USER MANUAL - Air Liquide
Contents
1. MOYS apes AUS Qam Jousazu qeq d ls 1 pIAO1d ale BWOH 3IA p S H W no 1noqe Jeay Is y NOA pip Bay yew 3 auoud diz AD ssalppy awen enas 221nap ay Jo uuonoq ay uo 2 si quunN uoneuuioju uone3unu pi 32npolq Wo gt sr1UOdIdsas saLasUrMMM Ye ul UuO 1 1SIB 1 10 Y ldulo se d uonexnsiB5 qi S S N JEISWIH 5390214534 pa onijsul se Way lew pue payed1pul se saul p llop ay Buo e way n spyed d 1 ay l duioD 001055 S N st uonnqinuo2 wnwiunu 3y s 1e1S p ltun u1 pisino sassaippe 104 32npoild Auedwo gt Aue puawiworal 40 asJopua 1ou s op uonepossv p udy daajs uesuawy ay UoNeziUeBbJo 1Uoid uou e sy uonelpossy NOILVIOOSSY eaudy d ls uesuawy ay JO Josuods BuIpunoj e se 21 s pue o Jue b e papiAoid Duy sstuondsay vand Y aaa s NvOluaNy S000 Ira uorburysem ZOE BUNS MN PNS J yerl uonelossy eaudy daajs uesuawy 101 0435 3SV31d rr x aw Jesu dnolb 3 y V ANV Ue S 3194 JI MOU O yil pInom N H SA U ay Jo Adod aay e aw pu s sp ld Ing p pbp punue 7 aoepyppau Jo JajadVq aye e3Ip uu 214 e uu pu s se d VVSV 24 JO JaquiaW e awo9ag 0 yil 10 eU yal2. Remove the Devic gt to the Device From the Humidifier FiGuRE 7 3 ATTACHING THE AIR OUTLET Port TO THE DEVICE REMsraR Pro M Series User MANUAL CHAPTER 8 SPECIFICATIONS ENVIRONMENTAL OPERATING STORAGE TEMPERATURE 5 C 41 F to 35 C 95 F 20 C 4 F to 60 C 140 F 15 to 95 non condensing 15 to 95 mor ATMOSPHERIC PRESSURE 77 to 101kPa 0 7500 ft PHYSICAL Dimensions 7 5 Lx 5 0 W x 3 125 H 19 x 12 7 x 7 9 em 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 EN ISO 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 Reorder number 1015642 Drip Proof IPX1 Mode of Operation Continuous Electromagnetic Compatibility Ihe device meets the requirements of EN 60601 1 2 2nd edition Fuses There are no user replaceable fuses REMsraR Pro 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 Stabilit
3. 1 7 How to LonfsckEResproNies anne ee 1 10 Chapter 2 Device Controls and Dep aus ans 2 1 2 1 Controls and isp aya u 2 1 2 1 1 Control Panellnaetivity sans 2 3 2 2 Bear Panel een 2 3 3 1 3 1 Installing the Air Filters nun 3 1 3 2 Where to Place the Davies 3 2 3 3 Connecting the Breathing Circuit ana rn 3 2 3 4 Supplying Power to the Device 3 5 3 4 1 Using PR Power ee 3 5 3 4 2 Using DC Power u ba l l d b siz 3 6 3 5 Complete Assembly Example nun 3 7 Chapter Device Dara OR aa a 4 1 4 2 Using the Ramp and 5 2 4 3 4 2 Ramp Features u a 4 3 4 2 2 C Flex Comfort Feature I I U aa saa 4 4 4 4 4 2 2 2 CRleX Disabled R DYP 4 4 REMsraR Pro M Series User MANUAL i 4 3 Changing the Device Settings nee 4 5 4 3 1 Navigating the Display 2222 4 6 4 3 1 1 Viewing Data on the Patient Data Screens 4 6 4 3 1 2 Viewing and Modifying Patient Setup Screens 4 8 4 4 Completing the FOSQ 2222 4 11 4 5 Patient Reminder Screen se 4 12 Chapter 5 Device Alerts and Troubleshooting 5 1 5 1 DEvice lerin maa bii ia 5 1 5 2 iroubleshinetinb ann
4. 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 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 An exhalation device to vent exhaled air from the circuit Patient Interface Exhalation il Device ask s Exhalation Connector Port Circuit Flexible Tubing Tubing Connector WW N Circuit with Separate Circuit with Mask with Exhalation Device Integrated Exhalation Port Figure 1 4 Typical BREATHING CircuITs REMsraR Pro 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 vvhen povver is applied the airflovv is on and the device is providing therapy Apnea A condition
5. 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 RATED Maximum Power SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER OUTPUT OF TRANSMITTER 150 kHz ro 80 MHz 80 MHz ro 800 MHz 800 MHz To 2 5 GHz d 1 2 P d 1 2 P d 2 3 P For transmitters rated at a maximum output power not listed above the recommended separation distance d in 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 REMsraR Pro 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 of sale by Respironics Inc to the dealer If the product fails to perform in accordance with the product
6. SmartCard is inserted or a modem is connected to the device 2 Therapy Usage Screen This screen displays the number of hours that the device provided rs Night 2 gt 7 therapy as 7 day and 30 day averages The maximum value that can l be displayed for both averages is 24 hours lt Therapy Usage Note This screen is only for reference Your home care provider may periodically ask you for this information REMsraR Pro M Series User MANUAL 4 5 4 6 lt Sessions gt 4 7 Days 30 Days 5 Sessions 8 Sessions System Leak L min 7 Day Avg 0 0 30 Day Avg 0 0 Apn Hyp Index 7 Day Avg 30 Day Avg AHI 0 0 AHI 0 0 3 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 for the 7 day period is 35 sessions while the maximum value for the 30 day period is 150 sessions Note This screen is only for reference Your home care provider may periodically ask you for this information 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 occur
