Fisher & Paykel SleepStyle 200 Series Humidified CPAP Systems

Introduction

The SleepStyle™ 200 Series are a range of CPAP systems designed for use in the home for the treatment of Obstructive Sleep Apnea (OSA). This manual provides comprehensive operating instructions, maintenance guidelines, troubleshooting tips, and product specifications.

Caution: USA Federal Law restricts this device for sale by or on the order of a physician.

Symbol Definitions

• Type BF Applied Part [Type BF symbol]
• ATTENTION ? Consult accompanying documents [Document symbol]
• Drip Proof [Drip symbol]
• Alternating Current ~
• Class II Double Insulated [Double Insulated symbol]
• Standby or On/Off [Power symbol]
• Certifications: CE 0123, 93/42/EEC Class IIb

Warnings

General Warnings:

• This manual refers to the SleepStyle™ 200 Series CPAP unit as "the device".
• Use only masks, connectors, and delivery tubes recommended by Fisher & Paykel Healthcare, or by your physician or respiratory therapist.
• Do not operate if the power cord, plug, or tube is damaged; if the device has been dropped or damaged; if it has been dropped into water; if it is not working properly; or if connected to a PC during CPAP treatment. Return to an authorized service center.
• Do not use if room temperature exceeds 35°C (95°F), as this may lead to elevated airflow temperature and airway irritation.
• Ensure an air filter is fitted when operating.
• Remove the humidification chamber before filling.
• Do not fill the chamber with boiling water.
• When handling the device with chamber and water, avoid tilting to prevent water entering the device enclosure.
• Place the device on a level surface lower than head height to prevent water entering the tubing if knocked over.
• Do not store or use where the device can fall or be pulled into water. If water enters the enclosure, disconnect power and discontinue use.
• Never block air openings or place on soft surfaces where the filter area may be blocked. Keep air openings free of lint and hair.
• Ensure the device is dry before plugging into a power socket.
• A mask should only be used when the device is switched on and operating properly. Vent holes associated with the mask should never be blocked.
• Avoid contact with the exposed heater plate or chamber base due to operating temperature.
• At low CPAP pressures, re-breathing may occur if exhaled gas is not cleared.
• Pressure control must only be adjusted by a healthcare professional.
• Never drop or insert objects into any opening or tube.
• Always switch off and unplug the device before cleaning.
• Empty all water from the chamber before transporting the device.
• Refer all maintenance to qualified service personnel, except as outlined in this manual.
• *Only applicable to integrated CPAP devices.

Oxygen Use Warnings:

• If supplemental oxygen is used, turn off the oxygen flow when the device is not operating to prevent accumulation.
• Locate the device where ventilation is not restricted.
• Supplemental oxygen is recommended at the mask.
• Oxygen should not be used while smoking or in the presence of an open flame.
• Take special care to reduce fire risk with oxygen use. Keep ignition sources away from the product and preferably out of the room.
• Avoid oil, grease, or greasy substances coming into contact with oxygen under pressure, as this can cause spontaneous and violent ignition.
• Inhaled oxygen concentration will vary based on pressure settings, breathing pattern, mask selection, and leak rate.

Intended Use

The device is used to assist patient breathing during sleep for the treatment of Obstructive Sleep Apnea (OSA) by delivering Continuous Positive Airway Pressure (CPAP). Heated respiratory humidification relieves drying and irritating effects on airways. The CPAP device is for use on adult patients at home or in a sleep lab. Refer to the HC230-Series Product range in the Appendix.

Description of the Device

The SleepStyle™ 200 Series are Humidified CPAP Systems.

Important Parts - Standard CPAP Range

Key components include:

• Power Cord
• ON/OFF Button
• Air Filter
• Filter Holder
• Serial Port
• Display
• 900HC010 Connector
• 900HC221 Tube

Important Parts - Integrated CPAP Range

Key components include:

• Power Cord
• ON/OFF Button
• Air Filter
• Filter Holder
• Serial Port
• Display
• Heaterplate
• 900HC221 Tube
• 900HC010 Connector
• Funnel
• Water Chamber
• Chamber Guard
• Water Level Line

Accessories

A list of available accessories includes:

• HC013 Conversion Kit - Cold Humidification
• HC014 Conversion Kit - Heated Humidification
• HC385S Standard Humidification Chamber
• HC355* Extended Life Humidification Chamber (*Not available in all countries)
• 900HC010 Connector
• 900HC221 Tube
• 900HC240 Filter
• 900HC230 Compliance Maximizer Software
• 900HC232 Compliance Download Serial Cable
• 900HC607 Titration Maximizer Software
• 900HC236 Isolated Serial Adaptor
• 900HC226 Lead Extension Kit

Package Contents

The device is supplied with accessories. Two package configurations are shown:

Package A: Includes the CPAP device, two (2) humidification chambers, one (1) breathing tube, one (1) power cord, and one (1) filter.

