CURASA Basic CPAP English USER MANUAL
Contents
1. Power frequency magnetic fields should be at normal levels typical of a location in a commercial or hospital environment NOTE UT is the A C mains voltage prior to application of the test level Sleep Apnea Breathing Therapy Device User Manual Immunity test IEC 60601 test level Electromagnetic environment guidance level Portable and mobile RF communications equipment including cables should not be used close to any part of the Curasa CPAPother than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 NPp Conducted RF 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz 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 metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a 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 gt 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 tra2. 55 C Relative humidity 10 93 non condensing Atmosphere pressure 500hPa 1060hPa DISPOSAL This device its accessories and its packaging have to be disposed correctly at the end of the usage Please follow Local Laws or Regulations for disposal Sleep Apnea Breathing Therapy Device User Manual ELECTRIC MAGNETIC INFORMATION GUIDANCE AND MANUFACTURERS DECLARATION OF ELECTROMAGNETIC IMMUNITY FOR EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE SUPPORTING Attention Please use Curasa CPAPSleep apnea breathing therapy device according to electric magnetic information in list The Curasa CPAPis intended for use in the electromagnetic environment specified below The user of the Curasa CPAPshould ensure that it is used in such an environment Emissiontest oo Compliance Electromagnetic environment guidance OO RF emissions Group 1 The Curasa CPAP uses RF energy only for its internal function Therefore its RF emissions are very low and are not a e i likely to cause any interference in nearby electronic equipment RF emission Class B The Curasa CPAPis suitable for use in all establishments including domestic establishments and those directly ae e connected to the public low voltage power supply network that supplies buildings used for domestic purposes IEC 61000 3 2 Voltage fluctuations Complies flicker emissions ei IEC 61000 3 3 Sleep Apnea Breathing Therapy Device User Manual Immunity test IEC 60601 test leve
3. CURASA Basic CPAP English USER MANUAL 0123 G CURATIVE e NE AE GAY ME A e o ERE E E e e ME KL EY Te YE ENR nents 4 Cautions A Af MNES IE O Pe Pi O II e 0 EE OOO nation istndetoasgancha T 5 CAUTIONS AA Pe o PI e po Ie 5 I PIN e OP A o E O II E o nests nes E E O EE 6 seers MN E E PANE EMPRENYE ME A A A RE MEM ON SENA AM ME RI OLEY DENEY 8 Ps o A AA E KM E KE FAY AYR e 8 el e US E E E A P N E A AE O A O E E A E E A E A E oli ota 8 AP ei o A o o O E ada E E E N 9 Meda lt lt NN E nn AA 10 Aia AA Om o o PA 10 FRONT AND BaCk VIEW annene Sml oz plana he M n alin So amilaz kas leer Error Bookmark not defined CONTO Dane A A A A A A SV A A A A EY 12 MCCS SONOS A AE GN YA ER e e 13 o e E oo An A ya 14 Al o SCC A o II o e O A 14 Parameters keys and a o AY RM ene Ea A YY MEN E e RE erene 15 PP A at MEYER SA e 15 G CURATIVE ME Re a e E KE e TN 16 e o e o n A A MN EY GEM e 17 FUNG ENS OF le e EN A o OO assess EA I E AE A A E E E E E AT 18 o PE EE E A E AP A o YY 18 aros Sp oes cise o e O e PE o UI yz ama ooo alaca 18 PP e o o o 5 YAY ER E A e e 18 dea As AP A A A a ea am a ea E an elde 18 ELA ay A A en o eo eve E 18 o a A A AE E O O o T 19 Checking the poOWertalure alar establo alna ei aa maas oie kinim 19 PP EE Re AP VA E OA E A E EE Y YA RE A YE ENNE EDA E e A EET 19 e a A VR Pr 19 ceann ME Be ee crs CPAP anat 20 A A PP A A R 20 WS eg a sci occas getters ccs ease PP PPP o YA Ae ee EM e
4. MHz 800 MHz to 2 5 GHz 35 p E For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres 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 80 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 Sleep Apnea Breathing Therapy Device User Manual CONTACT DETAILS Curative Medical Devices GmbH Manufacturer address Blasewitzer Str 41 01307 Dresden Germany Tel 49 351 4504500 Fax 49 351 4504511 info curative net
5. Off Key Input Keys Enter Key Air outlet Pressure tube Medical DC Power Jack of humidifier pin Information On bottom DC Power il Filter Production Calibration Sleep Apnea Breathing Therapy Device User Manual DATA TRANSMISSION N Attention The data transmission interface is only used during production or service when transmitting data to RS232 or the USB of a PC Equipment connected to the analog or digital interfaces must comply with the respective IEC standards e g IEC 950 for data processing equipment and IEC 60601 1 for medical equipment All configurations shall comply with the current version of the standard for SYSTEMS IEC 601 1 1 If you are in doubt consult the technical service department or your local representative RS232 and the USB port are only for technical use Sleep Apnea Breathing Therapy Device User Manual CONTROL PANEL LCD display EGE ON OFF key Input key ON Function key Sleep Apnea Breathing Therapy Device User Manual ACCESSORIES Power supply cord and power supply adapter WARNING The device should be used only with the external AC DC adapter provided by manufacturer Use of other AC DC adapters may cause damage to the device and cause fire and electric shock hazards Sleep Apnea Breathing Therapy Device User Manual ACCESSORIES AND PARTS e Curasa CPAP device including one fine filter e Power supply including one power supply cord for AC inp
