videomed Truelink 4 User manual

Instructions for use
Truelink 4
Video Management System
ENGLISH
en-US
Read the instructions for use carefully before using the
product and keep them safe for future reference.

This page is intentionally blank.

Truelink 4
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Manufacturer VIDEOMED S.r.l.
Via C. Battisti, 31/C
35010 Limena (Pd)
Italy
[email protected]
hillrom.com
VIDEOMED S.r.l. is a company of the Hill-Rom Holdings Group. The
manufacturer is hereinafter referred to as VIDEOMED.
Technical Customer Service The contact details for the current Technical Customer Service
hubs in the individual countries are listed on the Internet at
www.hillrom.com.
Information about the document Instructions for use
This document is identified by a code indicating its version and
update status. It is the user's responsibility to ensure the most
recent version is used.
This document applies to the following sales units:
Telephone: [phone]
Fax: [phone]
Document number: 80028008
Language ID: 030
Version: B
Material number: 773625
Date of publication: 2021-04-29
Product designation REF
Truelink 4 Main Unit R TVR401111-1
Truelink 4 Main Unit TVR401111-1ND
Truelink 4 Main Unit RD TVR401111-1D
Truelink 4 Main Unit RSD TVR401111-1DT
Truelink 4 Main Unit RS TVR401111-1T
Truelink 4 Main Unit S TVR401111-1TND
Truelink 4 Main Unit AR TVR401111-2
Truelink 4 Main Unit ARD TVR401111-2D
Truelink 4 Main Unit ARSD TVR401111-2DT
Truelink 4 Main Unit ARS TVR401111-2T
Truelink 4 Main Unit SSD R TVR401111-3
Truelink 4 UHD TVR401112
Truelink 4 UHD Plus TVR401113
Truelink 4 Conference TCM401326
Truelink 4 TCM TDC500102
Truelink 4 Rack (115V) TAC500920K
Truelink 4 Rack (230V) TAC500920K-2

Truelink 4
480028008_030_B – 773625 – 2021-04-29
The manual is provided by VIDEOMED S.r.l. in electronic PDF
format on digital media. A paper copy of the manual is available
upon request for qualified technical and medical personnel.
VIDEOMED S.r.l. declines any liability for improper use of the
system and/or for damage caused as a result of operations not
covered by the technical documentation.

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PREFACE
All rights reserved. No part of this publication may be copied, distributed, translated into other languages
or transmitted by any electronic or mechanical means, including photocopying, recording or any other
storage and retrieval system, for other purposes that are not exclusively personal use by the buyer,
without the express written permission of the Manufacturer.
The Manufacturer is in no way responsible for the consequences deriving from any incorrect operations
carried out by the user.
PUBLISHER'S NOTE
This documentation is expressly intended for clinically trained users of the system.
The Publisher is in no way responsible for the information and data contained in this manual: all
information contained herein has been provided, checked and approved by the Manufacturer for
verification.
The Publisher is in no way responsible for any consequences deriving from incorrect operations carried
out by the user.
GENERAL CONSIDERATIONS
All operating instructions and recommendations described in this manual must be complied with.
Clinical personnel must be trained on all operating procedures and safety standards prior to using the
system.
SIGNAL WORDS
Residual dangers that may occur while using the product are identified in the document with a signal
word. The safety measures required and potential consequences of failing to take these are listed. A
corresponding signal word provides information about the severity of the danger:
© 2021 VIDEOMED S.r.l.
Signal word Meaning
DANGER The signal word indicates a dangerous situation that will immediately lead to death
or serious injury if no precautionary measures are taken.
WARNING The signal word indicates a dangerous situation that may lead to death or serious
injury if no precautionary measures are taken.
CAUTION The signal word indicates a dangerous situation that may lead to moderate to slight
injury if no precautionary measures are taken.
NOTICE The signal word indicates a dangerous situation that may lead to material damage or
damage to the environment if no precautionary measures are taken.

