Section 2 - Other Product Information; Intended Use; Symbol Definitions; General Warnings And Cautions - Fisher&Paykel ICON Manual De Uso Y Cuidado

SECTION 2 - OTHER PRODUCT INFORMATION

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.

2. SYMBOL DEFINITIONS

Type BF Applied Part
ATTENTION
!
Consult accompanying documents
Do not discard as regular rubbish
IPX2
Drip-proof
Catalogue number
Prescription only
NZ Radio Interference C-tick mark
UL Classified symbol

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.
3.2.2 To avoid choking, or inhalation of a foreign object:
• Never place any non-approved objects into any opening of the device, breathing tube or mask.
• Ensure the recommended filter is fitted to the device before use.
• Ensure the breathing tube is positioned so it can not become entangled with the body or furniture during
sleep.
Alternating Current
Class II Medical Electrical Equipment
Conforms with medical device
directive 93/42/EEC
Date of manufacture
Serial number
Authorized representative in the
European community
A - 9