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REMstar Auto M Series Domestic

1. Chapter 1T Introductio sszssssesiecisstacteistuciassiticder san aaa A Aa 1 1 1 1 SYStOMCOMECIES sis ccisscectcistecactsschcsatesscusodssescsstaoszessnessayi aasteancistaisusscessiesusdseboepibsbetes V2 MAEMO SOUS AAE A A AE 1 3 Warnings Cautions and Contraindications 1 3 1 WANIMINGS sssssiscsscssscisssscccssssesscsssasansassteascassssagsdatacssesactsansaaacuscvastsansdatesosesuctosasaas 1 3 DACA ON San A A N RRO 1 3 3 Contraindicatii ON Sanini a a i aai ai 1 4 TA SyStEMOVErVIEW seriesas iesin ei neasa iiras rS asais 1 5 1 4 1 Breathing Circuit OVErViOW esssssssccsssscssssscesseceesnseecsnssscesneecsnseeseaseeees 1 6 1 3 GlOSSAr ap aA a E ENA OR 1 6 Symbol Key 1 7 How to Contact Respironics unenseensensennsennssnnsennnennsennnennsnnnnennsennsennssnnnennsennnenn 1 8 Chapter 2 Device Controls and Displays enessesssensseensseunssennssennssennssennssnnnssnnssennnssennnsenn 2 1 2 1 Controls and Displays usneessseennsennsseennnseennensennnnnennnnnsennnnnennnnnennnnnnennnnnennnnnennn 2 1 2 1 1 Control Panel Inactivity un 2 2 22 Rear Panels nenne an a R Chapter 3 SQtu Piisiassstsatesssuiscisacetarisivenaddiaaraiinastianentie iat R RA Aa 3 1 Installing the Air Filters 3 2 Where to Place the DeViCe escssssssussssssecsseesssecsnsccsnscessseessscesusccsseeceseecsneessneeesneees 3 2 3 3 Connecting the Breathing Circuit seseennseennnsennnnsennnnsennnnnsennnnnennnnnnennn 3 2 3 4 Supplying Power to the Device
2. gt Ka Auto Off Ramp Start Pres Feature ON 4 0 cmH20 gt Mask Alert Feature ON Figure 4 7 NAVIGATING THE PATIENT SETUP SCREENS REMstar Auto M Series User MANUAL 4 7 The Patient Setup screens are described below 4 8 RESPIRONICS FOSQ setup C Flex Setting 123 C Flex Setting FLEX comfort has been disabled on this unit Ramp Start Pres 4 0 cmH20 Mask Alert Feature ON 1 Standby Screen The Standby screen appears when you first apply power to the device You can access the Patient Setup menu from this screen by pressing the button Once inside the Setup menu press the gt or buttons to cycle through the screens C Flex Setting Screen This screen displays the C Flex level set by your home care provider This setting allows you to adjust the level of air pressure relief that you feel when you exhale during therapy Your home care provider will either enable or disable C Flex If C Flex is enabled and the setting is not comfortable for you you can increase or decrease the setting by pressing the or buttons The setting of 1 provides a small amount of pres sure relief with higher numbers providing additional relief Press the or buttons to increase or decrease the setting _ If your provider has disabled C Flex you cannot enable or ad just the setting The screen shown at left displays to indicate
3. unnsssesnssennsseennssennnssennnnsennnnssennnnsnnnnnnsennn 3 4 34 1 Vsing ACROWER neunten EEE 3 4 34 2 USING DE POW E A 3 5 3 5 Complete Assembly Example sssssssscssecsssessecsnscesseeessecssscccseeesseecsneeesneeesieees 3 6 Chapter 4 Device Operation 4 1 Available Therapies esssesssssescssecsssecssecsnscessseesseccsseecssecssseessseessuccesneceseecessessnseeste 4 1 4 2 Starting the DEVICE assener iin 4 1 4 3 Using the Ramp and C Flex FeatureS ssssssssssseesssssseesssssseeoessssteesensseeosssssteesesssee 4 3 4 31 RAMP FOACUNC sessscsissscescesccssessesssaacessasvcseasasesdacvastasisssiacacsesianssessaastanasvasiveascnied 4 3 4 3 2 C Flex Comfort Feature cseecssseccssecssscsssecsnscesseecsseecssecsseecsseecsneessneeesssees 4 3 4 3 21 C Flex Ema DOs scssatcsaascsesacssaccacsastedeascssessacszovieraisessscsscsseedsssewtastensciaes 4 3 2 2 C Flex Disabled REMstar Auto M Series User MANUAL i 4 4 Changing the Device Settings nennseensennnssenenssennnnennnnnsennnnnssennnssnnnnenenne 4 4 1 Navigating the Display Screens uunnesseeneeennsseensseennssseennnssennnssennnnne 4 4 1 1 Viewing Data on the Patient Data Screens 4 4 1 2 Viewing and Modifying Patient Setup Screens 4 7 4 5 Completing the FOSQ Questionnaire unesnsennsseeenneonnnnssennnsennnnnsennnnsennnnn 4 9 4 6 Patient Reminder Screen ssssscssssscesssecesssseesnssscessseecsnscecesssecesnseeesnasecesnseessnsseees 4 10 Chap
4. Co 1 Standby Screen The Standby screen appears when you first apply power to the RESPIRONICS device You can access the Patient Data menu from this screen by FOSQ setup pressing the or buttons Note You can access the Patient Setup screens by pressing the button and the FOSQ questionnaire by pressing the but ton as described later in this chapter Note The FOSQ option only appears if a SmartCard is inserted or a modem is connected to the device 2 Therapy Usage Screen ENERE This screen displays the number of hours that the device provided ere z therapy as 7 day and 30 day averages The maximum value that can be displayed for both averages is 24 hours Therapy Usage Note This screen is only for reference Your home care provider may periodically ask you for this information REMstar Auto M Series User MANUAL 4 5 Sessions gt 4 gt 7 Days 5 Sessions 30 Days 8 Sessions 90 Pressure gt cmH20 7 Day Avg 10 0 30 Day Avg 12 0 System Leak 7 Day Avg 0 0 30 Day Avg 0 0 Apn Hyp Index gt 7 Day Avg AHI 0 0 30 Day Avg AHI 0 0 Sessions Greater than 4 Hours Screen This screen displays the number of device therapy sessions that exceeded 4 hours in 7 day and 30 day periods The maximum value that can be displayed for the 7 day period is 35 sessions and the maximum value for the 30 day per
5. To change the C Flex setting press the C Flex button The screen shown in Figure 4 4 appears with an arrow above the current C Flex setting C Flex Setting 1 v 123 Figure 4 4 C FLex SETTING SCREEN The setting of 1 provides a small amount of pressure relief with higher numbers providing ad ditional relief To change the pressure relief press the or buttons to increase or decrease the setting Note You can also view and change the C Flex setting by navigating to the C Flex Set ting screen from the Patient Setup menu see Section 4 4 REMstar Auto M Series User MANUAL 4 3 4 4 4 3 2 2 C F ex DISABLED If C Flex has not been prescribed for you and your provider has disabled the C Flex feature the following screen appears when you press the C Flex button and you cannot enable or adjust the setting C Flex Setting FLEX comfort has been disabled on this unit Figure 4 5 C FLex DISABLED SCREEN 4 4 CHANGING THE Device SETTINGS You can view the set pressure on the Active Display screen and you can view the following set tings on the Patient Data screens e Therapy usage hours e Number of sessions greater than 4 hours e 90 therapy pressure averages only appears if in Auto CPAP therapy e System leak if enabled by your home care provider e Apnea Hypopnea Index if enabled by your home care provider e Compliance check value e Summary Data Additionally you can view
6. change your filters etc PATIENT ACTION Check your breathing circuit connections and re connect the tubing if it has come loose Press any of the display buttons to clear the alarm Make sure your mask is on properly before you press the d button to restart the airflow If the alert continues to occur disable the mask alert setting following the instructions in Chapter 4 and continue your therapy overnight Contact your home care provider the next morning to have your mask checked You may need a mask refitting Put your mask back on and press the button to turn the airflow on and resume therapy Press any of the display buttons to acknowledge the message and clear it If you do not acknowledge the reminder it will disap pear after 6 minutes and then reappear for three consecutive days whenever the device transitions from the Active state to the Standby state If you still do not acknowledge the mes sage the reminder period will reset and the message will not reappear until the next time the Patient Reminder setting expires 5 3 5 2 TROUBLESHOOTING The table below lists some of the problems you may experience with your device or mask and pos sible solutions to those problems PROBLEM Why It HAPPENED Nothing happens when There s no power you apply power to at the outlet or the device The audible the device is indicator does not sound unplugged and the backlights on the but
