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The Sandman Duo and Sandman Duo ST are indicated for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 30kg (66lb) within homecare and hospital environments.

The Sandman Duo and Sandman Duo ST are designed to deliver Continuous Positive Airway Pressure between 3 and 20 cmHzO, and may come in different configurations including an optional integrated pass-over or heated humidifier. The Sandman Duo and Sandman Duo ST are designed to deliver two levels of pressure in Bilevel mode. The positive inspiratory pressure (IPAP) is delivered during the inspiratory phase and can be set up to 25 cm H2O. The positive expiratory pressure (EPAP) is delivered during the expiratory phase and can be set to 20 cm H2O. The Sandman Duo and Sandman Duo ST 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 Sandman Duo and Sandman Duo ST are double-insulated so that grounding is not required. The Sandman Duo and Sandman Duo ST are for use by prescription only and displays the appropriate labeling. The Sandman Duo and Sandman Duo ST are configured for patient use by a homecare dealer according to the prescription using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual. The Sandman Duo and Sandman Duo ST do not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen. The device and accessories are not supplied sterile, nor are they intended to be sterilized. The Sandman Duo and Sandman Duo ST are for multiple use. The Sandman Duo and Sandman Duo ST contain no patient contact components. The Sandman Duo and Sandman Duo ST tubing is equivalent to that of the CPAP predicate devices. The Sandman Duo and Sandman Duo ST and the air filter are for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use. The Sandman Duo and Sandman Duo ST relv on 1 microprocessor for setting and viewing various control parameters and turning features on and off, and for controlling the heated humidification. Pressure delivery for The Sandman Duo ST is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system. The Sandman Duo and Sandman Duo ST use software to set the various device parameters such as the prescription pressure and the ramp starting pressure, and to provide heated humidification.

The Sandman Info and Sandman Auto are indicated for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 30kg (66lb) within homecare and hospital environments.

The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are designed to deliver Continuous Positive Airway Pressure between 3 and 20 cmHJO, and may come in different configurations including an optional integrated pass-over or heated humidifier. The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto 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 Puritan Bennett Sandman Info and the Puritan Bennett Sandman Auto are double-insulated so that grounding is not required. The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are for use by prescription only and displays the appropriate labeling. The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are configured for patient use by a homecare dealer according to the prescription using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual. The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto do not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen. The device and accessories are not supplied sterile, nor are they intended to be sterilized. The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are for multiple use. The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto contain no patient contact components. The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto tubing is equivalent to that of the CPAP predicate device. The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto and the air filter are for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use. The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto rely on 1 microprocessor for setting and viewing various control parameters and turning features on and off, and for controlling the heated humidification. The Puritan Bennett Sandman Info operates only 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. The Puritan Bennett Sandman Auto operates in either Constant or Automatic mode. In Constant mode, the main function of each device is to delier constant positive airway pressure to the patient at a fixed level prescribed by the practitioner and between 4 and 20 cmHO. In Automatic mode (APAP mode), the practitioner determines and sets a maximum and minimum pressure range above and below the prescribed reference pressure and between 4 and 20 cmH2O. The pressure is adjusted within the maximum and minimum limits according to the patient's respiratory pattern and the type of events detected. Pressure delivery for the Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system. The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto use software to set the various device parameters such as the prescription pressure and the ramp starting pressure, and to provide heated humidification. The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto comply with certain voluntary standards, specifically the draft ARDB Reviewer Guidance for Premarket Notification Submissions (Nov 1993) and IEC60601-1. The Puritan Bennett Sandman Info and Puritan Bennett Sandman Auto are not part of a kit.

KnightControl is a remote control for use by clinicians to adjust the settings of the GoodKnight 418, GoodKnight 420, GoodKnight 425 and Knightstar 330 devices.

