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.
For further assistance, please contact your local Fisher & Paykel Healthcare office see back cover for details. Please keep this manual for future reference.

TABLE OF CONtENtS
1. 2. 3. 4. 5. Symbol Definitions ................................................................................................................................................................................ Intended Use ......................................................................................................................................................................................... Warnings ................................................................................................................................................................................................. Oxygen Use Warnings .......................................................................................................................................................................... Description of the Device .................................................................................................................................................................... 5.1 Package Contents ........................................................................................................................................................................... 5.2 Important Parts of the Device ....................................................................................................................................................... 5.3 Accessories ...................................................................................................................................................................................... 5.4 ThermoSmart Technology ........................................................................................................................................................... 6. 7. 8. Cleaning and Maintenance . ................................................................................................................................................................ Setup Instructions . ................................................................................................................................................................................ Controls and Display . ........................................................................................................................................................................... 8.1 Display Description and Functions ............................................................................................................................................... 8.2 Patient Menu Summary .................................................................................................................................................................. 8.3 Patient Menu - Additional Settings Summary ............................................................................................................................. 9. Frequently Asked Questions ............................................................................................................................................................... 10. Product Specifications .......................................................................................................................................................................... 11. Operating Conditions . ......................................................................................................................................................................... 12. Storage and Transport Conditions . .................................................................................................................................................... 13. Troubleshooting .................................................................................................................................................................................... 14. Warranty . ................................................................................................................................................................................................ 15. Appendix ................................................................................................................................................................................................ PLEASE READ ALL INSTRUCTIONS BEFORE INITIAL USE Caution: USA Federal Law restricts this device for sale by or on the order of a physician. A-2 A-2 A-2 A-2 A-3 A-3 A-3 A-3 A-4 A-5 A-5 A-6 A-6 A-7 A-7 A-8 A-8 A-8 A-8 A-8 A-9 A-9

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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. A-2

5. DEScRIPtION

OF tHE dEVIcE

5.1 Package Contents

2 x Water Chamber

1 x ThermoSmart 1 x Power Cord Heated Breathing Tube

1 x Funnel 1 x SleepStyle 600 CPAP Series

1 x Spare Air Filter Accessories

5.2 Important Parts of the Device

POWER CORD ON/OFF BUTTON ThermoSmart HEATED BREATHING TUBE

FILTER HOLDER

Connector WITH sleeVe

ThermoSmart HEATED BREATHING TUBE CONNECTION PORT AIR FILTER

DISPLAY

HEATERPLATE WATER CHAMBER

FINGER GUARD WATER FILL LINE (vertical)

Funnel

WATER LEVEL LINE

5.3 Accessories
HC365 HC360* 900HC522 900HC604 900HC230 Standard Humidification Chamber Extended Life Humidification Chamber ThermoSmart Heated Breathing Tube Outlet Cleaning Kit HC600 ComplianceMaximizer Software 900HC232 900HC607 900HC236 900HC226 900HC627 Compliance Download Serial Cable TitrationMaximizer Software Isolated Serial Adapter Lead Extension Kit Elbow Funnel (10-Pack)

900HC240 Filter (2-Pack)

*Not available in all countries

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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 increments of 0.5. The device is preset to 2.5 which is suitable for most patients. If you experience dryness or find the air too cool: increase the setting If you find there is too much moisture in the tube or the air feels too hot: decrease the setting 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. ThermoSmart Climate setting 3 is recommended for oral CPAP delivery. If you feel the range of settings offered by the ThermoSmart Comfort setting are too dry or too cool: Increase the ThermoSmart Climate setting. 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.

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6. CLEANING ANd MAINtENANcE

PLEASE NOTE: The device should be cleaned as required. 1. 2. 3. Switch off the device 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. 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 Fig.1 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 requires 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. WEEKLY Fig.2 Thoroughly clean the chamber. 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 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.

4.

5.

7. SEtuP INStRuctIONS
When the chamber is fitted and filled, the device must remain upright, so that water cannot enter the enclosure. 1. 2. 3. 4. 5. 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.

Fig.1

Fig.2

6. 7.

Fig.3

Fig.4

8.

One end of the heated breathing tube has a grey plastic connector. Lift the sleeve and slide connector on to the device. Push the sleeve down to lock (Figs 5, 6 and 7). 9. Connect the other end of the heated breathing tube to the mask. 10. Plug the device power cord into your household power socket.
Fig.5 Fig.6

11. Switch on the device by pressing the on/off button (Fig.8). The current ThermoSmart Humidity setting is displayed. 12. For changing the setting refer to section 8 Controls and Display.

Your device is now ready for use.

Fig.7 Fig. 8

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8. CONtROLS ANd DISPLAY

8.1 Display Description and Functions
On/Off button Ramp button Up button
Increase Setting

Down button
Decrease Setting

Mode button
Step through the options

KEY

FUNCTION & DESCRIPTION

OPERATION

ON/OFF
Switches the device ON and OFF

TO SWITCH ON
Press button down briefly. The device will default to display the ThermoSmart Humidity setting.

