Operating Manual
Contents
1. Sting enh esr 20 Setting cmH O Pressure Difference 0 61 0 66 ON 0 91 0 98 cmH O at mask to to to to to connection port 0 94 0 90 0 86 0 85 0 86 Humidity Maximum Humidity 43 9 mg L BTPS 100 RH at 4 cmH20O with humidity setting 4 Typical Humidity 27 2 mg L BTPS 99 2 RH at 10 cmH gt O with humidity setting 4 Gas Temperature Max 105 8 F 41 C Noise Level lt 30 dBA 12 OPERATING CONDITIONS AMBIENT TEMPERATURE 41 95 F 5 35 C HUMIDITY 10 95 Relative Humidity ALTITUDE O 9000 ft 0 3000 m STANDARDS COMPLIANCE Complies with EN IEC 60601 1 AS3200 1 0 UL 60601 1 ELECTRICAL RATINGS Supply Frequency Supply Voltage and Current 50 60 Hz NZANSASOCNEJ max 0 8 A 1 8 A 220 240 V max NOTE These values represent average current DC to AC Inverter Requirements 115 V 200 W 300 W surge 230 V 300 W 500 W surge 85 W max 149 F 65 C max Heater Plate Heater Plate Temperature The device complies with the electromagnetic compatibility requirements of IEC 60601 1 2 In certain circumstances the device may affect or be affected by nearby portable mobile radio frequency communication equipment due to the effects of electromagnetic interference If this should happen try moving your device or the location of the equipment causing interference or alternatively consult your healthcare provider NOTE Above 4500 ft 1500 m the maximum operating p2. aner Place the device on a level surface lower than head height to prevent water entering the tubing If water does enter the tubing drain excess condensate Water in the tubing may result in aspiration e The device is intended to be used with CPAP masks and connectors that have exhaust flow holes to allow continuous flow of air out of the mask When the device is turned on and operating properly new air flushes exhaled air out of the mask through the exhaust flow holes At low CPAP pressures and in the event of power failure or machine malfunction remove the mask immediately as flow through the mask may be insufficient to clear all exhaled gas and CO re breathing may occur which can be hazardous e Failure to select the correct altitude level for any given location will have an adverse effect on delivered pressure e This device is not intended for life support CAUTIONS To prevent water damage to your device e Remove the humidification chamber from the device before filling e Empty water from the chamber before transporting the device If the device is required to be handled with water in the chamber avoid tilting the device to prevent water entering its enclosure Other e To prevent damage to your PC only operate the device if it is connected to a PC via an isolated serial port adapter 900HC236 e To prevent airway irritation do not use the device when room temperature exceeds 95 F 35 C OTPAD ANS Research i
3. SleepStyle200 Ambient CPAP SERIES Plus Operating Manual Model HC244 HC242 Fisher Paykel HEALTHCARE Se a 10 11 12 13 14 15 SleepStyle 200 Series HUMIDIFIED CPAP SYSTEMS The SleepStyle 200 Series is a range of CPAP systems designed for use in the home for the treatment of OSA This manual is specific to the operation of CPAP models HC244 and HC242 For further assistance please contact your local Fisher amp Paykel Healthcare office see reverse for addresses Please keep this manual for future reference SleepStyle 242 is not available in all countries TABLE OF CONTENTS SIMS IS hehehe va ita A 2 Taide ZSEE OE CA A 2 RAMNSE CaEIENE AEDMNANEAIENION ca ai GOA AAA AOR EEEE A DE GIOUSRO the Devies E E A LO A 3 ja o A e eo q ee ee ee ee ee A 3 Ampoent Pra a O DEVOE eiA E AGAT CE OO A 3 A nn eee E T eee A 3 Be SSS ON NE A 3 SAME Taek nA RNS erain OO E EKO A EA E E A A 3 o nn e E A A 4 OW IRE Eco APIS A 4 2 UDA o A ee ee eee eee A 4 BO EO DRY A 4 Controls MA BIC och as ARA A O AAAA O ACO AA eee ae ee en eee eee A 5 8 1 Display Descriplions and PUCH NS sra A 5 Oe Fann ISI N ak A 6 8 3 Patient Menu Additional Settings UNI di A 6 Ceanna and IVR SNS sn A 7 Frequentes E dY KO ER E A 7 aE E E E e MA AA A 8 Saa CONTI a A 8 o E E EE E E AEE EEN A 8 on o A E AO O AA E AO AAAA A 8 Device and Consumables Disposal INSTRUCTIONS sii ios A 8 PLEASE READ ALL INSTRUCTIONS BEFORE IN
4. Summary Press once to switch device on off Press to activate Ramp Increase Decrease Display Mode Altitude A Pressure Setting cmH 90 Average Usage Hour night n Humidity Setting Total Run default Hypopnea Index LES Hours M y hr System Leak RETURN TO DEFAULT 0 1 2 3 4 0 5 INCREMENT NOTE To exit menu wait six seconds for LCD to revert to default display Only displayed if activated by healthcare provider 8 3 Patient Menu Additional Settings Summary Altitude Level Actual Pressure Altitude Units RETURN TO DEFAULT N or V Select Units for Altitude A or V Increase Decrease Altitude Level e Warning Failure to select correct altitude setting for any given location will have an adverse effect on delivered pressure NOTE To exit menu wait six seconds for LCD to revert to default display 10 CLEANING AND MAINTENANCE PLEASE NOTE The device should be cleaned as required I 2 Unplug the device from mains power Wipe the exterior of the device with a clean damp not wet cloth and mild dishwashing detergent Do not use harsh abrasives or solvents as these may damage the device DAILY Clean chamber and tube O Remove the breathing tube from the chamber and mask O Clean the tube with warm soapy water Rinse the tube thoroughly Hang up the tube with the tube ends pointing to the floor to dry O Remove the chamber by pushing down the
