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2. Safety notes
Risks due to electromagnetic fields
The functionality of implantable systems, such
as cardiac pacemakers and ICD (implantable
cardioverter defibrillator) can be affected by
electric, magnetic and electromagnetic fields.
– Find out if patients and users have an implanted
device before using the product and consider the
applications.
– Weigh the risks and benefits.
– Keep the product away from implanted devices.
– Make appropriate emergency provisions and take
immediate action on any signs of ill-health.
– Symptoms such as raised heartbeat, irregular
pulse and dizziness can be signs of a problem with
a cardiac pacemaker or ICD (implantable
cardioverter defibrillator).
Danger zones M and G
In accordance with IEC 60601-1 /ANSI/AAMI ES 60601-1,
the control unit and the motor with cable are not suitable
for use in potentially explosive atmospheres or with
potentially explosive mixtures of anaesthetic substances
containing oxygen or nitrous oxide.
Control unit
The control unit is classed as “conventional equipment”
(closed equipment without protection against the ingress
of water).
The Osscora surgical set control unit is designed only to
be used with the Osscora contra-angle handpiece. Use of
other contra-angle handpieces may result in deviation from
the indicated torques and is the user’s responsibility.
The motor, motorcable and contra-angle handpiece are
applied parts.
Foot control
The foot control is approved for use in zone M (AP).
Please note that at low speeds, it is more difficult to
determine that the motor is running.
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