7. M RESPIRONICS 1001 Murry Ridge Lane Murrysville PA 15668 www respironics com EC REP Respironics Deutschland Gewerbestrasse 17 82211 Herrsching Germany 1050653 JR 1 22 08 EN DOM RESPIRONICS REMstar Auto M Series USER MANUAL IMPORTANT Fill in the information below when you receive the REMstar Auto M Series system Serial No located on the bottom of the device System Prescribed for Date of Purchase or Rental Pressure Setting cm H O Mask Type Mask Size If you have any questions concerning the system contact e Home Care Company Telephone Number e Health Care Professional Telephone Number e Respironics Inc 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 8550 USA Customer Service Telephone Number 1 800 345 6443 US and Canada or 1 724 387 4000 The REMstar Auto M Series with C Flex system is covered by one or more of the following patents 5 148 802 5 313 937 5 433 193 5 632 269 5 803 065 6 029 664 6 305 374 6 539 940 5 535 738 5 794 615 6 105 575 6 609 517 6 629 527 6 622 724 6 564 797 6 427 689 5 645 035 6 286 508 6 550 478 6 752 150 and 6 932 084 Other patents pending REMstar Whisper Swivel Encore Pro and Encore Pro SmartCard are trademarks of Respironics Inc NOTE The C Flex trademark is used under license 2008 Respironics Inc and its affiliates All rights reserved TABLE OF CONTENTS
8. Safety Standard Compliance Aius UL Recognized for Canada and the United States No User Serviceable Parts To have your device serviced contact your home care provider If you need to contact Respironics directly call the Respironics Customer Service department at 1 800 345 6443 or 1 724 387 4000 You can also use the following address Respironics 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 8550 USA Visit Respironics web site at www respironics com REMstar Auto M Series User MANUAL CHAPTER 2 Device CONTROLS AND DISPLAYS This chapter describes the device s control buttons and displays patient circuit connections and rear panel connections 2 1 CONTROLS AND DisPLays Figure 2 1 Primary Controt BUTTONS These buttons are described below BuTTON DESCRIPTION A Ramp When the airflow is on this button allows you to activate or restart the ramp function Ramp lowers the airflow pressure and then gradually increases it allowing you to fall asleep more easily Start Stop This button starts the device s airflow and places the device in the Active state or stops the C airflow and places the device in Standby You can also press this button to exit any setting screen C Flex C Flex This button adjusts the C Flex comfort setting 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 an
9. accessory slot on the back of the device to record information for the home care provider Your home care provider may ask you to periodically remove the SmartCard and send it to him her for evaluation Note The SmartCard does not need to be installed for the device to work properly The SmartCard records device usage information for use by your home care provider Contact your provider if you have any questions about the SmartCard REMstar Auto M Series User MANUAL 6 1 6 2 6 3 ADDING SUPPLEMENTAL OXYGEN Oxygen may be added at the mask connection Please note the warnings listed below when using oxygen with the device WARNINGS When using oxygen with this system the oxygen supply must comply with local regulations for medical oxygen 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 Oxygen accelerates fires Keep the device and the oxygen container away from heat open flames any oily substance or other sources of ignition Do not smoke in the area near the device or the oxygen When using oxygen with this system turn the device on before turning on the oxygen Turn the oxygen off before turning the device off This will prevent oxygen accumulation in the device If administering fixed flow supplemental oxygen the oxygen concentration may not be con stant The inspired oxygen concentration will
10. and modify the following settings on the Patient Setup screens e C Flex if enabled by your home care provider e Ramp starting pressure if enabled by your home care provider e Mask alert enable disable e Auto off enable disable e FOSQ questionnaire 4 4 1 NAVIGATING THE DISPLAY SCREENS Use the button to navigate to the next screen and the button to navigate to the previous screen Use the and buttons to adjust the settings on the Patient Setup screens REMstar Auto M Series User MANUAL 4 4 1 1 Viewing DATA ON THE PATIENT DATA SCREENS Figure 4 6 shows how to navigate the Patient Data screens Press A El Press gt RESPIRONICS Ts FOsQ Setup gt Summary Data s Therapy Usage Therapy Hours 0 12 Hrs Night Blower Hours 0 12 7 Day Avg 5 00 Total Sessions 0 30 Day Avg 8 00 r5 gt gt Compliance Check Sessions gt 4 7Days 5 Sessions 3467 30Days 8 Sessions ie Apn Hyp Index gt 90 Pressure Note Only appears if in 7 Day Avg AHI 00 PEPEN ee Auto CPAP therapy Sonay avs iison zug 108 je System Leak ad J Umin 7 Day Avg 00 30 Day Avg 00 Figure 4 6 NAVIGATING THE PATIENT DATA SCREENS Press the gt button to scroll forward through the data screens or press the button to scroll through the screens in the reverse order The Patient Data screens are described below
11. ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typi cal home or hospital environment Mains power quality should be that of a typi cal home or hospital environment Mains power quality should be that of a typical home or hospital environment If the user of the device requires continued opera tion during power mains interruptions it is recommended that the device be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital or home environment GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test IEC 60601 Test LeveL Comptiance LeveL ELECTROMAGNETIC ENVIRONMENT GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 12 P IEC 61000 4 6 150 kHz to 80 MHz d 1 2JP 80 MHzto 800 MHz Radiated RF 3V m d 23JP 800 MHz to 2 5 GHz IEC 61000 4 3 80 MHz to 2 5 GHz where P is the maximum output p
12. correctly oriented with the port opening at the top and insert the two latches at the bottom of the port into the openings on the bottom of the device Push the top of the port down to snap it into place Reattach your tubing turn on the airflow and check to make sure you do not still feel air com ing out of the port area PROBLEM The air out ofthe mask is much warmer than usual The mask feels uncom fortable to wear there is significant air leakage around the mask or you experience other mask related issues You have a runny nose You have throat or nose dryness You experience nasal sinus or ear pain Why It HAPPENED The air filters may be dirty The device may be operating in direct sunlight or near a heater This could be due to improper head gear adjustment or improper mask fitting etc This is caused by a nasal reaction to the airflow The air is too dry You may have a sinus or middle ear infection WHAT To Do Clean or replace the air filters as described in Chapter 7 The temperature of the air may vary somewhat based on your room temperature Make sure that the device is properly ventilated Keep the device away from bedding or curtains that could block the flow of air around the device Make sure the device is away from direct sun light and heating equipment If the problem continues contact your home care provider If you experience any issues with your
13. filter Caution Dirty inlet filters may cause high operating temperatures that may affect device perfor mance Regularly examine the inlet filters as needed for integrity and cleanliness 1 If the device is operating stop the airflow by pressing the d button a Disconnect the device from the power source 2 amp 2 Remove the filter s from the enclosure by gently squeezing the filter PSS in the center and pulling it away from the device as shown in Figure ww 7 1 3 Examine the filter s for cleanliness and integrity 4 Wash the gray foam filter in warm water with a mild detergent Rinse Figure 7 1 REMOVING THE thoroughly to remove all detergent residue Allow the filter to air dry FILTERS completely before reinstalling it If the foam filter is torn replace it Only Respironics supplied filters should be used as replacement filters _ 5 Ifthe white ultra fine filter is dirty or torn replace it L 6 Reinstall the filters inserting the white ultra fine filter first if applicable as shown in Figure 7 2 Caution Never install a wet filter into the device It is recommended j that you clean the filter in the morning and alternate using nn 0 ey the two foam filters provided with the system to ensure suf u ficient drying time for the cleaned filter Ficure 7 2 REINSTALLING THE FILTERS REMstar Auto M Series User MANUAL 7 1 7 2 7 3 CLEANING THE TUBING Clean the tubing daily Disconnect the flexible tubing from the