7. alert enable disable e Auto off enable disable 4 3 1 NAVIGATING THE DISPLAY SCREENS Use the gt 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 Pro M Series User MANUAL 4 3 1 1 ViEWING DATA ON THE PATIENT DATA SCREENS Figure 4 6 shows how to navigate the Patient Data screens lt Press 2 Press gt RESPIRONICS r FOSQ Setup lt gt Apn Hyp Index Therapy Usage 7 Day Avg AHI 0 0 7 Day Avg m 30 Day Avg AHI 0 0 30 Day Avg 8 00 System Leak lt Sessions gt 4 L min 7 Days 5 Sessions 20 30 Days 8 Sessions Yes u i 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 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 gt 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 ifa
8. 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 4 10 REMstar Pro 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 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 Additionally the backlights on the buttons will provide a high priority flashing pattern consisting of a continuous bright to off two flash pattern indicated in the following table as 00 00 00 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 following table as e Additionally the backlights on the buttons will provide a medium priority flashing pattern consisting of a continuous bright to dim
9. marked by the cessation of spontaneous breathing Auto Off VVhen 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 alvvays enabled BPM Breaths Per Minute C Flex A therapy feature that provides pressure relief during exhalation if enabled by your home care provider CPAP Continuous Positive Airway Pressure FOSQ Functional Outcomes of Sleep Questionnaire A quality of life ques tionnaire 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 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 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 com fortably Safe State The state in vvhich the device does not provide therapy The device enters this state if an error is detected Standby State The state of the device vvhen povver is applied b
10. one flash pattern indicated in the following table as 9 9 0 REMsraR Pro M Series User MANUAL 5 1 ALERT SUMMARY TABLE The following table summarizes the high and medium priority alerts ALERT AUDIBLE VISUAL Device AcTION PossIBLE CAUSE INDICATOR INDICATOR System Error Backlights The device enters the Device failure 00 00 00 Safe state in vvhich the device povver Screen displays the remains on butthe follovving symbol airflovv is disabled indicating that service is required A SmartCard Backlights The device continues A problem exists Error 0 0 9 to operate and vvith the Smart provide therapy but Card inserted in data logging is un the accessory available and FOSQ slot The card may is deactivated be improperly in serted or the data may be corrupt Screen displays the follovving flashing error symbol PATIENT AcTIoN Press any of the display screen buttons to silence the alert Remove the povver supply cord from the device 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 corrup
11. provider REMsraR Pro M Series User MANUAL 1 1 1 2 NTENDED UsE The Respironics REMstar Pro M Series system is a CPAP Continuous Positive Airvvay 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 Your home care provider will make the correct pressure settings according to your health care professional s prescription Several accessories are available to make your OSA treatment with the REMstar Pro 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 Warninas 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 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 This device is not intended for life support 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
12. specifications Respironics Inc will repair or replace at its option the defec tive 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 consequen tial 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 limita tion 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 RESPIRONICS RESPIRONICS 1001 Murry Ridge Lane Deutschland Murrysville Pennsylvania Gewerbestrasse
13. 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 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 VVARNINGS 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 Part number 302418 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 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 REMsraR Pro M Series Us
14. 17 1016444 15668 8550 USA 82211 Herrsching Germany 0123 www respironics com JH 6 14 06
15. MsraR Pro M Series User MANUAL 5 5 PRoBLEM Why It HAPPENED The device has fallen off 1 The device may your table or nightstand 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 make 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 REMsraR Pro M
16. RESPIRONICS C Flex the difference is real IMPORTANT Fill in the information below when you receive the REMstar Pro 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 Home Care Company Telephone Number e Health Care Professional Telephone Number 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 Pro 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 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 2006 Respironics Inc and its affiliates All rights reserved jew 3 uoud Wew aa DpOU1 NW SAA J ON Sa S3Iuouds t j Woy 5 Mau Bulp e a uoneuuoJul AI 3 1 yil no Ajlnads aseajd
