9600 Service Manual - gmecorp-usa.com

Introduction 9
UNAUTHORIZED MODIFICATIONS
Unauthorized changes or modifications could have hazardous consequences.
Changes or modifications must not be made unless specifically authorized by
OEC.
Modification requests can be made by obtaining a field modification request form
from OEC Mecical Systems.
NOTE: All OEC 9600 systems comply with International Electrotechnical
Commission safety standard IEC-601. Do not connect any external device to
the system that does not meet the requirements of IEC-601. Only devices
provided or approved by OEC Medical Systems, Inc. should be connected to
the system.
When properly assembled with a compatible beam limiting device, this
diagnostic source assembly will fully meet the Federal Performance Standards
for Diagnostic X-Ray Systems and Their Components (21CFR 1020.30-32)
provided no components or parts are removed from the unit and no unauthorized
adjustments are made in the beam limiting device or tube housing assembly.
• Never remove any part of the housing or beam limiting device.
• Never adjust any part of the beam limiting device unless under the direction
of the manufacturer.
• All hardware (i.e. screws, nuts, bolts, etc.) must be re-installed on the
equipment.
• All EMI-RFI shielding components must be re-installed on the equipment.
Any damaged shielding gasket must be replaced to ensure that the system
complies with EMI-RFI regulations.