The KnightControl is designed to control the GoodKnight 418, GoodKnight 420, GoodKnight 425, and Knightstar 330 devices in hospital, sleep laboratories, or other clinical settings. The KnightControl is powered by AC mains (100 VAC to 240 VAC nominal). The KnightControl is doubleinsulated so that grounding is not required. The KnightControl is set up for use by the clinician according to the instructions provided in the manual. The devices are operated according to the instructions contained in their respective Patient Manual and Clinical Manual. The KnightControl relies on a microprocessor for setting and viewing main control parameters and status of the attached device, and turning features on and off. The microprocessor is also required for getting data of some signals from the devices in order to output these signals to allow these signals to be recorded. The KnightControl is linked via an RS232 serial port to one of the following devices: GoodKnight 418 series, GoodKnight 420 series, GoodKnight 425 series, or Knightstar 330. The KnightControl uses software to recognize the device to which it is connected and automatically adapt its menu to the device. The KnightControl is not for use in life-supporting or life-sustaining situations. The device and it's accessories are not intended for sterile use. The KnightControl is for multiple use. The KnightControl contains no patient contact components. The KnightControl is for use in by physicians, nurses, and sleep lab technicians in a clinical (hospital, sleep laboratory, etc.) environment. The KnightControl does not contain any drugs or biological products as components. The KnightControl is not part of a kit.

The Puritan Bennett GoodKnight H2O is an accessory intended to warm and add moisture to the inspiratory gas flow for administration to a patient undergoing CPAP or bi-level therapy. It is intended for use with adult patients receiving CPAP or Bi-level therapy for the treatment of Obstructive Sleep Apnea in the homecare and hospital environments.

The GoodKnight H2O is a microprocessor-controlled heated passover humidifier used to provide evaporated water content to dry breathing gases, during treatment of Obstructive Sleep Apnea. The GoodKnight H2O has an ABS enclosure and a heater plate positioned in the front of the unit. A humidification chamber slides onto the heater plate and is held in place by a rim on the enclosure. The unit controls are located at the back of the device. The technological characteristics of the GoodKnight H2O Heated Humidifier are equivalent to that of the predicate device. The GoodKnight H2O is equivalent in terms of type (heated passover humidification), configuration (chamber, mounting arrangements), environmental conditions of use and control method (software). Non-clinical testing of the GoodKnight HyO has been carried out and covered mechanical safety, electrical safety, thermal safety, EMC, software verification and validation and performance. The GoodKnight H2O meets the performance and safety requirements of ISO 8185 related to humidification systems and which includes also the requirements of IEC 60601-1. The product complies also to the relevant USA deviations from UL 2601-1 and to the applicable requirements of the FDA Reviewers Guidance (November 1993).

The Puritan Bennett GoodKnight 425 is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.

The GoodKnight 425 is designed to deliver Positive Airway Pressure between 3 and 20 cmH2O in CPAP mode or between 3 and 25 cmH2O in bi-level mode (EPAP maximum 20 cmH2O). The GoodKnight 425 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 425 is double-insulated so that grounding is not required. The GoodKnight 425 is 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 425 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. Pressure delivery for the GoodKnight 425 is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system. The GoodKnight 425 uses the same pass over humidifier and interfaces as those approved for use with the GoodKnight 420S. The GoodKnight 425 tubing is equivalent to that of the GoodKnight 420S. The GoodKnight 425 can also be connected to a computer via an RS232 serial port. The device can be configured from the computer using the SilverLining™ software which is required for downloading and displaying compliance data stored in the device memory. The GoodKnight 425 is not for use in life-supporting or life-sustaining situations. The devices and/or their accessories are not intended for sterile use. The GoodKnight 425 is for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use. The GoodKnight 425 is for use by prescription only and display the appropriate labeling. The GoodKnight 425 is for use in a hospital and homecare environment. The GoodKnight 425 does not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen. The GoodKnight 425 is not part of a kit. The GoodKnight 425 uses software to set the various device parameters such as the prescription pressure and the ramp starting pressure.