Table of Contents
Advertisement
Titan Instructions for Use - EN
Hardware installation
When connecting the Titan to the mains supply and to a computer, the following warnings must be observed:
1. 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 connect to
a PC (IT equipment forming a system) ensure not to touch the patient while operating the PC.
2. If the instrument is connect 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.
3. Note! The USB connection on the instrument has insulation protections to the patient connections.
4. The consequence of not following this precaution could be a too high leakage current to the patient.
5. Before connection to the mains network, be sure that the local mains voltage corresponds to the
voltage labeled on the instrument. Always disconnect the power cord if the instrument is to be
opened for inspection.
6. For maximum electrical safety, turn off the power from a mains powered instrument when it is left
unused.
7. In order to comply with IEC 60601, use of the direct power adapter to mains for the Able AP1310
thermal printer when it is connected to the cradle is not permitted. The cradle connection provides
power for the thermal printer.
8. 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.
Transport and storage humidity range.
Transport and storage temperature range.
ETL listing marking
Page 7
Advertisement
Table of Contents
