Fisher & Paykel SLEEPSTYLE 600 User Manual

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Operating Manual
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.
Table of ConTenTs
1. Symbol Definitions ............................................................................................................................................................................... A - 2
2. Intended Use ......................................................................................................................................................................................... A - 2
3. Warnings ................................................................................................................................................................................................ A - 2
4. Oxygen Use Warnings ......................................................................................................................................................................... A - 2
5. Description of the Device .................................................................................................................................................................... A - 3
5.1 Package Contents .......................................................................................................................................................................... A - 3
5.2 Important Parts of the Device ....................................................................................................................................................... A - 3
5.3 Accessories ...................................................................................................................................................................................... A - 3
®
5.4 ThermoSmart
6. Cleaning and Maintenance ................................................................................................................................................................. A - 5
7. Setup Instructions ................................................................................................................................................................................. A - 5
8. Controls and Display ............................................................................................................................................................................ A - 6
8.1 Display Description and Functions .............................................................................................................................................. A - 6
8.2 Patient Menu Summary ................................................................................................................................................................. A - 7
8.3 Patient Menu - Additional Settings Summary ............................................................................................................................ A - 7
9. Frequently Asked Questions ............................................................................................................................................................... A - 8
10. Product Specifications ......................................................................................................................................................................... A - 8
11. Operating Conditions .......................................................................................................................................................................... A - 8
12. Storage and Transport Conditions ..................................................................................................................................................... A - 8
13. Troubleshooting .................................................................................................................................................................................... A - 8
14. Warranty ................................................................................................................................................................................................. A - 9
15. Appendix ............................................................................................................................................................................................... A - 9
Technology .......................................................................................................................................................... A - 4
English
PLEASE READ ALL INSTRUCTIONS BEFORE INITIAL USE
Caution: USA Federal Law restricts this device for sale by or on the order of a physician.
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1. symbol DefiniTions
Type BF
Applied Part
ATTENTION
Consult
accompanying
documents
Drip Proof
Alternating Current
Class II
Double Insulated
Power On/Off
93/42/EEC
Class IIb
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 & Paykel Healthcare, or by your physician or respiratory therapist.
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.
10. Never block the 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.
11. Ensure that the unit is dry before plugging into the power socket.
12. 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.
13. Due to the operating temperature of the heater plate, avoid making contact to the exposed heater plate or chamber base.
14. Ensure the water has cooled before emptying the chamber.
15. 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.
16. Adjusting the pressure control can result in ineffective therapy. The pressure control must only be adjusted by a healthcare professional.
17. Never drop or insert any object into any opening or heated breathing tube.
18. Always switch off the device and unplug the power cord from the power socket before cleaning.
19. Empty all the water from the chamber before transporting your device.
20. To remove the heated breathing tube, always push the sleeve up to avoid tube damage.
21. Refer all maintenance to qualified service personnel except as outlined in this manual.
22. Do not use an insulating sleeve or any similar accessories which are not approved by Fisher & Paykel Healthcare.
These may affect the humidification performance.
4. oxygen Use Warnings
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.
• The device should be located in a position where ventilation around the device is not restricted.
• It is recommended that supplemental oxygen be administered at the mask.
• Oxygen should not be used while smoking or in the presence of an open flame.
• 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.
• A spontaneous 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.
• At a 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.
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5. DesCripTion of The DeviCe
5.1 Package Contents
English
1 x SleepStyle™ 600 CPAP Series
5.2 Important Parts of the Device
POWER CORD
ON/OFF BUTTON
FILTER HOLDER
2 x Water Chamber
1 x Funnel
1 x ThermoSmart®
Heated Breathing
1 x Power Cord
Tube
1 x Spare Air Filter
Accessories
THERMOSMART® HEATED BREATHING TUBE
CONNECTOR with SLEEVE
THERMOSMART® HEATED BREATHING TUBE CONNECTION PORT
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
FINGER GUARD
WATER FILL LINE (vertical)
HEATERPLATE
WATER CHAMBER
FUNNEL
WATER LEVEL LINE
900HC232 Compliance Download Serial Cable 900HC607 TitrationMaximizer™ Software 900HC236 Isolated Serial Adapter 900HC226 Lead Extension Kit 900HC627 Elbow Funnel (10-Pack) *Not available in all countries
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