NIRx NIRSport Manual de usuario
NIRSport™ User Guide
NIRx Medical Technologies LLC
15 Cherry Lane
Glen Head, NY 11545, USA
www.nirx.net
Rev. No. 1.0, 0 /2012
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Table of Contents
1General Information..............................................................................................................................5
1.1 Electric Safety ..............................................................................................................................6
1.1 Intended Readership....................................................................................................................6
1.2 Related Documents......................................................................................................................6
1.3 Problem Reporting Instructions...................................................................................................7
2Handling and Maintenance...................................................................................................................7
2.1 Transport and Storage .................................................................................................................7
2.2 Safe Performance ........................................................................................................................7
2.3 Cleaning, Sterilization, and Disinfection ......................................................................................7
2.4 Routine Maintenance ..................................................................................................................
2.5 Waste Products and Disposal ......................................................................................................
2.6 Operating Environment ...............................................................................................................
2.7 Use of Device...............................................................................................................................
3Functional Description ..........................................................................................................................
4Hardware Description ...........................................................................................................................9
4.1 USB Connection/Powering the Instrument .................................................................................9
4.2 Optical Probes and Trigger Connections....................................................................................10
4.3 Optodes and Head Gear ............................................................................................................11
4.4 Trigger Inputs.............................................................................................................................11
5Electrical Safety Aspects of the Experimental Setup...........................................................................11
5.1 No Trigger Connections are Present..........................................................................................12
5.2 Trigger Signals are connected....................................................................................................12
5.3 Accessories ................................................................................................................................12
5.3.1 Medical Isolation Solutions ...................................................................................................12
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5.3.2 Fiber Optic Probes and LED Illuminators...............................................................................13
5.3.3 Probe Holders / Head Gear ...................................................................................................13
5.3.4 Cables ....................................................................................................................................13
5.4 Disposables................................................................................................................................14
6Error Messages and Trouble Shooting ................................................................................................15
6.1 List of Approved Accessories .....................................................................................................16
7NIRSport Technical Specifications .......................................................................................................17
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1General Information
,
Attention, consult accompanying documents.
Do not dispose off in household garbage. Contact
Manufacturer for proper disposal information.
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1.1 Electric Safety
In order to comply with electric safety standards according to IEC 60601, it is
mandatory that the NIRSport instrument NOT be electrically connected to other
electrical devices that do not conform to IEC 60601. In particular, this regards any
computers used for controlling the NIRSport or to send digital timing signals to its
Trigger Input.
For further details about how to ensure electric safety in an experimental setup, please refer to
section 5.
Do not open the instrument or any part of it.
1.1 Intended Readership
This document is required reading for operators of NIRx NIRS imaging devices of the NIRSport™ 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 NIRSport measurements.
Important notes and warnings are indicated with this symbol throughout the
document.
1. 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
•NILAB (Free MATLAB NIRS topography toolbox) User Manual
•Headgear and optode placement Manuals
WARNING! Modification of the equipment is not permitted.
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1.3 Problem Reporting Instructions
You may use the following ways of contacting NIRx for additional support and bug reports:
E-mail: [email protected]
Web: www.nirx.net/contact
Handling and Maintenance
.1 Transport and Storage
NIRSport devices are wearable 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. The
instrument is furthermore specifically designed to be used in free moving human experiments using
approved carrying solutions.
For storing and for transporting the instrument NIRx recommends dedicated hardcase containers
available from NIRx.
. 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 NIRSport instrument is intended for continuous operation.
.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 0% (non-condensing).
Ambient pressure should be within 700 hPa and 1060 hPa.
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.4 Routine Maintenance
The optical probes (LED sources and active detectors) are delicate electro-optical devices. Any strain,
kinking, pinching, and tight bending especially close to the connector should be avoided since this can
damage the wires. In the case of suspected damage, please contact the manufacturer.
No regular service, calibration, or inspection of the instrument by the user, vendor, manufacturer, is
required for proper operation of the instrument. In order to maintain adequate signal quality, the user is
advised to regularly perform the system check procedures such as a Dark Noise Check (see, NIRStar
Software User Manual) and a static phantom stability measurement.
.5 Waste Products and Disposal
There are no waste products from the equipment
Please contact the manufacturer for help with the disposal of the instrument or its components at the
end of its useful life.
.6 Operating Environment
.7 Use of Device
The NIRx NIRSport Near Infrared Spectroscopy (NIRS) imaging system is intended for non-invasive
transcranial Near-Infrared Spectroscopy (NIRS) of blood perfusion dynamics in the human head. NIRSport
is a research instrument. The instrument and all accessories are to be used for research purposes only.
