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REMstar Plus M-Series User Manual PDF

1. RESPIRONICS 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 8550 USA ry DirectHome MEDICAL Presented With Compliments From www DirectHomeMedical com USER MANUAL RESPIRONICS Deutschland Gewerbestrasse 17 1016438 82211 Herrsching Germany 0123 WWW respironics corm JH 9 12 05 RESPIRONICS C Flex the difference is real IMPORTANT Fill in the information below when you receive the REMstar Plus 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 1 724 387 4000 The REMstar Plus 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 and 6 427 689 Other patents pending REMstar Whisper Swivel Encore Pro and Encore Pro SmartCard are trademarks of Respironics Inc NOTE The C Flex mark is used under license 2005 Respironics Inc All rights reserved SALVLS GALINA AHL NI C
2. gt or lt 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 Attention Check your mask A replacement may be available Call XXX XXX XXXX Figure 4 9 Patient REMINDER SCREEN REMstar Pius M Series User MANUAL 4 11 REMstar Pius M Series User MANUAL CHAPTER 5 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 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 0 Medium Priority These alerts require
3. Whar ro 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 devices 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 follow 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 bea problem with your device Contact your home care provider for assistance Note When the device is functioning cor rectly after you press the b button the device beeps and the airflow turns on after a slight delay This brief delay is normal REMstar Pius M Se
4. u u u a 5 1 5 T Device Alleri u u aaa aaah tutore da e qalas 5 2 Troubleshooting Chapter 6 AC6 ssSorlesu u u au ua SOIN OG Tute eH MEO tes AEAEE NEESS 6 1 Adding allumidifler LI asp nanaspuphisiasamaysisnawwasqaashaq 6 1 6 2 Using the SmlartCard sestertia mereri r bua etae 6 3 Adding Supplemental Oxygen J Chapter 7 Cleaning and Maintenance 7 1 Cleaning the Device ou sssssssssssscssssscsssseccssssscssseesesnesssssescssssesssnsecsssseesesnesesseessene 7 2 Cleaning or Replacing the Filters 7 3 Cleaning the Tubing LLL treten tiet utet eee ee eRES VE AI 7 5 Traveling with the System l u 7 5 1 International Travel n Chapter 8 Specifications sssscsssecsssessssecssssssssesssecessscssuscessccessscesscecssscessccesseesseecesscsessecesseessneesse 8 1 Appendix A EMC Information u u uu A 1 REMstar Pius M Series User MANUAL CHAPTER 1 INTRODUCTION This chapter provides information on REMstar Plus M Series system contents Intended Use Warnings cautions and contraindications System overview Glossary and symbol key e How to contact Respironics 1 1 System CONTENTS Your REMstar Plus M Series system in
5. Control Panel Inactivity eerte tenente 2 2 Paci 2 3 Chapter 3 Setup 3 1 Installing the Air Filters trt erre ene i esie 3 1 3 2 Where to Place the Device u u 3 2 3 3 Connecting the Breathing Circuit 3 2 3 4 Supplying Power to the Device eene teen tenentes 3 5 3 4 1 Using AC POWEL tct sterio thee sst be toe eb cba tL nk bein 34 2 USI RQ DC gom 3 5 Complete Assembly Example Chapter 4 Device Operation sinnini i as 4 1 Starting the Device oen nap die s a usa 4 2 Using the Ramp and C Flex Features eret tenent 4 3 4 2 1 RAMP Feature E 4 3 4 2 2 C Flex Comfort Feature usuy eee aaa assasi ushassasapaq 4 4 4 2 2 1 C Flex Enabled ttt eicere 4 2 2 2 C Flex Disabled REMstar Pius M Series User MANUAL i 4 3 Changing the Device Settings 4 3 1 Navigating the Display Screens 4 3 1 1 Viewing Data on the Patient Data Screens 4 5 4 3 1 2 Viewing and Modifying Patient Setup Screens 4 7 4 4 Completing the FOSQ Questionnaire eerte 4 10 4 5 Patient Reminder Screen ssssssssssccssseccssseccsseescsssscessneeccsnsecesnsecessnsesssnsseessssesees 4 11 Chapter 5 Alerts and Troubleshooting
6. 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 REMstar Pius M Series User MANUAL 2 1 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 FOSQ or Setup menu o Allows you to access the Data screens Also allows you to navigate to the next screen when in the Data FOSQ or Setup menu Allows you to enter the FOSQ screens Also allows you to decrease the settings on the patient setup screens Allows you to enter the Setup screens Also allows you to increase the settings on the patient setup screens The devices 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 Cover Door Previous Screen Button Decrease Button A Placement Area for Optional Quick Reference Label Ramp Button Start Stop C Flex Next Screen Button Increase Button Button Button Figure 2 3 Device CoNTRoL PANEL 2 1 1 COonTROL PANEL INACTIVITY Some screens have time out periods The screen s timer starts wh
