FSN IPS4000 Manuale utente

Before connecting, operating or adjusting this product, please

read this instruction booklet carefully and completely.

English

Image Processing System

Instructions for Use

IPS4000

UHD Modular Video Matrix Switcher and Converter.

211/2022

eIFU

indicator

The specications 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/support/eifu/

Table of Contents

Product Description / Intended Use . . . . . . . . . . . . . . . . . . 3

Symbol Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Warnings, Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . 5, 6

Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . 10-14

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Sample Conguration . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17, 18

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19-28

Specication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Timing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30, 31

Mechanical Drawing . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Cleaning Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . 33

11/2022

Product Description / Intended Use

Intended Purpose

This device is intended to be connected to other medical equipment. This device is not intended

for diagnosis. This device is intended to be compatible with other highly specialized surgical and

diagnostic equipment used in surgical suites, operating rooms, emergency rooms, and proce-

dural 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. This device connects to medical imag-

ing equipment to display images, videos or patient information during surgical procedures. This

device is not intended for diagnosis.

The next generation of medical image processing and control is here with IPS4000. FSN has

developed a powerful, yet compact, digital video integration solution that oers compatibility

for today, and tomorrow.

Congurable up to 16 inputs, 32 outputs, IPS4000 features 4096 x 2160 max resolution, signal

options for DisplayPort, HDMI, 12G-SDI, and analog. Users can save and recall custom presets,

choose from multi window layouts including dual (9 types) and quad (6 types). Dashboard inter-

face control can be accessed on the built-in 7 inch diagonal touch screen, or an external screen

via web, tablet or PC.

411/2022

eIFU

indicator

Symbol Denitions

The following symbols appear on the product, its labeling, or the product packing. Each symbol

carries a special denition, as dened below:

Dangerous : High

Voltage Power adapter Consult accompanying

documents

Direct current lndicates equipotential

earth ground Unique Device Identier

Indicates protective

earth ground

Indicates top-bottom

direction Korea Certication

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 Importer Entity

UK Conformity Assessed UK Responsible Person

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.

11/2022

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 sucient

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 qualied 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) Classication:

UL safety Compliance:

This device is U.L. Classied WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL

HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1/CAN/CSA C22.2 NO. 601.1

EU Conformity and EMC Compliance:

This device meets the requirements of EN60601-1 and EN60601-1-2 so as to conform to the EU

Medical Devices Regulation (MDR 2017/745). CE class I medical device accessory.

Use 120V rating 5-15P type plug only in the U.S.

Caution: Make sure the power cord is the correct type that is required in your geographic area.

This device has a universal power supply that allows operation in either 100-120V AC or 200-240V

AC voltage areas (no user adjustment is required).

611/2022

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.

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 specied 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 device,

including cables specied 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 specied,

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.

11/2022

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 device. 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 qualied technician should open the case of the device.

Never use the device 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 device power cord from an

electric socket.

6. Unplug the device power cord when it is going to be left unused for an extended period of

time.

7. Unplug the device power cord from the AC outlet before any service.

If the device does not operate normally, in particular, if there are any unusual sounds or smells com-

ing 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 device 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 requirements

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 qualied technician or your local representative.

Warning: To avoid risk of electric shock, this device must only be connected to a supply mains

with protective earth. Power supply (AC/DC Adapter) is specied as a part of the device. Do not

position equipment in such a way that it is dicult 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.

811/2022

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 device cabinet are provided for ventilation. To prevent overheating, these

openings should not be blocked or covered. If you put the device in a bookcase or some

other enclosed space, be sure to provide adequate ventilation.

2. Do not expose the device to rain or use it near water. If the device accidentally gets wet, un-

plug it and contact an authorized dealer immediately. You can clean the device with a damp

cloth if necessary, but be sure to unplug the device rst.

3. Place your device near an easily accessible AC outlet.

4. High temperature can cause problems. Max operating temperature is 40°C. Don’t use your

device in direct sunlight and keep it away from heaters, stoves, replaces, and sources of

heat.

5. Always use only the original cables and accessories with the device.

Repair

Do not attempt to service the device yourself, as opening or removing covers may expose you

to dangerous voltages or other hazards, and will void the warranty. Refer all servicing to qualied

service personnel. Unplug the device from its power source and refer servicing to qualied

personnel under the following conditions:

- If the power cord or plug is damaged or frayed.

- If liquid has been spilled into the device.

- If objects have fallen into the device.

- If the device has been exposed to rain or moisture.

- If the device has been subjected to excessive shock by being dropped.

- If the cabinet has been damaged.

- If the device seems to be overheated.

- If the device emits smoke or abnormal odor.

- If the device fails to operate in accordance with the operating instructions.

11/2022

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 device and return it to FSN using the

original packaging. Include the accessories that came with the device 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 specied by the manufacturer, or sold with the device.

Classication 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 device 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.

10 11/2022

This unit has been designed and tested to comply with IEC 60601-1-2:2014/AMD1:2020 require-

ments for EMC with other devices. To ensure electromagnetic compatibility (EMC), the device

must be installed and operated according to the EMC information provided in this Instructions

for Use.

This 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 protection against

interference. This device 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 device and the subject of interference.

3. Plug the device into an outlet on a dierent 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 device generates or uses radio frequency energy. Changes or modications to this device

may cause harmful interference unless the modications are expressly approved in the instruc-

tion manual. The user could lose authority to operate this equipment if an unauthorized change

or modication is made.

PRODUCT LIFETIME

The performance of this device may deteriorate over long periods of time. Periodically check that

this device is operating correctly. The expected service life of the device is four years. Keep the

clean clean to prolong its operational lifetime.

Electromagnetic Compatibility

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