Instructions for use elements™ 8:1
2 Safety | 2.1 Infection hazard
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2 Safety
Note
All serious events occurring in relation to the product must be reported to the
manufacturer and the competent authority of the member state, in which the
user and/or patient resides.
The instructions for use are a component of the product and must be read care-
fully prior to use and be accessible at all times.
The device may only be used in accordance with the intended use, any other
type of use is not permitted.
2.1 Infection hazard
Patients, users or third parties could be infected by contaminated medical
devices.
▶
Take suitable personal protective measures.
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Follow the instructions for use of the components.
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Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.
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Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.
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If you deviate from this procedure, it is essential to make sure that the re-
processing is effective.
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Reprocess the product and accessories appropriately before disposal.
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If there is any injury to soft tissue, do not continue treatment in the oral
cavity with compressed air-driven instruments.
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Use gloves or finger guard whenever you test, insert, and remove the tool.
2.2 Improper use
The improper use of the device could lead to burns or injuries.
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Check the technical condition before each use.
See also:
2
2.3 Technical condition, Page 8
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Never press the push-button during operation of the device.
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Never use the instrument to keep the cheek, tongue or lip at a distance.
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Never touch soft tissue with the handpiece head or instrument cover.
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Do not use the medical device as a light probe.
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Use an appropriate light probe for illumination of the oral cavity or site of
preparation.
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After treatment, place the medical device properly in the cradle without the
tool.
2.3 Technical condition
A damaged device or components could injure patients, users and third parties.
▶
Only operate devices or components if they are undamaged on the outside.
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