Instructions to physicians prescribing PAP for Sleep Disordered Breathing

1. Instructions to physicians prescribing PAP for Sleep Disordered Breathing BYAHMAD YOUNES PROFESSOR OF THORACIC MEDICINE Mansoura Faculty of Medicine

2. PAP for SDB Studies have shown CPAP to increase upper airway size, especially in the lateral dimension. Positive intra-luminal pressure expands the upper airway (pneumatic splint) and increase in lung volume due to CPAP (due to a downward pull on upper airway structures during lung expansion “tracheal tug”), may also increase upper airway size and/or stiffen the upper airway walls, making them less collapsible.

4. Positive airway pressure (PAP) can: • 1-Bring the AHI down to below 5 to 10/hr in the majority of patients. • 2-Improves arterial oxygen saturation and decreases respiratory arousals. • 3-Increase the amount of stage N3 and stage R. • NB : • -The most difficult problem with PAP treatment is that adherence is suboptimal in a large percentage of patients.

5. MODES OF PAP

7. Autoadjusting (autotitrating) PAP, devices 1-Auto-titrating PAP to select an effective level of CPAP without the need for an attended titration 2- Auto-adjusting PAP for chronic treatment with the advantage of delivering the lowest effective pressure in any circumstance. • Chronic treatment with APAP would also eliminate the requirement for a CPAP titration

8. The APAP algorithms vary between different devices, but in most instances the pressure changes in response to variations in airflow magnitude (apnea or hypopnea), airflow limitation (flattening of the airflow contour), and snoring

9. Autobilevel positive airway pressure with a minimum (EPAP) of 6 cm H2O and a maximum (IPAP) of 25 cm H2O.

10. ASV is a variant of BPAP that was developed to treat Cheyne-Stokes central apnea. Both ASV and BPAP devices with a backup rate are approved for use with patients with central apnea and complexsleep apnea

11. ASV devices from two manufacturers • The Philips-Respironics device (BiPAP Auto SV): targets 90% of the previous average peak flow (moving time average) and has a within-breath adjustment capability • The ResMed device (VPAP Adapt SV): uses a goal of providing 90% of the recent average ventilation (moving time window).

12. COMFORT MEASURES • Ramp • Most PAP devices, with the exception of certain APAP devices, allow the patient to trigger the ramp option. • In the ramp option, the pressure starts at a preset level—usually a low level of CPAP—and then slowly increases to the treatment pressure (CPAP) over the set ramp time • Some APAP devices have a “settling time” at a low pressure before the device starts auto-adjusting pressure.

13. Flexible Pressure • Two manufacturers of PAP devices have developed flexible PAP 1- Philips-Respironics provide several comfort options (Cflex, Cflex+, and Aflex) 2- ResMed devices offer expiratory pressure relief (EPR). • In Cflex, expiratory pressure drops at the start of exhalation but returns to the set CPAP at end-exhalation. • The amount of drop (Cflex 1, 2, 3) is determined by a proprietary algorithm.

14. Cflex+ adds a smoothing of the transition from inhalation to exhalation. • Aflex is a form of APAP that provides a 2 cm H2O lower end-expiratory pressure than the inspiratory pressure (in addition to the features of Cflex*) • For both BPAP and autoBPAP devices, a form of expiratory pressure relief is available (Biflex). The technology provides a smoothing of transition from IPAP to EPAP as well as expiratory pressure relief during the EPAP cycle (Biflex 1, 2, 3)..

16. B-Flex found in the Bipap

17. Humidification • Today, most PAP devices come with the option of an integrated heated humidification system. They can be used in the cool humidity mode if desired. • Heated humidity can deliver a greater level of moisture than cool humidification and may be especially useful in patients with mouth leak or nasal congestion. Mouth leak can cause a dramatic fall in relative humidity and a loss of humidity from the upper airway/CPAP system, thus drying the nasal or oral mucosa. • Use of heated humidification is recommended to improve CPAP utilization. In the clinical guidelines for titration, having HH available for titration was recommended..

18. Interfaces: • Nasal pillow masks are often better tolerated than traditional nasal masks by patients with claustrophobia and are useful in patients with a mustache or edentulous patients who have no dental support for the upper lip. • For patients who have severe nasal congestion or open their mouths during PAP treatment, oronasal (full face masks) and oral interfaces are available • If the patient gets up to use the bathroom during the night, we encourage disconnection of the hose from mask rather than taking off the mask. Masks that are removed in the middle of the night are often not replaced..

