Respironics M SeRieS, User Manual

Page 1: ...1016511 JR 7 21 06 USER Manual ...

Page 2: ...________________________ Telephone Number _________________________________________ Health Care Professional _____________________________________ Telephone Number _________________________________________ Respironics Inc 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 8550 USA Customer Service Telephone Number 1 800 345 6443 US and Canada or 1 724 387 4000 The BiPAP Plus M Series with Bi Fle...

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Page 4: ...nto the power supply then plug the power cord into an electrical outlet Plug the power supply cord connector into the device Press the button to begin therapy Attach the tubing to the optional swivel and attach the swivel to the device s air outlet Or attach the tubing directly to the air outlet ...

Page 5: ...cord connector into the device Attach the tubing to the optional swivel and attach the swivel to the device s air outlet Or attach the tubing directly to the air outlet Lift the humidifier door to access the water tank Fill the tank with water until it reaches the fill line Place the water tank back in the humidifier Press the button to begin therapy Turn the humidifier knob to the desired setting...

Page 6: ...Final system setup for the device Final system setup for the device and humidifier ...

Page 7: ...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 4 1 Available Therapies 4 1 4 2 Sta...

Page 8: ...apter 5 Device Alerts and Troubleshooting 5 1 5 1 Device Alerts 5 1 5 2 Troubleshooting 5 3 Chapter 6 Accessories 6 1 6 1 Adding a Humidifier 6 1 6 2 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 3 7 5 1 International Travel 7 4 C...

Page 9: ...Series system includes the following items Flexible Tubing Reusable Gray Foam Filter Disposable Ultra fine Filter Power Supply AC Power Cord Carrying Case User Manual B i F le x BiPAP Plus M Series Device 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 No...

Page 10: ...rding the use of the device The operator should read and understand this entire manual before using the device 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 ...

Page 11: ...making unusual 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 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 Period...

Page 12: ...ad 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 bypassed Contact your physician if you have any questions concerning your therapy 1 4 System Overview The BiPAP Plus M Series system offers several options in ...

Page 13: ...ies the accuracy of patient reported therapy data The CheckValue is based on therapy hours hours of patient use and sessions 4 EPAP Expiratory Positive Airway Pressure IPAP Inspiratory Positive Airway Pressure LPM Liters Per Minute OSA Obstructive Sleep Apnea Patient Data Menu The display mode in which you can view certain stored information such as therapy usage hours Patient Setup Menu The displ...

Page 14: ...formity Canadian US Safety Certification Notified Body Approval for Standards Compliance TUV Safety Standard Compliance UL Recognized for Canada and the United States No User Serviceable Parts 1 7 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...

Page 15: ...flow and places the device in Standby You can also press this button to exit any setting screen Bi Flex Bi Flex This button adjusts the Bi 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 sho...

Page 16: ...nel Inactivity Some screens have time out periods The screen s timer starts when the screen is initially displayed and is restarted whenever a button is pressed The screen times out after one minute if there is no activity and returns to the Standby screen 2 2 Rear Panel Figure 2 4 shows the device s rear panel without a humidifier Air Outlet Port Filter Area DC Power Inlet Figure 2 4 Rear Panel T...

Page 17: ...ice is operating The white ultra fine filter is recommended for people who are sensitive to tobacco smoke or other small particles Two reusable gray foam filters and one disposable white ultra fine filter are supplied with the device If your filters are not already installed when you receive your device you must at least install the reusable gray foam filter before using the device To install the ...

Page 18: ...t or Respironics interface with a separate exhalation device such as the Whisper Swivel II Respironics 6 ft 1 83 m flexible tubing with optional swivel Respironics headgear for the patient interface Warning If the device is used by multiple persons e g rental devices a low resistance main flow bacteria filter shown in figure 3 2 should be installed in line between the device and the circuit tubing...

Page 19: ...he 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 connector to the exhalation device Figure 3 4 Connecting a Mask 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 not block or seal ...

Page 20: ... the airflow on or off Important If you 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 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...

Page 21: ...ack can be used to operate this device in a stationary recreational vehicle boat or motor home The Respironics DC Battery Adapter Cable when used with the DC Power Cord enables the device to be operated from a 12 VDC free standing battery Caution When DC power is obtained from a vehicle battery the device should not be used while the vehicle s engine is running Damage to the vehicle or the device ...

Page 22: ...al 3 5 Complete Assembly Example Figure 3 7 shows an example of how a complete assembly will look with breathing circuit con nected and power applied to the device Figure 3 7 Final Assembly Example Shown with Optional Accessory Module ...

