ResMed S8 User's Manual
Contents
1. Ports may be incorporated into the mask or in connectors that are near the mask In the event of power failure or machine malfunction remove the mask The S8 Lightweight II can be set to deliver pressures up to 20 cm H30 In the unlikely event of certain fault conditions pressures up to 30 cm H30 are possible If oxygen is used with this device the oxygen flow must be turned off when the device is not operating If the oxygen has been left on turn off the device then wait 30 minutes before turning on the device again Explanation When the CPAP device is not in operation and the oxygen flow is left on oxygen delivered into the air delivery tubing may accumulate within the CPAP machine enclosure and create a risk of fire This applies to most types of CPAP machines e Oxygen supports combustion Oxygen should not be used while you are smoking or in the presence of an open flame e Always ensure airflow is being generated by the device before the oxygen supply is turned on e Always turn the oxygen supply off before stopping the airflow from the device Note At a fixed rate of supplemental oxygen flow the inhaled oxygen concentration will vary depending on where the oxygen is introduced the pressure settings patient breathing pattern mask selection and leak rate Do not use the S8 Lightweight II if there are obvious external defects or unexplained changes in performance Do not open the S8 Lightwe2. Can I use my S8 Lightweight II if mains AC power is not available A DC 12 converter is available to connect the S8 Lightweight II to a 12V or 24V DC power source Contact your clinician for details CAUTION The device should not be connected to both AC and DC power sources simultaneously Troubleshooting If there is a problem try the following suggestions If the problem cannot be solved contact your equipment supplier or ResMed Do not attempt to open the device Problem Possible Cause Solution No display Power is not connected Ensure the power cable is connected and the power switch if available is on Displays error message Exxxx Call Service where xxxx defines an error or MOTOR FAULT Call Service or UPLOAD LANGUAGES Call Service or DATA LOST Call Service Component failure Call service Troubleshooting 11 Insufficient air delivered from S8 Lightweight II Ramp Time is in use Wait for air pressure to build up or change ramp time Air filter is dirty Replace air filter Air tubing is kinked or Straighten or replace tubing punctured Air tubing is not connected Check air tubing properly Mask and headgear are not Adjust position of mask and headgear positioned correctly Cap s are missing from Replace cap s access port on mask Pressure required for See your clinician to adjust the pressure treatment may have changed The following message is displayed on the LCD after you try
3. screen appears The key and LCD backlights also turn on 2 Lie down and arrange the air tubing so that it is free to move if you turn in your sleep CAUTION Do not leave long lengths of air tubing around the top of your bed They could twist around your head or neck while you are sleeping 3 Alter the ramp time if required see How to change the ramp time on page 6 4 Tostart treatment press 5 Fit your mask as described in the mask user instructions WARNING J A mask should not be used unless the S8 Lightweight II device is turned on and operating properly When ramping begins the LCD will display the word RAMPING with the current pressure indicated as dashes Each dash is approximately equivalent to 2 cm H20 For example 6 dashes represents approximately 12 cm H20 pressure Stop Treatment To stop treatment at any time remove your mask and press How to Use the Control Panel The control panel of the S8 Lightweight II includes an LCD screen which displays the menus and treatment screens as well as a keypad for navigating through the menus and delivering treatment The S8 Lightweight II keypad has the following keys Key Function Start Stop Starts or stops treatment Up Allows you to increase settings options and scroll through the S8 Lightweight II menu Down Allows you to decrease settings options and scroll through the S8 Lightweight II menu Left Performs the function indicate