19. MODES OF PAP INFLAMMATION Airway Hyperresponsiveness Airflow Obstruction Symptoms Risk Factors (for exacerbations)

20. You must first have a prescription to obtain a CPAP machine • It's "illegal" to adjust one's own CPAP machine pressure, that only a licensed, certified or qualified physician can do it. • The manufacturer of your CPAP machine has hidden some controls from you. In fact they've hidden an entire menu of controls found in what is commonly referred to as the "clinician's setup" or "provider setup" mode. • It's a very good idea to talk with your physician or sleep therapist before making any changes to your CPAP therapy. Pressures should be changed slowly, in small increments, over a long period of time.

21. Model type of REMstar series :

22. Respironics REMstar Auto M Series system: • The Respironics REMstar Auto M Series system is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of OSA only in spontaneously breathing patients weighing 30 kg. • The system can deliver CPAP therapy or Auto-CPAP therapy, both with and without C-Flex. • When set in the Auto-CPAP therapy, the system will monitor your breathing as you sleep and automatically adjust the pressure to meet your needs. • When in CPAP therapy, the system will deliver a continuous, set pressure during the night.

23. SYSTEM CONTENTS

24. WARNINGS (the possibility of injury to the user or the operator). • The operator should read and understand this entire manual before using the device. • This device is not intended for life support. • A mask should not be used unless the device is turned on and operating properly. • The exhalation port(s) associated with the mask should never be blocked

25. WARNINGS • If oxygen is used with the device, the oxygen flow must be turned off when the device is not in use.( When the device is not in operation and the oxygen flow is left on, oxygen delivered into the tubing may accumulate within the device’s enclosure. Oxygen accumulated in the device enclosure will create a risk of fire). • Oxygen should not be used while smoking or in the presence of an open flame. • When using oxygen with this system, a Respironics Pressure Valve must be placed in-line with the patient circuit. Failure to use the pressure valve could result in a fire hazard.

26. WARNINGS • If the device is used at room temperatures warmer than 35° C, the temperature of the airflow may exceed 41° C. This could cause irritation or injury to your airway. • Do not operate the device in direct sunlight or near a heating appliance because these conditions can increase the temperature of the air coming out of the device. • If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if the device or the power supply are dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, discontinue use and contact your home care provider. • Periodically inspect electrical cords, cables, and the power supply for damage .Discontinue use and replace if damaged. • To avoid electric shock, unplug the device before cleaning it.

27. CAUTIONS(the possibility of damage to the device). • The device may only be operated at temperatures between 5° C and 35° C. • If this device has been exposed to either very hot or very cold temperatures, allow it to adjust to room temperature before starting therapy. • Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter. • Tobacco smoke may cause tar build-up within the device, which may result in the device malfunctioning.

28. CONTRAINDICATIONS • Bullous Lung Disease • Pathologically Low Blood Pressure • Bypassed Upper Airway • Pneumothorax • Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway Pressure. Caution should be used when prescribing CPAP for susceptible patients such as those with: cerebral spinal fluid (CSF) leaks ,abnormalities of the cribriform plate, prior history of head trauma, and/or pneumocephalus • Temporarily contraindicated if you exhibit signs of a sinus or middle ear infection

29. SYSTEM OVERVIEW • It can deliver CPAP therapy or Auto-CPAP therapy. • The ramp function allows you to lower the pressure when you are trying to fall asleep. The air pressure will gradually increase until your prescription pressure is reached. • The C-Flex comfort feature provides you with pressure relief when you exhale during therapy.

30. SYSTEM OVERVIEW • Start/Stop Button This button starts or stops the airflow. • Ramp Button This button starts or restarts the ramp cycle. • C-Flex Button This button allows you to change the C-Flex comfort setting, • Display Screen Shows therapy settings, patient data, instructions, and error messages. 

31. SYSTEM OVERVIEW • Air Outlet Connect the flexible tubing here. • Filter Area A reusable, gray foam filter must be placed in the filter area to screen out normal household dust and pollens. An optional, white ultra-fine filter can also be used for more complete filtration of very fine particles. • Power Inlet Connect the power cord here • Accessory Module If pplicable, insert the optional accessory card here.

32. BREATHING CIRCUIT • Circuit tubing to deliver air from the device to your interface (e.g., mask) • A mask or other patient interface device to deliver the prescribed pressure to your nose or nose and mouth • An exhalation device to vent exhaled air from the circuit (The exhalation port may be part of the interface or may be part of a separate exhalation device)

33. GLOSSARY • Auto-CPAP Adjusts CPAP pressure automatically to improve patient comfort based on monitoring of apnea and snoring events. • Auto-Off The device automatically discontinues therapy whenever the mask is removed. • Auto-On The device automatically initiates therapy when you begin breathing on the device. This feature is always enabled. • BPM Breaths Per Minute • C-Flex A therapy feature that provides pressure relief during exhalation. • FOSQ Functional Outcomes of Sleep Questionnaire – A “quality of life” questionnaire designed specifically for people with sleep disorders. The results allow health care professionals to assess how CPAP therapy has improved the quality of their patients’ lives.

