XT Auto CPAP System Instruction Manual
Contents
1. Solutions No display 1 The power cord is not connected to the power socket 2 LCD failure or controlled PCB failure Ensure the power cord is connected Contact your equipment provider for repair Display code incorrect LCD failure or controlled PCB Contact your equipment provider for failure repair Illuminant under LCD is not LED failure Contact your equipment provider for on repair Buttons disable Button failure Contact your equipment provider for repair Air delivered is slow 1 During ramp time 1 Check the ramp time setting 2 Filter is too dirty 2 Change or clean the filter 3 Flow generator failure regularly 3 Contact your equipment provider for repair Data can not be copied to 1 SD card is full 1 Ensure the SD card has enough the SD card 2 SD card is not inserted capacity correctly 2 Ensure the SD card is inserted into 3 Data on the SD card is the slot corrupted 3 Format the card Error Warning Messages show in LCD 14 Message type Definition Message in LCD Error Error for abnormal system settings Error 001 Primary function te cantexecute Error for flow generator failure Error 002 Error for abnormal timer setting or timer failure Error 003 Error for flow sensor failure Error 004 Warning Out of system memory Warn 001 Syste2. 9S 006500 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 XT heated humidifier 9S 006500 instruction manual for complete setup information A NOTE When XT Auto CPAP 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 CPAP device and plug into main electrical outlet 6 Using the SD Card to Collect Data If physicians need to review the usage data they may ask you to use the SD card to copy data from the device and to return the card to them Data that is copied to the SD Card is still stored and available on the device 1 Insert the SD Card when the device is in standby mode 2 Data copying starts automatically when the SD Card is inserted into the slot 3 The COPY amp Card messages are displayed on the LCD while data is being copied 4 The End amp OK messages are displayed on the LCD when copying has finished 5 Remove the SD Card and mail it to the clinician 6 The SD card does not need to be uninstalled for the device to work properly Z caution Do not remove the SD card until End amp OK messages are displayed on the LCD or data copied to the card may be corrupted or missing 12 7 Cleaning amp Maintenance 7 1 Cleaning the Main Unit The main unit should be cl
3. 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 O 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 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 cmH50 to Therapy Pressure 1 cmH20 For example if your therapy pressure is 10 cmH2O the maximum ramp starting pressure you can select is 9 cmH20 3 Therapy Pressure only CPAP mode Press MENU button to select P XX XcmH O menu you can view the current pressure setting displayed in cmH2O 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 4 Initial Pressure only APAP mode Press MENU button to select Init 8 XX XcmH70 menu you can view the current pressure setting displayed in cmH O unit Initial pressure is adjustable only by the provider a respiratory therapist or physician NOTE The initial
4. pressure is to only be prescribed by a physician 5 Maximum Pressure only APAP mode Press MENU button to select Max Bs XX XcmH 0 menu you can view the current pressure setting displayed in cmH O unit Maximum pressure is adjustable only by the provider a respiratory therapist or physician NOTE The maximum pressure is to only be prescribed by a physician 6 Minimum Pressure only APAP mode Press MENU button to select Min XX XcmH 20 menu you can view the current pressure setting displayed in cmH O 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 7 PVA Pressure Variation Algorithm Press MENU button to select c on off menu you can view if the PVA function is enabled by the provider a respiratory therapist or physician The PVA function delivers pressure relief upon exhalation to improve comfort If the PVA function is enabled press UP or DOWN button to adjust the comfort level There are 3 adjustable levels of pressure relief that you feel while exhalation Level 1 provides small pressure variation and level 3 provides higher pressure variation 8 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 settin
