Indication for Use
The GSI Pello is intended to be used for the identification and etiology of hearing
loss in patients of any age. It is intended to be used by an audiologist, ENT,
hearing healthcare professional, or trained technician in a hospital, clinic,
healthcare facility or other suitable quiet environment as defined in ANSI S3.1 or
equivalent.
Intended Use
The GSI Pello is intended to be used for the purposes of determining patient
hearing sensitivity. It is intended to quantify the patient's level of hearing by
presenting pure tone stimuli through specific transducers at different frequencies
and at different sound pressure levels.
Caution
US Federal law restricts this device to sale by or on the order of a physician or
licensed hearing care professional.
Description
This instrument is a 1.5 channel audiometer. This instrument has functionality
that makes it ideal for testing in Ear, Nose and Throat (ENT) physicians’ offices,
hospitals, clinics and audiology private practices. The tests are administered via
headphones – supra-aural, circum-aural, or insert phones – or through a bone
vibrator or sound field speakers. User defined test protocols allow for basic
audiometric testing as well as detailed evaluations to assist in diagnosis of
audiologic pathologies. Careful handling of instrument transducers and testing
performed by a properly trained instrument operator should be of high priority.
The patient is to remain relaxed and still while testing is being performed for
optimal accuracy.
Warranty
We, Grason-Stadler, warrant that this product is free from defects in material and
workmanship and, when properly installed and used, will perform in accordance
with applicable specifications. If within one year after original shipment, it is
found not to meet this standard; it will be repaired, or at our option, replaced at
no charge except for transportation costs, when returned to an authorized Grason-
Stadler facility. If field service is requested, there will be no charge for labor or
material; however, there will be a charge for travel expense at the service center’s
current rate.
NOTE:
Changes in the product not approved in writing by Grason-Stadler shall
void this warranty. Grason-Stadler shall not be responsible for any indirect,
special or consequential damages, even if notice has been given in advance of the
possibility of such damages.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.