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Contents
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Contents
1 System identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
1.1 Identification plates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.2 Reference standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.3 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2 General preliminary information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1 Recipients of the instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
2.2 Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
2.3 Language. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
2.4 Personnel qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.5 Symbols used in the instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3 Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.1 General safety warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.2 Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.3 Useful life of the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.4 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.4.1 Preparing the system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.4.2 Cleaning the system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4 System description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
4.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.2 Reasonably foreseeable misuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.3 Use associated with other medical devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.4 Obligations and prohibitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.4.1 Personnel prohibitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.5 Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.6 Measurement and weight layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.7 System components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
4.7.1 Main unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
4.7.2 Conference unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.7.3 UHD unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.7.4 UHD Plus unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.7.5 Control software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5 Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
5.1 First system start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.2 Preliminary checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.3 System start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.4 Connection to the sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.5 System shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.6 System start-up/shutdown with remote button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.1 General description of the user interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
6.2 Control touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.3 “Video Routing” function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
6.3.1 Live Preview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
6.3.2 Quick Access - Recording. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
6.3.3 Quick Access - Streaming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
6.3.4 Ptz camera control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
6.3.4.1 Roomcam zoom adjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
6.3.4.2 Roomcam movement adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
6.3.4.3 Save camera setting (Preset) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
6.3.4.4 Delete camera setting (Preset) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Contents
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6.3.4.5 Enable camera setting (Preset) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
6.4 “Recording” function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
6.4.1 Image data post-processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
6.4.2 Selecting the signals to be recorded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
6.4.3 Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
6.4.4 Snapshot and video playback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6.4.5 Crop video. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
6.4.6 Export images and videos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.4.7 Delete images and videos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
6.5 “Video Conference” function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
6.5.1 Select the signals to be sent by video conference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
6.5.2 Removing the signals to be sent by video conference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
6.5.3 Call recipient selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
6.5.4 Call start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
6.6 Additional functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
6.6.1 Patient data management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
6.6.1.1 Selecting a patient present in the list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
6.6.1.2 Entering a new patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
6.6.1.3 Entering an emergency patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
6.6.1.4 Searching for a patient present in a list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
6.6.1.5 Patient master data modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
6.6.1.6 Accessing the worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
6.6.2 Check-List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
6.6.3 Preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
6.6.3.1 Preset setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
6.6.3.2 Enabling Preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
6.6.4 Multiview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
6.6.4.1 Multiview setting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
6.6.5 Audio control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
6.6.5.1 Volume adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
6.6.5.2 Disabling microphones and audio. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
6.6.6 Management of surgical lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
6.6.7 Environmental control panel management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
6.7 “Lock with PIN” function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
6.8 “Login” function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
7 Disposal instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
8 Annex I - Short manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
8.1 Video Routing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
8.2 Multiview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
8.3 PTZ camera control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
8.4 Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
8.5 Patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
8.6 Selection of signals to be recorded. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

System identification
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1 System identification
1.1 Identification plates
The Truelink 4 Video Management System units are fitted with identification plates. Each plate contains
the identification details of the unit to be quoted in case of need to VIDEOMED S.r.l.
The plates present are shown below:
Unit Image
Truelink 4 Main Unit R
Truelink 4 Main Unit
Truelink 4 Main Unit RD
Truelink 4 Main Unit RSD
Truelink 4 Main Unit RS
Truelink 4 Main Unit S

System identification
10 80028008_030_B – 773625 – 2021-04-29
Truelink 4 Main Unit AR
Truelink 4 Main Unit ARD
Truelink 4 Main Unit ARSD
Truelink 4 Main Unit ARS
Truelink 4 Main Unit SSD R
Truelink 4 Conference
Truelink 4 UHD
Unit Image

System identification
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CAUTION
It is absolutely forbidden to remove the identification plates
and/or replace them with other plates. If the plates are
damaged or removed, the customer must notify the
Manufacturer.
Truelink 4 UHD Plus
Truelink 4 TCM
Separable component Main Unit
Truelink 4 Rack (230V)
(input voltage 220-240V)
Truelink 4 Rack (115V)
(input voltage 100-120V)
Unit Image

