GE Innova 2100-IQ User manual

GE Healthcare
Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ
Cardiovascular Imaging System
Pre-Installation Manual
OPERATING DOCUMENTATION
5160944-13-1EN
Revision 2

Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
2

Important Information
LANGUAGE
Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
Important Information 3

Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
4 Important Information

Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
Important Information 5

Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
6 Important Information

Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
Important Information 7

Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
8 Important Information

Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
Important Information 9

Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
10 Important Information

Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
Important Information 11

Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
12 Important Information

Revision History
Part/Rev
Date Reason for Change Pages
5160944–1–100 rev 1
November 15, 2005 Initial release of 5160944–1–100. The previous
release of this document was 2347960–4–100.
224
5160944–2–100 rev 1
January 25, 2006 Initial release of 5160944–2–100. The changes
to this document integrate SPR’s EURge38169,
EURge38284 EURge40370, EURge38708,
EURge37673, EURge41938, EURge42555,
EURge41781, EURge41900, EURge29414,
EURge40374, EURge41551, EURge42555, and
EURge39919. The previous release of this docu‐
ment was 5160944–1–100.
226
5160944–3–100 rev 1
March 2, 2006 Initial release of 5160944–3–100. The changes
to this document integrate SPR EURge45185,
EURge46790, and EURge46473. The previous
release of this document was 5160944–2–100.
230
5160944–4–100 rev 1
July 12, 2006 Migration to Sigmalink platform.
Initial release of 5160944–4–100.
The changes to this document integrate
EURge48957, EURge49514, EURge49202,
EURge48960, EURge49457 EURge44751,
EURge37368, EURge51196 and EURge51014
. IVUS option integrated (EURge49970).
The previous release of this document was
5160944–3–100.
244
5160944–5–100 rev 1
October 10, 2006 Initial release of 5160944–5–100.
The changes to this document integrate SPR
EURge55430, EURge56463, EURge58420 and
EURge58503.
The previous release of this document was
5160944–4–100.
246
5160944–6–100 rev 1
January 02, 2006 Initial release of 5160944–6–100.
The changes to this document integrate SPR
EURge63490,and updates to texts and schemat‐
ics for more accuracy.
The previous release of this document was
5160944–5–100.
246
5160944–7–100 rev 1
October 24, 2007 Initial release of 5160944–7–100.
The changes to this document integrate SPR
EURge80492, EURge71850,
EURge72348EURge78791, EURge78830,
EURge81180 and EURge81345.
The previous release of this document was
5160944–6–100.
264
5160944-8-100 rev 1
January 22, 2008 Initial release of 5160944-8-100.
The changes to this document integrate SPRs
EURge60210, EURge 63679, EURge76233,
EURge84207 and EURge76360
The previous release of this document was
5160944-7-100.
264
Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
Revision History 13

5160944–9–1EN rev 1
March 20, 2008 Initial release of 5160944–9–1EN.
The changes to this document integrate SPR
EURge85506, EURge87876, EURge87958,
EURge86094, EURge88018.
The previous release of this document was
5160944–8–100.
266
5160944–10–1EN rev 1
October 13, 2008 Initial release of 5160944–10–1EN. The previous
release of this document was 5160944-9-100.
270
5160944–11–1EN rev 1
March 5, 2009 Initial release of 5160944–11–1EN. The previous
release of this document was 5160944-10-100.
280
5160944-12-1EN rev 1
April 9, 2009 Initial release of 5160944-12-1EN. 296
5160944-13-1EN rev 1
May 7, 2009 Initial release of 5160944-13-1EN. The previous
release of this document was 5160944-12-1EN.
290
5160944-13-1EN rev 2
24 June, 2009 Release of 5160944-13-1EN. The previous re‐
lease of this document was 5160944-13-1EN rev
1.
290
Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
14 Revision History

Table of Contents
CHAPTER 1 INTRODUCTION...............................................................................................................25
1 Object and Scope of this manual..................................................................................................25
2 Responsibilities of the Purchaser/Customer..................................................................................26
3 Pre-Installation Process.................................................................................................................27
CHAPTER 2 INNOVA SYSTEMS..........................................................................................................29
1 Description of Innova System........................................................................................................29
1.1 Description of the Innova LC positioner................................................................................29
1.2 Description of the Innova Patient table.................................................................................29
1.2.1 Innova 2100–IQ Case..................................................................................................29
1.2.2 Innova 3100/3100-IQ and 4100/4100-IQ Case...........................................................29
1.3 Description of the X–Ray generator......................................................................................30
1.4 Description of the X–Ray head.............................................................................................30
1.5 Description of the Innova Imaging System...........................................................................30
1.6 Description of the image monitors suspensions...................................................................31
1.7 Description of the DL and associated devices......................................................................31
1.8 AW workstation.....................................................................................................................32
1.9 TV monitors..........................................................................................................................32
1.10 CENTRICITY CA1000 option.............................................................................................32
1.11 Injectors..............................................................................................................................32
1.12 Fluoro UPS option..............................................................................................................32
1.13 Intravascular Ultrasound (IVUS) Option.............................................................................35
1.13.1 Purpose.....................................................................................................................35
1.13.2 Product Description...................................................................................................35
2 Innova Product Identification.........................................................................................................37
2.1 Innova LC Basic Product......................................................................................................37
2.2 C1 Cabinet............................................................................................................................38
2.3 C2 Cabinet............................................................................................................................38
2.4 Omega Patient Table............................................................................................................39
2.5 InnovaIQ Patient Table.........................................................................................................39
Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
Table of Contents 15

