Home Care Provider Setup Instructions
Contents
1. Home Care Provider REMstar 7 Setup Instructions Always use these instructions along with the User Manual when assembling or adjusting this equipment For clinical systems refer to the setup guide entitled Respironics Products in the Sleep Lab part 1009751 for equipment setup assistance System Contents Device with SmartCard Filter Cap Pollen Filters goU oro2 CPAP System This CPAP system is intended for the treatment of adult obstructive Sleep Apnea only NOTE The C Flex mark is used under license with f C Flex Piatto es www respironics com The FOSQ Quality of Life questionnaire is included with this system Your patients can periodically complete this questionnaire by recording their answers on the SmartCard or they can circle their answers on the enclosed FOSQ brochure Either the SmartCard or the brochure can then be mailed to you or their medical professional for evaluation Ultra fine Flexible Tubing Filter 6 ft 1 83 m x 22 mm I D Symbols Specifications Device Label Mode of Operation Continuous Attention consu AC Power Consumption 100 240 VAC 50 60 Hz 1 0 A max accompanying documents AC Power Type of Protection Against Electric Shock Class II Equipment DC Power Degree of Protection Against Electric Shock Type BF Applied Part Type BF Applied Part Class II Double Insulated Ordinary Equipment Rating Notified Body Approval for Standards Compli2. oxygen delivered into the ventilator tubing may accumulate within the CPAP machine enclosure Oxygen accumulated in the CPAP machine enclosure will create a risk of fire This warning applies to most types of CPAP machines Oxygen accelerates fires Keep the REMstar Pro 2 with C Flex 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 REMstar Pro 2 with C Flex or the oxygen container 3 System Setup Display Screens WARNING CAUTION Control Panel Display Screens Enter Therapy 1 To enter the Therapy Setup Menu hold the two top user buttons down while Setup Menu IMPORTANT At a fixed flow rate of supplemental oxygen flow the inhaled oxygen concentration will vary depending on the pressure settings patient breathing pattern mask selection and leak rate This warning applies to most types of CPAP machines If the REMstar Pro 2 with C Flex has been exposed to either very hot or very cold temperatures allow it to adjust to room temperature approximately 2 hours before beginning the following setup procedures This section provides detailed instructions for the Therapy Menu Display Screens Display Screen All device settings appear here Pressure Start Stop Button Use this button to start or stop the airflow DO NOT start the airflow until the circuit tubing is connected Heated Humidifier Button Use this button when the optio
3. coverings non synthetic clothing discharg ing one s body to the frame of the equipment or system or to earth or a large metal object and bonding oneself by means of a wrist strap to the equipment or system or to earth e Tobacco smoke may cause tar build up within the REMstar Pro 2 with C Flex that may result in the device malfunctioning e The use of accessories other than those specified with the exception of cables sold by the manufacturer of the equipment or system as replacement parts for internal components may result in increased emissions or decreased immunity of the equipment or system When assessing the relative risks and benefits of using this equipment the clinician should understand that the REMstar Pro 2 with C Flex can deliver pressures up to 20 cm H O In the event of certain fault conditions a maximum pressure of 30 cm H O is possible Studies have shown that the following pre existing conditions may contraindicate the use of CPAP therapy for some patients e Bullous Lung Disease e Pathologically Low Blood Pressure e Pneumothorax e Bypassed Upper Airway e Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway Pressure Caution should be used when prescribing CPAP for susceptible patients such as those with cerebral spinal fluid CSF leaks abnormalities of the cribriform plate prior history of head trauma and or pneumocephalus Chest 1989 96 1425 1426 The use of positive airway pressur
4. 0 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people II 12 RESPIRONICS 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 8550 USA 1021441 JH 10 15 04
5. REMstar Pro 2 with C Flex for delivery a Verify the settings before delivering the REMstar Pro 2 with C Flex to the patient Optional Pressure Verification via Manometer A water column manometer can be connected for additional pressure verification When the blower is turned on the current pressure will appear on the screen b Follow the instructions in the User Manual to install the filters and connect the patient circuit c Fill out the information form in the front of the User Manual Review the User Manual with the patient The REMstar Pro 2 with C Flex is delivered with an Encore Pro SmartCard installed The SmartCard is a plastic card similar in size and shape to a normal credit card But instead of holding information on a magnetic stripe it holds data in a small silicon chip embedded in the card When installed in the REMstar Pro 2 with C Flex the SmartCard records the date time and duration of each use storage capacity at least 6 months When capacity is reached the oldest data is overwritten Using the Respironics SmartCard reader writer and the Encore Pro software you can download and view the usage data Follow the instructions included with the Encore Pro software to download the data Note If the card is not installed this information will not be recorded When a SmartCard is installed the word Card will appear in the lower right corner of the display screen The REMstar Pro 2 with C Flex is pro
