GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H
Page 13 of 96
No parts of the equipment can be serviced or maintained while in use with the patient.
Never insert the probe into a patient’s ear canal without a suitable ear tip fitted to the
probe.
Use only the recommended disposable ear tips/cups. These are for single use only - that
is, each ear tip is intended to be used once only for a single ear for a single patient. Do
not reuse ear tips/cups as this will pose the risk of ear-to-ear or patient-to-patient cross
infection.
Latex is not used anywhere in the manufacturing process. The base material for the ear
tips is made from silicone rubber.
The device is not intended to be used in environments exposed to fluid spills. No
means is specified for fluid protection (not IP classed). Do not use the device in the
presence of fluid that can contact any of the electronic components or wiring. Should
the user suspect fluids have contacted the system components or accessories, the unit
should not be used until deemed safe by an authorized service technician. Do not
immerse the unit in any fluids. See the Routine Maintenance Section of this manual for
the proper cleaning procedure for the instrument and its accessories and the function
of single-use parts.
Do not drop or otherwise impact this instrument. If the instrument is dropped or
damaged, return it to the manufacturer for repair and/or calibration. Do not use the
instrument if any damage is suspected.
Do not attempt to open, modify or service the instrument. Return the instrument to the
manufacturer or distributor for all repair and servicing requirements. Opening the
instrument will void the warranty.
This equipment is intended to be connected to other equipment thus forming a Medical
Electrical System. External equipment intended for connection to signal input, signal
output or other connectors shall comply with the relevant product standard e.g. IEC
60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment. In
addition, all such combinations – Medical Electrical Systems – shall comply with the
safety requirements stated the general standard IEC 60601-1, edition 3, clause 16. Any
equipment not complying with the leakage current requirements in IEC 60601-1 shall be
kept outside the patient environment i.e. at least 1.5 m from the patient support or shall
be supplied via a separation transformer to reduce the leakage currents. Any person
who connects external equipment to signal input, signal output or other connectors has
formed a Medical Electrical System and is therefore responsible for the system to
comply with the requirements. If in doubt, contact qualified medical technician or your
local representative. If the instrument is connected to a PC (IT equipment forming a
system) ensure not to touch the patient while operating the PC. If the instrument is
connected to a PC (IT equipment forming a system) assembly and modifications shall be
evaluated by qualified medical technician according to safety regulations in IEC 60601.
The USB connection has a built-in galvanic insulation.