This document outlines the routine service and maintenance procedures for the Smiths Medical Pneupac paraPAC P200, P200D, and P220D ventilators, focusing on Level 1 periodic performance checks. It is intended for qualified personnel trained and certified by Smiths Medical to ensure the equipment's safe and effective operation.
Function Description
The Pneupac paraPAC series ventilators are designed for medical gas delivery, specifically for ventilation and oxygen therapy. These devices are crucial for providing respiratory support in various medical settings. The P200D and P220D models include additional features such as demand/inhibit functions and a nebuliser connection (P220D only), enhancing their versatility for different patient needs. The ventilators operate by delivering controlled breaths and can be configured for various tidal volumes and frequencies, with or without air mix, to suit the patient's requirements. They incorporate safety features like pressure relief mechanisms and audible/visual alarms to alert users to potential issues such as high pressure, low pressure, or low battery. The gas supply indicator changes from red to white when sufficient pressure is available, providing a clear visual cue of operational readiness.
Usage Features
The paraPAC ventilators are designed for ease of use while providing critical respiratory support. Key operational features include:
- Control Knobs: The device features clearly marked control knobs for adjusting frequency, tidal volume, and variable relief pressure. These knobs are designed for smooth movement and secure positioning, with click-stop mechanisms for precise settings (e.g., 12 bpm for frequency). The Air Mix/No Air Mix switch allows for selection between delivering 100% oxygen or an air-oxygen mixture, with a click-into-position feature for the No Air Mix setting and a spring-back action to Air Mix when released.
- On/Off (CMV/Demand) Switch: This switch controls the ventilator's primary function, allowing users to initiate or cease cycling. For models P200D and P220D, a "Demand" position enables patient-triggered breathing, inhibiting automatic cycling when the patient demands a breath.
- Gas Supply Indicator: A visual indicator changes from red to white when the gas supply pressure is adequate, ensuring the user is aware of the ventilator's operational status.
- Alarm Functions: The ventilators are equipped with comprehensive alarm systems, including:
- High Pressure Alarm: A red LED (top left) flashes, and a pneumatic audible alarm sounds, followed by an electronic audible alarm, when the pressure exceeds safe limits.
- Low Pressure/Disconnect Alarm: A yellow LED (top right) flashes, and a medium priority audible alarm sounds, indicating a disconnect or low supply pressure.
- Low Battery Alarm: A flashing low battery light alerts the user when the battery needs replacement.
- Breathing Detect LED (P200D/P220D only): A green LED (bottom centre) illuminates briefly when a patient-triggered breath is detected, providing feedback on demand ventilation.
- Silence Button: Allows for temporary silencing of audible alarms for 60 seconds.
- Nebuliser Connection (P220D only): This dedicated connection provides an output for nebuliser therapy, expanding the device's utility for patients requiring medication delivery via inhalation.
- Patient Valve: The patient valve assembly is designed to connect securely to patient hoses and masks, ensuring efficient gas delivery. It is designed for easy disassembly for cleaning and inspection of the valve element (lip membrane).
- Oxygen Therapy Unit (Optional): An optional oxygen therapy unit can be connected to the regulator assembly to provide continuous oxygen flow, independent of the ventilator's cycling.
Maintenance Features
The routine service manual emphasizes thorough periodic checks to ensure the paraPAC ventilators remain in optimal working condition. Key maintenance features and procedures include:
- Regular Performance Checks: The user is advised to determine the frequency of periodic checks based on intensity of use, typically not more often than every 6 months but at least once every 2 years. These checks require calibrated equipment to ensure accuracy.
- Qualified Personnel: All servicing and repairs must be performed by adequately trained and certified personnel who are fully conversant with the User's Manual and relevant health and safety regulations, particularly concerning pressurised gases.
- Oxygen Safety: Strict adherence to oxygen safety protocols is paramount. This includes never allowing oil, grease, or combustible lubricants to contact any part of the ventilator, regulator, cylinder, or repair tools. Regulator assemblies must never be immersed in liquid.
- Component Inspection:
- Carry Case: Regular inspection for tears, damage to wooden stiffeners, condition of elastic and Velcro strapping, security of handles, and operation of zips.
- Regulator Assembly: Detailed checks include verifying the condition of the T-handle, circlip, hexagonal nut, gas indexing pins, sintered filter (for cleanliness and blockage), outlet connector, pressure gauge (for damage, accuracy, and protection by the rubber shroud), and rubber blow-out discs. The secondary relief valve must also be checked for damage or blockage.
- Cylinder Key: Inspection for cracking or frayed attachment cable.
- Input Hose: Checks for damage, cuts, abrasions, internal damage, delamination, blisters, bubbles, and integrity of union ends. Pressure hoses dated from January 1, 2002, should be replaced after 5 years.
- paraPAC Unit: Inspection for damage to gas input/output fittings, gauge, control knobs, case, and labels. The nebuliser outlet connection (P220D) and manometer connection (EP option) must be checked for blockage and security. The sintered filter in the input connector must be clean and replaced if dirty.
- Patient Hose: Inspection for damage, splits, or holes in the corrugated tube. For EP Option circuits, the complete circuit and adaptor at the patient valve end must be checked for defects, and the filter (W7085) in the sensing line replaced.
- Patient Valve: Disassembly and inspection of the valve element (lip membrane) for splits or tears, and the annular disc (200D only) for condition.
- Battery Maintenance: The battery cap orientation must match the battery type. The existing battery should be removed to check its last change date, and replaced if older than 12 months. For MR environments, specific MR-compatible batteries (W269-023) must be used.
- Calibration and Performance Testing:
- Regulator Output: Testing static and dynamic output pressures using a Test Unit (500-A615) with both full and quarter-full cylinders. Creeping pressure indicates a leaking main valve seat.
- Constant Flow Selector Head (500-A958): If fitted, performance is checked using a calibrated flowmeter (e.g., 500-82636) across various flow settings.
- Air Entrainment NRV: Functionality is checked by occluding the patient valve outlet and observing the rapid rise of the inflation pressure monitor needle and the activation of pneumatic and electronic alarms. Jerky needle movement indicates a fault.
- CMV/Demand Function (P200D/P220D only): Testing involves demanding breaths at different rates and sizes to ensure the ventilator inhibits automatic cycling correctly and restarts when demand ceases. The spontaneous breathing valve is also checked for proper air intake when the gas supply is depleted.
- Frequency and Tidal Volume: Checked with and without air mix using a Pneupac backpressure device (500A82803) and ratePAC (510-A1541), and a calibrated respirometer (500-82802) across the full range of settings.
- Relief Pressure and Audible Alarm: Tested with and without air mix by temporarily closing the backpressure device at various settings to ensure the pneumatic and electronic alarms activate correctly.
- Oxygen Concentration: Checked with air mix using an oxygen monitor (POM 602) at specified tidal volumes and frequencies.
- Nebuliser Output (P220D only): Pressure output from the nebuliser connection is checked using a calibrated gauge during inspiration and expiration.
- Oxygen Therapy Unit (500-A253/CE): Flow accuracy is checked using a calibrated flowmeter.
- Documentation: Recording of serial numbers, service dates, repairs, and replacements is mandatory. An acceptance signature on the Service Record sheet is required.
- User Handbook: Verification that the User Handbook is present and in good condition, with replacement recommended if missing.
- MR Compatibility: For use in MR environments, it is critical to ensure that only MR-compatible spares or accessories are used.
- CE Marking: The manual highlights that only accessories, ancillaries, and spares authorized by Smiths Medical (marked with /CE) should be fitted to maintain conformity with the European Medical Devices Directive 93/42/EEC.
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