EGi Geodesic Photogrammetry System User manual

2 GPS 3 User Manual | 8103002-56 • 2018-07-17

The information in this document is subject to change without notice. Electrical

Geodesics, Inc. (EGI) makes no warranty or representation, either express or implied,

with respect to this manual, its quality, accuracy, merchantability, or fitness for a

particular purpose. In no event will Electrical Geodesics be liable for direct, indirect,

special, incidental, or consequential damages resulting from any defect or inaccuracy

in this manual, even if advised of the possibility of such damage.

Electrical Geodesics, Inc. (EGI)

500 E 4th Avenue, Suite 200

Eugene, OR 97401

USA

+1.541.687.7962 (tel)

+1.541.687.7963 (fax)

www.egi.com

supportteam@egi.com

orderdesk@egi.com

European Union (EU)

Authorized Representative

Gerhard Frömel

MPS

Medical Product Service GmbH

Borngasse 20

35619 Braunfels

Germany

011 49 6442 962073 (tel)

011 49 6442 962074 (fax)

g.froemel@mps-gmbh.eu

IMPORTANT NOTICE: The sale of medical devices is strictly regulated by

national laws. Please check EGI's regulatory clearances or contact EGI to get

the current regulatory status of EGI products in your country. This manual is

not an offer to sell a medical device in any country where its sale would be

prohibited by national law.

Geodesic Photogrammetry Systems (GPSs) are CE marked in conformity with

the European Medical Device Directive.

GPS 3 User Manual | 8103002-56 • 2018-07-17 3

Geodesic Photogrammetry

System (GPS)

Sensor Localization System

version 3.1.2

User Manual

4 GPS 3 User Manual | 8103002-56 • 2018-07-17

Key changes in this revision:

• Section 1.1: Revised Intended Use.

• Section 3.2: Added System Requirement for “Silver Dot” GSNs.

• Section 4.1.1: Added information on sensor label types.

• Section 4.3: Updated Exposure control instructions.

GPS 3 User Manual | 8103002-56 • 2018-07-17 5

Contents

Preface 7

1. Safety and Use Conditions 11

1.1 Intended Use 11

1.2 Features 12

1.3 Conditions for Use 13

1.4 Safety Warnings 17

2. GPS Hardware 25

2.1 Components 25

2.1.1 Dome 25

2.1.2 Gantry 27

2.1.3 Calibration Object 28

2.1.4 Computer and Monitor 29

2.1.5 Isolation Transformer 29

2.2 Connections 30

2.3 Raising and Lowering the Dome 32

2.4 Moving the GPS 33

2.4.1 Dome Lowered and Attached 34

2.4.2 Dome Lowered and Rotated 35

2.4.3 Dome Lowered and Removed 38

3. GPS Software 45

3.1 GPS Acquisition and GPS Solver 45

3.2 System Requirements 46

3.3 Software Installation 46

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4. Image Acquisition 47

4.1 Before Capturing Images 47

4.1.1 Imaging Guidelines 47

4.1.2 Positioning the Patient 48

4.2 GPS Acquisition 49

4.2.1 Menu Bar 49

4.2.2 Capture Images Window 49

4.3 Capturing Images 52

5. Sensor Modeling 56

5.1 GPS Solver Menu Bar 56

5.1.1 File > Import or Export 56

5.1.2 File > Reset Solution 57

5.1.3 File > GeoScan Batch Converter 57

5.1.4 Settings > Confirm Identification 59

5.1.5 Calibration > Open Calibration 59

5.2 Solving Sensor Locations 59

5.2.1 Load File 59

5.2.2 Identify Sensors 60

5.2.3 Verify Sensor Placement 62

5.2.4 Adjust Sensors 65

5.2.5 Specify the Fiducials (Nasion, LPA, and RPA) 66

5.2.6 Save 67

6. Data Exporting 68

6.1 Embedding a .xml Export into an MFF Data File 69

Appendix A: GSN Sensor Layouts 72

Appendix B: GPS Calibration 76

Appendix C: Calibration Object Target Layouts 84

Appendix D: EMC Declarations 90

GPS 3 User Manual | 8103002-56 • 2018-07-17 7

Preface

elcome to the Geodesic

Photogrammetry System™ (GPS)

from Electrical Geodesics, Inc. (EGI).

GPSs operate in conjunction with EGI’s

Geodesic EEG Systems™ (GES systems) and

Geodesic Sensor Nets (GSNs) to digitally

register sensor locations for source

estimation, working seamlessly with EGI’s

Net Station and optional GeoSource

software.

