1Introduction
a. 9
Introduction
Indications for use
The ApneaLink Air device is indicated for use by Health Care Professionals (HCP),
where it may aid in the diagnosis of sleep disordered breathing for adult patients.
ApneaLink Air records the following data: patient respiratory nasal airflow,
snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The
device uses these recordings to produce a report for the HCP that may aid in the
diagnosis of sleep disordered breathing or for further clinical investigation. The
device is intended for home and hospital use under the direction of a HCP.
Contraindications
•The ApneaLink Air system must not be used in the vicinity of an MRI device.
•Explosive Hazard: Do not use the ApneaLink Air system in an explosive
atmosphere or in the presence of flammable anesthetics or gases.
General warnings and cautions
The following are general warnings and cautions. Further specific warnings,
cautions and notes appear next to the relevant instruction in the manual.
WARNING
A warning alerts you to possible injury.
Do not set up the ApneaLink Air system while it is attached to a personal
computer via USB.
CAUTION
A caution explains special measures for the safe and effective use of the device.
•The ApneaLink Air should only be used with accessories recommended
by ResMed. Connection of other accessories could result in injury, or
damage to the device.
•Additional equipment connected to medical electrical equipment must
comply with the respective IEC or ISO standards (eg, IEC 60950 for data
processing equipment). Furthermore all configurations shall comply
with the requirements for medical electrical systems (see IEC 60601-1
clause 16 of the 3Ed.). Anybody connecting additional equipment to
medical electrical equipment configures a medical system and is
therefore responsible that the system complies with the requirements
for medical electrical systems. Attention is drawn to the fact that local
laws take priority over the above mentioned requirements. If in doubt,
consult your local representative or the technical service department.
•Depending on their skin condition or general state of health, patients
will have different levels of sensitivity to materials used in the
ApneaLink Air accessories. If the patient experiences an allergic reaction
use of the system should be discontinued.
