Proper Training; In Case Of Equipment Failure; Hygiene; Electrical Safety - KULZER cara i700 wireless Bedienungsanleitung

careful to avoid contact with the patient's teeth or restorations.
▪ If the i700 wireless system is dropped on the floor or if the unit is impacted, it must be calibrated before use. If the instrument is unable to
connect to the software, consult the manufacturer or authorized resellers.
▪ If the equipment fails to operate normally, such as having issues with accuracy, stop using the product, and contact the manufacturer or
authorized resellers.
▪ Install and use only approved programs to ensure the proper functionality of the i700 wireless system.
▪ In the event of a severe accident involving the i700 wireless system, notify the manufacturer and report it to the competent national
authority of the country where the user and patient reside.
▪ If the PC with the software installed does not have security software or if there is a risk of malicious code intrusion into the network,
the PC may be breached with malware (malicious software such as viruses or worms that damage your computer).
▪ The software for this product must be used in compliance with medical and personal information protection laws.
4.2

Proper Training

WARNING
Before using your i700 wireless system on patients :
▪ You should have been trained to use the system or read and fully understand this User Guide.
▪ You should be familiar with the safe use of the i700 wireless system, as detailed in this User Guide.
▪ Before use or after changing any settings, the user should check that the live image is displayed properly in the camera preview window of the
program.
4.3

In Case of Equipment Failure

WARNING
If your i700 wireless system is not working properly or if you suspect that there is a problem with the equipment :
▪ Remove the device from the patient's mouth and discontinue use immediately.
▪ Disconnect the device from the PC and check for errors.
▪ Remove the rechargeable battery from the i700 wireless system.
▪ Contact the manufacturer or authorized resellers.
▪ Modifications to the i700 wireless system are prohibited by law as they may compromise the safety of the user, patient, or a third party.
4.4

Hygiene

WARNING
For clean working conditions and patient safety, ALWAYS wear clean surgical gloves when :
▪ Handling and replacing the tip.
▪ Using the i700 wireless system on patients.
▪ Touching the i700 wireless system.
WARNING
The i700 wireless system and its optical window should be always kept clean. Before using the i700 wireless system on a patient, be sure to :
▪ Sterilize the i700 wireless system as described in the section "3.2 Cleaning, Disinfection, Sterilization Procedure."
▪ Use a sterilized tip.
4.5

Electrical Safety

WARNING
▪ The i700 wireless system is a Class I device. The i700 wireless system includes the i700 wireless handpiece, wireless hub, battery charger, and
rechargeable battery altogether.
▪ To prevent electric shock, the i700 wireless system must only be connected to a power source with a protective earth connection. If you
cannot insert the i700 wireless-supplied plug into the main outlet, contact a qualified electrician to replace the plug or outlet. Do not try to
circumvent these safety guidelines.
▪ Do not use a grounding-type plug connected to the i700 wireless system for any other purpose than its intended use.
▪ The i700 wireless system only uses RF energy internally. The amount of RF radiation is low and does not interfere with surrounding
electromagnetic radiation.
▪ There is a risk of electric shock if you attempt to access the inside of the i700 wireless system. Only qualified service personnel
should access the system.
▪ Do not connect the i700 wireless system to a regular power strip or extension cord, as these connections are not as safe as
grounded outlets. Failure to adhere to these safety guidelines may result in the following hazards :
▪ All connected equipment's total short circuit current may exceed the limit specified in EN/IEC 60601-1.
▪ The impedance of the ground connection may exceed the limit specified in EN/IEC 60601-1.
▪ Do not place liquids such as beverages near the i700 wireless system and avoid spilling any liquid on the system.
▪ Never spill liquid of any kind on the i700 wireless system.
▪ Condensation due to changes in temperature or humidity can cause moisture buildup inside the i700
Wireless system, which may damage the system. Before connecting the i700 wireless system to a power supply, be sure to
keep the i700 wireless system at room temperature for at least two hours to prevent condensation. If condensation is visible on the
product surface, the i700 wireless should be left at room temperature for more than 8 hours.
▪ You should only disconnect the i700 wireless system from the power supply via its power cord or rechargeable battery.
▪ When disconnecting the power cord or the rechargeable battery, hold the surface to remove it.
▪ Before disconnecting, make sure to turn off the power on the device using the power switch on the handpiece.
▪ The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 Class A). If used in a
residential environment (for which CISPR 11 Class B is normally required), this equipment might not offer adequate protection to radio-frequency
communication services.
▪ Use only batteries provided for use with the i700 wireless. Other batteries could damage the i700 wireless system.
▪ Avoid pulling on the communication cables, power cables, etc. used with the i700 wireless system.
▪ Use only medical adapters provided for use with the i700 wireless. Other adapters could damage the i700 wireless system.
▪ Do not touch the connectors of the device and the patient simultaneously.
4.6

Eye Safety

WARNING
▪ The i700 wireless system projects a bright light from its tip during scanning.
▪ The bright light projected from the tip of the i700 wireless is not harmful to the eyes. However, you should not look directly at
the bright light nor aim the light beam into the eyes of others. Generally, intense light sources can cause eyes to become brittle and the likelihood
of secondary exposure is high. As with other intense light source exposure, you may experience a temporary reduction in visual acuity, pain,
discomfort, or visual impairment, all of which increase the risk of secondary accidents.
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