5. re breathed CAUTION 1 Make sure the environment 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 If there is a possibility of electro magnetic interference with mobile phones please increase the distance between devices or turn off the mobile phone Do not connect the device to the personal computer for data downloading during the treatment This may cause the CPAP system failure To prevent from potential allergic reactions to mask used in the device This machine shall be used only with masks and connectors recommended by the manufacturer U S Federal law restricts this device to sale by or on the order of a licensed physician DANGER To reduce the risk of electrocution 1 N POND Always unplug this product immediately after using Do not use while bathing Do not place or store product where it can fall or be pulled into a tub or sink Do not place in or drop into water or other liguid 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 2 10 11 12 This product should never be left unattended when plugged in Close supervision
6. APEX XT Auto CPAP System Instruction Manual Model No 9S 005720 Please read the instruction manual before use Table of Content Important SafeguardS see ee ee Re ee Re nanana ana 1 1 INMOG UCT ON is ese NAN trek ioe ree ees es Adeeb ieee 3 2 Product Description riese ER EE ee Ee ee ER ER ER ER ER ER Ee ee ee ee ee n 5 ET SE Ee eisien 6 ell EE EE 7 5 Adding a Humidifier trees eek ee ee ee ee ee ER SR ER ER ee ee ee ee ee 12 6 Using the SD Card to Collect Data esse 12 7 Cleaning amp Maintenance ree ee Ee Ee ER ER ER ER Ee Ee ee ee 13 8 Troubleshooting ees Re ee 14 9 Technical Specifications EE EE OE EE 16 10 Note Caution And Warning Statements 17 11 Servicing EE EENKEER NINDA ARO ADA PRENO DA GE Ee tina ei oi re si ee ee 18 12 Limited Warranty EER EE EE EE decir nee dest 18 Appendix A EMC Information se EERS EE EES SEKERES SEER ESE KERE 19 IMPORTANT SAFEGUARDS PLEASE MAKE THIS PRECAUTIONS LIST AVAILABLE TO ALL USERS and PROVIDERS READ ALL INSTRUCTIONS BEFORE USING THIS SYSTEM WARNING 1 THIS DEVICE IS NOT INTENDED FOR LIFE SUPPORT It may stop operating due to power interruption but no hazards to patient 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
7. MECHANICAL HAZARDS ONLY US IN ACCORDANCE WITH ANSI AAMI 53DG ES60601 1 2005 3rd ed and CAN CSA C22 2 No 60601 1 2008 Le produit a t test avec des guipements m dicaux et respecte les normes ANSI AAMI ES60601 1 2005 3rd ed and CAN CSA C22 2 No 60601 1 2008 pr venant les choc lectrique le feu et les risques de blessures physiques EMC Warning Statement This eguipment 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 harmful interference in a typical medical installation This eguipment generates uses and can radiate radio freguency 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 M Reorient or relocate the receiving device Mm Increase the separation between the equipment m Connect the equipment into an outlet on a circuit different from that to which the other device s are connected m Consult the manufacturer or field service technician for help This system has been tested and com
8. and reduce the life A of the product CAUTION Do not wash or dry the mask or air tubing at a temperature above 70 C 160 F A WARNING Do not use any cleaner containing fragrance or conditioners as they will leave a residue A WARNING The mask must not be re used by another person This is to avoid the risk of cross infection 13 7 3 Air Filter Maintenance For an optimum operation of the device the air filter can be cleaned by the user at least once every two weeks or more often if this device is operated in a dusty environment lt is recommended that the filter be replaced with a new one after 6 months of use however depending on the air guality the replacement time may vary ZNCAUTION Dirty air filter may cause high operating temperatures that affect device performance Ensure the air filter is cleaned and fitted at all times device filter is torn replace it 3 Reinstall the filter 1 Remove the dirty filter from the enclosure on the rear of the 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 use a filter that is not completely dry If the NOTE Please follow national requirements to dispose the unit properly 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
9. d 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 NNOTE The plug is also served to disconnect the device 2 Connect one end of the air tubing firmly onto the air outlet of the CPAP Ko 3 Connect the other end of the air tubing to the mask system Putting on the mask and headgear according to the mask instruction manual English N 4 Operation A NOTE Always read the operating instruction before use 4 1 Control Panel Description Buttons arrangement on control panel and main use of the buttons N Vv O 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 XX X cmH O in cmH 0 unit MENU 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 to
