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A moderated chat event was held on Tuesday, November 12, 2002 featuring Simon J.P. Johnson with ResMed. The questions and answers from the chat are listed below. We all wish to thank Mr. Johnson for generously contributing his time to inform sleep disorder patients about the new AutoSet Spirit™ and S7 Elite™ CPAP. Each question is linked to the answer for your easy reference.
Simon J.P. Johnson, ResMed Sr. Product Manager. He came to ResMed in 2001 with eight plus years of international sales and marketing experience in medical devices. Mr. Johnson Holds a BA in Public and Business Administration from San Diego State University.
1. Has the algorithm changed from the AutoSet T?
ResMedSimon answers: The algorithm is unchanged - the algorithm continues to monitor flow limitation, snore and apnea on a breath-by-breath basis, and responds according to the severity of each event.
2. Do we still use Flow Limitation?
ResMedSimon answers: Flow limitation continues to be one of the key parameters used in the AutoSet® algorithm. We believe that monitoring and responding to all three parameters (flow limitation, snore, and apnea) are critical in effective autotitration.
ResMedSimon answers: When using a mathematical representation of the shape of the breath (flow time curve) to indicate the state of the upper airway, a "round" shape denotes an open patent airway while a "flattened" shape indicates a flow limited airway.
4. Will the flattening threshold for AutoSet Spirit™ be provided?
ResMedSimon answers: Slight variations in flow sensors and signal processing across devices can influence the flattening index. The flattening response threshold may be adjusted to ensure clinically equivalent response to flattening across devices. The AutoSet algorithm responds in the same way in each of ResMed's AutoSet devices - pressure is increased in response to the degree of flattening present.
5. Has the AutoSet Spirit been clinically trialed?
ResMedSimon answers: Yes. In eight veteran AutoSet T users, subjects expressed a slight subjective preference for AutoSet Spirit. The overall usage, median 95th percentile and peak pressure distribution, and device self-reported AHI were all as expected, very similar on the two devices
6. Why does AutoSet Spirit (and AutoSet T™) have the A10 algorithm?
ResMedSimon answers: The A10 algorithm increases pressure in response to Flow Limitation, Snore, and Apnea up to 10cm H2O. Above 10cm H2O, pressure response to Flow Limitation and Snore continues, but there is no response to Apnea. AutoSet Spirit and AutoSet T do not differentiate between obstructive and central apneas. Increasing pressures above 10cm H2O in response to apnea can lead to "runaway" central apneas.
7. Why does AutoSet Spirit cost less that AutoSet T?
ResMedSimon answers: AutoSet Spirit is the first AutoSet device designed as a home unit. AutoSet T had several diagnostic features whose design was intended for clinical use (e.g., SNS, 30 sessions of night profile), which placed greater and more costly demands on design. These features will be available through a future upgrade, thus isolating the costs from the flow generator. AutoSet T was the first of its kind and from its design we have learned cost efficiencies, which we are now passing onto the customer - fewer parts and shorter assembly time.
8. Is AutoSet Spirit as quiet as the AutoSet T?
ResMedSimon answers: Yes, and incremental improvements in noise performance are expected over the life cycle of the product.
9. Which masks are compatible with AutoSet Spirit and ResMed S7™ Elite?
ResMedSimon answers: The following ResMed masks have been validated for use with the AutoSet Spirit and ResMed S7 Elite: Mirage, Ultra Mirage, Modular Nasal, Mirage Full Face Mask, Series 2, Vista, and Protégé. We have not validated competitor masks with the AutoSet Spirit system.
10. Are the cables the same as for the AutoSet T?
ResMedSimon answers: Yes. Both the power cable and null modem cable for the AutoSet T have been maintained for AutoSet Spirit and ResMed S7 Elite.
11. Can you download using modems?
ResMedSimon answers: Yes. The instructions are provided in the AutoScan 4.0 Clinician's Manual.
12. Do AutoSet Spirit and ResMed S7 Elite have a switch mode power supply?
ResMedSimon answers: Yes. The AutoSet Spirit and ResMed S7 Elite can be used internationally. Note that power socket adaptors will be necessary.