14. for details on how to power the device and humidifier 3 4 1 Usinc AC Power Complete the following steps to operate the device using AC power 1 Plug the socket end of the AC power cord into the power supply as shown in Figure 3 5 Figure 3 5 CONNECTING THE POWER CorD To THE Power SUPPLY 2 Plug the pronged end of the AC power cord into an electrical outlet that is not controlled by a wall switch 3 Plug the power supply cord s connector into the power inlet on the back of the device as shown in Figure 3 6 3 4 REMstar Auto M Series User MANUAL Figure 3 6 CONNECTING THE Power SUPPLY CoRD TO THE DEVICE 4 Ensure that all connections are secure Important To remove AC power disconnect the power supply cord from the elec trical outlet Warning Inspect the power cord often for any signs of damage Replace a dam aged power cord immediately 3 4 2 Usinc DC Power The Respironics DC Power Cord Reorder Number 1001956 can be used to operate this device in a stationary recreational vehicle boat or motor home The Respironics DC Battery Adapter Cable when used with the DC Power Cord enables the device to be operated from a 12 VDC 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 Caution Only use a Respironics DC Power Cord and Battery Adapter Cable Use of any oth
15. mask refer to your mask instructions for information on proper fitting etc If the problem continues contact your home care provider Call your health care professional Increase the room humidity Consult with your health care professional about using a Respi ronics humidifier with the device If you have a humidifier refer to the instructions included with your humidifier to make sure it is working properly Stop using the device and contact your health care professional REMstar Auto M Series User MANUAL CHAPTER 6 CCESSORIES Contact your home care provider for additional information on the accessories available for your REMstar Auto M Series system When using optional accessories always follow the instructions enclosed with the accessories 6 1 ADDING A HUMIDIFIER You can use the M Series Heated humidifier or the M Series Pass over humidifier with your de vice They are available from your home care provider A humidifier may reduce nasal dryness and irritation by adding moisture and heat if applicable to the airflow Caution For safe operation the humidifier must always be positioned below the breathing circuit connection at the mask and the air outlet on the device The humidifier must be level for proper operation Refer to the humidifiers instructions for complete setup information 6 2 USING THE SMARTCARD Some REMstar Auto M Series systems come with a SmartCard accessory module installed in the
16. of sale by Respironics Inc to the dealer If the product fails to perform in accordance with the product specifications Respironics Inc will repair or replace at its option the defective material or part Respironics Inc will pay customary freight charges from Respironics Inc to the dealer location only This warranty does not cover damage caused by accident misuse abuse alteration and other defects not related to material or workmanship Respironics Inc disclaims all liability for economic loss loss of profits overhead or consequential damages which may be claimed to arise from any sale or use of this product Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you This warranty is given in lieu of all other express warranties In addition any implied warranties including any warranty of merchantability or fitness for the particular purpose are limited to two years Some states do not allow limitations on how long an implied warranty lasts so the above limitation may not apply to you This warranty gives you specific legal rights and you may also have other rights which vary from state to state To exercise your rights under this warranty contact your local authorized Respironics Inc dealer or contact Respironics Inc at 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 8550 1 724 387 4000
17. that C Flex is disabled Ramp Starting Pressure Screen You can increase or decrease the ramp starting pressure in 0 5 cm H O increments by pressing the or buttons The default setting is 4 cm H O You can adjust the setting from 4 cm H O to the CPAP pressure setting Note This screen will not display if your provider has not en abled Ramp on your device Mask Alert Screen You can enable or disable the mask alert setting by pressing the or buttons to select OFF or ON If this feature is enabled the words Mask Leak appear on the Active display screen when a significant mask leak is detected and an audible alert sounds Note Ifyour physician indicates that the Mask Alert is neces sary for you do not disable it REMstar Auto M Series User MANUAL gt 5 Auto Off Screen Auto Off You can enable this feature if you want the device to automati Feature ON cally turn the airflow off whenever you remove the interface e g mask from your airway Press the or buttons to select OFF or ON If this feature is en abled the words Auto Off appear on the Standby screen if the de vice detects that you have removed your mask The airflow shuts off and Auto Off continues to appear on the Standby screen until the condition is corrected After you have finished modifying the Patient Setup screens press the d button to return to the Standby screen Note The Setup menu automatically times o
18. therapy with pressure relief upon exhalation to improve patient comfort based on patient needs e Auto CPAP Delivers CPAP therapy while automatically adjusting the pressure level to meet the patient s needs e _ Auto CPAP with C Flex Auto CPAP therapy with pressure relief upon exhalation to improve patient comfort based on patient needs 4 2 STARTING THE DEVICE 1 Plug the device in to an AC or DC power source The three primary buttons light up and the Software Version screen momentarily appears shown in Figure 4 1 RESPIRONICS V1 0 FIGURE 4 1 SOFTWARE VERSION SCREEN Note Version 1 0 shown in Figure 4 1 is an example Your device may have a different software version installed 2 The next screen to appear is the Standby or Inactive screen shown in Figure 4 2 You can access the FOSQ questionnaire or patient settings and data from this screen See Section 4 3 for instructions on how to navigate the display screens RESPIRONICS FOSQ Setup FIGURE 4 2 STANDBY SCREEN REMstar Auto M Series User MANUAL 4 1 Note The FOSQ option will only appear on the Standby screen if a SmartCard is inserted in the device or ifa modem is connected 3 Press the button to turn on the airflow The Active Display screen appears shown in Figure 4 3 lt 15 0 oo Figure 4 3 Active DispLay with SMARTCARD The Active Display screen shows the set pressure Some symbols
19. vents radiators air conditioners 3 3 CONNECTING THE BREATHING CIRCUIT To use the system you will need the following accessories in order to assemble the recommended circuit e Respironics interface e g nasal mask with integrated exhalation port or Respironics inter face with a separate exhalation device such as the Whisper Swivel II e Respironics 6 ft 1 83 m flexible tubing e Respironics headgear for the patient interface Warning If the device is used by multiple persons e g rental devices a low resistance main flow bacteria filter should be installed in line between the device and the circuit tubing to prevent contamination To connect your breathing circuit to the device complete the following steps 1 Connect the flexible tubing to the air outlet on the back of the device as shown in Figure 3 2 FIGURE 3 2 CONNECTING THE FLEXIBLE TUBING Note If required connect a bacteria filter to the device air outlet and then connect the flexible tubing to the outlet of the bacteria filter REMstar Auto M Series User MANUAL 2 Connect the tubing to the mask a Ifyou are using a mask with a built in exhalation port connect the mask s connector to the flexible tubing as shown in Figure 3 3 Exhalation Port Mask s Connector Flexible Tubing Connector Figure 3 3 CONNECTING A Mask wiItH BUILT IN EXHALATION PORT b Ifyou are using a mask with a separate ex
20. IPMENT AND THIS Device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mo bile RF communications equipment transmitters and this device as recommended below according to the maximum output power of the communications equipment Raten Maximum Power SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER OUTPUT oF TRANSMITTER Ww 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz To 2 5 GHz d 1 2P d 1 2 P d 2 3P For transmitters rated at a maximum output power not listed above the recommended separation distance din meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people A 2 REMstar Auto M Series User MANUAL LimitED WARRANTY Respironics Inc warrants that the system shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of two 2 years from the date
