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510(k) Data Aggregation
K Number
K030803Device Name
PARAPAC 200D TRANSPORT, MODEL V200D
Manufacturer
PNEU PAC, LTD.
Date Cleared
2003-09-29
(200 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
PNEU PAC, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The paraPAC 200D 'Transport' ventilator is a portable, gas powered, time-cycled ventilator that is designed for ventilation during transportation and emergency ventilation of patients who have respiratory distress or insufficiency.
Device Description
The paraPAC 'Transport' ventilator is a gas powered, time cycled, volume preset, pressure limited ventilator which uses the same technology as existing legally marketed devices. It depends solely on the pressure of the supply gas for its operation. Additionally, it incorporates an integrated electronic pressure alarm unit to alert the user to certain significant changes that may occur in the patient's ventilation. Loss of battery power for the alarm is signalled to the user but will have no effect on the ventilation performance of the paraPAC "Transport" ventilator, nor affect the mechanically operated alarms and protection systems, which operate in an identical manner to the predicate devices.
The paraPAC 'Transport' ventilator consists of a control module and patient circuit comprising the following disposable items: Hose/ Patient Valve/ PEEP Valve/ Exhaust Collector and Mouthpiece.
The module weighs 3.1 kilograms.
The module control panel has the following features:
- Adjustable Relief Pressure Control, range 20 to 80 cm H2O. .
- Air Mix (45% oxygen) / No Air Mix (100% oxygen) Selector. ●
- Inspiratory Time Range 3.0 to 0.5 seconds. .
- . Expiratory Time Range 6.0 to 0.5 seconds.
- Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. .
- Flow Range 0.1 to 1.0 L/sec. .
- Ventilation: Off (Spontaneous breathing)/ On (Spontaneous breathing/ Controlled Mandatory . Ventilation).
- Supply Gas Failure Alarm A mechanically operated visual alarm gives a warning that the . supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification (< 35 psi). With low pressure it shows red, with adequate pressure it shows white. Any visible red indicates that the supply should be changed. In most cases the display will begin to oscillate from white to partial red as the supply pressure falls to the lower threshold level.
The visual indication will be accompanied by an electronically generated medium priority (to EN 475) audible warning. In order to conserve the battery, if this audible alarm is ignored for more than 60 seconds the alarm system will ultimately switch itself off.
- Electronic alarm bezel indicating: .
- High Pressure Indicator Flashes Red LED with audible alarm at set relief pressure and . with continuous positive pressure.
- Normal Cycle Indicator Flashes Green LED every time inflation pressure rises through . 10 cm H2O. ・
- Low Pressure/ Disconnect Indicator Flashes Yellow LED with audible alarm if pressure . does not rise through 10 cm H2O within ten seconds.
- Silence button silences audible alarm for 60 seconds. Flashes Orange LED to indicate to . the operator that the audible alarm is silenced.
- Breathing detect indicator Flashes Green LED each time a spontaneous breath is . detected.
- Low battery indicator Flashes Yellow LED with audible alarm. .
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K Number
K021841Device Name
COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
Manufacturer
PNEU PAC, LTD.
Date Cleared
2003-07-17
(407 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
PNEU PAC, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pneupac compPAC 200 ventilator is a self contained portable gas powered automatic ventilator intended to provide emergency ventilation, in a battlefield environment only, to adult and pediatric patients greater than 20 kg. The compPAC 200 is suitable for emergency and transport use in situations where conventional portable ventilators are not suitable.
Device Description
The compPAC COM 200 ventilator is primarily gas powered and is housed in an easily carried, chemically hardened housing. The housing is designed to accept the long endurance battery that is used to drive a small compressor, which in turn provides the inflating gas, through an 'oscillator', to the casualty. All ambient air for the ventilation of the casualty passes into the system through a filter (NATO No: 4240-01-361-1319). About 1/3 of the volume is compressed to drive the ventilator before expansion in an entrainment mixing device, which entrains the other 3/3 by creating a sub-atmospheric pressure. It can be operated from a range of power sources: Battery/ Compressed gas/ Mains Electricity (via power supply/ charger unit) and Auxiliary vehicle electrical source (via power supply/ charger unit) to provide maximum flexibility of operation in remote areas, in military campaigns and in disaster relief.
The compPAC COM 200 ventilator is a robust self-contained portable device comprising of the following standard kit parts:
- Control Module -●
- Green case variant: Part No 510A2433 . OR
- Yellow case variant: Part No 510A2434 ●
- Rubber Boot: Part No 510A2271 .