7. against Ingress of Water Device Drip Proof IPX1 AC Power Supply Reorder number 1015642 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 Pius 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 4 0 to 20 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 x5 C 50 RH 45 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 x2 C 50 RH 45 DIsPOSAL Dispose of the device in accordance with local regulations REMstar Pius M Series User MANUAL APPENDIX A EMC INFORMATION GuIDANCE AND Manuracturer 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 Emissions TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUID ANCE RF emissions Group 1 The device uses RF energy only for CISPR 11 its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The device is suitable for use in al
8. or a modem is 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 The device can record your answers on the SmartCard or via a wired or wireless 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 complete the questionnaire he or she will provide you with the ques tions 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 HSI TON 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 The symbol will fl
9. 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 REMstar Pius M Series User MANUAL 3 1 Filter Area Disposable Ultra Fine Reusable Gray Filter optional poni ied require 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 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 ven
10. the flexible tubing as shown in Figure 3 3 HL Exhalation Port og Mask s Connector Flexible Tubing Connector Figure 3 3 ConnectinG A Mask wirH BuiLT IN EXHALATION PORT REMstar Pius M Series User MANUAL 3 3 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 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 Pius M Series User MANUAL 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 temperatures allow it to adjust to room temperature before beginning the following setup p
11. this manual are not intended to super sede the health care professional s instructions regarding the use of the device 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 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 foxygen 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 r
12. to share information and support with others who have been affected by sleep apnea ASSOCIATION To reduce disability and To improve the clinical To provide Sleep To establish and To raise money for death from Sleep care of Sleep Apnea by Apnea sufferers with nurture mutual and to sponsor Apnea and other educating the public and information about new help support groups research on the breathing disorders medical profession advances in the treatment for apnea sufferers causes and treatment during sleep about the disorder of Sleep Apnea and their families of Sleep Apnea TABLE OF CONTENTS Chapter 1 I ntr od ctl l l Fpuaplpa oi zs gt xs8ai la lag jB a i Fa arvuss s 6smm es y sasana aa aaa sassa 1 1 11 System Contents sns e PE HERE e ERE ERGO NERO RE waq 1 1 1 2 Intended Use 1 3 Warnings Cautions and Contraindications sees 1 2 DEBET Sissin Sq aS Runa Saiyan Sisa R 1 2 132 CUON Scumann R RRR EN 1 4 1 3 3 Contraindications u u 1 4 IE BEcued 1 5 1 4 1 Breathing Circuit Overview eee tenente tenent 1 7 1 5 Glossary i 1 6 Symbol Key irre teer risit per ie ee tiir ic repre ia er 1 9 1 7 How to Contact Respironics cessssscssecssccssecssecsscsssccsscsnscssscesecsssecnecsnseeseeses 1 10 Chapter 2 Device Controls and Displays u 2 1 2 1 Controls and Displays rettet toti a 2 1 2 1 1
13. ATV 3l XAYVSSAOAN ANVLSOd ON 6208 V7ZSS NIN SdidV GNVYS vlLOZ XO8 Od SJINOelIdSael AASSANCV Ad AlYd 38 TIM 39VLSOd NW SdIdVvH QNVHO 1 2 ON LINHAd TIVA SSV 1O LSHI TYN A 1d38 SSANISNG WY OI CS 0I S0 61 6 j3pd rpaeo Atdez e NZ is Kimia ew O uouq O eN Paa DOUI N P 419J 1d SOA JI ONLI sa SoOluoulds t wo syonpoid Mau Buipue68J uoneuuojJurl AI9291 0 eyi no p nOAA Ajyioeds se jd 18ulO enBeej oo pueuJ Mwousepej O isq w18uu lu O qe1 d ls O 1 pIAO1q 1JeO LuOH IA D seues W ANOA 1noge seay js no pip eJeuM pew g euoud diz S o AIO sseJppy owen SIA p eui JO IBHSS U10310q y uo pejeoo SJOqUINN IPPON uoneuuoju uoneouimnuep 1onpoJgd ulo2 s3iuoJidsar salj9surMMM je eui uo 181SIB 1 10 BuiAojio BU ejejduuoo eseea d uoneagsib6eH SSUES N Je1isj gA3 SOINOelldSael WY 0Z ZZ TIT S0 6T 6 gpd zpaeo Atdex e ae An application to join the American Sleep Apnea Association should be attached here If it is not you can contact the American Sleep Apnea Association at 1 202 293 3650 Name Phone No Address City State Zip Please check 1000 500 250 100 50 25 annual membership All memberships include a one year subscription to the newsletter Membership and contributions are deductible for income tax p
14. IDANCE Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humid ity should be at least 30 Mains power quality should be that of a typical home or hos pital environment Mains power quality should be that of a typical home or hos pital environment Mains power qual ity should be that of a typical home or hospital environ ment If the user of the device requires continued operation during power mains interruptions it is rec ommended that the device be powered from an uninterrupt ible power supply or a battery NOTE U is the a c mains voltage prior to application of the test level REMstar Pius M Series User MANUAL GUIDANCE AND Manuracturer 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 COMPLIANCE ELECTROMAGNETIC ENVIRONMENT Test LEVEL LEVEL GUIDANCE Power frequency 50 60 3 A m 3 A m Power frequency magnetic fields should be Hz magnetic field at levels characteristic of a typical location ina typical hospital or home environment IEC 61000 4 8 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 frequen
