Respironics REMstar, User Manual

Page 1: ...1058374 JR 3 05 2009 EN DOM REMstar M Series with SmartCard ...

Page 2: ...____ cm H2 O Mask Type __________________________________________________ Mask Size ___________________________________________________ If you have any questions concerning the system contact Home Care Company _______________________________________ Telephone Number _________________________________________ Health Care Professional _____________________________________ Telephone Number ___________...

Page 3: ...2 1 2 1 1 Control Panel Inactivity 2 2 2 2 Rear Panel 2 2 Chapter 3 Setup 3 1 3 1 Installing the Air Filters 3 1 3 2 Where to Place the Device 3 2 3 3 Connecting the Breathing Circuit 3 2 3 4 Supplying Power to the Device 3 4 3 4 1 Using AC Power 3 4 3 4 2 Using DC Power 3 5 3 5 Complete Assembly Example 3 6 Chapter 4 Device Operation 4 1 4 1 Starting the Device 4 1 4 2 Using the Ramp Feature 4 2 ...

Page 4: ... Adding Supplemental Oxygen 6 2 Chapter 7 Cleaning and Maintenance 7 1 7 1 Cleaning the Device 7 1 7 2 Cleaning or Replacing the Filters 7 1 7 3 Cleaning the Tubing 7 3 7 4 Service 7 3 7 5 Traveling with the System 7 4 7 5 1 International Travel 7 4 Chapter 8 Specifications 8 1 Environmental 8 1 Physical 8 1 Standards Compliance 8 1 Electrical 8 1 Pressure 8 2 Disposal 8 2 Appendix A EMC Informati...

Page 5: ...r REMstar M Series system includes the following items Device Flexible Tubing Reusable Gray Foam Filter Disposable Ultra fine Filter Power Supply AC Power Cord Carrying Case User Manual 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 a...

Page 6: ... 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 ...

Page 7: ... incorrect elevation setting could result in airflow pressures higher than the prescribed setting Always verify the elevation setting when traveling or relocating Pins of connectors identified with the ESD warning symbol 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 ...

Page 8: ...iform 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 System Overview The REMstar M Series devi...

Page 9: ...een Shows therapy settings and patient data 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 medic...

Page 10: ...ze the potential for CO2 rebreathing 1 5 Glossary The following terms and acronyms appear throughout this manual Term Acronym Definition Active State The state of the device when power is applied the airflow is on and the device is capable of providing therapy Apnea A condition marked by the cessation of spontaneous breathing Auto Off When this feature is enabled the device automatically discontin...

Page 11: ...eases the pressure to the prescription setting so patients can fall asleep more comfortably Safe State The state in which the device does not provide therapy The device enters this state if a fault is detected Standby State The state of the device when power is applied but the airflow is turned off Therapy Hours The total amount of time that the blower is on and patient breathing is detected 1 6 S...

Page 12: ...e 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 ...

Page 13: ...device in Standby You can also press this button to exit any setting screen If you do not want to modify the settings that your home care provider has set for you you only need these two buttons to start and stop therapy and do not need to use the display buttons located under the device cover door Figure 2 2 shows the device display and navigation buttons that are under the cover door FOSQ Setup ...

Page 14: ...imer 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 Figure 2 4 shows the REMstar M Series device s rear panel without a humidifier Figure 2 4 Rear Panel The rear panel contains the following An accessory slot for optional accessories such as th...

Page 15: ...ble filter must be in place at all times when the device is operating The ultra fine filter is recom mended 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 filt...

Page 16: ...er 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 II Respironics 6 ft 1 83 m flexible tubing 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 sho...

Page 17: ...lation 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 CO2 from the patient circuit Do ...

Page 18: ...are using your device with a humidifier refer to the instructions included with your humidifier for details on how to power the device and humidifier 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...

Page 19: ... motor home The Respironics DC Battery Adapter Cable when used with the DC Power Cord enables the device to be operated from a 12 VDC free standing battery Caution When DC power is obtained from a vehicle battery the device should not be used while the vehicle s engine is running Damage to the vehicle or the device may occur Caution Only use a Respironics DC Power Cord and Battery Adapter Cable Us...

Page 20: ...rcuit con nected and power applied to the device Figure 3 7 Final Assembly Example Figure 3 8 shows an example of how you should route your tubing and situate your device on your night stand for the best setup possible This will help prevent the device from falling off your night stand or table Figure 3 8 Recommended Device and Tubing Placement ...

Page 21: ...vice 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 instructions on how to navigate the display screens FOSQ Setup Figure 4 2 Standby Screen Note The FOSQ option only appears if a SmartCard is inserted or a modem is connected...

Page 22: ...r 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 d...

