Getinge 170520A0 / TEGRIS BASE SOFTWARE (SW2) Operating instructions

Instructions for use

1705.20A0 / 1705.06A0 - Release 7.2

OR Integration

TEGRIS BASE SOFTWARE (SW2) /

TEGRIS BASE IO-BOX (HW2)

IFU 1705.20EN 082023-09-15

Copyright

pressly reserve and retain all right, title and interest in and to all existing intellectual property in the products of

Getinge, its subsidiaries and/or affiliates. , No right, title or interest is granted by Getinge.

Subject to technical modification!

Due to further development of the product, the figures used and technical specifications given in these Instruc-

tions for Use may slightly differ from the current state of the product.

Trademark

Getinge and Tegris are trademarks or registered trademarks of Getinge AB, Maquet GmbH, and/or their sub-

sidiaries and/or affiliates. All other company or product names are trademarks or registered trademarks of

their respective holders.

V08 07 15-09-2023

1705.20A0 / 1705.06A0

IFU 1705.20 EN 08

Contents

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Contents

1 Introduction .............................................................................................................. 11

1.1 How to use these instructions for use................................................................................................... 11

1.1.1 Abbreviations ......................................................................................................................... 11

1.1.2 Symbols and formatting ......................................................................................................... 12

1.1.3 Definitions .............................................................................................................................. 12

1.1.3.1 Design of safety notes......................................................................................... 12

1.1.3.2 Structure of notes ................................................................................................ 13

1.1.3.3 Definition of hazardous location, Zone AP-M ...................................................... 13

1.1.4 Symbols used ........................................................................................................................ 14

1.2 Disposal................................................................................................................................................ 18

1.2.1 Old products........................................................................................................................... 18

1.2.2 Packaging .............................................................................................................................. 18

1.2.3 Batteries and rechargeable batteries ..................................................................................... 18

1.2.4 Used electrical devices .......................................................................................................... 18

1.3 Basic requirements for medical devices ............................................................................................... 19

1.3.1 Use in accordance with the intended purpose ....................................................................... 19

1.3.2 Applicable standards.............................................................................................................. 19

1.3.3 Intended uses ........................................................................................................................ 19

1.3.3.1 Purpose [TEGRIS BASE IO-BOX (HW2)] (1705.06A0) ...................................... 19

1.3.3.2 Purpose [TEGRIS BASE SOFTWARE (SW2)] (1705.20A0)............................... 20

1.3.3.3 Intended use of the [OR TABLE CONTROL] (1703.71A0 / 1703.35A0) ............. 20

1.3.3.4 Intended use of the [OR LIGHT CONTROL] (1703.38A1) .................................. 21

1.3.4 Essential performance ........................................................................................................... 22

1.4 Basic requirements for non-medical devices........................................................................................ 23

1.4.1 Standards, interfaces and accessories .................................................................................. 23

1.4.2 Intended use of the [CENTRAL USER MANAGEMENT] (1703.05A0).................................. 23

1.4.3 Intended use of the [LIVE PREVIEW] (1703.26A0) ............................................................... 23

1.4.4 Intended use of the [IP RECORDING/ STREAMING (SW2)] ................................................ 24

1.4.5 Intended use of the [VIDEO DOCUMENTATION AUTORECORDING (SW)] (1703.30C0) .. 24

1.4.6 Intended use of the [DICOM INTERFACE] (SW) (1703.32A0).............................................. 25

1.4.7 Intended use of the [CAMERA CONTROL] (1703.33A0) ...................................................... 25

1.4.8 Intended use of the [ROOM CONTROL] (1703.39A0 / 1703.74A0/B0/C0) ........................... 25

1.4.9 Intended use of the [REMOTE CLIENT] (1703.40D0) ........................................................... 26

1.4.10 Intended use of the [PICTURE IN PICTURE] (1703.41XX)................................................... 27

1.4.11 Intended use of the [PATIENT CONTEXT SHARING] (1703.43A0)...................................... 27

1.4.12 Intended use of the [COMMUNICATION] (1703.44X0) ......................................................... 27

1.4.13 Intended use of the [EXTERNAL APPLICATION INTEGRATION] (1703.46A0) ................... 28

1.5 Reportable event .................................................................................................................................. 28

1.6 Data protection ..................................................................................................................................... 29

2 Safety notes.............................................................................................................. 30

2.1 General safety notes ............................................................................................................................ 30

2.2 Safety notes for the product ................................................................................................................. 30

2.3 Safety notes EMC................................................................................................................................. 32