17. Series User MANUAL PRoBLEM Why It HAPPENED What To Do You are having problems You have lost the If you are not using a humidifier you cannot connecting the tubing air outlet port or connect your tubing to the device vvithout the to the device are traveling and detachable air outlet port shown below forgot to bring the port vvith you 4 You must have port attached properly before connecting your tubing You are experiencing The air outlet port Remove the port and reattach it to make sure excessive air leaks where is not installed cor it s properly installed the tubing connects to rectly and doesn t the device seal properly 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 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 REMsraR Pro M Series User MANUAL 5 7 PRoBLEM The air out of the mask ismuch warmer than usual The mask feels uncom fortable to wear there is significant air leakage around the mask or you experie
18. THE AiR FILTER REMsraR Pro M Series User MANUAL 3 1 Note See Chapter 7 Cleaning and Maintenance for information on how to clean or replace the air filters 3 2 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 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 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 Respironics interface e g nasal mask with integrated exhalation port or Respironics inter face with a separate exhalation device such as the Whisper Swivel ID Respironics 6 ft 1 83 m flexible tubing with optional swivel 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 You can use the optional detachable swivel th
19. ains 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 A 1 GUIDANCE AND MANUFACTURER 5 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 COMPLIANCE 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 3Vrms dz124P IEC 61000 4 6 150 kHz to 80 MHz d 1 2JP 80 MHz to 800 MHz Radiated RF 3V m d 23 P 800 MHz to 2 5 GHz IEC 61000 4 3 80 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in vvatts VV according to the transmitter manufacturer and d is the recommende
20. 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 UsiNG 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 Reorder Number 532209 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 vehicles 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 other 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 REMsraR Pro M Series User MANUAL 3 5 3 5 COMPLETE 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 FINAL AssEMBLY EXAMPLE SHOWN WITH OPTIONAL Accessory MopuLe 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 pr
21. at is provided with your device and already attached to the tubing shown in Figure 3 2 or you can remove the swivel and con nect the tubing directly to the air outlet Detachable Swivel 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 REMsraR Pro 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 T Mask s Connector Flexible Tubing Connector Figure 3 3 CoNNEcTING A Mask WITH BUILT IN EXHALATION PORT b Ifyou are using a mask with a separate exhalation 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 II 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 ar
22. ature at all Additionally the C Flex comfort feature provides you with pressure relief during the expiratory phase of breathing Several accessories are also available for use with your REMstar Pro M Series device Contact your home care provider to purchase any accessories not included with your system Figure 1 2 REMstar Pro M SERIES Device Figure 1 3 illustrates many of the device features described in the table below R Start Stop amp Button Butt 75 C Flex Button Power Inlet Display Screen under door Air Outlet Equipment Note Filter Area on bottom Accessory Module Figure 1 3 REMsraR Pro M Series System OVERVIEW REMsraR Pro M Series User MANUAL 1 5 Device FEATURE DESCRIPTION Accessory Module If applicable insert the optional accessory card here Connect the flexible tubing here CFlex Button This button allows you to change the CFlex comfort setting if C Flex is prescribed for you See Chapter 4 for more information about CFlex 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 bottom of the device stating that it is medical equipment
23. c mixture in combination with oxygen or air or in the presence of nitrous oxide Do not use this device if the room temperature is warmer than 95 F 35 O 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 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 Contact your health care professional if symptoms of sleep 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 and adjustments must be performed by Respironics authorized service personnel only Unauthorized service could cause injury invalidate the warranty or result in costly damage Periodically inspect electrical cords cables and the power supply for damage or signs of wear Discontinue use and replace if damaged To avoid electric shock unplug the device before cleaning it DO NOT immerse the device in any fluids Pins of connectors identified with the ESD warning symbol 22 should not be touched Connections should not be made to t
