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InfraScan Infrascanner 2000 Operation Manual

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Infrascanner Model 2000
Operation Manual
DOCUMENT NO. 920012 REV 2
EFFECTIVE 03-14-18
INFRASCAN CONFIDENTIAL
PAGE 1 OF 35

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  • Page 1 Infrascanner Model 2000 Operation Manual DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 1 OF 35...
  • Page 2 DISCLAIMER Neither InfraScan nor any of its worldwide subsidiaries shall be liable in any manner in respect to bodily injury and/or property damage arising from this product or the use thereof if the Infrascanner...
  • Page 3 REVISION RECORD CRR Incorporation Approved Issue Rev. Date CRR No. Date Initials 06-10-15 15-046 06-10-15 D. Solt 01-25-18 18-014 01-25-18 T. Groch 03-14-19 19-025 03-14-19 I. Shipway DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 3 OF 35...
  • Page 4 Symbol Information InfraScan, Inc. 3508 Market Street Philadelphia, PA 19104 Caution, see Operation 215.387.6784, manual. Attention, voir www.infrascanner.com manuel d'utilisation Qarad b.v.b.a. Type BF equipment - Cipalstraat 3 having an applied part with B-2440 Geel or without an intentional Belgium electrical path to the patient.

  • Page 5: Table Of Contents

    Cleaning, Preventive Inspection and Maintenance ..........27 Support..........................29 Infrascanner Model 2000 TECHNICAL Specifications ..........33 Warranty..........................34 Limited Warranty ......................34 Limitation of Warranty ..................... 34 Limitation of Liability ......................35 DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 5 OF 35...
  • Page 6 • The performance of the Infrascanner has not been established for the detection of hematomas less than 3.5 cc in volume or more than 2.5 cm from the brain surface DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 6 OF 35...
  • Page 7 The Infrascanner is indicated for use by Physicians, or under the direction of a physician, who has been trained in the use of the device. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 7 OF 35...

  • Page 8: System Components

    Infrascanner is not charging. Disposable batteries cannot be charged by the Cradle. SYSTEM COMPONENTS The InfraScan Model 2000 Infrascanner is a handheld Near InfraRed (NIR) brain hematoma detector. This manual familiarizes the operator with the Infrascanner operation, the technology of the Infrascanner, and the software used in its operation.

  • Page 9: Theory Of Operation

    By comparing these levels to tissue in a “baseline” state, and using Figure 2-1: Simulated Photon Diffusion Path some basic knowledge about “interesting” DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 9 OF 35...
  • Page 10 = the intensity of reflected light on the normal side, I = the intensity of reflected Where I light on the hematoma side. LEFT SIDE FRONT RIGHT SIDE Figure 2-3: Head locations of NIR measurement DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 10 OF 35...

  • Page 11: The Infrascanner System

    The absolute value of optical density is not relevant, just the relative difference between left and right sides of the head. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 11 OF 35...
  • Page 12 The Cradle is used to charge the rechargeable battery pack, if it is used in the Infrascanner, and to transfer data from the Infrascanner to a Personal Computer (PC) or printer. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 12 OF 35...

  • Page 13: Operating Procedure

    SETTING UP THE SYSTEM Battery Installation. Use a ¼” flat blade screwdriver (or a coin) to release the 3.1.1. battery door latch by turning one half turn counter clockwise. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 13 OF 35...
  • Page 14 10 seconds, (unless the rechargeable battery pack is severely depleted at which point it can blink slowly for several hours). Do not place the Infrascanner into the Cradle with the Disposable Shield installed. If the DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 14 OF 35...
  • Page 15 Caution: Select a new Disposable for each patient. Do not reuse the Disposable Fiber Optic Shields on a different patient. Disposable Shields contact the patient and may be contaminated. The Disposable Shield is Single Patient Use. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 15 OF 35...

  • Page 16: Measurements With The System

    Attach a Disposable Fiber Optic Shield to turn on the Infrascanner. Press the “Measure” button, as shown in Figure 3-6. The indicator in the upper right corner of the screen shows the battery capacity status. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 16 OF 35...
  • Page 17 Mode or Guided Mode. Guided Mode helps the user through the measurement process by displaying tutorial screens (Figure 3-8) and guiding the user to repeat measurements when a potential hematoma is detected. Guided mode is intended DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 17 OF 35...
  • Page 18 Figure 3-9: Measurement sounded. Use your free hand to support patient’s head, Screen by placing it on the contra-lateral side of the measurement. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 18 OF 35...

