Steris 4095 - 3.2.7 EMC;High-Frequency Interference

3-6
056404-443 Operator Manual Introduction to Table
Figure 3-5. Base Dimensions
3.2.7 EMC/High-Frequency Interference
Note the following:
• Medical Electrical Equipment needs special precautions regarding EMC and needs installed and put into
service according to the EMC information provided in this manual.
• Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
• For table control via e-Serve (RS-232) connection, note the table has been tested for EMC compliance using
a 6’ (2 m) long, shielded serial cable. A longer or unshielded cable could cause problems and must be
observed to verify normal operation.
• The use of accessories, transducers and cables other than those specified by the manufacturer, may result in
increased emissions or decreased immunity of the STERIS 4095 General Surgical Table.
• The STERIS 4095 General Surgical Table should not be used adjacent to or stacked with other equipment. If
so, table should be observed to verify normal operation.
• Medical Electrical Equipment needs special precautions regarding high frequency interference. Equipment
needs installed and put into service according to facility regulations and procedures.
• Potential hazards from the interfering high-frequency device could be patient burns and/or electrical shock of
patient and operator.
• Potential explosion hazards caused by the interfering high-frequency device because this surgical table is
not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide.
WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: Use of accessories,
transducers or cables with this table, other than those specified, may result in increased emissions or
decreased immunity of the table.
WARNING – PERSONAL INJURY HAZARD: Appropriate components of this surgical table have been
tested and found in compliance with IEC 60601-2-46, 3rd Edition, Medical Electrical Equipment - Part 2-
46: Particular requirements for the basic safety and essential performance of operating tables. There is,
however, a potential that high frequency surgical equipment, cardiac defibrillators or cardiac
defibrillator-monitors could interfere with this equipment and cause unanticipated table movement
producing possible patient and/or staff injury. Should user experience any interference, relocate this
device or minimize the use of the interfering equipment while this device is in operation.
CAUTION – POSSIBLE EQUIPMENT DAMAGE: Appropriate components of this surgical table have been
tested and found in compliance with IEC 60601-1-2:
Edition 4 2014-02 , Medical Electrical Equipment –
Part 1; General Requirements for Safety; Electromagnetic Compatibility (EMC). There is, however, a
potential for electromagnetic or other interference between this equipment and other devices. Should
user experience interference, relocate this device or minimize the use of the affected equipment while
this device is in operation.
7”
(165 mm)
37”
(934 mm)
21”
(521 mm)
SAE measurements are approximate based on metric dimensions.