24. ce 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 Pro 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 remove the humidifier from the device and attach the air outlet port 7 5 1 INTERNATIONAL TRAVEL If you are traveling to a country with a line voltage different than the one you are currently 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 Attach Air Outlet Port
25. d 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 Mo LE RF Communications EQUIPMENT AND This Device The device is intended for use in an electromagnetic environment in which radiated
26. e 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 vvhen you exhale during therapy Your home care provider vvill 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 Ifyour provider has disabled C Flex you cannot enable or ad just the setting The screen shown at left displays to indicate ION lt gt Ramp Start Pres 4 0 cmH20 z that C Flex is disabled 4 8 lt gt Ramp Start Pres 4 0 cmH20 Mask Alert Feature ON lt Auto off Feature ON 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 settin
27. e e3Ip uu aay e s pni ul d ys qw W s lni UIYM s sod nd xe 2 104 lqn np p ae suonnq uo pue diysiaquiayy u y jsm u y o uonduosqns uo e pn 3u sd ys aqwu w y xdiysuaquuawi jenuue 25 0S 0015 0525 0065 00015 2942 aseatd diz 1e1S AD sseuppy oN uoud p udy d ls JO e udy apsosip jyu une npue uhpuesia jpns d ls Jo 1u une n ay noge uolss Joid daajs sasneday uo bpb ude so sdnol uhluls jueApe Mau jes paw pue gt lqnd s apuos p Bulyjeaiq 1054005 1ioddns d u noqe uoneuuoJu y Aq Jayjo pue eaudy pue 10 Jenjnwainyinu UMA sayns eaudy eaudy daajs JO l daajs woy yeap pue Aauow as e OL pue usilqess ol d fs oL polu y BAO OL Ayyiqesip SIVOD MERA d s Aq pay gt aye u q Aeu oym s ayo YUM Yoddns pue uoneuuojJul 5 o AUN Oddo y Y NEN s un ul g y V AWV sdnoi6 uoddns d u jenynw 220 yo WEISAS piWuoneu e 51 ylym q ff Er a HOAN N BuId y puy aM H lv IW VMV ay l 3d Ped o payau osje ale NOA NVOIHaMW V Jajade1q uone3unu pi 1 e3Ip uu e AI 3 1 JIM no osjy suleye annejs ba pue sdn s awoy u uuus duuo22e enpiAIpu JO salloJs 3s l ul ueuunu A5olouu mau s 3ueApe IE P UL Ul 45972 AY 1noq
28. e 5 4 bi 6 1 l Addio a Hu midiker nun ee 6 1 6 2 Using the SmartCard eae ae arvana ei 6 2 6 3 Adding Supplemental Oxygen a 6 2 Chapter 7 Cleaning and Maintenance een 7 1 7A Cleaning EL SE a R nee 7 1 7 2 Cleaning Or Replacing the 7 1 7 3 Cleaning the TUBING nee ee 7 3 FMT Me EA E aa Na NS EN Qa na Na u E 7 3 7 5 Traveling with the u 7 4 7 5 1 International Teyvaz dak ne 7 4 Chapter 2 H O a aa am aa 8 1 Appendix Ar EMC nformation AR nile yas n A 1 il REMsraR Pro M Series User MANUAL CHAPTER 1 INTRODUCTION This chapter provides information on REMstar Pro M Series system contents Intended Use Warnings cautions and contraindications System overview Glossary and symbol key How to contact Respironics 1 1 System CONTENTS Your REMstar Pro M Series system includes the follovving items User Manual Carrying Case 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
29. e NOK wozu IA 1 V JSM U SIY weak yea s uun xis 11 2 d 1 3MVAA Jana smau e AI 331 M no uonel2ossy eaudy d s uesuawy ay JO aqwau e sy uonepossy eaudy daajs uesuawy ay uror SALVLS 0311 AHL NI Q31lVN 41 AMVSS393N 39V1SOd ON 6208 95 NW 5014 7102 8 Od 33993400 Ag 0174 38 THM 397 1504 NW Sdldyu GNVYS LEZ ON LINYAd VW SSVTO LSUId TYN A ldad SSANISNG 5 z 1 A 3 N Q M SERIES with C Flex QUICKSTART GUIDE REMstar 2 rb o a REMstar M SERIES with C Flex Complete the following steps to set up your M Series device Plug the AC power cord Plug the power supply cord connector into the power supply connector into the device and attach the swivel to the device s then plug the power cord into an air outlet port Or attach the tubing electrical outlet directly to the air outlet port Press the button to begin therapy REMstar M SERIES with C Flex and humidifier Complete the following steps to set up your M Series device and humidifier Connect the humidifier power Plug the power supply cord Attach the swivel with the flexible tubing supply connector to the device connector into the device attached to the humidifier s air outlet port power supply Plug the AC power Or attach the tubing directl