6. SWD A password is required to change the therapy pressure PRESS on page 1 and also to clear the Therapy Time p on page 4 To set password page 7 key in 4 digits by using the input keys Once a password is accepted it will jump to page 1 or page 4 where a change of parameter is requested To exit password page select EXIT Sleep Apnea Breathing Therapy Device User Manual FUNCTIONS OF THE DEVICE AUTOON If AutoOn feature is selected the first breath will activate the device when the patient is wearing the mask e The device will switch to standby mode if o The mask is off for 3 seconds or more o Thepatient hose is disconnected or o The humidifier is switched off CPAP MODE In CPAP mode the device will output the set pressure constantly RAMP FUNCTION When this function is selected the device will start delivering the minimum air pressure first before increasing the pressure steadily to the set pressure within the set time This function is to allow the patient to fall asleep more comfortably This soft start function is particularly helpful for patients who are not accustomed to continuous positive airway pressure therapy The pressure delay time range is between 0 60 minutes with pressure steps every minute SKIPPING RAMP FUNCTION When using Ramp function pressing the On Off key will activate the Ramp If the On Off key is pressed again the Ramp function will be skipped and the air pressure will rise to the set pr
7. e Solution Ramp function is active Decrease soft start time Low air flow E Air inlet blocked Check air inlet The pressure tube is not connected or it is Check the pressure tube Motor always operates at blocked maximum speed Leakage in the device Contact our service center The device is in automatic operation AUTO Set the device to manual operation AUTO oh OFF Check wheth ble i ted When turned on the device Power is not plugged in IP a MEE with the device d t k OES Or No electric supply Check main electricity supply Fuse is blown Note before checking unplug Change fuse power cable Contact our service center Motor works normally but Patient hose or pressure tube is not correctl ae l Y l P y Check whether connection is correct and firm the output pressure is lower connected with the device than the set pressure Air leakage through mask or patient tube Contact our service center Dirty filter or air outlet blocked Change filter check air outlet Therapeutic pressure readjusted Consult your physician E If necessary cancel soft start function or set Soft start function active soft start function time again Patient hose is not connected or connected Check connection incorrectly Too noisy Only low output pressure Leakage through mask or patient hose Check patient hose Not air tight between humidifier and device Check humidifier and device Power failure alarm invalid The device not used fo
8. e device of it has been dropped in water o Keep device away from water o Before cleaning the device pull the power plug out of the socket e This device is for single patient use only and should not be shared with other patients e Ifthe patient experiences mucous membrane dryness in the nose and pharynx frontal sinus trouble earache a running nose or skin sensitivity etc you should consult your physician immediately e Operation of the device may be adversely affected by Electromagnetic fields exceeding the level of 3V m in the test conditions of EN 60601 1 2 7 Sleep Apnea Breathing Therapy Device User Manual The operation of high frequency diathermy equipment Defibrillators or short wave therapy equipment Radiation e g X ray CT Magnetic fields e g MRI Do not sterilize the device with high pressured steam LIABILTY The manufacturer shall not be held liable for any damages in case of e Tampering modifying adding expansion features or repair by persons who have not been authorized by the manufacturer e Using accessory or spare parts that are not recommended by us or not officially registered e Using the device in a way that was not instructed in the manual INTRODUCTION INTENDED USE The Curasa CPAP System is for the treatment of adult Obstructive Sleep Apnea OSA only The Curasa CPAP delivers CPAP Continuous Positive Airway Pressure therapy Your home care provider will make the corr
