Intended Patient Population; Intended Operators/Users; Required Skills/Operator Training; Environmental Conditions - Riester EliteVue Instrucciones Para El Uso

1.1. Safety symbols
Symbol Note on symbol
Indicates that the contents of the transport package are fragile and should there-
fore be handled with care.
Store in a dry place
Indicates the correct position for transporting the package.
Keep away from sunlight
"Green Dot" (country-specific)
Warning:
Please note that the proper and safe functioning of our instruments is only guaranteed if both
the instruments and their accessories are exclusively from Riester. The use of other accessories
may result in increased electromagnetic emissions or reduced electromagnetic immunity of the
device and may lead to incorrect operation.
1.3 Caution/contraindications
There may be a risk of ignition of gases if the instrument is used in the presence of flammable
mixtures or mixtures of pharmaceuticals.
− The instrument heads and battery handles must never be placed in liquids.
− The exposure to intense light during an extended eye examination using the ophthalmoscope
may damage the retina.
− The product and ear specula are non-sterile. Do not use on injured tissue.
− Use new or sanitised ear specula to limit the risk of cross-contamination.
− Used ear specula must be disposed of in accordance with current medical practices or local
regulations regarding the disposal of infectious, biological medical waste.
− Only use Riester or Riester-approved accessories/consumables.
− Cleaning frequency and sequence must comply with the cleaning regulations of non-sterile pro-
ducts in the respective facility. Note the cleaning/disinfection instructions in the user manual.
− The product may only be used by trained personnel.

1.4 Intended patient population

− The device is intended for adults and children.

1.5 Intended operators/users

− The otoscopes are only intended exclusively for use by doctors in clinics and medical practices.

1.6 Required skills/operator training

− Since only doctors use the otoscopes, they have the appropriate qualifications.

1.7 Environmental conditions

− Otoscopes
− The device is intended for use in rooms with a controlled environment.
The device must not be exposed to adverse/harsh environmental conditions.

1.8 Warnings/caution

Warning
The general warning symbol indicates a potentially dangerous situation that can lead to serious
injuries.
Do not use in a magnetic resonance environment!
There is a risk of ignition of gases if the device is operated in the presence of flammable mixtures
or mixtures of medicinal products and air or oxygen or nitrous oxide!
The device must not be operated in rooms in which flammable mixtures or mixtures of pharma-
ceuticals and air or oxygen or nitrous oxide are present, e.g. operating theatres.
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