5. collected without the correct software will result in all data stored on the SmartStick being lost If that were to happen follow up therapy would not be possible Operate the device if dropped or damaged Operate the device if not working properly Adjust the pressure Pressure must only be adjusted by a healthcare professional Operate the device if the tube has been damaged with holes tears or kinks Block the exhaust flow on the interface Use the mask if the unit is not turned on or not operating properly To avoid burns do not Fill the chamber with boiling water Touch the exposed heater plate or chamber base To avoid the risk of fire while using oxygen do not e Turn oxygen flow on when the device is not operating this can lead to accumulation of oxygen within the device e Locate the device in a position where ventilation around the device is restricted e Use oxygen while smoking or in the presence of an open flame e Use any materials which will burn in air or ignite easily at high oxygen concentration e Keep any source of ignition near the product To avoid ignition it is preferable to keep all sources of ignition out of the room where supplemental oxygen is being used e Keep oxygen regulators cylinder valves tubing connections and all other oxygen equipment near oil grease or greasy substances Spontaneous and violent ignition may occur if these substances come into contact with oxygen under pressure
6. finger guard and pulling out the chamber O Pour out and discard the remaining water NOTE To completely remove water guide residual water between vanes and shake well Fig 1 O For standard HC385S chambers clean and wash with soapy water then rinse and dry Extended life chambers HC355 can be cleaned in a domestic dishwashing machine WEEKLY Thoroughly clean the chamber O Soak the inside of the chamber for 10 minutes in a solution of one part white vinegar to two parts water Empty the vinegar solution and rinse chamber well with water Replace the air filter when it becomes significantly discolored at least once every three months or after 1000 hours machine running time O Remove the filter holder from the back of the device and take out the filter O Replace the old filter with a new filter ensure the vertical black line is facing towards the device Fig 2 This device does not require routine servicing or calibration FREQUENTLY ASKED QUESTIONS When wake up in the morning my nose and throat feel dry What can do Try increasing your humidity setting If this does not help please contact your healthcare provider for advice How do prevent condensation in the tubing The humidity setting enables adjustment of humidity so that there should be fine misting in the six inches 15 cm of the breathing tube closest to your face If the humidity setting is too high for the conditions condensation may occur in
7. repairs and maintenance to Fisher amp Paykel Healthcare Only insert or remove the SmartStick when the device is in standby mode or not connected to mains power The SmartStick should only be removed when downloadable data is required by your healthcare provider To avoid data loss do not remove the SmartStick from the device while the light is flashing Use only Fisher amp Paykel Healthcare supplied SmartSticks Do not operate the device without the SmartStick cap secured over the SmartStick port Do not operate the device without the cover over the serial port adapter WARNINGS To avoid electric shock from your device do not Operate the device if the power cord or plug is damaged Operate the device if it has been dropped in water Plug the device into the power socket if it is wet Clean the device while connected to the power socket Store or use the device where it can tilt fall or be pulled into water If water has entered the unit enclosure disconnect the power cord and discontinue use Seek advice from Fisher amp Paykel Healthcare To avoid choking or inhalation of a foreign body Never place any object into any opening of the tube Ensure the air filter is fitted during device use To ensure optimal therapy do not Insert the SmartStick into any PC that does not have PerformanceMaximizer software installed Changing the directories on the SmartStick or attempting to view the data
