NDS ZEROWIRE G2 Manuale del proprietario

ZEROWIRE® G2

Advanced Wireless HD-Video Transmission System

60A0571

Instructions for Use

Mode d’emploi

Gebrauchsanweisung

Istruzioni per l’uso

Instrucciones

en

es

fr

de

it

Information in this document has been carefully checked for accuracy; however, no guarantee is given to the correct-

ness of the contents. This document is subject to change without notice. NDS provides this information as reference

only. Reference to products from other vendors does not imply any recommendation or endorsement.

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aviso. NDS proporciona esta información solo como referencia. La referencia a productos de otros proveedores no im-

plica recomendación ni aval en modo alguno.

El presente documento contiene información de empresa protegida por los derechos de autor. Queda terminantemen-

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Symbols

Follow instructions for

use (white image on a

blue background)

Consult instructions for

use

Instructions for use and

translated copies are

published on the NDS

website at:

www.ndssi.com/user-

manuals/

General warning

Warning; Electricity

Authorized Representat-

ive in the European

Community

Medical Device

Authorized for Sale or

use by Physician only

Caution

Manufacturer

Date of manufacture

(YYYY-MM-DD)

Catalogue number

Serial number

Batch code

Atmospheric pressure

limitation

Humidity limitation

Temperature limit

Waste management

Fragile

Keep dry

This way up

Complies to IEC 60601-1

including US and Cana-

dian deviations in their

respective valid version

The Canadian Standards

Association (CSA) certi-

fication mark represents

safety approval by Cana-

dian Standards Associ-

ation for Canada and the

United States.

EurAsian Conformity

(EAC) mark represents

safety approval by Cus-

tom Union countries: Be-

larus, Russia, Kazakhstan,

Armenia, Kyrgyzstan.

en

China Compulsory Certi-

ficate (CCC) mark for In-

formation Technology

Equipment (ITE)

products.

United States Federal

Communications Com-

mission (FCC) symbol in-

dicates EMC compliance

per FCC standards.

No hazardous sub-

stances contained in the

device

Contains restricted sub-

stances. The symbol

number refers in years to

the Environmental Pro-

tection Use Period

(EPUP), during which the

product can be safely

used, and following

which should be imme-

diately recycled.

Equipotentiality

Closed (On) Switch.

Open (Off) Switch.

Protective earth; protect-

ive ground

Alternating current

Non-ionizing electro-

magnetic radiation

Symbols

Table of Contents

1 Important User Notes................................................................................................................................. 7

2 Safety Information ..................................................................................................................................... 8

2.1 Warnings and Cautions................................................................................................................................................... 8

2.2 Power Cord........................................................................................................................................................................10

2.3 Recycling............................................................................................................................................................................10

3 General Information................................................................................................................................. 11

3.1 About This Manual .........................................................................................................................................................11

3.2 Intended Use and Contraindications.......................................................................................................................11

3.3 Overview............................................................................................................................................................................12

3.4 Noninterference Distance............................................................................................................................................12

4 Set up and Installation.............................................................................................................................13

4.1 Connector Panels............................................................................................................................................................13

4.2 Installation.........................................................................................................................................................................14

4.3 Power Options .................................................................................................................................................................16

4.4 Wiring Diagrams..............................................................................................................................................................18

4.5 Cable Bend Radius..........................................................................................................................................................19

4.6 Setup ...................................................................................................................................................................................19

4.7 Typical Installation..........................................................................................................................................................21

4.8 Performance .....................................................................................................................................................................22

4.9 Positioning and Orientation .......................................................................................................................................22

4.10 Non Line of Sight Operation.......................................................................................................................................24

4.11 Avoiding Co-Channel Interference...........................................................................................................................25

4.12 Channel Usage.................................................................................................................................................................26

4.13 Multi System Installation..............................................................................................................................................26

4.14 Signal Strength and OSD Diagnostic Messages ..................................................................................................26

5 ZEROWIRE® G2 Troubleshooting ............................................................................................................ 28

6 Specifications............................................................................................................................................30

6.1 ZEROWIRE® G2 Specifications .................................................................................................................................30

6.2 Maximum EIPR Output Power of Test Frequency...............................................................................................31

6.3 Supported Video Modes ..............................................................................................................................................31

6.4 ZEROWIRE® G2 Accessory Kits by Display ...........................................................................................................32

6.5 Cleaning and Disinfecting Instructions...................................................................................................................33

7 Electromagnetic Compatibility Tables ...................................................................................................34

7.1 Guidance and Manufacturer's Declaration - Electromagnetic Emissions ..................................................34

7.2 Guidance and Manufacturer's Declaration - Electromagnetic Interference Immunity.........................34

7.3 Guidance and Manufacturer's Declaration - Recommended Separation Distances..............................35

8 Terms and Conditions.............................................................................................................................. 37

8.1 Declarations of Conformity.........................................................................................................................................37

8.2 Legal Statement ..............................................................................................................................................................38

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Important User Notes | 7

1 Important User Notes

Read the instructions for use carefully and become familiar with the operation and function of the device and

the accessories before use during surgical procedures. Non-observance of the instructions listed in this

manual can lead

• to life-threatening injuries of the patient,

• to severe injuries of the surgical team, nursing or service personnel,

• or damages or malfunction of device and/or accessories.

