Intended Use - Interacoustics Pediatric Audiometer PA5 Instructions D'utilisation

The PA5 handheld paediatric screening audiometer is designed to be a device for screening for
hearing loss primarily amongst children. Output and specificity of this type of device are based on the
test characteristics defined by the user, and may vary depending on environmental and operating
conditions. The screening for hearing loss using this kind of audiometer depends on the interaction
with the patient. However, for children not responding well, various test possibilities allow the tester of
having at least some evaluative result. Thus, a "normal hearing" result should not allow for ignoring
other contra indications in this case. A full audiologic evaluation should be administered if concerns
about hearing sensitivity persist.
1. Be sure to use only stimulation intensities, which will be acceptable for the patient.
2. The transducers (headphones, bone conductor, etc.) supplied with the instrument are
calibrated to this instrument - exchange of transducers require a recalibration.
3. It is recommended that parts which are in direct contact with the patient (e.g. earphone
cushions) are subjected to standard disinfecting procedure between patients. This includes
physically cleaning and use of a recognised disinfectant. Individual manufacturer's instruction
should be followed for use of this disinfecting agent to provide an appropriated level of
cleanliness.
4. Please note that the CE Marking is only legal if this Instruction is translated into the national
language of the user no later than at the delivery to him, if the national legislation demands a
text in the national language according to MDD article 4.4.
5. Although the instrument fulfils the relevant EMC requirements precautions should be taken to
avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the
device is used adjacent to other equipment it must be observed that no mutual disturbance
appears.
6. Disposal of batteries must be made according to national regulations.
If this apparatus is connected to one or more other devices with medical CE marking, to
make up a system or pack, the CE marking is only valid also for the combination if the
supplier has issued a declaration stating that the requirements in the Medical Device
Directive article 12 are fulfilled for the combination
.
PA5 Instruction for Use - English
Date: 1999-01-15

Intended Use

Precautions
WARNING indicates a hazardous situation which, if not avoided, could
result in death or serious injury.
CAUTION, used with the safety alert symbol, indicates a hazardous
situation which, if not avoided, could result in minor or moderate injury.
NOTICE is used to address practices not related to personal injury.
Page 1/5