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8-1

REM

STAR

M S

ERIES

SER

ANUAL

HAPTER

8: S

PECIFICATIONS

NVIRONMENTAL

PERATING

TORAGE

EMPERATURE

5° C (41° F) to 35° C (95° F)

-20° C (-4° F) to 60° C (140° F)

ELATIVE

UMIDITY

15 to 95% (non-condensing)

TMOSPHERIC

RESSURE

77 to 101kPa (0 - 7500 ft)

N/A

HYSICAL

Dimensions:

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

Weight:

Approximately 2.2 lbs. (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.

Содержание REMstar Pro

Страница 1: ...1016444 JH 2 14 06 USER MANUAL ...

Страница 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 co...

Страница 3: ... 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 ...

Страница 4: ...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 ...

Страница 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...

Страница 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...

Страница 7: ...1 10 Chapter 2 Device Controls and Displays 2 1 2 1 Controls and Displays 2 1 2 1 1 Control Panel Inactivity 2 3 2 2 Rear Panel 2 3 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 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...

Страница 8: ...n 4 12 Chapter 5 Device 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 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 ...

Страница 9: ...o M Series system includes the following items REMstarPro M Series Device Flexible Tubing Reusable Gray Foam Filter Disposable Ultra fine Filter Power Supply AC Power Cord Carrying Case User Manual Quickstart Guide C 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 mo...

Страница 10: ...or 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 wi...

Страница 11: ...e 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 Repairs and adjustments must be performed by Respironics authorized service personnel only Unauthorized service could cause injury invalidate the war...

Страница 12: ...ing 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 Pneumot...

Страница 13: ...ortable 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 u...

Страница 14: ... 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 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 ...

Страница 15: ...mouth 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 t...

Страница 16: ...al 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 view certain stored information such as therapy usage hou...

Страница 17: ...panying 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 Notiﬁed Body Approval for Standards Compliance TUV Safety Standard Compliance UL Recognized for Canada and the United States No User Serviceable Parts ...

Страница 18: ...ave 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 Visit Respironics web site at www respironics com ...

Страница 19: ...he 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 C Flex C Flex This button adjusts the C Flex comfort setting If you do not want to modify the settings tha...

Страница 20: ...e the settings on the setup screens Allows you to enter the Setup screens Also allows you to increase the settings on the setup screens The device s 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 Previ...

Страница 21: ... s rear panel without a humidiﬁer Air Outlet Port Accessory Slot Filter Area DC Power Inlet FIGURE 2 4 REMSTAR PRO M SERIES 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 A DC power inlet where the pow...

Страница 22: ...2 4 REMSTAR PRO M SERIES USER MANUAL ...

Страница 23: ...ﬁne particles 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 reu...

Страница 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 s...

Страница 25: ...n 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 If you are using a mask with a built in exhalation port connect the mask s connector to the ﬂex...

Страница 26: ...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 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 ...

Страница 27: ...ressing the button turns 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 po...

Страница 28: ...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 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 ...

Страница 29: ...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 nightstand or table FIGURE 3 8 RECOMMENDED DEVICE AND TUBING PLACEMENT ...

Страница 30: ...3 8 REMSTAR PRO M SERIES USER MANUAL ...

Страница 31: ...FTWARE 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 or Inactive 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 ...

Страница 32: ...tton The ramp symbol displays on the Active Display screen when the ramp function is active Mask Leak 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 Sm...

Страница 33: ... the instructions included with the mask 4 2 USING THE RAMP AND C FLEX FEATURES You can press the 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 disable This feature reduces the air pressure when y...

Страница 34: ...an arrow above the current C Flex setting 1 2 3 C FLEX 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 screen from the Patient Se...

Страница 35: ...usage hours Number of sessions greater than 4 hours System leak if enabled by your home care provider Apnea Hypopnea Index if enabled by your home care provider Additionally you can view and modify the following settings on the Patient Setup screens C Flex if enabled by your home care provider Ramp starting pressure if enabled by your home care provider Mask alert enable disable Auto oﬀ enable dis...

Страница 36: ...ENT DATA SCREENS Figure 4 6 shows how to navigate the Patient Data screens 7 Day Avg 0 0 30 Day Avg 0 0 Apn Hyp Index Press Press FOSQ Setup Therapy Usage 7 Day Avg 5 00 30 Day Avg 8 00 Hrs Night 7 Days 5 Sessions 30 Days 8 Sessions Sessions 4 System Leak L min 7 Day Avg AHI 0 0 30 Day Avg AHI 0 0 FIGURE 4 6 NAVIGATING THE PATIENT DATA SCREENS Press the button to scroll forward through the data sc...

Страница 37: ...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 7 Day Avg 0 0 30 Day Avg 0 0 System Leak L min 4 System Leak Screen This screen displays a 7 day and 30 day average of the leak history for the device in liters pe...

Страница 38: ... MODIFYING PATIENT SETUP SCREENS Figure 4 7 shows how to navigate the Patient Setup screens 4 0 cmH2O 1 2 3 Press Press Press FOSQ Setup C Flex Setting Ramp Start Pres Mask Alert Feature ON Auto Off Feature ON FIGURE 4 7 NAVIGATING THE PATIENT SETUP SCREENS ...

Страница 39: ...es a small amount of pres sure relief with 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 4 0 cmH2O Ramp Start Pres 3 Ramp Starting Pressure Screen You can increase or decrease the ramp starting pres...

Страница 40: ... 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 o...

Страница 41: ...e 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 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 wire...

Страница 42: ...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 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 S...

Страница 43: ... a continuous 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 patter...

Страница 44: ...back into 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...

Страница 45: ...ting that a mask disconnect has been detected The airﬂow shuts oﬀ and the device enters the Standby state approximately 45 60 seconds after detection 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 state to the...

Страница 46: ...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 fol...

Страница 47: ...ith troubleshooting software that automatically monitors perfor mance Such a reset poses no danger to the patient and assures that the patient receives prescribed therapy throughout the night If there is a pos sibility of damage to the device the device will shut down permanently The product will then display the following system error alert symbol to indicate that the device be returned to the ho...

Страница 48: ...lly 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 o...

Страница 49: ...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 open ing 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...

Страница 50: ...igniﬁcant 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 airﬂo...

Страница 51: ...ailable 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 Pro 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 m...

Страница 52: ...omply 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...

Страница 53: ... 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...

Страница 54: ...ied 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 FILTERS Caution Never install a wet ﬁlter into the device It is recommended tha...

Страница 55: ...ent Rinse thoroughly Air dry 7 4 SERVICE The REMstar Pro 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 ...

Страница 56: ...e sure you attach the air outlet port to your M Series device when you remove the humidi ﬁer 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...

Страница 57: ...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 against Ingre...

Страница 58: ...red 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 and an atmospheric pressure of 101 54 kPascals 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 and an atmospheric pressure of 101 54 kPascals DISPOSAL Dispose of the device in accordance with local regulations ...

Страница 59: ...NETIC 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 volta...

Страница 60: ...ower 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...

Страница 61: ...ter 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 guid...

Страница 62: ...TTER 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 fre...

Страница 63: ...ic 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 ...

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