FSN FM-E3203DC Manuale utente
Before connecting, operating or adjusting this product, please
read this instruction booklet carefully and completely.
English
4K UHD Monitor
Instructions for Use
FM-E3203DC
FM-E3204DGC
FM-A5502DC
FM-A5503DC
FM-A5505DGC
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eIFU
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Table of Contents
Product Description / Intended Use . . . . . . . . . . . . . . . . . . 3
Symbol Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . 7
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . 10
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Mechanical Drawings . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
On Screen Display (OSD) . . . . . . . . . . . . . . . . . . . . . . 20-29
Window Layouts, 3D Formats . . . . . . . . . . . . . . . . . . . 30-34
Standard Signal Tables. . . . . . . . . . . . . . . . . . . . . . . . 35-38
General Specications . . . . . . . . . . . . . . . . . . . . . . . . 39-43
Cleaning Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . 44
The specications and information in this document are subject to change without notice.
Instructions for Use for this product are also available in electronic form (eIFU). Choose
from several languages. Use Adobe Acrobat software to view eIFUs. Access the eIFUs
online at fsnmed.com.
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Product Description / Intended Use
This product from FSN Medical Technologies is a high-end surgical display monitor designed for
advanced digital OR applications. This medical display is uniquely equipped to handle tasks in
the demanding operating room environment. Performance characteristics include:
• Rapid signal detection, robust mode tables
• Artifact-free images
• Fanless - sterile eld compatible
• Calibrated to clinical color
• Zoom, freeze, picture-in-picture
Intended Purpose
This device is intended to be connected to other medical equipment, and to display images or
videos from endoscopic cameras, room cameras, and patient information such as ultrasound,
cardiology, and anesthesiology. This device is not intended for diagnosis. This device is intended
to be compatible with other highly specialized surgical and diagnostic equipment used in surgi-
cal suites, operating rooms, emergency rooms, and procedural facilities.
Intended Use Environment
This device is intended to be used by a trained medical professional in a healthcare facility set-
ting where contact with a patient is unlikely (no applied part).
This device is designed to meet the medical safety requirements for a patient vicinity device.
Warning: This device may not be used in connection with life support equipment.
Indications for Use
This device is to be used by a trained medical professional to display images from procedures,
such as endoscopy, ultrasound, cardiology, and anesthesiology. This device connects to medical
imaging equipment to display images, videos or patient information during surgical procedures.
This device is not intended for diagnosis.
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eIFU
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Symbol Denitions
The following symbols appear on the product, its labeling, or the product packing. Each symbol
carries a special denition, as dened below:
Dangerous : High
Voltage Power adapter Consult accompanying
documents
Direct current lndicates equipotential
earth ground Unique Device Identier
Indicates protective
earth ground
Indicates top-bottom
direction Korea Certication
DC Power control
switch Fragile Approved according to
the CCC regulations
Do not get wet Maximum Stacking China RoHS labels
Consult the operating
instructions
Indicates the
manufacturer Catalog Number
Indicates the
manufacturing date
Authorized representative in
the European community
Medical Device
Serial Number Humidity limitation Consult the operating
instructions - electronic
Temperature limitation Atmospheric pressure
limitation
Indicates proof of conformity to EU 2017/745 Medical Devices Regulation and applicable
standards.
Medical Equipment is in accordance with ANSI/AAMI ES60601‐1 (2005) + AMD 1 (2012) and CAN/
CSA‐C22.2 No. 60601‐1 (2014) in regards to electric shock, re hazards, and mechanical hazard.
Tested to comply with FCC Class B standard (USA).
Waste electrical and electronic equipment (WEEE Directive 2012/19/EU). This symbol indicates
that the waste of electronic equipment must not be disposed as unsorted municipal waste and
must be collected separately. Please contact the manufacturer or other authorized disposal
company to decommission your equipment.
Note: A printed copy of the manual in English is provided with the product. Users within EU member states,
please contact local distributor for other languages. This applies to EU member states where the product has
been purchased through authorized channels.
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Warnings and Precautions
Caution Information
CAUTION
RISK OF ELECTRICAL SHOCK
DO NOT OPEN
This symbol alerts the user that important literature concerning the operation of this unit
has been included. Therefore, it should be read carefully in order to avoid potential problems.
This symbol warns users that un-insulated voltage within the unit may have sucient
magnitude to cause electrical shock. Therefore, it is dangerous to make contact with any part
inside the unit. To reduce the risk of electrical shock, DO NOT remove cover (or back). There are
no user-serviceable parts inside. Refer servicing to qualied service personnel.
To prevent re or shock hazards, do not expose this unit to rain or moisture. Do not use this unit’s
polarized plug with an extension cord receptacle or other outlets unless the prongs can be fully
inserted.
