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The Mallinckrodt GoodKnight 418 Series is intended for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.

The GoodKnight 418 Series Devices consist of the following elements: C-PAP Machine; GoodKnight 418 A (GK418A) and GoodKnight 418 P (GK418P) C-PAP Machine. The GoodKnight 418 Series Devices are designed to deliver Continuous Positive Airway Pressure between 4 and 18 cmH2O. The GoodKnight 418 Series Devices can be powered either by AC mains (115 VAC or 230 VAC nominal) or by an external 24 VDC battery. The blower motor nominal voltage is 24 VDC, which is obtained directly from the external battery or by rectifying and filtering the nominal mains power. The GoodKnight 418 Series Devices are double-insulated so that grounding is not required. The GoodKnight 418 Series Devices are set up for use by the homecare dealer using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual. The GoodKnight 418 Series Devices rely on a microprocessor for setting and viewing various control parameters and turning features on and off. The microprocessor is also required for the treatment of various signals from the devices including signals relating to patient cycle detection. The GoodKnight 418 Series Devices can operate in either Constant or Automatic mode. In Constant mode, the main function of each device is to deliver constant positive airway pressure to the patient at a fixed level prescribed by the practitioner and between 4 and 18 cmH3O. In Automatic mode (A-PAP for the GoodKnight 418A and P-PAP for the GoodKnight 418P), the practitioner determines and sets a maximum and minimum pressure range above and below the prescribed reference pressure and between 4 and 18 cmH2O. The pressure is adjusted within the maximum and minimum limits according to the patient's respiratory pattern and the type of events detected. Data concerning the type of events detected, their frequency and duration etc. is stored in the device data memory and can be accessed by the practitioner through the use of the optional Silverlining™2 software. Pressure delivery for the GoodKnight 418 Series Devices is regulated by a pressure sensor which monitors both ambient and output pressure at the patient's mask and provides feedback to the control system. The GoodKnight 418A also uses the signal from the pressure sensor to detect the patient's respiratory cycle and any acoustical vibrations (snoring), However, the GoodKnight 418P has the additional feature of a flow sensor which monitors the patient's respiratory flow, the occurrence of obstructive/open airway apnea, leaks and flow limitation.

The Nellcor Puritan Bennett GoodKnight 418G is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare environment.

The GoodKnight 418G is a device used to provide Continuous Positive Airway Pressure between 4 and 18 cmH2O. The device is powered either by AC mains (115 VAC or 230 VAC nominal) or by an external 24 VDC battery. The blower motor nominal voltage is 24 VDC, which is obtained directly from the external battery or by rectifying and filtering the nominal mains power. The device is double-insulated so that grounding is not required. The device uses a microprocessor to set the various control parameters, turn features on and off and view the set parameters. Pressure regulation is accomplished by maintaining a constant motor speed. This is done by the microprocessor counting the motor RPM pulses and then changing the motor speed voltage supplied to the motor drive circuit as required to maintain constant speed. The GoodKnight 418G has the following functions: On/Off, Calibration, Set Prescription Pressure, Check Prescription Pressure, Enable/Disable Ramp Feature, Set Ramp Starting Pressure, Start Ramp Feature, Enable/Disable Altitude Compensation Feature, Compensating for Changes in Altitude, Check Compliance Meter, Reset Compliance Meter, Check Hour Meter. The device is not for use in life-supporting or life-sustaining situations. Neither the device nor its accessories are sterile. The device itself and the air filter are for multiple use. The other accessories, i.e. the patient circuit and nasal masks are for single patient use. The device is for prescription use and contains appropriate labeling. The device is for use in a homecare environment. The device does not contain a drug or biological product as a component. However, it can be used to provide the patient with supplemental oxygen. The device is not part of a kit. Software is used to set the various device parameters such as the prescription pressure and the ramp starting pressure, and to enable/disable the ramp and altitude compensation features. Software is also used to increase the hour meter and the compliance meter. The device is electrically operated.