Respironics REMstar M Series User Manual Download

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8-1

REM

staR

M s

ERiEs

sER

anUal

haptER

8: s

pECifiCations

nviRonMEntal

pERating

toRagE

EMpERatURE

41° F to 95° F

(5° C to 35° C)

-4° F to 140° F

(-20° C to 60° C)

ElativE

UMidity

15 to 95% (non-condensing)

tMosphERiC

REssURE

77 to 101 kPa (0 - 7500 ft.)

N/A

hysiCal

Dimensions:

7.5 in. L x 5.0 in. W x 3.125 in. H (19 x 12.7 x 7.9 cm)

Weight:

Approximately 2.2 lbs. (1 kg) without a humidifier

tandaRds

oMplianCE

This device is designed to conform to the following standards:

– IEC 60601-1 General Requirements for Safety of Medical Electrical Equipment
– EN ISO 17510-1 Sleep Apnea Breathing Therapy Devices

lECtRiCal

AC Power Consumption:

100 – 240 VAC, 50/60 Hz, 1.0 A max.

DC Power Consumption:

12 VDC, 3.0 A max.

Type of Protection Against Electric Shock:

Class II Equipment

Degree of Protection Against Electric Shock: Type BF Applied Part
Degree of Protection Against Ingress of Water: Device: Drip Proof, IPX1

AC Power Supply: (Reorder number 1015642):

Drip Proof, IPX1

Mode of Operation:

Continuous

Electromagnetic Compatibility:

The device meets the requirements of

EN 60601-1-2, 2nd edition.

Fuses:

There are no user-replaceable fuses.

Summary of Contents for REMstar M Series

Page 1: ...1016452 AM 2 09 06 ...

Page 2: ... Purchase or Rental ______________________________________ Pressure Setting _____ cm H2 O Mask Type __________________________________________________ Mask Size ___________________________________________________ If you have any questions concerning the system contact Home Care Company _______________________________________ Telephone Number _________________________________________ Health Care Pr...

Page 3: ...PO BOX 7014 GRAND RAPIDS MN 55744 8029 FIRST CLASS MAIL PERMIT NO 231 GRAND RAPIDS MN C M Y CM MY CY CMY K reply_card1 pdf 9 19 05 10 52 10 AM reply_card1 pdf 9 19 05 10 52 10 AM ...

Page 4: ... you like to receive information regarding new products from Respironics Yes No Product Identification Information Numbers located on the bottom of the device Model Serial Please complete the following or register online at www mseries respironics com If Yes Preferred Method Direct Mail Phone Email C M Y CM MY CY CMY K reply_card2 pdf 9 19 05 11 22 20 AM reply_card2 pdf 9 19 05 11 22 20 AM ...

Page 5: ...free medical alert _____bracelet or _____necklace _____I am undecided but please send me a free copy of the newsletter _____I would like to know if there is an A W A K E group near me PLEASE SEND TO American Sleep Apnea Association 1424 K Street NW Suite 302 Washington D C 20005 Respironics Inc provided a grant to and is recognized as a founding sponsor of the American Sleep Apnea Association As a...

Page 6: ... mutual help support groups A W A K E meetings provide the opportunity to share information and support with others who have been affected by sleep apnea G O A L S To reduce disability and death from Sleep Apnea and other breathing disorders during sleep To improve the clinical care of Sleep Apnea by educating the public and medical profession about the disorder To establish and nurture mutual hel...

Page 7: ... Displays 2 1 2 1 1 Control Panel Inactivity 2 3 2 2 Rear Panel 2 3 Chapter 3 Setup3 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 5 3 4 1 Using AC Power 3 5 3 4 2 Using DC Power 3 6 3 5 Complete Assembly Example 3 7 Chapter 4 Device Operation 4 1 4 1 Starting the Device 4 1 4 2 Using the Ramp Fea...

Page 8: ...mental 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 Information A 1 ...

Page 9: ...s system includes the following items REMstar M Series Device Flexible Tubing Reusable Gray Foam Filter Disposable Ultra fine Filter Power Supply AC Power Cord Carrying Case User Manual Quickstart Guide 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 Not...

Page 10: ...ended 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 ...

Page 11: ...ovider 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 damage or signs of wear Discontinue use and replace if damaged To avoid electric shock unplug the device before cleaning it DO NOT immerse th...

Page 12: ...tive risks and benefits of 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 follow ing pre existing conditions may contraindicate the use of CPAP therapy for some patients Bullous Lung Disease Pathologically Low Blood Pressure...

