Fisher & Paykel HC244, HC242, SleepStyle 200 HC244, SleepStyle 200 HC242 Operating Manual

Operating Manual

Model HC244, HC242

SleepStyle™ 200 Series

HUMIDIFIED CPAP SYSTEMS

The SleepStyle™ 200 Series is a range of CPAP
systems designed for use in the home for the
treatment of OSA. This manual is specific to the
operation of CPAP models HC244 and HC242*.

For further assistance, please contact your local
Fisher & Paykel Healthcare office – see reverse
for addresses. Please keep this manual for future
reference.

* SleepStyle™ 242 is not available in all countries.

English

Table of ConTenTs

1. Symbol Definitions ................................................................................................................................................................... A - 2

2. Intended Use ............................................................................................................................................................................ A - 2

3. Warnings, Cautions, Contraindications .................................................................................................................................. A - 2

4. Description of the Device ........................................................................................................................................................ A - 3

4.1 Package Contents .............................................................................................................................................................. A - 3

4.2 Important Parts of Your Device ......................................................................................................................................... A - 3

4.3 Accessories ......................................................................................................................................................................... A - 3

5. Device Technology ................................................................................................................................................................... A - 3

5.1 Ambient Tracking™ Plus ................................................................................................................................................... A - 3

6. Setup Instructions .................................................................................................................................................................... A - 4

6.1 System Setup ...................................................................................................................................................................... A - 4

6.2 Updating Settings .............................................................................................................................................................. A - 4

7. Oxygen Use .............................................................................................................................................................................. A - 4

8. Controls and Display ................................................................................................................................................................ A - 5

8.1 Display Descriptions and Functions ................................................................................................................................. A - 5

8.2 Patient Menu Summary ..................................................................................................................................................... A - 6

8.3 Patient Menu - Additional Settings Summary ................................................................................................................. A - 6

9. Cleaning and Maintenance ..................................................................................................................................................... A - 7

10. Frequently Asked Questions ................................................................................................................................................... A - 7

11. Product Specifications ............................................................................................................................................................. A - 8

12. Operating Conditions .............................................................................................................................................................. A - 8

13. Storage and Transport ............................................................................................................................................................. A - 8

14. Troubleshooting ....................................................................................................................................................................... A - 8

15. Device and Consumables Disposal Instructions ................................................................................................................... A - 8

P L E A S E R E A D A L L I N S T R U C T I O N S B E F O R E I N I T I A L U S E

Cau tio n: US A F ed e ra l L aw res tri cts t his d evi ce fo r s al e b y or on th e ord e r of a ph y si c ia n .

A - 1

1. Symbol DefinitionS

Type BF

Applied Part

ATTENTION

Consult accompanying

documents

Do not

throw away

Drip-proof

Alternating

Current

Class ll

Double-insulated

Standby

93/42/EEC

Class IIb

2. intenDeD USe

The SleepStyle™ 200 Series CPAP Humidifier (HC244/HC242) is for use on adult patients for the treatment of Obstructive Sleep Apnea.

The device is for use in the home or sleep laboratory.

3. WarningS, CaUtionS, ContrainDiCationS

NOTES

• This manual refers to the SleepStyle™ 200 CPAP Series unit as "the
device".

• If required to use CPAP by a referring physician, you should use
your device every time you sleep. Should your device stop working
for any reason, contact your healthcare provider immediately.

• The user of this system shall have sole responsibility and liability
for any injury to persons or damage to property resulting from
operation of the device which is not in accordance with the
operating instructions supplied.

• The device should only be used with ISO 17510-2 compliant masks,
connectors and delivery tubes recommended by Fisher & Paykel
Healthcare, or your healthcare provider.

• We recommend use of Fisher & Paykel Healthcare masks to ensure
true data accuracy.

• Under normal operating conditions, the air supplied by the device
will not exceed 105.8 ºF (41 ºC).

• Refer all repairs and maintenance to Fisher & Paykel Healthcare.

• Only insert or remove the SmartStick™ when the device is in
standby mode or not connected to mains power.

• The SmartStick™ should only be removed when downloadable
data is required by your healthcare provider.