2.6 User Interfaces.....................................................................................................................40
2.7 Fluoro UPS...........................................................................................................................42
2.8 UPS IF Box...........................................................................................................................43
2.9 X–Ray Tube Chiller...............................................................................................................43
2.10 Digital Detector Chillers......................................................................................................44
2.11 Innova User Area................................................................................................................45
2.12 IVUS Option........................................................................................................................46
3 Basic Innova System Compatibility...............................................................................................48
3.1 System Compatibility Cross–Reference – Innova LC Positioner..........................................48
3.2 System Compatibilities Cross–Reference – Tables Sub-System.........................................48
3.3 System Compatibilities Cross–Reference – Jedi X–Ray Generator.....................................48
3.4 System Compatibility Cross–Reference – X–Ray Head.......................................................48
3.5 System Compatibility Cross–Reference – Innova LC Imaging And X–Ray Control..............49
3.6 System Compatibility Cross–Reference – Monitor Support & Suspension...........................49
3.7 System Compatibilities Cross–Reference – 21” (53 CM), 17” (43 CM), 18” & 19”
Monitors...................................................................................................................50
4 Optional Innova System Components...........................................................................................51
4.1 System Compatibilities Cross–Reference – Omega Table Sub–System..............................51
4.2 System Compatibilities Cross–Reference – InnovaIQ Table Sub–System...........................51
4.3 System Compatibilities Cross–Reference – Wall Mount Monitor..........................................51
CHAPTER 3 PHYSICAL REQUIREMENTS OF ROOM........................................................................53
1 Presentation of the 3 Rooms.........................................................................................................53
1.1 Examination room.................................................................................................................53
1.2 Technical room.....................................................................................................................53
1.3 Control room.........................................................................................................................53
2 Environmental Requirements/Limitations......................................................................................54
2.1 Room Climate.......................................................................................................................54
2.2 Equipment Heat Output (Dissipation)...................................................................................56
2.2.1 Equipment Heat Output tables.....................................................................................56
2.2.2 Fluoro UPS Option.......................................................................................................57
2.2.3 IVUS Option.................................................................................................................59
Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
16 Table of Contents

2.2.3.1 Environmental Limitations in Use (room climate)...............................................59
2.2.3.2 Heat Output........................................................................................................59
2.3 Equipment Classifications....................................................................................................59
2.4 IEC60601–1–2 Electromagnetic Standard Compliance & Documentation...........................60
2.4.1 General Scope.............................................................................................................60
2.4.2 Electromagnetic Emission...........................................................................................60
2.4.3 Electromagnetic Immunity...........................................................................................61
2.4.3.1 Electromagnetic Immunity..................................................................................61
2.4.3.2 Electromagnetic Immunity IEC 60601–1–2.........................................................62
2.4.3.3 Recommended Separation Distances for Portable and Mobile RF
Communications Equipment IEC 60601–1–2..............................................63
2.4.4 Limitations Management..............................................................................................63
2.4.5 Use Limitation..............................................................................................................63
2.4.6 Installations Requirements & Environment Control.....................................................64
2.5 Radiation Protection.............................................................................................................65
2.6 Audible noise........................................................................................................................65
2.7 Windows and curtains..........................................................................................................65
3 Structural Requirements................................................................................................................66
3.1 Room Size............................................................................................................................66
3.2 Door Size Requirements......................................................................................................66
3.2.1 Door Height..................................................................................................................66
3.2.2 Door Width...................................................................................................................66
3.3 Floor.....................................................................................................................................66
3.3.1 General Vascular GEMS Policy...................................................................................66
3.3.2 Floor requirements when using provided floor anchors...............................................67
3.3.3 Pan Type Floor Construction Requirement.................................................................68
3.3.4 Hole dimension and preferred location in concrete floor.............................................69
3.3.5 Water Pipe Requirements............................................................................................71
3.3.6 Seismic areas..............................................................................................................74
3.4 Ceiling...................................................................................................................................74
3.4.1 Rail Mounting...............................................................................................................75
Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
Table of Contents 17

