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RSL 4500digital and RSL 5000digital by RODENSTOCK RSL 4500digital and RSL 5000digital by RODENSTOCK
2.2 WARNINGS AND CAUTIONS
Please note that the proper and safe functioning of our instruments is only guaranteed if
both the instruments and their accessories are exclusively from Rodenstock. The use of other
accessories may result in increased electromagnetic emissions or reduced electromagnetic
immunity of the device and may lead to incorrect operation.
Observe the following precautions in order to ensure safe operation of the instrument. For the
safety warning regarding the Rodenstock Slit Lamp please consult the Rodenstock Slit Lamp
IFU.
WARNINGS
• Never use the instrument if visibly damaged and periodically inspect it for signs of damage
or misuse.
• Check your Rodenstock product for signs of transport / storage damage prior to use.
• Do not use in the presence of flammable gases / liquids, or in an oxygen rich environment.
• US Federal Law restricts this device to sale by or on the order of a physician or practitioner.
• This device is intended to be used only by suitably trained and authorised healthcare
professionals.
• This product should not be immersed in fluid.
• Repairs and modifications to the instrument must be made only by the specialized
technicians of the manufacturer’s Technical Service Centre or by personnel trained and
authorised by the manufacturer. The manufacturer declines any and all responsibility for
loss and/or damages resulting from unauthorised repairs; furthermore, any such actions
will invalidate the warranty.
• The power switch and mains plug are the means of isolating the device from the mains
supply – ensure both the power switch and mains plug are accessible at all times.
• Do not position the equipment so that is difficult to press the power switch or remove the
mains plug from the wall socket.
• Route power cords safely to eliminate risk of tripping or damage to user.
• Before any cleaning of the instrument or the base unit ensure the power lead is
disconnected.
• LEDs can reach high temperatures in use – allow to cool before handling.
• Do not exceed maximum recommended exposure time.
• As the Digital Camera Assembly is medical equipment, special precautions are needed
regarding EMC (electromagnetic compatibility)
• It is important that the Digital Camera Assembly is configured and installed/put into
service, in accordance with the instructions/guidance provided herein and is used only in
the configuration as supplied.
• Should the instrument suffer shocks (for example, should it accidentally fall), and the
optical system or the illumination system are damaged it may be necessary to return the
instrument to the manufacturer for repair.
• Do not touch accessible connectors and the patient simultaneously.
• The owner of the instrument is responsible for training personnel in its correct use.
• Ensure the instrument or instrument table is placed on a level and stable surface.
• Use only genuine Rodenstock approved parts and accessories or device safety and
performance may be compromised.
• Refraction stand variants or adaptors should only be used in combination with EN/IEC
60601-1 and EN/IEC 60601-1-2 compliant power supplies and devices.
• Shut down after every use. In case the dust cover is used: risk of overheating.
• For indoor use only (protect from moisture).
• Electrical equipment can be affected by electromagnetic interference, for example
videostream may freeze for one minute or more. If this occurs whilst using this equipment,
switch the unit off and reposition. Essential performance is determined as continuous
videostream which cannot be interrupted for longer than one minute.
• Despite the testing of the Digital Camera Assembly that has been undertaken, normal
operation of the Digital Camera Assembly can be affected by other electrical/electronic
equipment and portable and mobile RF communications equipment.
• Rodenstock digital Slitlamp is not intended to be used with wireless technology. Do not
plug a wireless dongle into USB port. It is advisable to disable wireless technology on the
computer to prevent unauthorised access to the camera.
• Rodenstock digital Slitlamp cannot be used in the vicinity of sources known to cause
electromagnetic disturbance (magnetic resonance imaging, computed tomography,
radio-frequency identification, metal detectors, electronic article surveillance and other
electromagnetic security systems). Do not bring the Rodenstock digital Slit lamp into
magnetic resonance environment.
• The Digital Camera Assembly should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use with other equipment is necessary, the Digital
Camera Assembly and the other equipment should be observed/monitored, to verify
normal operation in the configuration in which it will be used.
Before use, the Slit Lamp should be allowed to adjust to the ambient
room temperature for several hours. This is especially important when the
unit has been stored or transported in a cold environment; this can cause
severe condensation to develop on the optical elements.