Sandman Info and Sandman Auto

[ozij]

http://investor.covidien.com/preview/ph ... id=1162848

The Sandman Info CPAP builds on the feature-rich Sandman Intro CPAP. The Sandman Info device detects and records respiratory events while the patient is sleeping. This data can easily be downloaded to a memory card, allowing sleep clinicians and home care providers to review and provide indications of patient benefits from use of the CPAP device. The premium Sandman Auto CPAP has the Sandman Info's capabilities, plus it optimizes pressure by increasing it during obstructive events and decreasing pressure once the event has passed (while still recording all critical data).

Covidien is uniquely capable of offering comprehensive solutions to better enhance diagnosis and treatment of OSA patients. Via the global "Unite to treat Sleep Apnea" campaign, Covidien is uniting patients, physicians, Sleep Labs and Home Medical Equipment providers in an effort to simplify diagnosis and improve patient compliance with therapy. Covidien's new trio of CPAP devices is united with Covidien's sleep diagnostic system under the Sandman line.

http://www.puritanbennett.com/prod/List.aspx?S1=SPT

510(k) SUMMARY

Predicate Device Equivalence

The Puritan Bennett Sandman Info is equivalent to the Puritan Bennett GoodKnight 420S CPAP device (K020886), with the optional additive functionality of the Puritan Bennett GoodKnight H20 heated humidifier (K042184).

The Puritan Bennett Sandman Auto is equivalent to the Puritan Bennett GoodKnight 420E CPAP device (K020886), with the optional additive functionality of the Puritan Bennett GoodKnight H20 heated humidifier (K042184).

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Device Description
The Puritan Bennett Sandman Info operates only in Constant mode: the main function of the device is to deliver constant positive airway pressire to the patient at a fixed level prescribed by the practitioner.

The Puritan Bennett Sandman Auto operates in either Constant or Automatic mode. In Constant mode, the main function of each device is to delier constant positive airway pressure to the patient at a fixed level prescribed by the practitioner and between 4 and 20 cmH2O.

In Automatic mode (APAP mode), the practitioner determines and sets a maximum and minimum pressure range above and below the prescribed reference pressure and between 4 and 20 cmH20. The pressure is adjusted within the maximum and minimum limits according to the patient's respiratory pattern and the type of events detected.

O.
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CPAPopedia Keywords Contained In This Post (Click For Definition): auto cpap, CPAP

[DreamStalker]

I thought they were supposed to add exhalation relief to their new model?

Nice looking machine ... looks more like something you would expect to see on a night stand. I guess they are trying to compete with ResMed styling appeal.

[-SWS]

In Automatic mode (APAP mode), the practitioner determines and sets a maximum and minimum pressure range above and below the prescribed reference pressure and between 4 and 20 cmH20. The pressure is adjusted within the maximum and minimum limits according to the patient's respiratory pattern and the type of events detected.

Thanks for the information, ozij! I wonder if Tyco will once again neglect to mention that key role of "reference pressure" in the clinician's set-up manual: that initial pressure should be set at the prescribed pressure (specifically a prescribed pressure that eliminates flow limitations). The medical community and patients should not have to dig around the patent archives for that essential information.

Another question that comes to mind is whether any of Rapoport's more recent patent refinements will go into that algorithm. For instance, will the prolific scoring or aggressive pressure response of FL change in any way?

[-SWS]

I thought they were supposed to add exhalation relief to their new model?

Nice looking machine ... looks more like something you would expect to see on a night stand. I guess they are trying to compete with ResMed styling appeal.

Think they dropped that feature, once the user community managed to ace it with tape calibrations on the RJ11 jack...

.

[Slinky]

BIG THANKS, Ozij. I appreciate reading this type of info about the various xPAP models!!!

Especially, in this case, since I've been used to the Purtian Bennett name rather than the Sandman name. Puritan Bennett is more familiar so inspired more confidence than an unfamiliar (to me) name such as Covidien.

I was familiar w/the name of Sandman as one of the professional software used for sleep evaluation and titration.

[ozij]

In Automatic mode (APAP mode), the practitioner determines and sets a maximum and minimum pressure range above and below the prescribed reference pressure and between 4 and 20 cmH20. The pressure is adjusted within the maximum and minimum limits according to the patient's respiratory pattern and the type of events detected.

Thanks for the information, ozij! I wonder if Tyco will once again neglect to mention that key role of "reference pressure" in the clinician's set-up manual: that initial pressure should be set at the prescribed pressure (specifically a prescribed pressure that eliminates flow limitations). The medical community and patients should not have to dig around the patent archives for that essential information.

Another question that comes to mind is whether any of Rapoport's more recent patent refinements will go into that algorithm. For instance, will the prolific scoring or aggressive pressure response of FL change in any way?

Good questions, both....
Do you realize the clinicain's manual for the 420E even had a graph showing the initial pressure falling between the min. and the max? (page 19).
The problem with using the PB properly configured is that the prescribing doctors don't know the machines, and the people who set them up are not allowed to change the doctor's Rx. If a doctor prescribes a PB auto, without an initial pressure - what's the DME to do - assuming her or she knows how the machine should be set up, but the doc thinks that this info is none of a doctor's business ?

O.

[-SWS]

Do you realize the clinicain's manual for the 420E even had a graph showing the initial pressure falling between the min. and the max? (page 19).

Yeah, I just took a peek at that graph on page 19. It shows that the 420e ramp function will gradually rise to either initial pressure or to CPAP pressure---depending on which modality is used.

So for good measure I text-searched the 420e clinician's manual for the word "initial". I wanted to see if PB/Tyco gave clinicians even the slightest hint that "initial pressure" should be set at a "reference pressure" or "prescribed pressure" that adequately eliminates flow limitations.

NOT A HINT IN THE MANUAL FOR CLINICIANS OR 420e APAP USERS!!!!




That omission of crucial set-up information in the clinician's manual is a HUGE problem IMHO. And I'm still amazed about it. But very glad you discovered it a few weeks back!

The problem with using the PB properly configured is that the prescribing doctors don't know the machines, and the people who set them up are not allowed to change the doctor's Rx. If a doctor prescribes a PB auto, without an initial pressure - what's the DME to do - assuming her or she knows how the machine should be set up, but the doc thinks that this info is none of a doctor's business ?

Absolutely! And that's assuming the doctors, clinicians, and DME providers somehow manage to discover the well-hidden secret of how "initial pressure" needs to be set! What a procedural mess!

In the meantime cpaptalk.com members now have a 420e "leg-up" on the rest of the world!

[ozij]

Sandman Therapy Software Clinical Kit 1.0

That's refreshing - having the software there before the machine... .

Did anyone say DeVilbiss Intellipap?

And by the way (from the first quote, above, my emphasis):

BOULDER, Colo.--(BUSINESS WIRE)--June 5, 2008--Covidien (NYSE: COV, BSX: COV), a leading global healthcare products company, today announced that two new continuous positive airway pressure (CPAP) devices, the Sandman Info(TM) and the Sandman Auto(TM), are now available in the United States

O.

[Slinky]

I know the Sandman software is a popular software used by sleep clinics for their titration studies. I just didn't realize it was a Puritan Bennett software.