15. 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 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 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 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 fadministering fixed flow supplemental oxygen the oxygen concentration may not be con stant The insp
16. ash if the SmartCard is inserted incorrectly 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 9 FOSQ 1 30 01234 Figure 4 9 FOSQ Screen 1 or 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 1 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 REMstar Pius M Series User MANUAL 4 11 3 After you answer the first question press the y button to access the next FOSQ screen and continue answering each question If you need to go back to a previous screen press the 4 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
17. ate 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 e Using this device at an incorrect elevation setting could result in airflow pressures higher than the prescribed setting Always verify the elevation setting when traveling or relocating Dins of connectors identified with the ESD warning symbol a 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 Pius 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 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
18. ble 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 Abut ton REMstar Pius M Series User MANUAL 4 3 4 2 2 C FLEx CoMFoRT 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 Figure 4 4 appears with an arrow above the current C Flex setting C Flex Setting 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 scre
19. cludes the following items Carrying Case User Manual Quickstart Guide X 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 Pius M Series User MANUAL 1 1 1 2 INTENDED Use The Respironics REMstar Plus 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 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 Plus 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 This manual serves as a reference The instructions in
20. cy of the transmitter Conducted RF 3 Vrms Recommended separation distance IEC 61000 4 6 150 kHz to 80 d 12P MHz d 1 APP 80MHzto 800 MHz Radiated RF 3V m d 2 3 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 watts W according to the transmitter manufacturer and d is the recom mended 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 equip ment marked with the following symbol a 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 observ
21. displays on the Standby screen if the Auto Off Off setting is enabled and the device detects a mask disconnect SmartCard This symbol appears if a SmartCard is inserted in the device If the SmartCard is inserted incorrectly this symbol will flash intermit tently Note This symbol will vary in appearance depending on the type of modem being used c Modem This symbol appears if a modem is connected to the device ca 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 If you are using the device while sleeping try placing the tubing from the device over your headboard This may reduce tension on the mask Note If you are having trouble with your mask refer to the instructions supplied with the mask 4 2 REMstar Pius M Series User MANUAL 4 22 UsiNG THE Ramp AND C FLeEX FEATURES You can press the lt 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 disa
22. e 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 Pius M Series User MANUAL PROBLEM You are having problems connecting the tubing to the device You are experiencing excessive air leaks where the tubing connects to the device Why It HAPPENED You have lost the air outlet port or are traveling and forgot to bring the port with you The air outlet port is not installed cor rectly and doesn t seal properly REMstar Pius M Series User MANUAL Whar ro Do If you are not using a humidifier you cannot connect your tubing to the device without the detachable air outlet port shown below 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 Putyourthumb underneath the port and insert your index finger into the port opening 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 o
23. ed 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 REMstar Pius M Series User MANUAL A 3 A 4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND Mosite RF COMMUNICATIONS EQUIPMENT AND THIS Device The device is intended for use in an electromagnetic environment in which radiated RF distur bances are controlled The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communica tions equipment transmitters and this device as recommended below according to the maxi mum output power of the communications equipment SEPARATION DisrANcE ACCORDING TO FREQUENCY OF TRANSMITTER 150 kHz To 80 MHz 80 MHz ro 800 MHz 800 MHz ro 2 5 GHz d 1 2P d 1 2P d 2 3 JP RATED Maximum Power OUuUTPUT OF 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 ap plies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is af fected by absorptio
