REMstar Homecare OIS2,dom
Contents
1. Home Care Provider Setup Instructions Always use these instructions along with the User Manual when assembling or adjusting this equipment System Contents Py Ultra fine Filter Pollen Filters REMstar Me RESPIRONICS CPAP System WW respironics com This CPAP System is intended only for the treatment of adult Obstructive Sleep Apnea User Manual Symbols Display Screen Control Buttons Device Label p Elevation Pressure Start Stop N Secompanying documents BE Humidifier Setting Ramp AC Power Hours of Use A Humidifier On Off DC Power Therapy Setup Menu Settings are being erased xx pa Button Lights Specifications AC Power Consumption 100 240 VAC 50 60 Hz 1 0 A max DC Power Consumption 12 VDC 3 0 A max Pressure Increments 4 0 to 20 0 cm H O in 1 0 cm H O increments Degree of Protection Against Ingress of Water IPXO Ordinary Equipment Type BF Applied Part o Class II Double Insulated IPX0 Ordinary Equipment European CE Declaration of Conformity 0123 Notified Body Approval T for Standards Compliance G Re Canadian US Certification C US Mode of Operation Continuous Type of Protection Against Electric Shock Class II Equipment Degree of Protection Against Electric Shock Type BF Applied Part Pressure Display Accuracy 0 15 4 of actual reading Sound Pressure Level lt 30 dB A Maximum Flow 35 LPM Warnings amp C2. Repairs and adjustments must be performed only by trained personnel fully acquainted with this equipment Service performed by unquali fied personnel or installation of unauthorized parts could cause personal injury invalidate the warranty or result in costly damage When necessary dispose of the REMstar and accessories in accordance with local regulations If you need product assistance call Respironics Customer Service Department 1 800 345 6443 within the U S A and Canada or 1 724 387 4000 1001 Murry Ridge Lane Deutschland Murrysville Pennsylvania Gewerbestrasse 17 1018876 15668 8550 USA 82211 Herrsching Germany 0123 HM 1 23 04 J RESPIRONICS RESPIRONICS
3. pressure setting over the next 20 minutes When the device is in the Therapy Setup Menu the humidifier and ramp buttons 4 operate as up and down keys to change the settings The pressure start stop Enter button will take you to the next screen a 1 Plug the pronged end of the power cord into an electrical outlet To enter the Therapy Setup Menu hold the ramp and pressure start stop buttons down while plugging the power cord into the device The airflow will automatically start and the display screen will show the current elevation setting and the unlock symbol Prescribed therapy settings can be set only using the Therapy Setup Menu To prevent patients from tampering with the settings do not reveal the directions to access the Therapy Setup Menu Elevation Setting Pressure Setting Fine Adjustment Setting Reset Device Usage Hours b The CPAP pressure setting will appear Range 4 to 20 cm H O in I cm H O increments c The CPAP fine adjustment setting will appear This setting allows System Setup a The elevation setting will appear The patient also has access to this setting in the Patient Setup Menu Lo or 1 less than 2 500 ft lt 762 m M or 2 2 500 to 5 000 ft 762 m to 1524 m Hi or 3 5 001 to 7 500 ft 1525 m to 2286 m NOTE Elevations of 7 500 ft 2 286 m may affect the accuracy of the pressure Verify the pressure settings with a water column manometer To change the setting press
4. the REMstar This total will appear on the display screen whenever the airflow is turned off The power cord must be plugged in For multiple patient use this total can be reset to zero in the therapy setup menu To erase the totals and go back to zero press and hold the ramp or humidifier button An X will appear under the hourglass symbol Hold the button down until the X disap pears System Setup amp Service Button Lights Exit Settings Service Disposal e The button lights setting will appear This setting allows you to have the lights behind the buttons turned on or off while the airflow is turned on The lights will always be on when the airflow is off The patient also has access to this setting in the Patient Setup Menu T on 0 off To change the setting press the ramp or humidifier button f The settings are complete To repeat the settings press the pressure start stop button To exit the Therapy Setup Menu hold the pressure start stop button down and press the ramp button one time The airflow will turn off 2 Final Steps a Follow the instructions in the User Manual to install the filter b Fill out the information form in the front of the User Manual Review the User Manual with the patient The REMstar system does not require routine servicing If the REMstar begins to malfunction refer to the Troubleshooting section of the User Manual or contact Respironics Inc
5. the ramp or humidifier button until the correct setting appears Press the pressure start stop button to go to the next setting To change the setting press the ramp or humidifier button until the correct pressure appears Press the pressure start stop button to go to the next setting you to calibrate the device so that the pressure setting can be verified with a manometer Range 1 5 to 1 5 cm H O in approximately 0 1 cm H O increments If you do not want to calibrate the device press and release the pressure start stop button to go to the next setting If you do want to calibrate the device follow the directions below 1 Connect the patient circuit to the REMstar Make sure there is an exhalation leak in the circuit 2 Zero the manometer and connect the manometer at the patient mask Make sure the pressure has stabilized for at least 60 seconds 3 If the pressure setting is not the same as the manometer reading press and release the ramp or humidifier button to change the setting Press the pressure start stop button to go to the next setting d The REMstar stores and displays device usage hours and blower hours Blower Hours Time is the total number of hours the REMstar 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 Device Usage Hours is the total number of hours the patient has run