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3 Operation of hardware............................................................................................. 33

3.1 IO-Box (1705.06A0).............................................................................................................................. 34

3.1.1 Overview of mounting points.................................................................................................. 34

3.1.2 IO-Box LED............................................................................................................................ 35

3.1.3 IO-Box LED-Status ................................................................................................................ 35

3.1.4 Setting up equipotential bonding............................................................................................ 36

3.1.5 Connecting the EDP network................................................................................................. 36

3.1.6 Provide power supply............................................................................................................. 37

3.1.7 Switch the IO-Box on/off ........................................................................................................ 38

3.1.8 Switching the TEGRIS BASE PC on/off................................................................................. 39

3.2 WIRELESS MICROPHONE SET (hardware) (1707.70A0) .................................................................. 39

3.2.1 Connecting the charging cradle ............................................................................................. 40

3.2.2 Connecting the microphone ................................................................................................... 40

3.2.3 Charging the rechargeable battery of the transmitter ............................................................ 41

3.2.4 Attaching the transmitter ........................................................................................................ 41

3.2.5 Attaching the microphone ...................................................................................................... 42

3.2.6 Switching the transmitter on/off.............................................................................................. 42

3.2.7 Mute function ......................................................................................................................... 43

3.3 OR TABLE CONTROL (HW2) (1705.81A0) ......................................................................................... 44

3.3.1 IR transmitter ......................................................................................................................... 44

3.3.1.1 Connecting/disconnecting the IR transmitter....................................................... 44

3.3.1.2 IR transmitter displays......................................................................................... 44

3.3.2 Connecting/disconnecting the STOP switch .......................................................................... 45

3.4 Monitors................................................................................................................................................ 45

3.4.1 Canvys 24" Touch monitor (1705.11A0)................................................................................ 45

3.4.2 Monitor Barco IP / STD (1707.2XX0)..................................................................................... 46

3.4.3 OR Viewport variants ............................................................................................................. 48

4 User interface and basic functions ........................................................................ 49

4.1 Structure of the user interface .............................................................................................................. 50

4.1.1 Overview: User interface........................................................................................................ 50

4.1.2 Open/Close sub-menu ........................................................................................................... 51

4.1.3 Menus for the OR procedure ................................................................................................. 51

4.1.4 Detail view: Patient data ........................................................................................................ 52

4.1.5 Status indication line .............................................................................................................. 52

4.1.6 IO-Box status display ............................................................................................................. 53

4.1.7 Overview of the menu: Clock ................................................................................................. 53

4.1.8 Menu: Service ........................................................................................................................ 54

4.1.8.1 Open the Service menu....................................................................................... 54

4.1.8.2 Menu item: Application ........................................................................................ 54

4.1.8.3 Menu item: Information........................................................................................ 55

4.1.8.4 Menu item: Configuration .................................................................................... 56

4.1.8.5 Menu item: Messages ......................................................................................... 56

4.1.8.6 Menu item: System Clock.................................................................................... 57

4.2 Basic functions ..................................................................................................................................... 57

4.2.1 Virtual keyboard ..................................................................................................................... 57

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4.2.2 Logging in to Tegris ............................................................................................................... 57

4.2.2.1 User login ............................................................................................................ 58

4.2.2.2 Logging a user out............................................................................................... 58

4.2.2.3 Emergency access .............................................................................................. 58

4.2.3 Adjusting the volume.............................................................................................................. 59

4.2.4 Accept/Dial/End/Reject calls .................................................................................................. 60

4.2.5 Display of OR status .............................................................................................................. 61

4.2.6 Menu: Connection list ............................................................................................................ 61

4.2.7 Save image ............................................................................................................................ 62

4.2.8 Record video.......................................................................................................................... 62

4.2.9 Menu item: Clock ................................................................................................................... 62

4.2.9.1 Menu item: Date / Time ....................................................................................... 63

4.2.9.2 Menu item: Stopwatch......................................................................................... 63

4.2.9.3 Menu item: Timer ................................................................................................ 64

4.2.10 Menu item: Surgical safety checklist...................................................................................... 65

4.2.10.1 Processing the surgical safety check list............................................................. 65

5 OR procedure menus............................................................................................... 66

5.1 Menu: PRE-OP..................................................................................................................................... 66

5.1.1 Overview of the menu: PRE-OP ............................................................................................ 66

5.1.2 Menu item: Patient Management ........................................................................................... 67

5.1.2.1 Tab: Local study .................................................................................................. 68

5.1.2.2 Tab: Worklist ....................................................................................................... 71