9. ect pressure settings A Sleep Apnea Breathing Therapy Device User Manual When prescribed by your physician 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 Several accessories are available to make your OSA treatment with the Curasa CPAP System as convenient and comfortable as possible and to ensure that you receive the safe effective therapy prescribed for you CONTRAINDICATIONS Studies have shown that the following pre existing conditions may contraindicate the use of positive airway pressure therapy for some patients e Bullous Lung Disease e Pneumocephalus e Pneumothorax e Pathologically Low Blood Pressure 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 pressure therapy may be temporarilycontraindicated if you exhibit signs of a sinus or middle ear infection Contact your physician if you have any questions concerning your therapy Sleep Apnea Breathing Therapy Device User Manual DESCRIPTION OF THE DEVICE CURASA CPAP On
10. er the mask Allergic reaction Ask your physician e If your dealer cannot resolve the problems please consult your physician or contact our service center Sleep Apnea Breathing Therapy Device User Manual MACHINE RELATED PROBLEMS Problem Solution Dry thoroughly or clean the pressure tube Check all connections to reduce leakage Re seat mask and adjust headgear to reduce leakage around mask You may take up to 4 weeks to be When pressure is over 13cmH O 1 3kPa accustomed to higher pressures When using Discomfort due to high some patients will feel discomfort However the device breathe through nose with mouth pressure this pressure may be needed for effective closed and keep calm If you continue to therapy experience discomfort consult your physician Low output pressure Air leak is detected by the device Symptoms of sleep apnea When your weight is increased your nose is syndrome appears again blocked or you drink etc you need higher Consult your physician like day time sleepiness pressures Dirty filter Change filter aie Air inlet blocked Check air inlet Air is too warm 4 The device is too close to wall curtains or Take away the device to keep it over 20cm other objects which hinders air circulation from wall curtains or other objects Defective device Contact our service center Water in the pressure tube Dry the pressure tube thoroughly Sleep Apnea Breathing Therapy Device User Manual Problem Caus
11. erse the device in liquid or allow any liquid to enter the enclosure inlet filter or any other openings 1 To clean the exterior of the device use a dampened cloth and a mild detergent Allow the device to dry completely before plugging in the power cord 2 The mask and tubing should be cleaned daily For details on cleaning your mask and accessories refer to the cleaning instructions packaged with the accessories CHANGING FILTER The fine filter is in the filter cassette at the back of the device Take it out and change it with a new one every week Never use the device without a filter Dirty inlet filters may cause high operating temperatures that may affect device performance Regularly examine the inlet filters for cleanliness If there is a lot of dust or smoke in the environment change the filter more frequently Sleep Apnea Breathing Therapy Device User Manual TROUBLESHOOTING e Different problems that may be encountered their causes and solutions are detailed below Problem Solution Dryness in mouth and Breathing through mouth Use chin strap or full face mask pharynx Low therapeutic pressure notify your dealer or physician Irritated or dry eyes Leakage between mask and skin Adjust the mask s position and headgear If the mask is worn out request a replacement from your dealer or physician Try another type of mask Redness Headgear is too tight Loose the headgear or inflammation of skin Ask your physician und
12. essure ALARMS Sleep Apnea Breathing Therapy Device User Manual POWER FAILURE N WARNING During use if a power failure occurs patients may inhale expired air e Incase of a power failure or if the power cord is disconnected the alarm will sound to inform the patient that they should remove the mask e The alarm can be switched off by pressing the on off key or will switch off automatically if power resumes CHECKING THE POWER FAILURE ALARM Switch the device on and keep running for at least 10 seconds If the power cord is unplugged or the power is switched off at the socket the alarm should sound Check whether the alarm lasts long enough around 30sec When the device is switched on the alarm should stop automatically Please check the alarm at least once a month LEAKAGE WARNING To minimize leakage ensure that the headgear is adjusted and fits appropriately e Ifthe AUTO ON function is disabled and the device detects that a patient s mask has been taken off or if there is an air leak the motor will run at a lower speed automatically and the pressure will reduce to below the set pressure e When the excessive air leakage is stopped the device will work normally again and return to the set pressure CLEANING AND MAINTENANCE Sleep Apnea Breathing Therapy Device User Manual CLEANING THE CURASA CPAP A WARNING To avoid electrical shock unplug the Curasa CPAP power cord before cleaning the device WARNING Do not imm