21. ake sure it is completely dry before reap plying power If the placement of the tubing causes the de vice to fall make sure that you use proper hose management when setting up your device Route the tubing behind the bed s headboard as shown in Chapter 3 Setup If the device falls or water gets into the device upon falling let the device dry completely be fore restarting it If the device does not operate correctly after falling contact your home care provider REMstar Auto M Series User MANUAL PROBLEM Why It HAPPENED You are having problems You have lost the connecting the tubing to air outlet port or the device are traveling and forgot to bring the port with you You are experiencing The air outlet port excessive air leaks where is not installed cor the tubing connectsto rectly and doesn t the device seal properly REMstar Auto M Series User MANUAL WHAT voy Do If you are not using a humidifier you cannot connect your tubing to the device without the detachable air outlet port shown below LA O S You must have the port attached properly before connecting your tubing Remove the port and reattach it to make sure it s properly installed To remove the port a Put your thumb underneath the port and insert your index finger into the port open ing Pivoting from the bottom unsnap the port and pull it away from the device To properly reattach the port a Make sure it is
22. d stop therapy and do not need to use the display buttons located under the device cover door Figure 2 2 shows the device display and navigation buttons that are under the cover door By RESPIRONICS FOSQ l Setup F sure 2 2 DispLay BUTTONS The display buttons are described below DESCRIPTION Allows you to access the Data screens Also allows you to navigate to the previous screen when in the Data or Setup menu Allows you to access the Data screens Also allows you to navigate to the next screen when in the Data or Setup menu Allows you to enter the FOSQ screens Also allows you to decrease the settings on the setup screens Allows you to enter the Setup screens Also allows you to increase the settings on the setup screens REMstar Auto M Series User MANUAL 2 1 2 2 The device s display screen shows the set pressure patient data instructions and error messages See Chapter 4 for instructions on navigating the display screens Figure 2 3 provides a view of the entire device control panel with the cover door open N A Placement Area for Optional Quick Reference Label Cover Door r a Previous Next Screen Screen a en Button Button Increase Decrease e 4 Button a NEN Ramp Button Start Stop C Flex Button Button Button Figure 2 3 Device ControL PANEL 2 1 1 ControL PANEL INACTIVITY So
23. device Gently wash the tubing in a solution of warm water and a mild detergent Rinse thoroughly Air dry 7 4 SERVICE The REMstar Auto M Series device does not require routine servicing Warning If you notice unexplained changes in the performance of this device if it is making unusual or harsh sounds if the device or power supply have been dropped or mishandled if the enclosure is broken or if water has entered the device discontinue use and contact your home care provider 7 5 TRAVELING WITH THE SYSTEM When traveling the carrying case is for carry on luggage only The carrying case will not protect the system if it is put through checked baggage For your convenience at security stations there is a note on the bottom of the device stating that it is medical equipment It may be helpful to bring this manual along with you to help security personnel understand the REMstar Auto M Series device If you typically use a humidifier with your device but leave the humidifier home when traveling make sure you attach the air outlet port to your device when you remove the humidifier from the device You need the port to connect the tubing directly to your device Figure 7 3 illustrates how to attach the air outlet port Attach Air Outlet Port to the Device Figure 7 3 ATTACHING THE AiR OUTLET Port TO THE Device 7 5 1 INTERNATIONAL TRAVEL If you are traveling to a country with a line voltage different than the one you are c
24. ent with the REMstar Auto M Series system as convenient and comfortable as possible To ensure that you receive the safe effective therapy prescribed for you use only Respironics accessories 1 3 _WARNINGS CAUTIONS AND CONTRAINDICATIONS Caution U S federal law restricts this device to sale by or on the order of a physician 1 3 1 WARNINGS A warning indicates the possibility of injury to the user or the operator e This manual serves as a reference The instructions in this manual are not intended to super sede the health care professional s instructions regarding the use of the device e The operator should read and understand this entire manual before using the device e This device is not intended for life support e The device should be used only with masks and connectors recommended by Respironics or with those recommended by the health care professional or respiratory therapist 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 Explanation of the Warning The device is intended to be used with special masks or con nectors that have exhalation ports to allow continuous flow of air out of the mask When the device is turned on and functioning properly new air from the device flushes the exhaled air out through the mask exhalation port However when the device is not operating enough fresh air will not be provided through the
25. er system may cause damage to the device or vehicle Refer to the instructions supplied with the DC Power Cord and adapter cable for information on how to operate the device using DC power REMstar Auto M Series User MANUAL 3 5 3 5 Comp ete ASSEMBLY EXAMPLE Figure 3 7 shows an example of how a complete assembly will look with breathing circuit con nected and power applied to the device Figure 3 7 Finat AssemBLy EXAMPLE SHOWN WITH OPTIONAL Accessory MoDuLeE Figure 3 8 shows an example of how 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 Figure 3 8 RECOMMENDED DEVICE AND TUBING PLACEMENT 3 6 REMstar Auto M Series User MANUAL CHAPTER 4 Device OPERATION This chapter explains the therapies available with the REMstar Auto M Series device how to start the device and how to change the settings 4 1 AVAILABLE THERAPIES The REMstar Auto M Series device delivers the following therapies e CPAP Delivers Continuous Positive Airway Pressure CPAP maintains a constant level of pressure throughout the breathing cycle If your health care professional prescribed ramp for you you can press the Ramp button to reduce the pressure and then gradually increase the pressure to the therapeutic pressure setting so that you can fall asleep more comfortably e CPAP with C Flex Delivers CPAP
26. ermanently The product will then display the following system error alert to indi cate that the device be returned to the home care provider for service Service Required If Ramp has not been prescribed for you dis cuss this feature with your home care provider to see if they will change your prescription If your provider has enabled Ramp but the feature still does not work check the pressure setting on your Active Display screen If it is set to the minimum setting 4 0 cm H O the Ramp feature will not work 5 6 PROBLEM The device has fallen off your table or nightstand Why It HAPPENED The device may not have been properly seated on the nightstand or the placement of the tubing may have caused the device to fall WHAT To Do Always make sure your device is placed on a hard flat surface so the feet on the bottom of the device can adhere to the surface make sure there is no fabric under the device The device and humidifier if using must be level for proper operation Also place the device away from the edge of the nightstand or table so it doesn t acciden tally get knocked off the table If you are using a humidifier with the device make sure that the device and humidifier are placed below your head and mask so that any condensation in the tubing drains back into the water chamber If the device and humidifier fall and water gets into the device drain all water out of the device and m