24. en from the Patient Setup menu see Section 4 3 4 2 2 2 C FLEx 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 QC Flex Setting 7 FLEX comfort has been disabled on this unit Figure 4 5 C FLex DISABLED SCREEN REMstar Pius M Series User MANUAL 4 3 CHANGING THE Device SETTINGS You can view the set pressure on the Active Display screen and the following information on the Patient Data screens Therapy usage hours Number of sessions greater than 4 hours Additionally you can view and modify the following settings on the Patient Setup screens C Flex if enabled by your home care provider Altitude Ramp starting pressure if enabled by your home care provider e Mask alert enable disable e Auto off enable disable 4 3 1 NAVIGATING THE DISPLAY SCREENS Use the button to navigate to the next screen and the lt button to navigate to the previous screen Use the and buttons to adjust the settings on the Patient Setup screens 4 3 1 1 ViEWiNG DATA ON THE PATIENT DATA SCREENS Figure 4 6 shows how to navigate the Patient Data screens fe lt Press Press gt J RESPIRONICS y t FOSQ Setup Sessins gt 4 lt Therapy Usage gt 7 Days 5 Sessions o Hrs Night 30 Days 8 Se
25. en 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 REMstar Pius M Series User MANUAL 2 2 REAR PANEL Accessory Slot Filter Area Figure 2 4 Rear PANEL The rear panel contains the following 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 Theair outlet port where the breathing circuit s flexible tubing is attached REMstar Pius M Series User MANUAL 2 3 2 4 REMstar Pius M Series User MANUAL CHAPTER 3 SETUP This chapter provides instructions on how to Install the air filters Dosition 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 opera tion 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
26. en 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 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 REMstar Pius M Series User MANUAL 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 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 prevent the device from falling off your nighstand or table Figure 3 8 RECOMMENDED DEVICE AND TUBING PLACEMENT REMstar Pius M Series User MANUAL 3 7 3 8 REMstar Pius 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 sh
27. equired 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 fea ture still does not work check the CPAP setting on your Active Display screen If CPAP is set to the minimum setting 4 0 cm H O the Ramp feature will not work 5 5 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 Whar ro Do Always make sure your device is placed on a hard flat surface so the rubber 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 hos
28. evel 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 lock or disable C Flex IfC Hexis 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 that C Flex is disabled Altitude Setting Screen This screen allows you to modify the altitude adjustment setting Press the or buttons to increase or decrease the setting by increments of 1 1 lessthan 2500 ft 762 m e 2 2500to 5000 ft 762 m to 1524 m e 32 5001 to 7500 ft 1525 m to 2286 m Note Elevations over 7500 ft 2286 m may affect the accuracy of the pressure Warning Ifyou incorrectly set the manual altitude setting the pressure may be too high or too low depending on your location 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 wi
29. f 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 of the 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 Whar 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 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 pr
30. here This button allows you to change the C Flex comfort setting if C Flex is prescribed for you See Chapter 4 for more information about C Flex Display Screen Shows therapy settings patient data instructions and error messages Filter Area Medical Equipment Note 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 For ease at airport security stations there is a note on the bottom 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 REMstar Pius M Series User MANUAL 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 e An exhalation device to vent exhaled air from the circuit Patient Interface Exhalation Device Exhalation ees EE Port Circuit Flex
31. ible Tubing Tubing Connector Nee Circuit with Separate Circuit with Mask with Exhalation Device Integrated Exhalation Port Figure 1 4 TypicAL BREATHING CIRCUITS 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 REMstar Pius M Series User MANUAL 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 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 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 Pat
