FLOTON CPAP/CPAP EUT USER MANUAL
Contents
1. CURATIVE HUMIDIFIER e Before the first use of the Floton CPAP CPAP EUT humidifier please clean it thoroughly e When filling the humidifier with water please disconnect it from the device e Fill the Floton CPAP CPAP EUT humidifier with purified or distilled water only The water must be cool contain no other additions and be below the maximum water line e The temperature range of the humidifier can be adjusted according to patient s requirement e When humidifier is connected correctly and the device is turned on and is delivering airflow the humidifier automatically heats and the indicator will light green When it reaches the set temperature the indicator light will switch off Use the knob to adjust the heating level MASK For information on use of the mask please refer to separate instructions provided with the mask CURATIVE Floton Auto CPAP PARAMETERS KEYS AND DISPLAY PARAMETERS Parameter PRESSURE EUT Level Introduction Pressure of airflow from device Level of the Expiratory Unloading Threshold EUT Ramp time When using the ramp function the pressure starts at 4cmH5 O and rises until the device reaches the set PRESS Automatic operation mode ON OFF Range 4 20cmH50 0 4 2 0kPa 0 5 cmH20 0 05kPa per step The Floton CPAP EUT has 4 operating modes In CPAP mode the device is set to a constant output pressure In EUT Expiratory Unloading Technology mode the device lowers the ou2. 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 air leakage stops the device will work normally again and return to the set pressure CURATIVE Floton Auto CPAP CLEANING AND MAINTENANCE CLEANING THE FLOTON CPAP CPAP EUT WARNING To avoid electrical shock unplug the Floton CPAP CPAP EUT power cord before cleaning the device WARNING Do not immerse the device in liquid or allow any liquid to enter the enclosure inlet filter or any other openings
3. GUIDANCE AND MANUFACTURERS DECLARATION OF ELECTROMAGNETIC IMMUNITY FOR EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE SUPPORTING Attention Please use Floton CPAP CPAP EUTSleep apnea breathing therapy device according to electric magnetic information in list The Floton CPAP CPAP EUTis intended for use in the electromagnetic environment specified below The user of the Floton CPAP CPAP EUTshould ensure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The Floton CPAP CPAP EUTuses RF energy only for its internal function Therefore its RF emissions are very low CISPR 11 and are not likely to cause any interference in nearby electronic equipment RF emission Class B The Floton CPAP CPAP EUTis suitable for use in all establishments including domestic establishments and those CISPR 11 directly connected to the public low voltage power supply network that supplies buildings used for domestic IEC 61000 3 2 Voltage fluctuations Complies flicker emissions mE IEC 61000 3 3 CURATIVE Immunity test IEC 60601 test level 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
4. breathing therapy device s safety instructions and cleaning instructions SPECIFICATIONS Floton CPAP CPAP EUT Pressure range Pressure variance Ramp time Noise 10 cm H O 1 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 H20 0 4kPa 20 H20 2 0kPa 0 4 cm H20 0 04kPa 0 60min adjustable 1min step 30dB A 170 mm L 117 mmW 93 mmH 1 6Kg 1 4Kg without humidifier 44 C Maximum 24VDC 2 5A Maximum Class II Type B Applied Part Ordinary Equipment IPXO Floton CPAP CPAP EUT sleep apnea breathing therapy device meets the requirements of EN 60601 1 2 There are no user replaceable fuses CURATIVE Floton Auto CPAP 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 55 C Relative humidity 10 93 non condensing Atmosphere pressure 500hPa 1060hPa DISPOSAL A 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 CURATIVE Floton Auto CPAP ELECTRIC MAGNETIC INFORMATION
5. 1 Toclean 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 THE FLOTON CPAP CPAP EUT CLOCK BATTERY A rechargeable Lithium Button Battery is used for the clock inside the device There is a danger of explosion and fire if the battery is incorrectly replaced Replace only with the same type RTC battery Model MC621 3 0 V 3 mAh CLEANING THE HUMIDIFIER 1 Disconnect the patient hose from the humidifier and remove the upper cap of the humidifier 2 Empty the water out of the humidifier before cleaning it with a moistened cloth with a mild detergent or soapy water 3 Never submerge the humidifier in water HUMIDIFIER FUSE The specification of the fuse for the heater in humidifier is 108 C 250V 10A CURATIVE 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 CURATIVE Floton Auto CPAP TROUBLESHOOTING e Di
