Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
2 Safety | 2.1 Infection hazard
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2 Safety
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.
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Take suitable personal protective measures.
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Follow the instructions for using 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.
2.2 Air embolism and skin emphysema
There is a danger that the insufflation of spray can cause air embolisms and
skin emphysema.
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Avoid the insufflation of spray in open wounds.
The improper use of the product might lead to emphysema. Emphysema may
arise in extreme individual cases, especially in the presence of pathological gin-
gival pockets (> 3 mm), mucosal lesions, direct skin contact or contact with
soft tissue and/or improper handling.
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The powder jet device must be used as briefly as possible.
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The PROPHYflex perio tip may be re-used for up to10 times.
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After the treatment, unscrew the empty powder container and rinse the
PROPHYFLEX perio tip with air and water for approx. 10 seconds.
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For safety reasons, the torque wrench should be placed on the perio tip as
protection against injuries when the is PROPHYflex in the holder.
2.3 Technical condition
A damaged device or components could injure patients, users and third parties.
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Only operate devices or components if they are undamaged on the outside.
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Check that the device is working properly and is in satisfactory condition
before each use.
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Have parts with sites of breakage or surface changes checked by the Ser-
vice.
Observe the following instructions in order to guarantee optimum functioning
and prevent material damage:
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The device should be cleaned, serviced and stored in a dry location, accord-
ing to instructions, if it will not be used for a longer period.