30. e device from the power source 2 Remove the filter s from the enclosure by gently squeezing the filter in the center and pulling it away from the device as shown in Figure 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 Filter Area 5 Ifthe white ultra fine filter is dirty or torn replace it a 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 Disposable Ultra Fine Reusable Gray that you clean the filter in the morning and alternate using Filter optional Foam Filter the two foam filters provided with the system to ensure ki sufficient drying time for the cleaned filter FIGURE 7 2 REINSTALLING THE FILTERS REMsraR Pro M Series User MANUAL 7 1 7 2 7 3 CLEANING THE TUBING Clean the tubing daily Disconnect the flexible tubing from the device Gently wash the tubing in a solution of warm water and a mild detergent Rinse thoroughly Air dry 7 4 SERVICE The REMstar Pro M Series device does not require routine servicing Warning If you noti
31. e 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 REMsraR Pro M Series User MANUAL 3 3 3 4 SuPPLYING 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 1 button turns the airflow on or off Important If you are using your device with a humidifier refer to the instructions included with your humidifler for details on how to power the device and humidifler 3 4 1 UsiNG 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 FIGURE 3 6 CONNECTING THE POWER SUPPLY CORD TO THE DEVICE 3 4 REMstar Pro M Series User MANUAL 4 Ensure that
32. en 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 Z Placement Area s for Optional Quick i i Reference Label Cover Door L Previous H Next Screen Screen Button Button _ Decrease Increase Button Start Stop C Flex Button Button Figure 2 3 Device CONTROL PANEL 2 1 1 CONTROL PANEL INACTIVITY Some 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 Accessory Slot Filter Area Figure 2 4 REMstar Pro 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 A filter area where the filter s supplied with your device should be inserted ADC power inlet where the power cord is connected see Chapter 3 Setup for complete information on supplying power to the device The air outlet port where the breathing circuit s flexible tubing is attached REMsraR Pro M Series User MANUAL CHAPTER 3 SETUP This chapter provides instructions on h
33. er 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 Pro 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 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 Ifthe device is operating stop the airflow by pressing the ly button Disconnect th
34. event the device from falling off your nightstand or table Figure 3 8 RECOMMENDED DEVICE AND TUBING PLACEMENT 3 6 REMstar Pro M Series User MANUAL CHAPTER 4 DEvicE OPERATION This chapter explains how to start the device and change the settings 4 1 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 V 1 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 a J RESPIRONICS FOSQ Setup Figure 4 2 STANDBY SCREEN Note The FOSQ option will only appear on the Standby screen if a SmartCard is inserted in the device or if a modem is connected REMsraR Pro M Series User MANUAL 4 1 3 Press the o button to turn on the airflow The Active Display screen appears shown in Figure 4 3 2 15 0 Figure 4 3 Active DispLAY WITH SMARTCARD The Active Display screen shows the set pressure Some symbols indicating when certain conditions are turned on or detected will al
35. g by pressing the or buttons to select OFF or ON If this feature is enabled then the vvords Mask Leak appear on the Active display screen if a signifi cant mask leak is detected and an audible alert sounds Note If your physician indicates that the Mask Alert is neces sary for you do not disable it Auto Off Screen You can enable this feature if you want the device to automati 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 then the words Auto Off appear on the Standby screen if the device detects that you have removed your mask The airflow shuts off and the Auto Off message continues to appear on the Standby screen until the condition is corrected After you have finished modifying the Patient Setup screens press the o button to return to the Standby screen Note The Setup menu automatically times out and returns to the Standby screen after one minute of inactivity REMsraR Pro M Series User MANUAL 4 4 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 vvith sleep disorders The results allovv health care profess
36. gure 4 4 appears with an arrow above the current C Flex setting C FLEX 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 3 REMsraR Pro M Series User MANUAL 4 3 4 2 2 2 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 2 FLEX comfort has been disabled on this unit Figure 4 5 C FLEx DISABLED SCREEN 4 3 CHANGING THE Device SETTINGS You can view the set pressure on the Active Display screen as well as the following information on the Patient Data screens Therapy usage hours Number of sessions greater than 4 hours System leak if enabled by your home care provider Index if enabled by your home care provider Additionally you can view and modify the following settings on the Patient Setup screens C Flex if enabled by your home care provider Ramp starting pressure if enabled by your home care provider e Mask
