804 APAP
Contents
1. Components including 1 Main CPAP device 2 Detachable power cord 3 User manual G Heese ae 5 Full face or nasal mask and headgear straps Optional Always use CE certified and 510 k cleared mask for CPAP Up to 8 000 ft 2 438 m when the pressure is set at 4 18 cmH O 6 Carrying bag optional Operating Altitude but limit to 5 000ft 1 524m when the pressure is set at 18 5 20 7 miniSD card and USB cable cmH2O Note 1 ONLY for Physician or Technician to download data Patient should not use this Dimensions W x D x H 14 5 x 13 0 x 10 0 cm or 5 7 x 5 1 x 3 9 function Weight Approximately 800 g or 1 76 Ib Aine 2 Only applicable for devices with miniSD card slot Sound Level 30 dBA at 10 cmH20 1 meter distance Note 3 Please use miniSD card smaller than 2GB which comply with SDHC standard Operating 5 C to 35 C 41 F to 95 F Temperature Storage 15 C to 50 C 5 F to 122 F Shipping 15 C to 70 C 5 F to 158 F caut ON Patient should not connect the device to the personal computer for data environne Operating 15 RH to 95 RH non condensing downloading This may cause the CPAP system failure Humidity Storage 10 RH to 90 RH non condensing Shipping 10 RH to 90 RH non condensing Before using it please format it to FAT16 to ensure correct data collection Class l Type BF Applied Parts Nasal Mask MENU Not suitable for use in the presence of a flammable anesthetic C2. time 12 Turn off the Device Remove the power cord from the electrical outlet and disconnect power cord from the power socket on the back of device NOTE Once the setting is confirmed press MENU button Otherwise the device will automatically go back to standby without saving the modification if no action is taken in 5 seconds 13 Event I ndication While the device is on standby mode press UP and DOWN button at the same time to see the latest data of Apnea Index Al Hypopnea Index HI Snoring Index SI and Flow Limitation Index FI on the display Press MENU button to show each index in sequence To go back to standby mode press START STANDBY button NOTE Once the device is re started all the indexes will be re calculated Index data can only be viewed by respiratory therapists or physicians by using APAP Compliance playback software 4 3 Flowchart of Menu settings Enter the user s menu mode by pressing the MENU button APAP APAP Mode Int P CPAP Mode CPAP Ramp Ramp Time lt 0 45 gt min Initial Pressure lt 3 0 19 0 gt cmH2O0 Max P Maximum Pressure lt 5 0 20 0 gt cmH2O Ramp P Ramp Starting Pressure lt 3 0 19 0 gt cmH2O Min P Minimum Pressure lt 4 0 19 0 gt cmH2O0 P Therapy Pressure lt 4 0 20 0 gt cmHO Low P Low Pressure Auto Off lt on off gt CM Compliance Meter lt XXXX X
3. use a filter that is not completely dry If the filter is torn replace it 3 Reinstall the filter NOTE Please follow national requirements to dispose the unit properly 12 5 Adding a Humidifier 804 APAP device can be used with the integrated heated humidifier 9S O06500 which is available from the home care provider The heated humidifier may reduce nasal dryness and irritation by providing adequate moisture and heat to the airflow Please refer to the integrated heated humidifier 9S O06500 instruction manual for complete setup information fy Re a pe e m a NOTE When 804 APAP device is used with the heated humidifier its power supply is from the power socket outlet of the heated humidifier Do not connect the power cord to APAP device and plug into main electrical outlet 6 Using the miniSD Card to Collect Data If physicians need to review the usage data they may ask you to use the miniSD card to copy data from the device and to return the card to them Data that is copied to the miniSD Card is still stored and available on the device Insert the miniSD Card when the device is in standby mode Data copying starts automatically when the miniSD Card is inserted into the slot The Card message is displayed on the LCD while data is being copied 1 2 3 4 The OK Card message is displayed on the LCD when copying has finished 5 Remove the miniSD Card and mail it to the clinician 6 The min
