Respironics C-Flex, Remstar Auto with C-Flex, Remstar Pro 2 with C-Flex Interview
Respironics Introduction and Background
History
Founded in 1976, Respironics is a leading developer, manufacturer and distributor of innovative
products and programs that serve the global sleep and respiratory markets. The Homecare Division
is recognized worldwide for its continuous stream of medical innovations and advancements in the
management of sleep disorders, integrating state-of-the-art technology in diagnostics, therapy
and monitoring with strategic programs to help homecare providers and sleep centers care for
patients efficiently and cost-effectively.
Respironics markets its products in over 125 countries and employs more than 3,400 associates
worldwide.
Respironics Homepage
Innovations
Respironics has demonstrated its dedication to the sleep therapy market with a proven track record of innovation and responsiveness to market needs. Widely considered a global leader in sleep therapy, Respironics introduced the first commercially available CPAP device in 1985 and was first to the market with BiPAP® bi-level therapy in 1989. Since then, many generations of increasingly advanced therapy devices and patient interfaces have been released. The company’s latest technological introduction to the sleep therapy marketplace is C-Flex™.
Product Managers
Jeff Maglin Product Manager, CPAP, C-Flex and Humidification
Shawn Trautman Product Manager, REMstar Auto and Encore Pro
About The Interview
We are proud to provide the cpaptalk community with a means to communicate with the manufacturers of the newest and most innovative CPAP equipment. We have made an effort to keep questions posted by our community members in as close to their original form as possible, however, some gramatical and structural changes to community questions have been made in an attempt to improve the clarity and capture the spirit of the question. User questions, in their exact and originally posted form, can be found on cpaptalk's "Request for Questions" thread. We thank each and every one of you for your involvement in this process and look forward to gathering your questions for future interviews soon!
Understanding Respironics C-Flex Technology
Description
Select Respironics’ REMstar® devices incorporate our patented C-Flex technology. C-Flex addresses one of the main obstacles to patient compliance: pressure intolerance. C-Flex lowers the pressure level at the beginning of exhalation, returning to set pressure before exhalation ends. The amount of pressure relief is based on the patient’s expiratory flow. Patients may select their preferred pressure level from a C-Flex setting of 1, 2 or 3. Using the triggering and cycling algorithms of Digital Auto-Trak™, C-Flex devices are able to respond on a breath-by-breath basis. C-Flex makes CPAP therapy more comfortable for users.
Videos
cpap.com Manufacturer Video, CPAP Without C-Flex
cpap.com Manufacturer Video, CPAP With C-Flex
Clinical Study and Technical Information
Q: Respironics claims that people who use C-Flex sleep an hour longer than those who don't use C-Flex. Can they tell us how to get a copy of that study or where there is a link posted for it?
Respironics did not make that claim. We referenced the results of a study conducted by researchers at Rhode Island Hospital, Brown Medical School, Brigham and Women’s Hospital, and Harvard Medical School* which showed patients on C-Flex averaged one hour and forty-two minutes more sleep per night than patients on CPAP after three months of use.
* Study funded by a grant from the National Institutes of Health. Poster presented at the 9th International Symposium on Sleep and Breathing. This peer- reviewed article has been accepted for publication in the journal Chest in 2005.
Q: Have studies been conducted to determine if the reduced exhalation pressure of C-Flex lowers the occurance of mouth leaks?
To date, no study has definitively shown that C-Flex lowers the occurrence of mouth leaks. In a patient preference study conducted by Respironics, 98% of respondents found C-Flex to be a comfortable form of therapy, while 9 out of 10 patients found that C-Flex was more comfortable than conventional CPAP.
Q: What is the relative decrease in pressure during the C-Flex phase (exhalation) of operation?
C-Flex offers variable pressure relief on a breath by breath basis with the aid of our patented
Digital Auto-Trak technology. Digital Auto-Trak detects the transition point between inhalation
and exhalation while accounting for system leak. C-Flex provides pressure relief at the beginning
of exhalation based on the patient’s respiratory flow and the C-Flex setting selected (1, 2, 3).
The patient is returned to set pressure by the end of exhalation.
Many believe that the C-Flex setting is equivalent to the actual pressure relief
(e.g., C-Flex Setting of 1 = 1 cm H2O pressure). This is not correct.
