displays Mean Airway Pressure (MAP), Pulse Frequency, Session Time, and Pulse Amplitude. NOTE: Refer to Chapter 5, Digital Display. Back Panel 1. Pole Clamp 2. Phasitron® 5 UC 3. AIR Connector 4. Bleed Vent 5.

  • Page 17: Digital Display

    5. Digital Display A digital display found on the front panel of the IPV® 1 device provides feedback of the patient proximal airway pressures, pulse frequency, and elapsed treatment time. The display has six different operating modes: POST, Wake, Active, Report, Sleep, and Fault. Note: The display will not awaken until feed- back from proximal line on the Phasitron®...

  • Page 18: Wake Mode

    Wake Mode To wake up the display, ensure the IPV® 1 Amplitude is greater than 7 cmH₂O/hPa at the Phasitron® 5 UC patient-delivery port for more than 1 second. The display remains on for the first 15 seconds, showing the bar-graph timer. If session is stopped within 12 seconds, the display enters Report mode.

  • Page 19: 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 session resumes and the display enters Active Mode. During the 5-minute period, a horizontal bar graph indicates the time by moving from left to right at a fixed rate.

  • Page 20: Fault Mode

    Fault Mode The display has both hardware and software fault detection. The dedicated hardware “watchdog” 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 21: Digital Display - Setup

    The user can exit the Fault mode by removing and replacing the batteries. This resumes normal operation of the IPV® 1 display but does not erase the faults stored in memory or fix the problem that caused the fault. NOTE: For instructions on changing batteries, refer to Changing Display Module Batteries in Chapter 12.

  • Page 22: Setup

    Digital Display - Setup, continued Install batteries into display Installing batteries: note positive terminals face same direction. USB serial port: for service only. Side view of display module 6. Setup IPV® Mounted to Standard Roll Stand Roll Stand Assembly The IPV® 1 mounts onto a standard 19 mm to 38 mm (0.75- to 1.5-inch) hospital roll stand assembly.

  • Page 23: Attaching Ipv® 1 To Stand

    Attaching IPV® 1 to Stand To mount device onto pole: Open clamp. Use adjuster nut to set pole thickness. Close and lock clamp. YWARNING: Do not force close clamp mount with tool or excessive force, damage may occur to the clamp. IPV®...

  • Page 24: Breathing Circuit - Phasitron ® 5 Uc

    Only use Sentec accessories designed specifically for use with the IPV® 1 device. Function is not guaranteed with any third-party equipment.

  • Page 25: Breathing Circuit - Phasitron® 5 Uc - Configurations

    Breathing Circuit - Phasitron® 5 UC - Configurations The Phasitron® 5 UC breathing circuit can be used with a mouthpiece or face mask. It can also be used without a mouthpiece or mask. Hydrophobic Filter Without mouthpiece With mouthpiece With face mask (sold separately) (included) or mask...

  • Page 26: Breathing Circuit - Connecting To The Ipv® 1

    Breathing Circuit - Connecting to the IPV® 1 The Phasitron® 5 UC breathing circuit connects into the bottom of the IPV® 1 device. Connecting Tubing to Phasitron® 5 UC NOTE: The tubing connectors will only fit onto the correct part. Connect yellow tubing quick-connect fitting to nebulizer bowl.

  • Page 27: Adding Liquid Solution

    Adding Liquid Solution OPEN nebulizer: Twist nebulizer bowl to the left to open. Add liquid solution, e.g., saline, as directed by physician. CLOSE nebulizer: Apply the lid and twist the nebulizer bowl to the right to close. IPV® 1 System Instruction Manual 23...

  • Page 28: Pre-Use Check

    7. Pre-Use Check 1. Verify the GAS SOURCE knob in the “OFF“ position. 2. Connect the IPV® 1 to medical oxygen or air gas supply. 3. Connect a Siemens®-style 1-liter ventilator test lung (A) to the Phasitron® 5 UC (B). 4.
  • Page 29 7. Rotate the FREQUENCY control knob fully counterclockwise. 8. Confirm frequency rate of 300 or above. NOTE: Displayed pressure and time are for illustrative purposes only. 9. Verify the mean airway pressure (MAP) indicated on the digital display is greater than 15 cmH₂O. NOTE: Displayed pulse amplitude, time, and frequency are for illustrative purposes only.
  • Page 30 12. Verify the mean airway pressure (MAP) indicated on the digital display is greater than 10 cmH₂O. NOTE: Displayed pulse amplitude, time, and frequency are for illustrative purposes only. 13. Rotate the FREQUENCY control knob to the center, straight up position. 14.