5.1.2.3 Tab: Log .............................................................................................................. 74

5.1.3 Menu item: Presets ................................................................................................................ 76

5.1.3.1 Overview of the menu: Presets ........................................................................... 76

5.1.3.2 Creating a preset................................................................................................. 77

5.1.3.3 Opening a preset................................................................................................. 77

5.1.3.4 Adapting a preset ................................................................................................ 78

5.1.3.5 Deleting a preset ................................................................................................. 78

5.1.4 Menu item: Video routing ....................................................................................................... 79

5.1.4.1 Overview of the menu: Video routing .................................................................. 80

5.1.4.2 Assigning an image source on the monitor ......................................................... 81

5.1.4.3 Assigning an image source on the recorder........................................................ 81

5.1.4.4 Assigning an image source for streaming ........................................................... 82

5.1.4.5 Switching the streamer on/off.............................................................................. 82

5.1.4.6 Setting the Picture-In-Picture module.................................................................. 83

5.1.4.7 Display overlays .................................................................................................. 84

5.2 Menu: INTRA-OP ................................................................................................................................. 85

5.2.1 Overview of the menu: INTRA-OP......................................................................................... 85

5.2.2 Menu item: Communication ................................................................................................... 85

5.2.2.1 Overview of the menu item: Communication....................................................... 86

5.2.2.2 Join Webex meeting............................................................................................ 88

5.2.2.3 Creating a contact entry ...................................................................................... 88

5.2.2.4 Editing a contact entry......................................................................................... 89

5.2.2.5 Deleting a contact entry....................................................................................... 90

5.2.3 Menu item: Recording............................................................................................................ 90

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5.2.3.1 Overview of the menu: Recording ....................................................................... 91

5.2.3.2 Creating an image ............................................................................................... 91

5.2.3.3 Recording video .................................................................................................. 92

5.2.3.4 Select the recording quality ................................................................................. 92

5.2.3.5 Creating and printing a single image................................................................... 93

5.2.3.6 Endosnap ............................................................................................................ 93

5.2.4 Menu item: Remote Workstation Interface............................................................................. 94

5.2.4.1 General................................................................................................................ 94

5.2.4.2 Overview: Remote Workstation Interface............................................................ 95

5.2.4.3 Activate/deactivate full screen display................................................................. 95

5.2.4.4 Tegris operating panel......................................................................................... 96

5.2.4.5 Display external system ...................................................................................... 96

5.2.4.6 Adapting the display area.................................................................................... 97

5.2.4.7 Refreshing the display area................................................................................. 98

5.2.4.8 Working with the external system in the display area ......................................... 98

5.3 Menu: POST-OP .................................................................................................................................. 99

5.3.1 Overview of the menu: POST-OP.......................................................................................... 99

5.3.2 Menu item: Finalize................................................................................................................ 100

5.3.2.1 Overview of the menu: Finalize ........................................................................... 100

5.3.2.2 Printing a clip of a video file................................................................................. 101

5.3.2.3 Print file(s) or create final report .......................................................................... 102

5.3.2.4 Deleting file(s) ..................................................................................................... 103

5.3.2.5 Adding a comment to a file.................................................................................. 103

5.3.2.6 Playing/pausing a video file................................................................................. 104

5.3.2.7 Creating a clip of a video file ............................................................................... 107

5.3.2.8 Extracting an image from a video file .................................................................. 108

5.3.2.9 Exporting file(s) to a USB storage media ............................................................ 109

5.3.2.10 Burning file(s) to DVD or BluRay......................................................................... 110

5.3.2.11 Exporting file(s) to the network (LAN) ................................................................. 111

5.3.2.12 Exporting file(s) to PACS..................................................................................... 112

5.3.2.13 Exporting file(s) to HL7........................................................................................ 113

5.3.2.14 Export status ....................................................................................................... 114

5.3.2.15 Closing a study (patient file) ................................................................................ 114

6 Menu: Direct access ................................................................................................ 115

6.1 Overview of the menu: Direct access ................................................................................................... 115

6.2 Menu item: Room settings.................................................................................................................... 115

6.2.1 Tab: Light ............................................................................................................................... 116

6.2.1.1 Overview ............................................................................................................. 116

6.2.1.2 Main switch light .................................................................................................. 116

6.2.1.3 Setting the room lighting...................................................................................... 117

6.2.1.4 Setting the lighting elements ............................................................................... 117

6.2.1.5 Display: Scenes................................................................................................... 118

6.2.1.6 Display: Operating theatre status ........................................................................ 118

6.2.1.7 Opening / closing the blinds ................................................................................ 119

