KaVo ERGOcam One, Instructions For Use Manual

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Instructions for use ERGOcam One
2 Safety | 2.3 Safety instructions
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2.2.2 Product-specific
The intraoral camera serves the generation of video signals for visualisation e.g. the
oral cavity of a patient via a suitable display medium. The generated data is used for
the patient´s information and to support the diagnosis.
The camera is a class II medical device according to the EC directive 93/42/EEC and
meets the requirements of 89/336/EEC in regard to electromagnetic compatibility.
The LED lighting is not harmful to eyes according to photobiological observation and
complies with the classification "Free Group" according to IEC 62471.
The camera is designed to be installed in dental treatment units according to DIN EN
ISO 7494.
2.3 Safety instructions
2.3.1 Product-specific
WARNING
Danger of injury from electric current.
Electric shock.
▶ Before connecting the camera tube, turn off the supply voltage to the device.
▶ Do not continue working with a damaged camera!
▶ Only connect accessories that conform with IEC 60601-1, IEC 60950 or IEC
601010 to the system.
WARNING
Danger of injury due to voltage at an operating height of above 3 000 m. The device
is only insulated for heights of up to 3 000 m.
Electric shock
▶ Only use the device at operating heights of up to 3 000 m.
WARNING
Highly flammable gases-.
Explosion.
▶ Allow product to cool before disinfecting.
WARNING
Danger of choking or injury when the camera is inserted too deeply.
Vomiting, aspiration of vomit.
Injuries.
▶ Do not insert the camera to a depth of more than 70 mm.
▶ Do not insert the camera into the patient's throat!
WARNING
Risk of infection due to soiled or contaminated camera
Infection.
▶ When using the camera, always use a disposable protective cover.
▶ Renew the disposable cover after each patient.
▶ Do not use damaged covers.
▶ Wipe the camera down with disinfectant after use.