CURASA CPAP PRO USER MANUAL
Contents
1. Curasa CPAP PRO Pressure range 4cm H20 0 4kPa 20 cm H20 2 0kPa Pressure variance 0 4 cm H20 0 04kPa Protection again electric shock Class II Electromagnetic Compatibility Curasa CPAP PROsleep apnea breathing therapy device meets the reguirements of EN 60601 1 2 Fuses There are no user replaceable fuses AC DC adapter Model SNP A069 Output 24V 2 5A G CURATIVE Curasa CPAP PRO Input 100 240V 50 60Hz 2 1A Operation Temperature 5 C 35 C Relative humidity 10 9396 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 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 7 CURATIVE Curasa CPAP PRO ELECTRIC MAGNETIC INFORMATION GUIDANCE AND MANUFACTURERS DECLARATION OF ELECTROMAGNETIC IMMUNITY FOR EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE SUPPORTING Attention Please use Curasa CPAP PROSleep apnea breathing therapy device according to electric magnetic information in list The Curasa CPAP PROis intended for use in the electromagnetic environment specified below The user of the Curasa CPAP PROshould ensure that it is used in such an environment Emissiontest Compliance Electromagneticenvironment guidance III L I RF emissions2. doesn t work AUTO ON AUTO OFF e Power is not plugged in Check whether power cable is connected e No electric supply with the device e Fuse is blown Note before checking Check main electricity supply unplug power cable Change fuse Contact our service center Motor works normally but e Patient hose or pressure tube is not Check whether connection is correct and the output pressure is lower correctly connected with the device firm than the set pressure e Air leakage through mask or patient tube Contact our service center e Defect device Only low output pressure e Dirty filter or air outlet blocked Change filter check air outlet e Therapeutic pressure readjusted Consult your physician e Soft start function active If necessary cancel soft start function or set soft start function time again Too noisy e Patient hose is not connected or Check connection connected incorrectly Check patient hose e Leakage through mask or patient hose Check humidifier and device e Not air tight between humidifier and device Power failure alarm invalid e The device not used for long time at e Put the device on stand by mode for 12 least three months hours SERVICE e Service of the Curasa CPAP PROshould only be performed by persons authorized by the company Q GURATIVE Curasa CPAP PRO e To increase the device s life the user must read the Curasa CPAP PROsleep apnea breathing therapy device s safety instructions and cleaning instructions SPECIFICATIONS
3. BOOKMARK NOT DEFINED CONTACT DETAILS 33 0 CURATIVE Curasa CPAP PRO SYMBOL KEY N w k uu E 06 Attention Consult accompanying documents Manufacturer Date of manufacture Serial number Type B Class II The device DC Power Standby CE marked applied part Double accessories product insulated and the packaging have to be disposed correctly at the end of the usage Please follow Local Laws and Ordinances for disposal Q CURATIVE Curasa CPAP PRO CAUTIONS AND WARNINGS CAUTIONS e This device is restricted to sale by or on the order of a physician e Do not 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 prevent water entering the breathing circuit connection on the mask the device must always be positioned below the head e Donotuse 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 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 y
4. 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 CURATIVE HUMIDIFIER e Before the first use of the Curasa CPAP PRO humidifier please clean it thoroughly e When filling the humidifier with water please disconnect it from the device e Fill the Curasa CPAP PRO 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 Q GURATIVE Curasa CPAP PRO PARAMETERS KEYS AND DISPLAY PARAMETERS Function Introduction Range PRESS CPAP Pressure 4 20cmH 0O 0 4 2 0kPa 0 5 cmH O 0 05kPa per step Ramp time When using the ramp function the pressure 0 60min starts at 4cmH O and rises until the device reaches the set 1 minute per step PRESS START Start pressure in Ramp time 4 20cmH 0 0 4 2 0kPa 0 5 cm
5. 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 o 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 the location where the Curasa CPAP PROis used exceeds the applicable RF compliance level above the Curasa CPAP PROshould 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