A GPS consists of a geodesic dome

structure containing 11 cameras, a

counterbalanced steel gantry, the GPS

Acquisition image capturing software, the GPS Solver sensor modeling

software, and a calibration object.

Different from stylus-based sensor registration methods, with the GPS

you simply position the patient under the dome, take a series of

photographs, and then release the patient. The saved data can be

analyzed when convenient.

NOT ALL SYSTEM OR SOFTWARE FEATURES ARE AVAILABLE FOR PURCHASE

OR USE IN ALL COUNTRIES OR MARKETS.

For all safety and use conditions for using your EGI system, refer to the manuals and

instructions that shipped with your GES system configuration.

W

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About This Manual

This manual provides general information for safely and effectively

using your GPS. It assumes a working proficiency with computer and

EEG systems.

Note that the term patient is used to refer to subjects, participants, or patients.

An EGI support or authorized engineer will install and configure your EGI system,

including all connections required for its operation. At the time of initial

installation, the EGI support or authorized engineer will also train relevant staff in

its operation. At any time you have additional questions or wish retraining, contact

EGI Technical Support (Table P-1).

Typographic conventions:

• Italics are used for definitions or newly introduced terms.

• Boldface italics are used for important concepts or special

emphasis.

• Boldface is used for command paths (for example, File > Open).

Warnings, Cautions, and Notes

The following are used to convey important information:

WARNING: Warnings provide important information that, if

unheeded, could result in serious physical injury, death, or

equipment damage.

CAUTION: Cautions provide important information that, if

unheeded, could hinder the use of a product, feature, or procedure,

or result in physical injury or equipment failure.

Note: Notes provide clarifying information about a product, feature, or procedure.

GPS 3 User Manual | 8103002-56 • 2018-07-17 9

Support, Repairs, and Documentation

Electronic copies of EGI’s user manuals and instructions are provided

under the Training and Technical Support tab of www.egi.com.

If you have a question, please:

• For urgent issues during acquisition, contact EGI immediately.

• For nonurgent issues, do the following before contacting EGI:

– Isolate the problem.

Try to repeat and define the problem.

– Document the problem.

Carefully record the sequential details of the problem.

– Report the defined problem.

Contact EGI.

Table P-1. EGI contact information

EGI Technical Support web page

www.egi.com/support

Email Technical Support

supportteam@egi.com

Email Sales

orderdesk@egi.com

Telephone

+1.541.687.7962

Fax

+1.541.687.7963

Address Electrical Geodesics, Inc. (EGI)

500 E 4th Avenue, Suite 200

Eugene, OR 97401

USA

10 GPS 3 User Manual | 8103002-56 • 2018-07-17

GPS 3 User Manual | 8103002-56 • 2018-07-17 11

1. Safety and Use

Conditions

For all safety and use conditions for using your EGI system, refer to the manuals and

instructions that shipped with your system configuration.

Do not operate your GES system, including the GPS, until you are fully

trained and understand all warnings, cautions, and conditions for use

provided in EGI’s manuals for the components of your system. If you

have any questions, contact EGI Technical Support (Table P-1).

WARNING: All system components must be installed and

configured by an EGI support or authorized engineer. Deviating

from the supported configuration or running the system with non-

EGI-approved components attached can cause hazards or

unexpected performance.

Note that the information in this manual is subject to change, without notice. The

manufacturer declines responsibility for the safety, reliability, and performance of EGI

system components, if not used in compliance with EGI documentation.

1.1 Intended Use

The Geodesic Photogrammetry System (GPS) is intended to record the

precise locations of EEG electrodes in the Geodesic Sensor Net (GSN)

on a patient’s head.

Rx only. For indoor use only.

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1.2 Features

• Simultaneous image capture and saving

• Minimal patient time requirement

• Flexible workflow for technicians

• High accuracy—the 3D photographic technique of the

GPS minimizes human error and environmental

sensitivities inherent in stylus-based methods

• Semi-automated identification of sensors using image

analysis

• Integrated with EEG analysis software

• Not susceptible to electromagnetic interference

• Provides reliable data in electrically noisy environments

• Uses a triangulation algorithm to solve for locations

• Converts GeoScan .txt files from the GeoScan™ handheld

sensor digitization system with the GeoScan Batch

Converter to the .xml, .sfp, .elp, and .nsi file formats

• The GPS system includes:

• a precision geodesic dome of 11 cameras

• a gantry with effortless counterweight movement

• the GPS Acquisition image capturing software

• the GPS Solver sensor modeling software

• a calibration object (includes stand)

• an iMac computer

• an isolation transformer

• assorted cables

• a manual, installation, training, and support

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1.3 Conditions for Use

1.3.1 Environmental Conditions

Table 1-1. Environmental conditions for the transport, use, and storage of the GPS