• To avoid data loss, do not remove the SmartStick™ from the device
while the light is flashing.

• Use only Fisher & Paykel Healthcare-supplied SmartSticks™.

• Do not operate the device without the SmartStick™ cap secured
over the SmartStick™ port.

• Do not operate the device without the cover over the serial port
adapter.

WARNINGS
To avoid electric shock from your device, do not:

• Operate the device if the power cord or plug is damaged.

• Operate the device if it has been dropped in water.

• Plug the device into the power socket if it is wet.

• Clean the device while connected to the power socket.

• Store or use the device where it can tilt, fall or be pulled into water.

If water has entered the unit enclosure, disconnect the power cord

and discontinue use. Seek advice from Fisher & Paykel Healthcare.

To avoid choking or inhalation of a foreign body:

• Never place any object into any opening of the tube.

• Ensure the air filter is fitted during device use.

To ensure optimal therapy, do not:

• Insert the SmartStick™ into any PC that does not have

PerformanceMaximizer™ software installed. Changing the

directories on the SmartStick™ or attempting to view the data
collected without the correct software will result in all data stored
on the SmartStick™ being lost. If that were to happen, follow-up
therapy would not be possible.

• Operate the device if dropped or damaged.

• Operate the device if not working properly.

• Adjust the pressure. Pressure must only be adjusted by a healthcare
professional.

• Operate the device if the tube has been damaged with holes, tears
or kinks.

• Block the exhaust flow on the interface.

• Use the mask if the unit is not turned on or not operating properly.

To avoid burns, do not:

• Fill the chamber with boiling water.

• Touch the exposed heater plate or chamber base.

To avoid the risk of fire while using oxygen, do not:

• Turn oxygen flow on when the device is not operating; this can lead
to accumulation of oxygen within the device.

• Locate the device in a position where ventilation around the device
is restricted.

• Use oxygen while smoking or in the presence of an open flame.

• Use any materials which will burn in air or ignite easily at high
oxygen concentration.

• Keep any source of ignition near the product. To avoid ignition, it
is preferable to keep all sources of ignition out of the room where
supplemental oxygen is being used.

• Keep oxygen regulators, cylinder valves, tubing, connections and
all other oxygen equipment near oil, grease or greasy substances.
Spontaneous and violent ignition may occur if these substances
come into contact with oxygen under pressure.

Other:

• Place the device on a level surface lower than head height to
prevent water entering the tubing. If water does enter the tubing,
drain excess condensate. Water in the tubing may result in
aspiration.

• The device is intended to be used with CPAP masks and connectors
that have exhaust flow holes to allow continuous flow of air out of
the mask. When the device is turned on and operating properly
new air flushes exhaled air out of the mask through the exhaust
flow holes. At low CPAP pressures and in the event of power failure
or machine malfunction, remove the mask immediately, as flow
through the mask may be insufficient to clear all exhaled gas and
CO2 re-breathing may occur which can be hazardous.

• Failure to select the correct altitude level (for any given location)
will have an adverse effect on delivered pressure.

• This device is not intended for life support.

CAUTIONS
To prevent water damage to your device:

• Remove the humidification chamber from the device before filling.

• Empty water from the chamber before transporting the device.
If the device is required to be handled with water in the chamber,
avoid tilting the device to prevent water entering its enclosure.

Other:

• To prevent damage to your PC, only operate the device if it is
connected to a PC via an isolated serial port adapter (900HC236).

• To prevent airway irritation, do not use the device when room
temperature exceeds 95 °F (35 °C).

CONTRAINDICATIONS

• Research indicates the following pre-existing conditions may
contraindicate the use of positive pressure for some patients:
pneumothorax, bullous lung disease, pneumocephalus,
cerebrospinal fluid leak, recent cranial surgery or trauma,
abnormalities of the cribriform plate, pathologically low blood
pressure or in patients whose upper airways are bypassed.

PRECAUTIONS

• The safety and effectiveness of positive pressure has not been
established in patients with respiratory failure or COPD.

ADVERSE EFFECTS

• Nosebleeds, ear and sinus discomfort may occur from the use of
positive pressure therapy.

Please contact your physician if you have any questions concerning
your therapy.

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