Safety Notes - Interacoustics Titan IMP440 Setup & Installation

1.2

Safety Notes

It is recommended that all staff working with the Titan read this manual and thereby learn the
precautionary measures.
1. External equipment intended for connection to signal input, signal output or other
connector, shall comply with the relevant IEC standard (e.g. IEC 60950 for IT equipment
and the IEC 60601 series for medical electrical equipment). In addition, all such
combinations - systems - shall comply with the standard 60601-1-1, Safety requirements
for medical electrical systems. Equipment not complying with IEC 60601 shall be kept
outside the patient environment, as defined in the standard (at least 1.5 m from the
patient).
2. Any person who connects external equipment to signal input, signal output or other
connectors has created a system and is therefore responsible for the system complying
with the requirements of IEC 60601-1-1. If in doubt, contact your service technician or local
representative for help.
3. In order to comply with IEC 60601, use of the direct power adapter to mains for the thermal
printer when it is connected to the cradle is not permitted. The cradle connection provides
power for the thermal printer.
4. In order to maintain a high level of safety it is necessary to have the instrument and its
power supply checked according to the medical electrical safety standard IEC 60601-1 on
a yearly basis by a qualified service technician.
1. Use this device only as described in this manual.
2. Use only the disposable Interacoustics ear tips designed for use with this instrument.
3. Never insert the probe tip into the ear canal without affixing an ear tip as omission may
damage the patient's ear canal.
4. Keep the box of ear tips outside the reach of the patient.
5. Be sure to insert the probe tip in a way which will assure an airtight fit without causing any
harm to the patient. Use of a correct and clean ear tip is mandatory.
6. Be sure to use only stimulation intensities acceptable to the patient.
Titan
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.
Setup and Installation Manual Page 2