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The Nuvo Nano Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel / mobile environments.

The Nuvo Nano Portable Oxygen Concentrator (Nano POC) begins its operation with air being pulled into the external air intake filter. This filtered air enters the compressor via a suction resonator and fine filter. Pressurized air then exits the compressor. Next, an electronic valve system directs the air into one of two tubes that contain molecular sieve (sieve beds). The molecular sieve adsorbs (physically attracts) the nitrogen from the air as it is pushed through the sieve beds, this process is called pressure swing adsorption (PSA). As one tube is generating the product gas, the other is being purged of the adsorbed nitrogen. After passing through the oxygen storage tank, the rate of product gas being delivered to the patient is set by a restricting orifice and pulse dose valve based upon detection of a breath. It then passes through a fine particle filter and thru a sensor that detects the oxygen concentration of the product gas before it exits the device through a fire-resistant outlet. Once the product gas leaves the device, it travels to the patient via oxygen tubing and a cannula inserted in the nose. The Nano POC offers the user multiple options to power the device; a detachable lithium ion battery, replaceable by the patient, and an external AC/DC power supply. The device will charge the lithium ion battery when the battery and power supply are both attached. The device operates from 100V to 240V and at 50/60Hz. The device is approximately 8.3″ wide by 3.5″ deep by 6.5″ high (21.6cm x 8.9cm x 16.5cm). The device weighs about 4.7 pounds (2.1 kg) including the battery. The device provides an intermittent supply of oxygen enriched gas at a concentration between 87% and 96% to patients requiring longterm oxygen therapy without the higher cost of bottled oxygen. The device produces a product pressure of less than 170 kPa (25 psig) and flow is set by a controller that delivers pulsed flow rates nominally equivalent to continuous flow rates of 1 to 5 LPM. The device provides pulsed dose delivery of oxygen to the user through a selection of 5 settings; setting 1 delivering the least and setting 5 delivering the greatest amount of oxygen enriched product gas. Oxygen pulse volume per minute is controlled electronically by monitoring the user's breath rate and therefore adjusting bolus volume to deliver the same amount of oxygen per minute to the user. The device does not contain, nor does it produce, any latex, phthalates, harmful chemicals, animal tissue, blood components, or radioactive materials that the user or patient could physically contact. The user has short term surface contact with the device (PC + ABS cabinet and PET HMI overlay), but the nasal cannula has contact with the face for the duration of the treatment. The product gas also has prolonged contact with the respiratory airways. The device is not invasive nor implanted. The device is not life supporting, life sustaining, sterile, or radioactive. The device does not incorporate a medical substance, animal tissue or blood component. The device is reusable and should be used as often as prescribed, for the duration prescribed. Smoking cigarettes while undergoing treatment, especially during treatment, is a contraindication to the intended purpose of the device. Nidek Medical Products, Inc. warns against the use of oil or grease, using the device around an open flame, and using the device without a prescription from a doctor.

The modified devices are intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

The modified devices are substantially equivalent to the predicate devices. Modifications were made to improve reliability, ease of assembly and serviceability The compressor was changed from a vertically oriented tension spring supported configuration to a horizontally oriented compression spring supported configuration to minimize damage from shipment and handling. The cabinet back was changed from a single part to two parts to simplify assembly and serviceability. Labeling was changed to increase type size for improved readability and to correct some clerical errors. The motor run capacitor was changed to a type that includes an internal protective device. The device circuit breaker was changed from a 10 A rating to a 5 A rating. The modified devices continue to be AC powered devices that provide a high level of inspired oxygen, using the same method as that of the predicate devices, by separating oxygen from ambient air with the pressure swing adsorption (PSA) process. Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components that are released when the pressure is vented to the atmosphere. This cycle is controlled by an electronic valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90% +6.5%/-3% at a flow rate of 5 l/min ±10%. The modified device is a durable, reusable, semi-portable unit weighing approximately 32 pounds [14.5 kg.]. The device is available in both 115V and 230V models. The device status indicators are the same as in the predicate devices: They are controlled by a printed circuit board which is device model specific. For the OCSI model, device status indicators are mains power and oxygen concentration. For the STD model, device status indicators are mains power and system pressure. The modified device is not life supporting, life sustaining or sterile. The modified devices may be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. Recommended accessory devices are described in the User's Guide. One of these devices may optionally be included with the device.

