crwdns2931319:0crwdne2931319:0 Respironics Virtuoso

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A microprocessor-controlled device that delivers Continuous Positive Airway Pressure (CPAP) therapy in three modes for the treatment of adult Obstructive Sleep Apnea (OSA). 

The Virtuoso LX Smart CPAP System is trademarked by  Respironics, Inc.  and registered under U.S. Patent #5239995.

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== Background and Information ==

The Virtuoso LX Smart CPAP System is a black, roughly rectangular plastic box about 10” long by 5.5” wide and 4.75” high. It weighs 3.5 lbs. On one end of the top of the device is a digital screen which is outlined in white, with four round buttons serving various functions. A plug for the hose is found below this screen on the short end of the device. The name of the device is seen directly underneath the digital screen, and a slot holding a memory card resides on the side of the device. No model number is seen on the device.

The predicate device, Virtuoso CPAP System,  was replaced in 1999 by this device, the Virtuoso LX Smart CPAP System, which was different due to the addition of a removable data card. This card was the size of a credit card and had two functions: data retrieval and device settings memory.

The Virtuoso LX system was manufactured for the treatment of adult obstructive sleep apnea. The machine is made of a blower-based system that generates positive pressures from 3-20 cm H,,2,,0. It is intended to be used with a patient circuit that connects to the CPAP device to route air to patients via a nasal mask. This patient circuit is made up of six feet of 20 mm tubing, an exhalation device, and a nasal mask.

Due to its multi-mode operation, the machine can be used all night. The Virtuoso LX is an automatically adjusting CPAP system, which means that it continually monitors the patient's airway and automatically delivers the appropriate pressure for therapy during operation.

The machine keeps the airway open by automatically adjusting the constant positive pressure throughout the breathing cycle. This is achieved by the motor speed adjusting and controlling the pressure, which is regulated by the microprocessor.

This device has been discontinued, and the manufacturer was bought out by a larger company in 2007. Although product support is limited to original instruction manuals and manufacturing has ceased, used units still occasionally appear for sale on medical device websites.

== Technical Specifications ==

***Environmental:***

++Operating Temperature++               

41– 104⁰F (5 – 40⁰C)

++Storage Temperature++                  

 -4 – 140⁰F (-20 - 60⁰C)

++Humidity++                                    

15 – 95% non-condensing

++Outlet Temperature Rise++             

Shall not exceed 122⁰F (50⁰C) when operating at a maximum ambient temperature of 104⁰F (40⁰C). ''Note: The outlet temperature rise can be as much as 18⁰F (10⁰C) higher than room temperature measured at the end of a 6 ft. tube.''

++Atmospheric Pressure++                

83 – 102 kPascals (Storage: 50 – 102 kPascals)

++Elevation++                                      

0 – 5,500 ft. (0 – 1.67 km) with three selected ranges available.

++Noise level++                                   

No specification given because various test instruments, test procedures, and unit operating conditions produce varying results.

***Fuses:***

++Fuses++

There are no replaceable fuses.

***Physical:***

++Electrical Safety++

IEC 601-1, general safety requirement for medical devices.

++Dimensions++                                       

10.00” (L) x 5.50” (W) x 4.75” (H) (25 x 14 x 12 cm)

++Weight++                                                

3.5 lbs (1.6 kg)

***Electrical:***

++AC Input Voltage++                             

93 – 126 VAC; 207 – 264 VAC; 47 – 63 Hz

++DC Input Voltage++                             

12 VDC

++AC Current Consumption++             

1.0 A maximum

++DC Current Consumption++             

3.0 A maximum

++Power Consumption++                      

80 VA maximum

++Class++                                                     

Class I for units with a 3-prong AC power inlet. Class II for units with a 2-prong AC power inlet.

++Type++                                                 

Type BF

***Functions:***

++Modes++                                             

CPAP

Auto-CPAP

Split Night with Auto-CPAP

***Ramp:***

''Note: The Ramp feature is only available in the CPAP mode.''

++Minimum Ramp Press++   

4.0 – 20.0 cm H,,2,,O

++Ramp Resolution++

1.0 cm H,,2,,O

++Ramp Time++

0 – 45 minutes

++Ramp Time Resolution++

5 minute increments

***Altitude Compensation:***

++Pressure Range++

83 – 102 kPascals

++Settings++

Low

(0 – 1,800 ft; 0 – 548 m)

Mid (Medium)

(1,801 – 3,600 ft; 549 – 1,097 m)

High

(3,601 – 5,500 ft; 1,098 – 1,677 m)

***Compliance Meter:***

++Compliance Meter (LCD)++

Total Operation Time

Time at Pressure

Percent Memory Remaining

***Pressure:***

++AC Operation++  

3.0 – 20.0 cm H,,2,,O

++DC Operation++  

3.0 – 20.0 cm H,,2,,O

++CPAP Mode++  

3.0 – 20.0 cm H,,2,,O

++Auto-CPAP Mode++  

Min Pressure Range

3.0 – 20.0 cm H,,2,,O

Max Pressure Range

min pressure setting – 20.0 cm H,,2,,O

++Split Night with Auto-CPAP Mode++

3.0 – 20.0 cm H,,2,,O

++Resolution++  

1.0 cm

++Accuracy++   

+/- 1.3 cm H,,2,,O   or 15% of the indicated control setting (whichever is greater). This tolerance assumes system setup similar to maximum pressure test.

++Setting Stability++

+/- 1.3 cm H,,2,,O over 8 hours

***Therapy Memory:***

++Therapy Memory++

Retrievable by Encore Software (version 2.5a or later)

***(CPAP Mode)***

++Min Capacity++   

9 months

++Content++

Pressure Setting

Date/Time of Each Use

Duration at Pressure

Ramp Usage

***(Auto-CPAP Mode)***

''''''++Max Capacity++   

4.5 months (at 6 hours/night usage)

++Content++

Pressure Setting

Date/Time of Each Use

Duration at Pressure

Pressure Summary (peak, mean)

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== Additional Information ==

* [link|https://www.sleeprestfully.com/prodimages/PDF%20Files/UserGuideVirtuosoLX.pdf|Operating Instruction Manual]: Sleeprestfully.com is a retail website for CPAP machines and various oxygen needs. Although the product is not currently available on their website, a full color, illustrated user’s guide is.
* [link|https://www.accessdata.fda.gov/cdrh_docs/pdf/K993433.pdf|FDA Summary of Safety & Effectiveness]: This copy of the manufacturer’s modification request states the intended use and description of the device. Additionally, the device modifications (making this the second generation) are listed. Finally, the letter from the FDA to Respironics okaying the placement of the device onto the market is included.
* [link|http://www.cpaptalk.com/search.php?keywords=virtuoso+lx+smart+cpap|Online forum]: Cpaptalk.com is a good place to start out looking for information and opinions from previous and/or current device users. Users can ask questions and look at previous discussions to gather information.

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Respironics Virtuoso LX Servic.pdf

Respironics Virtuoso LX Service Manual Part 3.pdf

Respironics Virtuoso LX Service Manual Part 2.pdf

Respironics Virtuoso LX Service Manual Part 1.pdf

Respironics Virtuoso LX Service Manual Part 4.pdf

SERVICEManual Virtuoso Lx