6.2.1.8 Looking through the LCD glass panel ON / OFF................................................. 119

6.2.1.9 Display: Laser and X-ray ON / OFF .................................................................... 120

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6.2.1.10 Open door ........................................................................................................... 120

6.2.2 Tab: Climate........................................................................................................................... 121

6.2.2.1 Overview ............................................................................................................. 121

6.2.2.2 Setting the temperature....................................................................................... 121

6.2.2.3 Setting the air humidity........................................................................................ 122

6.2.2.4 Setting the ventilation .......................................................................................... 122

6.2.3 Tab: Power & Gas.................................................................................................................. 123

6.2.3.1 Overview ............................................................................................................. 123

6.2.3.2 Gas status indicator............................................................................................. 123

6.2.3.3 Checking the insulation monitor .......................................................................... 124

6.2.3.4 Switching off the warning buzzer......................................................................... 124

6.3 Menu item: Remote client..................................................................................................................... 125

6.3.1 Establish the connection to a third-party system via Remote Client ...................................... 125

6.3.2 Disconnect the connection to a third-party system via Remote Client................................... 126

6.4 Menu item: Cameras ............................................................................................................................ 127

6.4.1 Overview of the menu: Cameras ........................................................................................... 127

6.4.2 Setting the camera................................................................................................................. 127

6.5 Menu item: Audio.................................................................................................................................. 129

6.5.1 Prioritisation of audio output .................................................................................................. 129

6.5.2 Overview of the menu: Audio AUX ........................................................................................ 129

6.5.3 Overview of the menu: Audio Microphone ............................................................................. 130

6.5.4 Adjusting the microphone ...................................................................................................... 130

6.5.5 Adjusting the auxiliary input ................................................................................................... 132

6.6 Menu item: OR light operation.............................................................................................................. 132

6.6.1 Overview: Operation of PowerLED 300 / 500 / 700 and HLED 300 / 500 / 700 .................... 133

6.6.1.1 OR light ON/OFF................................................................................................. 134

6.6.1.2 Switching lighting................................................................................................. 135

6.6.1.3 Adjusting the light intensity.................................................................................. 136

6.6.2 Overview: Operation of PowerLED II 500 / 700 ..................................................................... 137

6.6.2.1 OR light ON/OFF................................................................................................. 138

6.6.2.2 Switching lighting................................................................................................. 138

6.6.2.3 Adjusting the light intensity.................................................................................. 139

6.6.2.4 Adapting the light field diameter .......................................................................... 140

6.6.2.5 Activate comfort light ........................................................................................... 140

6.6.2.6 Selecting the light colour ..................................................................................... 141

6.6.2.7 Synchronising OR lights ...................................................................................... 141

6.6.3 Overview: Operation OR light VOLISTA ................................................................................ 142

6.6.3.1 OR light ON/OFF................................................................................................. 144

6.6.3.2 Switching lighting................................................................................................. 144

6.6.3.3 Adjusting the light intensity.................................................................................. 145

6.6.3.4 Adapting the light field diameter .......................................................................... 146

6.6.3.5 Setting the light temperature ............................................................................... 146

6.6.3.6 Synchronising OR lights ...................................................................................... 147

6.7 Menu item: OR table control................................................................................................................. 147

6.7.1 Overview of the menu: OR table control ................................................................................ 149

6.7.2 Setting the IR code ................................................................................................................ 149

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6.7.3 Selecting the OR table ........................................................................................................... 150

6.7.4 Release OR table control....................................................................................................... 151

6.7.5 Menu item: MAGNUS OR table control ................................................................................. 152

6.7.5.1 Switching leg side................................................................................................ 153

6.7.5.2 Sub-menu: Menu functions MAGNUS OR table ................................................. 154

6.7.6 Menu item: OTESUS OR table control .................................................................................. 154

6.7.6.1 Setting the OR table positions............................................................................. 156

6.7.7 Menu item: ALPHAMAQUET OR table control ...................................................................... 157

6.7.7.1 Individual adjustment of left/right leg plate .......................................................... 157

6.7.8 Menu item: YUNO OR table control....................................................................................... 158

6.7.8.1 Switching leg side................................................................................................ 158

6.7.8.2 Sub-menu: Menu functions YUNO OR table....................................................... 159

6.7.9 Menu item: ALPHAMAXX OR table control ........................................................................... 160

6.7.9.1 Individual adjustment of left/right leg plate .......................................................... 160

6.7.10 Menu item: ALPHASTAR OR table control............................................................................ 161