Page 23: ...p starting pressure if enabled by your home care provider Mask alert enable disable Auto off enable disable 4 3 1 Navigating the Display Screens Use the button to navigate to the next screen and the button to navigate to the previous screen Use the and buttons to adjust the settings on the Patient Setup screens 4 3 1 1 Viewing Data on the Patient Data Screens Figure 4 4 shows how to navigate the P...

Page 24: ...ns 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 4 Compliance CheckValue Screen This...

Page 25: ...eriodically ask you for this information 4 3 1 2 Viewing and Modifying Patient Setup Screens Figure 4 5 shows how to navigate the Patient Setup screens Press Press Press 1 2 3 4 0 cmH2O FOSQ Setup Altitude Ramp Start Pres Mask Alert Auto Off Feature ON Feature ON Figure 4 5 Navigating the Patient Setup Screens The Patient Setup screens are described below FOSQ Setup 1 Standby Screen The Standby sc...

Page 26: ...t Feature ON 4 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 If your physician indicates that the Mask Alert is neces sary for you do not disable it Auto Off Feature ON 5 ...

Page 27: ...esent 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 ...

Page 28: ...ttons or If you do not acknowledge the message within six minutes of it appearing on the screen it will time out and disappear The message will continue to display for three consecutive days whenever the device transitions from Active to Standby until it is acknowledged If after three days you still have not acknowledged the message then the reminder period will reset and no more reminders will di...

Page 29: ...nuous two beep pattern indicated in the following table as 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 Medium Priority These alerts require prompt operator response The alert signal consists of a medium priority sound which is a continuous one beep pattern ind...

Page 30: ...e device s power inlet to restore power If the alert continues to occur contact your home care provider SmartCard Error Backlights Screen displays the following flashing error symbol 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 ...

Page 31: ... mask disconnect has been detected The airflow shuts off and the device enters the Standby state approximately 45 60 seconds after a mask disconnect is detected The mask has been removed Put your mask back on and press the button to turn the airflow on and resume therapy Patient Reminder None Backlights Screen displays a customized reminder message whenever the de vice transitions from the Active ...

Page 32: ...ou 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...

Page 33: ...ers TVs electronic games hair dryers etc If the problem still occurs contact your home care provider for assistance Device Resets Reboots The device shuts down and restarts automati cally during therapy This is unlikely to occur The device comes in stalled with trouble shooting software that automatically monitors perfor mance Such a reset poses no danger to the patient and assures that the patien...

Page 34: ...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...

Page 35: ...ce The air outlet port is not installed cor rectly and doesn t seal properly Remove the port and reattach it to make sure it s properly installed To remove the port a Put your thumb underneath the port and insert your index finger into the port opening b 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...

Page 36: ...icant air leak age around the mask or you experience other mask related issues This could be due to improper headgear adjustment or im proper mask fitting etc 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 You have a runny nose This is caused by a nasal reaction to the airflo...

Page 37: ... humidifier must be level for proper operation Refer to your humidifier s instructions for complete setup information 6 2 Using the SmartCard Some REMstar 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 ...

Page 38: ...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 conce...

Page 39: ...leaning 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 nig...

Page 40: ...place it Only Respironics supplied filters should be used as replacement filters 5 If the optional 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 Figure 7 2 Reinstalling the Filters Caution Never install a wet filter into the device It is recommended that you clean the filter in the mornin...

Page 41: ...gent Rinse thoroughly Air dry 7 4 Service The REMstar 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 ...

Page 42: ...e the humidifier home when traveling make sure you attach the air outlet port to your device when you remove the humidifier from the device You need the port to connect the tubing directly to your device Figure 7 3 illustrates how to attach the air outlet port Attach Air Outlet Port to the Device Figure 7 3 Attaching the Air Outlet Port to the Device 7 5 1 International Travel If you are traveling...

Page 43: ...rm 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 Prot...

Page 44: ...H2 O 1 0 cm H2 O Measured in accordance with EN ISO 17510 1 1 3 2 3 and Pmax with BPM set to 10 15 and 20 BPM 68 F 9 F 20 C 5 C 50 RH 5 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 73 F 3 6 F 23 C 2 C 50 RH 5 Disposal Dispose of the device in accordance with local regulations ...

Page 45: ...t 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical FastTransient Burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for supply mains 1 kV for input output lines Mains power quality should be that of a typical home or hospital environment Surge IEC 61000 4 5 1 kV...

Page 46: ...ccuracy 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 orie...

Page 47: ... loss of profits overhead or consequential damages which may be claimed to arise from any sale or use of this product Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you This warranty is given in lieu of all other express warranties In addition any implied warranties including any warranty of merchant...