27. evice transitions from the Active Display to the Standby state if the period of time specified by your provider has expired You can acknowledge the message by pressing any of the display buttons gt or If you do not acknowledge the message within six minutes of it appearing on the screen it will time out and disappear The message will continue to display for three consecutive days whenever the device transitions from Active to Standby until it is acknowledged If after three days you still have not acknowledged the message then the reminder period will reset and no more reminders will display until the next time the patient reminder setting expires Figure 4 9 shows an example of a patient reminder message Patient Reminder Check your mask A new one may be available Call your provider Figure 4 9 Patient REMINDER SCREEN REMstar Auto M Series User MANUAL CHAPTER 5 Device ALERTS AND TROUBLESHOOTING This chapter describes the device alerts and also provides troubleshooting information for issues you may run into when using the device 5 1 Device ALERTS The device provides two alert levels high and medium priority e High Priority These alerts require immediate operator response The alert signal consists of a high priority sound which is a continuous two beep pattern indicated in the following table as e e e e Additionally the backlights on the buttons will provide a high priority flas
28. gure 1 3 REMstar Auto M Series System OVERVIEW REMstar Auto M Series User MANUAL 1 5 Device FEATURE DEscRIPTION Accessory Module If applicable insert the optional accessory card here Connect the flexible tubing here C Flex Button This button allows you to change the C Flex comfort setting if CFlex is prescribed for you See Chapter 4 for more informa tion about C Flex Display Screen Shows therapy settings patient data instructions and error messages 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 Medical Equipment Note For ease at airport security stations there is a note on the bot tom of the device stating that it is medical equipment It may help if you also take this manual with you when you travel Power Inlet Connect the power cord here Ramp Button This button starts or restarts the ramp cycle Start Stop Button This button starts or stops the airflow 1 4 1 BREATHING CiRCUIT OVERVIEW The patient breathing circuit shown in Figure 1 4 consists of the following e Circuit tubing to deliver air from the device to your interface e g mask e A mask or other patient interface device to deliver the prescribed pressure to your nose or nose and mouth depending on which interface has been prescribed for you e An exhalation device t
29. halation device connect the open end of the flexible tubing to the exhalation device as shown in Figure 3 4 Position the exhalation device so that the vented air is blowing away from your face Connect the mask s connec tor to the exhalation device Exhalation Device Flexible Tubing Connector FIGURE 3 4 CONNECTING A MASK WITH A SEPARATE EXHALATION DEVICE Warning The exhalation device e g Whisper Swivel Il or exhalation port on masks with an integrated exhalation port is designed to exhaust CO from the patient circuit Do not block or seal the ports on the exhala tion device Warning If you are using a full face mask i e a mask covering both your mouth and your nose the mask must be equipped with a safety entrain ment valve 3 Attach the headgear to the mask See the instructions that came with your headgear REMstar Auto M Series User MANUAL 3 3 3 4 SuppLyinc Power TO THE DEVICE You can power the device using AC or DC power Caution If this device has been exposed to either very hot or very cold tempera tures allow it to adjust to room temperature before beginning the following setup procedures Warning Route the wires to avoid tripping Warning This device is activated when the power cord is connected Pressing the ly button turns the airflow on or off Important Ifyou are using your device with a humidifier refer to the instructions included with your humidifier
30. hing pattern consisting of a continuous bright to off two flash pattern indicated in the following table as 00 00 00 e Medium Priority These alerts require prompt operator response The alert signal consists of a medium priority sound which is a continuous one beep pattern indicated in the fol lowing table as e Additionally the backlights on the buttons will provide a medium priority flashing pattern consisting of a continuous bright to dim one flash pattern indi cated in the following table as 9 0 9 REMstar Auto M Series User MANUAL 5 1 ALERT SUMMARY TABLE The following table summarizes the high and medium priority alerts AUDIBLE INDICATOR ALERT System Error SmartCard Error 5 2 VISUAL INDICATOR Backlights 00 00 00 Screen displays the following message Service Required Backlights 999 Screen displays the following flashing error symbol Device ACTION PossiBL E CAUSE The device enters the Device failure Safe state in which the device power remains on but the airflow is disabled The device continues to operate and provide therapy but data logging is un available and FOSQ is deactivated A problem exists with the Smart Card inserted in the accessory slot The card may be improperly in serted or the data may be corrupt Patient ACTION Press any of the display screen buttons to silence the alert Remove the power supply cord from the dev
31. ice to remove power Plug the cord back into the device s power inlet to restore power If the alert continues to occur contact your home care provider Remove the SmartCard to clear the alert Confirm that the card is properly oriented with the arrow pointing towards the de vice as shown below and reinsert the SmartCard If the alert continues to occur remove the Smart Card from the device and contact your home care provider The card may be corrupt and need to be replaced REMstar Auto M Series User MANUAL ALERT AUDIBLE INDICATOR Patient Reminder VISUAL INDICATOR Backlights 999 The words Mask Leak flash on the Active Display screen The words Auto Off flash on the Standby screen indicating that a mask disconnect has been detected Backlights 9 9 9 Screen displays a customized reminder message whenever the de vice transitions from the Active state to the Standby state REMstar Auto M Series User MANUAL Device ACTION The device continues to operate The airflow shuts off and the device enters the Standby state approximately 45 60 seconds after detection The device continues to operate PossiBL E CAUSE The breathing circuit is discon nected or there is a large air leak The mask has been removed Your home care provider may set a patient reminder sched uled to pop up at a particular time to remind you to replace your mask
32. indicating when certain conditions are turned on or detected will also appear on the Active Display screen or on the Standby screen These symbols are described below SYMBOL DESCRIPTION 2 Ramp You can initiate the ramp feature by pressing the Ramp button The ramp symbol displays on the Active Display screen when the ramp function is active Mask Mask Leak Alert This flashing text displays on the Active Display screen if the Leak Mask Alert setting is enabled and the device detects an excessive mask leak Auto Auto Off This flashing text displays on the Standby screen if the Auto Off Off setting is enabled and the device detects a mask disconnect SmartCard This symbol displays if a SmartCard is inserted in the device If the card is inserted incorrectly the symbol will flash intermittently Ta Modem This symbol displays if a modem is connected to the device Note This symbol will vary in appearance depending on the type of modem be ca ing used 4 Put on your mask assembly when the air starts to flow 5 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 See the instructions provided with your mask for more information Note A small amount of mask leak is normal and acceptable Correct large mask leaks or eye irritation from an air leak as soon as possible 6 Ifyou are using the device while sleeping t
33. iod is 150 sessions Note This screen is only for reference Your home care provider may periodically ask you for this information 90 Therapy Pressure Screen This screen displays a 7 day and 30 day average of the 90 pressure that you have used The 90 pressure is the pressure at which you spent 90 of the session time at or below For example if you have the device on with airflow for 10 hours and spend 9 hours at or be low 11 cm H O and 1 hour above 11 cm H O then the 90 pressure is 11 cm H O The maximum value for both averages is 20 0 cmH O Note This screen is only for reference Your home care provider may periodically ask you for this information Note This screen only displays if you are in Auto CPAP therapy System Leak Screen This screen displays a 7 day and 30 day average of the leak history for the device in liters per minute LPM System leak is a combina tion of intentional and unintentional air leak Intentional leak is the expected leak at the exhalation port Some leak is required to mini mize CO rebreathing Unintentional leak occurs around the patient interface If you see a large increase in the amount of leak indicated here contact your home care provider for assistance Note This screen only displays if your home care provider has enabled it It is only for reference Your home care provider may periodically ask you for this information Apnea Hypopnea Index Screen This screen displays your Ap