6.7.11 Menu item: BETASTAR OR table control .............................................................................. 162

6.7.12 Menu item: MEERA OR table control .................................................................................... 162

6.7.13 STOP button .......................................................................................................................... 164

6.8 Menu item: External Application Integration ......................................................................................... 165

6.8.1 Overview: External Application Integration ............................................................................ 165

6.8.2 Activate/deactivate full screen display ................................................................................... 166

7 Streaming client ....................................................................................................... 167

7.1 Starting the streaming client ................................................................................................................. 167

7.2 Setting the streaming client .................................................................................................................. 168

7.3 Starting the network streaming............................................................................................................. 169

8 Cleaning and disinfection ....................................................................................... 170

8.1 General information .............................................................................................................................. 170

8.1.1 No mechanical preparation .................................................................................................... 171

8.2 Cleaning agents and disinfectants........................................................................................................ 172

8.2.1 Suitable cleaning agents........................................................................................................ 172

8.2.2 Suitable disinfectants ............................................................................................................. 172

8.2.3 Non-usable products / substances......................................................................................... 172

8.3 Manual preparation of the Tegris system and accessories .................................................................. 173

8.3.1 Pre-cleaning........................................................................................................................... 173

8.3.2 Disinfection ............................................................................................................................ 173

8.3.3 Drying..................................................................................................................................... 173

8.3.4 Inspections............................................................................................................................. 173

8.3.5 Microphones .......................................................................................................................... 173

8.4 Preparation of monitors from other manufacturers............................................................................... 174

8.4.1 Manufacturer Barco ............................................................................................................... 174

8.4.2 Manufacturer: Rein Medical ................................................................................................... 174

8.4.3 Manufacturer: Canvys............................................................................................................ 175

9 Maintenance ............................................................................................................. 176

9.1 Visual and functional inspections ......................................................................................................... 176

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9.2 Malfunctions and troubleshooting......................................................................................................... 177

9.3 Replace mains fuse (1705.06A0) ......................................................................................................... 179

9.4 Inspection and Maintenance................................................................................................................. 179

9.5 Repair ................................................................................................................................................... 180

9.6 Type plate positions and manufacturer information.............................................................................. 180

10 Technical specifications.......................................................................................... 182

10.1 Ambient conditions ............................................................................................................................... 182

10.2 24" CANVYS touchscreen (1705.11A0) ............................................................................................... 182

10.3 22" IN-WALL Touch (1707.10A0) ......................................................................................................... 182

10.4 Electrical data IO-Box (1705.06A0) ...................................................................................................... 183

10.5 IO-Box dimensions (1705.06A0) .......................................................................................................... 183

10.6 Weight (1705.06A0).............................................................................................................................. 183

11 Electromagnetic compatibility (EMC)..................................................................... 184

11.1 Electro magnetic transmission and resistance to interference ............................................................. 184

11.2 Resistance to electro magnetic interference - Testing process............................................................ 184

12 Approved accessories............................................................................................. 187

12.1 New BASE SYSTEM 1705 ................................................................................................................... 187

12.2 CENTRAL (SERVER) COMPONENTS ................................................................................................ 187

12.3 VIDEO OVER IP (NEXXIS) .................................................................................................................. 187

12.4 MODULES (Software) .......................................................................................................................... 188

12.5 MODULES (Hardware) ......................................................................................................................... 189

12.6 ACCESSORIES.................................................................................................................................... 189

12.7 TOUCHSCREENS ............................................................................................................................... 190

12.8 MONITORS .......................................................................................................................................... 190

12.9 IN-WALL MONITORS........................................................................................................................... 191

12.9.1 27''.......................................................................................................................................... 191

12.9.2 32''.......................................................................................................................................... 191

12.9.3 46''.......................................................................................................................................... 191

12.9.4 49''.......................................................................................................................................... 192

12.9.5 55''.......................................................................................................................................... 192

12.9.6 PC Upgrade options............................................................................................................... 192

12.9.7 Keyboard and mouse options ................................................................................................ 192

12.9.8 Keyboard PLUS and mouse options...................................................................................... 192

12.9.9 Wall holder options ................................................................................................................ 193

12.9.10 USB options ........................................................................................................................... 193

13 Licenses.................................................................................................................... 194

13.1 Apache License .................................................................................................................................... 194

13.2 WITH License ....................................................................................................................................... 196

13.3 BSD License for DCMTK ...................................................................................................................... 197

13.4 Lesser General Public License ............................................................................................................. 198

Index.......................................................................................................................... 201

Contents

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Introduction

How to use these instructions for use 1

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1 Introduction

1.1 How to use these instructions for use

These instructions for use are provided to familiarise you with the features of this product. The in-

structions for use are divided into separate chapters.

