Safety notes
Leica HD C100 / Ref. 10 733 205 / Version 01 3
3 Safety notes
The Leica HD C100 camera system is state-of-the-art technology.
Nevertheless, hazards can arise during operation.
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Always follow the instructions in this user manual, and in
particular the safety notes.
3.1 Intended use
• The Leica HD C100 camera system is an optical instrument for
observation and documentation that works together with a
Leica surgical microscope.
• The Leica HD C100 camera system may be used in enclosed
rooms only.
• The Leica HD C100 camera system is subject to special
precautionary measures for electromagnetic compatibility. It
must be installed and put into operation in accordance with the
guidelines, manufacturer's declarations, and recommended
safety distances (Table 201, 202, 204, 206 in accordance with
EN 60601-1-2:2001, 2nd / 3rd edition).
• Portable and mobile RF communication equipment as well as
fixed communication equipment can have a negative influence
on the proper functioning of the Leica HD C100 camera system.
3.2 Indication for Use
• The HD C100 camera is used to display surgeon‘s field of view,
captures still image and records video.
• These Instructions for Use are intended for physicians, nurses
and other medical and technical staff who prepare, operate or
maintain the device. It is the duty of the device owner/operator
to train and brief all the operating personnel.
3.3 Contraindications
No known contraindications for Use.
3.4 Information for the person
responsible for the instrument
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Make sure that the camera system is used by qualified
personnel only.
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Ensure that this User Manual is always available at the place
where the camera system is used.
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Carry out regular inspections to make certain that the
authorized users are adhering to safety requirements.
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When instructing new users, do so thoroughly and explain the
meanings of the warning signs and messages.
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Allocate responsibilities for commissioning, operation and
maintenance. Monitor compliance with this.
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Do not use the camera system unless it is in proper condition.
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Inform your Leica representative or Leica Microsystems
(Switzerland) AG, 9435 Heerbrugg, immediately if you detect a
product defect that could potentially cause injury or harm.
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If you use accessories from other manufacturers with the
surgical microscope system, make sure that these
manufacturers confirm that the combination is safe to use.
Follow the instructions in the user manual for those accessories.
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Modifications and maintenance work on the camera system
may only be performed by professionals expressly authorized by
Leica.
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Only original Leica replacement parts may be used in servicing
the product.
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After service work or technical modifications, the device must
be readjusted in accordance with our technical specifications.
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If the instrument is modified or serviced by unauthorized
persons, is improperly maintained (as long as maintenance was
not carried out by us), or is handled improperly, Leica will not
accept any liability.
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The effect of the Leica HD C100 camera system on other
instruments has been tested as specified in EN 60601-1-2. The
system passed the emission and immunity test. Comply with
the usual precautionary and safety measures relating to
electromagnetic and other forms of radiation.
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Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the Leica HD
C100, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment
could result.
3.5 User qualifications
The Leica HD C100 camera system may be used only by physicians
and medical assistance personnel with appropriate qualifications
who have been instructed in the use of the instrument. Specific
training is not required.
3.6 Directions for the user of the
instrument
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Follow the instructions described here.
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Follow the instructions given by your employer regarding the
organization of work and safety at work.