The manufacturer reserves the right to modify the appearance, graphics, and technical data of the product

through continued development of its products.

Please note: Paragraphs marked with the words WARNING, CAUTION, and NOTE carry special meanings. Sec-

tions marked with these words must be given special attention.

WARNING!

The safety and/or health of the patient, user, or a third party are at risk. Comply with this

warning to avoid injury to the patient, user, or third party.

CAUTION!

These paragraphs include information provided to the operator concerning the intended and

proper use of the device or accessories.

NOTE!

These paragraphs contain information to clarify the instructions or provide additional useful

information.

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8 | Safety Information

2 Safety Information

2.1 Warnings and Cautions

This symbol alerts the user that important information regarding the installation and/or operation

of this equipment follows. Information preceded by this symbol should be read carefully.

This symbol alerts the user that the user manual and translated copies are published on the NDS

website at: www.ndssi.com/user-manuals/

This symbol warns the user that un-insulated voltage within the unit may have sufficient mag-

nitude to cause electrical shock. Do not touch any part inside the unit. To reduce the risk of electric

shock, DO NOT remove the cover or back.

This symbol alerts the user that information preceded by this symbol should be read carefully to

avoid damage to the equipment.

This symbol denotes the manufacturer.

This symbol denotes the manufacturer’s European Community representative.

This symbol indicates the device is a Medical Device. This product is intended only for use by

healthcare professionals in professional healthcare environments.

This product is T.U.V. approved with respect to electric shock, fire and mechanical hazards only in

accordance with CAN/CSA C22.2 No. 60601-1 and ANSI/AAMI ES60601-1.

This product meets the requirements of EN60601-1 so as to conform to the 2017/745 Medical

Device Regulation of European Union.

CAUTION!

In case of serious incident

Please report any serious incident that has occurred in relation to the device to the manu-

facturer and the competent authority of the State in which the user and/or patient is estab-

lished.

CAUTION!

This product is a Class I medical device according to the MDR in Europe. No modifications

are allowed.

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Safety Information | 9

CAUTION!

This product is a Class II medical device in the United States and Canada. No modifications

are allowed.

NOTE!

This equipment/system is intended for use by healthcare professionals only.

NOTE!

There are no user serviceable parts inside. Refer servicing to qualified service personnel.

WARNING!

Fire and shock hazard

Do not expose this product to rain or moisture.

WARNING!

Do not use this unit's polarized plug with an extension cord receptacle or other outlets un-

less the prongs can be fully inserted.

NOTE!

This product is designed to meet medical safety requirements for a patient vicinity device.

Hereby, NDS Surgical Imaging, LLC, declares that this ZEROWIRE® G2 System is in compliance with the essen-

tial requirements and other relevant provisions of Directive 2014/53/EU. The full text of the EU Declaration of

Conformity is available upon request.

Federal (USA) law restricts this device to sale by or on the order of a physician.

Radio Approval:

This device meets the requirements of Draft EN302 567 V2.0.24 and conforms to Radio and Equipment Direct-

ive (RED) 2014/53/EU.

FCC Identification: UK2-SII-SK63102, UK2-SII-SK63101 or 2ASUJ-SII-SK63102, 2ASUJ-SII-SK63101

Industry Canada: 6705A-SIISK63102, 6705A-SIISK63101 or 25001-SIISK63102, 25001-SIISK63101

This product complies to the above standards only when used with an NDS supplied medical grade power

supply.

Model ZEROWIRE® G2

Power Supply GlobTek GTM91120-3024-T3A

AC Input 100 to 240 Volts at 50 to 60 Hz

DC Output 24 volts at 1.25 amps

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10 | Safety Information

2.2 Power Cord

Use the supplied hospital grade power cord with the correct plug for your power source.

• The power cord is the only recognized disconnect device for this product. To power off the product, dis-

connect the power cord from the AC mains.

• If the device is wall mounted, disconnect the wall mount power adapter to power off the product.

• The product and other medical equipment should be positioned so that the power cord and connection to

AC mains is readily accessible.

