70
Electrical safety
ThissystemmeetsEN 60601‐1,ClassI/internally‐poweredequipmentrequirementsandType
BFisolatedpatient‐appliedpartssafetyrequirements.
Thissystemcomplieswiththeapplicablemedicalequipmentrequirementspublishedinthe
CanadianStandardsAssociation(CSA),EuropeanNormHarmonizedStandards,and
UnderwritersLaboratories(UL)safetystandards.SeeChapter 8, “Specifications.”
Formaximumsafetyobserve
thefollowingwarningsandcautions.
WARNING:
To avoid discomfort or minor risk of patient injury, keep hot surfaces away from the
patient.
Under certain circumstances, the transducer connector and back of the display
enclosure can reach temperatures that exceed EN60601-1 limits for patient contact,
therefore only the operator shall handle the system. This does not include the
transducer face.
To avoid discomfort or minor risk of operator injury when handling the transducer
connector, the system should not be operated for more than 60 minutes
continuously in a live-scan mode (as opposed to freeze or sleep modes).
To avoid the risk of injury, do not operate the system in the presence of flammable
gasses or anesthetics. Explosion can result.
To avoid the risk of electrical shock or injury, do not open the system enclosures. All
internal adjustments and replacements, except battery replacement, must be made
by a qualified technician.
To avoid the risk of electrical shock:
• Use only properly grounded equipment. Shock hazards exist if the power supply is
not properly grounded. Grounding reliability can only be achieved when
equipment is connected to a receptacle marked “Hospital Only” or “Hospital
Grade” or the equivalent. The grounding wire must not be removed or defeated.
• When using the system in an environment where the integrity of the protective
earth conductor arrangement is in doubt, operate the system on battery power
only without using the power supply.
• Do not touch any of the following:
• The ungrounded signal input/output connectors on the back of the ultrasound
system
• The system battery contacts (inside the battery compartment)
• The system transducer connector when the transducer is disconnected
• Do not connect either of the following to an MPSO or extension cord:
• System power supply
• Auxiliary mains outlet receptacles on the S Series stand or the V-Universal
stand