Respironics REMstar Plus, User Manual

Page 1: ...1050655 JR 1 22 08 EN DOM REMstar Plus M Series ...

Page 2: ...____________________ located on the bottom of the device System Prescribed for __________________________________________ Date of Purchase or Rental ______________________________________ Pressure Setting _____ cm H2 O Mask Type __________________________________________________ Mask Size ___________________________________________________ If you have any questions concerning the system contact Ho...

Page 3: ... Device Controls and Displays 2 1 2 1 Controls and Displays 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...

Page 4: ...10 Chapter 5 Alerts and Troubleshooting 5 1 5 1 Device Alerts 5 1 5 2 Troubleshooting 5 4 Chapter 6 Accessories 6 1 6 1 Adding a Humidifier 6 1 6 2 Using the SmartCard 6 2 6 3 Adding Supplemental Oxygen 6 2 Warnings 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 2 7 4 Service 7 2 7 5 Traveling with the Syst...

Page 5: ...ents Your REMstar Plus 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 F le x 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 information N...

Page 6: ...r 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 wit...

Page 7: ... 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 Repairs and adjustments must be performed by Respironics authorized service personnel only Unauthorized service could cause injury invalidate the warranty or result in costly damage Periodically inspect electrical cords cables and the power supply for ...

Page 8: ...using this equipment the clinician should understand that this device can deliver pressures up to 20 cm H2 O In the event of certain fault conditions a maximum pressure of 30 cm H2 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 Pneum...

Page 9: ...e 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 F...

Page 10: ...take this manual with you when you travel Power Inlet Connect the power cord here Ramp Button This button starts or restarts the ramp cycle Start Stop Button This button starts or stops the airflow 1 4 1 Breathing Circuit Overview The patient breathing circuit shown in Figure 1 4 consists of the following Circuit tubing to deliver air from the device to your interface e g mask A mask or other pati...

Page 11: ...ta CPAP Continuous Positive Airway Pressure FOSQ Functional Outcomes of Sleep Questionnaire A quality of life ques tionnaire designed specifically for people with sleep disorders The results allow health care professionals to assess how CPAP therapy has improved the quality of their patients lives LPM Liters Per Minute OSA Obstructive Sleep Apnea Patient Data Menu The display mode in which you can...

Page 12: ... Certification TUV Safety Standard Compliance UL Recognized for Canada and the United States No User Serviceable Parts 1 7 How to Contact Respironics To have your device serviced contact your home care provider If you need to contact Respironics directly call the Respironics Customer Service department at 1 800 345 6443 or 1 724 387 4000 You can also use the following address Respironics 1001 Murr...

Page 13: ... 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 located under the device cover door Figure 2 2 shows the device display and navigation buttons...

Page 14: ...n 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 Plus M Series device s rear panel without a humidifier Air Outlet Port Accessory Slot Filter Area DC Power Inlet Figure 2 4 Rear Panel The rear panel contains the following An ac...

Page 15: ...er 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 If you are using the white disposable...

Page 16: ...cs interface e g nasal mask with integrated exhalation port or Respironics interface with a separate exhalation device such as the Whisper Swivel II Respironics 1 83 m 6 ft 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 should be installed in line between the device and t...

Page 17: ...exhalation device so that the vented air is blowing away from your face Connect the mask s connector 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 ...

Page 18: ...u 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 prong...

Page 19: ...r 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 U...

Page 20: ...d and power applied to the device Figure 3 7 Final Assembly Example Shown with Optional Accessory Module 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 ...

Page 21: ...1 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 instructions on how to navigate the display screens FOSQ Setup Figure 4 ...

Page 22: ...reen if the Auto 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 Modem This symbol appears if a modem is connected to the device Note This symbol will vary in appearance depending on the type of modem being used 4 Put on your mask as...

Page 23: ...thing will happen when you press the button 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 f...

