Leica DI C800 / Ref. 10 743 250 / Version 00
Safety Notes
11
Designated use
• The Leica DI C800 Digital Imaging Color Module is an optical instrument for
operating microscopes in Ophthalmology which can superimpose data or
images. These superimpositions can be overlaid over the microscope image.
• Only use the plug and cable provided with the delivery package for connecting
the Leica DI C800, even to a system used as a data source.
Non-intended use
• Only use the Leica DI C800 as described in this manual. Failure to observe these
instructions may result in property damage.
Information for the person responsible
for the instrument
• Ensure that only instructed users use the Leica DI C800.
• Ensure that this User Manual is always available at the place where the
instrument is used.
• Carry out regular inspections to make sure the users are complying with safety
requirements.
• Brief the users thoroughly and explain the meaning of the warning signs and
warning messages to them.
• Allocate responsibilities for preparing the instrument for work, for operating it
and for maintaining it. Monitor compliance with these.
• Do not use the Leica DI C800 unless it is in proper condition.
• Inform your Leica representative or Leica Microsystems (Schweiz) AG,
9435 Heerbrugg, immediately if you detect a product defect that could
potentially cause injury or harm.
• Ensure that the usual precautionary measures for electromagnetic and other
radiation are observed.
• Do not make any changes to this instrument.
• Connected units and all the configurations for the analog and digital interfaces
(signal inputs and outputs) have to be certified in accordance with IEC 601-1/
EN 60601-1 for medical devices. It is the responsibility of the user to ensure that
the limits of the above-mentioned standards are not exceeded. If in doubt,
please contact the appropriate technical department or the representative
responsible.
• The complete system does not conform to CE if the instrument is operated
together with components that do not have CE certification.
Directions for the user of the
instrument
• The Leica DI C800 is suited only for use with selected Leica surgical microscopes
with a corresponding updated software version. If in doubt, please contact the
appropriate technical department or the representative responsible.
• Follow directions provided by your employer regarding work organization and
safety.
• Follow the instructions given in this manual.
• The electrical system at the installation location must conform to IEC, CEC and
NEC specifications.
• Do not sterilize the Leica DI C800.
• Observe the applicable statutory and country-specific regulations for accident
prevention and environmental protection.
Safety Notes
Dangers during use
Care
Caution
Danger of damage to the instrument due to improper storage!
➩
Only put the Leica DI C800 in storage with the protective dust
cover in place.
➩
Protect the instrument from direct sunlight and heat.
➩
Protect the Leica DI C800 from improper operation.
➩
Remove dust on the optics of the Leica DI C800 using a bellows and a soft brush.
➩
Clean the Leica DI C800 using a moist towel and dry it using a soft, lint-free cloth.
➩
Protect the Leica DI C800 from moisture, vapors, acids, alkalis, and corrosive
substances.
➩
Do not store chemicals near the instrument.
➩
Protect the instrument from oil and grease. Never grease or oil mechanical parts
or sliding surfaces.
➩
During breaks in work, use protective dust covers to protect the Leica DI C800.
➩
Do not roll the cables too tightly and do not kink them.
➩
Do not sterilize the Leica DI C800.
Maintenance
The unit does not require maintenance. In order to maintain reliability, we
recommend contacting the responsible service organization to be on the safe side.
Here you can arrange for periodic inspections and, if appropriate, conclude a
maintenance contract.
Service
Service work must only be performed by Leica service technicians.
Only original Leica spare parts must be used.
Disposal
Observe the relevant national regulations on disposing the unit. Suitable waste
disposal companies are to be used. The unit packaging is to be recycled.