32. ient 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 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 Pius M Series User MANUAL 1 6 Symesor KEY The following symbols appear on the device and power supply SYMBOL DEFINITION Cla Consult accompanying instructions for use ENG DC Power Type BF Applied Part m Class Il Double Insulated IPX1 Drip Proof Equipment Electrostatic Discharge Ata C European Declaration of Conformity 0123 G B Canadian US Certification Cc US Notified Body Approval for Standards Compliance L N TUV Safety Standard Compliance cm US UL Recognized for Canada and the United States No User Serviceable Parts REMstar Pius M Series User MANUAL 1 9 1 7 How ro Contact REsPIRONICS To have your device serviced contact your home care provider If you need
33. ired 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 REMstar Pius 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 Plus 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 enclosure 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 dir
34. isk of fire Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame REMstar Pius M Series User MANUAL 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 anaesthetic 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 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 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 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 invalid
35. l CISPR 11 establishments including domestic Eiamienicamissans establishments and those directly IEC 61000 3 2 connected to the public low voltage Voltage fluctuations Flicker Complies power UPPI TENNOR emissions IEC 61000 3 3 REMstar Pius M Series User MANUAL A 1 A 2 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 interruptions and voltage variations on power supply input lines IEC 61000 4 11 IEC 60601 Test LEVEL 6 kV contact 8 kV air 2 kV for power sup ply lines 1 kV for input out put 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 6 kV contact 8 kV air 2 kV for supply mains 1 kV for input out put 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 ELECTROMAGNETIC ENVIRONMENT GU
36. lay buttons to clear the alarm Make sure your mask is on properly before you press the b 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 b button toturn 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 you apply power to the device The audible indicator does not sound and the backlights on the buttons do not light There s no power atthe outlet or the device is un plugged The device does not op There may be a erate when you press the problem with the b button The airflow blower does not turn on
37. leaned filter REMstar Pius M Series User MANUAL 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 Plus 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 REMstar Pius M Series User MANUAL 7 3 7 4 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 Plus 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 ai
38. ll not display if your provider has not en abled Ramp on your device REMstar Pius M Series User MANUAL 5 Mask Alert Feature ON lt Auto Off gt 6 Feature ON 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 then the words Mask Leak appear on the Active display screen if a signifi cant 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 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 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 REMstar Pius M Series User MANUAL 4 9 4 4 COMPLETING THE FOSQ QUESTIONNAIRE Note The FOSQ option only appears on the Standby screen if a SmartCard is inserted
39. n and reflection from structures objects and people REMstar Pius 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 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 give
40. ofessional 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 Pius M Series User MANUAL CHAPTER 6 ACCESSORIES Contact your home care provider for additional information on the accessories available for your REMstar Plus 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 Passover 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 Plus M Series device Caution For safe operation the humidifier must always be positioned below the breathing circuit connection at the mask The humidifier must be level for proper operation Humidifer without Device Humidifer Device Attached Figure 6 1 HUMIDIFIER ALONE AND ATTACHED TO THE DEVICE Refer to the humidifier s instructions for complete setup information REMstar Pius M Series User MANUAL 6 1 6 2 USING THE SMARTCARD Some REMstar Plus M Series systems come with a
41. or allow any liquid to enter the enclosure or the inlet filter 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 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 thera
42. own in Figure 4 1 9 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 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 in structions on how to navigate the display screens e RESPIRONICS FOSQ Setup FIGURE 4 2 STANDBY SCREEN Note The FOSQ option only appears if a SmartCard is inserted or a modem is con nected to the device REMstar Pius M Series User MANUAL 4 1 3 Press the b button to turn on the airflow The Active Display screen appears shown in Figure 4 3 lt TO sao Figure 4 3 Active DisPLAv WITH SMARTCARD The Active Display screen shows the set pressure Symbols also appear on the Active Display screen or Standby screen to indicate when certain conditions are turned on or detected These symbols are described below SYMBOL DESCRIPTION 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