10. device s enclosure and create a risk of fire Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame Always ensured the device is generating airflow before the oxygen supply is turned Always turn off the oxygen supply before stopping the airflow from the device This device should not be used in the vicinity of a flammable anesthetic mixture in combination with oxygen or air and nitrous oxide The airflow for breathing generated by this device may be as much as 7 C 12 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 If this device overheats it will stop operating and show Error 002 on the display After cooling down to proper temperature the device can restart again 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 after cooling down please re connect the power cord to reset the machine At low CPAP pressure some exhaled gas may remain in the mask and be
11. e information that you should pay special attention to CAUTION Indicate correct operating or maintenance procedures in order to prevent damage to or destruction of the equipment or other property WARNING Calls attention to a potential danger that requires correct procedures or practices in order to prevent personal injury 17 11 Servicing The XT series systems are intended to provide safe and reliable operation according to the instructions provided by Apex Medical Apex Medical recommends that the XT system be inspected and serviced by authorized technicians if there is any sign of wear or concern with device function Otherwise service and inspection of the devices generally should not be required during the five year design life of the device 12 Limited Warranty Apex Medical Corp hereafter Apex gives the customer a limited manufacturer warranty on new original Apex products and any replacement part fitted by Apex in accordance with the warranty conditions applicable to the product in question and in accordance with the warranty periods from date of purchase as listed below This warranty does not cover damage caused by accident misuse abuse alteration and other defects not related to material or workmanship To exercise your rights under this warranty please contact your local authorized Apex dealer Product Warranty period CPAP devices 2 years Water chamber 6 months Mask systems 6 months Disposable pr
12. eaned regularly at least every 30 days To clean the unit wipe it down with a damp cloth using a mild detergent When selecting a cleaning agent take precautions tochoose one that is not chemically abrasive to the surface of the plastic case All parts should be air dried thoroughly before use During storage the unit should be kept in a dust free location A WARNING Don t try to open this device Repairs and internal servicing should only performed by an authorized service agent Don t drop any subject into the air tube or air outlet 7 2 Tubing and Mask The tubing and mask should be checked and cleaned daily 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 nasal mask 3 Wash the mask system according to the instructions supplied with it Wash the air tubing in warm water using mild detergent 4 Rinsed thoroughly hang and allow to dry 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 ZN 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
13. g is adjustable only by the provider a respiratory therapist or physician 9 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 10 Alarm Press MENU button to select Alarm on 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 11 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 9 12 Clock Press MENU button to select Clock XX XX menu press UP or DOWN button to set the current time 13 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 20 seconds 14 Event Indication While the device is on
14. is necessary when this product is used by on or near children or invalids Choking resulting from a child swallowing a small part that has become detached from the device or its accessories Use this product only for its intended use as described in this manual do not use attachments not recommended by the manufacturer 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 Keep the cord away from heated surfaces Never block the air openings 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 Never drop or insert any object into any opening on the unit or into the tubing When disposing the unit because of damage or failure you must comply with the regulations of your particular region or country for disposing such eguipment No modification of this equipment is allowed Do not modify this equipment without authorization of the manufacturer If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe use of the equipment Do not leave long lengths of air tubing around the top of your bed It could twist around your head or neck while you are sleeping and lead to strangulation 1 1 1 Introduction Thi
