FSN Image Processing System IPS4000 Instructions for Use April 2022

Table of Contents Product Description / Intended Use... 3 Symbol Definitions... 4 Warnings, Precautions... 5, 6 Safety Instructions... 7-9 Electromagnetic Compatibility... 10-14 Accessories... 15 Sample Configuration... 16 Connections... 17, 18 Operation... 19-28 Specification... 29 Timing... 30, 31 Mechanical Drawing... 32 Cleaning Instructions... 33

The specifications and information in this document are subject to change without notice.

eIFU indicator

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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/ 4/2022

Product Description / Intended Use

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 offers compatibility for today, and tomorrow. Configurable 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 interface control can be accessed on the built-in 7 inch diagonal touch screen, or an external screen via web, tablet or PC.

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 procedural facilities.

Intended Use Environment This device is intended to be used by a trained medical professional in a healthcare facility setting 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 imaging equipment to display images, videos or patient information during surgical procedures. This device is not intended for diagnosis.

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Symbol Definitions The following symbols appear on the product, its labeling, or the product packing. Each symbol carries a special definition, as defined below: Dangerous : High Voltage

Power adapter

Consult accompanying documents

Direct current

lndicates equipotential earth ground

Unique Device Identifier

Indicates protective earth ground

Indicates top-bottom direction

Korea Certification

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 eIFU indicator

Temperature limitation

Atmospheric pressure limitation

UK Conformity Assessed

UK Responsible Person

Consult the operating instructions - electronic Importer Entity

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, fire 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 sufficient 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 qualified service personnel. To prevent fire 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) Classification: UL safety Compliance: This device is U.L. Classified 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).

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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 tandem (T blade) type attachment plug with ground conductor power cord that meets the respective 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 specified 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 specified 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 interference with radio services. Warning: The use of cables and/or other accessories with this device, other than those specified, may result in increased emissions or decreased immunity of this device. Warning: This product is not considered physically to connect to HF (High Frequency) electrosurgical equipment. Warning: Not suitable for use in the presence of a flammable 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 designation 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 qualified technician should open the case of the device. 4. 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. 8. If the device 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 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 qualified 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 specified as a part of the device. Do not position equipment in such a way that it is difficult 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, prospective short-circuit current exceeding 35 A. 4/2022

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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 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, unplug 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 first. 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, fireplaces, 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 qualified service personnel. Unplug the device from its power source and refer servicing to qualified 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.

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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 specified by the manufacturer, or sold with the device.

Classification 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, fire hazards, and mechanical hazard. - Applied Parts : No Applied Parts. - Degree of safety in the presence of flammable anesthetics mixture with air or with oxygen or with nitrous oxide. Not suitable for use in the presence of a flammable 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 manufacturer 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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Electromagnetic Compatibility This 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 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 different 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 modifications to this device may cause harmful interference unless the modifications are expressly approved in the instruction manual. The user could lose authority to operate this equipment if an unauthorized change or modification 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.

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1. Guidance and manufacturer’s declaration - electromagnetic emission The device is intended for use in the electromagnetic environment specified below. The user of the device should make sure that the device is operated in such an environment. Interference emission measurements

Conformity level

Electromagnetic environment -guidance

RF emissions acc. to CISPR 11

Complies with Group 1

RF emissions acc. to CISPR 11

Complies with Class B

Emission of harmonic oscillations acc. to IEC 61000-3-2

Complies with Class A

Voltage fluctuations/flicker emissions acc. to IEC 61000-3-3

Complies

The characteristics of this device determined by broadcasting permit its industrial and hospital use (CISPR 11, Class A). When used in a living area (for which CISPR 11 usually requires Class B), this device may not provide adequate protection of radio services. The user must, if necessary, take remedial action such as implementation or reorientation of the device.

2. For the use of ME devices in professional healthcare facilities. Guidance and manufacturer’s declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user of the device should make sure that it is used in such an environment. Interference immunity test

IEC 60601-1-2:2014 conformity level

Electrostatic discharge (ESD) acc. to IEC 61000-4-2

Complies ±2 kV, ±4 kV, ±6 kV, ± 8 kV contact discharge ±2 kV, ±4 kV, ±8 kV, ± 15 kV air discharge

Floors should be made of wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity must be at least 30%

Rapid transient electric interferences/ bursts acc. to IEC 61000-4-4

Complies ± 2 kV for mains lines ± 1 kV for input/output lines

The quality of the supply voltage should correspond to that of a typical business or hospital environment.