37. hese 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 REMsraR Pro 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 temperatures between 41 F 5 C and 95 F 35 O 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
38. ionals to see hovv therapy has improved the quality of your life By completing the questionnaire periodically you can provide valuable information about the effectiveness of your treatment The device can record your ansvvers on the SmartCard or via a vvired or vvireless modem for later review by the health care professional Contact your home care provider for further instructions Note If your 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 ansvvers into the device Make sure a SmartCard or modem is installed before ansvvering the questions The FOSQ screens will not display ifa 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 wireless modem when available If you are using a SmartCard a SmartCard symbol 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 2 From the Standby screen press the button to access the first FOSQ screen shown in Figure 4 8 FOSQ 1 30 4 01234 Figu
39. is possible Studies have shown that the following pre existing conditions may contraindicate the use of CPAP therapy for some patients e Bullous Lung Disease Pathologically Low Blood Pressure Bypassed Upper Airway Tneumothorax 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 therapy 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 REMsraR Pro M Series User MANUAL 1 4 System OVERVIEW The REMstar Pro M Series device shown in Figure 1 2 is a sleep apnea system that delivers Continuous Positive Airway Pressure CPAP CPAP maintains a constant level of pres sure throughout the breathing cycle 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 fe
40. 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 mask and exhaled air may be rebreathed Re breathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation 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 Oxygen accumulated in the device enclosure will create a risk of fire REMsraR Pro M Series User MANUAL Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame e When using oxygen with this system a Respironics Pressure Valve Part Number 302418 must be placed in line with the patient circuit Failure to use the pressure valve could result in a fire hazard Do not use the device in the presence of a flammable anaestheti
41. nce 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 havea 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 somevvhat based on your room temperature Make sure that the device is properly ventilated Keep the device avvay from bedding or curtains that could block the flovv of air around the device Make sure the device is avvay from direct sun light and heating equipment Ifthe problem continues contact your home care provider If you experience any issues with your 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 ncrease the room humidity Consult vvith your health care professional aboutusing a Respi ronics humidifier with the device If you have a humidifter 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 REMsraR Pr
42. o M Series User MANUAL CHAPTER 6 ACCESSORIES Contact your home care provider for additional information on the accessories available for your REMstar Pro M Series system When using optional accessories always follow the instructions enclosed with the accessories 6 1 A HUMIDIFIER You can use the M Series Heated humidifier or the M Series Pass over humidifier with your device 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 Figure 6 1 shows the humidifier by itself and attached to the REMstar Pro M Series device 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 Humidifer without Device Humidifer Device Atached Figure 6 1 HUMIDIFIER ALONE AND ATTACHED TO THE DEVICE Refer to the humidifier s instructions for complete setup information REMsraR Pro M Series User MANUAL 6 1 6 2 USING THE SMARTCARD Some REMstar Pro M Series systems come with a SmartCard accessory module installed in the 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
43. ontact 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 functioning 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 REMsraR Pro M Series User MANUAL PRoBLEM Why It HAPPENED What To Do The devices display is The device or Unplug the device and the power supply erratic power supply has Reapply power to the device If the problem been dropped continues relocate the device to an area vvith or mishandled lower EMI emission
44. ow to Install the air filters Position the device Connect the breathing circuit 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 reusable filter must be in place at all times when the device is operating The 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 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 Filter Area Disposable Ultra Fine Reusable Gray Filter optional Foam Filter required FiGuRE 3 1 INSTALLING