Please note:

• Read these instructions for use through carefully and completely before using the product for

the first time.

• Always proceed in accordance with the information provided in these instructions for use.

• Store these instructions for use in the vicinity of the product.

1.1.1 Abbreviations

AIM Automatic Illumination Management

EC European Community

EMC Electromagnetic compatibility

EN European standard

ESD Electrostatic discharge

EEC European Economic Community

FullHD Full high definition

4K-UHD Ultra High Definition

GUI Graphical User Interface

HD High Definition

HDD Hard Disk Drive (permanent/bulk storage)

RU Rack Units

RF Radio frequency

HW Hardware

IEC International Electrotechnical Commission

INT Intermittent

IP(XY) International Protection (type of protection against ingress of solid bodies

and liquids)

IP Internet Protocol (network protocol)

IPS Internal Power Source

IR Infrared

HIS Hospital Information System

KVM Keyboard Video Mouse

MDD Medical Devices Act

OR Operating room

PACS Picture archiving and communication system

PVC Polyvinylchloride

RIS Radiology information system

SD Standard definition

SELV Safety Extra Low Voltage

SN Serial no.

PLC Programmable logic controller

SW Software

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UPS Uninterrupted Power Supply

VDE Verband der Elektrotechnik Elektronik Informationstechnik

1.1.2 Symbols and formatting

Symbol Meaning

1.

2.

Instructions to follow / list with numbered steps

Result of an action

● Numbered steps / List entry / precondition

Reference to other pages within this document

[...] Key / Module / Mode

bold Menu / on-screen button

[italics] Field to be filled in

1122.33XX Order number with different variants (XX)

Tab.1: Symbols and formatting

1.1.3 Definitions

1.1.3.1 Design of safety notes

Pictogram Descriptor Text

DANGER! Identifies an immediate danger to people, which may

result in death or serious injuries.

WARNING! Identifies a potential danger to people or property, which

may result in damage to health or serious property dam-

ages.

CAUTION! Identifies a potential danger to property, which may res-

ult in property damages.

Tab.2: Design of safety notes

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1.1.3.2 Structure of notes

Pictogram Descriptor Explanation

NOTE Supplementary assistance or further useful information

which does not indicate a risk of injury to persons or a

risk of property damage are described in the text of the

note.

ENVIRONMENT Information regarding proper disposal.

Tab.3: Structure of notes

1.1.3.3 Definition of hazardous location, Zone AP-M

The term "AP-M zone" 1 is used to refer to the medical environment.

1

Fig.1: Area with a risk of explosions, AP-M zone

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1.1.4 Symbols used

Symbols are attached to products, type plates and packaging.

Symbols Labelling

Labelling of products developed and marketed in accordance with relevant

European legal provisions.

Labelling of products that have been placed on the market in accordance with

the relevant legal requirements of the United Kingdom.

UL classification mark from Underwriters Laboratories as proof that the

product has been assessed by Underwriters Laboratories for specific proper-

ties in order to exclude risks and to confirm the usability under certain circum-

stances.

This labelling signifies compliance with the requirements both for the USA and

for Canada.

Labelling in accordance with the ISO15223-1 standard.

Symbol for "Serial number".

Labelling in accordance with the standard ISO 15223-1.

Symbol for "Catalogue number / product number".

Labelling in compliance with the IEC 60417 standard.

Symbol for "Electrostatically sensitive components".

Labelling in compliance with the IEC 60529 standard.

Symbol for “No protection against water”.

Labelling in accordance with the ISO 15223-1 standard.

Symbol for "Consult instructions for use".

Labelling in accordance with the IEC 60601-1 standard.

Symbol for "Follow Instructions for use".

Labelling in compliance with the IEC 60601-1 standard.

Symbol for "Equipotentiality".

Tab.4: Symbols

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Symbols Labelling

Labelling of devices with a protective earth (ground) in accordance with the

IEC 60601-1 standard.

Labelling in accordance with the ISO15223-1 standard.

Labelling of packaging materials.

Symbol for "Keep dry".

Labelling in accordance with the ISO 15223-1 standard.

Symbol for "Fragile! Handle with care".

Labelling in accordance with the ISO 7000 standard.

Symbol for "Top".

Labelling in accordance with the ISO15223-1 standard.

Symbol for "Temperature limit".