6. ance e lomi D Canadian US Certification O rT amp Sound Pressure Level lt 30 dB A Degree of Protection Against Ingress of Water IPXO Ordinary Equipment Pressure Range 4 to 20 cm H O in 0 5 cm increments Pressure Stability 4 to 10 cm H O 0 5 cm H O gt 10 to 20 cm H O 41 0 cm H O Measured in accordance with EN 17510 6 6 13 2 amp 20 cm H O 500 ml with BPM set to 10 15 amp 20 BPM performed at 23 C 2 C 50 RH 5 and an atmospheric pressure of 101 54 kPascals Measured in accordance with EN 17510 10 cm H O at the patient circuit This measurement applies to the REMstar Pro 2 with C Flex with or without the optional REMstar Heated Humidifier Maximum Flow 34 LPM Measured in accordance with EN 17510 6 6 13 2 amp 20 cm H O 500 ml with BPM set to 10 15 amp 20 BPM 23 C 42 C 50 RH 5 and an atmospheric pressure of 101 54 kPascals I Warnings amp Cautions CAUTION Indicates the possibility of damage to the device WARNING Indicates the possibility for injury to the user or the operator CAUTION Contraindications e US federal law restricts this device to sale by or on the order of a physician e This device is intended for adult use only e This device is not intended for life support e CPAP devices have the potential to allow rebreathing of exhaled air To reduce this potential observe the following Use Respironics circuit acce
7. cm H_O the following C Flex level settings will not appear Go to Step e Set the C Flex d If you chose the C Flex mode the C Flex level will appear This setting Level allows you to adjust the level of air pressure that the patient is feeling when they exhale during therapy We recommend starting with the setting of 1 which provides the least relief Levels 2 and 3 progressively reflect increased pressure relief Range 1 3 1 ea increments The patient also has access to this setting in the Patient Setup Menu and Pressure level Th ra decreases To change the setting press the ramp or humidifier button Pressure z until the correct setting appears c Flex ee evels a ere MA Press the right user button to go to the next setting Inhalation le Exhalation gt System Setup Display Screens Set the e The ramp time will appear Ramp Time Range 0 to 45 minutes 5 minute increments To change the ramp time press the ramp or humidifier button until the correct time appears If you do not want ramp set the time to 0 Press the right user button to go to the next setting Note If the ramp time is set to 0 the ramp settings are complete Go to Step g Set the f The ramp starting pressure will appear Ramp Starting Range 4cm H O j CPAP Pressure Setting 0 5 H O increments The patient also has access to this setting in the Patient Setup Menu if prescribed Pressure To change the
8. d 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 relocating the device Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 V m 10 EMC Requirements cont Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Device This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of this device can help prevent electro magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and this device as recommended below according to the maximum output power of the communications equipment Rated Maximum Separation Distance According to Frequency of Transmitter Power Output of m Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz W d 1 NP d 1 NP d 23 P 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 frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 8
9. e therapy may be temporarily contraindicated if the patient exhibits signs of a sinus or middle ear infection Should the patient have any of these conditions a health care professional will determine if CPAP therapy is appropriate WARNING Patient Circuit WARNING DC Power Humidifier Adding Oxygen WARNING WARNING WARNING WARNING WARNING Accessories Do not connect any equipment to the REMstar Pro 2 with C Flex unless recommended by Respironics or the health care professional Verify that an exhalation port is present to exhaust CO from the circuit If circuit accessories other than those recommended by Respironics are connected to the REMstar Pro 2 with C Flex pressures must be verified Use of these accessories may alter the pressure received reducing the effectiveness of treatment Respironics Accessories When using accessories always follow the instructions enclosed with the accessories Recommended Patient Circuit 1 Respironics nasal mask with integrated exhalation port or Respironics mask with separate exhalation port such as the Whisper Swivel II Respironics 6 ft 1 83 m x 22 mm LD flexible tubing 3 Respironics headgear not shown N If the REMstar Pro 2 with C Flex is used for multiple persons e g rental devices a low resistance main flow bacteria filter should be installed in line between the REMstar Pro 2 with C Flex and the circuit tubing Pressures must be verif
10. grammed to allow the users to take a Functional Outcomes of Sleep Questionnaire FOSQ FOSQ is a quality of life questionnaire designed specifically for people with sleep disorders The results allow health care professionals to see how therapy has improved the quality of their patients lives By having their patients complete the questionnaire periodically health care professionals can collect valuable information about the effectiveness of their treatment The FOSQ brochure included with this package details the questionnaire The SmartCard will record the answers to questions displayed on the REMstar Pro 2 with C Flex screens The card can then be removed from the REMstar Pro 2 with C Flex and mailed to the health care professional for evaluation using the Encore Pro software application The REMstar Pro 2 with C Flex stores and displays device usage and patient compliance Therapy Hours is the total number of hours the patient has received therapy on the REMstar Pro 2 with C Flex This total will appear on the display screen whenever the airflow is turned off The power cord must be plugged in This total can be reset to zero Like a trip meter in a car this total can be reset to give a detailed look at patient usage This data may be useful in tracking patient compliance Resetting the total will not erase the total operation time or other patient data The patient can view this reading but cannot reset it Nights with Greate
