10 - CPAP Supplies
Contents
1. Home Care Provider Setup Instructions REMstar o US RESPIRONICS Always use these instructions along with the User Manual when Www respironics com assembling or adjusting this equipment For clinical systems f CPA P System refer to the setup guide entitled Respironics Products in the This CPAP System is intended only for the Sleep Lab part 1009751 for equipment setup assistance treatment of adult Obstructive Sleep Apnea Carrying ag Ps Filter CAA Pollen Filters Flexible Tubing 6 ft 1 83 m x 22 mm I D Symbols Display Screen Control Buttons Device Label l Attention consult A Elevation O en ney IN accompanying documents T Ramp Start Pressure Ramp AC Power SSS idifi Humidifier Setting AAA Humidifier On Off DC Power Hours of Use a Type BF Applied Part Number of nights DAA X gt 4 is oradhan 4 0 Class II Double Insulated d i hours usage IPXO Ordinary Equipment Therapy Setup Menu European CE Declaration of Conformit Settings are being erased C e y 0123 Button Lights Notified Body Approval C for Standards Compliance GP Canadian US Certification c US N Electrostatic Discharge ESD Susceptibility 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 Ingress2. 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 ELECTROMAGNETIC ENVI RONMENT 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 Information 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 10 Immunity Test IEC 60601 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 INOTE 1 At 80 MHz and 800 MHz the higher frequency range applies Test LEVEL 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONME
3. and can be used in addition to the pollen filter The ultra fine filter is recommended for people who are sensitive to tobacco smoke or other small particles 1 If you are using the ultra fine filter place one of the pollen filters over the ultra fine filter 2 Insert the filter s into the filter area on the back of the REMstar Plus An extra filter is included for the patient s convenience 3 Attach the filter cap Position the cap so that the small opening on the cap is facing down Insert the cap s tabs into the filter area opening CAUTION 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 Control Panel Display Screen All device settings will appear here Display Pressure Start Stop Button Use this button to turn start or Screen stop the airflow DO NOT start the airflow until the circuit tubing is connected Heated Humidifier Humidifier Button Use this button when the optional Button REMstar Heated Humidifier has been prescribed This Ramp Pressure button will turn the humidifier on off and control the heat set Button ae Stop ting Follow the instructions included with the humidifier Ramp Button Use this button to start the ramp cycle which lowers the airflow pressure IMPORTANT When the device is in the Therapy Setup Menu the humidifier and ramp buttons 4 operate as up and down keys to ch
4. by Respironics or the doctor 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 Plus pressures must be verified Use of these accessories may alter the pressure received reducing i the effectiveness of treatment Respironics Accessories When using accessories always follow the instructions enclosed with the accessories D N v Recommended Patient Circuit 1 Respironics nasal mask with integrated exhalation port or Respironics mask with separate exhalation port such as the Whisper Swivel II 2 Respironics 6 ft 1 83 m x 22 mm I D flexible tub ing 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 Iter endl 3 me 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 Humidi fier are available for use with this device The humidifiers may reduce nasal dryness and irritation by adding moisture a
5. 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 C O 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 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 replace any damaged parts before continuing use To avoid electrical shock disconnect the power cord before cleaning DO NOT immerse the REMstar Plus 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 coverings and non synthetic clothing discha
6. NT GUIDANCE Power frequency magnetic fields should be at levels characteristic of a typical location in a typical home or hospital environment Portable 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 ESAP d 1 24 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz 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 NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a 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 considered If the measured field stre
7. ange the settings The pressure start stop button Enter will take you to the next screen IMPORTANT For devices with serial numbers of 2 000 000 and greater the display screen has been updated and an 8 pin communications connector has been added Both display screens are shown below Thera py Setup 1 Plug the pronged end of the power cord into an electrical outlet To enter the Therapy Setup Menu hold the ramp and pressure on off buttons down while plugging the power cord into the Menu device The airflow will automatically start and the display screen will show the current elevation setting and the unlock symbol IMPORTANT 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 System Setup Elevation Setting Pressure Setting Fine Adjustment Setting Ramp Time Setting a The elevation setting will appear The patient also has access to this Setting in the Patient Setup Menu A J Lo or 1 less than 2 500 ft lt 762 m H 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 A wo NOTE Elevations of 7 500 ft 2 286 m may affect the accuracy of the 3 pressure Verify the pressure settings with a water column manometer To change the setting press the ramp or humidifier button until the correct setting appears Press the pressure