Package B: Includes the CPAP device, one (1) humidification chamber, one (1) breathing tube, one (1) power cord, and one (1) filter.

Cleaning & Maintenance

General Cleaning:

• Switch off and unplug the device before cleaning.
• Wipe the exterior with a clean, damp cloth and mild dishwashing detergent. Avoid harsh abrasives or solvents.

Daily Cleaning:

• Clean the chamber and tube.
• Remove the breathing tube from the chamber.
• Rinse the tube with soapy water and hang to dry.
• Remove the chamber by pushing the finger guard and pulling it out. Discard water. Clean the chamber with soapy water, rinse, and dry.

Weekly Cleaning:

• Thoroughly clean the chamber by soaking it for 10 minutes in a solution of one part white vinegar to two parts water.

Air Filter Replacement:

• Replace the air filter when discoloured, at least every 3 months or 1000 hours.
• Remove the filter holder from the back of the device, take out the old filter, and insert a new one with the vertical black line facing towards the device.

Setup Instructions

How to Set Up Your System:

1. Remove the device from its packaging.
2. Place the device on a low shelf or floor beside your bed, positioned below head height.
3. Chamber Setup (for integrated CPAP devices):
   • Remove one water chamber from packaging.
   • Remove and discard blue caps (Fig. 1).
   • Fill the chamber to the water line with distilled water only (Fig. 2). Never fill while attached to the device. Ensure chamber is empty when moving the device. Device failure due to water damage is not covered by warranty.
   • Attach the water chamber by pressing the finger guard and sliding it on (Fig. 3, Fig. 4). The guard will click when fitted correctly.
4. Connect one end of the tube (white plastic connector) to the chamber outlet (Fig. 5) or CPAP outlet (Fig. 5a).
5. Connect the other end of the tube to the mask.
6. Plug the device power cord into the household socket and the rear of the device.
7. Switch on the device by pressing the on/off button (See Fig. 6). The current humidity setting is displayed.
8. Refer to Section 8 for changing settings.

Your device is now ready for use.

Controls and Display - Integrated CPAP Range

Display Description and Functions

Control Buttons:

• [On/Off Button]: Switches the device ON & OFF.
• [Ramp Button]: Reduces pressure to a lower level to help you fall asleep. Pressure gradually returns to full operating pressure over 20 minutes.
• [Up Button] ▲ / [Down Button] ▼: Adjusts settings up or down.
• [Mode Button] ►: Steps through options.

Operations:

• To Switch ON: Press [On/Off Button] briefly. The device defaults to humidity setting.
• To Switch OFF: Remove mask, then press [On/Off Button] briefly.
• To Start Ramp: Press [Ramp Button]. (To reset ramp, switch device off first).

Patient Menu

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

To View Items: Press the [Mode Button] ► sequentially:

• Humidity Setting (default display) SSS: Adjust humidity levels. Use ▲/▼ buttons.
• Total Run Hours hr: Displays total hours the device has been switched on.
• Average Compliance Hours per Night* hr/C: Displays average hours used with mask on per night.
• Checksum* ?: For medical practitioner/dealer use to check compliance.
• Altitude Setting ⛰️: Displays altitude setting.
• Pressure Setting cmH₂O: Displays pressure setting.

Patient Menu - Additional Settings

To Access Additional Settings: From the default "HUMIDITY" setting, press and hold the [Mode Button] ► for 3 seconds.

To View Subsequent Items: Press the [Mode Button] ► key.

• Altitude ⛰️: Select "m" (metres) or "ft" (feet) using ▲/▼ buttons.
• Altitude Level: Set altitude level using ▲/▼ buttons. Press [Mode Button] ► to exit. Note: Incorrect altitude setting can adversely affect delivered pressure.
• Actual Pressure cmH₂O: Displays actual pressure. (Only available on devices with Automatic Altitude Adjustment/Leak Compensation feature).

* Only available on devices with Compliance Monitoring.