System identification
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1.2 Reference standards
VIDEOMED S.r.l. declares that the Truelink 4 Video Management System complies with the specific
standards of the medical sector.
Legislation and rules applicable to the United States of America (USA) countries:
Standard Description
21 CFR Part 820 Quality System Regulation
21 CFR Part 821 Medical Device Tracking Requirements
21 CFR Part 803, 806, 807 Medical Device Reporting,
Medical Device Reports of Corrections and Removals,
Establishment Registration and Device Listing for Manufacturers
and initial Importers of Devices
21 CFR Part 801 Labeling
19 CFR Part 134 Country of origin marking.
AAMI / ANSI / ISO 14971:
2007/(R)2010
Medical Devices - Application Of Risk Management To Medical
Devices
AAMI / ANSI / IEC 62304:2006 Medical Device Software - Software Life Cycle Processes
ANSI AAMI IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to
medical devices
AAMI / ANSI HE75: 2009 Human Factors Engineering - Design Of Medical Devices
AAMI / ANSI ES60601-1:
2005/(R)2012 and A1:2012,
C1:2009/(R)2012
and A2:2010/(R)2012
Medical electrical equipment - part 1: general requirements for
basic safety and essential performance (IEC 60601-1:2005, Mod).
(General II (ES/EMC))
(U.S. Identical Adoption of Standard IEC 60601-1-2 Edition 4.0
2014-02
AAMI / ANSI / IEC 60601-1-2:2014 Medical electrical equipment -- part 1-2: general requirements for
basic safety and essential performance -- Collateral standard:
Electromagnetic disturbances -- Requirements and tests.
(General II (ES/EMC))
AAMI / ANSI / ISO 15223-1:2016 Medical Devices - Symbols To Be Used With Medical Device
Labels, Labelling And Information To Be Supplied - Part 1: General
Requirements
ISO 7010: Second edition 2011-06-01,
including amendment 1 (2012)
through amendment 7 (2016)
Safety Signs
California Proposition 65 Safe Drinking Water and Toxic Enforcement Act of 1986

System identification
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Legislation and rules applicable to European Union (EU) countries:
1.3 Warranty
The complete warranty clauses are provided in the sales contract.
VIDEOMED S.r.l. assures the safety and functional reliability of the
system provided that:
– the system is used, managed and repaired exclusively as
described in these instructions for use;
– installations, modifications and repairs are carried out
exclusively by the VIDEOMED S.r.l. assistance services
– only spare parts and accessories authorized by the
Manufacturer are used;
– no structural changes to the devices are carried out.
The system status after system testing must be recorded in an
installation protocol. Commissioning is used as proof of the start
of the warranty period.
Further details may be present in the commercial contract.
The conditions required by the commercial contract (if different)
have priority over what is provided in this section.
Standard Description
Regulation (EU) 2017/745 Regulation on medical devices amending Directive 93/42/EEC
will enter into force on 26 May 2021
93/42/EEC Medical Devices Directive (MDD) and f.m. 2007/47/EC
EN 1041:2008 Information provided by the manufacturer of medical devices
EN ISO 13485:2016 Management systems for the quality of medical devices
EN ISO 14971:2012 Applying risk management to medical devices
EN ISO 15223-1:2016 Symbols to be used in medical device labels, labelling and
information to be provided — Part 1: General requirements
EN 60601-1:2006/A1:2013 General requirements for fundamental safety and essential
performance
EN 60601-1-2:2015 General requirements relating to fundamental safety and
essential performance - Collateral standard: Electromagnetic
compatibility
EN 60601-1-6:2010 General safety standards — Collateral rule: Usability
EN 62304:2006 + A1:2015 Medical Device Software — Software Lifecycle Processes
EN 62366-1:2015 Application of user characteristics engineering to medical
devices
WEEE 2012/19/EU Waste electrical and electronic equipment
RoHS 2011/65/EU Restriction of the use of certain hazardous substances in
electrical and electronic equipment

General preliminary information
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2 General preliminary information
2.1 Recipients of the instructions for use
The instructions for use of Truelink 4 Video Management System
are intended for operators trained and authorized to handle it.
Operator training must be documented.
The instructions for use contain the topics that refer to a correct
use of the system, in order to maintain its functional and
qualitative characteristics unchanged over time. All the
information and warnings for a correct use in full safety are also
provided.
The instructions for use, like the CE conformity certificate, are an
integral part of the system and must always accompany it in any
movement or resale. It is the user's responsibility to keep this
documentation intact, so that it may be consulted, throughout the
entire lifespan of the system.
2.2 Updates
VIDEOMED S.r.l. reserves the right to update the instructions for
use at any time with modifications and/or translations without
prior notice.
Contact the Customer Service office of VIDEOMED S.r.l. to be
updated on the latest version of the instructions.
2.3 Language
The original instructions for use have been written in Italian.
Any translations into additional languages must be made starting
from the original instructions.
The Manufacturer is responsible for the information contained in
the original instructions; translations in different languages cannot
be completely verified, therefore if an inconsistency is detected it
is required to follow the text in the original language or to contact
the Customer Service office of VIDEOMED S.r.l.

