KaVo MULTIflex Coupling 465 RN, Инструкция по эксплуатации

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Instructions for use MULTIflex Coupling 465 RN – 0.553.1600, MULTIflex LUX Coupling 465 LRN – 0.553.1550
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 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 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 centre /
control unit meets the requirements in accordance with DIN EN IEC
60601-1.
2.3 Use
Direct exposure to the lamp or blue light might cause damage or blinding to the
eyes of the patient, user or third parties.
4
Do not look directly into the lamp.
4
Do not look into the lamp for any extended period of time when it is in oper-
ation.
2.4 Technical condition
A damaged 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.
4 Check to make sure that the device is working properly and is in satisfactory
condition before each use.
4
Have parts with sites of breakage or surface changes checked by the service
personnel.