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1.2 Cautions
1. Stryker trained personnel are the only personnel authorized to install the equipment described in this
manual.
2. Follow the care and cleaning instructions in this manual.
3. The electrical installation of the operating room must comply with any applicable IEC, CEC, NEC
requirements as well as the local codes and pre-installation manual.
4. Shielded video cables are required in order to assure proper function so that portable and mobile RF
communications equipment do not aect this device’s performance.
5. Using accessories or cables other than those provided may result in increased emissions or decreased
immunity of the system.
6. For operating rooms only:
• The Visum Blade LED Surgical Light must be equipped with emergency power back up systems.
• The emergency power back up system must have the capability to restore power in 50 milliseconds
or less.
1.3 EMC Precautions
This device is considered medical electrical equipment and requires special precautions regarding EMC and
needs to be installed and put into service according to the information provided.
1.4 Electrical Safety Notes
1. Class 1 Equipment: equipment in which the protection against electric shock does not rely on Basic
Insulation only, but includes an additional safety precaution in such a way that means are provided for
the connection of Accessible Conductive Parts to Protective (ground) Conductor in the xed wiring of
the installation in such a way that Accessible Conductive Parts cannot become Live in the event of a
failure of the Basic Insulation.
2. All electrical services for at panel power connections must be routed in accordance with all applicable
regulations including but not limited to local building and electrical codes. System circuits must be
connected to correctly rated and protected branch circuits.
3. In the event that it becomes necessary to terminate power to the light head(s) and at panel monitors,
refer to hospital’s electrical diagrams to interrupt power at the mains breaker.
4. Refer to IEC 60601-1 Ed. 3.0 and 3.1 for requirements of an ME system.
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