6. FLOTON CPAP CPAP EUT USER MANUAL C Sleep Apnea Breathing Therapy Device 0123 ENGLISH CURATIVE SYMBOL KEY CAUTIONS AND WARNINGS LIABILTY INTRODUCTION INTENDED USE CONTRAINDICATIONS DESCRIPTION OF THE DEVICE AND HUMIDIFIER FLOTON CPAP CPAP EUT FRONT AND BACK VIEW CONTROL PANEL HUMIDIFIER ACCESSORIES ERROR BOOKMARK NOT DEFINED 10 11 11 12 13 14 15 FUNCTIONS KEYS AND DISPLAY ERROR BOOKMARK NOT DEFINED FUNCTIONS KEYS ON OFF KEY INPUT KEYS RETURN KEY ERROR BOOKMARK NOT DEFINED 19 19 19 19 CURATIVE DISPLAY FLOTON CPAP EUT FLOTON CPAP ACCESSORIES AND PARTS CONNECTING THE SYSTEM HUMIDIFIER IMASK REGULAR USE OF THE DEVICE TURNING THE DEVICE ON AND OFF AUTOMATIC MODE MANUAL MODE CPAP MODE RAMP FUNCTION LEAKAGE ALARMS CLEANING AND MAINTENANCE CLEANING THE FLOTON CPAP CPAP EUT CHANGING THE FLOTON CPAP CPAP EUT CLOCK BATTERY CLEANING THE HUMIDIFIER HUMIDIFIER FUSE CHANGING FILTER TROUBLESHOOTING 20 20 20 ERROR BOOKMARK NOT DEFINED 16 17 17 20 ERROR BOOKMARK NOT DEFINED 21 21 21 21 22 22 23 23 23 23 23 24 25 CURATIVE SERVICE 28 SPECIFICATIONS 28 DISPOSAL 29 QUALITY WARRANTY ERROR BOOKMARK NOT DEFINED ELECTRIC MAGNETIC INFORMATION ERROR BOOKMARK NOT DEFINED DISCLAIMER OF WARRANTY AND LIMITATION OF CURASA ERROR BOOKMARK NOT DEFINED CURATIVE SYMBOL KEY Floton CPAP CPAP EUT N h x A
7. connection CURATIVE FRONT AND BACK VIEW Front Air inlet of humidifier Air outlet of humidifier a T Measuring tube connection Data transmission interface Air outlet of host Floton Auto CPAP Back Filter Temperature knob Power light Power cord of humidifier N Attention The data transmission interface is only used during production or service when transmitting data to RS232 or the USB ofa 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 CURATIVE Floton Auto CPAP CONTROL PANEL floton On Off key Up Down keys Return key LCD display CURATIVE Floton Auto CPAP HUMIDIFIER Top of Humidifier Air Outlet Min Water Line Max Water line Warning The humidifiers DC power jack can only be used to connect to the device with the provided power cable for the humidifier Do not connect it with the other devices ij m dis a Arita CDA i A U L U C Ar CURATIVE ACCESSORIES Power supply cord and power supply adapter Connecting tube Hose
8. e The device is in automatic operation AUTO ON Power is not plugged in No electric supply Fuse is blown Note before checking unplug power cable Patient hose or pressure tube is not correctly connected with the device Air leakage through mask or patient tube Defect device Dirty filter or air outlet blocked Therapeutic pressure readjusted Soft start function active Patient hose is not connected or connected incorrectly Leakage through mask or patient hose Not air tight between humidifier and device e The device not used for long time at least three months Floton Auto CPAP Solution Decrease soft start time Check air inlet Check the pressure tube Contact our service center Set the device to manual operation AUTO OFF Check whether power cable is connected with the device Check main electricity supply Change fuse Contact our service center Check whether connection is correct and firm Contact our service center Change filter check air outlet Consult your physician If necessary cancel soft start function or set soft start function time again Check connection Check patient hose Check humidifier and device e Put the device on stand by mode for 12 hours Q CURATIVE Floton Auto CPAP SERVICE e Service of the Floton CPAP CPAP EUT should only be performed by persons authorized by the company e To increase the device s life the user must read the Floton CPAP CPAP EUT sleep apnea
9. e may not be connected with the device inflammation When pressure is over 13cmH20 1 3kPa some patients will feel unpleasant But this pressure may be needed for effective therapy When your weight is increased your nose is blocked or you drink etc you need higher pressures Dirty filter Air inlet blocked The device is too close to wall curtains or other objects which hinders air circulation e Defective device e Water in the pressure tube Floton Auto CPAP Solution Dry thoroughly or clean the pressure tube Connect the pressure tube with the device correctly Stop therapy and see your physician immediately You may take up to 4 weeks to be accustomed to higher pressures