NDS ZEROWIRE G2 Manuale utente

ZEROWIRE® G2

Advanced Wireless HD-Video Transmission System

60A0571 Rev. G

USER MANUAL

ENGLISH

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

correctness of the contents. This document is subject to change without notice. NDS provides this informa-

tion as reference only. Reference to products from other vendors does not imply any recommendation or

endorsement.

This document contains proprietary information protected by copyright. No part of this manual may be re-

produced by any mechanical, electronic, or other means, in any form, without prior written permission of

NDS.

All trademarks are the property of their respective owners.

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

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:

Belarus, Russia, Kazakh-

stan, Armenia, Kyrgyz-

stan.

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

Protection 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; pro-

tective 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.........................................................................................................................................................................15

4.3 Power Options .................................................................................................................................................................17

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.......................................................................................................................................25

4.11 Avoiding Co-Channel Interference...........................................................................................................................26

4.12 Channel Usage.................................................................................................................................................................26

4.13 Multi System Installation..............................................................................................................................................26

4.14 Signal Strength and OSD Diagnostic Messages ..................................................................................................27

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 .........................35

7.3 Guidance and Manufacturer's Declaration - Recommended Separation Distances ..............................36

8 Terms and Conditions .............................................................................................................................. 37

8.1 Declarations of Conformity .........................................................................................................................................37

8.2 Legal Statement ..............................................................................................................................................................38

7 / 40

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.

8 / 40

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.

9 / 40

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

10 / 40

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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