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The Sunrise Medical Quickie Rhythm Powered Wheelchairs intended use is to provide mobility to persons limited to a seating position that have the capability of operating a powered wheelchair. The Quickie Rhythm Power Wheelchairs provide an optional means of mobility for physically challenged people.

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The DeVilbiss Sleep Recorder is intended for screening patients suspected of or exhibitina symptoms of sleep disorders. The DeVilbiss Sleep Recorder can be used with an autotitrating CPAP to record the results of CPAP treatment for adults diagnosed with sleep apnea syndrome. Patients suffering from excessive daytime sleepiness should be referred to a sleep disorder specialist. The results of an unattended screening are insufficient to identify all possible medical disorders that may produce these symptoms. This device is intended to aid the physician in diagnosing adult sleep apnea. A qualified medical professional should score the device's recorded signals to determine respiratory events.

The DeVilbiss Sleep Recorder consists of a main control box, a chest mounted interface box and several sensors mounted to the patient. The main control box contains a Novametrix oximeter board, the microcontroller and memory board, four AA battery compartment and connectors for external devices. The main control box is intended to be placed on a night stand or near the patient's bed. A chest mounted interface box containing body position sensors and connections for a nasal thermistor, a nasal cannula, snore microphone and three ECG leads is attached to the patient. The sensors used for a standard diagnostic recording are: 1. ECG leads (3) 2. Snore Microphone 3. Nasal Thermistor or Nasal Cannula 4. Oximeter Probe 5. Body Position sensor (inside chest box)

The DeVilbiss PD1000 Compact Conserver is intended as a delivery device for medial-grade oxygen from high-pressure oxygen cylinders. This is an ambulatory device, which allows patients to ambulate Joneer than they would with a continuous flow regulator on the same cylinder.

The DeVilbiss PD1000 compact conserving device is designed to extend the use time of oxygen cylinders. The device uses PulseDose technology to accomplish the oxygen savings. PulseDose senses the start of inhalation and instantly releases a short "pulsed" dose at the very beginning of the inhalation cycle. Since all of the "pulsed" oxygen finds its way deep into the lungs, less oxygen is required to accomplish the same effect than with traditional continuous flow oxygen systems. The PD1000 compact conserving device contains an integral pressure regulator with CGA 870 style yoke. The pressure regulator reduces the cylinder pressure to 19 - 25 psig. The PD1000 then delivers oxygen to the patient by sensing inhalation via a pressure switch and opening a two-way valve for a specified period of time controlled by a microprocessor. The unit is designed to deliver 16.5 cc/lpm of oxygen to the patient at 1.0. 1.5. 2.0, 2.5, 3.0, 4.0, 5.0 and 6.0 flow settings. The unit is powered by two "AA" alkaline or nickel metal hydride batteries. The PD1000 has a continuous flow back-up mode that will deliver 2 ipm continuous to the patient in the event of a device failure or dead batteries. The device has two LED's that indicate battery status and valve activation. When the unit is first turned on, either a red or green LED will flash to indicate the unit is turned on and the battery status. Each time the valve is activated during an inhalation, the red or green LED will flash to indicate the valve was activated and the battery status. The device will operate approximately 4 -- 8 hours when the red LED first begins to flash. When the battery voltage drops below approximately 1.9 vdc the red LED will remain on continuously and the valve will no longer operate. The continuous flow back-up mode can still be used to provide oxygen therapy to the patient when the batteries are no longer able to operate the unit. The ability of the PD1000 to detect patient inspirations is based on the sensitivity of the pressure switch which is set within a range of .1 to .25 cm H2O. The device is capable of delivering a bolus of oxygen at the beginning of each inhalation up to 40 breaths per minute (every 1.5 second minimum delay between breaths will cause the device to "skip" breaths at rates greater than 40 breaths per minute.