6. 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 ac f D A n D D N ACCESSORIES Power supply cord and power supply adapter Connecting tube Hose with a pressure tube Power supply cord 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 DEVICE AND HUMIDIFIER CONFIGURATION ACCESSORIES AND PARTS e 1 Curasa CPAP PRO device including one fine filter e 1 Humidifier e 1 Power supply adapter including one power supply cord for AC input e 1Hosewith an inserted pressure tube e 1 Mask connector diameter 22mm e 1 Headgear for use with mask e 1 Connecting 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 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 e Connect the pressure tube to the pressure port in the device e
7. ears Discomfort due to high pressure Symptoms of sleep apnea syndrome appears again like day time sleepiness Air is too warm No air flow Problem Low air flow Motor always operates at inflammation When pressure is over 13cmH O 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 Defective device Water in the pressure tube Ramp function is active Air inlet blocked The pressure tube is not connected or it 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 Contact our service center Dry the pressure tube thoroughly Solution Decrease soft start time Check air inlet Check the pressure tube Q CURATIVE meme maximum speed is blocked e Contact our service center e Leakage in the device When turned on the device e The device is in automatic operation Set the device to manual operation
8. ke Input key Function key Ms _ Pressure Tube Temperature knob E Pawer light k J n J La 5 LA ae p Power cord of humidifier Q CURATIVE Curasa CPAP PRO FRONT AND BACK VIEW Front Back Air inlet of humidifier Air outlet of humidifier Power cord of humldifler Fliter IC card slat TAN S Lo fe te n Temperature knob DC power jack Data transmission iv i E ofhost interface Air outlet of host Measuring tube connection DC power jack Power light of humidifier 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 0 CURATIVE Curasa CPAP PRO CONTROL PANEL LCD display DQHE ON OFF key Input key Function key Q CURATIVE Curasa CPAP PRO HUMIDIFIER Top of Humidifier Z i uh d f gt 2 L gt A r Outlet Min Water Line Max Water line Warning The humidifiers DC power jack
9. power failure occurs patients may inhale expired air Q CURATIVE Curasa CPAP PRO 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 If the 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 CLEANING AND MAINTENANCE CLEANING THE CURASA CPAP PRO WARNING To avoid electrical shock unplug the Curasa CPAP PRO 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 CURATIVE openings 1 To clean the exter
10. AND THE FLOTON AUTO CPAP The Curasa CPAP PROis intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user ofthe Curasa CPAP PROcan help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Curasa CPAP PROas 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 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz el E For transmitters rated at maximum output power 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 0 CURATIVE Curasa CPAP PRO 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
11. CURASA CPAP PRO USER MANUAL C ENGLISH CURATIVE SYMBOL KEY CAUTIONS AND WARNINGS CAUTIONS WARNINGS LIABILTY INTRODUCTION INTENDED USE CONTRAINDICATIONS DESCRIPTION OF THE DEVICE AND HUMIDIFIER CURASA CPAP PRO FRONT AND BACK VIEW CONTROL PANEL HUMIDIFIER ACCESSORIES DEVICE AND HUMIDIFIER CONFIGURATION ACCESSORIES AND PARTS CONNECTING THE SYSTEM 10 ERROR BOOKMARK NOT DEFINED 11 12 13 14 15 15 15 CURATIVE HUMIDIFIER 16 MASK 16 PARAMETERS KEYS AND DISPLAY 17 PARAMETERS 17 KEYS 18 ON OFF KEY 18 INPUT KEYS 18 RETURN KEY 18 DISPLAY 19 REGULAR USE OF THE DEVICE 20 AUTOMATIC MODE MANUAL MODE CPAP MODE RAMP FUNCTION ALARMS POWER FAILURE CHECKING THE POWER FAILURE ALARM LEAKAGE CLEANING AND MAINTENANCE ERROR BOOKMARK NOT DEFINED 20 20 20 20 20 21 21 21 CURATIVE CLEANING THE CURASA CPAP PRO 21 CHANGING THE CURASA CPAP PRO CLOCK BATTERY 22 CLEANING THE HUMIDIFIER 22 HUMIDIFIER FUSE 22 CHANGING FILTER 22 TROUBLESHOOTING 23 SERVICE 26 SPECIFICATIONS 27 DISPOSAL 228 QUALITY WARRANTY ERROR BOOKMARK NOT DEFINED ELECTRIC MAGNETIC INFORMATION GG 29 GUIDANCE AND MANUFACTURERS DECLARATION OF ELECTROMAGNETIC IMMUNITY FOR EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE SUPPORTING 29 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE FLOTON AUTO CPAP 32 DISCLAIMER OF WARRANTY AND LIMITATION OF CURASA ERROR
