NIRx NIRSport User manual

NIRSport APD/LED Module
User Guide
NIRx Medical Technologies LLC
15 Cherry Lane
Glen Head, NY 11545, USA
www.nirx.net
NIRSport APD-LED Module-2014-05-27_R10.docx

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Table of Contents
1 General Information.............................................................................................................................. 4
1.1 Intended Use ............................................................................................................................... 5
1.2 Correct Use .................................................................................................................................. 5
1.3 Electric Safety .............................................................................................................................. 6
1.4 Intended Readership ................................................................................................................... 6
1.5 Related Documents ..................................................................................................................... 6
1.6 Problem Reporting Instructions................................................................................................... 7
2 Handling 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 .................................................................................................................. 8
2.5 Waste Products and Disposal ...................................................................................................... 8
2.6 Operating Environment ............................................................................................................... 8
2.7 Use of Device ............................................................................................................................... 8
3 The NIRSport APD/LED Coupler Module............................................................................................... 9
3.1 Mainframe ................................................................................................................................... 9
3.2 NIRSport Cradle ........................................................................................................................... 9
3.3 Source Coupler ..........................................................................................................................10
3.4 Detector Coupler ....................................................................................................................... 11
4 Operation ............................................................................................................................................ 11
NIRSport APD/LED Coupler Module Technical Specifications.....................................................................13
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1 General 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.
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1.1 Intended Use
The NIRSport NIRS measurement system and its accessories and extensions (in the following also
referred to as, ‘the device’) are not medical devices 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 devices are 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).