Controls and Display - Standard CPAP Range

Display Description and Functions

Control Buttons:

• [On/Off Button]: Switches the device ON & OFF.
• [Ramp Button]: Reduces pressure to a lower level to help you fall asleep. Pressure gradually returns to full operating pressure over 20 minutes.
• [Up Button] ▲ / [Down Button] ▼: Adjusts settings up or down.
• [Mode Button] ►: Steps through options.

Operations:

• To Switch ON: Press [On/Off Button] briefly. The device defaults to humidity setting.
• To Switch OFF: Remove mask, then press [On/Off Button] briefly.
• To Start Ramp: Press [Ramp Button]. (To reset ramp, switch device off first).

Patient Menu

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

To View Items: Press the [Mode Button] ► sequentially:

• Model Type 23x (default display): Displays model type.
• Total Run Hours hr: Displays total hours the device has been switched on.
• Average Compliance Hours per Night* hr/C: Displays average hours used with mask on per night.
• Checksum* ?: For medical practitioner/dealer use to check compliance.
• Altitude Setting ⛰️: Displays altitude setting.
• Pressure Setting cmH₂O: Displays pressure setting.

Patient Menu - Additional Settings

To Access Additional Settings: From the default setting, press and hold the [Mode Button] ► for 3 seconds.

To View Subsequent Items: Press the [Mode Button] ► key.

• Altitude ⛰️: Select "m" (metres) or "ft" (feet) using ▲/▼ buttons.
• Altitude Level: Set altitude level using ▲/▼ buttons. Press [Mode Button] ► to exit. Note: Incorrect altitude setting can adversely affect delivered pressure.
• Actual Pressure cmH₂O: Displays actual pressure. (Only available on devices with Automatic Altitude Adjustment/Leak Compensation feature).

* Only available on devices with Compliance Monitoring.

Frequently Asked Questions

For integrated CPAP devices:

• Q: When I wake up, my nose and throat feel dry. What can I do?
  A: Try increasing your humidity setting. If this does not help, contact your clinician.
• Q: How do I prevent condensation in the tubing?
  A: The humidity setting controls misting. If too high, condensation may occur. Using tubing longer than 6' (183cm) can increase condensation. Ways to reduce condensation:
  • Ensure the device is not in a cool draft.
  • Slightly decrease the humidity setting until condensation stops.
  • Warm the air in the room.
• Q: Do I have to use distilled water with my device?
  A: Yes, distilled water maximizes chamber life. Tap water contains minerals that can damage the chamber.
• Q: When do I replace my water chamber?
  A: Replace if plastic walls crack or become cloudy, or if the base becomes pitted. Replace immediately if it leaks.
• Q: Can I use my device in other countries?
  A: Yes. Use an appropriate electrical socket adapter; the device adapts to any voltage supply. Ensure the water chamber is empty when moving the device. Machine failure due to water damage is not covered by warranty.
• Q: Can I use supplemental oxygen with my device?
  A: Yes, oxygen can be administered at the mask. Turn the device on before turning on oxygen. Turn off the oxygen source before turning off the device to avoid oxygen accumulation.

Specifications

Standards Compliance

Designed to conform to the requirements of:

• EN / IEC 60601-1
• UL60601-1
• CSA C22.2/No.601.1
• AS3200.1.0

The device complies with electromagnetic compatibility requirements of IEC 60601-1-2. If interference occurs, try moving the unit or consult your homecare provider.

Operating Conditions

• Ambient Temperature: 5 - 35°C
• Humidity: 10 - 95% RH
• Altitude: 0 - 3000m (9000ft)

Above 1500m (4500 ft) the maximum operating pressure will be reduced.

Storage and Transport Conditions

The device should be stored and transported in environmental conditions of: -10 to 60°C.

Troubleshooting

If your device is not operating correctly, consult your homecare dealer. Do not attempt to repair the device yourself.

Fisher & Paykel Healthcare has a policy of continued product improvement and reserves the right to alter specifications without notice.

Appendix

The following table lists the main differences in features across the HC230 Product Range.

Note: Some models may not be available for sale in certain countries.

Fisher & Paykel Healthcare Offices

INTERNATIONAL: PO Box 14 348, Panmure, Auckland 1741, New Zealand Tel:+64 9 574 0100 Fax:+64 9 574 0158 Email: info@fphcare.com Web Site: www.fphcare.com

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INDIA: Tel:+91 80 4123 6041 Fax:+91-80-4123 6044

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UK (EU Authorised Representative): Tel:+44 1628 626 136 Fax:+44 1628 626 146

Nthn Ireland: Tel: 0800 132 189