43. 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 e Additionally the backlights on the buttons will provide a medium priority flashing pattern consisting of a continuous bright to dim one flash pattern indicated in the following table as 0 9 REMstar Pius M Series User MANUAL 5 1 ALERT SUMMARY TABLE The following table summarizes the high and medium priority alerts VISUAL INDICATOR AUDIBLE INDICATOR ALERT System Error Backlights 00 00 00 Screen displays the following message Service Required SmartCard Error Backlights o 9 9 Screen displays the following flashing error symbol 5 2 Device AcTIoN PossIBLE 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 device to remove power Plug the cord back into the devices power inlet to restore power If the alert continues to occur contact your home care provider Remove the Sma
44. py 1 4 REMstar Pius M Series User MANUAL 1 amp System Overview The REMstar Plus 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 feature 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 Plus M Series device Contact your home care provider to purchase any accessories not included with your system Figure 1 2 REMstar Putus M Series Device REMstar Pius M Series User MANUAL 1 5 Figure 1 3 illustrates many of the device features described in the table below Start Stop Ramp Button Button C Flex Button Equipment Note on bottom Display Screen under door Power Inlet Air Outlet Filter Area Accessory Module Figure 1 3 System Overview Device FEATURE Accessory Module C Flex Button DESCRIPTION If applicable insert optional accessory module here Connect the flexible tubing
45. r outlet port Remove the Device From the Humidifier 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 currently using a different power cord or an international plug adaptor may be required to make your power cord compatible with the power outlets of the country to which you are traveling Contact your home care provider for additional information REMstar Pius 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 RELATIVE HUMIDITY 15 to 95 non condensing 15 to 95 non condensing ATMOSPHERIC PRESSURE 77 to 101kPa 0 7500 ft N A PHYSICAL Dimensions 7 5 Lx 5 0 W x 3 125 H 19 x 127 x 7 9 cm Weight Approximately 2 2 Ibs 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
46. ries 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 O 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 auto matically monitors performance Your home care provider did not prescribe Ramp for you or your CPAP pressure is already set to the mini mum setting REMstar Pius M Series User MANUAL Whar ro Do 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 pre scribed therapy throughout the night If there is a possibility of damage to the device the device will shut down permanently The prod uct will then display the following system error alert to indicate that the device be returned to the home care provider for service Service R
47. rocedures Warning Route the wires to avoid tripping Warning This device is activated when the power cord is connected Pressing the b button turns the airflow on or off Important Ifyou are using your device with a humidifier refer to the Quickstart Guide included with your device or the instructions included with your humidifier for details on how to power the device and humidifier 3 4 1 Usiuc 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 Conp 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 connector into the power inlet on the back of the device as shown in Figure 3 6 REMstar Pius M Series User MANUAL 3 5 FiGURE 3 6 CONNECTING THE Power SUPPLY Conp 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 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 wh
48. rtCard 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 Pius M Series User MANUAL ALERT AUDIBLE INDICATOR I Patient Reminder VISUAL INDICATOR Backlights 0 9 9 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 0 9 9 Screen displays a customized reminder message whenever the de vice transitions from the Active state to the Standby state REMstar Pius 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 a mask disconnect is detected The device continues to operate PossiBLE CAUSE The breathing circuit is discon nected or there is alarge 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 disp
49. s 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
50. ssions sO Day pod 2 dE RN ond Figure 4 6 NAVIGATING THE PATIENT DATA SCREENS REMstar Pius M Series User MANUAL 4 5 4 6 Press the button to scroll forward through the data screens or press the 4 button to scroll through the screens in the reverse order The Patient Data screens are described below eT RESPIRONICS FOSQ Setup a Therapy Usage io Hrs Night 7 Day Avg 5 00 30 Day Avg 8 00 lt Sessions gt 4 5 Sessions 8 Sessions 7 Days 30 Days 1 Standby Screen The Standby screen appears when you first apply power to the device You can access the Patient Data menu from this screen by pressing the or buttons Note You can also access the Patient Setup screens by pressing the button and the FOSQ questionnaire by pressing the button 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 Therapy Usage Screen This screen displays the number of hours that the device provided therapy as 7 day and 30 day averages The maximum value that can be displayed for both averages is 24 hours Note This screen is only for reference Your home care provider may periodically ask you for this information Sessions Greater than 4 Hours Screen This screen displays the number of device therapy sessions that exceeded 4 hours in 7 day and 30 da