13. ime A A N VERSION Displays the software version of the device N PASSWD Password for changing pressure password can only be 4 digits accessed in edit mode Sleep Apnea Breathing Therapy Device User Manual KEYS ON OFF KEY Press the key down gently for about 1 2 seconds to turn on the device When the device is turned on the background light of LCD display will be illuminated It will be turned off if no any action is performed within 5 seconds When the Power supply is plugged in the device is in stand by mode The power indicator will be continuously on when the device is in stand by mode Device On Off means that motor is On or Off Power On Off means that power supply is On or Off INPUT KEYS Y Q Input keys are used for selecting functions and adjusting the parameters of a given function RETURN KEY Return key is used for accessing edit mode and confirming changes of parameters e To access edit mode to adjust parameters press the Y key once so that the editing function field blinks e With the input keys Y change the value of the selected parameter e Press key again to confirm and move to next parameter automatically Sleep Apnea Breathing Therapy Device User Manual DISPLAY PRESS XX X cm H20 A XX min OPERATE AUTOON OFF XX XemH20 THERAPY 00900 0000 0006 CLEAR THERAPY DD MM YYYY VERSION YES NO NO HH MM 55 V 2 00 The Ramp pressure page 2 always starts at 4cm H20 PAS
14. l Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60Hz Magnetic field IEC 61000 4 8 6 kV contact 4 kV air 8 kV air 2 kV for power supply lines 1 kV differential mode lt 5 UT gt 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 lt 5 UT gt 95 dip in UT for 5 sec 6 KV contact 4 kV air 2kV for power supply lines 1 kV differential mode lt 5 UT gt 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 lt 5 UT gt 95 dip in UT for 5 sec Floors should be wood concrete or ceramic tile If floor are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Curasa CPAPrequires continued operation during power mains interruptions it is recommended that the Curasa CPAPbe powered from an uninterruptible power supply or a battery
15. nsmitters 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 strength in the location where the Curasa CPAPis used exceeds the applicable RF compliance level above the Curasa CPAPshould be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re adjusting or relocating the Floton Auto CPAP b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Sleep Apnea Breathing Therapy Device User Manual RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE FLOTON AUTO CPAP The Curasa CPAPis intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Curasa CPAPcan help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Curasa CPAPas recommended below according to the maximum output power of the communications equipment Separation distance according to the frequency of transmitter Rated maximum output power of transmitter m W 150 kHz to 80 MHz 80 MHz to 800
16. r 21 MACHINE RELATED PROBLEM o suscrita aio oo 22 A A A A o o A 24 PP e o UOC E A e GRO o A 24 Q CURATIVE Curasa CPAP EUT BIS AR PE EE O PP Pe RP ER AMMA E e o a PEY en 25 cn e ER AE E A MN E Error Bookmark not defined Electric Magnetic eg MATION waidssisncaacerestenszsencnscvace nacactussinmesictadaivaisieawtadaunnndvantiesdeasineaianetacenaiesists bannsaiedloneienswanech A Eaa EAA A A aana 26 Guidance and manufacturers declaration of electromagnetic immunity for equipment and systems thatarenotlifesupporting 26 Recommended separation distances between portable and mobile RF communicationseguipmentandtheFlotonAutoCPAP 29 Disclaimer of warranty and limitation Of CuraSa s ssseessssersssrrserersserrssrrrsserrsssrerssrrssrersseresssrressrrreserressrrrssresserrsereeseeeeeseerrserersseeese Error Bookmark not defined Conce 94 e o KT A E E E E 30 SYMBOL KEY A M pi E O CURATIVE Attention Manufacturer Date of Serial manufacture number Consult accompanying documents Type B applied part Class Il Double insulated Curasa CPAP EUT The device DC Power Standby CE marked accessories product and the packaging have to be disposed correctly at the end of the usage Please follow Local Laws and Ordinances for disposal CAUTIONS AND WARNINGS CAUTIONS e This device is restricted to sale by or on the order of a phy
17. r long time at least Put the device on stand by mode for 12 three months hours Sleep Apnea Breathing Therapy Device SERV CE User Manual e Service of the Curasa CPAP should only be performed by persons authorized by the company e To ensure the device is properly maintained the user must read the Curasa CPAP sleep apnea breathing therapy device s safety instructions and cleaning instructions SPECIFICATIONS Curasa CPAP Pressure range Pressure variance Ramp time Noise 10 cm H20 71 0kPa Dimensions Weight Water temperature DC Voltage DC Current Protection again electric shock Degree of protection against electric shock Degree of protection against harmful ingress of water Electromagnetic Compatibility 4cm H20 0 4kPa 20 cm H20 2 0kPa 0 4 cm H20 0 04kPa 0 60min adjustable in min step lt 29dB A 170 mm L 117 mmW 93 mmH 1 4Kg 1 0Kg without humidifier 44 C Maximum 24VDC 2 5A Maximum Class Il Type B Applied Part Ordinary Equipment IPXO Curasa CPAP sleep apnea breathing therapy device meets the requirements of EN 60601 1 2 There are no user replaceable fuses Sleep Apnea Breathing Therapy Device User Manual AC DC adapter Model SNP A069 Output 24V 2 5A Input 100 240V 50 60Hz 2 1A Operation Temperature 5 C 35 C Relative humidity 10 93 non condensing Atmosphere pressure 700hPa 1060hPa Transport or storage Temperature 20 C
