Getting Started with Schick AE
Page 11
Safety and Compliance (continued)
Any instrumentation or equipment for professional use located near the Schick AE Sensor
and USB Interface must conform to Electromagnetic Compatibility regulations, to which the
EMC tables in the User Guide serve as guidance. Non-conforming equipment, with known poor
immunity to electromagnetic fields, may not operate properly unless they are installed at a
distance of at least 10 feet (3m) and supplied by a dedicated electrical line.
Installers to Ensure that Schick AE Sensor and USB Interface Operate
Optimally
Installers must ensure that the Schick AE Sensor and USB Interface provide the user with the
optimal use of the equipment. This includes, but is not limited to, ensuring that the system
operates as described in this document. To avoid unintentional contact with the USB Interface by
the patient, place the USB Interface in a location where accidental contact is prevented. Installers
must also ensure that the system presents no physical obstacles or hazards during operation
and when not in use. To verify this requirement, installers shall confirm that the Schick AE Sensor
and USB Interface are installed as described in the User Guide and shall perform the appropriate
procedures therein.
Only Dentists or Authorized Designees Are Permitted to Operate the
System
To ensure the correct use of the Schick AE Sensor and USB Interface in a clinical environment, for
purposes that correspond to its intended design and application, only dentists, or their designees,
are authorized to operate the system.
Ensure Proper System and PC Workstation Installation and Operation
The Schick AE Sensor and USB Interface have been determined to be in accordance with
international safety standards andare deemed suitable for use within the patient area, which
extends from the patient for a distance of 5 ft (1.5m). To comply with these standards, do not
operate non-medical equipment (such as a PC workstation) inside the patient area.
Outside the patient area, the presence of approved non-medical grade equipment and Listed /
Approved / IEC 60950-1 certified Information Technology Equipment (ITE) computer equipment
is acceptable.
The host computer (PC workstation) should be CE-approved and conform with the Low Voltage
[73/23/EC] and EMC Directive [89/336/ERC]. Also, to help ensure optimal performance, ensure
that all software programs residing on the workstation are virus-free and have been adequately
tested so they will not impact imaging applications after installation.
Operate the Schick AE Sensor and USB Interface as Directed
Always use the Schick AE Sensor and USB Interface in accordance with the directions and
recommendations contained in the Schick AE User Guide. Do not attempt to modify the Schick
AE Sensor and USB Interface or use it in system configurations not specified in the User Guide.