4. Distributed by CVO Medical Solutions 2636 289th Place Adel IA 50003 USA 515 993 5001 515 993 4172 fax 800 759 3038 toll free www evomedical com APEX MEDICAL S L Maximo Aguirre 18 Bis 8 planta 48011 Bilbao Vizcaya Spain APEX MEDICAL CORP 9 Min Sheng St Tu Cheng Taipei County 236 Taiwan 676001 6310 V1 3 804 APAP Instruction Manual Model No 9S 005740 Please read the instruction manual before use Limited Warranty evo warrants the 804 APAP to be free from defective workmanship and materials for a period of 2 years from the date of purchase This warranty is limited to the dealer Any defective part or assembly will be repaired or replaced at the sole discretion and determination of evo if the unit has not been misused or tampered with during the warranty period Normal maintenance items as outlined in this manual and disposable components are not covered by this warranty Shipping charges if any shall be paid by the purchaser NOTE There is no other express warranty Implied warranties including those of merchantability and fitness for a particular purpose are limited to the duration of the express limited warranty and to the extent permitted by law and all implied warranties are excluded This warranty does not cover providing a loaner APAP compensating for costs incurred for APAP rental or labor costs incurred in repairing or replacing defective part s Contents Important Sal
5. UP or DOWN button to set the preferred ramp starting pressure and press MENU for confirmation The ramp starting pressure can be changed from 3 cmH O to Therapy Pressure 1 cmH20 For example if your therapy pressure is 10 cmH20 the maximum ramp starting pressure you can select is 9 cmH20 3 Therapy Pressure only CPAP mode 4 Press MENU button to select P XX XcmH2O menu you can view the current pressure setting displayed in cmH20 unit Therapy pressure is adjustable only by the provider a respiratory therapist or physician NOTE The therapy pressure is to only be prescribed by a physician Low Pressure Auto Off only CPAP mode Press MENU button to select LOW P on off menu you can view if the Low Pressure Auto Off setting is enabled and the device will be automatically turned off while detecting a large leak for 3 minutes This setting is adjustable only by the provider a respiratory therapist or physician 5 Initial Pressure only APAP mode Press MENU button to select Init XX XcmH2O menu you can view the current pressure setting displayed in cmH20O unit Initial pressure is adjustable only by the provider a respiratory therapist or physician NOTE The initial pressure is to only be prescribed by a physician 6 Maximum Pressure only APAP mode Press MENU button to select Max XX XcmH2O menu you can view the current pressure setting displayed in CMH20 unit Maximum pressure
6. cal location in a typical I EC61000 4 8 commercial or hospital environment NOTE U is the a c mains voltage prior to the application of the test level 16 BF symbol which indicated this product is according to the degree of protecting against electric shock for type BF equipment Attention should read the instructions Class II Ba Attention should read the instructions el Disposal of Electrical amp Electronic Equipment WEEE Ndi This product should be handed over to an applicable collection point for the recycling of electrical and electronic equipment For more detailed information about the recycling of this product please contact your local city office household waste disposal service or the retail store where you purchased this product Authorized representative in the European community Manufacturer 10 NOTE CAUTION AND WARNING STATEMENTS A NOTE Fos ON Indicate correct operating or maintenance procedures in order to prevent Indicate information that you should pay special attention to damage to or destruction of the equipment or other property LZ warn NG Calls attention to a potential danger that requires correct procedures or practices in order to prevent personal injury 15 EMC Warning Statement This equipment has been tested and found to comply with the limits for medical devices to the EN 60601 1 2 2007 These limits are designed to provide reasonable protection against harm
7. d Format the card Error Warning Messages show in LCD Message type Definition in LCD Error for abnormal system settings Primary function can t Error for abnormal timer setting or execute timer failure System memory is nearly full Wam wam 002 miniSD card module communication failure Remove the miniSD card while data is being processed Warning miniSD card is full NOTE When the warning message appears contact your physician or equipment provider to download the memory data and reset the meter 13 3 Installation 3 1 Unpacking To secure its contents inside the CPAP device and accessories are bundled in a paper packaged box Unpack this box by removing the CPAP and its accessory and checking for any damage which may have occurred during shipping If there are damages please contact your dealer immediately 3 2 Setting Up 1 Connect the power cord to CPAP device and plug into main electrical outlet Once the power cord is plugged into the electrical outlet the device is in ready to operate position STANDBY sign appears in LCD display J N NOTE The plug can also be used to disconnect the device 2 Connect one end of the air tubing firmly onto the air outlet of the CPAP 3 Connect the other end of the air tubing to the mask system Putting on the mask and a headgear according to the mask instruction manual 4 Operation AN wore Always read the operating instructio