4. see Replacing the Air Filter on page 9 Replacing the Air Filter WARNING J Do not wash the air filter The air filter is not washable or reusable e The air filter cover protects the device in the event of accidental liquid spillage onto the device Ensure the air filter and air filter cover are fitted at all times 1 Remove the air filter cover at the back of the S8 Lightweight II Air filter cover 2 Remove and discard the old air filter Insert a new filter with the blue tinted side facing out from the device 4 Replace the air filter cover w Cleaning and Maintenance 9 Servicing CAUTION Do not attempt to open the S8 Lightweight Il case There are no user serviceable parts inside e Inspection and repair should only be performed by an authorised agent Under no circumstances should you attempt to service or repair the S8 Lightweight II yourself This device is intended to provide safe and reliable operation when operated and maintained in accordance with the instructions provided by ResMed To ensure that your device continues to provide optimum performance it is recommended that this product S8 Lightweight II be inspected by an authorised ResMed Service Centre five years from the date of purchase Applicable ResMed warranty details are provided with the device at the time of original supply Of course as with all electrical devices if any irregularity becomes apparent you should exercise caut
5. Supply Air Filter Air Tubing Air Outlet IEC 60601 1 Classifications 4 to 20 cm H20 112 mm x 164 mm x 145 mm 1 3 kg e Input range for S8 Lightweight II with HumidAire 4i 100 240V 50 60Hz 110V 400Hz 2 5A lt 140VA 110W maximum power consumption Instantaneous peak power consumption lt 340VA e Refer to the DC 12 converter instructions for DC ratings Only use the ResMed DC 12 converter for DC input Typical power consumption at 20 cm H20 is 34VA or 20W Two layered powder bonded polyester non woven fiber Flexible plastic 2 m The 22 mm conical outlet complies with EN 1281 1 Class II double insulation Type CF DECLARED DUAL NUMBER NOISE EMISSION VALUES in accordance with ISO 4871 Sound Pressure Level Sound Power Level Supplemental Oxygen Housing Construction Operating Temperature Operating Humidity Storage and Transport Temperature Storage and Transport Humidity Operating Altitude Electromagnetic Compatibility 26 dBA with uncertainty of 2 dBA as measured according to ISO 17510 1 2002 28 dBA with uncertainty of 2 dBA as measured according to ISO 17510 1 2007 36 dBA with uncertainty of 2 dBA as measured according to ISO 17510 1 2007 Recommended maximum supplemental oxygen flow 4 L min Flame retardant engineering thermoplastic 5 C to 35 C 10 95 non condensing 20 C to 60 C 10 95 non condensing Sea level to 2591 m Product complies with all applicable electromagnetic c
6. in all regions f the product fails under conditions of normal use ResMed will repair or replace at its option the defective product or any of its components This Limited Warranty does not cover a any damage caused as a result of improper use abuse modification or alteration of the product b repairs carried out by any service organization that has not been expressly authorised by ResMed to perform such repairs c any damage or contamination due to cigarette pipe cigar or other smoke d any damage caused by water being spilled on or into a flow generator Warranty is void on product sold or resold outside the region of original purchase Warranty claims on defective product must be made by the initial consumer at the point of purchase This warranty is in lieu of all other express or implied warranties including any implied warranty of merchantability or fitness for a particular purpose Some regions or states do not allow limitations on how long an implied warranty lasts so the above limitation may not apply to you ResMed shall not be responsible for any incidental or consequential damages claimed to have occurred as a result of the sale installation or use of any ResMed product Some regions or states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation may not apply to you This warranty gives you specific legal rights and you may also have other rights which vary fr
7. RESMED S8 Lightweight II POSITIVE AIRWAY PRESSURE DEVICE User Guide English ResMed Ltd Manufacturer 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia e ResMed Corp US Designated Agent 14040 Danielson Street Poway CA 92064 6857 USA ResMed UK Ltd EU Authorized Representative 96 Milton Park Abingdon Oxfordshire OX14 4RY UK ResMed Offices Australia Austria Belgium Brazil China Finland France Germany Greece Hong Kong India Ireland Italy Japan Malaysia Mexico Netherlands New Zealand Norway Portugal Singapore South Africa Spain Sweden Switzerland UK USA see www resmed com or contact details Protected by patents US 5199424 US 5522382 US 6705315 Other patents pending Protected by design registrations AU 302180 AU 302181 AU 302182 AU 302183 AU 302184 AU 302185 AU 302186 CN 200430121212 2 CN 200430121213 7 CN 200430121211 8 CN 200430121214 1 CN 200430121215 6 CN 200430121216 0 CN 2004301212175 EP 269436 HK 0412901 9 JP 1257662 JP 1257663 JP 1266956 JP 1266957 JP 1267270 JP 1267271 NZ 405614 NZ 406923 NZ 406924 NZ 406925 NZ 406926 NZ 406927 NZ 406928 US D544598 US D553228 US D557406 US D557407 US D560795 US D561891 US D565160 Others pending S8 S8 Lightweight ResScan ResControl ResLink and ResTraxx are trademarks of ResMed Ltd and Lightweight and HumidAire are registered in U S Patent and Trademark Office 2008 ResMed Ltd 338567 2 08 10 Conten
