Pilot²
Doc. No 609 2210 v04
5
Catalogue Number
Indicates catalogue number, part number of device
ISO 15223-1:2016 / Ref. 5.1.6
Serial Number
Serial number so the device can be identified
ISO 15223-1:2016 / Ref. 5.1.7
Waste Collection
Separate collection for waste of electrical and electronic equipment.
EN 50419 - Marking of electrical and electronic equipment in accordance with article 11(2) of Directive 2002/96/EC
Do not dispose of with domestic waste
Data Matrix Code for product information
including UDI (Unique Device Identification)
Date of Manufacture
Indicates the medical device manufacturer / Indicates Date of Manufacturer
ISO 15223-1:2016 / Ref. 5.5.1 /5.1.3
Medical Device
This item is a medical-device
ISO 15223-1 draft
Caution!
According to Federal law, this medical device may only be sold by or on the order of a dentist,
physician or any other medical practitioner licensed by the law of the State in which he or she
practices and who intends to use or order the use of this medical device.
First usage – Safety notes
•
Before using the medical device for the first time, store it at room temperature for
24 hours.
•
The operation of the medical device is permitted only on supply units which
correspond to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN
60601-1-2).
•
Always ensure the correct operating conditions.
•
Check the medical device for damage and loose parts each time before using
(e.g. push-button).
•
Do not operate the medical device if it is damaged.
•
Only attach the medical device onto the motor when the motor is at a complete
standstill.
•
Do not activate the push-button of the medical device during operation. This
leads to detachment of the root canal instrument and/or makes the medical
device hot.
•
Perform a test run each time before using.
•
Do not touch the soft tissue with the contra-angle head (risk of burning due to
the push-button heating up)!
EN