8. d above the recommended separation distance od 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 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 18 Guidance and Manufacturer s Declaration Electromagnetic mmunity 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 EC60601 test level Compliance Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of this device including cables than there commended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2P 150kHz to 80MHz Conducted RF 3Vrms150 kHz to 80 3Vrms IEC 61000 4 6 MHz outside ISM bands d 1 2JP 150kHz to 80MHz d 2 3 P 80 MHz to 2 5G MHz Radiated RF IEC 61000 4 3 3V m_ 80 MHz to 2 5 3V m Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the
9. d successfully approved to the following standards EN 60601 1 EN 60601 1 2 0197 EN 61000 3 2 Class A EN 61000 3 3 AN For US and CANADA only S gt Fle Medical Equipment CPAP E228589 U with respect to electrical shock fire and CAS L US mechanical hazards only in accordance with 53DG UL60601 1 and CAN CSA C22 2 No 601 1 Le produit t test avec des quipements m dicaux et respecte les normes UL 60601 1 amp CAN CSA C22 2 No 601 1 pr venant les choc lectrique le feu et les risques de blessures physiques Appendix A EMC I nformation 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 Harmonic emissions Class A I EC61000 3 2 The device is suitable for use in all establishments including Voltage domestic establishments and those directly connected to the public fluctuations low voltage power supply network Flicker emissions I EC61000 3 3 Guidance and Manufacturer s Declaration Electromagnetic mmunity 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 EC60601 test Electromagnetic level Environment Guidance Floors should be
10. efore stopping the airflow from the device 5 This device Should not be used in the vicinity of a flammable anesthetic mixture in combination with oxygen or air and nitrous oxide NOTE L equipment ne peut tre utilis s il y a risqu de m lange d un anesth sique inflammable avec l air ou l oxyg ne ou oxide nitreux 6 The airflow for breathing generated by this device may be as much as 7 C 44 6 F higher than the room temperature This device should not be used if the room temperature is warmer than 35 C 95 F to prevent the airflow temperature from exceeding 40 C 104 F and causing irritation to your airway 7 If this device overheats it will stop operating and show message Error 002 on the display After cooling down to proper temperature the device can restart again 8 This machine should be used only with masks and connectors recommended by the manufacturer or by your physician or respiratory therapist A mask should not be used unless the CPAP machine is turned on and operating properly The vent holes associated with the mask should never be blocked for proper exhaling purpose If the vent hole is blocked the CPAP machine will stop and show message Error 002 Unplug the power cord and allow unit to cool down After unit has cooled please re connect the power cord to reset the machine 9 At low CPAP pressure some exhaled gas may remain in the mask and be re breathed CAUTION 1 Make sure the envi
11. equardS a saiuteteseic iets ERR ec inigo lilana a AAA A T AAAA E Oo ON OU A W N 10 Note Caution and Warning Statements u sese 2026 APPENDIX A EMC Information cc cece eee ee cues gt Product DESCNPTON iatxietateteieatumebeidinieiekwhetentes x NSC UO MGs 25 fasten kce Beecher eeh Ou aeRe Recah boa ota Se te eae c OPTa sai tatostnn tre aie E eee aly Adding a humidifier sieve cee aver da dad acecews Using the miniSD Card to Collect Data u e ae aae e ae v me e ae me Cleaning amp Maintenance u sesse aee aeeoe annae mennan meme mene S roUDIESROOUNG ease are a a E teens Technical Specification u u s a aeo aeu eaeoe oaeeo oeann omena IMPORTANT SAFEGUARDS SAVE THESE INSTRUCTIONS READ ALL INSTRUCTIONS BEFORE USING WARNING 1 THIS DEVICE IS NOT INTENDED FOR LIFE SUPPORT It may stop operating due to power interruption but no hazards to patient 2 If oxygen is used with the device the oxygen flow must be turned off when the device is not in use Explanation of the Warning When the device is not in operation and the oxygen flow is left on oxygen delivered into the tubing may accumulate within the device s enclosure and create a risk of fire 3 Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame 4 Always ensure the device is generating airflow before the oxygen supply is turned on Always turn off the oxygen supply b
