Hoffman Laboratories BreatheX CPAP Machine Interview
Product Overview
Introduction To The BreatheX CPAP Machine
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Product Page: BreatheX CPAP Machine
Product Page: BreatheX CPAP and HC150 Heated Humidifier
Breathex.com
User Reviews By: Rested Gal,
Mike Moran,
Wading Thru The Muck,
Neversleeps
Hoffman Laboratories Introduction and Background
History
The BreatheX story starts with Leslie Hoffman, founder of Hoffman Laboratories, LLC. He established Hoffman Laboratories hoping to design a CPAP that was completely battery operated, making it far more portable than any other CPAP. It had never been done before; CPAP motors simply weren't small enough, lightweight enough, efficient enough or able to operate at low enough temperatures to be used in this way.
Mr. Hoffman was born in Budapest, Hungary, escaping to the United States following the Hungarian Revolution in 1956. He held positions of increasing responsibility in a major electric motor manufacturing company. While a Vice President for Magnetic Technologies in Canoga Park, California, he first began working with Raymond Lathrop, the company's Chief Engineer. The two became close friends and business associates and began collaborating on a number of highly original motor designs.
Working together over the years, they have designed and manufactured a range of innovative new products, among them electric motors for the early Panavision studio cameras, IBM typewriters and disk drives, and TOW anti-armor missile systems.
In 1985, Mr. Hoffman founded Servo Magnetics Inc (SMI), which designed and manufactured electric motors used in anti-submarine surveillance equipment, the fin actuator motors for the Tomahawk cruise missile, high end medical centrifuges, anesthesiology gas analyzers, and numerous other industrial applications. SMI secured contracts with most of the major CPAP manufacturers, designing and building close to a million motors that have powered many of the world's CPAP devices, including those manufactured by Respironics, ResMed, Puritan Bennett (Tyco), and Sunrise. Mr. Hoffman sold SMI to ResMed, Inc, in 2002.
Answering The Questions
Tom Hoffman Tom is the son of Les Hoffman, the founder of Hoffman Laboratories. Tom is also a CPAP user and is involved in product development.
The Interview
Market Pull and Design
Q: We would like to know about the creative process behind the BreatheX. Can you please tell us how this CPAP came to be?
A: Les Hoffman, the founder of Hoffman Laboratories, was aware of the market's demand for smaller, lighter, more portable CPAP devices. For years his previous company, Servo Magnetics, had supplied close to 1,000,000 CPAP motors to all the major CPAP companies, including Respironics and ResMed.
Once, Les was on a long plane flight. Several seats away, a man was attempting to sleep. He had visible signs of sleep apnea, and Les was struck by the difficultly he was having. The man mentioned that he was having problems because he couldn't use his CPAP on the plane. Years later, Les was in a Sharper Image, noticed an airline pillow with built-in sound speakers, and asked himself, “why can't I design a battery-operated CPAP that will fit inside an airline pillow?†In March 2006, Hoffman Laboratories introduced the BreatheX to the marketplace.
Q: Are there any funny stories floating around the halls of Hoffman Labs that came from the process of bringing this CPAP from concept to production?
A: I really don't know if anyone will find this funny but maybe my personal journey with sleep apnea is good to put in here.
For several years my wife had been complaining that my snoring was getting worse. It became so bad that she would leave the room
in the middle of the night to escape my thunder. A close friend of mine who has been treated for years suggested that I go for a
sleep study. I fought this tooth and nail. The thought of being hooked up scared and disturbed me. Like others I opted for surgery to correct my deviated
septum hoping that this would help. Well it really didn't. When we started to develop our final prototypes I decided to give it a try.
I was astounded by my positive reaction. I actually started to sleep well and wake up refreshed. Soon afterwards, I finally went for
my sleep study and was formally diagnosed. I am at a pressure of 12cm.
A side note: I went through the process, purchased a traditional mask and CPAP and had a lot of trouble with them. I just couldn't get
used to them. I am proud to say that using the BreatheX I am fully compliant. By the way, my wife is really happy as well.
Q: What did Hoffman Labs set out to accomplish with this CPAP?
A: There are many people whose needs aren't met by conventional modes of CPAP therapy. In addition to those who want a more mobile, portable and convenient device as their primary CPAP or for traveling, there are many who refuse conventional CPAP therapy or, if they begin CPAP therapy, discontinue use. We're offering these people an alternative.
Q: What makes this machine more than just a "when I go camping" machine? Why is this ideal for every night use?
A: CPAP users report that they would love to get rid of the 6 foot tubing because it interferes with their freedom of movement while sleeping and tugs on their masks. Many patients at pressures below 12 cm, even those who currently use heated humidification, appreciate the comfort and convenience of the BreatheX.