Underwriters Laboratories (UL) Classication:
UL safety Compliance:
This medical monitor is U.L. Classied WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANI-
CAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1/CAN/CSA C22.2 NO. 601.1
EU Conformity and EMC Compliance:
This medical monitor unit meets the requirements of EN60601-1 and EN60601-1-2 so as to con-
form to the EU Medical Devices Regulation (MDR 2017/745). CE class I medical device accessory.
This medical monitor complies to the above standards only when used with the supplied medi-
cal grade power supply (FM-E3203DC, FM-E3204DGC). Use 120V rating 5-15P type plug only in
the U.S.
ATM160T-P240
Caution: Make sure the power cord is the correct type that is required in your geographic area.
This medical monitor has a universal power supply that allows operation in either 100-120V AC
or 200-240V AC voltage areas (no user adjustment is required).
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Use the proper power cord with correct attachment plug type. If the power source is 120 V AC,
use a power cord which is a Hospital Grade Power Cord with NEMA 5-15 style plug, labeled for
125 volts AC with UL and C-UL approvals. If the power source is a 240 V AC supply, use the tan-
dem (T blade) type attachment plug with ground conductor power cord that meets the respec-
tive European country’s safety regulations.
A ground post, located on the back of the display, may be used for the purpose of grounding
the display’s chassis. Any such ground must be installed in accordance with applicable electrical
codes. The ground post is shown on the mechanical drawing found in this instructions for use.
Recycling (WEEE Directive 2012/19/EU)
Follow local governing ordinances and recycling plans regarding the recycling or disposal of this
equipment.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and the
other equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specied or provided
by the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of this
medical monitor, including cables specied by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
Warning: Using this equipment in the X-ray or magnetic resonance environment could result in
degradation of the performance of this equipment, interference with other equipment or inter-
ference with radio services.
Warning: The use of cables and/or other accessories with this device, other than those specied,
may result in increased emissions or decreased immunity of this device.
Warning: This product is not considered physically to connect to HF (High Frequency) electrosur-
gical equipment.
Warning: Not suitable for use in the presence of a ammable anesthetics mixture with oxygen or
with nitrous oxide.
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Safety Instructions
On Safety
1. Before connecting the AC power cord to the DC adapter outlet make sure the voltage desig-
nation of the DC adapter corresponds to the local electrical supply.
2. Never insert anything metallic into the cabinet openings of the medical monitor. Doing so
may create the danger of electric shock.
3. To reduce the risk of electric shock, do not remove cover. No user-serviceable parts inside.
Only a qualied technician should open the case of the medical monitor.
4.
Never use your medical monitor if the power cord has been damaged. Do not allow anything to
rest on the power cord, and keep the cord away from areas where people can trip over it.
5. Be sure to hold the plug, not the cord,when disconnecting the medical monitor power cord
from an electric socket.
6. Unplug your medical monitor power cord when it is going to be left unused for an extended
period of time.
7. Unplug your medical monitor power cord from the AC outlet before any service.
8.
If your medical monitor does not operate normally, in particular, if there are any unusual sounds or
smells coming from it, unplug it immediately and contact an authorized dealer or service center.
9. Please contact the manufacturer if the set should be installed in an inaccessible area.
Warning: Do not touch input or output connectors and the patient simultaneously.
Warning: This medical monitor is intended for connection to input/output signals and other
connectors that comply with relevant IEC standard (e.g.,IEC60950 for IT equipment and IEC60601
series for medical electrical equipment). In addition, all such combination-system shall comply
with the standard IEC 60601-1-1 or clause 16 of the 3 Ed. of IEC 60601-1, respectively, safety re-
quirements for medical electrical systems. Any person who has formed a combination-system is
responsible for the system to comply with the requirements of IEC 60601-1-1 or clause 16 of the 3
Ed. of IEC 60601-1, respectively. If in doubt, contact qualied technician or your local representative.
Warning: To avoid risk of electric shock, this equipment must only be connected to a supply
mains with protective earth. Power supply (AC/DC Adapter) is specied as a part of the Color
Display. Do not position equipment in such a way that it is dicult to disconnect the power cord
plug from the appliance inlet.
Warning: Do not modify this equipment without authorization of the manufacturer.
Product fuse has a lower breaking capacity. Do not install at the building power system, prospec-
tive short-circuit current exceeding 35 A.
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Environmental Conditions for Operation and Storage
Temperature range within 0°C to 40°C(operation), -20°C to 60°C (storage)
Relative humidity range 10% to 85%
Atmospheric pressure range within 500 to 1060hPa.
On Installation
1. Openings in the medical monitor cabinet are provided for ventilation. To prevent overheat-
ing, these openings should not be blocked or covered. If you put the medical monitor in a
bookcase or some other enclosed space, be sure to provide adequate ventilation.