Shipping temperature 0˚ to 47˚C (32˚ to 116˚F)

Storage temperature -10˚ to 50˚C (14˚ to 122˚F)

Operating temperature 10˚ to 35˚C (50˚ to 95˚F)

Shipping and relative

operating humidity 5% to 95% noncondensing

Shipping altitude 11,500 m (38,000 ft) maximum

Operating altitude 3,000 m (10,000 ft) maximum

1.3.2 Site Requirements

Table 1-2. Site requirements for the location and use of the GPS

Location For indoor use only; in or adjacent to the room

containing the EGI EEG data acquisition system

Area 102 x 150 cm (40 x 59 in.)

Ceiling height 221 cm (87 in.)

Door width 89 cm (35 in.)

Lighting Even and diffuse; no exposed light bulbs; may

need to open or shut curtains or blinds to adjust

natural light

Patient chair Low-backed for clear lines of sight between the

cameras and the Net’s sensors

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1.3.3 System Power

Table 1-3. Nominal power values for the GPS

Monitor only 80 VA

Computer only 150 VA

Dome only 20 VA

Inactive system

(computer, monitor, and dome)

125 VA

Active system

(all components in operation) 250 VA

1.3.4 Contraindications

No contraindications for the use of GPSs are known to exist.

1.3.5 Certifications and Classifications

For all current EGI regulatory certifications, including CE declarations, go to

www.egi.com or contact EGI Technical Support (Table P-1).

This medical equipment is certified to the following:

• CAN/CSA-C22.2 No. 60601-1-08

Medical Electrical Equipment - Part 1: General Requirements

for basic safety and essential performance

• ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD)

3rd Edition Medical electrical equipment, Part 1: General

requirements for basic safety and essential performance

• CAN/CSA C22.2 60601-1-6-07

Medical Electrical Equipment part 1-6: General requirements for

basic safety and essential performance - Collateral Standard:

Usability adopted IEC 60601-1-6 (06) Ed. 2

GPS 3 User Manual | 8103002-56 • 2018-07-17 15

• IEC 60601-1-6:2006

Medical electrical equipment, Part 1-6: General requirements

for basic safety and essential performance - Collateral

standard: Usability

• EN 60601-2-2007 Class A

Medical electrical equipment - Part 1-2: General requirements

for basic safety and essential performance – Collateral

standard: Electromagnetic compatibility - Requirements and

tests<="" 60601-1-2:2007="">

• EN 60601-1-2-26:2002 Class A

Medical electrical equipment. Particular requirements for

safety. Particular requirements for the safety of

electroencephalographs

This medical equipment is classified as follows:

• Applied Part: Type BF

1.3.6 Rating

Table 1-4. Input and output ratings for the GPS

Input 100–240 VAC, 50/60 Hz, 1.8 A, 1.1 A

Output 5 VDC, 7.0 A, 12 VDC, 3.0 A

1.3.7 Interference

It is your responsibility to ensure that your GPS system and its

components are safe and operate properly before using them.

All GPS components have been tested and found to comply with the

electromagnetic compliance limits for the Medical Device Directive

93/42/EEC (EN 60601-1-2:2007 Class A and JIS T 0601-1-2:2002). See

Appendix D.

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These limits are designed to provide reasonable protection against

harmful interference in a typical medical installation. The equipment

generates radio-frequency energy and, if not installed and used in

accordance with the instructions, may cause interference to other

devices in the vicinity. If this equipment does interfere with other

devices, which can be determined by turning the equipment off and

on, try to correct the interference by one or more of the following

measures:

• Reorient or relocate the receiving device.

• Increase the separation between the equipment.

• Connect the equipment to an outlet on a different circuit than

the one used by the other devices.

• Consult EGI Technical Support (Table P-1).

1.3.8 Symbols

The following symbols are used on GPS components or in this manual.

Table 1-2. Symbols used on GPS components and in this manual

Symbol Description Symbol Description

Imminent hazard

Read product

documentation

(EGI and third-party mfr)

Potential hazard

Precautions presented in

manual

Electrical hazard

European conformity

Tipping hazard

Canadian Standards

Association approval

Crush hazard

Manufacturer

Head hazard

EU authorized

representative

GPS 3 User Manual | 8103002-56 • 2018-07-17 17

Symbol Description Symbol Description

Child hazard

Interference hazard

Type B applied part

(body protected,

patient isolation)

Temperature limits

Hard power on/off

Humidity limits

Soft power on/off

Functional earth terminal

1.4 Safety Warnings

1.4.1 General Safety Warnings

WARNING:

• Always connect all GPS components to the isolation transformer.