Personally, I use the BreatheX every night and wouldn't change for anything.
Q: Why did Hoffman Labs decide to offer the CPAP only in the pillow? If the motor is light years ahead of your competitors, why not make a super small traditional CPAP and compete in that niche?
A: "Light years" might not be totally accurate, but we appreciate the compliment! The best response to your question is that the BreatheX is our first CPAP and that we have other product offerings in the development pipeline.
Q: Does this design have the battery in one side and the blower in the other? If so, where is the internal tubing and does it run through the "thin" part of the pillow?
A: Yes, the battery and control panel are located on one side, and the motor-blower assembly on the other. The two are connected by a small cable.
Testing, Feedback and Trials
Q: How large a user base was this CPAP tested on? Were the patients being served by DME or online providers? Were they previously compliant on other masks? How many nights in a row did they use it? How many hours per night?
A: We worked with a highly regarded sleep clinic to conduct our clinical trials. All of the patients were established, compliant CPAP users. Each individual test spanned a week period. Although we can't publish details of our clinical trials, we can say that we made several design changes in response to patient feedback.
I was involved in the testing and redesign and am probably one of the pickiest people you can find. If it can pass my demanding requirements and idiosyncrasies, then there's a good chance we have a winner.
Q: What were some of the changes that were made to the BreatheX as a result of patient testing?
A: These are a few of the changes: we reduced the amount of cushioning in the nape of the BreatheX (behind the neck), increased the overall circumference to better fit patients with larger necks, changed the configuration of the control buttons, and modified the tubing.
Q: Has the BreatheX been tested for side sleepers? How did it perform?
A: We did not test the BreatheX specifically for side sleepers, but there were patients in the clinical trials who tried the BreatheX in a number of positions.
I spend at least 50% of my night on my side and do well with it.
Q: What kinds of people are best suited for BreatheX? Which kinds should avoid it?
A: We really don't have enough data to predict how any single patient will use the BreatheX. Some prefer to wear it, like an airline pillow, while others prefer not to have anything around their necks and set the unit above their heads using the slightly longer tubing we provide. Our web site shows several options for using the BreatheX. Because of the flexibility of the device, most people can get comfortable with it.
The CPAP
The Battery and Power Components
Q: What type of battery powers this CPAP?
A: 8 cell, 14.4 volt lithium-ion battery pack, similar to that used in a notebook computer.
Q: How big is this battery? What does it weigh?
A: The battery is 3†X 3†X 1.75†and weighs 15.4 oz.
Q: Can I purchase multiple batteries?
A: Yes.
Q: How are extra batteries charged? Are they easy to pop in and out of my machine?
A: The batteries can easily be switched. At this time, the battery can only be charged while in the BreatheX by connecting the BreatheX charger to a 110V – 240V power source.
Q: Can the BreatheX operate from an AC power source?
A: No. The BreatheX was designed to be operated only under battery power.
Q: Can the battery be charged from a generator? Can the BreatheX battery be charged on DC power? Via a DC connection? Via a DC cable?
A: Basically, if you have a power source that you can plug the BreatheX charger into, you can charge the BreatheX, provided the source power rating is at least 100 watts.
Q: How long does the battery take to charge?
A: It takes approximately 5 hours to fully charge a completely discharged battery. In ordinary use, most users won't completely discharge the battery. Sometimes I only have it plugged in for little over an hour after a night's sleep, and that's enough, but I usually try to fully charge it.
Q: What was the reason for not making it capable of being plugged into the wall when battery power isn't needed? Do you plan to ever add that capability?
A: Since our goal in developing the BreatheX was to eliminate the need for a 6-foot length of tubing, we also wanted to eliminate the need for a power cord. If there's strong feedback from the marketplace, we'll consider adding that capability.
Q: Does the pressure level decay with battery consumption? What is the pressure to battery drain curve like?
A: No, the pressure level does not decay with battery consumption; the BreatheX will operate at the set pressure until the battery is discharged. At 10 cm of pressure, the battery will last 11-12 hours; at 12 cm of pressure, the battery life will be proportionately less. At a lower pressure, of course, the battery life will increase. Roughly, the battery life is inversely proportional to the pressure setting.
Q: How large is the charger and cord for this machine? What do they weigh?
A: The charger is 2.5†X 4†X 1.5†and weighs 11.7 oz.
The Pillow
Q: How warm is this pillow to wear?
A: The BreatheX memory foam is comparable to most other memory foam products on the market. The blower, because it is extremely efficient, adds very little heat.
Q: What types of fabrics is the pillow offered in? Are multiple colors offered?