3Functional Description
NIRSport performs dual-wavelength continuous-wave (CW) near infrared (NIR) diffuse tomographic
measurements on large tissue structures at high (= several Hz) sampling rates. The system facilitates NIR
illumination of multiple target locations in a time-multiplexed, scanning fashion. Using LED emitters at
two distinct wavelengths allows discrimination of the two oxygenation states of tissue hemoglobin. Both
NIRSport
Instruments
are
for indoor use only.
NIRSport instruments are not safe for the use in presence of inflammable
anesthetics. NIRSport instruments are not to be used in an operating room.
The equipment should be operated at a temperature of -10°C to +40°C and at a
relative humidity of 20% to 0% (non-condensing). Ambient pressure should be
within 700 hPa and 1060 hPa.
NIRx products are NOT “medical devices” intended to be used for the purpose of
diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or
prevention of disease, or used as a life support device. Use of NIRx products are
solely for research purposes.
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wavelengths are emitted simultaneously and are distinguished by modulating and demodulating each at
distinct frequencies in the low kHz-range.
The instrument employs parallel readout of multiple optical detector channels, each of which uses
adaptive gain switching to maximize the dynamic measurement range). NIRSport uses innovative active
optical sensors which are placed directly on the skin, and which avoid the use of optical fiber bundles.
The device features four parallel, optically isolated digital input channels (TTL level) for the acquisition of
event trigger signals. The NIRSport instrument is operated through a graphical user interface (GUI) on a
personal computer (PC), to which it is connected by USB 2.0.
To allow time stamping of the measured data for the purpose of event synchronization with concurrent
measurements or experimental protocols, the instrument provides four parallel digital input channels.
Each of these is optically isolated from the rest of the system. Each input is over-voltage protected and
contains a comparator circuit ('Schmitt Trigger') to improve noise immunity. The inputs are TTL/CMOS
compatible and are positive-edge triggered.
4Hardware Description
All functional components of the imager are integrated into one small form-factor enclosure to which
the sensors and control cables are attached. Fig. 1 shows the instrument.
Fig. 1. Left: NIRSport 8x8 imaging system. Center: Front panel with connectors for (1 LED sources; (2 active
detectors; (3 digital timing signals; (4 USB. Right: Rear panel with power supply connector (5 .
4.1 USB Connection/Powering the Instrument
The instrument communicates with the control PC through a USB 2.0 connection. Once connected the
system goes through a startup sequence during which the green status indicator (2) lights up and then
starts to blink. At this point, the data link to the host PC is established.
A green blinking LED in the front panel signifies proper USB connection and
readiness for operation. The green LED will keep blinking all through system
operation until the USB connection is terminated.
A dark or continuously lit green LED signifies connection problems.
1
3
4
1
1
2
3
4
5
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Even with the control LED blinking, all main functions of the instrument are disabled, and the internal
electronics is not powered. Internal power is automatically provided under control of the NIRStar
acquisition software. This is the only means of switching the unit physically on or off, and is transparent
to the operator. This feature serves to prevent undue strain on the hardware and to conserve battery life.
The instrument houses a three-cell Li-Ion rechargeable battery to make its operation independent from
the availability of building power. A fully charged battery provides more than eight hours of continuous
operation.
To charge the battery an external power supply (included with the instrument) has to be plugged into the
power supply connector located on the rear panel (Fig. 1). Whenever the external power supply is
connected, the instrument’s internal supply is immediately switched from battery to external power
operation. Charging of the battery is internally regulated to prevent battery damage and to maximize the
battery lifetime and to avoid memory effects. The battery is protected against over- or undercharging by
the hardware. There are no specific charging guidelines to be followed by the user.
A battery charge monitor is provided through the NIRStar software.
4. Optical Probes and Trigger Connections
The NIRSport imager employs direct electro-optical illumination and detection, i.e both the optical
sources and the detectors are directly attached to the skin so additional optical coupling trough fiber
bundles is avoided.
One eight-channel, dual-wavelength LED illuminator (NIRx LED-POD) connects to the 20-pin ‘source’
connector on the instrument.
One eight-channel active detector probe plugs into the 14-pin ‘Detector’ connector.
Details about the optode cables and their connection to the imager are illustrated in Fig. 2
Fig. 2. Left: Optical probe cables (top: Group of eight LED sources; bottom: eight-channel active
detector). Center: Connection of sources, detectors, and triggers in the instrument front (USB connector
not shown for clarity). Right: NIRSport instrument with source and detector cables connected.
ONLY connect and disconnect optode cables while the instrument is powered OFF,
i.e., the USB is NOT connected OR the control software is NOT RUNNING!
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