34. GLOSSARY • LPM Liters Per Minute • Patient Data Menu The display mode in which you can view certain stored information ,such as therapy usage hours. • Patient Setup Menu The display mode in which you can change patient-adjustable device settings, such as the ramp starting pressure. • Safe State The state in which the device does not provide therapy. The device enters this state if an error is detected. • Standby State The state of the device when power is applied but the airflow is turned off

35. CONTROLS AND DISPLAYS

36. If you do not want to modify the settings that your home care provider has set for you, you only need these three buttons to start and stop therapy and do not need to use the display buttons located under the device cover door.

37. The device display and navigation buttons that are under the cover door

38. The entire device control panel, with the cover door open.

39. INSTALLING THE AIR FILTERS • The device uses a gray foam filter that is washable and reusable, and an optional white ultra-fine filter that is disposable. The reusable filter screens out normal household dust and pollens, while the optional ultra-fine filter provides more complete filtration of very fine particles. • The gray reusable filter must be in place at all times when the device is operating. • The white ultra-fine filter is recommended for people who are sensitive to tobacco smoke or other small particles. • If you are using the white disposable ultra-fine filter, insert it into the filter area first, meshside facing in, towards the device. • Insert the gray foam filter into the filter area

40. Respironics M Series Ultrafine CPAP filters • These filters are manufactured by one of the nation's leading manufacturers of home care supplies and are comparable to the original Respironics Ultrafine filter

41. In-line Outlet Bacteria Filter for CPAP/BiPAP • This Bacteria Viral filters that helps stop the viruses and bacteria that often plague CPAP BiPAP users. • They are easy to install and should not require re-calibration on most CPAP machines. Simply attach it to your machine between the air outlet and your standard CPAP tubing. After that, turn on your machine and experience a steady flow of clean, pure, good tasting air. • These filters will fit all standard machines from:RespironicsResmedFisher PaykelDeVilbissPuritan Bennett and more!

42. In-line Outlet Bacteria Filter for CPAP/BiPAP • Features & Benefits:(1)- Low resistance to gas flow means that you can keep the strong airflow you expect from your CPAP/BiPAP machine.(2) Naturally hydrophobic filter media(3) Bi-directional flow(4) Non-conductive

43. WHERE TO PLACE THE DEVICE • Place the device on a firm, flat surface somewhere within easy reach of where you will use it. • Make sure the filter area on the back of the device is not blocked by bedding, or curtains, .Air must flow freely around the device for the system to work properly. • Make sure the device is away from any heating or cooling equipment (e.g., forced air vents, radiators, air conditioners).

44. CONNECTING THE BREATHING CIRCUIT • Connect the flexible tubing to the air outlet on the back of the device. • If the device is used by multiple persons (rental devices), a low-resistance, main flow bacteria filter should be installed in-line between the device and the circuit tubing to prevent contamination.

45. CONNECTING THE BREATHING CIRCUIT • If you are using a mask with a built-in exhalation port, connect the mask’s connector to the flexible tubing,

46. CONNECTING THE BREATHING CIRCUIT • If you are using a mask with a separate exhalation device, connect the open end of the flexible tubing to the exhalation device. • Position the exhalation device so that the vented air is blowing away from your face. • Connect the mask’s connector to the exhalation device • Attach the headgear to the mask.

47. SUPPLYING POWER TO THE DEVICE Plug the socket end of the AC power cord into the power supply, Plug the pronged end of the AC power cord into an electrical outlet that is not controlled by a wall switch. Plug the power supply cord’s connector into the power inlet on the back of the device This device is activated when the power cord is connected. Pressing the button turns the airflow on or off.

48. USING DC POWER • The Respironics DC Battery Adapter Cable , when used with the DC Power Cord, enables the device to be operated from a 12 V DC free-standing battery. • Caution: When DC power is obtained from a vehicle battery, the device should not be used while the vehicle’s engine is running. Damage to the vehicle or the device may occur.

49. RECOMMENDED DEVICE AND TUBING PLACEMENT You should route your tubing and situate your device on your nightstand for the best setup possible. This will help prevent the device from falling off your nightstand or table. Try placing the tubing from the device over your headboard. This may reduce tension on the mask.

50. STARTING THE DEVICE • Plug the device in to an AC or DC power source. The three primary buttons light up and the Software Version screen momentarily appears. • The next screen to appear is the Standby (or Inactive) screen, You can access the FOSQ or patient settings and data from this screen. • The FOSQ option will only appear on the Standby screen if a Smart Card is inserted in the device • Press the button to turn on the airflow. The Active Display screen appears • Put on your mask assembly when the air starts to flow. • Make sure that no air is leaking from your mask into your eyes. If it is, adjust the mask and headgear until the air leak stops.