11. ied when alternate or optional accessories are in place The Respironics DC Power Cord can be used to operate the REMstar Pro 2 with C Flex in a stationary recreational vehicle boat or motor home The Respironics DC Battery Adapter Cable when used with the Respironics DC Power Cord enables the device to be operated from a 12 VDC free standing battery The Respironics REMstar Heated Humidifier is available for use with the REMstar Pro 2 with C Flex The humidifier may reduce nasal dryness and irritation by adding moisture and heat if applicable to the airflow When using other humidifiers verify that the delivered pressure is correct and that proper therapy is being delivered The humidifier cannot be operated with DC power Oxygen may be added at the mask connection Please note the warnings listed below when using oxygen with the REMstar Pro 2 with C Flex The oxygen supply must comply with the local regulations for medical oxygen A Respironics Pressure Valve Part number 302418 must be placed in line with the patient circuit Turn the REMstar Pro 2 with C Flex on before turning the oxygen on Turn the oxygen off before turning the REMstar Pro 2 with C Flex off This will prevent oxygen accumulation in the device If oxygen is used with this CPAP machine the oxygen flow must be turned off when the CPAP machine is not operating Explanation of warning When the CPAP device is not in operation and the oxygen flow is left on
12. in such an environment Compliance Emissions Test RF emissions CISPR 11 Group 1 RF Class B emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations Flicker emissions IEC 61000 3 3 Complies Electromagnetic Environment Guidance This 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 This device is suitable for use in all establish ments including domestic establishments and those directly connected to the public low voltage power supply network Guidance and Manufacturer s Declaration Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test Electrostatic 6 kV contact 8 kV air 2 kV for power supply lines Electrical fast Transient burst 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U 95 dip in U for 5 sec Voltage dips short interruptions and voltage variations on power supply input lines TEC 61000 4 11 6 kV contact 8 KV air 2 kV for supply mains 1 kV for input output lines 1 kV differential mode 2 kV for c
13. nal REMstar Heated Humidifier has been prescribed This button will control the optional heated humidifier s output Follow the instruc ey a tions included with the humidifier Button Pressure Ramp Button When the airflow is turned on use this button to SA cee Start Stop lower the airflow pressure This will allow you to fall asleep more Button easily When the airflow is turned off use this button to access the patient menu User Buttons Use these buttons to change the device settings When in the Setup Menu the humidifier and ramp buttons operate as up and down keys to change the settings the left right user buttons allow you to go to the previous next question or setting and the pressure start stop button is used to exit the Setup Menu Holding the humidifier or ramp buttons down will cause the values to change more quickly Previous Next plugging in the power cord Continue holding the buttons down until the op REMstar Pro 2 with C Flex beeps 4 aa XI Note The word setup will appear on all of the screens indicating that v seuings STOP you are in the Therapy Setup Menu If you press the pressure start stop button you will exit the Setup Menu Prescribed therapy settings can only be set using the Therapy Menu To prevent patients from tampering with the settings do not reveal the directions to Therapy Menu access to the patient System Setup Display Screens Reset the a The number of
14. nights the REMstar Pro 2 with C Flex was used for Compliance more than four consecutive hours will appear Like a trip meter in a car NGHTS gt 4 HRs Totals this total and the therapy hours see page 7 for a description of therapy hours 2 can be reset to give a detailed look at patient usage This data may be useful in tracking patient compliance Resetting these totals will not erase the total operation time or other patient data The patient can view this reading but cannot reset it NIGHTS gt 4 HRS To erase the totals and go back to zero press and hold the ramp or humidifier button The word ERASE will appear on the screen Hold the button down until the time changes to 0 and the word ERASE disappears Press the right user button to go to the next setting Choose b The therapy mode will appear CPAP or CFLE The C Flex mode is the Mode CPAP therapy along with the C Flex comfort setting step d The CPAP mode is CPAP therapy without the C Flex setting To change the mode press the ramp or humidifier button until the correct mode appears Press the right user button to go to the next setting Set the c The CPAP pressure setting will appear Pressure Range 4 to 20 cm H O 0 5 cm H O increments To change the pressure setting press the ramp or humidifier button until the correct pressure appears Press the right user button to go to the next setting Note If the CPAP pressure setting is 4
