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K Number
K071527Device Name
PNEUPAC VR1 AIR MIX
Manufacturer
SMITHS MEDICAL INTERNATIONAL, LTD.
Date Cleared
2007-10-04
(122 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
SMITHS MEDICAL INTERNATIONAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pneupac VR1 Airmix is a hand-held, portable, time maled, gas powered, flow generator ventilatory resuscitator that is suitable for emergency and transport use and will operate safely in an MRI environment up to 3 Tesla. It is designed for use by qualified medical caregivers, paramedics and other trained personnel for the following conditions: Pneupac VR1 Airmix Ventilatory resuscitator intended for use on adults and children above a bodyweight of 22 lb (10 kg) with either respiratory distress/ insufficiency or no respiratory function and including a control for providing oxygen concentrations of either 100% or 50% nominal.
Device Description
Pneupac VR1 Airmix is intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital and for ventilation by medical personnel inside and outside hospital in emergency situations and inter- hospital transport. The Pneupac VR1 Airmix allows two modes of ventilation, automatic and manual. In automatic mode the device cycles in accordance with the setting of the single tidal volume/frequency control that changes the tidal volume and frequency dependently whilst maintaining a constant I:E ratio of 1:2. In manual mode, preset breaths, singly or in a controlled breathing pattern may be selected by use of an omni-directional lever or push button. The tidal volume and rate possible are limited by the position of the single tidal volume/frequency control. The Pneupac VR1 Airmix includes a control for providing oxygen concentrations of either 100% or 50% nominal. The Pneupac VR1 Airmix uses the same technology as existing legally marketed devices and depends solely on the pressure of the supply gas for its operation. The Pneupac VR1 Airmix incorporates a pneumatic high-pressure audible alarm which dumps excess patient pressure according to the in-built relief pressure (40 cmH2O standard, 60cmH2O optional) which operates in an identical manner to the predicate devices. The Pneupac VR1 Airmix consists of a hand-held control module connected to the patient at its outlet via a mask, endotracheal tube or laryngeal mask airway and is used with various patient circuits and accessories comprising the following items; User replaceable patient valve, Oxygen input gas hose assemblies, Breathing filter, Biological breathing filter kit (optional for contaminated atmospheres), Masks, airways and airway adjuncts, Manual suction, Oxygen therapy kits, Oxygen cylinders and regulators, Carrying bag, Breathing circuits, PEEP accessories. The mass of Pneupac VR1 Airmix is 1.001lb, 0.455kg. The Pneupac VR 1 Airmix control module has the following features; Interdependent and continuous control of tidal volume and frequency from 150ml/25bpm to 1050ml/10bpm using a single tidal volume/frequency control, Demand breathing system, Spontaneous breathing under power failure, Audible pressure relief alarm, Integrated, user replaceable patient valve, Automatic or Manual mode selector, Manual mode push button and omni-directional lever, Airmix control for providing oxygen concentrations of either 100% or 50% nominal.
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K Number
K051322Device Name
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
Manufacturer
SMITHS MEDICAL INTERNATIONAL, LTD.
Date Cleared
2005-08-05
(77 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
SMITHS MEDICAL INTERNATIONAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pneupac VR1 range are hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are suitable for emergency and transport use and will operate safely in an MRI environment up to 3 Tesla. They are designed for use by qualified medical caregivers, paramedics and other trained personnel for the following conditions:
Pneupac VR1 Standard - Ventilatory resuscitator intended for use on adults and children above a bodyweight of 22 lb (10 kg) with either respiratory distress/insufficiency or no respiratory function.
Pneupac VR1 Responder Basic ventilatory resuscitator intended for use on adults and children above a bodyweight of 22 lb (10 kg) with no respiratory function.
Device Description
Pneupac VR1 Standard and VR1 Responder is intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital and for ventilation by medical personnel inside and outside hospital in emergency situations and for intra- and interhospital transport.
The Pneupac VR1 range comprises two variants - Pneupac VR1 (standard model) and Pneupac VR1 Responder (standard model without spontaneous breathing system).
The Pneupac VR1 Standard and VR1 Responder allow two modes of ventilation, automatic and manual. In automatic mode the device cycles in accordance with the setting of the single tidal volume/frequency control that changes the tidal volume and frequency dependently whilst maintaining a constant I:E ratio of 1:2. In manual mode, preset breaths, singly or in a controlled breathing pattern may be selected by use of an omni-directional lever or push button. The tidal volume and rate possible are limited by the position of the single tidal volume/frequency control.
The Pneupac VR1 Standard and VR1 Responder use the same technology as existing legally marketed devices and depends solely on the pressure of the supply gas for its operation.
The Pneupac VR1 Standard and VR1 Responder incorporate a pneumatic high-pressure audible alarm which dumps excess patient pressure according to the in-built relief pressure (40 cmH2O standard, 60cmH20 optional) which operates in an identical manner to the predicate devices.
The Pneupac VR1 Standard and VR1 Responder consists of a hand-held control module connected to the patient at its outlet via a mask, endotracheal tube or laryngeal mask airway and is used with various patient circuits and accessories comprising the following items;
- User replaceable patient valve
- Oxygen input gas hose assemblies
- Breathing filter
- Biological breathing filter kit (optional for contaminated atmospheres)
- Masks, airways and airway adjuncts
- Manual suction
- Oxygen therapy kits
- Oxygen cylinders and regulators
- Carrying bag
- Breathing circuits
- PEEP accessories
The specification for the recommended, optional biological breathing filter are as follows;
- Filter efficiency at least 99.99% efficient against a 0.3micron mass median aerodynamic diameter aerosol challenge at 32 1/min.
- Airflow resistance at 32 1/min. is 10-17 mm H2O
- Connector size 40mm DIN NATO compatible threads
The mass of Pneupac VRI Standard and VRI Responder resuscitators is; Pneupac VR1 0.880lb. 0.400kg Pneupac VR1 Responder 0.825lb, 0.375kg
The Pneupac VR1 Standard and VR1 Responder standard control module has the following features:
- Interdependent and continuous control of tidal volume and frequency from 150ml/25bpm to 1050ml/10bpm using a single tidal volume/frequency control
- Demand breathing system (not featured on the VRI Responder model)
- Spontaneous breathing under power failure
- Audible pressure relief alarm
- Integrated, user replaceable patient valve
- Automatic or Manual mode selector
- Manual mode push button and omni-directional lever
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