NIRx NIRSport Operation & User’s Manual

NIRx Medical Technologies LLC 15 Cherry Lane Glen Head, NY 11545, USA www.nirx.net Rev. No. 1.0, 08/2012 ...

Page 3/18 Table of Contents 1 General Information..............................................................................................................................5 1.1 Electric Safety ..............................................................................................................................6 1.1 Intended Readership...................................................................................... ...

Page 4/18 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 ...

Page 5/18 1 General Information , Attention, consult accompanying documents. Do not dispose off in household garbage. Contact Manufacturer for proper disposal information. ...

Page 6/18 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 ...

Page 7/18 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 2 Handling and Maintenance 2.1 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. ...

Page 8/18 2.4 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 requi ...

Page 9/18 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 o ...

Page 10/18 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 in ...

Page 11/18 A rectangular 10-pin connector provides four parallel, positive-edge triggered digital TTL input lines. Details about the timing I/O signals can be found in sections 4.4 and 5.3. These inputs are optically isolated from the instrument electronics to enhance electrical safety and signal integrity. 4.3 Optodes and Head Gear A variety of optode placement solutions and head gear is available for NIRSport. An example of a fa ...

Page 12/18 5.1 No Trigger Connections are Present NIRSport runs on internal battery or external power AND the control PC (a) Is medically rated OR (b) is sufficiently isolated from building power by other means (e.g., runs on battery, through a medically rated isolation transformer, or a dedicated medical power supply) (c) a medical grade USB 2.0 isolator is used. In addition, the PC must not be electrically connected to any other ...

Page 13/18 5.3.2 Fiber Optic Probes and LED Illuminators A wide range of fiber optic probes and LED illuminators is available for the NIRSport Series to suit a diverse range of intended user applications. To provide up-to-date information about available products, please inquire with NIRx or one of its authorized vendors. 5.3.3 Probe Holders / Head Gear A wide range of head caps and probe holders is available for the NIRSport Seri ...

Page 14/18 5.4 Disposables Third-party disposables such as spatulas (for parting hair), contact gel, etc. may be used as long as the applicable directives for medical safety (biocompatibility, etc.) are complied with. To assure uncompromised data quality, we strongly advise use of disposables recommended by NIRx. ...

Page 15/18 6 Error Messages and Trouble Shooting Error / Warning / Problem Potential Cause Recommended Action No power to instrument Check if power switch is turned on Check if AC line is properly connected. Power LED does not light up Check fuses and replace if necessary No data connection to PC Reconnect USB cable Status LED does is off or on continuously Try different cable or different port Make sure software and drivers are i ...

Page 16/18 6.1 List of Approved Accessories For a complete list of approved accessories please contact NIRx or one of its authorized distributors directly. ...

Page 17/18 7 NIRSport Technical Specifications Optical Detection No. of Channels .......................................................8 (Parallel Digital Demodulation) Sensitivity ................................................................better 1pW NEP Dynamic Range .......................................................>50dBopt Sensor Type .............................................................Si Photodiode Optical ...

Page 18/18 Optical Safety The device uses low-power NIR LED illumination and falls under Laser Class I (eye safe). Methods of sterilization or disinfection Applied parts (fiber optic probe tips) can be disinfected with diluted isopropyl ('rubbing') alcohol 70%. Fiber optics are NOT suitable for autoclaving. Fiber optics /LED probes and fabric caps are suitable for cold-gas sterilization. Please see also section “Cleaning, steril ...