Fisher & Paykel SLEEPSTYLE 600 User's Manual
Contents
1. 2 Never operate the device if a it has a damaged power cord or plug b the heated breathing tube has been damaged with holes tears or kinks c it has been dropped or damaged d it has been dropped into water e it is not working properly f it is connected to a PC during CPAP treatment Return the device to an authorised service center for examination and repair 3 Do not use the device when the room temperature exceeds 35 C 95 F as this may lead to an elevated airflow temperature which may give rise to an irritation of the airways 4 Ensure an air filter is fitted when operating your unit 5 Remove the humidification chamber before filling Do not fill water through the heated breathing tube connection 6 Do not fill the chamber with boiling water 7 When handling or operating the device avoid tipping the machine to prevent any chance of water entering the unit enclosure If this does occur immediately disconnect the power cord and discontinue use Seek advice from your homecare provider 8 Place your device on a level surface lower than your head height to prevent water entering the respiratory tubing should the device be knocked over 9 Do not store or use your device where it can fall or be pulled into water If water has entered the unit enclosure disconnect the power cord and discontinue use Seek advice from your homecare provider 4 OXYGEN USE WARNINGS 14 19 20 21 22 Never block t2. 626 146 USA Tel 1800 446 3908 1 949 453 4000 Fax 1 949 453 4001 1 85044288 REV D Fisher amp Paykel Healthcare Limited
3. and unplug from the power socket Wipe the exterior of the device with a clean damp not wet cloth and mild dishwashing detergent Do not use harsh abrasives or solvents or these may damage the device DAILY Clean chamber heated breathing tube and heated breathing tube connection port WEEKLY Thoroughly clean the chamber Remove the heated breathing tube from the device by pulling sleeve upwards to unlock the connector Then remove connector Wash the heated breathing tube with soapy water rinse and then hang up the heated breathing tube with its ends pointing to the floor to dry Remove the chamber by pushing down the finger guard and pulling out the chamber Pour out and discard the remaining water For standard HC365 chambers clean and wash with soapy water then rinse and dry The extended life HC360 chamber reguires disassembly before cleaning Push the base off the chamber top as shown in Fig 1 Ensure the round seal at the base is not loose or damaged Wash the chamber top and base in a mild dishwashing detergent Rinse thoroughly and dry This chamber may also be cleaned in a domestic dishwashing machine Thoroughly wipe the inside of the heated breathing tube connection port with a clean damp low lint cloth Soak the inside of the chamber for 10 minutes in a solution of one part white vinegar to two parts water and rinse well with distilled water MAINTENANCE Replace the air filter when it becomes significantly
4. i i a R a a aiak aueta A 8 FON e e azeri A 8 IDC AS OO 0 A ai i i a i i i i a a T dO A 8 OGONA Transpor COICO S ais skai iai i i GEEWA WAL A 8 MMM FO j c i PP PPP a A 8 I NEM A 9 PSS issiverkti N E A A 9 PLEASE READ ALL INSTRUCTIONS BEFORE INITIAL USE Caution USA Federal Law restricts this device for sale by or on the order of a physician 1 SYMBOL DEFINITIONS Be O CE 0123 nt IPX1 42 EEG Type BF ATTENTION Power 93 Consult Drip Proof Alternating Current Class Il On Off Class Ilb Applied Part Double Insulated accompanying documents 2 INTENDED USE The device is used to assist with patient breathing while sleeping for the purpose of treating Obstructive Sleep Apnea OSA This is done by the delivery of Continuous Positive Airway Pressure CPAP in order to prevent airway obstruction The addition of heated respiratory humidification to the device relieves the drying and irritating effects on the patient airways which usually arises from use of a CPAP system The device is for use on adult patients at home or in the sleep lab Please refer to the SleepStyle 600 Series product range listed in the appendix section of this manual 3 WARNINGS PLEASE NOTE This manual refers to the SleepStyle 600 CPAP Series unit as the device 1 The device should only be used with masks connectors and delivery tubes recommended by Fisher amp Paykel Healthcare or by your physician or respiratory therapist