When using the device breathe through nose with mouth closed and keep calm If you continue to experience discomfort consult your physician Consult your physician Change filter Check air inlet Take away the device to keep it over 20cm from wall curtains or other objects e Contact our service center e Dry the pressure tube thoroughly CURATIVE Problem Low air flow Motor always operates at maximum speed When turned on the device doesn t work Motor works normally but the output pressure is lower than the set pressure Only low output pressure Too noisy Power failure alarm invalid Ramp function is active Air inlet blocked The pressure tube is not connected or it is blocked Leakage in the devic
10. en 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 CURATIVE Floton Auto CPAP INTRODUCTION INTENDED USE The Floton CPAP CPAP EUT respiratory sleep apnea breathing therapy device is for use by patients with sleep apnea or hypopnea syndrome to reduce the frequency of sleep apnea hypopnea and increases nocturnal SaO2 It provides a stable continuous positive airway pressure whilst the humidifier provides warm and humid air which helps to avoid nose and airway dryness increasing the comfort for the patient The therapeutic pressure is prescribed by a physician according to patient s condition CURATIVE CONTRAINDICATIONS The use of positive airway pressure may be contraindicated if the patient suffers from the following pre existing conditions e Pneumothorax e Pneumomediastinum Air in mediastinum e Cerebrospinal fluid leakage e Pneumocephalus e Extremely low blood pressure or shock e Confusion or coma resulting in the patient not been able to co operate with or accept the mask e Excessive secretions in the airway as well as not coughing effectively and weak voluntary breathing CURATIVE Floton Auto CPAP DESCRIPTION OF THE DEVICE AND HUMIDIFIER Host Humidifier FLOTON CPAP CPAP EUT LCD display On Off key Return key Measuring tube Connecting Tube
11. fferent problems that may be encountered their causes and solutions are detailed below e f your dealer cannot resolve the problems please consult your physician or contact our service center Problem Dryness and irritation of nose and throat Cold nose Dryness in mouth and pharynx Irritated or dry eyes Redness or inflammation of skin under the mask Water in the mask e Dryair e Low room temperature e Breathing through mouth Leakage between mask and skin Headgear is too tight Wrong mask size Allergic reaction When the room temperature is low and the humidifier is on it may cause water to condense Solution e Usea humidifier or heated humidifier e Increase room temperature Use chin strap or full face mask Low therapeutic pressure ask your physician Adjust the mask s position and headgear If the mask is worn out change it Try another type of mask Loose the headgear Ask your physician Ask your physician Lower the humidifier s heating temperature or increase the room temperature Wrap the patient hose ina towel or a soft cloth to keep warm CURATIVE Problem Low output pressure or big pressure fluctuation Pain in nose sinuses or ears Discomfort due to high pressure Symptoms of sleep apnea syndrome appears again like day time sleepiness Air is too warm No air flow Water getting in the pressure sampling tube or the pressure tube blocked The pressure tub
12. he location where the Floton CPAP CPAP EUTis used exceeds the applicable RF compliance level above the Floton CPAP CPAP EUTshould 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 CURATIVE RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE FLOTON AUTO CPAP The Floton CPAP CPAP EUTis intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Floton CPAP CPAP EUTcan help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Floton CPAP CPAP EUTas 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 MHz 800 MHz to 2 5 GHz 4 22 Jp 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 manufactu
13. 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 Floton CPAP CPAP EUTrequires continued operation during power mains interruptions it is recommended that the Floton CPAP CPAP EUTbe powered from an uninterruptible power supply or a battery 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 CURATIVE Immunity test IEC 60601 test level Electromagnetic environment guidance level Portable and mobile RF com