General preliminary information
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2.4 Personnel qualifications
Consult the following table in order to establish the personnel skills
and qualifications:
2.5 Symbols used in the instructions for use
Qualification Description
Operator Natural or legal person (for example a doctor or a hospital) who
owns and uses the Truelink 4 Video Management System.
They must provide a safe system and adequately instruct the
user in the intended and permitted use of the system.
User Person suitably trained or who, thanks to their professional
qualification, is authorized to operate and use the Truelink 4
Video Management System in the activities required. They are
responsible for the correct and safe operation of the system and
ensures that it is used solely for the intended purpose.
Qualified Personnel Authorized persons who are generally employees of the
manager or who have acquired their skills through professional
training in the medical sector, who are able to evaluate their work
and recognize potential risks based on their professional
experience and knowledge of safety regulations. Where
required, qualified personnel must certify their qualifications by
means of a valid document.
Symbol Description
Symbol used to indicate the need to consult the instructions for
use before using the equipment.
Symbol of compliance with Regulation (EU) 2017/745 on medical
devices.
Equipotential: symbol for “potential equalization”.
Protective earth (ground)
Connection point for the neutral conductor on
PERMANENTLY INSTALLED equipment
Caution - Refer to the operating instructions.
Symbol used to indicate the date of manufacture.

General preliminary information
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Symbol used to identify the manufacturer's name.
Barred bin: this product must not be disposed of as municipal
mixed waste, collect separately.
Symbol used to indicate the VIDEOMED material number.
Symbol used to indicate the serial number.
Symbol used to indicate a medical device.
Indicates the Unique Device Identification UDI code, is composed
of UDI-DI (01) and UDI-PI ((11) date of production (21) serial
number).
MEDICAL — GENERAL MEDICAL EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS
ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) +
AMD 1 (2012), CAN/CSA-C22.2 No. 60601-1 (2014)
Symbol Description

Safety information
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3 Safety information
3.1 General safety warnings
The Truelink 4 Video Management System must be used by
suitably trained personnel.
DANGER
ELECTRIC SHOCK FROM DAMAGED MAINS POWER CABLE!
Check the mains power cable before connecting it and do not
use it if it has been crushed or if the insulation is damaged.
DANGER
ELETRIC SHOCK FROM PRESENCE OF LIVE PARTS EXPOSED!
It is also recommended to periodically check the integrity of the
parts of the device, to detect the presence of parts exposed
following an impact or a fall and not to use the device in the
presence of damage to the structure or to the its components.
WARNING
This product can expose you to chemicals including Lead and
Di(2-ethylhexyl) phthalate (DEHP), which are known to the State
of California to cause cancer, and Lead and Di(2-ethylhexyl)
phthalate (DEHP), which are known to the State of California to
cause birth defects or other reproductive harm. For more
information go to www.P65Warnings.ca.gov.
CAUTION
All safety information must be complied with for a safe use of
the Truelink 4 Video Management System.
CAUTION
To avoid complications due to electrostatic balancing charges
between parts of the device and the patient, the user must not
simultaneously touch the metal parts of the system and the
patient.
CAUTION
RISK OF CONTAMINATION AND INFECTION OF THE PATIENT!
Free particles hidden in worn parts may end up in open wounds.
A monitor with a damaged surface cannot be used in a medical
environment. If the control screen is mounted on a suspension
system, do not place the control screen over the sterile
operating area during medical use.

Safety information
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CAUTION
MEASUREMENT OF DISPERSAL CURRENTS!
It is necessary to measure the leakage currents with the circuits
downstream of the Truelink 4 system open. Otherwise, the
leakage currents of these circuits will be added to those of the
Truelink 4 system.
3.2 Electromagnetic compatibility
The Truelink 4 Video Management System supplied contains
electronic components subject to the Electromagnetic
Compatibility regulations, affected by conducted and radiated
emissions.
The emission values comply with regulatory requirements thanks
to the use of components compliant with the Electromagnetic
Compatibility Directive, suitable connections and installation of
filters where required.
The Truelink 4 Video Management System is therefore compliant
with the Electromagnetic Compatibility (EMC) directive.
CAUTION
Any maintenance activities on the electrical equipment carried
out in a non-compliant manner or incorrect replacement of
components may compromise the efficiency of the solutions
adopted.
The Truelink 4 product is a Class A electromedical device
according to CEI 60601-1-2 (CISPR 11), it is suitable for use in a
specific electromagnetic environment. The customer and / or the
user of the product must ensure that it is used in an
electromagnetic environment as described below.
Emission Test Compliance Electromagnetic Environment Guide
Radiated and conducted RF
emission
CISPR 11
Group 1 Truelink 4 uses RF (radio-frequency) energy
only for its internal operation. Therefore, the
RF emissions are very low and should not
cause interference in adjacent electronic
devices.
Class A Truelink 4 is suitable for use in all buildings,
except domestic buildings and those directly
connected to the public low-voltage power
supply network that supplies buildings used
for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Not applicable