8. abled and so on The reminder message is displayed on the LCD and is visible if the device is not delivering therapy The backlight on the LCD flashes when a message is displayed Your clinician can set any of the following reminders on your LCD Message Description Action INSERT May appear if your Insert your Data Card and follow any CARD device is Data Card instructions that your clinician has given you enabled When you have done this the message will disappear from the LCD Pressing Ok will also remove the message REPLACE May appear when Press Ok to remove the message from MASK your mask is due for your LCD and replace your mask with a new replacement one CALL May appear as a Press Ok to remove the message from PROVIDER reminder to contact your LCD and contact your clinician your clinician eg to discuss how your therapy is going REPLACE May appear as a Press gj Ok to remove the message from FILTER reminder to replace your LCD and replace the air filter the air filter on your device SERVICE May appear as a Press Ok to remove the message from DUE reminder to return your LCD and contact your clinician your device for service Using the S8 Lightweight II 7 Using the Data Card to Collect data If your clinician needs to review your treatment they will ask you to use the Data Card to copy data from your S8 Lightweight II and to return the card to them The Data Card will be
9. d by the guiding text displayed above it on the LCD screen Guiding text includes menu change and apply Right Performs the function indicated by the guiding text displayed above it on the LCD screen Guiding text includes exit and cancel Yia k The keypad and LCD are equipped with backlights that come on when the device is powered The LCD backlight turns off after two minutes of inactivity and comes back on when you press a key The keypad backlight is always on while the S8 Lightweight II is on Using the S8 Lightweight II 5 How to Change the Settings on your S8 Lightweight II You can change settings such as Ramp Time on the S8 Lightweight II by using the keypad and LCD When the S8 Lightweight II is in standby mode you can display a series of screens a menu on the LCD screen in order to view and change the settings for a particular function S8 ESCAPE II PATIENT MENU RAMP 10min Menu EPR LEVEL 1 Change 4 Exit C Only displayed if clinician enabled USED HRS 960 Exit USAGE 120 180 t Exit LANG ENGLISH Change Exit SW SX123456789 t Exit Use the menu screens to change the ramp time and language You can also view details about the usage and software version of your S8 Lightweight II How to change the ramp time During ramp time the pressure increases from a low pressure to the prescribed treatment pressure You can set the ramp time in 5 minute i
10. gs this message is not displayed 2 Remove the Data Card from the S8 Lightweight II 3 Store the Data Card in its protective folder when not in use WARNING If your clinician has told you to use this Data Card to update the settings on your device and the Settings Success message does not appear contact your clinician immediately Cleaning and Maintenance WARNING Beware of electric shock Do not immerse the unit or power cord in water Always unplug the unit before cleaning and be sure it is dry before plugging back in CAUTION Do not hang the air tubing in direct sunlight as it may harden over time and eventually crack e Do not use bleach chlorine alcohol or aromatic based solutions moisturising or antibacterial soaps or scented oils to clean the air tubing or the S8 Lightweight Il These solutions may cause hardening and reduce the life of the product Daily Disconnect the air tubing and hang it in a clean dry place until next use Weekly 1 Remove the air tubing from the S8 Lightweight II and the mask 2 Wash the air tubing in warm water using mild detergent 3 Rinse thoroughly hang and allow to dry 4 Before next use reconnect the air tubing to the air outlet and mask Monthly 1 Clean the exterior of the S8 Lightweight II with a damp cloth and mild liquid soap 2 Check the air filter for holes and blockage by dirt or dust Replace it every six months or more often in a dusty environment
11. ight II case There are no user serviceable parts inside Repairs and internal servicing should only be performed by an authorised service agent Explosion hazard do not use in the vicinity of flammable anesthetics Cautions At low pressures the flow through the exhalation ports of your mask may not clear all exhaled gas from the tubing Some rebreathing may occur The airflow for breathing produced by this device can be as much as 6 C higher than the temperature of the room Caution should be exercised if the room temperature is warmer than 32 C When AC mains power 100 240V AC is not available always use a ResMed DC 12 converter The DC 12 converter is available as an optional accessory It is not supplied with all models Note The above are general warnings and cautions Specific warnings cautions and notes appear with the relevant instructions in the manual General Warnings and Cautions 15 Limited Warranty ResMed warrants that your ResMed product shall be free from defects in material and workmanship for the period specified below from the date of purchase by the initial consumer This warranty is not transferable Product Warranty Period ResMed humidifiers ResControl ResLink ResTraxx 1 Year ResMed flow generators 2 Years Accessories mask systems including mask frame cushion 90 Days headgear and tubing Excludes single use devices Note Some models are not available