8. GERMANY Tel 49 7182 93777 0 Fax 49 7182 93777 99 INDIA Tel 91 80 4123 6041 Fax 91 80 4123 6044 IRISH REPUBLIC Tel 1800 409 011 ITALY Tel 39 06 7839 2939 Fax 39 06 7814 7709 JAPAN Tel 81 3 3661 7205 Fax 81 3 3661 7206 MIDDLE EAST Tel 9 71 4 360 0849 Fax 9 71 4 368 8110 NORTHERN IRELAND Tel 0800 132 189 SPAIN Tel 34 902 013 346 Fax 34 902 013 379 SWEDEN Tel 46 8 564 76 680 Fax 46 8 36 63 10 SWITZERLAND Tel 0800 83 47 63 Fax 0800 83 47 54 UK EU Authorized Representative Fisher amp Paykel Healthcare UK Ltd Unit 16 Cordwallis Park Clivemont Road Maidenhead Berkshire SL6 7BU UK Tel 44 1628 626 136 Fax 44 1628 626 146 USA Tel 1 800 446 3908 or 1 949 453 4000 Fax 1 949 453 4001 1 85045254 REV A O Fisher amp Paykel Healthcare Ltd
9. ITIAL USE Caution USA Federal Law restricts this device for sale by or on the order of a physician 1 SYMBOL DEFINITIONS 2 CE Type BF Applied Part KR OF Do not Drip proof throw away ATTENTION Consult accompanying documents INTENDED USE The SleepStyle 200 Series CPAP Humidifier HC244 HC242 is for use on adult patients for the treatment of Obstructive Sleep Apnea The device is for use in the home or sleep laboratory ee I zz O 0123 Alternating Class Standby 93 42 EEC Current Double insulated Class Ilb WARNINGS CAUTIONS CONTRAINDICATIONS NSIT This manual refers to the SleepStyle 200 CPAP Series unit as the device If required to use CPAP by a referring physician you should use your device every time you sleep Should your device stop working for any reason contact your healthcare provider immediately The user of this system shall have sole responsibility and liability for any injury to persons or damage to property resulting from operation of the device which is not in accordance with the operating instructions supplied The device should only be used with ISO 17510 2 compliant masks connectors and delivery tubes recommended by Fisher amp Paykel Healthcare or your healthcare provider We recommend use of Fisher amp Paykel Healthcare masks to ensure true data accuracy Under normal operating conditions the air supplied by the device will not exceed 105 8 F 41 C Refer all
10. er is empty Machine failure due to water damage is not covered by warranty Can I use supplemental oxygen with my device Yes oxygen can be administered at the mask Turn the device on before turning on the oxygen Ensure that the oxygen source is turned off before turning off the device to avoid oxygen accumulating in the machine See Section 7 for more details Which masks are suitable for use with a SleepStyle 200 CPAP Series device It is recommended that you use a Fisher amp Paykel Healthcare mask Consult your healthcare provider regarding mask selection What happens to my device during power failure Upon restoration of the power supply the device will restart in the same operation mode with the same settings as before the power failure A 7 11 PRODUCT SPECIFICATIONS DIMENSIONS O SS 275 mm xX 170 man x 140 mm WEIGHT 4 2 lbs 1 9 kg 3 0 kg packaged in bag incl accessories PERFORMANCE Pressure Range 4to20cmH 0O In the unlikely event of fault conditions pressure may reach up to 30 cmH 0 Altitude Range 0 to 9000 ft or O to 3000 m Maximum Flow Rates CPAP Pressure Setting cmH O Measured pressure at the patient connection port cmH O Maximum flow rate L Min at mask connection port Static Pressure Stability long term 0 05 to 0 18 cmH O pressure difference measured at the mask connection port at the pressure setting of 10 cmH O Dynamic Pressure Stability short term
11. ings e When humidity is displayed the level of humidity can be changed using A and V buttons increase if experiencing airway dryness decrease if experiencing excessive condensation Standby Turns pressure ON OFF Ramp button Up button Increase setting Down button Decrease setting Mode button Step through options KEY FUNCTION AND DESCRIPTION OPERATION STANDBY switches the pressure ON and OFF RAMP TO START PRESSURE pressure on e Press O button briefly ON will flash three times on the LCD then the default will display TO STOP PRESSURE pressure off e Remove your mask e Press button briefly OFF will flash three times on the LCD then the device will return to standby mode and the default will display TO START PRESSURE pressure on Reduces pressure to a lower level to help you e Press the 4 button fall asleep The pressure will gradually return to Note To reset ramp during a cycle the device must be switched off first full operating pressure over 20 minutes TO SWITCH OFF INCREASE DECREASE Adjusts settings up or down MODE To step through options PATIENT MENU For viewing settings Humidity and Usage Data Starting from the default display press gt sequentially to view NOTE To exit menu wait six seconds for LCD to revert to default display PATIENT MENU ADDITIONAL SETTINGS e To access additional settings From the default display Press the P gt button for three second
