GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H
Page 12 of 96
W
ARNINGS AND
C
AUTIONS
I
MPORTANT
S
AFETY
I
NSTRUCTIONS
The following safety precautions must be observed always. General safety
precautions must be followed when operating electrical equipment. Failure
to observe these precautions could result in damage to the equipment and
injury to the operator or patient.
The instrument must only be used by hearing health care professional qualified to
perform newborn hearing screening tests such as an audiologist, otolaryngologist,
researcher or a technician under the direct supervision by the specialist. Users should
use their professional skills when interpreting the results and this should be done in
conjunction with other testing as deemed appropriate given their professional skills.
Incorrect use could lead to wrong results. It is intended for transient use as a screening
tool; however, no surgical or medical procedure should be undertaken solely based on
results obtained from the instrument.
The employer should instruct each employee in the recognition and avoidance of
unsafe conditions and the regulations applicable to his or her work environment to
control or eliminate any hazards or other exposure to illness or injury. It is understood
that safety rules within individual organizations vary. If a conflict exists between the
material contained in this manual and the rules of the organization using this
instrument, the more stringent rules should take precedence.
S
AFETY
P
RECAUTIONS
This product and its components will perform reliably only when operated
and maintained in accordance with the instructions contained in this
manual, accompanying labels, and/or inserts. A defective product should
not be used. Make sure all connections to external accessories are snug
and secured properly. Parts which may be broken or missing or are visibly worn,
distorted, or contaminated should be replaced immediately with clean, genuine
replacement parts manufactured by or available from GSI.
To comply with the standards IEC 60601-1 for safety and IEC 60601-1-2 for EMC the
instrument is designed to be used only with the medically approved mains adapter
supplied, which is specified as part of the equipment.
Do not use any other type of
mains adapter with this instrument.
In case of emergency, disconnect the instrument from the supply mains by pulling the
plug out of the power USB socket.
Before the first use of the instrument each day, or if suspect or inconsistent results are
apparent, the checks specified in the Performing Daily Checks section should be carried
out. If the system is not functioning properly, do not operate it until all necessary
repairs are made and the unit is tested and calibrated for proper functioning in
accordance with Grason-Stadler published specifications.