Labelling in accordance with the ISO15223-1 standard.

Symbol for "Humidity limitation".

Labelling in accordance with the ISO15223-1 standard.

Symbol for "Atmospheric pressure limitation".

Labelling in accordance with the 2012/19/EU directive (on used electrical

equipment and electronics).

Symbol for "Do not dispose of product via the municipal collection points for

used electrical equipment".

Labelling in accordance with the IEC60417-1 standard.

Symbol for "Device protection".

Labelling in accordance with the standard ISO15223-1.

Symbol for "Name and address of the manufacturer". The date of manufactur-

ing can be combined with this symbol.

Labelling in accordance with the ISO 15223-1 standard.

Symbol for "Name and address of the importer".

Tab.4: Symbols

1Introduction

How to use these instructions for use

16 / 204 1705.20A0 / 1705.06A0

IFU 1705.20 EN 08

Symbols Labelling

Labelling in accordance with the ISO 15223-1 standard.

Symbol for the labelling of medical devices

Marking according to the standard ISO15223-1.

Symbol for "Pay attention to the supplied documents".

Labelling of devices in the AP class in accordance with the IEC60601-1

standard.

Explosion protection ensured by the avoidance of ignition sources when using

flammable blends of anaesthetics that are mixed with air, oxygen or nitrous

oxide.

Labelling of equipment. Symbol for "Output".

Labelling of equipment. Symbol for "Input".

Labelling of equipment. Symbol for "Optional input".

Labelling of equipment. Symbol for "Relay output".

Labelling of equipment. Symbol for "Speaker".

Labelling of equipment. Symbol for "Microphone input, symmetrical".

Labelling of equipment. Symbol for "Microphone input, asymmetrical".

Tab.4: Symbols

Introduction

How to use these instructions for use 1

1705.20A0 / 1705.06A0

IFU 1705.20 EN 08 17 / 204

Symbols Labelling

Labelling of equipment. Symbol for "iPod connection".

Labelling of equipment. Symbol for "Network connection".

Tab.4: Symbols

1Introduction

Disposal

18 / 204 1705.20A0 / 1705.06A0

IFU 1705.20 EN 08

1.2 Disposal

1.2.1 Old products

Getinge will take back used products or those which are no longer in service. For further informa-

tion, please contact your personal Getinge representative.

Used products or parts thereof may be contaminated. In order to avoid potential infection risks,

the product must be cleaned and disinfected prior to its return/disposal.

The national regulations and disposal regulations must be observed for all disposal measures.

1.2.2 Packaging

The packing materials are made of materials compatible with the environment. The packing ma-

terial may be disposed of by Getinge on request.

1.2.3 Batteries and rechargeable batteries

Rechargeable batteries/batteries can be submitted to your regional disposal system.

ENVIRONMENT

Defective rechargeable batteries must be recycled in accordance with guideline

2006/66/EC.

Defective rechargeable batteries may not be opened, disposed of in household

waste, burned or thrown in water.

Defective rechargeable batteries should be returned to local collection points.

1.2.4 Used electrical devices

Within the European Economic Community

This product is within the scope of the validity of guideline 2012/19/EU (waste electrical and elec-

tronic equipment). This product is not registered for use in private households, it may also not be

disposed of disposal via municipal collection points for waste electrical and electronic equipment.

For further information on legally compliant disposal, please contact the assigned Getinge repres-

entative.

Outside the European Economic Community

When disposing of this product, ensure compliance with the applicable national regulations on

the handling and disposal of used electrical equipment.

Introduction

Basic requirements for medical devices 1

1705.20A0 / 1705.06A0

IFU 1705.20 EN 08 19 / 204

1.3 Basic requirements for medical devices

1.3.1 Use in accordance with the intended purpose

This product is a medical device.

The product may only be operated by persons who have been instructed in the use of the product

by an authorised person.

The product is designed solely for the purpose of human medicine.

The patient may only be placed and positioned under medical supervision.

Rooms used for medical purposes in which the product is used must comply with HD

60364-7-710 or the appropriate national regulations.

The EMC characteristics of this product allow its use in industrial and hospital environments

(CISPR 11, Class A). This product may not provide adequate protection against radio services

when used in a residential environment (which typically requires Class B according to CISPR 11).

If necessary, the user must take corrective measures such as conversion or reorientation of the

product.

The test levels use conform to those used for professional medical equipment.

Interfaces and accessories

Tegris offers standard interfaces for connecting accessories and devices from other manufactur-

ers, if they support the described standards and do not interfere with the performance character-

istics and safety requirements.

