Electrical Shock; Technical Condition; Electromagnetic Fields - KaVo ESTETICA E30 Instructions For Use Manual

Instructions for use ESTETICA E30
2 Safety | 2.3 Electrical shock

2.3 Electrical shock

Improper connection of a non-medical system to the USB interfaces of the
device can lead to electrical shock and injury to patient, user and third parties.
4 Connect any USB device to the medical system in accordance with IEC
60601-1 / IEC 62368-1.
4 Set up the external PC outside of the patient environment keeping a min-
imum distance of 1.5 m.
4 Connect the PC and equipment connected to the PC in accordance with IEC
60601-1 / 62368.
4 Use USB devices with no additional power supply (USB-powered) only.
4 Applied parts connected to the USB interface of the treatment centre must
comply with IEC 60601-1 type BF.
4 USB-powered devices failing to meet the requisite insulation for applied
parts must be placed appropriately such that direct contact of the USB
device and the patient is excluded.
4 It is not permissible to touch USB-powered devices failing to meet the re-
quisite insulation for applied parts and the patient at the same time.

2.4 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.
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.
4 If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage
▪ Irregular running noise
▪ Excessive vibration
▪ Overheating
▪ Dental bur is not seated firmly in the handpiece
The electrical safety of the device may be affected by improper operating condi-
tions.
4 Comply with the operating conditions specified in the "Technical Specifica-
tions" chapter.
Instrument hoses may burst due to stickers.
4 Do not affix stickers or adhesive tape to instrument hoses.

2.5 Electromagnetic fields

Electromagnetic fields might interfere with the functions of implanted systems
(such as pacemakers).
4 Ask patients if they have a cardiac pacemaker or other system implanted
and counsel them about the risks before you start the treatment.
High-frequency communications devices may interfere with medical electrical
devices.
4 Do not use cell phones in medical offices, hospitals or laboratories.
4 Remove electronic devices such as e.g. computer storage media, hearing
aids etc. during operation.
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