• If an extension cord or power strip is needed for connection of this product to AC mains, confirm that the

power cord plug can be securely connected to the cord or power strip.

• This product should be powered from a center tapped circuit when used in the US at voltages over

120volts.

2.3 Recycling

Follow local governing ordinances and recycling plans regarding the recycling or disposal of this

equipment.

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General Information | 11

3 General Information

3.1 About This Manual

This manual is designed to assist the user with installation, setup and operation of the ZEROWIRE® G2 wire-

less video system.

The functional descriptions in this manual are representative of:

1. ZEROWIRE® G2 Receiver

2. ZEROWIRE® G2 Transmitter (input: DVI and 3G-SDI)

See ZEROWIRE® G2 Accessory Kits by Display [}32] for product part numbers and accessories.

3.2 Intended Use and Contraindications

Intended Use

The NDS ZEROWIRE® G2 is a paired wireless video communication transmitter and receiver, intended for de-

livery of video signals from a source such as an endoscopy camera/processor, or other video source over a ra-

dio-frequency link to a ZEROWIRE® G2 Receiver for display of images during endoscopic and general surgical

procedures.

The ZEROWIRE® G2 wireless video system is a non-sterile reusable device not intended for use in the sterile

field.

Contraindications

1. These units are non-sterile reusable devices and are not intended for use within a sterile field.

2. This equipment may not be used in the presence of flammable anesthetics mixture with air, oxygen or ni-

trous oxide.

Do not use in MR Environments

WARNING!

No part of this product may come in contact with a patient. Never touch the product and a

patient at the same time. At any time, a minimum separation of 20 cm must be maintained

from the operating device and the user or patient.

WARNING!

For mission critical applications, we strongly recommend that a replacement ZEROWIRE® G2

transmitter and receiver pair, and a DVI cable, be immediately available.

Additionally, we recommend that a display that is hard wired to the video source be imme-

diately available whenever a surgical procedure is in progress.

See Typical Installation [}21].

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12 | General Information

3.3 Overview

The ZEROWIRE® G2 System allows wireless delivery of video signals from the DVI or 3G-SDI output of an en-

doscopic camera processor or other video source to the DVI input of a video display.

It operates as a 60GHz-based wireless HD system in compliance with FCC (Part 15) rules governing the unli-

censed 57-64GHz band which is located in the millimeter-wave (mmW) portion of the electromagnetic spec-

trum.

A System is composed of a Transmitter and Receiver pair. The Transmitter and Receiver are designed to be

mounted on the top rear edge of a display.

The Transmitter may obtain its input video signal from either an endoscopic camera processor or the display’s

DVI or SDI re-drive outputs.

The Receiver’s output is connected to a display’s DVI input. The units are powered from an NDS 24VDC power

supply or through the Yadapter cable.

NOTE!

The Yadapter cables are only for use with NDS displays that are powered by an NDS 24VDC

power supply.

For information on the Yadapter, see Power Options [} 16]. For a typical setup, see Typical Installation

[}21].

3.4 Noninterference Distance

The listed devices on the following table have been tested to demonstrate the minimum safe distances for the

ZEROWIRE® G2 to be operating without any interference with each other.

At any time, if the ZEROWIRE® G2 is believed to be causing or getting the interference from those devices,

simply move the devices away from each other, and then maintain at least the separations as specified in the

table below.

Tested Equipment Distance to Transmitter Distance to Receiver

Electrocautery >2ft >1ft

RFID >1cm >1cm

2.4GHz Wireless Access Point >6in >6in

5.8GHz Wireless Access Point >6in >6in

Cell Phone >1cm >1cm

Bluetooth Device >1cm >1cm

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Set up and Installation | 13

4 Set up and Installation

4.1 Connector Panels

(1)

(2)

(3) (4) (5) (6) (7) (8)

ZEROWIRE® G2 Transmitter and Receiver connector panels

(1) ZEROWIRE® G2 Transmitter (5) DVI input

(2) ZEROWIRE® G2 Receiver (6) DVI output

(3) ON/OFF switch (7) 3G-SDI input

(4) Power connector (8) USB ports (for firmware updates)

NOTE!

USB ports are used for installing updates to the Transmitter or Receiver firmware, and not

for use as a general purpose I/O port.

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14 | Set up and Installation

(1)(2) (3) (4)

(1)(2)

Transmitter/Receiver link and status LED

(1) Link LED

(2) Link button

(3) Status LED Transmitter

(4) Status LED Receiver

The LINK button is used to link a Transmitter to a Receiver.

On the Receiver, the LINK button is also used to activate the Signal Strength bar graph described in section

Signal Strength and OSD Diagnostic Messages [}26].

