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SleepStyle 200 Auto Series
Operating Manual
11 pgs1.87 Mb0

Fisher & Paykel SleepStyle 200 Auto Series Operating Manual

A U T O S E R I E S
Operating Manual
TABLE OF CONTENTS
1. Symbol Definitions .................................................................................................................................................................... A - 2
4.1 Package Contents ...............................................................................................................................................................
A - 3
4.2 Important Parts of Your Device .........................................................................................................................................
A - 3
4.3 Accessories ..........................................................................................................................................................................
A - 3
5.1
AmbientTracking® Plus .......................................................................................................................................................... A - 4
8.1 Display Descriptions and Functions ..................................................................................................................................
A - 5
8.2 Patient Menu Summary ......................................................................................................................................................
A - 6
8.3 Patient Menu - Additional Settings Summary ..................................................................................................................
A - 6
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
Cauti on: USA Federa l L a w restri ct s this devic e f o r sale by or on the order of a physi ci an.
A - 1
The SleepStyle™ 200 Auto Series 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 – as detailed on the back cover. Please keep this manual for future reference.
English
1. SYMBOL DEFINITIONS
Type BF
Applied Part
ATTENTION
Consult accompanying
documents
Alternating
Current
Drip-proof
Class ll
Double-insulated
93/42/EEC
Class IIb
A - 2
Standby
2. INTENDED USE
The SleepStyle™ 200 Auto Series CPAP Humidifier is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA).
The device is for use in the home or sleep laboratory.
Notes
• This manual refers to the SleepStyle™ 200 Auto Series unit as
"the device".
• If required to use CPAP or Auto 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 masks, connectors and
delivery tubes recommended by Fisher & Paykel Healthcare, your physician or sleep specialist.
• We recommend use of Fisher & Paykel Healthcare interfaces to ensure true data accuracy.
• Under normal operating conditions the air supplied by the device will not exceed 105.8ºF (41ºC).
• Refer all repair and maintenance to Fisher and Paykel Healthcare.
• Only insert or remove the SmartStick™ when the device is in standby mode or not connected to mains power.
• SmartStick™ should only be removed when downloadable data is required by your physician or sleep specialist.
• To avoid data loss do not remove the SmartStick™ from the device while the light is flashing.
• To avoid damage and data loss, transport the SmartStick™ in the transportation case provided.
• 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 your healthcare provider.
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; therefore therapy follow-up can not be conducted.
• 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 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 by 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 CO
2
rebreathing 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.
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, middle ear infections, perforated ear drum, sinusitis, or dehydration.
• This auto adjusting device is not suitable for use in patients with congestive heart failure, obesity hypoventilation syndrome, central sleep apnea, respiratory failure, COPD or in patients whose upper airways are bypassed.
• Please contact your physician if you have any questions concerning your therapy.
3. WARNINGS, CAUTIONS, CONTRAINDICATIONS
4. DESCRIPTION OF THE DEVICE
4.1 Package Contents
A - 3
HC385S Standard Humidification Chamber HC355* Extended Life Humidification Chamber 900HC010 Connector 900HC221 Tube – To fit 22mm (0.86”) conical connector 900HC240 Air Filter *Not available in all countries
900HC615 PerformanceMaximizer™ Software 900HC611 SmartStick™ 900HC236 Isolated Serial Adapter 900HC323 Serial Cable 900HC226 Extension Cable
English
1 x
1 x
2 x
1 x1 x 1 x
POWER CORD
TUBE
CONNECTOR
WATER CHAMBER
CHAMBER GUARD
HEATER PLATE
WATER LEVEL LINE
ON/OFF BUTTON
DISPLAY
FILTER HOLDER
AIR FILTER
SERIAL PORT
SmartStick™ PORT
SmartStick™
SmartStick™ CAP
4.2 Important Parts of Your Device
5. DEVICE TECHNOLOGY
5.1 SensAwake™
The SleepStyle™ 200 Auto Series features unique SensAwake™ technology. Sensitive to sleep, SensAwake™ technology has been
designed for optimal comfort. SensAwake™ has the ability to differentiate between quiet comfortable breathing during sleep and anxious breathing during wake. When anxious breathing is detected the delivered pressure lowered towards the minimum set pressure thus facilitating the rapid return to sleep whilst optimizing comfort. SensAwake™ can be turned on or off. Refer to Section 8:
"Controls and Display".
5.2 AmbientTracking
®
Plus
AmbientTracking
®
Plus automatically adjusts the heater plate in response to changes in room temperature and air leaks caused by
mouth leak and/or mask leak to maximize humidity and minimize condensation.
Note: For serial data communication only
4.3 Accessories
(HC254)
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