12. ion and have the device inspected by an Authorised ResMed Service Centre If you feel that your device is not performing properly see Troubleshooting on page 11 Frequently Asked Questions How will it feel when am breathing with the S8 Lightweight II When you first use your S8 Lightweight II you may feel uncomfortable breathing against the airflow This is normal You will continue to breathe normally while you sleep The EPR setting may also improve comfort Take time to adjust to this new sensation What do I do when I want to get up in the night If you need to get up during the night remove your mask and stop therapy Always remember to restart therapy and put your mask on when you return to bed What do do if I feel air leaking out of the mask The S8 Lightweight II delivers the most effective treatment when the mask is well fitted and comfortable Treatment can be affected by leaks so it is important to eliminate any leaks that may arise For example try repositioning the mask and adjusting the straps If you are using a nasal mask try to keep your mouth closed during treatment Air leaks from your mouth can decrease the effectiveness of your treatment If mouth leaks are a problem a full face mask or chin strap may help Contact your clinician or equipment supplier for further details If you are using a full face mask and you have problems trying to get a comfortable mask fit contact your clinician or equipment s
13. ntervals from 0 minutes OFF up to a maximum ramp time set by your clinician The standby screen displays the current ramp time in the right corner 1 Press or until the desired ramp time appears 2 Once a ramp time is selected begin therapy by pressing When ramping begins the LCD will display the word RAMPING with the current pressure indicated as dashes Each dash is approximately equivalent to 2 cm H20 For example six dashes represents approximately 12 cm H20 pressure How to change the EPR level EPR can be used to help ease any discomfort you may experience when breathing out during treatment If your clinician has allowed access you can change the EPR level There are four settings OFF 1 lowest EPR 2 and 3 highest EPR 1 On the standby 2 Press unti RAMP screen press GI you see EPR LEVEL then press Change 3 Press or until you see the setting that you require 4 Press S App How to change t 1 On the standby y to save the setting he language setting Ramp screen press Menu 2 Press until you see LANG Language then press Change 3 Press or until you see the language that you require 4 Press Apply to save the new language Messages on the S8 Lightweight II LCD Your clinician may have set your S8 Lightweight I to remind you about important events such as when to replace your mask when to insert your Data Card if your device is Data Card en
14. om region to region For further information on your warranty rights contact your local ResMed dealer or ResMed office RO01 307 2 05 06 Limited Warranty 17
15. ompatibility requirements EMC according to IEC60601 1 2 for residential commercial and light industry environments The electromagnetic compatibility tables for these ResMed devices can be found on www resmed com on the Products page under Service amp Support Click on the PDF file for your device Note The manufacturer reserves the right to change these specifications without notice Technical Specifications 13 Symbols which appear on the device A Attention consult accompanying documents AR Follow instructions for use 4 Drip proof Yy Type CF equipment 4 Dangerous voltage o Class II equipment Co Start Stop taal Manufacturer H Environmental information WEEE 2002 96 EC is a European Directive that requires the proper disposal of electrical and electronic equipment This device should be disposed of separately not as unsorted municipal waste To dispose of your device you should use appropriate collection reuse and recycling systems available in your region The use of these collection reuse and recycling systems is designed to reduce pressure on natural resources and prevent hazardous substances from damaging the environment If you need information on these disposal systems please contact your local waste administration The crossed bin symbol invites you to use these disposal systems If you require information on collection and disposal of your ResMed device please contact your ResMed office local distributo
