Getting Started with Schick AE
Page 10
Safety and Compliance
Check Schick Sensor, USB Interface, and USB Cable before Using Them
Before each usage, check the outer surface of the Sensor and cable, the USB Interface, and the
USB cable for any signs of physical damage or defect. Sensor and USB Interface surfaces should
have a smooth finish, with no evidence of chipping or damage and the cables should appear
undamaged. If visual defects are detected, discontinue use and contact your local distributor of
Sirona Dental products for further instructions.
Do Not Touch Exposed Connectors on Non-Medical Equipment and
the Patient at the Same Time
When the Schick AE Sensor and USB Interface are in use, avoid touching exposed connectors on
non-medical electrical equipment and the patient at the same time. The human body is capable
of conducting electrical current and may cause a shock hazard to patients if appropriate safety
practices are not observed
Follow All Instructions to Ensure Cable Replacement Procedures
are Performed Correctly
Follow all instructions to ensure the successful replacement of your Schick AE cables. When
performing the cable replacement procedure, it is especially important to tighten the screws that
attach the cable to the Sensor by turning them at least one-quarter revolution clockwise after
initial resistance or until they cannot be turned any further. An improperly attached cable may
cause an intermittent connection and prevent the Sensor from operating effectively. Refer to the
Schick AE User Guide for complete instructions.
Use Only USB Cables Approved for the Schick AE System
For normal operation of your Schick AE system and to ensure compliance with regulatory EMC
and EMI standards, use only the USB cables described and specified for your system. Refer to the
User Guide for details.
Do Not Connect Items that are Not Part of the System
Only items specified for use with the Schick AE Sensor and USB Interface are to be connected
to it. The device should not be used adjacent to other equipment that is not part of the system.
If, however, use with adjacent equipment is necessary, normal operation should be observed and
verified in that configuration.
RF Interference Considerations
Although the Schick AE Sensor and USB Interface are designed to provide a reasonable degree
of protection from electromagnetic interference, according to IEC International regulations, they
must be installed at an adequate distance from electricity transformer rooms, static continuity
units, two-way amateur radios and cellular phones. To ensure proper operation, the latter
(meaning, electricity transformer rooms, static continuity units, two-way amateur radios and
cellular phones) can be used only at a minimum distance of 5 feet (1.5m) from any part of the
Schick AE Sensor and USB Interface.
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.
NOTE: Please refer to the User Guide for the latest information.