12. ful interference in a typical medical installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving device Increase the separation between the equipment Connect the equipment into an outlet on a circuit different from that to which the other device s are connected Consult the manufacturer or field service technician for help This system has been tested and compliance to the following volunteer standards FDA 1 2 Intended Use This device is intended to provide continuous positive airway pressure CPAP for the treatment of adult Obstructive Sleep Apnea OSA A Cautions Some patients might have pre existing contraindications for CPAP therapy or might experience some potential side effects of using CPAP device please consult your physician if you have any questions concerning your therapy 9 Technical Specifications 2 Product Description Item Specifications Universal power supply AC100 240V 50 60 Hz 0 5 0 3A
13. gt hr lt on off gt lt hh mm gt In each setting when the preferred value has been selected press MENU for confirmation and press MENU again to enter next selection NOTE For physicians please refer to a separated Physician s Additional Instruction page
14. iSD Card should be stored in the plastic card case when not in use The miniSD card does not need to be uninstalled for the device to work properly Z cauti ON Do not remove the miniSD card until OK Card message is displayed on the LCD or data copied to the card may be corrupted or missing 7 Cleaning amp Maintenance 7 1 Device The device should be checked and dusted regularly at least every 30 days Wipe with a damp cloth and a mild detergent and keep it free from dust If other detergent is used choose one that will have no chemical effects on the surface of the plastic case All parts should be air dried thoroughly before use AN Don t try to open this device Repairs and internal servicing should only WARNI NG performed by an authorized service agent Don t drop any foreign object into the air tube or air outlet 11 4 2 Function Description 1 Ramp Time only CPAP mode Ramp time function allows the user to fall asleep with a lower more comfortable pressure and helps them gradually become accustomed to increasing treatment pressure The second selection of pressing MENU is Ramp XX MIN When the MENU setting is in Ramp XX MIN mode press UP or DOWN button to set the preferred ramp time and press MENU for confirmation There are 10 adjustable levels 0 5 10 15 20 25 30 35 40 and 45 minutes 2 Ramp Starting Pressure only CPAP mode Press MENU button to select Ramp P XX X menu press
15. is adjustable only by the provider a respiratory therapist or physician NOTE The maximum pressure is to only be prescribed by a physician 7 Minimum Pressure only APAP mode Press MENU button to select Min XX XcmH2O menu you can view the current pressure setting displayed in cmH20 unit Minimum pressure is adjustable only by the provider a respiratory therapist or physician NOTE The minimum pressure is to only be prescribed by a physician 8 8 Compliance Meter Press MENU button to select CM XXXX X hr menu the compliance meter records the total therapy hours for the device The compliance meter should be re set only by the provider a respiratory therapist or by a physician 9 Alarm Press MENU button to select Alarm ony off menu press UP or DOWN button to set the alarm on or off When alarm is turned on the audible alarm will activate with warning messages showed on the LCD display Set alarm off for mute the audible alarm 10 Clock Alarm Press MENU button to select Clock Alarm on off menu press UP or DOWN button to set the clock alarm on or off When clock alarm is set on the display will show the time on the left side Press UP or DOWN button to set the time to wake you up Once the clock alarm is activated press the start standby button to mute the audible alarm 11 Clock Press MENU button to select Clock XX XX menu press UP or DOWN button to set the current