The DeVilbiss Heated Humidifier System, consisting of the 9100D DeVilbiss CPAP Humidifier and the 9200 DeVilbiss Humidifier Heater, is to be used in conjunction with most positive airway pressure devices that require humidity to be added to the circuitry. The DeVilbiss Heated Humidifier System is not intended to be used with auto-adjusting CPAP devices unless the labeling for the CPAP machine states that the CPAP machine will function in autoset mode when used with the 9200 heated humidifier system. The heated humidifier system may adversely affect the operation of certain CPAP machines that have automated pressure setting. The DeVilbiss Heated Humidifier System is for use in the home environment and is to be used only on the order of a physician. The humidifier can be used with CPAP and Bilevel devices, which have a maximum operating pressure of 20 cm H20. The humidifier can also be used with noninvasive ventilation devices that have a maximum operating pressure of 40 cmH20.

Model 9200D Heated Humidifier

The system is used on the order of a physician for the treatment of asthma, bronchitis and other respiratory diseases. The nebulizer converts the liquid medication into a fine aerosol mist which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patients airway.

The Sunrise Medical Model 800 Series jet nebulizer is a reusable hand held, small volume jet nebulizer. The nebulizer is designed for use in conjunction with a compressed gas source such as the Sunrise Medical Pulmo-Aide Model 5650 Compressor (FDA 510(k) Registration # K923888), Sunrise Medical Pulmo-Mate Model 4650 Compressor (FDA 510(k) Registration # K931015) or Sunrise Medical Pulmo-Aide LT Model 3650 Compressor (FDA 510(k) Registration # K970289). The nebulizer & compressor system is used on the order of a physician to treat various respiratory problems. The nebulizer converts the liquid medication into a fine aerosol mist, which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patient's airway. The Sunrise Medical Model 800 Series iet nebulizer is designed to offer high respirable aerosol output for the patient. The nebulizer is intended as a long term usage nebulizer (approximately 1 year) similar to other reusable nebulizers that are currently being marketed by competitors of Sunrise Medical such as the Pari LC Plus and Pari Jet permanent nebulizers manufactured by Pari of Germany and distributed here in the U.S. Accessories include a triggering system to shut off airflow to the nebulizer to conserve medication between breaths.

The revised DeVilbiss 5 Liter Oxygen Concentrator is designed to provide supplemental low flow oxygen therapy for patients suffering from COPD, cardiovascular disease, and lung disorders. The oxygen concentrator is used in home type environments: homes, patient care facilities, etc. The DeVilbiss 5 Liter Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc.

The revised DeVilbiss 5 Liter Oxygen Concentrator is a 1-5 lpm, pressure swing adsorption, oxygen concentrator based on molecular sieve technology. Room air is drawn into the concentrator via a piston style compressor. The air then passes through a series of filters that remove dust, bacteria, and other particulates. A pneumatic valve directs air into one of the two sieve beds. Nitrogen is adsorbed in the bed as the pressure increases while oxygen flows through, thereby producing an enriched oxygen product for the patient. Simultaneously in the other bed, nitrogen is desorbed as the pressure decreases and is exhausted into the atmosphere. A momentary intermediate pneumatic sequence ties the beds together with the exhaust blocked for an enhanced nitrogen purge. The cycle continues, providing a continuous flow of oxygen at a purity of 93% +/-3% to the patient. The concentrator is available with or without an oxygen monitoring device.

The DeVilbiss Suction Unit is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. Configurations of the device will be intended for the home, institutional, and field/transport environments. The device is for use only on the order of a physcian or other lincensed practitioner (e.g. EMT-field use).

The DeVilbiss Suction Unit is a portable AC/DC powered suction pump. It consists of (depending on configuration) a pump unit, collection bottle, relief valve, vacuum gage, bacteria filter, suction tubing, internal battery, and an AC to DC adapter. The device is designed and manufactured to comply with UL 2601-1 and/or CAN/CSA-C22.2 No. 601.1 M90 safety standards.

The DeVilbiss Model 6305D Heavy Duty AC Aspirator is used primarily to provide a vacuum source for oral, nasal and pulmonary aspiration. The device is used on the order of a physician.

The DeVilbiss Model 6305D Heavy Duty AC Aspirator is an AC powered vacuum pump assembly designed to be used in conjunction with a collection canister to meet the requirements for oral, nasal and pulmonary aspiration.