34. less modem when available If you are using a SmartCard a SmartCard symbol D appears in the upper right corner of the Active Display screen If the SmartCard is inserted incor rectly this symbol flashes to indicate that the card is incorrectly installed and the FOSQ questionnaire will not be available REMstar Auto M Series User MANUAL 4 9 2 From the Standby screen press the button to first FOSQ screen shown in Figure 4 8 FOSQ 1 30 4 01234 Figure 4 8 FOSQ Screen 1 oF 30 Press the or button to select your answer to the first question and an arrow appears over your answer O indicates that you choose 0 as the answer to the question 1l indicates that you choose 1 as the answer to the question 2 indicates that you choose 2 as the answer 3 indicates that you choose 3 as the answer 4 indicates that you choose 4 as the answer 3 After you answer the first question press the gt button to access the next FOSQ screen and continue answering each question If you need to go back to a previous screen press the amp button 4 There are 30 FOSQ questions Once you have reached the last question press the gt button to save your answers and exit the questionnaire 4 6 PATIENT REMINDER SCREEN Your home care provider may set a patient reminder that will appear periodically to alert you to take certain actions such as replacing your mask A message will appear whenever the d
35. lue curacy of reported data CPAP Continuous Positive Airway Pressure FOSQ Functional Outcomes of Sleep Questionnaire A quality of life question naire 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 LPM Liters Per Minute OSA Obstructive Sleep Apnea Patient Data The display mode in which you can view certain stored information such Menu as therapy usage hours Patient Setup The display mode in which you can change patient adjustable device set Menu tings such as the ramp starting pressure Ramp A feature that may increase patient comfort when therapy is started The ramp feature reduces pressure and then gradually increases the pressure to the prescription setting so you can fall asleep more comfortably 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 REMstar Auto M Series User MANUAL 1 7 1 8 1 6 Symeot Key The following symbols appear on the device and power supply SYMBOL DEFINITION 2 Consult accompanying instructions for use N DC Power e Type BF Applied Part Ol Class Il Double Insulated IPX1 Drip Proof Equipment Electrostatic Discharge Canadian US Certification A Arad amp A TUV
36. mask and exhaled air may be rebreathed Re breathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation REMstar Auto M Series User MANUAL e If oxygen is used with the device the oxygen flow must be turned off when the device is not in use Explanation of the Warning 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 Oxy gen accumulated in the device enclosure will create a risk of fire e Oxygen supports combustion Oxygen should not be used while smoking or in the presence ofan open flame e 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 e Do not use the device in the presence of a flammable anaesthetic mixture in combination with oxygen or air or in the presence of nitrous oxide e Do not use this device if the room temperature is warmer than 95 F 35 C If the device is used at room temperatures warmer than 95 F 35 C the temperature of the airflow may exceed 106 F 41 C This could cause irritation or injury to your airway e Do not operate the device in direct sunlight or near a heating appliance because these condi tions can increase the temperature of the air coming out of the device e Contact your health care professional if symptoms of slee
37. me screens have time out periods The screen s timer starts when the screen is initially displayed and is restarted whenever a button is pressed The screen times out after one minute if there is no activity and returns to the Standby screen 2 2 Rear PANEL Air Outlet Port Accessory Slot Filter Area Figure 2 4 REMstar Auto M Series REAR PANEL The rear panel contains the following e An accessory slot for optional accessories such as the SmartCard or modem see Chapter 6 Accessories for more information e A filter area where the filter s supplied with your device should be inserted e ADC power inlet where the power cord is connected see Chapter 3 Setup for complete information on supplying power to the device e The air outlet port where the breathing circuit s flexible tubing is attached REMstar Auto M Series User MANUAL CHAPTER 3 SETUP This chapter provides instructions on how to e Install the air filters e Position the device e Connect the breathing circuit e Supply power to the device 3 1 INSTALLING THE AIR FILTERS Caution A properly installed undamaged foam filter is required for proper operation 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 re
38. nctioning cor rectly after you press the d button the device beeps and the airflow turns on after a slight delay This brief delay is normal REMstar Auto M Series User MANUAL PROBLEM The device s display is erratic Device Resets Reboots The device shuts down and restarts automati cally during therapy This is unlikely to occur The Ramp feature does not work when you press the Ramp button Why It HAPPENED The device or power supply has been dropped or mishandled or the device or power supply is in an area with high Electromagnetic Interference EMI emissions The device comes installed with troubleshooting software that automatically monitors perfor mance Your home care provider did not prescribe Ramp for you or your CPAP pressure is already set to the minimum setting REMstar Auto M Series User MANUAL WHAT ToDo Unplug the device and the power supply Reapply power to the device If the problem continues relocate the device to an area with lower EMI emissions e g away from electronic equipment such as cellular phones cordless phones computers TVs electronic games hair dryers etc If the problem still occurs contact your home care provider for assistance Such a reset poses no danger to the patient and assures that the patient receives prescribed therapy throughout the night If there is a pos sibility of damage to the device the device will shut down p
39. nea Hypopnea index AHI for the last 7 and 30 days Note This screen only displays if your home care provider has enabled it It is only for reference Your home care provider may periodically ask you for this information REMstar Auto M Series User MANUAL y Compliance Check gt 7 Compliance Check Value Screen This screen displays a number used by your home care provider to 3467 validate that the data provided by you is the data taken from the Summary Data Screen This is a read only screen and you cannot change the number on the screen Note This screen is only for reference Your home care provider may periodically ask you for this information Summary Data gt 8 Summary Data Screen Serer This screen displays the total therapy hours for the device the total Blower Hours 0 12 blower hours and the total number of sessions greater than 4 hours Total Sessions 0 since the device was last reset by the home care provider This is a read only screen and you cannot change the numbers on the screen Note This screen is only for reference Your home care provider may periodically ask you for this information 4 4 1 2 VIEWING AND Mopiryine PATIENT SETUP SCREENS Figure 4 7 shows how to navigate the Patient Setup screens RESPIRONICS FOSQ setup Press gt Press lt C Flex Setting Press gt 75 123 Zu
