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510(k) Data Aggregation
K Number
K140598Device Name
PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC
Manufacturer
DIMA ITALIA SRL
Date Cleared
2014-10-16
(220 days)
Product Code
NHJ
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
DIMA ITALIA SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PEGASO A-COUGH PERC is designed for the use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotrached tube. For use in hospital, institutional setting, or home use given adequate training.
For use on adult patients and pediatric patients 3 years old and up.
The PEGASO A-COUGH is designed for the use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in hospital, institutional setting, or home use given adequate training.
For use on adult patients and pediatric patients 3 years old and up.
The PEGASO COUGH is designed for the use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube. For use in hospital, institutional setting, or home use given adequate training.
For use on adult patients and pediatric patients 3 years old and up.
The Dima Italia Srl Pegaso Cough assists patients in clearing retained bronchopulmonary secretions by gradually applying a positive pressure to the airway, then rapidly shifting to a negative pressure. This rapid shift in pressure, via a facemask, mouthpiece or an endotracheal or tracheostomy tube, produces a high expiratory flow rate from the lungs, simulating a cough.
Device Description
The Dima Italia Srl Pegaso Cough is an electric device useful in clearing retained bronchopulmonary secretions. It acts a "cough" patient simulation, applying a positive air pressure to the airway, then rapidly shifting to a negative air pressure. At the end of this pressure shifting, the Pegaso Cough leaves the airways free, at zero pressure, for a pause time determined by operator.
The Inspiratory Flow rising time can be selected on four levels: Peak, High, Medium, Low.
This "Forced Insufflation" is destinated to patients with reduced coughing possibilities due to muscular dystrophy, myasthenia gravis, poliomyelitis respiratory muscles paralysis, such as spinal cord injury. Even patients with other diseases, such emphysema, cystic fibrosis, can be treated with Pegaso Cough.
It can be used with a facemask or, with an adapter, to an endotracheal or tracheostomy tube.
The Pegaso Cough is realized with a blower, used as pressure and flow generator, and a mechanical valve, commanding the sign and the air pressure intensity outing to the patient.
The blower takes air from atmosphere, and compresses it in order to generate a positive or negative pressure. The pressure value is controlled by an electronic sensors.
In order to reduce the risks of adverse reactions, an (optional) Masimo oximeter has been added.
An optional flow sensor (trigger) has been added in order to synchronize the inspiration cycles to the first or all the inspiratory efforts of the patient.
An optional high frequency oscillatory vibration (percussion mode) has been added in order to help to clear retained bronchopulmonary secretions.
So, Pegaso Cough (without options), Pegaso A-Cough (with the trigger option), Pegaso A-Cough Perc (with trigger and percussion options) identification names will be used.
Pegaso Cough, Pegaso A-Cough, Pegaso A-Cough Perc are equivalent devices.
The Inspiratory/Expiratory cycles are determined by the blower rotation and the mechanical valve positioning. This valve is connected to a step-motor, whose position is detected through an optical sensor. The valve lets the positive flow go toward the patient and the negative flow toward the atmosphere or, instead, the positive flow to the atmosphere and the negative flow toward the patient.
The working parameters are visualized on a colour TFT display and modified through a touch keyboard.
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K Number
K140605Device Name
MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC
Manufacturer
DIMA ITALIA SRL
Date Cleared
2014-10-03
(207 days)
Product Code
NHJ
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
DIMA ITALIA SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MINI PEGASO A-COUGH PERC is designed for the use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in hospital, institutional setting, or home use given adequate training. For use on adult patients and pediatric patients 3 years old and up.
The MINI PEGASO A-COUGH is designed for the use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube. For use in hospital, institutional setting, or home use given adequate training. For use on adult patients and pediatric patients 3 years old and up.
The MINI PEGASO COUGH is designed for the use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube. For use in hospital, institutional setting, or home use given adequate training. For use on adult patients and pediatric patients 3 years old and up.
