Packaging Symbols; Intended Use; Indication; Contraindication - Riester ri-focus LED Instrucciones Para El Uso

1.3 Packaging symbols

Symbol Note on symbol
Indicates that the contents of the transport package are fragile and should therefore 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)
Notes on electromagnetic compatibility
There are currently no indications that electromagnetic interactions with other devices can occur when the devices are used as intended.
Nevertheless, under the increased influence of unfavourable field strengths, e.g. during the operation of wireless telephones or radiological instruments, disturban-
ces cannot be completely excluded.
Warning:
The use of other accessories may result in increased electromagnetic emissions or reduced electromagnetic imm¬unity of the device and lead to incorrect operation.
The electromagnetic compatibility of this device has been verified by tests according to the requirements of IEC 60601-1-2.

1.4 Intended Use

Riester headlights and head mirrors are manufactured for the illumination of body parts under examination.
These products are most often used in hospitals or medical practices by a trained doctors or specialists. It is an active diagnostic medical device/ME device operation
is dependant on an internal power source.
Intended use:
The LED examination lamps serve as a light source for the detection, diagnosis, monitoring, treatment or alleviation of diseases, injuries or disabilities. These pro-
ducts are most often used in hospitals or medical practices, etc.
The examination lamps are not intended for eye exams and should not be used for such.

1.4.1 Indication

The LED headlights and head mirrors clinicians in diagnostic examinations and surgical interventions. The light source used, a 6 V LED or 6 V vacuum lamp, is powe-
red by a battery compartment.
The examination lamps assist the trained doctor or specialist in the detection, diagnosis, monitoring, treatment or alleviation of illnesses, injuries and disabilities.

1.4.2 Contraindication

There may be a risk of ignition of gases if the instrument is operated in the presence of flammable mixtures or mixtures of pharmaceuticals.
The examination lamps must never be placed in liquids.
Only use Riester or Riester-approved accessories/consumables.
Cleaning frequency and sequence must comply with the cleaning regulations of non-sterile products in the respective facility.
Cleaning/disinfection instructions must be observed.
The product may only be used by trained personnel.

1.4.3 Intended patient population

The device is intended for use on adults and children.

1.4.4 Intended operators/users

The examination lamps are intended exclusively for use by doctors and clinicians (trained medical professionals) in clinics and medical practices.
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