Never connect components directly to mains electricity supply, which

may result in physical injury or equipment damage.

• Never deviate from supported configurations and never connect non-

GPS components to the isolation transformer or to other GPS

components. All system components must be installed and configured

by an EGI support or authorized engineer. Deviating from the

supported configurations or running the system with non-GPS

components attached may result in unexpected hazards or

performance due to additional loading or leakage.

• Use only approved equipment. Do not connect the GPS to

unauthorized equipment, as physical injury or equipment damage may

result. The user is responsible for ensuring that a reconfigured GPS

meets all applicable local and national regulations for safety and

performance. See IEC 60601-1.

• Never connect a non-GPS multiple socket outlet (i.e., power strip or

extension cord) to the GPS. Use only those power cables with the GPS

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that came with the GPS. Do not use power cords, extension cords,

adapters, or multiple socket outlets with the GPS that are not approved

by EGI.

• Only connect the GPS to a mains electricity supply with protective

earth to avoid the risk of electrical shock or electrocution.

• Do not obstruct access to any GPS component, including the isolation

transformer, such that it is difficult to access, difficult to operate, or

results in entanglements. As the mains disconnect, the isolation

transformer’s mains disconnect switch must remain accessible.

• Never place the GPS isolation transformer on the floor.

• Certify all accessory equipment according to the relevant IEC

standards. Accessory equipment connected to the digital and analog

ports of the amplifier must be certified according to the respective IEC

standards (e.g., IEC 60950 for data processing equipment and IEC

60601-1 for medical equipment). Furthermore, all configurations shall

comply with the system standard IEC 60601-1-1. Any person who

connects additional equipment to the signal input part or signal output

part configures a medical system, and is therefore responsible for

ensuring that the system complies with the requirements of the system

standard IEC 60601-1-1. If in doubt, consult your EGI support engineer

at supportteam@egi.com or your local sales representative.

• Ensure that the environment is safe. The room where the GPS is used

must comply with all applicable local and national safety requirements.

• Only use the GPS on a flat surface. A flat surface is necessary for all four

locking casters to make contact with the floor in order to securely lock

the GPS to avoid lateral shift.

• Moving parts are a pinch-and-crush hazard. Keep all clothing, hair, and

body parts well away from moving parts to prevent physical injury.

• Keep objects clear of system during adjustment to prevent physical

injury or equipment damage.

• Position the patient and operate the GPS only as described in this

manual.

• Not intended to be used in pediatric patient care areas, unless fitted

with tamper-resistant outlet covers.

• Do not use in flammable gas environments.

• Do not use in oxygen-rich environments.

• Do not immerse or splash electrical equipment. Physical injury or

equipment damage may result. If liquids are spilled on any GPS

electronic component, immediately disconnect it from its power source.

Do not use a GPS that has suffered exposure to liquids until EGI or other

GPS 3 User Manual | 8103002-56 • 2018-07-17 19

qualified personnel certifies that the liquid or liquid residue has not

affected device operation or patient safety.

• Do not use the system if it has been damaged, unless it has been

verified that the system is working correctly.

• Only EGI support or authorized engineers may service this equipment.

Hazardous mains voltage inside. Refer all servicing to your EGI support

or authorized engineer.

1.4.2 Patient Isolation

WARNING:

• Connect the GPS only to the power mains cord supplied with the

protective ground terminal. The presence of ground protection

preserves the patient’s safety, as well as your own. Check that your local

electrical plant can guarantee an efficient grounding. The grounding

reliability of a GPS can be ensured only when used with a hospital-grade

plug.

• Connect all GPS components to the isolation transformer’s outlets.

Never connect the computer or other system components directly to

a wall power socket, because the leakage currents in the computer

can present an electrical hazard to you and the patient.

• Ensure electrode isolation. Prevent contact between the conductive

part of the electrodes and other conductive parts, including the

ground.

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• Maintain patient isolation within patient environment. Never

simultaneously touch the patient and any component outside of the patient

area and never let patients touch any component, other than the Net that is

being worn, inside or outside of the patient area.

1.4.3 Moving Warnings

WARNING: The GPS weighs 100 kg (220 lb.).

• Tipping hazards.

• Use caution when moving the GPS and do not tip the GPS more

than 10 degrees in any direction. Physical injury or equipment

damage may result.

• Only move the GPS:

• By pushing it forward from behind the gantry.

• With the upper gantry and dome (if attached) completely

lowered.

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EGi Geodesic Photogrammetry System User manual

EGi Geodesic Photogrammetry System User manual

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