5. 0 m or O to 9000 ft 30 min 30 mg l 11 OPERATING CONDITIONS AMBIENT TEMPERATURE HUMIDITY AEMIODE 225 10 95 RH 0 3000 m 9000 ft STANDARDS COMPLIANCE Designed to conform to the requirements of IEC 60601 1 UL60601 1 CSA C22 2 No 601 1 AS3200 1 0 EN60601 1 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 equipment due to the effects of electromagnetic interference If this should happen try moving your unit or the location of the device causing interference or alternatively consult your homecare provider Above 1500 m 4500 ft the maximum operating pressure will be reduced 12 STORAGE AND TRANSPORT CONDITIONS The device should be stored and transported in environmental conditions of 14 to 140 F 10 to 60 C 13 TROUBLESHOOTING If you feel that your device is not operating correctly consult your homecare dealer Do not attempt to repair the device yourself Fisher amp Paykel Healthcare have a policy of continued product improvement and reserve the right to alter specifications without notice 6 14 WARRANTY Please contact your Fisher amp Paykel Healthcare Provider regarding warranty 15 APPENDIX The following table lists the main difference in features across the SleepStyle 600 Product Range MODEL Fully Integrated CPAP with Patient Compliance Auto Altitude Adj
6. ER CORD gt ON OFF BUTTON FILTER HOLDER f AIR FILTER DISPLAY 5 3 Accessories HC365 Standard Humidification Chamber HC360 Extended Life Humidification Chamber 900HC522 ThermoSmart Heated Breathing Tube 900HC240 Filter 2 Pack 900HC604 Outlet Cleaning Kit HC600 900HC230 ComplianceMaximizer Software 1 x ThermoSmart Heated Breathing Tube 1 x Spare Air Filter 2 x Water Chamber 1 x Power Cord 1 x Funnel Accessories CONNECTOR witH SLEEVE THERMOSMART HEATED BREATHING TUBE CONNECTION PORT HEATERPLATE WATER CHAMBER Rt FINGER GUARD FUNNEL WATER FILL LINE vertical WATER LEVEL LINE 900HC232 Compliance Download Serial Cable 900HC607 TitrationMaximizer M Software 900HC236 Isolated Serial Adapter 900HC226 Lead Extension Kit 900HC627 Elbow Funnel 10 Pack Not available in all countries 5 4 ThermoSmart Technology This device has been designed for optimal patient comfort and offers the unique heated breathing tube technology ThermoSmart ThermoSmart Technology allows for the delivery of optimal higher and customized levels of humidity to the patient independent of ambient temperature This device can be adjusted on two levels to achieve optimal comfort ThermoSmart Humidity setting this setting regulates the temperature of the heater plate adjusting the humidity levels for the comfort of the patient Adjustment can be made from 1 to 4 with increm
7. SleepStyle600 CPAP SERIES Operating Manual Fisher amp Paykel HEALTHCARE SleepStyle600 CPAP SERIES The SleepStyle 600 CPAP Series has integrated heated humidification and a heated breathing tube It is designed for use in the home or sleep laboratory for the treatment of Obstructive Sleep Apnea For further assistance please contact your local Fisher amp Paykel Healthcare office see back cover for details Please keep this manual for future reference TABLE OF CONTENTS 1 2 3 4 5 10 11 12 13 14 15 FS WN ONS ania E i i E E i peop i a a a a ss yhest A 2 PE ao EE riai asai O i i i A EN NEA tj EEE A 2 VIRA E ete EE E EE E NANE EE E AA EE EA E A E E E AA A A E TA A 2 OSS VAMC E vai i i i i E i a a i r i A AE AAAA A 2 Bce en eke i EB E a CCC CZE A 3 E e 2961 E gcc ay E A OE OEN E E a T i A E T A 3 5 2 mportanti ofthe DEV CE di iais ROT i a i e d a a sa i i MTA A 3 S CO ONES AR so i i i i i i i a t p i i a a A 3 52 S Mo Mar TEA oe i i IIA a A 4 ae Mantenan e sessio i iir i p pp PPP FP P ni saatat ak A 5 SDA EEE LI FIS LINNE ISI A 5 Seko in BD IE ans ai i i a ii i EW I i I a ee A 6 oT Dispay Description ana TU CHO S seo iii i ii i i i i i i i i etc A 6 O ra SUM Menti AE soreo i i o S i i i a i i i a i k EE A 7 52 Patient Menu Additional S ttings SUMMAN msssvsssutsa AAA AA R A AAA AO s ss usea v yst e im aisa veen A 7 PROQUEST IU ASS UE TO AS a AE EZ AAA i o
8. discoloured at least once every three months or after 1000 hours machine run time To do this remove the filter holder from the back of the device as shown in Fig 2 Ensure the vertical black line of the new filter is facing towards the device and fit both back to the device Replace the chamber if it is cracked discoloured or scratched Replace the heated breathing tube after 4000 hours usage or once per year A damaged tube needs to be replaced immediately 7 SETUP INSTRUCTIONS When the chamber is fitted and filled the device must remain upright so that water cannot enter the enclosure 1 2 11 12 Remove your device from its packaging Place the device on a low shelf or on the floor beside your bed the unit needs to be placed below head height Remove water chamber from the packaging Remove the blue caps and discard them Fig 1 Fill the chamber up to the water filling line with distilled water only Fig 2 Never fill the chamber through the heated breathing tube connector port When moving your device ensure that the water chamber is empty Machine failure due to water damage is not covered by warranty To attach the water chamber to the device press down the finger guard and slide the chamber on Figs 3 and 4 When the chamber is fitted correctly the finger guard will click into place One end of the heated breathing tube has a grey plastic connector Lift the sleeve and slide connector on to the devic