16. lassification mixture START STANDBY Button IPXO Enclosed equipment without protection against ingress of LCD Display water Continuous operation UF Button NOTE the manufacturer reserves the right to modify the specification without notice USB Connector Mini SD Card Slot Power Socket 8 Troubleshooting The table below lists troubleshooting solutions for the problems that may happen If the problem persists contact your equipment provider service agent Problem Possible Causes Solutions 1 The power cord is not 1 Ensure the power cord is connected connected to the power socket No display 2 Contact your equipment provider for 2 LCD failure or controlled PCB repair failure i i LCD failure or controlled PCB f i Display code incorrect Failure Contact your equipment provider for repair Illuminant under LCD i LED failure Contact your equipment provider for repair aa not on Buttons Buttons disable Button failure Contact your equipment provider for repair Check the ramp time setting Change or clean the filter regularly Contact your equipment provider for repair 1 During ramp time Air delivered is slow 2 Filter is too dirty 3 Flow generator failure miniSD card is full Ensure the miniSD card has enough Data can not miniSD card is not inserted capacity copied to the miniSD correctly Ensure the miniSD card is inserted into card Data on the miniSD card is the slot corrupte
17. n electromagnetic site survey should be considered If the measured field strength 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 reorienting or relocating the device d Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m DANGER To reduce the risk of electrocution 1 Always unplug this product immediately after using 2 Do not use while bathing 3 Do not place or store product where it can fall or be pulled into a tub or sink 4 Do not place in or drop into water or other liquid 5 Do not reach for a product that has fallen into water Unplug immediately WARNING To reduce the risk of burns electrocution fire or injury to persons 1 This product should never be left unattended when plugged in 2 Close supervision is necessary when this product is used by on or near children or invalids 3 Use this product only for its intended use as described in this manual do not use attachments not recommended by the manufacturer 4 Never operate this product if it has a damaged cord or plug if it is not working properly if it has been dropped or damaged or dropped into water Return the product to a service center for examination and repair 5 Keep the cord away from heated surfaces 6 Never block the air openi
18. n before use 4 1 Control Panel Description Button arrangement on control panel and main use of the buttons START STANDBY To start the treatment simply press the START STANDBY button To stop the treatment press the START STANDBY button again The display will switch between STANDBY and Therapy Pressure XXX cmH2O in cmH20 unit or APAP J ven UP Press the MENU button to enter the setting mode when device is in standby mode The adjustment setting includes mode selection ramp time selection ramp starting pressure therapy pressure adjustment initial pressure adjustment maximum pressure adjustment minimum pressure adjustment alarm ON OFF clock alarm and clock setting compliance meter and total operating meter When each setting s value has been changed press MENU for confirmation and press MENU again for next setting selection Please refer to 4 2 Function Description section for detailed information Press the UP button to increase the value A YY vom Press the DOW N button to decrease the value 7 7 2 Tubing and Mask The tubing and mask should be checked and cleaned regularly Please refer to the cleaning instruction packaged with the accessories 1 Disconnect the air tubing from the air outlet of the device 2 Remove the air tubing and headgear straps from the mask 3 Wash the mask system according to the instructions supplied with it 4 Wash
19. ngs of this product or place it on a soft surface such as a bed or couch where their Openings may be blocked Keep the air opening free of lint hair and other similar particles 7 Never drop or insert any object into any opening or hose 8 Follow the national requirement to dispose unit 1 Introduction This manual should be used for initial set up of the system and saved for reference purpose 1 1 General Information Obstructive Sleep Apnea OSA is a condition that an intermitted and repetitive obstruction of the upper respiratory tract causes a complete apnea or partial hypopnea block of breathing airflow during sleep The syndrome varies depending on the degree of relaxation of the tongue and soft palate muscle The most common treatment for OSA is Continuous Positive Airway Pressure CPAP CPAP devices can deliver a constant air pressure into your upper airway via a nasal mask This constant air pressure can keep your airway open during sleep therefore prevents the OSA This device is a micro processor controlled continuous positive airway pressure device It features the illuminated menu driven LCD display universal power supply and ramp time adjustment The ramp time adjustment and ultra quiet operation ensure you to fall asleep comfortably while air pressures slowly build up to treatment level The user compliance meter records the total system s operating time for physician s reference The system has been tested an
