NIRx NIRScout Manuale utente

NIRx NIRScout User Manual

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User Manual for

NIRScout™, NIRScoutX™, and

NIRScoutXP™ Systems

NIRx Medical Technologies LLC

15 Cherry Lane

Glen Head, NY 11545, USA

www.nirx.net

Rev. No. 4.1, 08/2015

NIRx NIRScout User Manual

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NIRx NIRScout User Manual

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NOTICE OF INTENDED USE:NIRx NIRS imaging systems are NOT

intended for use as a clinical diagnostic or treatment guidance tool.

Neither the system hardware (NIRSport, NIRScout, NIRScoutX) nor system control

software (NIRStar) has FDA Approval. Use of these resources is for investigational

use only and requires IRB approval prior to performing measures on human

subjects.

Disclaimer

NIRx, NIRScout, NIRScout Extended, NIRScoutX, NIRSport, NIRStar, NIRSlab, NAVI are Trademarks of

NIRx Medical Technologies, LLC.

NIRx products are protected by one or more of the following issued US patents and associated

foreign patents:

6,081,322, 6,662,128, 6,795,195, 6,937,884, 7,046,832, 7,099,519, 7,142,304, 7,471,975,

7,576,853, 7,616,984, 7,617,080, 7,778,693

Any third party trademarks mentioned in this document are the protected property of their rightful

owners.

The content of the manual is the intellectual property of NIRx Medical Technologies, LLC. No part

of the manual may be reproduced or distributed in any form without the express written

permission of NIRx Medical Technologies, LLC.

Subject to change without notice.

NIRx NIRScout User Manual

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NIRx NIRScout User Manual

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Table of Contents

1 General Information.............................................................................................................................. 7

1.1 Intended Use ................................................................................................................................. 8

1.2 Correct Use.................................................................................................................................... 8

1.3 Electric Safety................................................................................................................................ 8

1.4 Intended Readership ..................................................................................................................... 9

1.5 Related Documents....................................................................................................................... 9

1.6 Problem Reporting Instructions .................................................................................................. 10

2 Handling and Maintenance................................................................................................................. 10

2.1 Transport and Storage.................................................................................................................10

2.2 Safe Performance........................................................................................................................ 10

2.3 Cleaning, Sterilization, and Disinfection...................................................................................... 10

2.4 Routine Maintenance.................................................................................................................. 11

2.5 Waste Products and Disposal...................................................................................................... 11

2.6 Operating Environment............................................................................................................... 11

2.7 Use of Device............................................................................................................................... 11

3 Functional Description ........................................................................................................................ 12

4 Hardware Components ....................................................................................................................... 13

4.1 Main Frame .................................................................................................................................13

4.2 USB Controller Card ....................................................................................................................14

4.3 LED Driver Card ...........................................................................................................................15

4.4 Detector Card.............................................................................................................................. 15

4.5 Optical Probes .............................................................................................................................15

4.5.1 Connecting Fiber Optics to the Imager...............................................................................16

4.5.2 Connecting the LED POD Emitters to the Imager................................................................16

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4.6 Optodes and Head Gear.............................................................................................................. 16

4.7 Experimental Setup..................................................................................................................... 17

4.8 Trigger Inputs .............................................................................................................................. 17

4.9 Trigger Output............................................................................................................................. 18

5 Accessories.......................................................................................................................................... 18

5.1 Fiber optic probes and Led illuminators ..................................................................................... 18

5.2 Probe holders / Head Gear..........................................................................................................18

5.3 Cables.......................................................................................................................................... 18

5.4 Disposables .................................................................................................................................19

6 NIRScout Extended (NIRScoutX) Devices ............................................................................................ 20

6.1 Overview .....................................................................................................................................20

6.2 Hardware Components ............................................................................................................... 20

6.2.1 Main Frame .........................................................................................................................20

6.3 USB Connection ..........................................................................................................................20

6.4 LED Driver Card ...........................................................................................................................21

6.5 Detector Card.............................................................................................................................. 21

6.6 Digital I/O Trigger Card................................................................................................................21

6.7 Optical Probes .............................................................................................................................22

7 Accessories.......................................................................................................................................... 22

7.1 Fiber optic probes and Led illuminators ..................................................................................... 22

7.2 Probe holders / Head Gear..........................................................................................................22

7.3 Cables.......................................................................................................................................... 22

8 Error Messages and Trouble Shooting ................................................................................................ 27

8.1 List of Approved Accessories.......................................................................................................28

9 NIRScout / NIRScoutX Technical Specifications................................................................................... 29

NIRx NIRScout User Manual

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1General Information

Attention, consult accompanying documents.

Type BF equipment.

Warning, high voltage.

Protective earth (ground).