C-Flex and Software
Will the data available to Encore Pro be affected when a machine is in C-Flex mode?
No. The only change to the Encore® Pro report is that that the C-Flex banner will appear in the upper right corner of every page when C-Flex is enabled.
Will there be a different set of Encore Pro measurements when using C-Flex? Is there C-Flex specific data that Encore Pro doesn't display?
No. The same measurements will be used whether C-Flex is enabled or disabled. Encore Pro will display the C-Flex banner in the upper right hand corner of every report page when C-Flex is enabled. The C-Flex setting is displayed in any Encore Pro report.
Q: Is there a firmware upgrade available to add C-Flex to existing Remstar Autos?
No. REMstar Auto units without C-Flex cannot be upgraded to add C-Flex.
Respironics Remstar Auto with C-Flex
The Respironics Remstar Auto with C-Flex is the only
Auto CPAP with an easy breathing capability. Like all
Auto CPAPs it automatically adjusts pressure based on
air-flow changes relating to an unstable airway. C-Flex
technology offers a more comfortable way to deliver
sleep therapy by giving pressure relief at exhalation.
The amount the pressure is lowered is determined by
one of three settings that you can adjust to your
comfort.
The component REMstar Heated Humidifier integrates
with the REMstar Pro to become one unit with only one
hose and one power cord. Other features of note include
an automatic start and stop operation and a mask leak
alert.
REMstar Auto C-Flex CPAP with bag, hose and manuals
REMstar Auto C-Flex CPAP, REMstar Heated Humidifier with bag, hose and manuals
Product Specifications
| Pressure Range | 4cm to 20cm H2O |
| Ramp Time | Automatic in Auto mode |
| Starting Ramp Pressure | From 4cm up to CPAP pressure |
| Smart Card | Records 9 Months usage, Date/Time, Duration at pressure, snoring and apneic events information. Download the Smart Card to your computer with additional purchase of Encore Pro Software & Smart Card Reader |
| CPAP Dimensions | 9.45" x 6.69" x 4.72" |
| Heated Humidifier Dimensions | 13.25" x 6.5" x 2.125" |
| CPAP with Heated Humidifier Dimensions | 13.25" x 6.69" x 6.84" |
| CPAP Weight | 3.96 lbs. |
| CPAP with Heated Humidifier Weight | 5.81 lbs. |
| Altitude Compensation | Automatic |
| Electrical Requirements | 100 - 240 AC, 12volt DC |
Clinical Studies and Patient Reaction
Q: Before release of the product, was this machine evaluated on a user base? If so, how many users and how long were they asked to try it?
Yes. There were extensive user trials of this product prior to launch as well as validation studies. The initial user trial consisted of over 20 patients with downloads performed at 15 days, 30 days, and 60 days. The trial ran for a total of 5 months before the product was launched. Participants completed questionnaires to provide feedback on usability and functionality.
Q: What type of comments did you receive from patients during the clinical trials? Is there a common theme to their opinions?
The response to the device was overwhelmingly positive with users complementing how comfortable the device was to breathe on as well as how quiet it was.
Q: Is there a specific demographic of CPAP users Respironics has targeted with this machine? If so, how do the Auto's features reflect your goals?
There is not a specific demographic targeted with this product.
Product Release, Warranty and Care
Q: This machine was recently released in America. Is this product available in Canada? Does Respironics slowly release products to different countries or is this currently available world wide?
This product is currently available in the United States, Canada and targeted areas worldwide. There are additional launches scheduled during the January and February of 2005.
Q: Will the Remstar Auto carry the same warranty as the Remstar Auto without the C-Flex?
Yes. The REMstar Auto with C-Flex will carry Respironics standard CPAP 2-year warranty.
CPAP Mask and Interface Compatibility
Q: Is this machine compatable with all popular masks and nasal interfaces? If not, what interfaces will it not work with?
Yes. Testing has demonstrated that this machine is compatible with all Respironics masks and nasal interfaces; however, pressures should be verified when using masks and nasal interfaces produced by other manufacturers.
Q: Will wearing a nasal pillow interface (Comfort-Lite, Breeze, etc) 'throw-off' the RemStar Auto or alter treatment efficacy in any way? If so, will there be any way for the user to input the type of interface being used so that the RemStar Auto can optimize treatment based on the interface used?