Page 23: ...sure to the therapeutic pressure setting so that you can fall asleep more comfortably Bi level with Bi Flex Bi level therapy with pressure relief upon exhalation to improve patient comfort based on patient needs 4 2 Starting the Device 1 Plug the device in to an AC or DC power source The three primary buttons light up and the Software Version screen momentarily appears shown in Figure 4 1 V 1 0 Fi...

Page 24: ...ssure Mask Alert Mask Leak Alert This flashing text displays on the Active Display screen if the Mask Alert setting is enabled and the device detects an excessive mask leak Auto Off Auto Off This flashing text displays on the Standby screen if the Auto Off setting is enabled and the device detects a mask disconnect 4 Put on your mask assembly when the air starts to flow 5 Make sure that no air is ...

Page 25: ...will happen when you press the button 4 3 2 Bi Flex Comfort Feature The Bi Flex comfort feature allows you to adjust the level of air pressure relief that you feel when you exhale during therapy Your home care provider can enable or disable this feature 4 3 2 1 Bi Flex Enabled When your provider enables Bi Flex a Bi Flex level will already be set for you on the device If this is not comfortable fo...

Page 26: ...ng settings 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 Bi Flex if enabled by your home care provider Rise Time if Bi flex is disabled Ramp starting pressure if enabled by your home care provider Mask alert enable disable Auto off ...

Page 27: ...later in this chapter 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 both averages is 24 hours Note This screen is only for reference Your home care provider may periodically ask you for this information 7 Days 5 Sessions ...

Page 28: ...by the home care provider This is a read only screen and you cannot change the numbers on the screen 4 4 1 2 Viewing and Modifying Patient Setup Screens Figure 4 7 shows how to navigate the Patient Setup screens 4 0 cmH2O 1 2 3 Press Press Press Setup Bi Flex Setting Ramp Start Pres Mask Alert Feature ON Auto Off Feature ON off 1 2 3 Rise Comfort Figure 4 7 Navigating the Patient Setup Screens The...

Page 29: ...dify the Rise Comfort Setting by 1 when either the or button is touched This is only available if Bi Flex has been disabled If Bi Flex is disabled and the RiseTime setting is not comfortable for you you can increase or decrease the setting by pressing the or buttons Note The rise time settings of off and 1 are functional only when the pressure change between IPAP and EPAP is 8 cm H2 O Atpressuredi...

Page 30: ...er 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 or If you do not acknowledge the message wit...

Page 31: ...ontinuous 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 operator response The alert signal consists of a medium priority sound which is a continuous one beep pattern indica...

Page 32: ...k 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 Auto Off None ThewordsAuto Off flash on the Standby screen indicating that a mask disconnect has been detected The airflow shuts off and the device enters the Standby state approximately 45 60 seconds af...

Page 33: ...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 The device does not operate when you press the button The airflow does not turn on There may be a problem with the blower Make sure the device is powered correctly following the instructions...

Page 34: ...he Ramp feature will not work The device has fallen off your table or nightstand The device may not have been properly seated on the nightstand or the placement of the tubing may have caused the device to fall Always make sure your device is placed on a hard flat surface so the feet on the bottom of the device can adhere to the surface make sure there is no fabric under the device The device and h...

Page 35: ...tom 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 b Push the top of the port down to snap it into place Reattach your tubing turn on the airflow and check to make sure you do not still feel air comi...

Page 36: ...the problem continues contact your home care provider You have a runny nose This is caused by a nasal reaction to the airflow Call your health care professional You have throat or nose dryness The air is too dry Increase the room humidity Consult with your health care professional about using a Respironics humidifier with the device If you have a humidifier refer to the instructions included with ...

Page 37: ...lable 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 BiPAP Plus M Series device Caution For safe operation the humidifier must always be positioned below the breathing circuit connection at the mask and the air outlet on the device The humidifier...

Page 38: ...ce 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 oxyge...

Page 39: ...he 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 Th...

Page 40: ...ing 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 Filter optional Reusable Gray Foam Filter required Figure 7 2 Reinstalling the Filt...

Page 41: ...rovider 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 th...

Page 42: ...vice 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 ...

Page 43: ...llowing 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 again...

Page 44: ...ynamic pressure accuracy is measured at the patient end of the circuit with a Whisper Swivel II and varying flow conditions Rise time settings are adjustable by the patient and the provider from 0 off to 3 Rise time varies from 150 msec to 400msec dependent on patient setting and the pressure differential from IPAP to EPAP The rise time settings of off and 1 are functional only when the pressure c...

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 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 k...

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

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...