Surge acc. to IEC 61000-4-5

Complies ± 1 kV push-pull voltage ± 2 kV common-mode voltage

The quality of the supply voltage should correspond to that of a typical business or hospital environment.

Voltage dips, short interruptions and fluctuations of the supply acc. to IEC 61000-4-11

0 % UT*; 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315°

Mains power quality should be that of a typical commercial or hospital environment.

0% UT; 1 cycle and 70% UT; 25/30 cycles Single phase: at 0°

If the user of the device requests continued functioning even when interruptions of the power supply occur, it is recommended that the device be supplied from a power supply that is free of interruptions.

0% UT; 250/300 cycle

Electromagnetic environment-guidance

*Note: UT is the mains alternating voltage before applying the test levels.

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3. For the use of ME devices in professional healthcare facilities. Test specification for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment (according to IEC 60601-1-2:2014) The device is intended for use in the electromagnetic environment specified below. The user of the device should make sure that it is used in such an environment. Test frequency MHz

Band MHz

Service

Modulation

Maximum power W

Distance m

IMMUNITY TEST LEVEL V/m

385

380 to 390

TETRA 400

Pulse modulation 18 Hz

1.8

1.0

27

450

430 to 470

GMRS 460, FRS 460

FM ± 5 kHz stroke ± 1 kHz sine wave

2

1.0

28

704 to 787

Band 13, 17

Pulse modulation 217 Hz

0.2

1.0

9

800 to 960

GSM 800/900 TETRA 800, iDEN 820, CDMA 850, LTE Band 5

Pulse modulation 18 Hz

2

1.0

28

Pulse modulation 217 Hz

2

1.0

28

Pulse modulation 217 Hz

2

1.0

28

Pulse modulation 217 Hz

0.2

1.0

9

710 745 780 810 870 930 1720 1845

1700 to 1990

1970

2450

2400 to 2570

GSM 1800, CDMA 1900, GSM 1900, DECT, LTE Band 1,3, 4, 25 UMTS Bluetooth, WLAN 802.11 b/g/n, RFID 2450, LTE Band 7

5240 5500

5100 to 5800

WLAN 802.11 a/n

5785 *Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the device may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

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4. Guidance and manufacturer’s declaration – electromagnetic immunity – for equipment and systems that are not life-supporting The device is intended for use in the electromagnetic environment specified below. The user of the device should make sure that it is used in such an environment. Interference immunity tests

IEC 60601-12:2014 test level

Conformity level

Electromagnetic environment – guidelines Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1.2

Conducted RF disturbances acc. to IEC 61000-4-6 Radiated RF disturbances according to IEC 61 000·4·3

3 V rms 150 kHz to < 80 MHz 3 V/m 80 MHz to 2.5 GHz

P

Where P is the nominal power of the transmitter in watts [W] according to the information provided by the manufacturer of the transmitter and d is the recommended separation distance in meters [m]. 3 V eff 3 V/m

The field strength of stationary transmitters at all frequencies on site a should be, according to a study, less than the conformity level b. d = 1.2 P 80 MHz to < 800 MHz d = 2.3 P 800 MHz to 2.5 GHz Interference may occur in the vicinity of equipment marked with the following symbol:

Note: These guidelines may not apply in all situations. The propagation of electromagnetic quantities is affected by absorptions and reflections of buildings, objects, and persons.

a Field strengths from fixed transmitters, such as base stations for radio [cellular/cordless] telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment of the stationary transmitters, a site survey should be considered. If the measured field strength in the location at which the device is used exceeds the above conformity levels, the device should be observed to verify normal operation. If unusual performance characteristics are observed, additional measures may be necessary, such as a modified orientation or a different location for the device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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5. Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in the electromagnetic environment in which the RF disturbances are controlled. The user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device – as a function of the output power of the communication device, as shown below. Nominal power of transmitter [W]

Separation distanced [m] according to frequency of transmitter 150kHz to< 80 MHz d = 1.2 P

80 MHz to< 800 MHz d = 1.2 P

800 MHz to 2.5 GHz d = 2.3 P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

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Accessories

IPS4000

2

3

4

5

6

1

7

8

9

Item 1 2 3 4 5 6 7 8 9

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Description Carton Box Cushion IPS4000 Unit DisplayPort Cable HDMI Cable 12G-SDI Cable AC power Cord (6ft, Medical Grade) Instructions For Use Rack Mount Brackets

Pack Qty 1 2 1 2 4 2 1 1 2

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IPS4000 Sample System Configuration Input

Output

Up to 4096 x 2160 resolution. Up to 16 inputs, 32 outputs.