A: Our initial product comes in 1 color, a dark gray, and is a terry cloth fabric. As we grow, we'll be very responsive to your feedback. We are also planning to make available cloth "sleeves", a pillowcase for your BreatheX that can easily be removed and washed.
The Tubing
Q: The tubing on the BreatheX is much shorter than traditional tubing. Please tell us why this design decision was made, why you think it is better, and what size tubing will work with this CPAP.
A: We provide 2 sizes of tubing with the BreatheX: 8" and 21". If you use the BreatheX around your neck, like an airline pillow, the 8" tubing works best. If you choose to open the BreatheX and place it above your head, the 21" tubing is best.
There are two advantages to using shorter tubing. The user doesn't become "entangled" in the tubing when moving in bed. More important, a shorter, lighter tube doesn't "tug" or "pull" on the nasal interface, causing masks leaks. Some users report that the fit with their existing masks is better using the BreatheX.
Q: Can I use the BreatheX with longer tubing than the default or is your tubing proprietary?
A: The BreatheX tubing is not proprietary. You can use any standardly available 22 mm cuffed tubing.
Operation
Humidification
Q: Can I use this with a non-heated humidifier or better yet a heated humidifier?
A: We have not yet tested the BreatheX with any passover or heated humidifiers from other manufacturers.
Q: Does Hoffman Labs have plans to make an integrated humidifier with this unit?
A: Because of the constraints of battery power and the small package size, adding humidification to a battery operated device presents some interesting challenges.
Air Intake
Q: Where is the air intake port on the machine? What can you do to make it not get covered by your blanket or sheets?
A: The air intake is on the right side of the BreatheX. Part of our design process was to test the BreatheX when it was covered by both blankets and sheets, and we found no reduction in airflow. Some users place the BreatheX under their blankets or sheets, while others reported tucking their blankets underneath the BreatheX. We recommend whatever feels most comfortable to you and encourage you to experiment.
Pressure
Q: I notice the pressure only goes up to 12cm. Why is that?
A: While our motor is fully capable of high pressures, we felt that heated humidification was much more important for users on pressures above 12 cm. Since approximately 80% - 85% of CPAPs are prescribed with pressures under 12 cm, we were comfortable limiting the BreatheX to 12 cm.
Sound
Q: How loud is the BreatheX CPAP compared to night stand CPAPs in decibels?
A: Many patients can't believe how quiet the BreatheX is. The motor-blower is highly efficient, which means it runs quiet, smooth and cool. Each BreatheX is tested to meet a maximum 31 decibel specification.
Ramp
Q: What is fixed ramp and how does it work?
A: By "fixed" ramp, we mean that there is a 15 minute ramp. With the ramp feature “on,†the BreatheX starts delivering pressure at 3.5 cm, then steadily increases the pressure up to your prescribed pressure over a 15 minute period.
Specifications
Q: What is the weight of the CPAP? What is the weight of the CPAP and battery? What is the weight of the CPAP, battery and pillow?
A: The CPAP components are built into the memory foam housing. The weight of the entire BreatheX system is approximately 4.5 lbs, including battery, and the battery alone weighs 15.4 oz.
Q: Is the BreatheX flame retardant?
A: The memory foam pillow is flame retardant. The removable, terry cloth outer cover is not.
Travel
Q: Which airlines have approved the BreatheX for inflight use?
A:
We are in contact with the FAA to determine what tests need to be completed to have the BreatheX approved for use on commercial aircraft.
Currently, if you want to use it on an airplane you need to individually make that request.
Q: If I am boating and it accidentally goes overboard, will it be damaged?
A: I'm sorry the BreatheX cannot be used as a floatation device. As with other CPAPs, the BreatheX should be kept dry.
The Mask In The Product Pictures
Q: What is the name of the mask shown in the pictures on the BreatheX.com website?
A: We designed the headgear and nasal cushions shown on our website specifically for the BreatheX, and we're waiting for clearance from the FDA. The nasal mask in one of the photos is a Respironics mask.
Q: If that is a mask made by Hoffman Lab, is the mask included in the purchase price of the machine?
A: No, as it is not released.
Future Products
Q: What products can we expect from your company in the future?
A: We have a number of products in various states of development, but we're not in a position to discuss any of them at this time. We have submitted to the FDA a new interface designed specifically for use as part of the BreatheX system.
Q: Does your company plan on offering an auto adjusting version of the BreatheX in the future? Does your company plan on offer a bi-level machine in the future?
A: The BreatheX is the first product we've introduced to the market, and there will certainly be other products to follow.
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!
Thank You
A very special thanks to the cpaptalk users who participated in this interview.
3isles, Titrator, bill2, monica2344, pnash, CPAPEXPERT, chdurie2, roztom, rested gal, Marzzz and birdshell.