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Chapter 4
INDICATIONS FOR USE
User's Manual |
MDP156
Chapter 4 - Indications for Use
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Definition
An electrically-powered LCD Monitor designed as an output device for displaying data (e.g.,
patient images, videos) from endoscopic/ laparoscopic camera systems and other compatible
healthcare imaging systems. It is typically a mounted liquid crystal display (LCD) or light-emitting
diode (LED) unit, and may include an antimicrobial material to prevent cross-contamination in
healthcare environment.The Monitor is a widescreen, high-definition, healthcare grade for use
during minimally invasive surgical procedures and is suitable for hospital operating rooms, surgi-
cal centers, clinics, doctors’ offices and similar healthcare applications.
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Classification information
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Power by Class I power supply
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No protection against ingress of water (IPX0)
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No Applied part
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Mode of operation: Continious operation
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Provides isolation: MOPP
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Customers in the U.S.A
This equipment has been tested and found to comply with the limits for a Class A digital de-
vice, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference when the equipment is operated in a commercial envi-
ronment. This equipment uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instruction manual, may cause harmful interference to radio com-
munications.
All interface cables used to connect peripherals must be shielded to comply with the limits for
a digital device pursuant to Subpart B of part 15 of FCC Rules.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any
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Customers outside the U.S.A
Inquiries related to product compliance based on European Union legislation shall be addressed
to the authorized representative. For any service or guarantee matters, please refer to the ad-
dresses provided in the separate service or guarantee documents.
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Important safeguards/notices for use in the healthcare applications
1.
All the equipment connected to this unit shall be certified per Standard IEC60601-1,
IEC60950-1, IEC60065 or other IEC/ISO Standards applicable to the equipment.
2.
Furthermore, all configurations shall comply with the system standard IEC60601-1-1. Every-
body who connects additional equipment to the signal input part or signal output part con-
figures a healthcare system, and is therefore, responsible that the system complies with the
requirements of the system standard IEC60601-1-1.
3.
If in doubt, consult the qualified service personnel.
4.
The leakage current could increase when connected to other equipment.
5.
For this equipment, all accessory equipment connected as noted above, must be connected
to mains via an additional isolation transformer conforming to the construction require-
ments of IEC60601-1 and providing at least basic insulation.
6.
This equipment generates, uses, and can radiate radio frequency energy. If it is not installed
and used in accordance with the instruction manual, it may cause interference to other
equipment. If this unit causes interference (which can be determined by unplugging the
power cord from the unit), try these measures: Relocate the unit with respect to the suscep-
tible equipment. Plug this unit and the susceptible equipment into different branch circuit.
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Important EMC notices for use in the healthcare applications
The display needs special precautions regarding EMC and needs to be installed and put into ser-
vice per the EMC information provided in the instructions for use.
The portable and mobile RF communications equipment such as cellular phones can affect the
display.
Warning:
The use of accessories and cables other than those specified, with the
exception of replacement parts sold by DFI, may result in increased emis-
sions or decreased immunity of the device.