Page 24: ...e Display screen and the following information on the Patient Data screens Therapy usage hours Number of sessions greater than 4 hours Compliance check value Summary Data 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 Mask alert enable disable...

Page 25: ...OSQ 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 7 Day Avg 5 00 30 Day Avg 8 00 Hrs Night 2 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 ...

Page 26: ...he total therapy hours for the device the total blower hours and the total number of sessions greater than 4 hours since the device was last reset by the home care provider This is a read only screen and you cannot change the numbers on the screen Note This screen is only for reference Your home care provider may periodically ask you for this information 4 3 1 2 Viewing and Modifying Patient Setup...

Page 27: ...higher numbers providing additional relief Press the or buttons to increase or decrease the setting If your provider has disabled C Flex you cannot enable or ad just the setting The screen shown at left displays to indicate that C Flex is disabled 1 2 3 Altitude 3 Altitude Setting Screen This screen allows you to modify the altitude adjustment setting Press the or buttons to increase or decrease t...

Page 28: ...Setup menu automatically times out and returns to the Standby screen after one minute of inactivity 4 4 Completing the FOSQ Questionnaire Note The FOSQ option only appears on the Standby screen if a SmartCard is inserted 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 designe...

Page 29: ...o access the first FOSQ screen shown in Figure 4 8 0 1 2 3 4 FOSQ 1 30 Figure 4 8 FOSQ Screen 1 of 30 Press the or button to select your answer to the first question and an arrow appears over your answer 0 indicates that you choose 0 as the answer to the question 1 indicates that you choose 1 as the answer to the question 2 indicates that you choose 2 as the answer 3 indicates that you choose 3 as...

Page 30: ... buttons 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...

Page 31: ...ntinuous 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 ...

Page 32: ... the 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 ...

Page 33: ... a 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 Activ...

Page 34: ... 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 foll...

Page 35: ...roubleshooting software that auto matically monitors performance 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 pro...

Page 36: ... 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 plac...

Page 37: ...ice 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 wit...

Page 38: ...nificant air leakage around the mask or you experience other mask related issues This could be due to improper head gear adjustment or improper 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 airf...

Page 39: ...afe operation the humidifier must always be positioned below the breathing circuit connection at the mask The humidifier must be level for proper operation Refer to the humidifier s instructions for complete setup information 6 2 Using the SmartCard Some REMstar Plus M Series systems come with a SmartCard accessory module installed in the accessory slot on the back of the device to record informat...

Page 40: ...and the oxygen container away from heat open flames any oily substance or other sources of ignition Do not smoke in the area near the device or the oxygen When using oxygen with this system turn the device on before turning on the oxygen Turn the oxygen off before turning the device off This will prevent oxygen accumulation in the device If administering fixed flow supplemental oxygen the oxygen c...

Page 41: ...ears dirty DO NOT clean the ultra fine filter Caution Dirtyinletfiltersmaycausehighoperatingtemperaturesthatmayaffectdevice performance Regularlyexaminetheinletfiltersasneededforintegrityand cleanliness 1 If the device is operating stop the airflow by pressing the button Disconnect the device from the power source 2 Remove the filter s from the enclosure by gently squeezing the filter in the cente...

Page 42: ... 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 ...

Page 43: ...e following standards IEC 60601 1 General Requirements for Safety of Medical Electrical Equipment EN ISO 17510 1 Sleep Apnea Breathing Therapy Devices Electrical AC Power Consumption 100 240 VAC 50 60 Hz 1 0 A max DC Power Consumption 12 VDC 3 0 A max Type of Protection Against Electric Shock Class II Equipment Degree of Protection Against Electric Shock Type BF Applied Part Degree of Protection a...

Page 44: ...0 to 20 cm 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 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 23 C 2 C 50 RH 5 Disposal Dispose of the device in accordance with local regulations ...

Page 45: ...ct 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 fast Transient 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 typi cal home or hospital environment Surge IEC 61000 4 5 1...

Page 46: ...To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or...

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