  • Page 19: Database, Archive, And Printing

    To view archived measurements click on “View” button, as shown in Figure 3-11. In the list of all the measurements select the required serial number of the measurement and click on “View” button, as shown in Figure 3-12. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 19 OF 35...
  • Page 20 (embedded in Windows 7 and above) while the Infrascanner is installed in a Cradle connected via USB to a computer running Windows. Plug the power supply adapter into a power outlet, then plug the other end into the Cradle. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 20 OF 35...
  • Page 21 Move the PC cursor to select the “Connect without setting up your device”. Move the PC cursor to select the “File Management”, then select “Browse the contents of your device” as shown in Figure 3-15. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 21 OF 35...
  • Page 22 Pindex.dat file, the Psettings.dat file, and the HSTrace file(s) in the root directory. This resets the sequential patient ID counter. The Infrascanner will regenerate the necessary files the next time it is turned on. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 22 OF 35...

  • Page 23: Settings

    Click on Save to store the new parameters and Back to return to the main screen. Figure 3-17 Settings Screen Figure 3-18: Date/Time Setup Screen DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 23 OF 35...

  • Page 24: Troubleshooting

    Problem: The Cradle amber Charge indicator does not illuminate when charging. Disposable batteries are installed The Cradle does not charge disposable AA in Infrascanner batteries. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 24 OF 35...
  • Page 25 The optical density algorithm Clear the error message by pressing the green detected a problem with the button and then follow the recommended corrective incoming data. action on the screen. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 25 OF 35...

  • Page 26: Error Messages

    Low Signal – Hair may be trapped under the light guide or light guide might not be making contact with scalp, Repeat the measurement. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 26 OF 35...

  • Page 27: Cleaning, Preventive Inspection And Maintenance

    To change the AA disposable batteries, remove the used disposable batteries per the image below. Ensure that proper polarity is observed when inserting the new batteries. Replace the battery door and engage the latch. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 27 OF 35...
  • Page 28 3. Inspect the battery leads and ascertain that there is no bare wire exposed going into the connector. If there are, discard the battery pack and use disposable batteries, or contact InfraScan to obtain a new battery pack. 4. Plug in the leads from the battery pack to the connector in the battery compartment assuring proper polarity.

  • Page 29: Support

    When disposing of the Infrascanner, or the batteries, ensure that environmental regulations are followed. SUPPORT The Infrascanner 2000 has an expected service life of 7 years and will be supported for 7 years from the date of manufacture. Parts List There are no field serviceable components in the Infrascanner.
  • Page 30 Floors should be wood, concrete or ceramic tile. If floors are synthetic the relative humidity should be a IEC 61000-4-2 +8KV Air +8KV Air least 30%. Passed: Criteria C Not Applicable Not Applicable Not Applicable DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 30 OF 35...
  • Page 31 Maximum output power (W) Separation (m) Separation (m) Separation (m) d=[3.5/v1]P d=[3.5/E1]P d=[7/E1]P 150KHz-80MHz 80-800MHz 800MHz-2.5GHz 0.01 0.11667 0.11667 0.23333 DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 31 OF 35...
  • Page 32 If the operating temperatures have been exceeded during storage or transport, allow the Infrascanner to acclimate to an operating temperature. If the Infrascanner will not be used for 2 weeks, remove the batteries. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 32 OF 35...

  • Page 33: Infrascanner Model 2000 Technical Specifications

    Relative Humidity (non-cond) 0% to 90% 0% to 90% Atmospheric Pressure 70-106 kPa 50-106 kPa Complies with IEC 60601-1 3 Edition, C22.2 No 601.1-M90 and UL Std. No 60601-1. DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 33 OF 35...

  • Page 34: Warranty

    WARRANTY Limited Warranty The Infrascanner 2000 is distributed with a one year (from the date of shipment from the manufacturer) full replacement warranty provided the integrity of the device has not been compromised by the user. This warranty does not apply to: •...

  • Page 35: Limitation Of Liability

    For warranty service or repair, the InfraScan Service Department must be contacted by phone (215.387.6784) or e-mail (service@infrascanner.com). The Service Department will first attempt to resolve the issue by phone or email. If InfraScan determines, at its sole discretion, that the product is in need of repair, InfraScan will provide a returned merchandise authorization (RMA) to return the unit.

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