51. 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 Pius 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 shows the three primary control buttons on the REMstar Plus M Series device eoo Figure 2 1 Primary CoNTRoL BUTTONS These buttons are described below BurroN DESCRIPTION Ramp When the airflow is on this button allows you to A 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 C 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 and stop therapy and do not need to use the display buttons lo cated under the device cover door
52. ts 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 1 83 m 6 ft 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 REMstar Pius M Series User MANUAL 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 that 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 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
53. ty DO NOT clean the ultra fine filter Caution Dirty inlet filters may cause high operating temperatures that may affect device performance Regularly examine the inlet filters as needed for integ rity and cleanliness 1 Ifthe device is operating stop the airflow by pressing the l button Disconnect the device from the power source 2 Remove the filter s from the enclosure by gently squeezing the filter in the center and pull ing it away from the device as shown in Figure 7 1 REMstar Pius M Series User MANUAL 7 1 7 2 FiGURE 7 1 REMOVING THE FILTERS 3 Examine the filter s for cleanliness and integrity 4 Wash the gray foam filter in warm water with a mild detergent Rinse thoroughly to remove all detergent residue Allow the filter to air dry completely before reinstalling it If the foam filter is torn replace it Only Respironics supplied filters should be used as replacement filters 5 If the white ultra fine filter is dirty or torn replace it 6 Reinstall the filters inserting the white ultra fine filter first if applicable as shown in Figure 7 2 Filter Area Disposable Ultra Fine Reusable Gray Filter optional Foam Filter required Ficure 7 2 REINSTALLING THE FILTERS Caution Never install a wet filter into the device It is recommended that you clean the filter in the morning and alternate using the two foam filters provided with the system to ensure sufficient drying time for the c
54. urposes within IRS rules Membership includes a free medical alert necklace or bracelet ____1 would like to become a member of the ASAA Please send me a free medical alert braceletor necklace lam undecided but please send me a free copy of the newsletter _____ would like to know if there is an A W A K E group near me PLEASE SEND TO American Sleep Apnea Association AMERICA 1424 K Street NW Suite 302 Washington D C 20005 L E E N P A P N E N Respironics Inc provided a grant to and is recognized as a founding sponsor of the American Sleep Apnea Association As a non profit organization the American Sleep Apnea Association does not endorse or recommend any company or product ASSOCIATIO For addresses outside the United States the minimum contribution is U S 50 00 Join the American Sleep Apnea Association As a member of the American Sleep Apnea Association you will receive a newsletter WAKE UP CALL six times each year This newsletter will inform you about the latest in medical advances new technology human interest stories of individual accomplishment home care tips and legislative affairs Also you will receive a medical alert identification bracelet AMERICAN You are also invited to participate in the A W A K E Alert Well And Keeping Energetic Network which Is L E E P is a nationwide system of local mutual help support groups A W A K E meetings provide the opportunity ES EE E
55. y 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 REMstar Pius M Series User MANUAL 4 3 1 2 VIEWING AND MobpirviNG PATIENT SETUP SCREENS Figure 4 7 shows how to navigate the Patient Setup screens 6 RESPIRONICS FOSQ Setup Press re gt Press lt C Flex Setting Press gt lt P 123 CN lt autoof lt Altitude Feature ON 1 3 gt Mask Alert Ramp Start Pres Feature ON 4 0 cmH20 Feen d FicunE 4 7 NAVIGATING THE PATIENT SETUP SCREENS REMstar Pius M Series User MANUAL The Patient Setup screens are described below 4 8 e RESPIRONICS FOSQ Setup C Flex Setting gt 123 C Flex Setting 2 FLEX comfort has been disabled on this unit gt Altitude i 123 lt gt Ramp Start Pres 4 0 cmH20 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 gt or buttons to cycle through the screens C Flex Setting Screen This screen displays the C Flex l

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