Respironics REMstar Auto M Series User Manual Download

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This device is intended for use in the

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RF emissions

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The device uses RF energy only for its internal function. Therefore, its RF emissions

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RF emissions

CISPR 11

Class B

The device is suitable for use in all establishments, including domestic establish-

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network.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations/Flicker emissions

IEC 61000-3-3

Complies

Summary of Contents for REMstar Auto M Series

Page 1: ...001 Murry Ridge Lane Murrysville PA 15668 w w w r e s p i r o n i c s c o m Respironics Deutschland Gewerbestrasse 17 8221 Herrsching Germany 1020121 AM 9 12 06 EN US FR CA ES LA PT BR 1040442 JR 1 15 07 ...

Page 2: ...ed under license 2007 Respironics Inc and its affiliates All rights reserved Important Fill in the information below when you receive the REMstar Auto M Series system Serial No ______________________________ located on the bottom of the device System Prescribed for __________________________________________ Date of Purchase or Rental ______________________________________ Pressure Setting _____ cm...

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Page 7: ...ols 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 4 1 Availabl...

Page 8: ...uestionnaire 4 11 4 6 Patient Reminder Screen 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 2 7...

Page 9: ...Series system includes the following items REMstar Auto M Series Device Reusable Gray Foam Filter Disposable Ultra fine Filter Power Supply AC Power Cord Carrying Case User Manual F le x Flexible Tubing Swivel may not be included 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 humidifie...

Page 10: ...ies 1 3 Warnings Cautions and Contraindications Caution U S federal law restricts this device to sale by or on the order of a physician 1 3 1 Warnings A warning indicates the possibility of injury to the user or the operator This manual serves as a reference The instructions in this manual are not intended to super sede the health care professional s instructions regarding the use of the device Th...

Page 11: ...ease the temperature of the air coming out of the device Contact your health care professional if symptoms of sleep apnea recur If you notice any unexplained changes in the 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 yo...

Page 12: ...ng the relative 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 following pre existing conditions may contraindicate the use of CPAP therapy for some patients Bullous Lung Disease Pathologically Low Bloo...

Page 13: ...your prescription pressure is reached You also have the option of not using the ramp feature at all Additionally the C Flex and A Flex comfort features provide you with pressure relief when you exhale during therapy Several accessories are also available for use with your REMstar Auto M Series device Contact your home care provider to purchase any accessories not included with your system Figure 1...

Page 14: ... 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 pat...

Page 15: ...ome care provider Compliance CheckValue Represents a code used by the home care provider to determine the ac curacy of reported data CPAP Continuous Positive Airway Pressure FOSQ Functional Outcomes of Sleep Questionnaire A quality of life question naire designed specifically for people with sleep disorders The results allow health care professionals to assess how CPAP therapy has improved the qua...

Page 16: ...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 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 17: ...n also press this button to exit any setting screen Flex Flex This button adjusts the 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 lo cated under the device cover door Figure 2 2 shows the device display and navigation buttons that ar...

Page 18: ...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 Auto M Series device s rear panel without a humidifier Air Outlet Port Accessory Slot Filter Area DC Power Inlet Figure 2 4 REMstar Auto M Series Rear Panel The rear panel contains the follow...

Page 19: ...en the device 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 in...

Page 20: ...inter face 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 should be installed in line between the device and the circuit tubing to prevent contamination To connect...

Page 21: ...halation 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 D...

Page 22: ...flow on or off Important If you 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...

Page 23: ...ary 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 ...

Page 24: ...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 ...

Page 25: ...P therapy while automatically adjusting the pressure level to meet the patient s needs Auto CPAP with C Flex Auto CPAP therapy with pressure relief upon exhalation to improve patient comfort based on patient needs Auto CPAP with A Flex Auto CPAP therapy with pressure relief taking place at the end of inhalation and at the start of exhalation to improve patient comfort based on patient needs 4 2 St...

Page 26: ...uto 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 SmartCard This symbol displays if a SmartCard is inserted in the device If the card is inserted incorrectly the symbol will flash intermittently Modem This symbol displays if a modem is connected to the device Note This symbol will vary in appearance depend...

Page 27: ...ng will happen when you press the button 4 3 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 3 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 for ...

Page 28: ...ange the A Flex setting press the Flex button The screen shown in Figure 4 6 appears with an arrow above the current A Flex setting 1 2 3 A Flex Setting Figure 4 6 A Flex Setting Screen The setting of 1 provides a small amount of pressure relief with higher numbers providing additional relief To change the pressure relief press the or buttons to increase or decrease the setting Note You can also v...

Page 29: ...ndex if enabled by your home care provider 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 A 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 disable FOSQ questionnaire 4 4 1 Naviga...

Page 30: ...r The Patient Data screens are described below FOSQ Setup 1 Standby Screen The Standby screen appears when you first apply power to the device You can access the Patient Data menu from this screen by pressing the or buttons Note You can access the Patient Setup screens by pressing the button and the FOSQ questionnaire by pressing the but ton as described later in this chapter Note The FOSQ option ...

Page 31: ...nly for reference Your home care provider may periodically ask you for this information Note This screen only displays if you are in Auto CPAP therapy 7 Day Avg 0 0 30 Day Avg 0 0 System Leak L min 5 System Leak Screen This screen displays a 7 day and 30 day average of the leak history for the device in liters per minute LPM System leak is a combina tion of intentional and unintentional air leak I...

Page 32: ...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 4 1 2 Viewing and Modifying Patient Setup Sc...

Page 33: ...ss the or buttons to increase or decrease the setting If your provider has disabled C Flex you cannot enable or adjust the setting The screen shown at left displays to indicate that C Flex is disabled Note These screens will only display if your unit is set for C Flex 1 2 3 A Flex Setting FLEX comfort has been disabled on this unit A Flex Setting 3 A Flex Setting Screen This screen displays the A ...

Page 34: ...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 6 Auto Off Screen You can enable this feature if you want the device to automati cally turn the airflow off whenever you remove the interface e g mask from your airway Press the or buttons to select OFF or ON If this feature is en a...

Page 35: ...e Make 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...

Page 36: ...ctive 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...

Page 37: ... 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 patte...

Page 38: ... 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 39: ...ating 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...

Page 40: ...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 l...

Page 41: ...roubleshooting 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 to indi cate that the device be returned to the home care pro...

Page 42: ...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 placeme...

Page 43: ...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 wi...

Page 44: ...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 45: ...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 REMstar Auto 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 humidifi...

Page 46: ...ply 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 th...

Page 47: ...r sooner if it appears dirty DO NOT clean the ultra fine filter Caution Dirtyinletfiltersmaycausehighoperatingtemperaturesthatmayaffectdeviceperfor mance Regularlyexaminetheinletfiltersasneededforintegrityandcleanliness 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 fi...

Page 48: ...vice stating that it is medical equipment It may be helpful to bring this manual along with you to help security personnel understand the REMstar Auto 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 humidifier from the device You need the port to connect the t...

Page 49: ... 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 Ingr...

Page 50: ...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 ...

Page 51: ...netic Environment Guidance 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 equip ment RF emissions CISPR 11 Class B The device is suitable for use in all establishments including domestic establish ments and those directly connected to the public low volt...

Page 52: ...ferential mode 2 kV common mode 1 kV differential mode 2 kV for common mode Mains power quality should be that of a typi cal home or hospital environment Voltage dips short interrup tions 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 for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for...

Page 53: ...d 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 equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and ref...

Page 54: ...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...

Page 55: ...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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