13. Can the AutoSet Spirit / ResMed S7 Elite and HumidAire® 2i be run off a battery?
ResMedSimon answers: Yes, a deep-cycle battery, gel cell is needed. (You cannot use a typical car battery.) The AutoSet Spirit or ResMed S7 alone needs an 80 AH battery. The AutoSet Spirit or ResMed S7 plus HumidAire 2i needs a 300 AH battery (or 2 x 250 AH batteries). These batteries can be purchased from specialty stores (e.g., Radio Shack). An inverter is also needed. The specification for the required inverter will be released shortly.
14. Why is there no dedicated 'Mask Fit' function button?
ResMedSimon answers: The 'Mask Fit' function is popular with patients for the first few nights of therapy. Most patients then adjust to fitting their mask without the 'Mask Fit' function. It has been combined with the Start / Stop Front button to save keypad space and reduce cost. The Mask Fit function is easy to access by holding the 'Front' button for more than 3 seconds.
15. Why is the Mask Fit function leak calculated as the 95th percentile and the Smart Data leak calculated as the 70th percentile?
ResMedSimon answers: It is more difficult for the patient to obtain a low leak (good fit) throughout the night than it is while using the Mask Fit function when awake. Calculating the Smart Data leak as the leak only exceeded for 30% of the night allows the patient to achieve a higher star rating for realistic leak levels and therefore stay motivated.
16. Does a session run 12 noon - 12 noon?
ResMedSimon answers: Yes. The same clock logic as in the AutoSet T has been implemented. The majority of patients sleep during the night and the best time to reset for a new session is during the day so that sleeping time is not broken across two sessions. For shift workers, the same display as AutoSet T will apply. Smart Data will reset at 12 noon. For shift workers who wish to use this feature, you may want to reset the clock by 12 hours.
17. Can the flow generator be damaged by water spilling back from the humidifier?
ResMedSimon answers: No. The water chamber, docking station, and flow generator have all been designed for safe integrated humidifier use under all normal operating conditions. Additionally, water will not damage the flow generator if the combined unit is tilted into any position (except for upside down). The spillback protection design mechanisms of the water chamber can be demonstrated by tilting the chamber by 90 degrees in every direction. This should be done while the chamber is disconnected from the flow generator. While rigorous tests have been performed during product development, we do not recommend that the flow generator be deliberately tilted with the water chamber connected.
18. Can you use other humidifiers?
ResMedSimon answers: Yes. The AutoSet Spirit and ResMed S7 Elite are compatible with the HumidAire and ResMed Passover humidifiers.
19. Why is there only one indicator light on the HumidAire 2i?
ResMedSimon answers: The HumidAire needed two indicator lights; one to indicate that power was being supplied to the heater plate and the second to indicate whether the heater plate was actively heating. HumidAire 2i has a hard off position on the dial. In this position, the user can be assured that no power is being supplied to the heater plate. Only 1 light is required - to indicate whether the heater plate is actively heating (as on HumidAire.)
20. Is there a fixed pressure Model of the Spirit?
ResMedSimon answers: Clinicians can set the AutoSet Spirit to fixed pressure (CPAP) mode and still have access to all the features of the AutoSet Spirit. Alternatively, the ResMed S7 Elite is available for fixed CPAP use.
21. Why can't I buy the AutoSet Spirit or ResMed S7 Elite with the HumidAire 2i connected?
ResMedSimon answers: This is planned for in the future. For the first three months of launch, the two components will need to be purchased separately to allow us to monitor the demand for the different configurations for accurate forecasting. During this period, the humidifier and flow generator can be easily connected and the patient can transport them home together in the carry bag.
22. Will I have access to future flow generator software upgrades?
ResMedSimon answers: Yes. Software will be used to upgrade units in the field. This will be able to be done by either dealer or clinician.
23. What maintenance is required?
ResMedSimon answers: Daily, clean mask and water chamber (or after each use). Weekly, wash the air tubing. Periodically, clean the exterior of the AutoSet Spirit flow generator and HumidAire 2i docking station, check for air filter blockage for holes in air filter. Inspect filter monthly. And every six months replace air filter. The pressure sensor adaptor does not need to be cleaned for home use. Replace the pressure sensor after 12 months.