Multi window layouts. Streaming.

HDMI 2.0 DP 1.2 12G SDI Analog (option)

IPS4000

Interface Control Dashboard is accessed on the builtin 7 inch diagonal touchscreen, or an external touchscreen or tablet.

16

Multi window layout options.

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Connections IPS4000 is designed for modular configuration. Various combinations of input and output cards can be assembled at the factory. Not all IPS4000 units will look the same. Following are descriptions of IPS4000 input and output cards and their unique functions.

HDMI quad input card. Name: HDIN

HDMI quad output card. Name: HQOUT

HDIN

DisplayPort quad input card. Name: DPIN

HDMI 1

HDMI 2

HDMI 3

HDMI 4

DP 1

DP 2

DP 3

DP 4

HDMI 1

HDMI 2

DP 1

DP 2

DisplayPort quad output card. Name: DQOUT

DPIN

Dual HDMI, dual DisplayPort input card. Name: DHIN

CVBS 1

12G SDI input card. Name: SDIN

CVBS 2

VGA 1

INPUT

12G-SDI 2

OUTPUT

INPUT

OUTPUT

HDMI 4

DP 1

DP 2

DP 3

DP 4

RS-232

HDMI

RS-232

DP

DPOUT

12G SDI (scalable)* output card. Name: SDOUT

SDIN

12G-SDI 1

HDMI 3

HDOUT

DisplayPort (scalable)* output card. Name: DPOUT

ANIN

VGA 2

HDMI 2

DQOUT

HDMI (scalable)* output card. Name: HDOUT

DHIN

Analog input card. Name: ANIN

HQOUT

HDMI 1

SDOUT

RS-232

12G-SDI 2

* Scaled output. Adjustments available for resolution, window layout, zoom, pan functions.

Input

Output

Up to 4 input slots available.

Output

Up to 8 output slots available.

1

5

9

2

6

10

I O INPUT SLOT 1-4

OUTPUT SLOT 9-12

7

11

4

8

12

RS-232

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OUTPUT SLOT 5-8

3

UART

AS

1

3

2

4

IN

MONITOR OUTPUT

OUT

AUDIO

1

2

3

4

17

Connections 1

5

9

2

6

10

I O INPUT SLOT 1-4

OUTPUT SLOT 5-8

OUTPUT SLOT 9-12

3

7

11

4

8

12

RS-232

UART

Earth terminal AC Inlet AC On/Off Switch

Item Earth terminal USB Service port UART RS-232 Monitor output Ethernet ports Audio in / out

AS

1

3

2

4

IN

MONITOR OUTPUT

OUT

AUDIO

1

2

3

4

USB (USB 3.0) Service port (Mini USB, A/S) UART (Mini USB, Console terminal) RS-232 (Dsub9)

Ethernet Ports (RJ45) Audio in / out (3.5Ø phone) Monitor output (HDMI 1.4 1080p@60)

Description A direct physical connection to ground or earth. Connects a keyboard, mouse, or memory stick, or firmware updating. For factory use. Use for serial communication with other devices. Use for serial communication with other devices. Connects an external web or PC screen for interface viewing and controlling. For network streaming. Connects audio.

Connect Power Only use the specified plug and voltage. Power requirements are: AC 100~240V / 50~60Hz , 2A(max). Use the supplied 6 ft. hospital grade AC power cord. Improper power may cause electric shock or equipment damage. To avoid the risk of electric shock, this equipment must only be connected to a power supply with protective grounding. 1

5

2

6

I O INPUT SLOT 1-4 7

4

8

RS-232

18

O

3

UART

AS

1

3

2

4

IN

MONITOR OUTPUT

OUT

AUDIO

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Starting IPS4000 1

2 I O INPUT SLOT 1-4 3

4

1 2 RS-232

UART

AS

1. Turn on power using the AC switch on the back of IPS4000.

2. The power button on the front will illuminate green.

3. Press the power button to turn on IPS4000. The green light will flash during initialization, then go dark when the system is ready.

Powering Off IPS4000

Press the power button, and a dialog will appear. Press Power Off or Cancel. After powering off, the green light will stay on unless power is turned off on the back of IPS4000.

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Dashboard After IPS4000 has initalized, the interface control dashboard will appear on the built-in 7 inch diagonal touch screen, or a connected external screen (tablet or PC).

Input source list.

Output destination list. Active layout.

Routed source.

Streaming on/off indicator.

Setup

User preset control.

Routed sources for multi-window layouts.

Swipe up or down to show more of any list on the dashboard.

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