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1.3 Electric Safety
Properly ground the instrument.
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 the NIRx NIRSport APD/LED Coupler Module 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 measurements obtained with the NIRx NIRSport APD/LED Coupler Module.
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 NIRSport 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.
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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 nirsLAB 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
2 Handling and Maintenance
2.1 Transport and Storage
NIRSport 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 NIRSport 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%.
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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DO NOT USE ETHANOL OR METHANOL OR ACETONE FOR CLEANING OF THE FIBER-
OPTIC SURFACES. THE FIBERS MUST NOT BE STERILIZED IN AN AUTOCLAVE.
2.4 Routine Maintenance
The fiber optic probes are delicate optical devices. Any strain, kinking, pinching, and tight bending
(bending radius < 2 cm) should be avoided since this can damage the fibers. Before each measurement,
the fibers should be visually inspected for signs of physical damage. In the case of suspected fiber
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.
2.5 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.
2.6 Operating Environment
2.7 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.
NIRScout is a research instrument. The instrument and all accessories are to be used for research
purposes only.
NIRSport Instruments are for indoor use and may be used outdoors if precautions
are taken against undue temperature and humidity exposure.
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 80% (non-condensing). Ambient pressure should be
within 700 hPa and 1060 hPa.
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3 The NIRSport APD/LED Coupler Module
The NIRSport APD/LED coupler module provides an integrated solution to adding optical fiber-based
illumination and detection to NIRSport devices. The module consists of a mainframe (enclosure) with
integrated power supply, a cradle for the NIRSport, illumination unit, and detection unit (Figure 1).
Figure 1: NIRSport APD/LED coupler module and main components: (1) Main frame; (2) NIRSport cradle; (3)
illumination unit; (4) detection unit; (5) NIRSport.
3.1 Mainframe
The Mainframe provides a sturdy, compact, and protected environment for integrating the NIRSport into
fiber-based NIRS setups. It contains a power supply to provide electrical power to the NIRSport and the
detection electronics.
3.2 NIRSport Cradle
The cradle serves to hold the NIRSport firmly in the module, and to connect it to the internal power
supply. Insertion of the NIRSport into the cradle and its installation inside the enclosure is shown in
Figure 2.
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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Figure 2: Installation of the NIRSport with the cradle in the coupler module (For details, see text).
The installation procedure is as follows:
1. From the top, carefully slide the NIRSport into the cradle. Please note the orientation: The
‘Detector’ connector must be on the top, and the ‘Source’ connector on the bottom (Figure 2,
1,2).
2. Carefully slide the cradle with the NIRSport into the plastic rails of the enclosure. The cradle may
meet a resistance from a power connector inside the enclosure, which mates with the power
input in the NIRSport rear panel. If resistance is met, carefully execute slight sideways and
up/down motions of the cradle while exerting moderate pressure to facilitate mating of the
power connector.
3. Once fully seated (front panel of cradle is flush with the detector and source units), tighten the
four jack screws in the corners of the cradle front panel.
4. Connect the detector and source ports of the NIRSport with the neighboring connector on the
detector and source units using the short ribbon cables.
To remove the NIRSport from the module, follow these steps in reverse order.
While installed in the mainframe, and while the mainframe power is turned on the NIRSport will receive
its electrical power through the APD/LED coupler module, and its internal battery will be automatically
charged.
3.3 Source Coupler
The source coupler unit contains LED light sources to convert the electrical energy provided by NIRSport
into NIR light at two wavelengths (760 nm/860 nm standard), which is launched into fiber optic cables.
For each source channel, separate fiber connectors are provided for each wavelength to maximize the
coupling efficiency. Bifurcated fiber optics combine the two wavelengths into a single fiber-optic
illumination point for each source channel (Figure 3, left).
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To connect the fiber optics, carefully insert the ferrule into the threaded connector and finger-tighten
the knurled locking nut. For each source channel connect the two fiber-optic branches with the same
channel number label. It is recommended to start at the bottom (channel no. 8) and proceed toward the
top in descending channel number order as this provides the best physical access to the locking nuts.
Figure 3: Fiber optic connections on the source coupler unit (left) and detector unit (right).
3.4 Detector Coupler
The detector coupling unit contains eight fiber-coupled photoelectric sensors. High-sensitivity avalanche
photo diode (APD) type sensors are used to compensate for optical losses that may occur especially in
long (> 5m) fiber optic transmission lines. Connecting the detection fibers to the detector ports is
performed in the same way as described above for the sources (Figure 3, right).
4 Operation
To operate the NIRSport with the APD/LED coupler module make sure the system is prepared according
to the description in Section 3 and connected to a wall outlet, then proceed as follows:
1. Provide a USB connection between the host PC and the NIRSport front panel USB connector. The
USB status light will blink. Connect a trigger cable to the NIRSport front panel trigger connector if
desired.
2. Turn on the APD/LED module (switch is located in the back of the unit).
3. Proceed with the cap setup and other experimental preparation as usual.
4. Use the NIRStar software to operate the NIRSport as usual.
5. After use, turn off the mainframe.
Remember to switch on the APD/LED coupler before using the device and to turn it
off after use.

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NIRSport APD/LED Coupler Module Technical Specifications
Optical Illumination
No. of illumination Sources ..................................... 16 light emitting diodes (LED)
No. of illumination channels.................................... 8 at 2 wavelengths
Wavelengths ........................................................... 760 nm, 850 nm standard, others on request
Power ...................................................................... 10 mW / Wavelength max.
Connectors............................................................... SMA 905 fiber optic connector
Multiplexing Rate .................................................... 62.5 Hz ÷(No. of Sources)
Optical Detection
No. of Channels ....................................................... 8
Sensitivity ................................................................ better 0.1pW NEP
Dynamic Range ....................................................... 50dBopt
Sensor Type ............................................................. Avalanche Si Photodiode
Physical
Size (W L H) ....................................................... 257 mm × 326 mm × 165 mm
Weight ..................................................................... 3 Kg
Electrical
Supply Voltage ........................................................ 90-260 VAC (50-60Hz)
Power consumption................................................. 60 W max
Phases ..................................................................... 1
Environmental
Temperature range ................................................. 10°C to 40°C (operating)
-15°C to +70°C (storage and transport)
Humidity...................................................................20 to 80% relative humidity non-condensing
Ambient pressure.....................................................700 hPa to 1060 hPa