16. provided in a protective folder Data that is copied to a Data Card is still stored and available on the S8 Lightweight II Copy data onto the Data Card 1 Switch on the S8 Lightweight II and wait until you see the standby Ramp screen 2 Hold the Data Card with the arrow facing up and insert it into the Data Card slot until it stops Data copying starts automatically The Card Inserted Please Wait message is displayed on the S8 Lightweight II LCD while data is being copied Copying takes approximately five seconds The Copy Complete Remove Card message is displayed on the LCD when copying has finished 3 Remove the Data Card by gripping the end of the Data Card and pulling it out 4 Store the Data Card in its protective folder when not in use 5 Return the card in its protective folder to your clinician using a postal envelope Using the Data Card to Update Settings If your clinician has provided a Data Card with new device settings 1 With the device in standby Ramp mode insert the Data Card into the slot on the Data Card module Updating will start automatically The Card Inserted Please Wait message is displayed on the LCD while updating is in progress Updating takes approximately five seconds The Settings Success Remove Card message is displayed on the LCD if the settings were updated successfully Note This message only appears once If you re insert the Data Card after you have updated your settin
17. r or go to www resmed com environment General Warnings and Cautions Warnings e Read the entire guide before using the S8 Lightweight II e Advice contained in this guide should not supersede instructions given by the prescribing physician e A patient should not connect a device to the data communication port unless instructed to do so by their health care provider or physician Only ResMed products are designed to be connected to the data communication port Connecting other devices could result in injury or damage to the S8 Lightweight II device The S8 Lightweight II should be used with masks and connectors recommended by ResMed or by a physician or respiratory therapist A mask should not be used unless the S8 Lightweight II device is turned on and operating properly The vent hole or holes associated with the mask should never be blocked Explanation The S8 Lightweight II is intended to be used with special masks or connectors which have vent holes to allow continuous flow of air out of the mask When the device is turned on and functioning properly new air from the device flushes the exhaled air out through the mask vent holes However when the device is not operating insufficient fresh air will be provided through the mask and the exhaled air may be rebreathed Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation This applies to most models of CPAP devices
18. se pneumothorax e pathologically low blood pressure dehydration e cerebrospinal fluid leak recent cranial surgery or trauma Adverse Effects Patients should report unusual chest pain severe headache or increased breathlessness to their prescribing physician An acute upper respiratory tract infection may require temporary discontinuation of treatment The following side effects may arise during the course of therapy with the CPAP device drying of the nose mouth or throat nosebleed e bloating e ear or sinus discomfort eye irritation e skin rashes Introduction 1 The S8 Lightweight II System Your S8 Lightweight II comprises e S8 Lightweight I positive airway pressure device e 2mair tubing e Power cord e Carry bag Carry handle Data Screen Card slot Keypad Air outlet Optional components include e ResScan Data Card e 3m air tubing e DC 12 converter Masks For information on using masks see your mask manual Recommended masks are available on www resmed com on the Products page under Service amp Support WARNING Only ResMed mask systems are compatible for use with the S8 Lightweight Il Please refer to Adverse Effects on page 1 Humidifiers A list of humidifiers compatible with ResMed devices can be found on www resmed com on the Products page under Service amp Support ResScan Data Card The ResScan Data Card may be used with the S8 Lightweigh