Do not dispose off in household garbage. Contact

Manufacturer for proper disposal information.

Mains disconnect OFF.

Mains disconnect ON.

Visible and invisible laser radiation

Device or component sensitive to electrostatic

discharge (ESD)

NIRx NIRScout User Manual

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1.1 Intended Use

The NIRScout/NIRScoutX NIRS measurement system is not a medical device and may be used in the

context of non-medical applications in order to carry out fundamental research on the basis of

neurophysiological methodology and data.

The device is intended to be used for the Quantification of relative concentration changes of oxy- and

deoxy-hemoglobin in tissue blood based on superficial diffuse near-infrared spectroscopic

measurements.

Use of the device for diagnosis, therapy, monitoring of vital life functions (such as

cardiovascular functions etc.) or other medical purposes is expressly forbidden.

The user is solely liable for any risks to test subjects (patients) associated with the investigation if the

device is not used in accordance with the correct use described.

1.2 Correct Use

Application environment

The device is permitted to be used in hospitals, clinics, other medical environments, research

institutes and other environments, provided that all the other stipulations regarding correct use

(e.g. with respect to the user) are met and that the device is used in accordance with its

intended use.

The device is not permitted to be used in the vicinity of explosive gases as may be the case in

operating theaters, for example.

Target group

The device is permitted to be used on healthy and sick adults, children and animals.

Users

The device is permitted to be used by physicians and medical experts.

The device is not permitted to be used by unqualified persons.

The device is not to be used by people who personally cannot read or understand the User

Manual (e.g. due to insufficient language knowledge, due to blindness).

1.3 Electric Safety

Properly ground the instrument.

NIRx NIRScout User Manual

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This instrument is grounded through the power cord. It is a Class 1 device. Use

only the power cord specified for your instrument (see section “Specifications”).

Use only a power cord that is in good condition.

WARNING: To avoid the risk of electric shock, this equipment must only be

connected to a supply mains with protective earth.

Do not operate without covers and panels installed

1.4 Intended Readership

This document is required reading for operators of NIRx NIRS imaging devices of the NIRScout™ product

family in order to avoid instrument misuse potentially leading to hardware malfunctions or data

corruption.

We furthermore recommend this document to any user concerned with the experimental planning or

data analysis of NIRScout measurements.

Important notes and warnings are indicated with this symbol throughout the

document.

1.5 Related Documents

The following user manuals and documents may contain additional information pertinent to the topic

matter of this user manual:

NIRx API Design Document for the real-time data streaming Software Development Kit (SDK)

NIRx NIRStar Software User Manual

NIRx DOTS (Dynamic Optical tissue Simulator) User Manual

NIRx NAVI (Near-Infrared Analysis, Visualization, and Imaging) optical tomography software User

Manual

To avoid personal injury and equipment damage, the user needs to turn off the

mains disconnect before removing covers, panels, or grounding connections.

Reinstall covers, panels, or grounding connections before turning the mains

disconnect back on.

WARNING! Modification of the equipment is not permitted.

NIRx NIRScout User Manual

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NILAB (Free MATLAB NIRS topography toolbox) User Manual

Headgear and optode placement Manuals

1.6 Problem Reporting Instructions

You may use the following ways of contacting NIRx for additional support and bug reports:

E-mail: [email protected]et

Web: www.nirx.net/contact

2Handling and Maintenance

2.1 Transport and Storage

NIRScout devices are mobile instruments and may be moved by the user between different investigation

sites (i.e., labs, exam rooms, etc.) within the institution of the original installation. When storing the

instrument, it should be covered to protect it from dust. NIRx recommends its dedicated hardcase

containers for prolonged storage and transport.

2.2 Safe Performance

The equipment should only be handled and operated by trained personnel. Operators must familiarize

themselves with the latest revision of the user’s manual before using the device.

The NIRScout instruments are intended for continuous operation.

2.3 Cleaning, Sterilization, and Disinfection

The outside of the instrument may be cleaned with a damp cloth. A mild soap or a window cleaner may

be used to aid cleaning; do not use solvents. Allow the instrument to thoroughly dry before use.

The fiber optic probe ends that come in contact with the skin can be cleaned and disinfected by wiping

them after use with isopropyl alcohol 70%.

DO NOT USE ETHANOL OR METHANOL OR ACETONE FOR CLEANING OF THE FIBER-

OPTIC SURFACES. THE FIBERS MUST NOT BE STERILIZED IN AN AUTOCLAVE.

The equipment must not be exposed to fluids or condensation humidity conditions.

During storage or transport, the equipment should be kept at a temperature

between -15°C to +70°C and at a relative humidity of 20% to 80% (non-condensing).

Ambient pressure should be within 700 hPa and 1060 hPa.

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