24. Is AutoScan 4.0 backwards compatible?
ResMedSimon answers: No. Both versions of AutoScan can co-exist on the same PC.
25. What are the differences between AutoScan 4.0 and AutoScan 3.12?
ResMedSimon answers: The differences are minimal. AutoScan 4.0 does allow download of data from AutoSet Spirit and ResMed S7 Elite, but does not allow setting changes to be uploaded to AutoSet Spirit or ResMed S7 Elite. This modification is a result of recent FDA guidelines. AutoSet Ts and VPAPs should be downloaded to AutoScan 3.12.
26. When will the rest of the system be available?
ResMedSimon answers: Further functionality will be available by the end of 2002.
27. Why introduce altitude adjustment to the Lightweight range?
ResMedSimon answers: The accuracy of the delivered pressure can be greatly improved with adjustments for changes in altitude.
28. What masks is the ResMed S7 Lightweight compatible with?
ResMedSimon answers: All three devices are compatible with the Mirage®, Ultra Mirage™, Protégé™, Mirage Vista™, and Mirage Full Face Mask Series 2. No competitor masks have been validated for use with this device.
29. How is patient compliance measured on the S7 Lightweight?
ResMedSimon answers: The S7 Lightweight records machine run hours, which can be reset.
30. Can other humidification units be used with these devices?
ResMedSimon answers: Yes
31. Can these devices be used on aircraft?
ResMedSimon answers: Each airline carrier has a different policy regarding CPAP use onboard aircraft.; Check with the appropriate airline.
32. Can the ResMed S7 Lightweight be used with an AB filter?
ResMedSimon answers: Not at this stage
33.Can an i33. nverter be used with the S7 Lightweight?
ResMedSimon answers: Yes
34. At what altitude is the unit initially calibrated?
ResMedSimon answers: The altitude setting will be calibrated at approximately 262 feet (80m)
35. What is the software-derived maximum delivered pressure for the S7 Lightweight?
ResMedSimon answers: 26 cm H2O; this is mitigation against the event that the patient was to set the altitude to the high setting while using the flow generator at sea level.
36. What data is held in non-volatile memory of the S7 Lightweight?
ResMedSimon answers: Patient usage hours, machine use hours, calibration constants, clinical settings, and software version.
37. Is there a humidifier cool down mode in the ResMed S7 Lightweight?
ResMedSimon answers: No, this basic model does not include a cool down period at the end of therapy. The ResMed S7 Elite and AutoSet Spirit have this function
38. How are changes in air pressure and density compensated with the S7 Lightweight?
ResMedSimon answers: This is achieved via increases and decreases in the motor speed; this is managed using elevation settings via the LCD
39. Are changes in the altitude setting and fine adjustment reflected in changes to the ramp pressures?
ResMedSimon answers: Yes
40. What happens if there is a power interruption during use?
ResMedSimon answers: On the resumption of power, the device will revert back to the operating mode that it was in prior to the interruption. If in operating mode when a disruption occurs, the device will start with the ramp time and pressure set up in the device. In the event of an interruption during calibration, the device will revert to standby mode
41. Can the same accessories used with the ResMed S7 Elite and AutoSet Spirit be used with the ResMed S7 Lightweight?
ResMedSimon answers: Yes.
42. Does the ResMed S7 Lightweight monitor pressure feedback to manage Smart Start, automatic altitude adjustment, and patient usage at pressure type options?
ResMedSimon answers: No; the ResMed S7 Lightweight uses software controlled motor speed for pressure management
43. Can the ResMed S7 Lightweight be upgraded to a ResMed S7 Elite or AutoSet Spirit?
ResMedSimon answers: No
44. Can the ResMed S7 Lightweight be used with AutoScan software?
ResMedSimon answers: No
View the ResMed AutoSet Spirit™, S7 Elite CPAP and other ResMed products in the Talk About Sleep Equipment Fair
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