8. ext setting 0 20 NOTE If the ramp time is set to 0 minutes or if the CPAP pressure setting is 4 cm H 0 the following ramp setting will not be displayed Go to Step f Ramp Starting Pressure Setting gt 4 Setting Button Lights Exit Settings Service Disposal System Setup amp Service e The ramp starting pressure will appear Range 4 to Prescription Setting in 1 cm H O increments 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 f The number of nights this device has been used for more than four consecutive hours gt 4 will appear To erase the total and go back to zero press and hold the ramp or humidifier button An a will appear in the lower left corner and the total will change to 0000 Pressing the button again will restore the z gt 4 d original count N Press the pressure start stop button to go to the next setting 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 g The button lights setting will appear This setting allows you to have wv the lights behind the buttons turned on or off while the airflow is turned E 43 i I r l on O olf To change the setting press the ramp or humidifier button h The settings are complete To repeat the settings press the pressu
9. ion 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 establishments including domestic establishments and those directly connected to the public low voltage power supply network RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations Flicker emissions IEC 61000 3 3 EMC Information 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 Discharge ESD IEC 61000 4 2 Electrical fast Transient burst TEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 IEC 60601 Test LEVEL 6 kV contact 8 kV air 2 kV for power supply lines 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 gt 95 dip in U for 5 sec COMPLIANCE LEVEL 6 kV contact 8 kV air 2 kV for supply mains 1 kV for input output lines 1 kV differential mode 2 kV for common mode lt 5 U
10. nd heat if applicable to the airflow When 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 the 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 Install the filters CAUTION The pollen filter must be in place at all times when the REMstar Plus is operating The white ultra fine filter is optional
11. ngth 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 b Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 V m EMC Information RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND Tus 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 electromagnetic 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 SEPARATION DISTANCE ar TO FREQUENCY OF TRANSMITTER 150 kHz to 80 MHz 80 MHz to MHz 800 MHz to 2 5 GHz d 12 P d 1 2 P 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 RATED Maximum Power OUTPUT OF TRANSMITTER Note 1 At 80 MHz and 800 MHz the sepa
12. of Water IPXO Ordinary Equipment 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 Pressure Stability 4 0 to 20 0 cm H O 1 0 cm H O Measured in accordance with EN 17510 7 13 amp 20 cm H O 500 ml with BPM set to 10 15 amp 20 BPM 23 C 42 C 50a RH 5 and an atmospheric pressure of 101 54 kPascals Sound Pressure Level lt 30 dB A Measured in accordance with EN 17510 10 cm H O at the patient circuit This measurement applies to the REMstar Plus with or without the optional REMstar Heated Humidifier Maximum Flow 35 LPM Measured in accordance with EN 17510 7 13 amp 20cm H O 500 ml with BPM set to 10 15 amp 20 BPM 23 C 2 C 50 RH 5 and an atmospheric pressure of 101 54 kPascals CAUTION Indicates the possibility of damage to the device WARNING Indicates the possibility for injury to the user or operator Contraindications Warnings amp Cautions e US federal law restricts this device to sale by or on the order of a physician 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
13. ration 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 11 RESPIRONICS 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 8550 USA RESPIRONICS Deutschland Gewerbestrasse 17 82211 Herrsching Germany Ce 0123 1027796 JW 07 06 05
14. re 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 Plus System does not require routine servicing If the REMstar Plus begins to mal function refer to the Troubleshooting section of the User Manual or contact Respironics Inc Repairs and adjust ments must be performed only by trained personnel fully acquainted with this equipment Service per formed 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 Plus and accessories in accordance with local regulations If you need product assistance call Respironics Customer Service Department 1 800 345 6443 within he U S and Canada or 1 724 387 4000 EMC Information 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 in such an environment Emissions TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions Group 1 This device uses RF energy only for CISPR 11 its internal funct
15. rging 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 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 maxi mum 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 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 si gns 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 3 Accessories WARNING WARNING DC Power Humidifiers Oxygen WARNING WARNING WARNING WARNING WARNING Do not connect any equipment to the REMstar Plus unless recommended
16. start stop button to go to the next setting b The CPAP pressure setting will appear J Range 4 to 20cm H O in 1 cm H O increments em To change the setting press the ramp or humidifier button until g H20 the correct pressure appears Press the pressure start stop button to go to the next setting c The CPAP fine adjustment setting will appear This setting allows you to calibrate the device so that the pressure setting can be rh verified with a manometer Range 1 5 to 1 5 cm H O in cm 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 Plus 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 ramp time will appear vw Range 0 to 45 minutes in 5 minute increments The patient also has N 4 access to this setting in the Patient Setup Menu 5 J A To change the setting press the ramp or humidifier button Press the pressure start stop button to go to the n
Download Pdf Manuals
Related Search