15. m memory is nearly full Warn 002 SD card module communication failure Warn 003 Remove the SD card while data is being processed Warn 004 SD card is full Warn 005 Inconsistent ID no of device with SD card Warn 006 Wrong firmware version of SD card module Warn 007 SD card is damaged Warn 008 NOTE When the warning message appears contact your physician or equipment provider to download the memory data and reset the meter 15 9 Technical Specifications Item Power Supply Specifications Universal power supply AC100 240V 50 60 Hz 0 5 0 3A Pressure Range 4 20 cmH 0 adjustable in 0 5 cmH O increment Initial Pressure 3 19 cmH 0 adjustable in 0 5 cmH20 increment Maximum Pressure 5 20 cmH 0 adjustable in 0 5 cmH20 increment Minimum Pressure TEITE 4 19 cmH 0 adjustable in 0 5 cmH O increment Ramp Time 0 45 minutes adjustable in 5 minute increment Ramp Starting Pressure 3 19 cmH 0 adjustable in 0 5 cmH20 increment Operating Altitude up to 8 000 ft 2 438 m when the pressure is set at 4 18 cmH20 but limit to 5 000ft 1 524m when the pressure is set at 18 5 20 cmH O Dimensions W x D x H 14 5 x 13 0 x 10 0 cm or 5 7 x 5 1 x 3 9 Weight Approximately 800 g or 1 76 Ib Temperature Operating 5 C to 35 C 41 F to 95 F Storage 15 C to 50 C 5 F to 122 F Shipping 15 C to 70 C 5 F to 158 F Envir
16. oducts None 18 English gm Appendix A EMC Information Guidance and Manufacturer s Declaration Electromagnetic Emissions This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Emissions Test RF emissions CISPR 11 Group1 Compliance Electromagnetic Environment Guidance The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic eguipment RF emissions Class B CISPR 11 Harmonic emissions Class A IEC61000 3 2 Voltage fluctuations Complies Flicker emissions IEC61000 3 3 The device is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network Guidance and Manufacturer s Declaration Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test Electrostatic Discharge ESD IEC60601 test level 6kV contact Compliance 6kV contact Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered Voltage dips short interruptions and voltage variations on power supply inp
17. onment TE Humidity Operating 15 RH to 95 RH non condensing Storage 10 RH to 90 RH non condensing Shipping 10 RH to 90 RH non condensing Classification Class II Type BF Applied Parts Mask Not suitable for use in the presence of a flammable anesthetic mixture IP21 Protected against solid foreign objects of 12 5 mm and greater Protected against vertically falling water drops Continuous operation Note The manufacturer reserves the right to modify the specification without notice Symbols 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 Refer to instruction manual Attention should read the instructions Class Il OP i BI Protected against solid foreign objects of 12 5 mm and greater Protected against vertically falling water drops 7 N o Disposal of Electrical amp Electronic Equipment WEEE 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 sx recycling of this product please contact your local city office household waste disposal service or the retail store where you purchased this product m O I m U Authorized representative in the European community Manufacturer 10 Note Caution And Warning Statements NOTE Indicat
18. pliance 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 2 Product Description Components including 1 2 3 4 5 6 Main CPAP device Detachable power cord User manual Flexible air tubing with 1 8 m length Carrying bag SD card and USB cable A Note 1 ONLY for Physician or Technician to download data Patient should not use this unction A Note 2 Only applicable for devices with SD card slot A Note 3 Please use SD card smaller than 2GB which comply with SDHC standard Before using it please format it to FAT16 to ensure correct data collection AN caution Patient should not connect the device to the personal computer for data Air Filter downloading This may cause the CPAP system failure Menu Button Start Standby Button LCD Display Up Button Down Button Air Outlet SD Card Slot Mini USB Connector Power Socket 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 an
19. romagnetic propagation is affected by absorption and reflection from structures objects and people 20 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 freguency 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 an 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 streng
20. ry St Suite D Brea CA 92821 USA ec Rer APEX MEDICAL S L Elcano 9 6 planta 48008 Bilbao Vizcaya Spain tel APEX MEDICAL CORP No 9 Min Sheng St Tu Cheng New Taipei City 23679 Taiwan www apexbrand com Print 2012 All rights reserved
21. s manual is provided to explain initial set up and operating instructions This manual should be stored in a safe location and be readily accessible for future reference 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 pressure 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 and successfully approved to the following standards C d EN 60601 1 dier EN 60601 1 2 EN 61000 3 2 Class A EN 61000 3 3 AN For US and CANADA only WSSIE Medical Eguipment CPAP Ss AA WITH RESPECT TO ELECTRICAL SHOCK E348970 FIRE AND
