Heka Dental Unicline S, Operating And Technical Instructions

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1.6 Use of instruments
Documentation of the safety certification of the accessories must be in compliance
with current IEC 60601-1 international standards and the current ISO 7494.

A complete listing of standards that the UnicLine S Dental Delivery System
complies with can be found in Section 12.3 of this manual.
The UnicLine S Dental Delivery System meets the requirements of Directive
93/42/EEC.
IMPORTANT!
To ensure the safety, reliability, and functionality of this Dental Delivery System:

Use only qualified and authorized technicians for installation, calibration,
modification, and repair of the UnicLine S

Compliance with IEC 60364 for all electrical installations

Use of only authorized OEM instruments

Use this Dental Delivery System only in accordance with instructions
provided in this manual
DO NOT:

Attempt to modify this equipment without authorization by Heka Dental A/S

If modification is made, the Dental Delivery System must be fully tested and
inspected prior to use to ensure safety
1.7 Regulatory Classification

Class I

Type B Applied Parts

Ordinary Protection

Not suitable for use in the presence of a flammable anesthetic mixture with
air, oxygen, or nitrous oxide.