3.4.2 Bolt Specifications.......................................................................................................75
3.4.3 Select Rails..................................................................................................................75
3.4.4 Boom Mounted for Monitor Suspension......................................................................75
3.4.5 Cable Support for Monitor Cables...............................................................................77
3.5 Walls.....................................................................................................................................77
3.5.1 General requirement....................................................................................................77
3.5.2 Seismic Areas..............................................................................................................77
4 Functional Requirements...............................................................................................................79
4.1 Electrical Requirements........................................................................................................79
4.2 Room Speaker......................................................................................................................80
4.3 Room Lighting......................................................................................................................81
5 Emergency....................................................................................................................................82
5.1 Main power supply cut..........................................................................................................82
5.2 System failure.......................................................................................................................82
6 Insite/Network Connection.............................................................................................................83
CHAPTER 4 ROOM LAYOUTS.............................................................................................................85
1 Room Layout Considerations........................................................................................................85
1.1 Radiation Protection.............................................................................................................85
1.2 Service Access.....................................................................................................................85
1.3 Clinical Access.....................................................................................................................85
1.4 Peripheral Equipment...........................................................................................................85
1.5 Emergency Stop...................................................................................................................86
1.6 Patient Environment Equipment...........................................................................................86
1.7 Preference Cabinet locations...............................................................................................87
1.8 Layout Constraints................................................................................................................88
2 Room Layout Drawings.................................................................................................................89
2.1 Room layout and room min length........................................................................................90
2.2 Room Layout for Innova System (example 1 & 2- Suspension rails parallel to table)..........92
2.3 Room Layout for Innova System (example 3)......................................................................96
2.4 Room Layout for Innova System (example 4)......................................................................99
Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
18 Table of Contents

2.5 Room Lighting for Innova System......................................................................................102
2.6 Room Layout for Innova System (example with Mobile system 9800)...............................105
3 IVUS Option.................................................................................................................................108
3.1 Functional Diagram............................................................................................................108
CHAPTER 5 PHYSICAL CHARACTERISTICS...................................................................................111
1 Dimension Drawings....................................................................................................................111
2 Mounting Requirements..............................................................................................................139
2.1 Floor Loading and Recommended Mounting Methods.......................................................139
2.2 Positioner and Table Floor Mounting..................................................................................140
2.3 Innova LC Positioner and Omega/InnovaIQ Table Floor Preparation Kits (GEMS
supplied)................................................................................................................151
2.3.1 2285048 - Base Plate Assembly................................................................................153
2.3.2 2360538 – InnovaIQ Table Add–On Kit.....................................................................154
2.3.3 2285050 – Assembly and separation select kit..........................................................155
2.3.3.1 2285051 – Above grade, Floor Anchors without insert.....................................155
2.3.3.2 2285646 – Through bolts without insert............................................................156
2.3.3.3 2286398 – On grade, Floor anchor...................................................................157
2.3.3.4 2285052 – Above grade, Floor anchor with insert............................................158
2.3.3.5 2285053 – Through bolts with insert.................................................................159
2.3.3.6 2285632 – Floor plate / Base plate assembly...................................................160
2.3.4 2285054 – Templates................................................................................................161
2.3.4.1 2285056 - A/C/N Templates.............................................................................161
2.3.4.2 2186109 – EP Template...................................................................................161
2.4 Injector Mounting Requirements ........................................................................................164
CHAPTER 6 ELECTRICAL CONNECTIONS......................................................................................165
1 Power Distribution.......................................................................................................................165
2 Recommended Power Distribution System.................................................................................168
2.1 Main functions....................................................................................................................168
2.2 Typical PDB (Europe CE)...................................................................................................169
2.3 Typical US PDB..................................................................................................................174
Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
Table of Contents 19

2.4 Typical EMI Filter Enclosure...............................................................................................176
3 Grounding....................................................................................................................................178
4 Power and Grounding Requirements..........................................................................................181
4.1 Requirements for ground cables provided by the customer...............................................181
4.2 Requirements for power supply cables provided by the customer.....................................181
4.3 Requirements for all power supply and ground cables provided by the customer.............181
5 IVUS Rev 1 Option......................................................................................................................183
5.1 Wiring Diagram...................................................................................................................183
5.2 IVUS Floor Conduits...........................................................................................................184
5.3 Run Interconnection cables through the Conduit...............................................................185
5.4 Electrical Requirements......................................................................................................186
5.5 Ethernet Network Requirement..........................................................................................186
6 IVUS Rev 2 Option......................................................................................................................187
6.1 Wiring Diagram...................................................................................................................187
6.2 IVUS Floor Conduits...........................................................................................................187
6.3 Run Interconnection cables through the Conduit...............................................................188
6.4 Electrical Requirements......................................................................................................189
6.5 Ethernet Network Requirement..........................................................................................190
7 X-Ray Lamp Room Distribution...................................................................................................191
8 Room Light Distribution...............................................................................................................192
9 Room Speaker.............................................................................................................................193
10 Door Interlocks..........................................................................................................................194
11 Emergency................................................................................................................................195
11.1 Partial UPS Fluoro (option)...............................................................................................195
11.2 Full UPS Record (option)..................................................................................................195
12 Injectors.....................................................................................................................................196
12.1 Remote Injector (rack mount)...........................................................................................196
12.2 Pedestal Injector...............................................................................................................196
12.3 Injector L.F. ILLUMINA.....................................................................................................196
13 Advantage Windows..................................................................................................................197
14 MAC-LAB System EX................................................................................................................198
Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
20 Table of Contents