45. re 4 8 FOSQ Screen 1 or 30 Press the or button to select your answer to the first question and an arrow appears over your answer 0 indicates that you choose 0 as the answer to the question 1 indicates that you choose 1 as the answer to the question 2 indicates that you choose 2 as the answer indicates that you choose 3 as the answer indicates that you choose 4 as the answer REMsraR Pro M Series User MANUAL 4 9 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 button 4 There are 30 FOSQ questions Once you have reached the last question press the button to save your answers and exit the questionnaire 4 5 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 device 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
46. s e g away from electronic or the device or equipment such as cellular phones cordless power supply isin phones computers TVs electronic games hair an area with high dryers etc Electromagnetic Interference EMI If the problem still occurs contact your home emissions care provider for assistance Device Resets Reboots The device comes Such a reset poses no danger to the patient installed with and assures that the patient receives prescribed The device shuts down troubleshooting therapy throughout the night If there is a pos and restarts automati software that sibility of damage to the device the device will cally during therapy automatically shut down permanently The product will then This is unlikely to occur monitors perfor display the following system error alert symbol mance to indicate that the device be returned to the home care provider for service A The Ramp feature does 1 Your home care If Ramp has not been prescribed for you dis not work when you provider did not cuss this feature with your home care provider press the Ramp button prescribe Ramp for to see if they will change your prescription you or your CPAP pressure is already If your provider has enabled Ramp but the set to the mini feature still does not work check the CPAP set mum setting ting on your Active Display screen If CPAP is set to the minimum setting 4 0 cm H O the Ramp feature will not work RE
47. s 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 Apnea 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 REMsraR Pro M Series User MANUAL 4 3 1 2 VIEWING AND MopirYiNG PATIENT SETUP SCREENS Figure 4 7 shows how to navigate the Patient Setup screens RESPIRONICS FOSQ Setup Press Press gt Figure 4 7 NAVIGATING THE PATIENT SETUP SCREENS lt gt Press amp C Flex Setting 123 lt Auto Off gt Feature ON Mask Alert Feature ON The Patient Setup screens are described below te RESPIRONICS FOSQ Setup gt C Flex Setting 123 C Flex Setting 2 FLEX comfort has been disabled on this unit 1 REMsraR Pro M Series User MANUAL 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 th
48. s 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 airflow and places the device in Standby You can also press this button to exit any setting screen 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 and stop therapy and do not need to use the display buttons lo cated under the device cover door Figure 2 2 shows the device display and navigation buttons that are under the cover door Ay RESPIRONICS FOSQ Setup Figure 2 2 DisPLAY Buttons The display buttons are described below BUTTON 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 and 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 REMsraR Pro M Series User MANUAL 2 1 2 2 The devices display scre
49. so appear on the Active Display screen or on the Standby screen Ihese symbols are described below SYMBOL DESCRIPTION lt A 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 Leak if the 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 e SmartCard This symbol displays if a SmartCard is inserted in the device Ifthe Smartcard is inserted incorrectly the symbol will flash intermit tently 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 being used 4 Puton 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 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 try placing the tubing from the device over your headboard This may reduce
50. t and need to be replaced 5 2 REMsraR Pro M Series User MANUAL ALERT AUDIBLE INDICATOR Patient Reminder VISUAL INDICATOR Backlights 0 0 0 The vvords Mask Leak flash on the Active Display screen The vvords Auto Off flash on the Standby screen indicating that a mask disconnect has been detected Backlights 0 0 0 Screen displays a customized reminder message whenever the de vice transitions from the Active state to the Standby state REMsraR Pro 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 PossIBLE 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 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 b button to restart the airflovv 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 ne
