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The intended use of the GoodKnight 420 Evolution is to provide Continuous Positive Airway Pressure between 4 and 20 cmHzO to spontaneously breathing patients over 30 Kg for the treatment of Obstructive Sleep Apnea in a hospital and homecare environment. The Puritan Bennett GoodKnight 420 Evolution 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 420 Evolution is designed to deliver Continuous Positive Airway Pressure between 4 and 20 cmHzO. Power may be supplied either through AC mains (100 VAC to 240 VAC nominal) or by an external 12 VDC battery. The blower motor nominal voltage is 13 VDC. The GoodKnight 420 Series is double-insulated so that grounding is not required. The GoodKnight 420 Evolution is set up for use by the homecare dealer using the Clinician Manual provided and operated according to the instructions contained in the Patient Manual. The GoodKnight 420 Evolution relies on a microprocessor for setting and viewing various control parameters and turning features on and off. The microprocessor is also required for the interpretation of various signals from the device including signals relating to patient cycle detection. The GoodKnight 420 Evolution can operate in either Constant or Automatic mode. In Constant mode, the device delivers a constant positive airway pressure to the patient at a fixed level prescribed by the practitioner between 4 and 20 cmHzO. In Automatic mode (APAP mode), the practitioner sets a maximum and minimum pressure range above and below the prescribed reference pressure and between 4 and 20 cmHzO. The pressure is adjusted within this range according to the patient's respiratory pattern and the type of respiratory 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™ software. Pressure delivery for the GoodKnight 420 Evolution is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system. The GoodKnight 420 Evolution and accessories are not intended for sterile use. The GoodKnight 420 Evolution and the air filter are intended for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use. The GoodKnight 420 Evolution uses software to set the various device parameters such as the prescription pressure and the ramp starting pressure. The device can also be connected to a computer via an RS232 serial port, and can be configured from the computer using the optional Silverlining" software which is required for downloading and displaying compliance data stored in the device memory. The GoodKnight 420 Evolution is not for use in life-supporting or life-sustaining situations. However, the device can be used to provide the patient with supplemental oxygen. The device is for use by prescription only and displays the appropriate labeling. The device is intended for use in a hospital or homecare environment. The GoodKnight 420 Evolution complies with the draft ARDB Reviewer Guidance for Premarket Notification Submissions (Nov 1993), IEC 60601-1 and EN ISO 17510-1.

The intended use of the GoodKnight 420 Series Devices is to provide Continuous Positive Airway Pressure (C-PAP) between 4 and 20 cmHxO to spontaneously breathing patients over 30 Kg for the treatment of Obstructive Sleep Apnea in a hospital and homecare environment. The Puritan Bennett GoodKnight 420 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 420 Series Devices consist of the following elements: - GoodKnight 420G (GK420G) C-PAP Machine; - GoodKnight 420S (GK420S) C-PAP Machine. The GoodKnight 420 Series Devices are designed to deliver Continuous Positive Airway Pressure between 4 and 20 cmH2O. The GoodKnight 420 Series Devices can be powered either by AC mains (100 VAC to 240 VAC nominal) or by an external 12 VDC battery. The blower motor nominal voltage is 13 VDC. The GoodKnight 420 Series power supply is double-insulated so that grounding is not required. The GoodKnight 420 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 420 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 420 Series devices operate only in either Constant mode. In Constant mode, the main function of the device is to deliver constant positive airway pressure to the patient at a fixed level prescribed by the practitioner and between 4 and 20 cmH2O. Pressure delivery for the GoodKnight 420 Series Devices is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system. The GoodKnight 420 Series Devices use the same pass over humidifier and masks as those approved for use with the GoodKnight 418G. The GoodKnight 420 Series Device tubing is equivalent to that of the GoodKnight 418G with the exception of an additional internal tube used for measuring the pressure at the patient's mask on the 420S model. The GoodKnight Control clinical remote is also available for use with the GoodKnight 420S Device. The remote is used by the practitioner to configure the devices from a distance via a serial link. The GoodKnight 420S Device can also be connected to a computer via an RS232 serial port. The device can be configured from the computer using the Silverlining™2 software which is required for downloading and displaying compliance data stored in the device memory. The GoodKnight 420 Series Devices are not for use in life-sustaining situations. The devices and/or their accessories are not intended for sterile use. The GoodKnight 420 Series Devices and the air filter are for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use. The GoodKnight 420 Series Devices are for use by prescription only and display the appropriate labeling. The GoodKnight 420 Series Devices are for use in a hospital and homecare environment. The GoodKnight 420 Series Devices do not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen. The GoodKnight 420 Series Devices are not part of a kit. The GoodKaight 420 Series Devices use software to set the various device parameters such as the prescription pressure and the ramp starting pressure. The GoodKnight 420 Series Devices are electrically operated. The GoodKnight 420 Series Devices comply with certain voluntary standards, specifically the draft ARDB Reviewer Guidance for Premarket Notification Submissions (Nov 1993) and IEC 60601-1.