9. e Push the sleeve down to lock Figs 5 6 and 7 Connect the other end of the heated breathing tube to the mask Plug the device power cord into your household power socket Switch on the device by pressing the on off button Fig 8 The current ThermoSmart Humidity setting is displayed For changing the setting refer to section 8 Controls and Display Your device is now ready for use 8 CONTROLS AND DISPLAY 8 1 Display Description and Functions FUNCTION amp DESCRIPTION OPERATION ON OFF TO SWITCH ON switches the device ON and OFF e Press O button down briefly e The device will default to display the ThermoSmart Humidity setting TO SWITCH OFF e Remove your mask e Press D button briefly RAMP TO SWITCH ON Reduces pressure to a lower level e Press 41 to help you fall asleep The pressure NB to reset ramp during a cycle the device must be switched off first will gradually return to full operating pressure over 20 minutes TO SWITCH OFF o Press INCREASE DECREASE Adjusts settings up or down e Press A and V button to raise or lower settings MODE To step through options e Press sequentially to step through and view options available PATIENT MENU DISPLAY OPERATION For viewing CPAP settings humidity TO VIEW ITEMS compliance data altitude and pressure Press gt key to sequentially view ee e ThermoSmart Humidity setting default display For adjust
10. ents of 0 5 The device is preset to 2 5 which is suitable for most patients e f you experience dryness or find the air too cool increase the setting e fyou find there is too much moisture in the tube or the air feels too hot decrease the setting e If you do not achieve optimal comfort with this setting further adjustments can be made by altering your ThermoSmart Climate setting ThermoSmart Climate setting this setting provides further adjustment options to the humidity by increasing the temperature in the tube Adjustment can be made from 1 to 3 with increments of 1 The device is preset to 2 which is suitable for most patients Note if the climate setting is adjusted the humidity setting will revert back to the default setting e ThermoSmart Climate setting 3 is recommended for oral CPAP delivery e If you feel the range of settings offered by the ThermoSmart Comfort setting are too dry or too cool Increase the ThermoSmart Climate setting e If you feel the range of settings offered by the ThermoSmart Comfort setting are too warm or too humid Reduce the ThermoSmart Climate setting It is recommended to keep the heated breathing tube on top of bedding for the best humidity performance To operate ThermoSmart Humidity and Climate settings refer to section 8 Controls and Display of this manual 6 CLEANING AND MAINTENANCE PLEASE NOTE The device should be cleaned as required 1 2 Switch off the device
11. fication performance If supplemental oxygen is used with the device the oxygen flow must be turned off when the device is not operating This ensures that oxygen will not flow through the heated breathing tube and accumulate in the device enclosure e The device should be located in a position where ventilation around the device is not restricted e tis recommended that supplemental oxygen be administered at the mask e Oxygen should not be used while smoking or in the presence of an open flame e The use of oxygen in therapy requires that special care be taken to reduce the risk of fire Any materials which will burn in air and some that will not are easily ignited and burn rapidly in high concentrations of oxygen Accordingly for safety it is necessary that all sources of ignition be kept away from the product and preferably out of the room in which it is being used e Aspontaneous and violent ignition may occur if oil grease or greasy substances come in contact with oxygen under pressure These substances must be kept away from oxygen regulators cylinder valves tubing and connections and all other oxygen equipment e Ata fixed flow rate of supplemental oxygen flow the inhaled oxygen concentration will vary depending on the pressure settings patient breathing pattern mask selection and leak rate A 2 5 DESCRIPTION OF THE DEVICE 5 1 Package Contents 1 x SleepStyle 600 CPAP Series 5 2 Important Parts of the Device POW
12. he air openings of the device or place it on a soft surface such as a bed or couch where the filter area may be blocked Keep the air openings free of lint hair or the like Ensure that the unit is dry before plugging into the power socket A mask should not be used unless the device is switched on and operating properly The vent hole s associated with the mask should never be blocked Due to the operating temperature of the heater plate avoid making contact to the exposed heater plate or chamber base Ensure the water has cooled before emptying the chamber At low CPAP pressures the flow through the mask may be insufficient to clear all exhaled gas from the tubing and consequently some re breathing may occur Adjusting the pressure control can result in ineffective therapy The pressure control must only be adjusted by a healthcare professional Never drop or insert any object into any opening or heated breathing tube Always switch off the device and unplug the power cord from the power socket before cleaning Empty all the water from the chamber before transporting your device To remove the heated breathing tube always push the sleeve up to avoid tube damage Refer all maintenance to qualified service personnel except as outlined in this manual Do not use an insulating sleeve or any similar accessories which are not approved by Fisher amp Paykel Healthcare These may affect the humidi