- Filter: Part No W7265 ●
- Patient Valve and Hose assembly: Part No 510A1082 .
- O2 Auxiliary gas input lead, Schrader probe (BS5682): Part No -- 510A2600 .
- Support ramp: Part No 510A2372 ●
- 28 volt open-ended Vehicle Supply lead to compPAC: Part No 510A2564 ●
- compPAC C200 User Manual: Part No -- 504-2055/A ●
And the following fitted labels:
- Valance Panel Label: Part No 504-228 .
- Instrument Panel Label: Part No 504-227 ●
- Supplementary O2 Table Label: Part No 504-224 ●
- . Battery fitting and removal instruction Label: Part No - 504-223
- Alarm Bezel Label (set of 2): Part No 504-222 ●
The module can be used individually as a robust seff-contained portable device powered by a NiCad rechargeable battery specified for fitting inside the unit, will provide approximately 2 hours continuous ventilation. The module weighs 18.7 lb with the battery installed. The ventilator has a socket to accept an external 24V d.c. supply from e.g. a vehicle electrical circuit. This enables the system to be used for extended periods wherever a 24-28V d.c. supply is available. The power requirement is less than 50 watts. If the Pneupac PS11 power supply (weight: 3.86 lb) is connected to this socket, simultaneous trickle charging of internal battery will occur whilst the ventilator is running. When not required as a power supply it can be switched. to fast charge the battery whilst it is in situ inside the ventilator.
An input gas connector is provided to allow the compPAC ventilator to be connected to a 44 to 87 psig gas supply so that it can be operated independently of its internal battery electrical supply. In this way, if oxygen cylinders or liquid oxygen are available, 100% or 45% oxygen can be supplied to the casualty and the internal battery can be conserved. This facility also allows connection to air compressor systems.
Alternatively, there is a supplementary oxygen intake connector, in parallel with the filter, enabling 21-45% oxygen to be supplied to the casualty, from e.g. an oxygen cylinder, when the ventilator is operating on its compressor.
Calibrated controls for frequency and tidal volume are provided to set the required ventilation pattern. A fixed pressure relief valve is fitted to limit the peak inspiratory pressure to a maximum of 60 cm H2O and provides a pneumatically operated audible high-pressure alarm (an adjustable pressure relief device will also be available in the future as a retro-fittable option). In addition an electronic high-pressure alarm sounds if the inflation pressure exceeds 60 cm H>O.
Most of the controls and input and output connections are mounted on the front panel, which is deeply shrouded to give maximum protection from chemical "rain".
The module control panel has the following features:
- . Minute Volume Control, This calibrated rotary control knob gives continuous adjustment of the minute volume delivered to the patient over the range 6 to 14 L/min.
- Frequency Control, This rotary control knob gives continuous adjustment of frequency over . the range 10 to 30 breaths per minute.
The I:E ratio is nominally constant at 1:1.6 throughout the range of frequency.
- . Patient Inflation Pressure Manometer, range -10 to +100 cm H2O.
- Oxygen Concentration Control This two-position rotary control knob selects either the 100% . or 45% inspired oxygen concentration when an oxygen supply is connected to the gas-input connector. When no external gas is connected this switch is disabled internally. In the 45% O2 position the driving gas requirement is reduced by 66% and the balance of the gas supplied to the patient is entrained atmospheric air which is drawn through the filter canister.
- A mechanically operated visual alarm gives a warning that the supply gas has dropped to a . pressure at which the ventilator will no longer be operating to specification (< 35 psi). With low pressure it shows red, with adequate pressure it shows white. Any visible red indicates that the supply should be changed. In most cases the display will begin to oscillate from white to partial red as the supply pressure falls to the lower threshold level.
The visual indication will be accompanied by an electronically generated medium priority* audible warning..
- Electronic alarm bezel indicating: .
- High Pressure Indicator Flashes Red LED with audible alarm at set relief pressure and . with continuous positive pressure.
- Normal Cycle Indicator Flashes Green LED every time inflation pressure rises through . 10 cm H2O.
- Low Pressure/ Disconnect Indicator Flashes Yellow LED with audible alarm if pressure . does not rise through 10 cm H2O within ten seconds.
- . Silence button - silences audible alarm for 60 seconds. Flashes Orange LED to indicate to the operator that the audible alarm is silenced.