14. munications equipment including cables should not be used close to any part of the Floton CPAP CPAP EUTother than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 2132 Jp 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 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 considered If the measured field strength in t
15. rer 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 CURATIVE Floton Auto CPAP 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
16. rts 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 wait for 2 hours to allow temperature to normalize before switching the device on CURATIVE e The device can only be operated at temperatures between 5 C and 35 C WARNINGS e The device cannot be used whilst 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 e The device cannot be used for life support e Do 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 sure the exhalation opening in the mask or swivel is open so that the e
17. tomatic Operation The Ramp pressure minutes ON OFF always starts at 4cm H20 FLOTON CPAP Pressure Value cmH20 10 0 20 Omin RAMP Time Automatic O peration minutes ON OFF CURATIVE Floton Auto CPAP FUNCTIONS OF THE DEVICE AUTOMATIC MODE If the device is in Automatic mode 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 maskis off for 3 seconds or more o The patient hose is disconnected or o The humidifier is switched off MANUAL MODE If the device is in Manual mode then use the ON OFF key to start the device 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 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 pressure CURATIVE Floton Auto CPAP ALARMS POWER FAILURE
18. tput pressure during expiration and then gradually returns to the set therapy pressure for inspiration You can select from 3 comfort levels 1 the lower level 2 the middle level 3 the higher level Level 3 provides the largest pressure decrease 0 60min increasing pressure 1 step per minute CURATIVE KEYS ON OFF KEY FI D 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 Input keys 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 access edit mode to adjust parameters press the ae key once so that the editing function field blinks e With the input keys Uv change the value of the selected parameter e Press e key again to confirm and move to next parameter automatically CURATIVE Floton Auto CPAP DISPLAY FLOTON CPAP EUT Pressure Value EUT Level 0 1 2 3 temno 10 0cmH20 Omin Notes RAMP Time Au
19. ttention Consult accompanying documents Manufacturer Date of manufacture Serial number Type B applied part Class II Double insulated The device accessories and the packaging have to be disposed correctly at the end of the usage Please follow Local Laws or Regulations for disposal DC Power Standby Q CURATIVE Floton CPAP CPAP EUT CAUTIONS AND WARNINGS CAUTIONS AND WARNINGS CAUTIONS e This device is restricted to sale by or on the order of a physician e Do use the device before the recommended therapeutic pressure is prescribed by a physician 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 Donot 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 device should only be used with CE marked pa
20. with a pressure tube Power supply cord LJ 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 CURATIVE DESCRIPTION OF ACCESSORIES AND PARTS e 1 Floton CPAP CPAP EUT device including one fine filter e 1 Humidifier e 1 Power supply adapter including one power supply cord for AC input e 1 Hose with an inserted pressure tube e 1 Mask connector diameter 22mm e 1 Headgear for use with mask e 1Connecting tube Note Items with can be supplied by the manufacturer or purchased from other vendors that are CE marked 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 Connect the power supply adapter with the power supply 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 e Connect the pressure tube to the pressure port in the device 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
21. xhaled 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 Relevant to curative 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 Do use the device of it has been dropped in water Q CURATIVE Floton Auto CPAP 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 If the 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 The operation of high frequency diathermy equipment Defibrillators or short wave therapy equipment Radiation e g X ray CT Magnetic fields e g MRI Donotsterilize 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 be
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