Fisher & Paykel SLEEPSTYLE 600 User Manual

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. 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.

A - 1

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

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

A - 3

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
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.

ThermoSmart® Climate

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.

®

A - 4

6. Cleaning anD mainTenanCe

PLEASE NOTE: The device should be cleaned as required.

1. Switch off the device and unplug from the power socket.

2. 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

3.

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
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

4. WEEKLY

Thoroughly clean the chamber.

• Soak the inside of the chamber for 10 minutes in a solution of one part white vinegar to two parts

5. MAINTENANCE

• Replace the air filter when it becomes significantly discoloured, at least once every three months or after 1000 hours machine run

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.

water and rinse well with distilled water.

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.

Fig.1

Fig.2

English

7. seTUp insTrUCTions

When the chamber is fitted and filled, the device must remain upright, so that water
cannot enter the enclosure.

1. Remove your device from its packaging.

2. Place the device on a low shelf or on the floor beside your bed, the unit needs
to be placed below head height.

3. Remove water chamber from the packaging.

4. Remove the blue caps and discard them (Fig.1).

5. 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.

6. To attach the water chamber to the device, press down the finger guard and
slide the chamber on (Figs 3 and 4).

7. When the chamber is fitted correctly, the finger guard will click into place.

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.1

Fig.3

Fig.2

Fig.4

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.

A - 5

Fig.5

Fig.7

Fig.6

Fig. 8

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

<

INCREASE/DECREASE

Adjusts settings up or down

<

MODE

To step through options.

PATIENT MENU DISPLAY OPERATION

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

hr

Press and button to raise or lower settings.

Press sequentially to step through and view options available.

TO VIEW ITEMS

Press key to sequentially view:

ThermoSmart® Humidity setting (default display)

For adjusting ThermoSmart® Humidity setting levels to minimize upper airway

side effects from CPAP use.
Press and button to raise or lower settings

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 or to change altitude.

cmH2O

PATIENT MENU - Additional Settings DISPLAY OPERATION

To access additional settings:

From the Default setting

"THERMOSMART®
HUMIDITY"

Press the key for 3 seconds

3000

Pressure setting: displays pressure setting.

ThermoSmart® Climate setting*

To change the delivered temperature: Press for warmer more humid air

delivery. Press for cooler and drier air delivery.* Refer to Section 5.4

Altitude

Select “m” for metres or “ft” for feet using and keys.

Altitude setting

- Set the altitude level by pressing and keys

- Press to exit menu

Actual Pressure (Displays actual pressure)

cmH2O

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

- Display reverts to default if the menu is not exited. Press button in order to

exit menu (only available in HC602).

A - 6

8.2 Patient Menu Summary

Model

HC604

Model

HC608

Press to activate

Ramp

Increase

Decrease

Mode

ThermoSmart®

Humidity Setting

(default)

<

or

<

ThermoSmart®

Humidity Setting

(default)

0,1,2,3,4

hr

±

0.5 Increment

hr

Average Hours

per night*

hr/

Average Hours

per night*

hr/

Press once to switch

device on/off

English

Display

Altitude Setting

Check sumTotal Run Time

Pressure

Check sumTotal Run Time

Setting

cmH2O

Pressure

Setting

cmH2O

Return to

Default

Return to

Default

8.3 Patient Menu - Additional Settings Summary

Mode

Advanced

Model
HC604

Patient Menu

Hold for 3 seconds

<

or

<

Increase/Decrease

ThermoSmart® Climate Setting

ft

or

<

or

<

Select Units
for Altitude

m

3000

Return to Default

<

or

<

Increase/Decrease

Altitude Level

Advanced

Model
HC608

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

Patient Menu

Hold for 3 seconds

Actual

Pressure

cmH2O

A - 7

Return to Default

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: 273 mm x 170 mm x 175 mm

(10.7” x 6.7” x 6.9”)

WEIGHT: 2.1 kg (4.6 lbs) unit only

3.4 kg (7.5 lbs) packaged in
bag incl. accessories

ELECTRICAL RATINGS

Supply Frequency:
Supply Voltage and Current:

220-240 V (1.0 A, max 2.0 A)
Note: These values represent

DC to AC Inverter
requirements: 115 V - 200 W/300 W surge

230 V – 300 W/500 W surge

Heater Plate: max. 85 W
Heater Plate Temperature:
Heated breathing tube
Power Setting: max. 30 W

PERFORMANCE

Pressure Range:
Altitude Range:
Warm-up time:
Humidity delivered:

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

50-60 Hz

100-115 V (1.5 A, max 1.7 A),

average current.

max. 65 °C (149 °F)

4 to 20 cmH2O

0 to 3000 m, or 0 to 9000 ft

30 min

30 mg/l*

STANDARDS COMPLIANCE:

Designed to conform to the
requirements of:

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.

IEC 60601-1

11. operaTing ConDiTions

AMBIENT TEMPERATURE: 5 - 35 ºC
HUMIDITY: 10 - 95% RH

ALTITUDE: 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.

A - 8

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.

English

MODEL

HC604
HC608

NOTE:

●

 All models are fully integrated with ThermoSmart

●

 Some models are not available for sale in all countries.

Fully Integrated CPAP with

Heated Humidification

✓

✓

Patient Compliance

Monitoring (LCD & Download)

✓

✓

®

Auto Altitude Adjustment/

Leak Compensation

-

✓

Technology

A - 9

Fisher & Paykel Healthcare Offices:

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Tel:[phone] Fax:[phone] Email: [e-mail] Website: www.fphcare.com

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SPAIN Tel: [phone] Fax: [phone] SWEDEN Tel: [phone] Fax: [phone] SWITZERLAND Tel: [phone] Fax: [phone]
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185044288 REV D

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