Device Description
The Dima Italia Srl Mini Pegaso Cough is an electric device useful in clearing retained bronchopulmonary secretions. It acts a "cough" patient simulation, applying a positive air pressure to the airway, then rapidly shifting to a negative air pressure. At the end of this pressure shifting, the Mini Pegaso Cough leaves the airways free, at zero pressure, for a pause time determined by operator. The Inspiratory Flow rising time can be selected on four levels: Peak, High, Medium, Low. This "Forced Insufflation" is destinated to patients with reduced coughing possibilities due to muscular dystrophy, myasthenia gravis, poliomyelitis respiratory muscles paralysis, such as spinal cord injury. Even patients with other diseases, such emphysema, cystic fibrosis, can be treated with Mini Pegaso Cough. It can be used with a facemask or, with an adapter, to an endotracheal or tracheostomy tube. The Mini Pegaso Cough is realized with a blower, used as pressure and flow generator, and a mechanical valve, commanding the sign and the air pressure intensity outing to the patient. The blower takes air from atmosphere, and compresses it in order to generate a positive or negative pressure. The pressure value is controlled by an electronic sensors. In order to reduce the risks of adverse reactions, an (optional) Masimo oximeter has been added. An optional flow sensor (trigger) has been added in order to synchronize the inspiration cycles to the first or all the inspiratory efforts of the patient. An optional high frequency oscillatory vibration (percussion mode) has been added in order to help to clear retained bronchopulmonary secretions. So, Mini Pegaso Cough (without options), Mini Pegaso A-Cough (with the trigger option), Mini Pegaso A-Cough Perc (with trigger and percussion options) identification names will be used. Mini Pegaso Cough, Mini Pegaso A-Cough, Mini Pegaso A-Cough Perc are equivalent devices. The Inspiratory/Expiratory cycles are determined by the blower rotation and the mechanical valve positioning. This valve is connected to a step-motor, whose position is detected through an optical sensor. The valve lets the positive flow go toward the patient and the negative flow toward the atmosphere or, instead, the positive flow to the atmosphere and the negative flow toward the patient. The working parameters are visualized on a colour TFT display and modified through a touch keyboard.
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K Number
K072290Device Name
PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS
Manufacturer
DIMA ITALIA SRL
Date Cleared
2008-05-29
(287 days)
Product Code
BYT
Regulation Number
868.5935Why did this record match?
Applicant Name (Manufacturer) :
DIMA ITALIA SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The New Negavent Ventilator DA-3 Plus Pegaso V is a timed-cycled, pressure ventilator that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient. The ventilator works with a cuirass, poncho, or a ventilating chamber (Porta-Lung).
Device Description
The Pegaso V is an assisted/controlled non-invasive ventilation system. It can work with a cuirass, poncho, or a ventilating chamber (Porta-Lung). An optional Trigger can be installed, sensing the spontaneous demands of the patient and permitting the use in Synchro/Timed, Spontaneous/Timed and Spontaneous with Plateau modes. If the Triggers are installed, the Autoparameters Function is enabled too, permitting the evaluation of the Respiratory Frequency and I/E Ratio of the patient in automatic mode. The negative pressure ventilation is a mechanical kind of ventilation similar to the human spontaneous ventilation. The Pegaso V is designed around a blower, used as pressure and flow generator, and a mechanical valve, commanding the sign and the air pressure intensity outing to the patient. The blower takes air from the atmosphere, compresses it in order to generate a pressure/depressure controlled by electronic sensors. Leaks are compensated cycle by cycle. The Inspiratory/Expiratory cycles are determined by the blower rotation and the mechanical valve positioning. This valve is connected to a step-motor, whose position is detected through an optical sensor. The valve lets the compressed flow go toward the patient and the depressed flow toward the atmosphere or, instead, the compressed flow to the atmosphere and the depressed flow toward the patient. The working parameters are displayed on an LCD and controlled through a touch keyboard.
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K Number
K072292Device Name
NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS
Manufacturer
DIMA ITALIA SRL
Date Cleared
2008-01-07
(144 days)
Product Code
NHJ
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
DIMA ITALIA SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in a hospital, institutional setting, or home use given adequate training. For use on adult or pediatric patients.
Device Description
The Pegaso Cough Assist is a negative pressure, non-invasive ventilation system useful in clearing retained bronchopulmonary secretions. It produces a patient "cough" simulation, applying a positive pressure to the airway, then rapidly going to a negative pressure. At the end of this pressure shifting, the Pegaso Cough leaves the airway free, at zero pressure, for a pause time determined by the operator. The Peak Inspiratory Flow can be selected on three different levels: High, Medium, Low.
This "forced insufflation-exsufflation" is designated for patients with reduced coughing possibilities due to muscular dystrophy, myasthenia gravis, poliomyelitis, and respiratory muscle paralysis such as spinal cord injury. Even patients with other diseases, such as emphysema and cystic fibrosis, can be treated with the Pegaso Cough. It may be used with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. The Pegaso Cough is indicated for use in a hospital, institutional setting, or home use given adequate training.
The Cough Assist device applies a positive pressure in the airway initially. The device shifts to a negative pressure through a facemask, mouthpiece, or an adapter to the patient's endotracheal tube or tracheostomy tube. The rapid shift produces a high expiratory flow from the lungs simulating a cough and clearing secretions. At the end of this pressure shifting, the Pegaso Cough leaves the airway free at zero or ambient pressure. A pause time between cycles is operator selected.
FDA classifies this device as a noncontinuous ventilator under 868.5905. Product Code NHJ under the Anesthesiology Review Panel. The device meets the requirements for medical equipment general requirements for basic and essential safety performance and electromagnetic compatibility.
The Pegaso Cough is comparable to the Emerson Cough Assist cleared under K002598 and have the similar indications for use.
The device is software controlled and has safety alarms for no pressure, high pressure, valve fault, low pressure, and power failure. Performance is controlled from a touch screen keyboard in manual or automatic modes.
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