TO SWITCH OFF
Remove your mask Press button briefly

RAMP

Reduces pressure to a lower level to help you fall asleep. The pressure will gradually return to full operating pressure over 20 minutes.

TO SWITCH ON Press

(NB: to reset ramp during a cycle the device must be switched off first)

TO SWITCH OFF Press

Press and button to raise or lower settings.

INCREASE/DECREASE MODE

<

For viewing CPAP settings, humidity, compliance data, altitude and pressure settings

PATIENT MENU - Additional Settings To access additional settings: From the Default setting "TheRMOSMaRt HUMIDItY" Press the key for 3 seconds

Warning: Failure to select correct altitude setting (for any given location) will have an adverse effect on delivered pressure. * When the ThermoSmart Climate setting is altered the Humidity Setting will revert back to default setting 2.5

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Adjusts settings up or down To step through options.

Press sequentially to step through and view options available. DISPLAY OPERATION

PATIENT MENU

TO VIEW ITEMS
Press key to sequentially view: For adjusting ThermoSmart Humidity setting levels to minimize upper airway side effects from CPAP use. Press and button to raise or lower settings

ThermoSmart Humidity setting (default display)

hr

Total run hours: displays the total number of hours the device has been
switched on (includes hours without mask use)

hr/

Average compliance hours per night: displays average number of hours

the device has been used at night with the mask on.

Check sum: displays information for the medical practitioner or the dealer to
check compliance.

Altitude setting: displays altitude setting. Press

cmH2O DISPLAY

or

to change altitude.

Pressure setting: displays pressure setting.

OPERATION

ThermoSmart Climate setting* To change the delivered temperature: Press

delivery. Press

for warmer more humid air for cooler and drier air delivery.* Refer to Section 5.4 and keys keys.

3000

Altitude Select m for metres or ft for feet using Altitude setting

- Set the altitude level by pressing - Press to exit menu and

cmH2O

Actual Pressure (Displays actual pressure) - Display reverts to default if the menu is not exited. Press
exit menu (only available in HC602).

button in order to

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8.2 Patient Menu Summary

Press to activate Ramp

Press once to switch device on/off

Increase Decrease

Display

Mode

Model HC604

ThermoSmart Humidity Setting (default)

Total Run Time hr

Average Hours per night* hr/

Check sum

Altitude Setting

Pressure Setting
cmH2O

Model HC608

ThermoSmart Humidity Setting (default)

<

or

0,1,2,3,4

0.5 Increment

Return to Default

Total Run Time hr

Average Hours per night* hr/

Check sum

Pressure Setting
cmH2O

Return to Default

8.3 Patient Menu - Additional Settings Summary

Mode

Model HC604

Advanced Patient Menu

Hold for 3 seconds

ft or

3000

Return to Default

<

<

Increase/Decrease ThermoSmart Climate Setting

Select Units for Altitude

Increase/Decrease Altitude Level

Model HC608

Advanced Patient Menu

Hold for 3 seconds

Actual Pressure
cmH2O

Return to Default

Warning: Failure to select correct altitude setting (for any given location) will have an adverse effect on delivered pressure.

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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 I 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 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.

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. The device will then not display the heated breathing tube symbol and show the following display:

10. PROduct SPEcIFIcAtIONS

DIMENSIONS: WEIGHT: 273 mm x 170 mm x 175 mm (10.7 x 6.7 x 6.9) 2.1 kg (4.6 lbs) unit only 3.4 kg (7.5 lbs) packaged in bag incl. accessories STANDARDS COMPLIANCE: Designed to conform to the IEC 60601-1 requirements of: UL60601-1 CSA C22.2/No. 601.1 AS3200.1.0 EN60601-1

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. DC to AC Inverter requirements: 115 V - 200 W/300 W surge 230 V 300 W/500 W surge Heater Plate: max. 85 W max. 65 C (149 F) Heater Plate Temperature: Heated breathing tube Power Setting: max. 30 W PERFORMANCE Pressure Range: Altitude Range: Warm-up time: Humidity delivered: 4 to 20 cmH2O 0 to 3000 m, or 0 to 9000 ft 30 min 30 mg/l*

ELECTRICAL RATINGS Supply Frequency: Supply Voltage and Current:

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.

*measured at 22 C ambient temperature: 10 cmH2O at bias flow.

11. OPERAtING CONdItIONS

AMBIENT TEMPERATURE: HUMIDITY:
ALTITUDE:

5 - 35 C 10 - 95% RH
0 - 3000 m (9000 ft)

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 & Paykel Healthcare have a policy of continued product improvement and reserve the right to alter specifications without notice.

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14. WARRANtY
Please contact your Fisher & Paykel Healthcare Provider regarding warranty.

15. APPENdIX
The following table lists the main difference in features across the SleepStyle 600 Product Range. MODEL HC604 HC608
Fully Integrated CPAP with Heated Humidification Patient Compliance Monitoring (LCD & Download) Auto Altitude Adjustment/ Leak Compensation

Note: All models are fully integrated with ThermoSmart Technology Some models are not available for sale in all countries.

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