External equipment intended for connection to
signal input, signal output or other connector, shall
comply with 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 patient environment,
as defined in standard (at least 1.5 m from the patient).
Any person who connects external equipment to signal input, signal
output or other connectors has formed a system and is therefore
responsible for the system to comply with the requirements of IEC
60601-1-1. If in doubt, contact your service technician or local
representative for help.
If connection is made to a standard PC which is powered through the
mains network, special precautions must be taken in order to
maintain medical safety.
A standard USB cable can only be used, if the connected PC is:
• running on battery, or
• medical approved, or
• powered via a medical approved safety transformer.
In all other cases, a galvanic separator must be inserted in the USB
connection.
The AS608/AS608e is intended to be
powered from a PC as described above,
from batteries or from a medical power
supply type ASA30M-0301. Using other supplies is not allowed.
Do not site the AS608/AS608e next to a
radiator or any other heat source. Allow six
inches between the back panel and the wall
to ensure proper ventilation.
In operation the instrument should not be
subject to temperatures below 15C or
above 35C. If the instrument is moved from
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