Sunoptic Surgical HDC-300 Manual De Instrucciones página 6

Use only manufacturer's specified compatible accessories and peripheral equipment.
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Use of non-approved equipment may cause loss of function.
Before each use, check the outer surface of this equipment to be used to ensure that
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there are no rough surfaces, sharp edges, or protrusions that can cause injury.
Avoid dropping the camera system or rough handling. The camera system contains
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sensitive components prone to damage by mechanical shock.
• This device complies with the IEC 60601-1 safety standard. When peripherals are
connected to this device, a Medical Electrical (ME) System is formed and the system
should be evaluated for conformance to IEC 60601-1 safety standards. When used
with other equipment, the leakage currents may be additive. The person creating the
ME system is responsible to comply with the applicable safety regulations and safety
standards for their location. Connect only IEC 60601-1 approved equipment to this
device. Never touch peripheral equipment connections on this device and the patient
at the same time. This can create a risk of shock to the patient.
Do not use the equipment in the prescence of flammable liquids, gases, or other
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materials susceptible to ignition due to electrical sparking.
This equipment generates and radiates EMI which may affect the normal
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function of nearby installed equipment. Equipment that generates and radiates EMI
may affect the normal function of the HD Camera System. Place the equipment away
from strong EMI sources.
Data stored on the HDC-300 may be sensitive data that could breach patient
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confidentiality if the data is accessed by an unauthorized user. It is the user's
responsibility to protect any sensitive data stored on this device.
Any serious incident that has occurred in relation to this device should be reported to
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the manufacturer and the competent authority of the Member State and/or Country in
which the user and/or patient is established.
Cautions
To prevent improper use and/or damage to this device, please note the following cautions:
Carefully unpack this unit and check if any damage occurred during shipment. If
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damage is detected, refer to the Warranty and Return Policy section of this manual.
This equipment generates heat and uses cooling fans during normal use. To reduce
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the risk of overheating and possible loss of function and/or damage to the equipment,
install the equipment in a well-ventilated space within the operating conditions listed
herein.
• There is a risk of damage to the equipment if the equipment is subjected to cleaning
or sterilization methods not approved be the manufacturer. To reduce risk of loss of
funtion and/or damage to the equipment, only use the approved cleaning and
sterilization methods described herein.
High frequency surgical devices may cause interference with the video image
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displayed on the surgical monitor. To reduce this risk, high frequency devices and
imaging equipment should be located on separate supply circuits.
• There are no user serviceable parts inside the console or camera heads. There are
hazardous voltages present inside the console. Do not remove the cover. Return the
device to the manufacturer for service.
Ensure that the HDC-300 is setup in a manner that any cables that are connected to
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the console or head are not a tripping hazard during use.
LIT- 248 SUNOPTIC SURGICAL
Rev. D
®
Page 6 of 189
(English)