15. ommon mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec NOTE U is the a c mains voltage prior to application of the test level IEC 60601 Test Level Compliance Level Electromagnetic Environent Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical home or hospital environment Mains power quality should be that of a typical home or hospital environment Mains power quality should be that of a typical home or hospital environment If the user of the device requires continued operation during power mains interruptions it is recommended that the device be powered from an uninterruptible power supply or a battery EMC Requirements cont Guidance and Manufacturer s Declaration Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test IEC 60601 Compliance Electromagnetic Environment Test Level Level Guidance Power frequency Power frequency magnetic fields should be at levels 50 60 Hz magnetic characteristic of a typical location in a typical home or field hospital environment TEC 61000 4 8 Po
16. r Than Four Hours Usage is the total number of nights that REMstar Pro 2 with C Flex therapy took place for four or more consecutive hours This total can also be reset to zero This total can also be viewed in the patient setup menu Total Operation Time is the total number of hours the REMstar Pro 2 with C Flex has been in use This total includes factory testing time When the power cord is plugged in this total will appear for a few seconds This total cannot be reset to zero Service Service Disposal The REMstar Pro 2 with C Flex does not require routine servicing If the REMstar Pro 2 with C Flex begins to malfunction refer to the Troubleshooting section of the User Manual or contact Respironics Repairs and adjustments must be performed only by trained personnel fully acquainted with this equipment Service performed by unqualified personnel or installation of unauthorized parts could cause personal injury invalidate the warranty or result in costly damage When necessary dispose of the REMstar Pro 2 with C Flex and accessories in accordance with local regulations If you need product assistance call Respironics Customer Service Department 1 800 345 6443 USA and Canada or 1 724 387 4000 EMC Requirements Guidance and Manufacturer s Declaration Electromagnetic Emissions This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used
17. ramp starting pressure press the ramp or humidifier Airflow button until the correct pressure appears Z Ramp Button A Pressed Therapy Pressure Press the right user button to go to the next setting Minimum 4 Ram i Pressure 0cm H20 Minutes Set the Patient g The patient disconnect setting will appear This setting has two Disconnect Alert functions When a large continuous air leak such as mask removal has been detected in the circuit it enables disables the audible alert a beeping sound and the Auto off feature which allows the REMstar Pro 2 with C Flex to automatically turn the airflow OFF The patient also has access to this setting in the Patient Setup Menu 1 o0n 0 off To change the setting press the ramp or humidifier button Press the right user button to go to the next setting Set the h The button lights setting will appear This setting allows you to have SETUP Button Lights the lights behind the buttons turned on or off while the airflow is rm turned on The lights will always be on when the airflow is off The patient also m has access to this setting in the Patient Setup Menu LED 1 on 0 off To change the setting press the ramp or humidifier button The settings are complete Press the pressure start stop button to exit the settings menu Prepare for Delivery SmartCard FOSQ Device Usage and Patient Compliance System Setup 2 Prepare the
18. rtable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 12NP TEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m TEC 61000 4 3 80 MHz to 2 5 GHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz P 3 P where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol y e 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 reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considere
19. ssories Do not wear the mask and headgear for more than a few minutes while the unit is not operating Do not block or try to seal the vent holes in the exhalation port As with most CPAP devices At low CPAP pressures some exhaled gas CO may remain in the mask and be rebreathed Do not use this device if the room temperature is warmer than 95 F 35 C If this device is used at room temperatures warmer than 95 F 35 C the temperature of the airflow may exceed 106 F 41 C This could cause irritation to the patient s airway This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide If you notice any unexplained changes in the performance of the REMstar Pro 2 with C Flex if it is making unusual or harsh sounds if it has been dropped or mishandled or if the enclosure is broken discontinue use Contact Respironics Customer Service Department and replace any damaged parts before continuing use e To avoid electrical shock disconnect the power cord before cleaning DO NOT immerse the REMstar Pro 2 with C Flex in any fluids e Pins of connectors identified with the ESD warning symbol should not be touched Connections should not be made to these connectors unless ESD precautionary procedures are used Precautionary procedures include methods to prevent build up of electrostatic discharge e g air conditioning humidification conductive floor
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