
RM500SL
®
User's Guide Version 3.12
March 2015
How to Avoid Undesirable Side Effects
During the development of the hearing aid analyzer, Audioscan performed a rigorous Risk Assessment to
identify any undesirable side effects that a user could be exposed to during the use of the RM500SL, and
incorporated numerous risk reduction design elements into the RM500SL to minimize the risk to users and
patients.
Following are the actions which a user should take to ensure that these risk control measures continue to be
effective
Loud Sounds:
The RM500SL is designed to produce sound pressure levels as high as 85 dB at the probe reference microphone.
Exposure to these levels for more than 7 hours can produce hearing damage. When such levels are amplified by
a hearing aid, the level in the ear canal will be determined by the settings of the hearing aid but may reach levels
that can produce hearing damage in less than 30 seconds. To avoid this possibility,
1. hearing aids should be adjusted to limit sound pressure levels to safe levels
2. the maximum TM SPL setting (see Max TM SPL Setup) should be used to terminate tests if an unsafe level
is detected in the ear canal
3. test levels should be limited to 70 dB SPL except when necessary to verify the limiting levels of the hearing
aid, in which case, the test should not last longer than 15 seconds
4. be aware of the test signal and patient reaction during a test and be prepared to respond to any sign of
discomfort by reducing the SPL setting, switching off the equipment or the hearing aid, or removing the
patient from the area.
When using the equipment to measure the Real-Ear to Coupler Difference in small ear canals, it is possible to
induce a hearing loss if the test is allowed to continue for more than 1 hour. Since accurate results can be
obtained in less than 10 seconds, this possibility should never occur in normal practice.
Power and Grounding:
This product contains numerous safety features to ensure that the probability of electrical shock is as low as
reasonably practicable. In order to ensure that all of the safety features work optimally you must ensure that the
power cord is plugged into a grounded outlet. Any line-powered peripherals connected to the RM500SL must
comply with UL/IEC 60601-1 OR comply with UL or IEC or ISO safety standards for such equipment, AND a)
be operated from an isolating transformer complying with UL/IEC 60601-1, OR b) be kept at least 6 feet (1.8m)
from the patient.
Ear Infection:
Probe tubes or RECD foam tips should not be re-used on another patient. There is a possibility of transferring an
ear infection to the other patient. Probe tubes and RECD foam tips are for single-patient use only. Do not
attempt to clean or re-use.
Ear Canal Discomfort:
An otoscopic examination should always be performed prior to inserting a probe tube into the ear canal to ensure
that it is healthy and free of obstructions. Care is needed when inserting probe tubes into the ear canal. Although
the probe tubes are made of soft, flexible material specially designed for this application, it is possible to scrape
the ear canal or touch the eardrum causing brief discomfort. You should carefully follow the instructions in
“Positioning the probe tube” section of this User’s Guide.
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