22. 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 F1 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 Easy Compliance playback software 10 4 4 Flowchart of Menu settings Enter the user s menu mode by pressing the MENU button CPAP Mode CPAP APAP ie Ram Int P Ramp Time Initial Pressure lt 0 45 gt min lt 3 0 19 0 gt cmH20 Ramp P Max P Ramp Starting Pressure Maximum Pressure lt 3 0 19 0 gt cmH20 lt 5 0 20 0 gt cmH20 i P Min P Therapy Pressure Minimum Pressure lt 4 0 20 0 gt cmH20 lt 4 0 19 0 gt cmH20 C C oo Oo f PVA Comfort Level PVA Comfort Level pics FYA DT lt on off gt lt on off gt CM Compliance Meter lt XXXX X 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 A NOTE For physicians please refer to a separated Physician s Additional Instruction page 5 Adding a Humidifier XT Auto CPAP device can be used with XT Heated Humidifier
23. tal 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 UP Press the UP button to increase the value DOWN Press the DOWN button to decrease the value 4 2 Function Description Getting Started First time use For first time use follow the steps below 4 3 1 Make sure that your physician or care provider has initialized and configured the appropriate treatment values into the unit Make sure that your package contains a face or nasal mask with headgear If not your physician or care provider can recommend the type of mask and headgear you must obtain Attach tubing and mask see Setup section Attach power cord to the unit and an electrical outlet see Setup section Unit will power on automatically Use the MENU button to set the Current Time Ramp Up Time and Ramp Starting Pressure see MENU Button Section for description of these options Note that these values may have been already set by your physician or care provider Press the START STANDBY button Airflow to the mask will begin You can now place the Headgear and Mask over your head and face and begin treatment Menu Button Option Descriptions The following items describe the options presented to you after you press the MENU button on the control panel 1 Ramp
24. the a c mains voltage prior to the application of the test level 19 Guidance and Manufacturer s Declaration Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test IEC60601 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 2VP 150kHz to 80MHz d 1 2VP 150kHz to 80MHz d 2 3VP 80 MHz to 2 5G MHz Where P is the maximum output power rating of the transmitter in watts W 3Vrms150 kHz to 80 according to the transmitter manufacturer Conducted RF MHz outside ISM 3 Vrms and d is the recommended separation IEC 61000 4 6 bands distance in meters m P Field strengths from fixed RF transmitters Radiated RF 3 V m as determined by an electromagnetic site IEC 61000 4 3 3 V m 80 MHz to 2 5 survey should be less than the GHz compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Cp NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Elect
25. ths should be less than 3 V m 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 ma outp eparation distance according to fregue of tra e ele e of tra e 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 24P d 1 2NP d 2 3VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer 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 21 USA APEX MEDICAL USA CORP 615 N Ber
26. ut lines IEC61000 4 11 Ur for 0 5 cycle 40 Yo Ur 60 Yo dip in Ur for 5 cycles 70 Yo Ur 30 Yo dip in Ur for 25 cycles 25 Ur 795 dip in Ur for 5 sec IEC61000 4 2 8kV air 8kV air with synthetic material the relative humidity should be at least 30 Ng F A Electrical rast transient b ret ev for power supply Hel for power supply Mains power quality shou d be nat IEC61000 4 4 line line of atypical commercial or hospital 1kV for input out line 1kV for input out line environmen 1kV for differential 878 1kV for differential 3 i Mains power quality should be that Surge eee mode of atypical commercial or hospital IEC61000 4 5 2kV for common 2kV for common JIP P environment mode mode lt 5 Yo Ur gt 95 dip in lt 5 Yo Ur gt 95 dip in Mains power quality should be that Ur for 0 5 cycle 40 Yo Ur 60 Yo dip in UT for 5 cycles 70 Yo Ur 30 Yo dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec of atypical commercial or hospital environment If the user of this device requires continued operation during power mains interruptions it is recommended that the device be powered from an_ uninterruptible power supply or a battery Power frequency 50 60Hz magnetic field IEC61000 4 8 3 A m 3 A m Power freguency magnetic fields should be at levels characteristic of atypical typical commercial hospital environment location in a Or NOTE Ur is
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