40. o vent exhaled air from the circuit Patient Interface Typical A Exhalation Balto Ee Port Connector Circuit __ Flexible Tubing Tubing Connector Circuit with Separate Circuit with Mask with Exhalation Device Integrated Exhalation Port F sure 1 4 TypicAt BREATHING CIRCUITS REMstar Auto M Series User MANUAL Note The exhalation port may be part of the interface or may be part of a separate exhalation device but is required to minimize the potential for CO rebreathing 1 5 GLOSSARY The following terms and acronyms appear throughout this manual Term AcRONYM DEFINITION Active State The state of the device when power is applied the airflow is on and the device is providing therapy Apnea A condition marked by the cessation of spontaneous breathing Auto CPAP Adjusts CPAP pressure automatically to improve patient comfort based on monitoring of apnea and snoring events Auto Off When this feature is enabled the device automatically discontinues therapy whenever the mask is removed Auto On With this feature 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 if enabled by your home care provider Compliance Represents a code used by the home care provider to determine the ac Check Va
41. ower rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 V m RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND Mosie RF Communications EQU
42. p apnea recur e Ifyou notice any unexplained changes in the performance of this device if it is making un usual 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 e Repairs and adjustments must be performed by Respironics authorized service personnel only Unauthorized service could cause injury invalidate the warranty or result in costly damage e Periodically inspect electrical cords cables and the power supply for damage or signs of wear Discontinue use and replace if damaged e To avoid electric shock unplug the device before cleaning it DO NOT immerse the device in any fluids e Pins of connectors identified with the ESD warning symbol Zds should not be touched Connections should not be made to these connectors unless ESD precautionary procedures are used Precautionary procedures include methods to prevent build up of electrostatic discharge e g air conditioning humidification conductive floor coverings non synthetic clothing discharging one s body to the frame of the equipment or system or to earth or a large metal object and bonding oneself by means of a wrist strap to the equipment or system or to earth REMstar Auto M Series User MANUAL 1 3 1 3 2 CAUTIONS A Caution indicates the possibility of damage to the device The device may only be operated at temperat
43. pter provides information on 1 1 REMstar Auto M Series system contents Intended Use Warnings cautions and contraindications System overview Glossary and symbol key How to contact Respironics SYSTEM CONTENTS User Manual 7 B Reusable Gray Foam Filter Disposable Ultra fine Filter Figure 1 1 System CONTENTS Note If your system includes a humidifier you will receive additional items with your package See the instructions included with your humidifier for more informa tion Note If any of the above items are missing contact your home care provider REMstar Auto M Series User MANUAL 1 1 1 2 1 2 INTENDED Use The Respironics REMstar Auto M Series system is a CPAP Continuous Positive Airway Pressure device designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing gt 66 lbs 30 kg The device is to be used only on the instruction of a licensed physician The system can deliver CPAP therapy or Auto CPAP therapy both with and without C Flex Your home care provider will make the correct pressure settings according to your health care professional s prescription 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 Several accessories are available to make your OSA treatm
44. rapy may be temporarily contraindicated if you exhibit signs of a sinus or middle ear infection Not for use with patients whose upper airways are by passed Contact your physician if you have any questions concerning your therapy 1 4 REMstar Auto M Series User MANUAL 1 4 System Overview The REMstar Auto M Series device shown in Figure 1 2 is a CPAP Continuous Positive Air way Pressure device designed for the treatment of Obstructive Sleep Apnea OSA It can deliver CPAP therapy or Auto CPAP therapy When prescribed for you the device provides several special features to help make your therapy more comfortable 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 You also have the option of not using the ramp feature at all Additionally the C Flex comfort feature provides you with pressure relief when you exhale during therapy Several accessories are also available for use with your REMstar Auto M Series device Contact your home care provider to purchase any accessories not included with your system Figure 1 2 REMstar Auto M Series Device Figure 1 3 illustrates many of the device features described in the table below Start Stop Ramp Button Butte MER Flex Button Power Inlet Display Screen under door Air Outlet Equipment Note on bottom Accessory Module Filter Area Fi
45. ry placing the tubing from the device over your headboard This may reduce tension on the mask Note Ifyou are having trouble with your mask refer to the instructions included with the mask 4 2 REMstar Auto M Series User MANUAL 4 3 Us nG THE Ramp AND C FLex FEATURES You can press the _4 Ramp button to activate the Ramp feature or the C Flex button to change the C Flex setting if your provider has enabled these features 4 3 1 Ramp FEATURE The device is equipped with an optional ramp feature that your home care provider can enable or disable This feature reduces the air pressure when you are trying to fall asleep and then gradually increases ramps the pressure until your prescription setting is reached allowing you to fall asleep more comfortably If ramp is enabled on your device after you turn on the airflow press the J button on the top of the device You can use the Ramp button as often as you wish during the night Note If the ramp feature is disabled nothing will happen when you press the lt but ton 4 3 2 C FLex Comrort FEATURE The C Flex comfort feature allows you to adjust the level of air pressure relief that you feel when you exhale during therapy Your home care provider can enable or disable this feature 4 3 2 1 C FLex ENABLED When your provider enables C Flex a C Flex level will already be set for you on the device If this is not comfortable for you you can increase or decrease the setting
46. ssions Class A IEC 61000 3 2 Voltage fluctuations Flicker emissions Complies IEC 61000 3 3 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment IMMUNITY TEST Electrostatic Discharge ESD IEC 61000 4 2 Electrical fast Transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interrup tions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 Test LEVEL 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec COMPLIANCE LEVEL V contact V air V for supply mains V for input output lines V differential mode V for common mode SAU gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec NOTE U is the a c mains voltage prior to application of the test level REMstar Auto M Series User MANUAL ELECTROMAGNETIC ENVIRONMENT GUIDANCE Floors should be wood concrete or
47. ter 5 Device Alerts and Troubleshooting uasesseenseeensseennsseennsssennnnssennnseennnnee 5 1 5 1 Device Alei S sesisccssvescessisactizscctssvvesstxicctcvisecss svsctvecsessdensssiachiidens isectaricons itensszicetaies 5 1 SA Troubleshoot ssessenionenne i lea 5 4 Chapter 6 Accessories 6 1 Adding a Humidifier ccs sscossdsevsasdecsnsssarsassctonasecossas niet eanaeekennn garen arms en 6 1 6 2 Using the SmartCard cnnssccscsssciesssecondsesioss tionvesconsssitass stony eedtous itenv cians videssseceaierd ens 6 1 6 3 Adding Supplemental Oxygen ssssssssecssssccsssecssseecesecssnseessnsescsssecssnseessase 6 2 Chapter 7 Cleaning and Maintenance ssccssssssesusesessseessnssecesssesssnseeeesuseessnseessnaneeesueessnseecs 7 1 2 1 Cle ning THE Device here nie in when pa 7 1 7 2 Cleaning or Replacing the Filters usnennseennssennnnseennnneennnrsennnnreennnntenn 7 1 7 3 Cleaning the Tubing TAP SOUN S E A EE EE E A OSE E 7 5 Traveling with the System ssssssssccssssecssseecessseecsnseecesseccessssecsnsescessneecsnsecenseeeess 7 2 7 5 1 International Travel uussesseosssonesennnnsennenesennnnsennnnnsennnnsenennnsnennssennnne 7 2 Chapter 8 Specihcati nsiasansassessssennssensssdsttessnnkreenitentenente ine iaa ENa 8 1 Appendix A EMC Information ssseseesseensseensssunsssnssennssnnssenssnnsssnnsssnnssennsssnnsssnnnssunsssnnnsennn A 1 REMstar Auto M Series User MANUAL CHAPTER 1 INTRODUCTION This cha