  • Page 31: Prepare For Patient-Airway Connection

    8. Prepare for Patient-Airway Connection To prepare for patient-airway connection, complete the following steps: 1. Rotate AMPLITUDE control knob clockwise to stop (off). 2. Connect the IPV® 1 to medical gas source. Ensure GAS SOURCE switch is switched to OFF. 3.
  • Page 32 9. Administer IPV® Therapy, continued 5. After the patient obtains the ability to prevent the leaking of percussive air deliveries from the nose and around the lips, the entire Pulse Frequency range should be scanned by rotating the FREQUENCY control knob. This works to raise secretions from the bronchial airways.

  • Page 33: Cleaning And Maintenance Protocol

    CaviWipes if needed to remove visible soil. A visual inspection should be performed to ensure soil has been removed. NOTE: Sentec 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 34: Breathing Circuit - Phasitron® 5 Uc

    10. Cleaning and Maintenance Protocol, continued We recommend testing cleaning solutions on a small, non-visible area of the mounting assembly to verify compatibility (will not damage stand). CAUTION: • Do not use strong chemicals or solvents such as acetone or trichloroethylene. •...

  • Page 35: Breathing Circuit - Phasitron® 5 Uc - Cleaning Process

    4. Twist the white cap on the rear of the Phasitron® 5 UC to remove. 5. Remove the cap. 6. Remove the sliding venturi and spring from the Phasitron® 5 UC body. Breathing Circuit - Phasitron® 5 UC - Cleaning Process To clean the Phasitron 5®...

  • Page 36: Troubleshooting

    WARNING: Do not disinfect the Phasitron® 5 UC breathing circuit kit for reuse for more than one patient. NOTE: The Phasitron® 5 UC breathing circuit is a single-patient device. 11. Troubleshooting CAUTION: If you notice any unexplained changes in the performance of the IPV® 1 controller unit or Phasitron®...

  • Page 37: Breathing Circuit - Phasitron® 5 Uc

    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 incin- erate. Replace cell with type recognized CR123A only, or Sentec Part# B13350. Use of another cell may present a risk of fire or explosion.

  • Page 38: Disposal Of Equipment

    – with a replacement component. Warranty Exclusions and System Performance Sentec can neither guarantee nor verify product performance characteristics, nor accept warranty or product liability claims, if the recommended procedures are not carried out, if the product has been subject to misuse, neglect or accident, if the product has been damaged by extraneous causes, or if accessories other than those recommended by Sentec are used.

  • Page 39: Technical Specifications

    14. Technical Specifications Controller Dimensions (W x H x D) 23.79 cm x 18.31 cm x 17.53 cm (9.4” x 7.2” x 6.9”) Weight 1.45 kg (3.2 lb) Phasitron Holder Safe 4.54 kg (10 lb) Working Load Operating Range 18°C to 26°C (64.4°F to 78.8°F) -30°C to +60°C (-22°F to 140°F) Storage and Transport Up to 75% relative humidity...

  • Page 40: Electromagnetic Susceptibility

    WARNING: The use of accessories and cables other than those specified, with the exception of parts sold by Sentec as replacements for internal components, may result in increased emissions or decreased immunity of the IPV® 1 System.

  • Page 41: Electromagnetic Emissions

    (1) the IPV® 1 does not cause harmful interference received, including interference that may cause unde- sired operation. Changes or modifications not expressly ap- proved by Sentec can void the user authority to operate the device. Immunity Test Compliance level Electromagnetic Environment...
  • Page 42 Electromagnetic Emissions, continued Proximity IEC 60601 Compliance Electromagnetic Test Test Level Level Environment Guid- ance: IEC 61000-4-3 385 MHz: 27 V/m @ 18 Hz 27 V/m The IPV® 1 System pulse modulation is suitable for the electromagnetic environment of 450 MHz: 28 V/m 28 V/m typical hospital @ FM modulation...

  • Page 43: Glossary

    15. Glossary Active Mode: the digital display actively measures the pressure, computes the parameters, and displays them on the display. The Active mode display metrics include pulse frequency and mean airway pressure. Airway Clearance Therapy (ACT): Loosens thick, sticky mucus so it can be cleared from the lungs.
  • Page 44 magnetic field gradients, and radio waves to generate images of the organs in the body. Mean Airway Pressure (MAP): the average pressure lungs are exposed to during mechanical ventilation both during inspiration and expiration. Nebulizer: a device for producing a fine spray of liquid, used, for example, for inhaling a prescribed medication.
  • Page 45 Total Usage timer: a timer that displays the total number of time the device has been operated. Transient error: an error that will resolve itself. Most typically these errors manifest as a connection to the database server being dropped. Transient errors can occur, for example, when hardware or network failure happens.
  • Page 46 M Percussionaire®, 130 McGhee Rd., Suite 109, Sandpoint, Idaho 83864 y MDSS GmbH, Schiffgraben 41, 30175 Hannover, Germany sentec.com  +1.208.263.2549  0123 P20220 Rev B Date of Release: 2024-08...