12. ndicates the following pre existing conditions may contraindicate the use of positive pressure for some patients pneumothorax bullous lung disease pneumocephalus cerebrospinal fluid leak recent cranial surgery or trauma abnormalities of the cribriform plate pathologically low blood pressure or in patients whose upper airways are bypassed PRECAUTIONS e The safety and effectiveness of positive pressure has not been established in patients with respiratory failure or COPD ADVERSE EFFECTS e Nosebleeds ear and sinus discomfort may occur from the use of positive pressure therapy Please contact your physician if you have any questions concerning your therapy 4 DESCRIPTION OF THE DEVICE 4 1 Package Contents d LH 2 po SR 2 x HC385 S 0r 1x FIGS557 Depending on model of device S gt 4 2 Important Parts of Your Device FILTER HOLDER POWER CORD lt A ON OFF BUTTON SmartStick CAP S SmartStick PORT 900HC221 BREATHING TUBE AIR FILTER Sy HEATER PLATE SERIAL PORT Note For serial data communication only SmartStickTM DISPLAY 900HC010 CONNECTOR FINGER GUARD WATER CHAMBER e WATER LEVEL LINE 4 3 Accessories HC385S Standard Humidification Chamber 900HC611 SmartStickTM 5 Pack HC355 Extended Life Humidification Chamber 900HC225 Water Funnel 10 Pack 900HC010 Connector 900HC630 SmartStick Mailer 25 pack 900HC221 Breathing Tube 900HC240 Air Filter Not a
13. ressure will be reduced 13 STORAGE AND TRANSPORT The device should be stored and transported in environmental conditions of 14 to 140 F 10 to 60 C 14 TROUBLESHOOTING If you feel that your device is not operating correctly please contact your local Fisher amp Paykel Healthcare office see back cover for addresses and contact information 15 DEVICE AND CONSUMABLES DISPOSAL INSTRUCTIONS e Unit Disposal Instructions This unit contains electronics Please do not discard as regular rubbish Dispose according to local guidelines for disposing of electronics Gi e Consumable Disposal Instructions Place the mask breathing tube and water chamber in a rubbish bag at the end of use and discard with normal rubbish Fisher amp Paykel Healthcare has a policy of continued product improvement and reserves the right to alter specifications without notice Fisher amp Paykel CE 0123 HEALTHCARE Fisher amp Paykel Healthcare Offices MANUFACTURER Fisher Paykel Healthcare Ltd 15 Maurice Paykel Place East Tamaki Auckland 2013 P O Box 14 348 Panmure Auckland 1741 New Zealand Tel 64 9 574 0100 Fax 64 9 574 0158 Email info fphcare com Web www fphcare com AUSTRALIA Tel 61 3 9879 5022 Fax 61 3 9879 5232 AUSTRIA Tel 0800 29 31 23 Fax 0800 29 31 22 BENELUX Tel 31 40 216 3555 Fax 31 40 216 3554 CHINA Tel 86 20 3205 3486 Fax 86 20 3205 2132 FRANCE Tel 33 1 6446 5201 Fax 33 1 6446 5221
14. s e To view subsequent items Press the gt button NOTE To exit menu wait six seconds for LCD to revert to default display e Press the button e Press A and W buttons to raise or lower settings e Press sequentially to step through and view options available DISPLAY OPERATION e Displays humidity setting Adjust humidity to minimize upper airway side effects from treatment Press A and W to adjust humidity setting HI e Apnea Hypopnea Index AHI A Displays the average AHI for the last treatment session O System leak Displays system leak history for the last treatment session in liters per minute LPM System leak is comprised of exhaust flow mask leak and mouth leak Exhaust flow is the expected leak at the interface exhalation port required to flush CO from the mask A reading of 60 or below indicates an acceptable level of leak e Total run hours Displays the total hours the device has been run with the pressure on h Y e Average usage hours per night C Displays the average number of hours per night the device has been used DISPLAY OPERATION e Altitude units Displays altitude units Select m for meters or ft for feet using A and W buttons e Altitude level Displays altitude level Press A and W buttons to alter altitude j Activated by your healthcare provider if not activated will not be displayed Refer to your interface instructions regarding exhaust flow characteristics A 5 8 2 Patient Menu
15. see Section 8 1 11 For changing settings refer to Section 8 Controls and Display Your device is now ready for use Updating Settings 1 The SmartStick can be used by your healthcare provider to remotely view your compliance or efficacy data and make adjustments to the settings 2 Once the device is in standby mode or disconnected from mains power the SmartStick can be safely removed and sent to your healthcare provider 3 When the SmartStick is returned follow instructions above to ensure the SmartStick is reinserted correctly A blue light will illuminate on the end of the SmartStick when it is inserted correctly and USB will flash on the device LCD 4 When the blue light has stopped flashing press any button on the device to acknowledge data download The settings will now be updated on the device OXYGEN USE If oxygen is required it is recommended that supplemental oxygen be administered at the mask Please see instructions specific to your mask type NOTE e At a fixed flow rate of supplemental oxygen the inhaled oxygen concentration will vary depending on the pressure settings patient s breathing pattern mask selection and leak rate Before using oxygen with the device please see oxygen warnings in Section 3 8 CONTROLS AND DISPLAY 8 1 Display Descriptions and Functions NOTES Default Display For initial use the device will default to display humidity 00 as per factory sett
