Safety Information; Emc Guidance And Manufacturer's Declaration - AtriCure System Cart Manual Del Usuario

4.9.

Safety Information

4.9.1. PRECAUTION: To avoid electrical hazards, all parts of the ORLab,
including the computer, monitor, Stimulus Generator Unit, and Lexmark
laser printer must be connected to the Isolation Transformer and never
directly to a mains outlet.
4.9.2. PRECAUTION: To avoid risk of electric shock, the Isolation
Transformer must only be connected to a supply mains with protective
earth.
4.9.3. PRECAUTION: To avoid electrical hazards and prevent overloading
the transformer, do not connect any non-AtriCure approved equipment to
the supplied Mains Isolation Transformer.
4.9.4. PRECAUTION: Use AtriCure® System Cart only in ventilated areas
and away from flammable gasses. To avoid risk of explosion, the Basic
Cart should only be used in a ventilated area as gasses may be released
during charging of backup battery, and should not be used in rooms with
flammable anaesthesia.
4.9.5. PRECAUTION: AtriCure® System Cart is not suitable for use in the
presence of a flammable anaesthetic mixture with air or with oxygen or
nitrous.
4.9.6. PRECAUTION: Secure tank with chain and ONLY use N2O Tanks ≤ 20
cm (8") in diameter that weigh ≤ 29.5 kg (65 pounds). Due to the weight of
the N2O tanks, use caution while lifting and securing the tanks.
4.9.7. PRECAUTION: If the cryoICE Box is connected to a grounded hospital
AC power receptacle, it must be connected into the same grounded
hospital AC power receptacle as Isolation Transformer.
4.9.8. PRECAUTION: When the Isolation Transformer is plugged into the
mains outlet, leave at least 2 ft clearance between the back of the AtriCure®
System Cart and the wall to allow access for disconnection.
4.9.9. PRECAUTION: AtriCure® System Cart atmospheric storage condition
is 68.6 kPa to 101.3 kPa and the operating condition is 69.1 kPa to 101.3 kPa
4.9.10. PRECAUTION: No modification of this equipment is allowed.
5.0.

EMC Guidance and Manufacturer's Declaration

5.1. Electromagnetic Emissions
The AtriCure System Cart (ASC2), along with its associated equipment (ASU2 / ASU3,
ASB3, ACM1 / ACM2, and ORLab), from here on referred to as the AtriCure RF, Cryo,
and EP Mapping System (ARC-EPMS) have been tested and found to comply with the
limits for medical devices in IEC 60601-1-2:2014. These limits are designed to provide
reasonable protection against harmful interference in a typical medical installation.
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