KaVo 1.007.0150, Instructions For Use Manual

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Instructions for use INTRA LUX Motor KL 703 LED – 1.007.0150
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 an integral part of the product and must be read
carefully prior to use and must 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.
4
Take suitable personal protective measures.
4
Follow the instructions for use of the components.
4 Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.
4
Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.
4 If you deviate from this validated procedure, make sure that the repro-
cessing procedure is effective.
4 Reprocess the product and accessories appropriately before disposal.
2.2 Explosion hazard
Electrical sparks in the product can lead to explosion or fire.
4
Do not use the product in explosion hazard areas.
4
Do not operate the product in an oxygen-enriched atmosphere.
4 Do not use the product in the vicinity of flammable gases.
2.3 Electrical shock
Connecting a non-KaVo system to the medical device can lead to electrical
shock and injury to patient, user and third parties.
4 During installation and operation of the product on treatment devices and
equipment from other manufacturers, comply with the provisions of "Protec-
tion from electrical shock," "Leakage current," and "Not grounding the ap-
plied part" in accordance with DIN EN IEC 60601-1.
4 Make sure to combine the product only with a treatment centre / control
unit that has been released by KaVo.
4
Make sure that the product combined with the dental treatment unit / con-
trol unit meets the requirements in accordance with DIN EN IEC 60601-1.
2.4 Improper use
The bluish LED light of the motors can damage the cornea or lens of the eye.
4 Do not gaze into the lamp when it is in operation.
4
Use adequate shielding for eye protection.
2.5 Technical condition
If damaged, the device or components could injure patients, users and third
parties.
4
Only operate devices or components if they show no signs of damage on the
outside.