- Electrical power indicator Flashes Yellow LED with audible alarm. .
The PS11 power supply/ charger for use in association with the compPAC ventilator has the following controls and features:
- Line Output In conjunction with the negative common, a +28V dc output for general . purpose use or for powering the compPAC ventilator when the appropriate lead is fitted. The output is fully protected against short circuits and overload.
- Trickle charge output In conjunction with the negative common, a +28V dc output . exclusively for use with the compPAC 200 ventilator. This line provides a trickle charge facility for the compPAC's internal Clansman battery.
- Battery Charge Output In conjunction with the negative common, this is the output used to . charge a Clansman +28V dc NiCad battery.
- On/Off Switch The switch on the front panel of the PS11 selects two different operating . modes:-
- 28V dc & Trickle Chg. ON: This activates the 28V dc Line and Trickle Charge outputs and . open circuits the compPAC internal battery.
- Output OFF & Charge Battery: This activates the Battery Charge output and removes power . from the 28V dc Line and Trickle Charge outputs.
When the compPAC is operating its internal compressor, the incoming air is filtered. The specifications of the recommended filter are as follows:-
- Filter efficiency is at least 99.99% efficient against a 0.3um Mass Median Aerodynamic ● Diameter aerosol challenge at 32 L/min.
- Airflow resistance at 32 Liters per Minute is 10 to 17 mm H2O .
- Connector size is 40mm DIN NATO compatible threads. .
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K Number
K020899Device Name
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
Manufacturer
PNEU PAC, LTD.
Date Cleared
2002-12-13
(268 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
PNEU PAC, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The paraPAC 200 & 200D are portable, gas powered, time-cycled ventilators that are designed for emergency ventilation of patients who have respiratory distress or insufficiency.
Device Description
The paraPAC 'Medic' ventilator is a gas powered, time cycled, volume preset, pressure limited ventilator which uses the same technology as existing legally marketed devices. It depends solely on the pressure of the supply gas for its operation. Additionally, it incorporates an integrated electronic pressure alarm unit to alert the user to certain significant changes that may occur in the patient's ventilation. Loss of battery power for the alarm is signalled to the user but will have no effect on the ventilation performance of the paraPAC 'Medic' ventilator, nor affect the mechanically operated alarms and protection systems, which operate in an identical manner to the predicate device, except for the addition of a mechanically operated gas supply indicator and the addition of a secondary relief valve.
The paraPAC 'Medic' ventilator consists of a control module and patient circuit comprising the following disposable items: Hose/ Patient Valve/ PEEP Valve/ Exhaust Collector and Mouthpiece. The module is available as either a non- demand version (P200) or demand version (P200D), and weighs 2.7 kilograms (non-demand version) or 3.1 kilograms (demand version) respectively. The module control panel for both models have the following features: Adjustable Relief Pressure Control, range 20 to 80 cm H2O. Air Mix (45% oxygen) / No Air Mix (100% oxygen) Selector. Tidal Volume Control, range 65 to 1570 ml. Frequency Control, range 8 to 40 b.p.m. with click stop detent at 12 b.p.m. for Cardiopulmonary Resuscitation. Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. Supply Gas Failure Alarm A mechanically operated visual alarm gives a warning that the supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification (< 35 psi). With low pressure it shows red, with adequate pressure it shows white. Any visible red indicates that the supply should be changed. In most cases the display will begin to oscillate from white to partial red as the supply pressure falls to the lower threshold level. The visual indication will be accompanied by an electronically generated medium priority* audible warning. In order to conserve the battery, if this audible alarm is ignored for more than 60 seconds the alarm system will ultimately switch itself off. Electronic alarm bezel indicating: High Pressure Indicator Flashes Red LED with audible alarm at set relief pressure and with continuous positive pressure. Normal Cycle Indicator Flashes Green LED every time inflation pressure rises through 10 cm H2O. Low Pressure/ Disconnect Indicator - Flashes Yellow LED with audible alarm if pressure does not rise through 10 cm H2O within ten seconds. Silence button silences audible alarm for 60 seconds. Flashes Orange LED to indicate to the operator that the audible alarm is silenced. Breathing detect indicator (demand model only) Flashes Green LED each time a spontaneous breath is detected. Low battery indicator Flashes Yellow LED with audible alarm.
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K Number
K960515Device Name
PARAPAC
Manufacturer
PNEU PAC, LTD.
Date Cleared
1996-10-10
(248 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
PNEU PAC, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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