Other accessories, combinations of accessories or consumables may only be used if they are de-

signed specifically for the application in question and will not adversely affect either performance

features or safety requirements.

Devices connected to the interfaces must conform to standard IEC 60601-1 or another IEC

device standard.

1.3.2 Applicable standards

The product meets the basic safety and performance requirements in accordance with the local

applicable legal specifications for medical devices.

1.3.3 Intended uses

1.3.3.1 Purpose [TEGRIS BASE IO-BOX (HW2)] (1705.06A0)

The module TEGRIS BASE IO-BOX (HW2) (1705.06A0) can optionally be connected to TEGRIS

BASE PC (HW2), and offers a compatible interface for:

• OR TABLE CONTROL (HW) (1703.71A0) (not available for China)

• OR TABLE CONTROL (HW2) (1705.81A0) (not available for China)

In addition, it offers standard interfaces for use in combination with the TEGRIS BASE SOFT-

WARE (SW2) and compatible modules:

• Audio inputs and outputs

• RS232 interfaces

• GPIO - Relay interface

• Low voltage outputs

• USB ports

• IP network

The [TEGRIS BASE IO-BOX (HW2)] has no explosion protection and is not suitable for use in

AP-M zones prone to explosion.

1Introduction

Basic requirements for medical devices

20 / 204 1705.20A0 / 1705.06A0

IFU 1705.20 EN 08

Intended for the following users:

• Trained specialist medical staff

• Trained technical and administrative specialist personnel (for maintenance and service)

Any further use is not in accordance with the intended use.

The [TEGRIS BASE IO-BOX (HW2)] is not to be used for the following purposes:

• Delivering information for the recognition, diagnosis, monitoring or treatment of physiological

conditions, health conditions, illnesses or congenital deformities

• Connecting incompatible devices or modules

1.3.3.2 Purpose [TEGRIS BASE SOFTWARE (SW2)] (1705.20A0)

The TEGRIS OR integration system is used to distribute audio and video signals within the oper-

ating room. A TEGRIS system consists of a compatible computer, the [TEGRIS BASE SOFT-

WARE (SW2)] (1705.20A0) and a touch monitor user interface.

The [TEGRIS BASE SOFTWARE (SW2)] is the basic application for the OR Integration system. It

has an integrated surgical safety checklist, and supports a structured OR workflow.

The [TEGRIS BASE SOFTWARE (SW2)] requires a compatible computer environment including

an input device for operation.

The [TEGRIS BASE SOFTWARE (SW2)] also offers a software environment and a graphic user

interface to integrate compatible medical device and non-medical device software modules.

The following software modules for controlling medical devices are compatible with the [TEGRIS

BASE SOFTWARE (SW)]:

• OR TABLE CONTROL (SW) (1703.35A0) (not available for China)

• OR LIGHT CONTROL (SW) (1703.38A1) (not available for China)

Additional software modules that have been approved by Maquet can be integrated into the

[TEGRIS BASE SOFTWARE (SW2)].

Intended for the following users:

• Trained specialist medical staff

• Trained technical and administrative specialist personnel (for maintenance and service)

Any further use is not in accordance with the intended use.

The [TEGRIS BASE SOFTWARE (SW2)] is not to be used for the following purposes:

• Delivering information for the recognition, diagnosis, monitoring or treatment of physiological

conditions, health conditions, illnesses or congenital deformities

• As a legally permissible archive for medical records

• Operation of incompatible software

1.3.3.3 Intended use of the [OR TABLE CONTROL] (1703.71A0 / 1703.35A0)

The [OR TABLE CONTROL] module is a separate module that may be optionally integrated into

TEGRIS. The module consists of hardware (1703.71A0, 1705.81A0) and software (1703.35A0).

[OR TABLE CONTROL] enables the integration of the following OR tables:

Operating table IR hand control

MAQUET BETASTAR 1131 (1131.12XX) 1131.91A0 IR transmitter to 1131.12

MAQUET ALPHASTAR 1132 (1132.11XX,

1132.12XX, 1132.13XX, 1132.17XX,

1132.21XX, 1132.22XX)

1132.91C0 IR transmitter

MAQUET ALPHAMAXX 1133 (1133.12XX,

1133.22XX)

1133.91R0 IR transmitter to 1133 Norm/Rev

MAQUET ALPHAMQUET 1150 (1150.01XX,

1150.02XX)

1150.91C0 IR transmitter to 1150 without char-

ger

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Getinge 170520A0 / TEGRIS BASE SOFTWARE (SW2) Operating instructions

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