19. t Il either to help your clinician to monitor your treatment or to provide you with updates to your device settings Using the S8 Lightweight II WARNING Make sure the power cord and plug are in good condition and the equipment is not damaged Only ResMed air tubing should be used with the device A different type of air tubing may alter the pressure you actually receive reducing the effectiveness of your treatment Blocking the hose and or air inlet of the device while in operation could lead to overheating of the device CAUTION Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord If you put the device on the floor make sure the area is free from dust and clear of bedding clothes or other objects that could block the air inlet Make sure the area around the device is dry and clean Set Up the S8 Lightweight II 1 2 3 4 Connect the power cord to the socket at the rear of the S8 Lightweight Il Plug the other end of the power cord into the power outlet Connect one end of the air tubing firmly onto the air outlet Connect the assembled mask system to the free end of air tubing For information on assembling your mask see your mask manual Using the S8 Lightweight II 3 Start Treatment LCD screen Keypad Start Stop key 1 Make sure the power is on The product name is displayed briefly on the LCD screen then the standby Ramp
20. to update settings or copy data to the Data Card Card Error Remove Card Data Card is not inserted Check that you are inserting the Data Card into the Data correctly Card slot with the arrow facing up while the S8 Lightweight II is switched on and not delivering therapy standby mode The Data Card is only partly Ensure that the Data Card is inserted into the Data Card inserted slot as far as it will go You may have removed the Reinsert the Data Card and wait for the Settings Data Card before settings Success Remove Card message to appear on the were copied to the LCD S8 Lightweight II The card is nota ResScan Data Only use a ResScan Data Card Card The following message is displayed on the LCD after you try to update settings or copy data to the Data Card Settings Invalid Remove Card The identification details on Contact your clinician immediately the Data Card do not match the identification details on your device The following message is displayed on the LCD after you try to update settings or copy data to the Data Card Settings Error Remove Card There is a data error on the Contact your clinician immediately Data Card The following message is NOT displayed on the LCD after you try to update the settings using the Data Card Settings Success Remove Card The settings were not Contact your clinician immediately updated Technical Specifications Operating pressure range Dimensions H x W x D Weight Power
21. ts Introduction 00 ccc een eet nee n eens Contraindications Adverse Effects The S8 Lightweight II System 00 Masks Humidifiers ResScan Data Card Using the S8 Lightweight Il 0 Set Up the S8 Lightweight II Start Treatment Stop Treatment How to Use the Control Panel How to Change the Settings on your S8 Lightweight II Using the Data Card to Collect data Cleaning and Maintenance 00205 Daily Weekly Monthly Replacing the Air Filter Servicing Frequently Asked Questions 002 0 Troubleshooting hearers raana OS hosed deen EREE E Meee Technical Specifications 000 000 anaana ee General Warnings and Cautions Limited Warranty 0 00 0 00 0 Contents Introduction The S8 Lightweight II continuous positive airway pressure CPAP system is indicated for the treatment of obstructive sleep apnoea OSA in patients gt 30 kg The S8 Lightweight II CPAP system is intended for home and hospital use Contraindications The S8 Lightweight II is not a life support device and may stop operating during power failure or certain fault conditions It should not be used by patients who are dependent on continuous therapy Positive airway pressure therapy may be contraindicated in some patients with the following pre existing conditions e severe bullous lung disea
22. upplier You may benefit from a different size or style of mask Anything special should do before putting the mask on Before wearing your mask wash your face to remove excess facial oils This will allow a better fit and prolong the life of the mask cushion Do not use moisturiser when wearing a mask My mouth feels dry during treatment what can I do You may experience dryness of the nose mouth and or throat during the course of treatment especially during winter In many cases a humidifier may resolve this discomfort Contact your clinician for advice My nose is irritated during treatment what can I do You may experience sneezing and or a runny or blocked nose during the first few weeks of treatment In many cases nasal irritation can be resolved with a humidifier Consult your clinician or equipment supplier for advice Can I travel with the S8 Lightweight II Your S8 Lightweight II has an internal power supply that enables it to operate in other countries It will operate on power supplies of 100 240V and 50 60Hz No special adjustment is necessary but you will require an approved power cord for the region in which you are using the device Please consult the medical services department of your carrier if you intend to use your S8 Lightweight II on an aircraft The S8 Lightweight II complies with US FCC Part 15 Class B requirements Note Do not use your S8 Lightweight II while the aircraft is taking off or landing
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