16. the breathing tube NOTE Using greater than 6 ft 183 cm of tubing will increase condensation There are several ways to reduce condensation in the tube i Ensure the device is not positioned in a cool draft ii Decrease the humidity setting on your device slightly Gradually decrease the setting until the condensation no longer occurs iii Warm the air in the room Do I have to use distilled water with my device The use of distilled water will maximize the life of the water chamber Water from the faucet even if it is passed through a filter will often contain minerals which can damage the chamber causing pitting in the base corrosion and possibly leaks When do replace my water chamber It is recommended that the chamber is replaced every six months or if the plastic walls of the chamber become cracked or discolored or the chamber base becomes pitted Regular cleaning will increase the lifesoan of your chamber NOTE If the chamber leaks at all it should be replaced immediately When do replace my breathing tube It is recommended that the breathing tube is replaced every six months or if there are any signs of cracking or deterioration Regular cleaning will increase the lifespan of your breathing tube Can I use my device in other countries Yes Simply use the appropriate electrical socket adapter and the device will automatically adapt to any voltage supply NOTE When moving your device ensure that the water chamb
17. top of the chamber Fig 5 5 Connect the other end of the tube to the mask Plug the device power cord into the rear of the device and into your household power socket 7 When connected to mains power the device will be in standby mode 8 The SmartStick is located at the rear of the device Detach the cap and ensure the SmartStick is inserted in the correct orientation The Fisher amp Paykel Healthcare logo should be the right way up If the label is upside down remove the SmartStick and reinsert the SmartStick in the correct orientation When the SmartStick is inserted into the device a small light at the end of the SmartStick will flash The light will remain illuminated indicating that data is being logged to the SmartStick Fig 6 NOTES e To download or update settings only insert or remove the SmartStick when the device is in standby mode or disconnected from mains power Do not insert or remove the SmartStick while the pressure is on e Only SmartSticks supplied by Fisher amp Paykel Healthcare can be used in the device 9 Once the SmartStick is correctly inserted secure the SmartStick cap over the SmartStick If the SmartStick is not being used the cap must still be secured in place Fig 7 10 Activate the device by pressing the on off button Fig 8 Upon activation ON will flash three times on the LCD display followed by a humidity setting factory default setting
18. vailable in all countries DEVICE ECHNOLOGY 5 1 Ambient Tracking Plus Ambient Tracking M Plus provides effective humidification under changing conditions by automatically adjusting the heater plate in response to changes in room temperature and leaks caused by the mouth and or mask leak This humidification technology maximizes humidity under ambient conditions and minimizes condensation to reduce mask pressure fluctuations ensuring the most effective performance of the device 6 6 1 6 2 SETUP INSTRUCTIONS System Setup 1 Remove the device from its packaging 2 Place the device on a low shelf or on the floor beside your bed so the device is positioned below head height 3 Chamber Setup a Remove one water chamber from the packaging b Remove the blue caps and discard them Fig 1 c Fill the chamber up to the water filling line with distilled water only an optional funnel is supplied for easy filling Fig 2 Never fill the chamber while it is attached to the device When moving your device ensure the water chamber is empty Machine failure due to water damage is not covered by warranty d To attach the water chamber to the device press down the finger guard line up the rear chamber hole to the CPAP outlet and slide the chamber on Fig 3 Fig 4 e When the chamber is fitted correctly the finger guard will click into place 4 One end of the tube has a white plastic connector Push this onto the outlet on
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