4.2 Installation

Mounting Brackets

See ZEROWIRE® G2 Accessory Kits by Display [}32].

Installation (mounted displays)

NOTE!

This installation requires two people: one to support the display, and one to perform the in-

stallation.

Replace the left-side mounting screws with two of the provided longer length mounting screws. See A in

graphic Installation back view – mounting screws [}15].

Tighten the provided left-side screws only 2-3 turns.

Remove the two right-side screws from the VESA mount. See B in graphic Installation back view – mounting

screws [}15].

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Set up and Installation | 15

AB

Installation back view – mounting screws

With the mounting blade facing the front of the display, slide the step bracket between

the VESA mount and the back of the display until notches labeled for the display you

are working with fit over the two left-hand screws. See C in graphic Installation back

view – step bracket and modules [}16].

Replace the right-hand screws with the provided screws.

Tighten all screws.

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16 | Set up and Installation

C D

Installation back view – step bracket and modules

With the back of the ZEROWIRE® G2 Transmitter or Receiver module facing the front of the display, align the

slot on the bottom of the module with the mounting blade, and push the module onto the mounting blade

until the module is firmly seated. See D in graphic Installation back view – step bracket and modules [}16].

4.3 Power Options

ZEROWIRE® G2 Transmitters and Receivers used with a supported 32" or smaller NDS display can use an op-

tional Y adapter cable for powering the ZEROWIRE® G2 unit. The two types of Yadapter cables are shown be-

low.

Where applicable, the appropriate Y-cable is included in the accessory kit (see ZEROWIRE® G2 Accessory Kits

by Display [}32] to determine the correct accessory kit for the NDS display being used).

ZEROWIRE® G2 Transmitter and Receiver units can also be powered using the included 24VDC power supply.

SwitchCraft ‘Y’ Adapter Cable (35X0096)

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Set up and Installation | 17

XLR ‘Y’ Adapter Cable (35X0097)

(1) (2)

(1) Model numbers of 24VDC power supplies

(2) J3 of the ‘Y’ adapter or 24 VDC power supply cable connects here

GlobTek GTM91120-3024-T3A

When using the power supply, select and install the plug adapter that matches the power requirement.

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18 | Set up and Installation

4.4 Wiring Diagrams

ZEROWIRE® G2 Transmitter Wiring

(1)

(2)

(3)

(4)

(5)

(1) DVI video source

(2) DVI output (DVI cable)

(3) SDI output (optional 3G-SDI cable)

(4) Power to display (24VDC)

(5) Power to transmitter (24VDC)

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Set up and Installation | 19

ZEROWIRE® G2 Receiver Wiring

(1)

(2)

(3)

Wiring Receiver

(1) DVI input (DVI cable)

(2) Power to transmitter (24VDC)

(3) Power to display (24VDC)

4.5 Cable Bend Radius

CAUTION!

Degradation of the video signal

We recommend that the bend radius of metallic cables be no less than 2.5inches (63mm) or

7 times the diameter of the cable whichever is greater. Sharper bends may damage the

cable and/or degrade the video signal.

4.6 Setup

Linking the Transmitter and Receiver

Prior to placing the ZEROWIRE® G2 system in service, the Transmitter and Receiver pair must be linked.

Once a Transmitter and Receiver pair is linked, they remain linked until the Transmitter is explicitly linked to

another Receiver or the Receiver is explicitly linked to another Transmitter.

NOTE!

If a linked pair is turned off they will automatically link to each other when they are turned

on again.

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20 | Set up and Installation

Linking procedure:

1. Connect a DVI or SDI video source to the Transmitter unit (2) and a display to the Receiver unit’s DVI out-

put (3).

2. Press and hold the LINK button (6) on the Receiver unit (3) until its linking LED (5) begins flashing blue

rapidly, then release. At this point, the user has 60 seconds to move to the other unit and press the LINK

button on that device (2).

3. Press and hold the LINK button (6) on the Transmitter (2) unit until its linking LED (5) begins flashing

blue rapidly, then release.

4. When the Transmitter and Receiver units identify each other and begin to link, both the status LED (7)/

(8) and link LED (5) on both units will flash rapidly for several seconds. Once the link is established, each

unit’s linking LED turns off.

(5) (6)

(2)

(7)

(3)

(8)

(1) (2) (3) (4)

Linking procedure

(1) DVI or SDI Signal

(2) Transmitter

(3) Receiver

(4) DVI Output to Display

(5) Linking LED

(6) Linking button Transmitter/Receiver (press to start linking)

(7) Status LED Transmitter

(8) Status LED Receiver

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