13. ing ThermoSmart Humidity setting levels to minimize upper airway side effects from CPAP use Press A and V button to raise or lower settings e Total run hours displays the total number of hours the device has been switched on includes hours without mask use e Average compliance hours per night displays average number of hours the device has been used at night with the mask on f o Check sum displays information for the medical practitioner or the dealer to check compliance M e Altitude setting displays altitude setting Press A or W to change altitude cmH9O e Pressure setting displays pressure setting PATIENT MENU Additional Settings DISPLAY OPERATION To access additional settings ZZ e ThermoSmart Climate setting From the Default setting To change the delivered temperature Press A for warmer more humid air THERMOSMART 006 delivery Press V for cooler and drier air delivery Refer to Section 5 4 HUMIDITY ZM e Altitude Select m for metres or ft for feet using A and W keys Press the gt key for 3 seconds e Altitude setting 3900M Set the altitude level by pressing A and V keys Press D gt to exit menu e Actual Pressure Displays actual pressure Display reverts to default if the menu is not exited Press D button in order to exit menu only available in HC602 cmH 30 Warning Failure to select correct altitude setting for any given location will have an adverse effect
14. ith 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 When do I replace my water chamber Replace the chamber if the plastic walls of the chamber become cracked or cloudy or the chamber base becomes pitted Note If the chamber leaks at all it should be replaced immediately Can I use my device without a heated breathing tube Yes you can but you will not gain the optimum humidity performance the device offers gt m The device will then not display the heated breathing tube symbol and show the following display 10 PRODUCT SPECIFICATIONS DIMENSIONS WEIGHT ELECTRICAL RATINGS Supply Frequency Supply Voltage and Current DC to AC Inverter requirements Heater Plate Heater Plate Temperature Heated breathing tube Power Setting PERFORMANCE Pressure Range Altitude Range Warm up time Humidity delivered measured at 22 C ambient temperature 10 cmH O at bias flow 27 3 mm x 170 mm x 175 mm O7 3G GZ 2 1 kg 4 6 lbs unit only 3 4 kg 7 5 Ibs packaged in bag incl accessories 50 60 Hz 100 115 V 1 5 A max 1 7 A 220 240 V 1 0 A max 2 0 A Note These values represent average current 115 V 200 W 300 W surge 230 V 300 W 500 W surge max 85 W max 65 C 149 F max 30 W 4 to 20 cmH O O to 300
15. on delivered pressure When the ThermoSmart Climate setting is altered the Humidity Setting will revert back to default setting 2 5 8 2 Patient Menu Summary ThermoSmart Average Hours Pressure k A a per night Checksum i Setting 0 hr T cmH 0 Return to 0 5 Increment Default ThermoSmart Average Hours Pressure aay wee gt Total Run Time p gt per night Setting Return to x hr J cmH 50 Default 8 3 Patient Menu Additional Settings Summary Advanced Patient Menu Return to Default Hold for 3 seconds Increase Decrease ThermoSmart Climate Setting Advanced Actual Patient Menu gt Pressure Return to Default cmH9 O Hold for 3 seconds e Warning Failure to select correct altitude setting for any given location will have an adverse effect on delivered pressure 9 FREQUENTLY ASKED QUESTIONS 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 will often contain minerals which can damage the chamber causing pitting in the base even if the water is passed through a filter Can use my device in other countries Yes Simply use the appropriate electrical socket adaptor and the device will automatically adapt to any voltage supply Note When moving your device ensure that the water chamber is empty Machine failure due to water damage is not covered by warranty Can use supplemental oxygen w
16. ustment Heated Humidification Monitoring LCD amp Download Leak Compensation SS V HC608 NOTE e All models are fully integrated with ThermoSmart Technology e Some models are not available for sale in all countries Fishera Paykel C 0123 HEALTHCARE Fisher amp Paykel Healthcare Offices INTERNATIONAL Fisher amp Paykel Healthcare Limited 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 Website 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 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 Ltd Unit 16 Cordwallis Park Clivemont Road Maidenhead Berkshire SL6 7BU United Kingdom Tel 44 1628 626 136 Fax 44 1628
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