Page 13: ...el of pres sure throughout the breathing cycle When prescribed for you the device provides a special feature 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 Figure 1 2 REMs...

Page 14: ... Filter Area A reusable gray foam filter must be placed in the filter area to screen out normal household dust and pollens An optional white ultra fine filter can also be used for more complete filtration of very fine particles Medical Equipment Note For ease at airport security stations there is a note on the bottom of the device stating that it is medical equipment It may help if you also take t...

Page 15: ...uth depending on which interface has been prescribed for you An exhalation device to vent exhaled air from the circuit Circuit Tubing Exhalation Device Patient Interface Circuit with Separate Exhalation Device Circuit with Mask with Integrated Exhalation Port Flexible Tubing Connector Mask s Connector Exhalation Port Figure 1 4 Typical Breathing Circuits Note The exhalation port may be part of the...

Page 16: ...l amount of time that the blower has been on LPM Liters Per Minute OSA Obstructive Sleep Apnea Patient Data Mode The display mode in which the patient can view certain stored information such as session count Patient Setup Mode The display mode in which the patient can change patient adjustable device settings such as the ramp starting pressure Ramp A feature that may increase patient comfort when...

Page 17: ...ing instructions for use DC Power Type BF Applied Part Class II Double Insulated IPX1 Drip Proof Equipment Electrostatic Discharge European Declaration of Conformity Canadian US Certification TUV Safety Standard Compliance UL Recognized for Canada and the United States Notified Body Approval for Standards Compli ance No User Serviceable Parts ...

Page 18: ...vice serviced contact your home care provider If you need to contact Respironics directly call the Respironics Customer Service department at 1 800 345 6443 US and Canada only or 1 724 387 4000 You can also use the following address Visit Respironics web site at www respironics com ...

Page 19: ... ramp function Ramp lowers the airflow pressure and then gradually increases it allowing you to fall asleep more easily Start Stop This button starts the device s airflow and places the device in the Active state or stops the airflow and places the device in Standby You can also press this button to exit any setting screen If you do not want to modify the settings that your home care provider has ...

Page 20: ...rease the settings on the patient setup screens Allows you to increase the settings on the patient setup screens The device s display screen shows the prescribed or ramping pressure and patient data See Chap ter 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 Next Screen Bu...

Page 21: ...he Standby screen 2 2 Rear Panel Figure 2 4 shows the REMstar M Series device s rear panel without a humidifier Power Inlet Filter Area Air Outlet Figure 2 4 Rear Panel The rear panel contains the following A filter area where each filter supplied with your device should be inserted A DC power inlet where the power cord is connected see Chapter 3 Setup for complete information on supplying power t...

Page 22: ...2 4 REMstar M Series User Manual ...

Page 23: ...cles The gray reusable filter must be in place at all times when the device is operating The ultra fine filter is recommended for people who are sensitive to tobacco smoke or other small particles Two reusable gray foam filters and one disposable ultra fine filter are supplied with the device If your filters are not already installed when you receive your device you must at least install the reusa...

Page 24: ...work properly Make sure the device is away from any heating or cooling equipment e g forced air vents radiators air conditioners 3 3 Connecting the Breathing Circuit To use the system you will need the following accessories in order to assemble the recommended circuit Respironics interface e g nasal mask with integrated exhalation port or Respironics inter face with a separate exhalation device su...

Page 25: ...emove 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 If you are using a mask with a built in exhalation port connect the mask s connector to the fle...

Page 26: ...lexible 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 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 n...

Page 27: ...you are using your device with a humidifier refer to the Quick Start 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 in Figure 3 5 Figure 3 5 Connectin...

Page 28: ... recreational vehicle boat or motor home The Respironics DC Battery Adapter Cable Reorder Number 532209 when used with the DC Power Cord enables the device to be operated from a 12 VDC free standing battery Caution When DC power is obtained from a vehicle battery the device should not be used while the vehicle s engine is running Damage to the vehicle or the device may occur Caution Only use a Res...

Page 29: ...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 30: ...3 8 REMstar M Series User Manual ...

Page 31: ...n will be different from the number shown below Figure 4 1 Software Version Screen 2 The next screen to appear is the Standby screen which displays the cumulative therapy hours When you first begin using this device the number shown will be zero but as you use it the number shown here will increase Your provider may ask you for this number Figure 4 2 Standby Screen 3 When you press the Start Stop ...

Page 32: ... 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 Using the Ramp Feature The optional Ramp feature can be enabled or di...