20. 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 R 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 a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges c 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 a
21. ronment around the machine is dry and clean Dust and foreign particles may affect the treatment Keep the air inlet on the back of the machine clear to prevent overheating and damage of the device Do not place the machine near a source of hot or cold air Extreme cold or hot environment may damage user s respiratory airway 2 If there is a possibility of electro magnetic interference with mobile phones please increase the distance between devices or turn off the mobile phone 3 Do not connect the device to the personal computer for data downloading during the treatment This may cause the CPAP system failure 4 U S Federal law restricts this device to sale by or on the order of a licensed physician Recommended separation distances between portable and mobile RF communications equipment and this 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 Rated maximum Separation distance according to frequency of transmitter m output power CUS a 150 kHz to 80 MHz 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P For transmitters rated at a maximum output power not liste
22. the air tubing in warm water using mild detergent Rinsed thoroughly hang and allow to dry 5 Before next use assemble the mask and headgear according to the mask user instructions 6 All items of the mask and air tubing are subject to normal wear and tear and may eventually be replaced Replace the mask and the air tubing if they are damaged A CAUTION Do not use blench chlorine alcohol or aromatic based including all scented oils moisturizing or antibacterial soaps to clean the cushion mask air tubing These solutions may cause hardening and reduce the life of the product AN CAUTIO Do not wash or dry the mask or air tubing at a temperature above 70 C 160 F UN WARNIN Do not use any cleaner containing fragrance or conditioners as they will leave a residue AN WARNIN The mask must not be re used by another person This is to avoid the risk G of cross infection 7 3 Air Filter The air filter should be cleaned at least once every two weeks or more often if this device is operated in a dusty environment and replaced with a new one every six months AN CAUTI ON Dirty air filter may cause high operating temperatures that affect device performance Ensure the air filter is cleaned and fitted at all times 1 Remove the dirty filter from the enclosure on the rear of the device 2 Wash the filter in warm water with a mild detergent and rinse with water Allow the filter to air dry completely before reinstalling Do not
23. wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 2kV for power 2kV for power Mains power quality should be that supply line supply line of atypical commercial or hospital 1kV for input out 1kV for input out environment line line 1 kV line s to Surge line s 1 kV line s to I EC61000 4 5 2 kV line s to line s earth Immunity Test Compliance Electrostatic Discharge ESD I EC61000 4 2 6kV contact 6kV contact 8kV air 8kV air Electrical transient burst EC61000 4 4 Mains power quality should be that of atypical commercial or hospital environment lt 5 UT gt 95 dip lt 5 UT gt 95 dip Mains power quality should be that Voltage dips shortjin UT for 0 5 cycle in UT for 0 5 cycle of atypical commercial or hospital interruptions and 40 UT 60 dip in 40 UT 60 dip injenvironment If the user of this voltage variations on UT for 5 cycles UT for 5 cycles device requires continued operation power supply input 70 UT 30 dip in 70 UT 30 dip in during power mains interruptions it lines UT for 25 cycles UT for 25 cycles is recommended that the device be I EC61000 4 11 lt 5 UT gt 95 dip lt 5 UT gt 95 dip powered from an uninterruptible in UT for 5 sec in UT for 5 sec power supply or a battery Power frequency Power frequency magnetic fields 50 60Hz magnetic should be at levels characteristic of field atypi
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