No. Testing has demonstrated that this machine is compatible with all Respironics masks and nasal interfaces; however, pressures should be verified when using masks and nasal interfaces produced by other manufacturers.
The Remstar Auto and Encore Pro Software
Q: Will the report that the Remstar Auto with C-Flex generates with Encore Pro note that you are using a specific C-Flex setting?
The report will note that C-Flex is being used but will not note the C-Flex setting. The C-Flex setting is adjusted by the user for comfort and is accessible via the unit’s display.
Benefits Compared to Features of Similar Machines
Q: Why doesn't the REMstar Auto use pressure sensor tubing as the Puritan Bennett and Resmed machines do? Is the Auto as accurate without one?
The product has been designed to include pressure and flow sensors internal to the device. Testing has demonstrated that there is no need for additional sensors or external sensor tubing to meet its published accuracy specifications.
Q: Will the RemStar Auto have any onboard firmware or add-on features such as pulse and/or oximetry measurement and recording? (Similar to ResMed Spirit)
The device is designed to provide 4 therapy types. The device can be configured as a standard CPAP, CPAP with C-Flex, standard Auto-CPAP or Auto-CPAP with C-Flex. The REMstar Auto with C-Flex is compatible with a Respironics’accessory -- the SleepLink™ Modem -- which can deliver oximetry information combined with compliance data.
Q: Can the RemStar Auto tell the difference between a central apnea and an obstructive apnea? If so, how? If not, at what pressure will the machine max out? (ResMed Spirit will not go above 10 cm to treat a detected apnea).
The REMstar Auto algorithm looks for apnea’s that are non-responsive to treatment which could indicate that these are central events. At any pressure 8 cm H2O or higher we will make three pressure increases in response to a sustained string of events. If there is no improvement after the third increase, indicated by the persistence of events, the pressure is dropped 2 cm and a constant pressure is held for several minutes. If there is snoring noted during this period of constant pressure, which would indicate obstruction, we will increase pressure and reset the non-responsive treatment, thus allowing for three more pressure increases. Apneas can potentially be treated up to the device's maximum pressure setting (20 cm H2O).
Q: Will the RemStar Auto allow the user to get treatment information (AI/AHI index, etc) directly from the LCD screen as the ResMed Spirit does or will the user need to purchase Encore Pro software and a SmartCard reader?
The REMstar Auto is able to detect events and report that data via the internal SmartCard or the SleepLink Modem using Encore Pro 1.4i Rev 3. This treatment information is intended to be confirmatory that the therapy being provided is effective. It is not intended for diagnostic purposes.
Q: Will the RemStar Auto allow any tweaking of treatment parameters like the Puritan Bennett 420E does? Specifically, inspiration flow limitation settings or changing default settings?
There is no need to make these changes to the device settings when using the REMstar Auto with C-Flex.
Q: I am very senstive to noise coming from both the mask and machine. How does the noise level of the new Remstar compare to the other models, is it any quieter? If so, by how much?
The REMstar Auto with C-Flex device is rated at the same noise level as that of our current REMstar line of product (< 30 dB).
Future Plans
Q: Will you continue to manufacture the Remstar Auto without C-Flex?
No, there is no need to continue the REMstar Auto without C-Flex since the REMstar Auto with C-Flex can be setup to provide Auto-CPAP therapy without C-Flex.
Q: Could this machine be used to give some relief to BiPAP users with a lower AHI and a higher titrated pressure.
There are different reasons that BiPAP is prescribed. It can be as a rescue for those patients who did not initially tolerate CPAP or for those patients who require BiPAP to treat their disorder. If BiPAP was prescribed because it was necessary to treat a specific problem then the answer would be no. If BiPAP was prescribed due to intolerance to standard CPAP and the patient was still not tolerant of treatment then REMstar Auto with C-Flex could be an option.
Q: Will the new Remstar Auto with C-Flex come in any other color than the black? Do you have any future plans to make our machines look less medical?
There is only one color option.
Remstar Auto Features
Q: Can the new auto with C-Flex be used with a battery?
Yes. When doing so we recommend using Respironics "Shielded 12 VDC power cord system" which includes a DC power cord and a battery adapter.