18. sician e Do not use the device before the recommended therapeutic pressure is prescribed by a physician a Sleep Apnea Breathing Therapy Device User Manual e The device should be used with the external AC DC adapter provided by manufacturer Use of other AC DC adapters may damage the device or cause fire and electric shock hazards e To prevent water entering the breathing circuit connection on the mask the device must always be positioned below the head e Do not use the device at room temperatures above 35 C If the device is used when temperature is above 35 C then the temperature of the airflow may exceed 41 C which could cause thermal irritation or injury to the patient s airway e Do not place the device near any items curtains bedding couch or heating devices air conditioners radiators vents that may disrupt the airflow around the device e Before carrying or packing the device you must empty the humidifier of water e The device should only be used with CE marked parts provided or recommended by your authorized dealer e Check the alarm function regularly and if the device has not been used for a long time please check the power failure alarm before use If the Power failure alarm is invalid the device must be left in stand by mode or left running for at least 12 hours before checking the alarm again to make sure it is functioning normally e If the device has recently been placed in a very hot or very cold environment wai
19. t for 2 hours to allow temperature to normalize before switching the device on e The device can only be operated at temperatures between 5 C and 35 C WARNINGS e The device cannot be used while mobile e This device is for adult use only and not for use by children or persons with certain disabilities who would require supervision in order to use the device safely Sleep Apnea Breathing Therapy Device User Manual e The device cannot be used for life support e Do not use the device in the presence of nitrous oxide or flammable anesthetic mixtures in combination with oxygen or air e Inthe event that the device noise level becomes higher than normal the devices output of air becomes too hot the device has an abnormal smell or if any part of the device becomes broken stop using it immediately contact an authorized dealer e The device can only be switched off completely when the power supply is disconnected from the wall socket e Make sure the exhalation opening in the mask or swivel is open so that the exhaled air containing CO can escape e To avoid rebreathing do not wear the mask for more than 3 minutes when the device is not switched on Note At low pressures the airflow may not be sufficient to remove all exhaled gas CO2 therefore some rebreathing may occur e The air inlet of the device should never be covered e To avoid electric shock o Donot use the device if the device if the casing or cables are damaged o Donot use th
20. ut e Hose CONNECTING THE SYSTEM e Check whether the device is damaged and if any accessories or parts are missing e Put the device on a stable and even surface Make sure the air inlet in the back of the device is not blocked e Connectthe power supply adapter with the power supply cord and then connect the DC output of adapter with DC power jack on the back of the device e Connect the two ends of the hose to the device s air outlet and mask separately Mask not included e Connect to the power supply Power supply adapter AC input voltage range AC 100 240V 50 60Hz DC output 24VDC2 5A Max When the device is on the power indicator light will illuminate and the display will show the preset parameters Sleep Apnea Breathing Therapy Device User Manual PARAMETERS KEYS AND DISPLAY PARAMETERS Function Introduction Range PRESS CPAP Pressure 4 20cmH20 70 4 72 0kPa 0 5 cmH20 0 05kPa per step AUTOON Automatic operation mode ON OFF N A Ramp time When using the ramp function the pressure 0 60min increasing pressure 1 step per minute starts at 4cmH gt 50 and rises until the device reaches the prescribed setting for CPAP therapy START Start pressure in Ramp time 4 20cmH gt 20 70 4 72 0kPa 0 5 cmH20 0 05kPa per step OPERATE Display the operation time 0 99999hr THERAPY Display the therapy time 0 99999hr CLEAR Clear the therapy time Choose between YES or NO THERAPY DD MM YYYY Displays the date N A HH MM SS Displays the t
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