6. autions CAUTION Indicates the possibility of damage to the device WARNING Indicates the possibility for injury to the user or the operator 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 induce rebreathing of exhaled air To reduce this potential observe the following Use Respironics circuit accessories 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 CO2 may remain in the mask and be rebreathed e 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 e This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide e If you notice any unexplained changes in the performance of this device 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 rep
7. en using other humidifiers verify that the delivered pressure is correct and that proper therapy is being delivered DC power cannot be used to operate the heated humidifier Oxygen may be added at the mask connection Please note the warnings listed below when using oxygen with this device 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 this device on before turning the oxygen on Turn the oxygen off before turning this device off This will prevent oxygen accumulation in the device Oxygen accelerates fires Keep this device and the oxygen container away from heat open flames any oily substance or other sources of ignition DO NOT smoke in the area near this device or the oxygen container When administering fixed flow supplemental oxygen the O concentration may not be constant The inspired oxygen concentration will vary depending on the CPAP settings patient breathing pattern and leak rate Substantial leaks around the mask may reduce the inspired oxygen concentration to less than the expected concentrations Appropriate patient monitoring should be implemented System Setup Filters CAUTION CAUTION Control Panel Ramp IMPORTANT Therapy Setup Menu IMPORTANT Install the filters operating The white ultra fine filter is optional and can be used in addition to the pollen fil
8. lace any damaged parts before continuing use e To avoid electrical shock disconnect the power cord before cleaning DO NOT immerse the REMstar in any fluids When assessing the relative risks and benefits of using this equipment the clinician should understand that this device 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 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 CPAP therapy may be temporarily contraindicated if a patient exhibits signs of a sinus or middle ear infection Not for use with patients whose upper airways are bypassed Should your patient have any of these conditions a physician will determine if CPAP therapy is appropriate WARNING WARNING DC Power Humidifiers Oxygen WARNING WARNING WARNING WARNING WARNING Accessories Do not connect any equipment to the REMstar unless recommended by Respironics or the doctor Verif
9. ter The ultra fine filter is recommended for people who are sensitive to tobacco smoke or other small particles The pollen filter must be in place at all times when the REMstar is 1 If you are using the ultra fine filter place one of the pollen filters over the ultra fine filter 7 white ultra fine filter 2 Insert the filter s into the filter area on the back of the REMstar gray An extra filter is included for the patient s convenience pollen filter If this device has been exposed to either very hot or very cold temperatures allow it to adjust to room temperature before beginning the following setup procedures Display Screen All device settings will appear here Pressure Start Stop Button Use this button to turn start Display or stop the airflow DO NOT start the airflow until the circuit screen tubing is connected Humidifier Button Use this button when the optional PA REMstar Heated Humidifier has been prescribed This Button button will turn the humidifier on off and control the heat Pressure gia Ramp setting Follow the instructions included with the humidifier Button Start Stop Button Ramp Button Use this button to start the ramp cycle which lowers the airflow pressure The ramp pressure and time settings are fixed When the airflow is turned on and the ramp button is pressed the airflow pressure will decrease to 4 cm H O and then will gradually increase ramp up to the prescribed
10. y 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 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 z mask with separate exhalation port such as the Whisper Swivel II 2 Respironics 6 ft 1 83 m x 22 mm I D flexible tubing 3 Respironics headgear not shown If this device is used for 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 Pressures must be verified when alternate or optional accessories are in place The Respironics DC Power Cord can be used to operate this device in a stationary recreational vehicle boat or motor home The Respironics DC Battery Adapter Cable when used with the Respironics DC Power Cord enables the device to be operated from a 12 VDC free standing battery The Respironics REMstar Heated Humidifier and Pass over Humidifier are available for use with this device The humidifiers may reduce nasal dryness and irritation by adding moisture and heat if applicable to the airflow Wh
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