Sony LMD-XH550MD Manual de Usario
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5-052-059-11(1)
LCD Monitor
Instructions for Use
Before operating the unit, please read this manual thoroughly
and retain it for future reference.
LMD-XH550MD
© 2023 Sony Corporation
2023-06
2
Indications for Use/Intended Use
The LCD Monitor is intended to provide 4K 2D color
video displays of surgical and other medical
images.
Regulatory Information relevant under
the European Medical Device Regulation
2017/745 as amended (MDR)
The LCD Monitor is intended to provide displays of
surgical and other medical images for review and
treatment of disease or an injury.
Notes
This equipment is not intended for diagnostic
use.
This equipment is for medical professionals.
This equipment is intended for use in medical
environments, such as clinics, examination
rooms, and operating rooms.
Contraindications
There are no known specific situations that
contraindicate the use of this device.
Patient population
Patient population is not subject to any
restrictions.
To reduce the risk of fire or electric shock, do not
expose this equipment to rain or moisture.
To avoid electrical shock, do not open the
cabinet. Refer servicing to qualified personnel
only.
No modification of this equipment is allowed.
Warning
To avoid the risk of electric shock, this
equipment must only be connected to a supply
mains with protective earth.
Warning
This unit has no power switch.
To disconnect the main power, unplug the power
plug.
When installing the unit, incorporate a readily
accessible disconnect device in the fixed wiring, or
connect the power plug to an easily accessible
socket-outlet near the unit.
Do not position the ME equipment where it is
difficult to unplug the power plug.
If a fault should occur during operation of the unit,
operate the disconnect device to switch the power
supply off, or disconnect the power plug.
Warning
Symbols on the product
Consult the instructions for use
Follow the directions in the instructions
for use for parts of the unit on which this
symbol appears.
This symbol indicates the manufacturer,
and appears next to the manufacturers
name and address.
This symbol indicates the Importer, and
appears next to the Importers name and
registered office address.
This symbol indicates the European
Community representative, and appears
next to the European Community
representatives name and address.
This symbol indicates the UK
Responsible Person, and appears next to
the UK Responsible Persons name and
address.
This symbol indicates the Swiss
authorized representative, and appears
next to the Swiss authorized
representatives name and address.
This symbol indicates the medical device
in the European Community.
This symbol indicates the date of
manufacture.
This symbol indicates the serial number.
This symbol indicates the Unique Device
Identifier (UDI), and appears next to the
bar code representation of the Unique
Device Identification.
This symbol indicates the equipotential
terminal which brings the various parts
of a system to the same potential.
Storage and transport temperature
This symbol indicates the acceptable
temperature range for storage and
transport environments.
3
For customers in the U.S.A.
This equipment has been tested and found to
comply with the limits for a Class A digital device,
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 environment. This
equipment generates, 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
communications. Operation of this equipment in a
residential area is likely to cause harmful
interference in which case the user will be
required to correct the interference at his own
expense.
You are cautioned that any changes or
modifications not expressly approved in this
manual could void your authority to operate this
equipment.
All interface cables used to connect peripherals
must be shielded in order to comply with the
limits for a digital device pursuant to Subpart B of
part 15 of FCC Rules.
If you have any questions about this product, you
may call;
Sony Customer Information Service Center 1-800-
222-7669 or http://www.sony.com/
Caution
Federal law (United States of America) restricts
this device to sale by or on the order of a licensed
healthcare practitioner.
For customers in Canada
This unit has been certified according to Standard
CAN/CSA-C22.2 No. 60601-1.
Important safeguards and notices for use
in the medical environments
1. All devices connected to the unit must be
certified or compliant according to IEC 60601-1,
IEC 60950-1, IEC 62368-1, and IEC 60065
standards and other IEC/ISO standards
applicable to the devices.
2. Furthermore, the system as a whole must
comply with IEC 60601-1 standards. All
peripheral devices connected to the signal
input/output sections of the unit constitute the
medical-use system, and therefore, the user is
responsible for ensuring that the system as a
whole complies with IEC 60601-1 standards. If
in doubt, consult qualified Sony service
personnel.
3. Connecting the unit to other devices may
increase the leakage current.
4. For all peripheral devices connected to the unit
that operate on commercial power supplies
and do not comply with IEC 60601-1 standards,
incorporate an isolation transformer that
complies with IEC 60601-1 standards and
connect to the commercial power supply via
the transformer.
5. The unit generates, uses, and may radiate radio
frequency energy. If it is not installed and used
in accordance with the instruction manual, it
may cause interference on other devices. If the
unit causes interference (which can be
determined by disconnecting the power cord
from the unit), try the following.
Relocate the unit with respect to the affected
devices.
Connect the unit and the affected devices to
different branch circuits.
For more information, consult qualified Sony
service personnel.
(Applicable standard: IEC 60601-1-2)
Storage and transport humidity
This symbol indicates the acceptable
humidity range for storage and transport
environments.
Storage and transport pressure
This symbol indicates the acceptable
atmospheric pressure range for storage
and transport environments.
Suppliers Declaration of Conformity
Trade Name : SONY
Model : LMD-XH550MD
Responsible party : Sony Electronics Inc.
Address : 16535 Via Esprillo,
San Diego, CA 92127 U.S.A.
Telephone Number: 858-942-2230
Especificaciones del producto
| Marca: | Sony |
| Categoría: | Monitor |
| Modelo: | LMD-XH550MD |
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