48. to M Series User MANUAL 8 1 8 2 PRESSURE Pressure Increments 4 0 to 20 0 cm H O in 0 5 cm H O increments Pressure Stability lt 10 0 cm H O 40 5 cm H O 210 0 to 20 0 cm H O 1 0 cm H O Measured in accordance with EN ISO 17510 1 1 3 2 3 and Pmax with BPM set to 10 15 and 20 BPM 20 C 5 C 50 RH 5 and an atmospheric pressure of 101 54 kPascals Maximum Flow 35 LPM Measured in accordance with EN ISO 17510 1 1 3 2 3 and Pmax with BPM set to 10 15 and 20 BPM 23 C 2 C 50 RH 5 and an atmospheric pressure of 101 54 kPascals DISPOSAL Dispose of the device in accordance with local regulations REMstar Auto M Series User MANUAL Arpenod x A EMC INFORMATION GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment COMPLIANCE Emissions TEST RF emissions CISPR 11 Group 1 ment ELECTROMAGNETIC ENVIRONMENT GUIDANCE The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equip RF emissions Class B The device is suitable for use in all establishments including domestic establish CISPR 11 ments and those directly connected to the public low voltage power supply z ag network Harmonic emi
49. tons do not light The device does not op There may bea erate when you press the problem with the l button The airflow blower does not turn on 5 4 WHAT To Do If you are using AC power check the outlet power and verify that the device is properly plugged in Make sure the AC power cord is connected correctly to the power supply and the power supply cord is securely connected to the device s power inlet If the problem contin ues to occur contact your home care provider Return both the device and power supply to your provider so they can determine if the problem is with the device or power supply If you are using DC power make sure your DC power cord and battery adaptor cable con nections are secure Check your battery It may need recharged or replaced If the problem persists check the DC cord s fuse following the instructions supplied with your DC cord The fuse may need to be replaced If the problem still occurs contact your home care provider If you are using a humidifier make sure you fol low the instructions for applying power that are provided with your humidifier Make sure the device is powered correctly fol lowing the instructions on the previous page If the audible indicator sounds and the button backlights turn on when you apply power but the airflow does not turn on there may be a problem with your device Contact your home care provider for assistance Note When the device is fu
50. ures between 41 F 5 C and 95 F 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 Condensation may damage the device Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter A properly installed undamaged reusable foam inlet filter is required for proper operation Tobacco smoke may cause tar build up within the device which may result in the device malfunctioning Note Additional warnings cautions and notes are located throughout this manual 1 3 3 CONTRAINDICATIONS When assessing the relative risks and benefits of using this equipment the clinician should understand that this device can deliver pressures up to 20 cm H O In the event of certain fault conditions a maximum pressure of 30 cm H O is possible Studies have shown that the following pre existing conditions may contraindicate the use of CPAP therapy for some patients Bullous Lung Disease Pathologically Low Blood Pressure Bypassed Upper Airway Pneumothorax Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway Pres sure 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 Chest 1989 96 1425 1426 The use of positive airway pressure the
51. urrently using a dif ferent power cord or an international plug adaptor may be required to make your power cord compat ible with the power outlets of the country to which you are traveling Contact your home care provider for additional information REMstar Auto M Series User MANUAL CHAPTER 8 SPECIFICATIONS ENVIRONMENTAL OPERATING STORAGE TEMPERATURE 41 F 5 C to 95 F 35 C 4 F 20 C to 140 F 60 C ReLar ve Humipity 15 to 95 non condensing 15 to 95 non condensing ATMOSPHERIC PRESSURE 77 to 101kPa 0 7500 ft N A PHYSICAL Dimensions 75 Lx 5 0 W x 3 125 H 19 x 12 7 x 7 9 cm Weight Approximately 2 2 lbs without a humidifier STANDARDS COMPLIANCE This device is designed to conform to the following standards IEC 60601 1 General Requirements for Safety of Medical Electrical Equipment ENISO 17510 1 Sleep Apnea Breathing Therapy Devices ELECTRICAL AC Power Consumption 100 240 VAC 50 60 Hz 1 0 A max DC Power Consumption 12 VDC 3 0 A max Type of Protection Against Electric Shock Class II Equipment Degree of Protection Against Electric Shock Type BF Applied Part Degree of Protection against Ingress of Water Device Drip Proof IPX1 AC Power Supply Drip Proof IPX1 Mode of Operation Continuous Electromagnetic Compatibility The device meets the requirements of EN 60601 1 2 2nd edition Fuses There are no user replaceable fuses REMstar Au
52. us able 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 Two reusable gray foam filters and one disposable white ultra fine filter are supplied with the device If your filters are not already installed when you receive your device you must at least install the reusable gray foam filter before using the device To install the filter s 1 Ifyou are using the white disposable ultra fine filter insert it into the filter area first mesh side facing in towards the device 2 Insert the gray foam filter into the filter area as shown in Figure 3 1 Note If you are not using the white disposable filter simply insert the gray foam filter into the filter area Disposable Ultra Fine Reusable Gray Filter optional Foam Filter required FIGURE 3 1 INSTALLING THE Air FILTER Note See Chapter 7 Cleaning and Maintenance for information on how to clean or replace the air filters REMstar Auto M Series User MANUAL 3 1 3 2 WNHERE 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 curtains or other items 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
53. ut and returns to the Standby screen after one minute of inactivity 4 5 COMPLETING THE FOSQ QUESTIONNAIRE Note The FOSQ option only appears on the Standby screen if you have a SmartCard inserted or a modem connected to the device From the Standby screen you can access the FOSQ questionnaire by pressing the button The FOSQ test is a quality of life questionnaire designed specifically for people with sleep disorders The results allow health care professionals to see how therapy has improved the quality of your life By completing the questionnaire periodically you can provide valuable information about the effectiveness of your treatment Ihe device can record your answers on the SmartCard or viaa wired or wireless modem for later review by the health care professional Contact your home care provider for further instructions Note Ifyour health care professional or home care provider instructs you to com plete the questionnaire he or she will provide you with the questions and you can enter your answers into the device Make sure a SmartCard or modem is installed before answering the questions The FOSQ screens will not display if a SmartCard or modem is not present and able to store data To answer the FOSQ questionnaire complete the following steps 1 Make sure that the SmartCard or modem is properly installed Answers to the questionnaire are saved onto the SmartCard or sent to the health care professional via a wired or wire
54. vary depending on the CPAP setting patient breathing pattern and leak rate Substantial leaks around the mask may reduce the inspired oxygen concentration to less than the expected concentrations Appropriate patient monitor ing should be implemented REMstar Auto M Series User MANUAL CHAPTER 7 CLEANING AND MAINTENANCE This chapter describes how to clean the device and its filters and provides tips on traveling with your REMstar Auto M Series system 7 1 CLEANING THE DEVICE Warning To avoid electrical shock always unplug the power cord from the wall outlet or DC power source before cleaning the device Caution Do not immerse the device in liquid or allow any liquid to enter the enclo sure inlet filter or any opening 1 Unplug the device and wipe the outside of the device with a cloth slightly dampened with water and a mild detergent Let the device dry completely before plugging in the power cord 2 Inspect the device and all circuit parts for damage after cleaning Replace any damaged parts 7 2 CLEANING OR REPLACING THE FILTERS Caution Operating the device with a dirty filter may keep the system from working properly and may damage the device Under normal usage you should clean the gray foam filter at least once every two weeks and replace it with a new one every six months The white ultra fine filter is disposable and should be replaced after 30 nights of use or sooner if it appears dirty DO NOT clean the ultra fine

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