Fisher & Paykel ICON, Use And Care Manual, Page: 12 / 19

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ENGLISH
2. SYMBOL DEFINITIONS
1. INTENDED USE
The device 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.
3. GENERAL WARNINGS AND CAUTIONS
This manual refers to the F&P ICON series model as “the device”.
The device treats OSA by delivering a flow of continuous positive airway pressure (CPAP) at a level
prescribed by the physician, to splint open the airway and prevent airway collapse.
3 . 1 Contraindications
Research indicates that 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.
3 . 1 . 1 Precautions:
• The safety and effectiveness of positive pressure has not been established in patients with
respiratory failure or chronic obstructive pulmonary disease.
• The safety and effectiveness of the auto-adjusting device has not been established in patients with
congestive heart failure, obesity hypoventilation syndrome or central sleep apnea.
3 . 1 . 2 Adverse effects:
• Nosebleeds, ear and sinus discomfort may occur from the use of positive pressure therapy.
3 . 2 Warnings
3 . 2 . 1 To avoid electric shock from the device:
• Only operate if the device, power cord and plug are dry and in good working order.
• If water damage occurs to your device, disconnect the power cord, discontinue use immediately
and seek advice from your healthcare provider.
• Do not store or use the device where it can be pulled into water.
SECTION 2 - OTHER PRODUCT INFORMATION
Authorized representative in the
European community
Serial number
Catalogue number
Type BF Applied Part
Alternating Current
ATTENTION
Consult accompanying documents Class II Medical Electrical Equipment
Do not discard as regular rubbish
Conforms with medical device
directive
93 / 42 /EEC
Date of manufacture Drip-proof IPX2
Prescription only
NZ Radio Interference C-tick mark
UL Classified symbol
Brazil INMETRO symbol