2. Do not expose the medical monitor to rain or use it near water. If the medical monitor acci-
dentally gets wet, unplug it and contact an authorized dealer immediately. You can clean the
medical monitor with a damp cloth if necessary, but be sure to unplug the medical monitor
rst.
3. Place your medical monitor near an easily accessible AC outlet.
4. High temperature can cause problems. Max operating temperature is 40°C. Don’t use your
medical monitor in direct sunlight and keep it away from heaters, stoves, replaces,and
sources of heat.
5. Don’t place your medical Monitor on an unstable stand, Medical monitor may malfunction or
fall.
6. This medical monitor should not topple over when tilted at a 5° angle, in any position, during
NORMAL USE, excluding transport.
7. In the position specied for transport, medical monitor shall not overbalance when tilted at a
10 degree angle.
8. When carrying this product, please use both handles (if included) on the left and right side of
the product, and carry using two people. If you want the product to be installed in another
place, please call your service center.
9. Always use only the original cables and accessories with the device.
10. Do not lay this monitor on other equipment.
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Repair
Do not attempt to service the medical monitor yourself, as opening or removing covers may
expose you to dangerous voltages or other hazards, and will void the warranty. Refer all servicing
to qualied service personnel. Unplug the medical monitor from its power source and refer
servicing to qualied personnel under the following conditions:
- If the power cord or plug is damaged or frayed.
- If liquid has been spilled into the medical monitor.
- If objects have fallen into the medical monitor.
- If the medical monitor has been exposed to rain or moisture.
- If the medical monitor has been subjected to excessive shock by being dropped.
- If the cabinet has been damaged.
- If the medical monitor seems to be overheated.
- If the medical monitor emits smoke or abnormal odor.
- If the medical monitor fails to operate in accordance with the operating instructions.
Biohazards
To prevent spreading of infections, this device should only be used in environments where
biological decontamination can be successfully performed.
Returned Product
After troubleshooting, if problems persist, disinfect the monitor and return it to FSN using the
original packaging. Include the accessories that came with the monitor in the return shipment.
Please enclose a brief explanation of the malfunction.
Contact FSN Medical Technologies for a Return Authorization Number and instructions, prior to
returning the device.
Accessories
Use only accessories specied by the manufacturer, or sold with the medical monitor.
Classication for Safety Compliance
- Protection against electric shock : Class I including AC/DC adapter. This medical equipment is in
accordance with ANSI/AAMI ES60601‐1 (2005) + AMD 1 (2012) and CAN/CSA‐C22.2 No. 60601‐1
(2014) in regards to electric shock, re hazards, and mechanical hazard.
- Applied Parts : No Applied Parts.
- Degree of safety in the presence of ammable anesthetics mixture with air or with oxygen or
with nitrous oxide. Not suitable for use in the presence of a ammable anesthetics mixture with
oxygen or with nitrous oxide.
- For critical applications, it is recommended to have a replacement monitor available.
- Mode of operation : Continuous.
Notice to the user:
Any serious incident that has occurred in relation to the device should be reported to the manu-
facturer and the competent authority of the Member State in which the user and/or patient is
established. Contact your local FSN Medical Technologies sales representative for information on
changes and new products.
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This medical monitor unit has been designed and tested to comply with IEC 60601-1-2:2014/
AMD1:2020 requirements for EMC with other devices. To ensure electromagnetic compatibility
(EMC), the monitor must be installed and operated according to the EMC information provided in
this Instructions for Use.
This medical monitor unit has been tested and found to comply with the limits of a Class B digital
device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable pro-
tection against interference. This monitor can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, it may interfere with other radio communications
equipment. There is no guarantee that interference will not occur in a particular installation. If
this equipment is found to cause harmful interference to radio or television reception, the user
is encouraged to try to correct the interference by carrying out one or more of the following
measures:
1. Reorient or relocate the receiving antenna.
2. Increase the distance between the medical monitor and the subject of interference.
3. Plug the monitor into an outlet on a dierent electrical circuit than that to which the subject of
interference is connected.
4. Consult the dealer or an experienced radio/TV technician for help.
NOTICES TO USER
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 interference received, including interference that may cause undesired operation.
FCC WARNING
This medical monitor generates or uses radio frequency energy. Changes or modications to
this medical monitor may cause harmful interference unless the modications are expressly ap-
proved in the instruction manual. The user could lose authority to operate this equipment if an
unauthorized change or modication is made.
PRODUCT LIFETIME
The performance of panels may deteriorate over long periods of time. Periodically check that
this monitor is operating correctly. The expected service life of the device is four years. Keep the
monitor clean to prolong its operational lifetime.
Electromagnetic Compatibility
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