Safety information
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Guidance and manufacturer's declaration - Electromagnetic immunity
The product is suitable for use in a specific electromagnetic environment. The customer and / or the user
of the product must ensure that it is used in an electromagnetic environment as described below:
IMMUNITY test IEC test level Compliance
level
Electromagnetic environment – guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±8 kV in contact
±2, ±4, ±8, ±15 kV
in the air
IEC 60601-1-2
Test level
The floor must be in wood, concrete or
ceramic tiles. If the floors are covered with
synthetic material, the relative humidity must
be at least 30%. Temporary loss of the signal
is possible (a few seconds).
Radiated
electromagnetic
fields
IEC 61000-4-3
3 V/m
from 80 MHz to
2,7 GHz
IEC 60601-1-2
Test level
Portable and mobile RF communications
equipment should be used no closer to any
part of the EUT. including cables.
Minimum distance 30 cm.
Fast electrical
transients (burst)
IEC 61000-4-4
± 2 kV for power
lines
± 1 kV for input /
output lines > 3 m
IEC 60601-1-2
Test level
The quality of the mains supply must be that
typical of a commercial and / or hospital
environment.
Pulses
IEC 61000-4-5
±0.5, ±1 kV
differential mode
±0.5, ±1, ±2 kV in
common mode
IEC 60601-1-2
Test level
Mains power quality should be typical of a
commercial or hospital environment.
Conducted
disorders, induced
by RF fields
IEC 61000-4-6
3 V
150 kHz to 80 MHz
6V
ISM frequencies
IEC 60601-1-2
Test level
Portable and mobile RF communications
equipment should be used no closer to any
part of the EUT. including cables.
Minimum distance 30 cm.
Networkfrequency
magnetic field (50/
60 Hz)
IEC 61000-4-8
30 A/m IEC 60601-1-2
Test level
Power frequency magnetic fields should have
the characteristic levels of a typical location in
a typical commercial or hospital environment.
Voltage dips, brief
interruptions and
voltage variations
on the power input
lines
IEC 61000-4-11
10 ms – 0% a 0°,
45°, 90°, 135°, 180°.
225°, 270°, 315°
20 ms – 0% a 0°
500 ms – 70% a 0°
5 s – 0%
IEC 60601-1-2
Test level
The quality of the mains voltage should be
that typical of commercial or hospital
environments. If the user of the appliance
requires it to continue to operate even when
the mains power supply is interrupted, it is
recommended to power the appliance with
an uninterruptible power supply (UPS) or with
batteries.

Safety information
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Guidance and manufacturer's declaration - Range and frequency level: RF wireless communication
equipment
3.3 Useful life of the system
Provided that all applicable safety and maintenance regulations
are strictly observed, the video integration system has been
designed to guarantee a duration of 8 years.
The life cycle includes guaranteeing the functionality of the
product in compliance with the specific instructions for use, the
supply of the assistance service and the availability of spare parts;
VIDEOMED applies a certified quality management system
according to EN ISO 13485 to all its business processes which is a
guarantee of:
–highestquality;
– product and accessory reliability;
– ease of use;
– functional design;
– optimization for the intended purpose.
Test frequency
(MHz)
Modulation Minimum IMMUNITY
level (V / m)
Applied IMMUNITY
level (V / m)
385 ** Pulse modulation: 18 Hz 27 27
450 * FM + 5 Hz deviation: 1 kHz sine
** Pulse modulation: 18 Hz
28 28
710
745
780
** Pulse modulation: 217 Hz 9 9
810
870
930
** Pulse modulation: 18 Hz 28 28
1720
1845
1970
** Pulse modulation: 217 Hz 28 28
2450 ** Pulse modulation: 217 Hz 28 28
5240
5500
5785
** Pulse modulation: 217 Hz 9 9