Page 33: ...n the Patient Data screens Hours of Patient Use Session Counter number of sessions greater than 4 hours Compliance Check Value Additionally you can view and modify the following settings on the Patient Setup screens Altitude Ramp starting pressure if enabled by your home care provider Note You can view your therapy usage hours on the Standby screen each time you turn on the device ...

Page 34: ...e the Patient Data screens Session Counter View Screen Hours of Patient Use View Screen Compliance Check Value View Screen Press To Enter These Screens Standby Screen showing therapy hours 4 Figure 4 4 Navigating the Patient Data Screens Press the button to scroll forward through these screens or press the button to scroll through the screens in the reverse order From any of these screens press th...

Page 35: ...r this information 4 2 Session CounterView Screen This screen shows you the number of sessions greater than four hours Your home care provider may periodically ask for this information 3 Compliance CheckValueView Screen This screen shows you the Compliance CheckValue which typically is a different number from the one shown here Your home care provider may periodically ask for this infor mation ...

Page 36: ...nt Screen Ramp Start Pressure Adjustment Screen Figure 4 5 Navigating the Patient Setup Screens Note the ramp screen appears only if the ramp feature is enabled Press the button to scroll forward through these screens or press the button to scroll through the screens in the reverse order From any of these screens press the Start Stop button to return to the Standby screen Note After one minute of ...

Page 37: ...he accuracy of the pressure Your home care provider can verify the pressure setting with a water column manometer Warning If you set the manual altitude setting incorrectly the pressure may be too high or too low depend ing on your location 2 Ramp Starting Pressure Adjustment Screen You can increase or decrease the ramp starting pressure in 0 5 cm H2 O increments by pressing the Plus or Minus butt...

Page 38: ...reen a sample is shown on the left Give the provider the value for hours of patient use as shown on your screen 4 3 Press the left arrow button to advance to the sessions 4 screen a sample is shown on the left Give the provider the value for total sessions 4 as shown on your screen 4 Press the left arrow button to advance to the next screen a sample is shown on the left Give the provider the compl...

Page 39: ...rity flashing pattern consisting of a continuous bright to off two flash pattern indicated in the following table as Alert Summary Table The following table summarizes the high priority alerts Alert Visual Indicator Device Action Possible Cause Patient Action System Error Backlights The following symbol displays to indicate that service is required The device enters the Safe state in which the dev...

Page 40: ...the power supply cord is securely connected to the device s power inlet If the problem continues to occur contact your home care provider Return both the device and power supply to your provider so they can deter mine 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 connections are secure Check your battery It may ne...

Page 41: ...lectro magnetic Interference EMI emissions 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 elec tronic 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 Device Rese...

Page 42: ...en 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 reapplying power If the pla...

Page 43: ... prescription If your provider has enabled Ramp but the feature still does not work check the CPAP setting on your Active Display screen If CPAP is set to the minimum setting 4 0 cm H2 O the Ramp feature will not work You are having prob lems connecting the tubing to the device You have lost the air outlet port or are traveling and forgot to bring the port with you If you are not using a humidifie...

Page 44: ...es 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 coming out of the port area The air out of the mask is much warmer than usual The air filters may be dirty The device may be operating in direct sun light or near a heater Clean or ...

Page 45: ...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 46: ...5 8 REMstar M Series User Manual ...

Page 47: ...oisture and heat if applicable to the airflow Figure 6 1 shows the humidifier by itself and attached to the REMstar 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 Device with Humidifier Attached Figure 6 1 Heated Humidifier Alone and Att...

Page 48: ...evice 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 ox...

Page 49: ...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 50: ...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 Filter Area Disposable Ultra Fine Filter optional Reusable Gray Foam Filter required Figure 7 2 Reinstalling the Filters Caution Never install a wet filter into the device It is recommend...

Page 51: ...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 52: ...e sure you attach the air outlet port to your device when you remove the humidifier from the device You need the port to connect the tubing directly to your device Figure 7 3 illustrates how to remove the humidifier from the device and attach the air outlet port Attach Air Outlet Port to the Device Remove the Device From the Humidifier Figure 7 3 Attaching the Air Outlet Port to the Device 7 5 1 I...

Page 53: ...ollowing 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 Agai...

Page 54: ...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 55: ...tic Environment Guid ance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The device is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage...

Page 56: ...er quality should be that of a typical home or hos pital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV for common mode Mains power quality should be that of a typical home or hos pital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT...

Page 57: ...manufacturer and d is the recom mended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equip ment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guideli...

Page 58: ...er W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 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 frequ...

Page 59: ...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 merchan...

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