The proposed devices are intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

Mark 5 Nuvo 8 OCSI Mark 5 Nuvo 8 STD

The proposed devices are intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

The proposed device is an AC powered device that provides a high level of inspired oxygen by separating oxygen from ambient air utilizing pressure swing adsorbers (PSA). Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components that are released when the pressure is vented to the atmosphere. This cycle is controlled by an electronic valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90% +6.5%/-3% at a flow rate of 5 l/min ±10%. The proposed device is a durable, reusable, semi-portable unit weighing approximately 32 pounds [14.5 kg]. The device is available in both 115V and 230V models. The device status indicators are controlled by a printed circuit board which is device model specific. For the OCSI model, device status indicators are mains power and oxygen concentration. For the STD model, device status indicators are mains power and system pressure. The proposed device is not life supporting, life sustaining or sterile. The proposed device may be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. One of these devices may optionally be included with the device.

The Mark 5 Nuvo OCSI (M5C5) Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

The proposed device is an AC powered device that provides a high level of inspired oxygen by separating oxygen from ambient air utilizing pressure swing adsorbers (PSA). Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized rotary 4-way valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90% ±3% at a flow rate of 5 l/min ±10%. The oxygen concentration status indicator (OCSI) board controls the device status indicators including an operator alert when the oxygen concentration in the product gas is below the set point. It is not a life-supporting, life-sustaining or sterile device. The proposed device is a durable, reusable, semi-portable unit weighing approximately 50 pounds [23 kg]. The device is available in both 115V and 230V models that have been designed and validated according to applicable requirements of EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999, ISO 8359 and FDA Reviewer Guidance document "Excerpts Related to EMI from November 1993" as appropriate to the area of usage. The proposed device may be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. One of these devices may optionally be included with the device.

The Mark 5 Nuvo (M5C5) Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

The Mark 5 Nuvo (M5C5) oxygen concentrator is an AC powered device that provides a high level of inspired oxygen by separating oxygen from ambient air utilizing pressure swing adsorbers (PSA). Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized rotary 4-way valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90 ±3% at a flow rate of 5 l/min ±10%. It is not a life-supporting, life-sustaining or sterile device. The Mark 5 Nuvo (M5C5) oxygen concentrator is a durable, reusable, semi-portable unit weighing approximately 50 pounds [23 kg]. The device is available in both 115V and 230V models that have been designed and validated according to applicable requirements of EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999 as appropriate to the area of usage. The Mark 5 Nuvo (M5C5) oxygen concentrator is intended to be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. One of these devices may optionally be included with the device.

The Pulmo-Mist compressor is designed for use by adult or pediatric patients requiring aerosolized medications. The Pulmo-Mist Nebulizer Compressor is intended to be used to supply a continuous positive pressure to a nebulizer device for the purpose of generating an aerosol medicine.

The Pulmo-Mist compressor is an electrically powered piston type compressor that provides approximately 6 I/min of air flow against a back pressure of 10 psig. It is designed to supply air to a small volume nebulizer. The package optionally contains a legally marketed small volume disposable nebulizer kit, specifically the Westmed "VIXONE®", manufactured by Westmed, Inc. and private labeled for distribution by Nidek Medical Products, in the original manufacturer's unopened package, Each such package includes a mouthpiece, a nebulizer, a connector tube and flexible air tubing and labeling. The nebulization particle size varies slightly depending on the nebulizer used and on the viscosity of the material being nebulized. When used with the VIXONE, the MMAD is approximately 1 µm with a saline solution. Other manufacturers of small volume nebulizers report similar values for similar flow rates. The Pulmo-Mist compressor is a portable unit. It weighs approximately 3.2 pounds and has dimensions of 7.5 in w x 4.5 in h x 7.5 in d.

The Silenzio Delta is intended for the treatment of Obstructive Sleep Apnea (OSA) in adult patients 30 kg and over. Silenzio Delta has three modes of operation. In CPAP mode,treatment is carried out by applying a continuous positive airway pressure through a nasal mask. In the BPAP mode, the pressure during expiration is lower than during inspiration, as prescribed by the physician. In a third mode, a minimum breathing rate can be set between 0 to 25 BrPM. The operation is identical as in BPAP mode, but if the patient fails to make an inspiratory effort within the interval set by the minimum BrPM control, the device will cycle to the pressure support level to deliver the breath to the patient based on the minimum BrPM setting. The Silenzio Delta can be used to administer oxygen by using external oxygen tank and bleeding oxygen into the patient circuit. This therapy is not metered or otherwise regulated. Patient monitoring must be performed to ensure effective administration of oxygen therapy.

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