Respironics Remstar Pro 2 with C-Flex
The Respironics Remstar Pro 2 with C-Flex can make the
claim that it is the most feature packed non-auto
adjusting CPAP. A cutting edge feature is the easy
breathing C-Flex technology. Research indicates that
patients with C-Flex average more sleep time on CPAP
than those that do not. The improvement in
breathability is remarkable and immediately noticable.
Other major features include the ability to output
enhanced compliance data (AHI, leak, and snoring) with
the Encore Pro SmartCard and Data Management Software.
The CPAP also offers the features expected from
Respironics, including quiet operation, advanced power
supply (12 volt, 110 and 220 volt), and an optional
intregrated heated humidifier.
REMstar Pro 2 C-Flex CPAP with bag, hose and manuals
REMstar Pro 2 C-Flex CPAP, REMstar Heated Humidifier with bag, hose and manuals
Product Specifications
| Pressure Range | 4cm to 20cm H2O |
| Ramp Time | 0 to 45 min (5-min increments) |
| Starting Ramp Pressure | From 4cm up to CPAP pressure, patient-adjustable |
| Dimensions | 9.54" (l) x 6.69" (w) x 4.72" (h)
24 cm (l) x 17 cm (w) x 12 cm (h) |
| Weight | Less than 4 lbs. (1.8 kg) |
| Filters | Pollen and optional ultra-fine |
| Device Setup | On-board keypad and Smart Card |
| Data Storage Capacity | (minimum) 6 months @ 3 usage sessions/day; 7-9 days in depth data analysis |
| Data Storage Content | Date/time, duration at pressure, patient event histograms, short-term detailed events, long-term trends, FOSQ tests |
| Compiance Meter | Breathing detection; sessions > 4 hours |
| Altitude Compensation | Automatic |
| Electrical Requirements | 100-240 AC, 12 VDC |
| DC Power | Direct-connect cord |
| Warranty | 2 years |
| Misc | Integrated heated humidification control, lighten keys on pad, automatic on/off, mask off alert |
Clinical Studies and Patient Reaction
Q: Before release of the product, was this machine evaluated on a user base? If so, how many users and how long were they asked to try it?
Several existing CPAP patients trialed the REMstar Pro 2 for a period of five months before the official product release of the device in the United States. Trial participants responded favorably to the device, several indicating that it was quieter and more comfortable than their existing devices.
Q: What type of comments did you receive from patients during the clinical trials? Is there a common theme to thier opinions?
The response to the device was overwhelmingly positive with users complementing how comfortable the device was to breathe on as well as how quiet it was.
Product Release, Warranty and Care
Q: Will the warranty be the same as the Remstar Pro without the C-Flex?
Yes. The REMstar Pro 2 with C-Flex will carry Respironics standard CPAP 2-year warranty.
Benefits Compared to Features of Similar Machines
Q: What will be the difference between the current Respironics Pro with C-Flex and the new Remstar Pro 2 model?
The REMstar Pro 2 with C-Flex functions identically to the REMstar Pro with C-Flex. The only difference is that the REMstar Pro 2 has enhanced reporting capability which includes daily details for apnea, hypopnea, snore and leak.
Q: Will there be a method of determining how you are doing (such as Encore 2) with the Remstar Pro 2 model?
Each REMstar Pro 2 comes with an Encore Pro SmartCard that collects daily usage information including CPAP pressure, number of hours of use and patterns of use, as well as apnea, hypopnea, snore and leak indexes for up to six months. The card also records detailed daily data on apnea, hypopnea, snore and leak events for the last 7 to 9 days. The SmartCard can be downloaded and read on any Windows-based computers using Respironics’ Encore Pro software (Version 1.4i) and card reader.
Remstar Pro 2 Features
Q: I am very senstive to noise coming from both the mask and machine. How does the noise level of the new Remstar compare to the other models, is it any quieter? If so, by how much?
The REMstar Pro 2 device is rated at the same noise level as that of our current REMstar line of product (< 30 dB).
Thank You
A very special thanks to the cpaptalk users who participated in this interview.
wading thru the muck!, Titrator, WillSucceed, GotREMBack, Miko, SleepyTimeGal, bill2, bp, Yoga, unclebob, rested gal