12. Group 1 The Curasa CPAP PROuses RF energy only for its internal function Therefore its RF emissions are very low and are Mw Tw not likely to cause any interference in nearby electronic equipment RF emission Class B The Curasa CPAP PROis suitable for use in all establishments including domestic establishments and those directly 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 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 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 Flo
13. H O 0 05kPa per step OPERATE Setting the operation time 0 99999hr THERAPY Setting 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 time N A VERSION Displays the software version of the device N A PASSWD Password for changing pressure password can only be 4 digits accessed in edit mode Q CURATIVE Curasa CPAP PR 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 A 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 D key once so that the editing function field blinks e With the input keys is Q change the value of the selected parameter e Press e key again to confirm and move to next parameter automatically Q CURATIVE DISPLAY CPAP cmH20 1 MONTH 1 WEEK VERSION
14. V 2 00 Curasa CPAP PRO OPERATE THERAPY CLEAR THERAPY DD MM YYYY YES NO PASSWD EXIT NO 990096 Notes The Ramp pressure page 2 always starts at 4cm H20 A password is required to change the therapy pressure PRESS on page 1 and also to clear the Therapy Time 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 0 CURATIVE Curasa CPAP PRO REGULAR USE OF THE DEVICE 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 ALARMS POWER FAILURE WARNING During use if a
15. ase 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 CURATIVE Curasa CPAP PRO INTRODUCTION INTENDED USE The Curasa CPAP PRO 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 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 Q CURATIVE Curasa CPAP PRO DESCRIPTION OF THE DEVICE AND HUMIDIFIER CURASA CPAP PRO LCD display ON OFF
16. ior 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 CURASA CPAP PRO 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 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 month Never use the device without a filter Q GURATIVE Curasa CPAP PRO 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 TROUBLESHOOTING e Different problems that may be encountered their cau
17. ors 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 CPAP PROreguires continued operation during power mains interruptions it is recommended that the Curasa CPAP PRObe powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at normal levels typical of a location in acommercial or hospital environment NOTE UTis 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 communications equipment including cables should not be used close to any part of the Curasa CPAP PROother than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance gau Conducted 3 Vrms 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz gt p 80 MHz to 800 MHz Q Radiated RF 3 V m 3 V m 61000 4 3 80 MHz to 2 5 GHz 7 d WP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W
18. ou must empty the humidifier of water e device should only be used with 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 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 WARNINGSI 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 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
19. ses and solutions are detailed below e If your dealer cannot resolve the problems please consult your physician or contact our service center Q CURATIVE 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 Problem Low output pressure or big pressure fluctuation Dry air Low room temperature 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 Water getting in the pressure sampling tube or the pressure tube blocked The pressure tube may not be connected with the device Curasa CPAP PRO Solution e Use 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 in a towel or a soft cloth to keep warm Solution Dry thoroughly or clean the pressure tube Connect the pressure tube with the Q CURATIVE Curasa CPAP PRO device correctly Pain in nose sinuses or
20. wall socket e Make sure the exhalation opening in the mask or swivel is open so that the exhaled air containing 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 Donotuse the device if the device if the casing or cables are damaged o Donotuse the device of it has been dropped in water CURATIVE Curasa CPAP PRO 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 Do sterilize the device with high pressured steam LIABILTY The manufacturer shall not be held liable for any damages in c
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