51. tension on the mask Note If you are having trouble with your mask refer to the instructions included with the mask 4 2 REMstar Pro M Series User MANUAL 4 2 UsiNG THE RAMP AND C FLEX FEATURES You can press the 1 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 2 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 1 but ton 4 2 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 2 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 To change the C Flex setting press the C Flex button The screen shown in Fi
52. user of this device should make sure it is used in such an environment RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations Flicker emissions IEC 61000 3 3 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 59596 dip in U for 5 sec COMPLIANCE LEVEL 6 kV contact 8 kV air 2 kV for supply mains 1 kV for input output lines 1 kV differential mode 2 kV for 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 NOTE U is the a c mains voltage prior to application of the test level REMsraR Pro M Series User MANUAL ELECTROMAGNETIC ENVIRONMENT GUIDANCE Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 M
53. ut the airflovv is turned off REMsraR Pro M Series User MANUAL 1 7 1 8 1 6 5 KEY The following symbols appear on the device and power supply SYMBOL DEFINITION Consult accompanying instructions for use DC Power Type BF Applied Part Class Il Double Insulated Drip Proof Equipment Electrostatic Discharge European Declaration of Conformity Canadian US Safety Certification Notified Body Approval for Standards Compliance TUV Safety Standard Compliance UL Recognized for Canada and the United States No User Serviceable Parts 1 7 HowTo CONTACT REsPIRONICS 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 REMsraR Pro M Series User MANUAL CHAPTER 2 Device CONTROLS AND DISPLAYS This chapter describes the devices control buttons and displays patient circuit connections and rear panel connections 2 1 CONTROLS AND DIsPLAYS Figure 2 1 shows the three primary control buttons on the REMstar Pro M Series device F GURE 2 1 Primary CONTROL BUTTONS These buttons are described belovv DEscRIPTION Ramp When the airflow i
54. xt morning to have your mask checked You may need a mask refitting Put your mask back on and press the o button to turn the airflow on and resume therapy Press any of the display buttons to acknovvledge the message and clear it If you do not acknovvledge the reminder it will disap pear after 6 minutes and then reappear for three consecutive days vvhenever the device transitions from the Active state to the Standby state If you still do not acknovvledge 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 Nothing happens when you apply power to the device The audible in dicator does not sound and the backlights on the buttons do not light The device does not operate when you press the I button The air flow does not turn on Why It HAPPENED There s no power atthe outlet or the device is un plugged There may be a problem with the blower 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 c
55. y x10 0 cm H O 20 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 45 C 50 RH 4596 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 42 C 50 45 and an atmospheric pressure of 101 54 kPascals D sPOSAL Dispose of the device in accordance vvith ocal regulations REMsraR Pro M Series User MANUAL APPENDIX A EMC INFORMATION GUIDANCE AND V ANUFACTURER 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 ELECTROMAGNETIC ENVIRONMENT GUIDANCE COMPLIANCE Emissions TEST RF emissions CISPR 11 Group 1 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 ment Class B The device is suitable for use in all establishments including domestic establish ments and those directly connected to the public low voltage power supply network GUIDANCE AND V ANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY This device is intended for use in the electromagnetic environment specified below The
56. y to the air cord connector into the power outlet port supply then plug the power cord into an electrical outlet ee gt Lift the humidifier door to access Fill the tank with water until it Place the water tank back in the water tank reaches the fill line the humidifier CAUTION DO NOT TIP OR TRANSPORT THE DEVICE WITH WATER IN THE HUMIDIFIER TANK Press the button to begin Turn the humidifier knob to the therapy desired setting as REMstar M SERIES with C Flex Final system setup for the device REMstar M SERIES with C Flex and humidifier Final system setup for the device and humidifier PFSPIRONICS RESPIRONICS 1001 Murry Ridge Lane Deutschland Murrysville Pennsylvania Gewerbestrasse 17 15668 8550 USA 82211 Herrsc hing German y 0123 TABLE oF CoNTENTS Chapter 1 MTP UAC THON een ieh 1 1 1 17 m na aswanqa 1 1 12 intended Be alabay niaaa 1 2 1 3 Warnings Cautions and Contraindications 1 2 1 3 1 a u u 1 2 1 3 2 C L L daa b l l dl d llal balan 1 4 1 3 3 Contraindications u u 1 4 14 System DYeEV EW ni ea re 1 5 1 4 1 Breathing Circuit Overview 1 7 15 Glossary E AEE ni 1 8 16 Symbol Key sssrini aya 1 9
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