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I
S
NFRA
CAN
Infrascanner Model
Distribution authorized to the Department of Defense and U.S. DoD contractors only;
Administrative or Operational Use, 13 February 2014. Other U.S. requests shall be
referred to Commander, MARCORSYSCOM (PM CSS), 2200 Lester Street, Quantico,
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 is not operated and maintained in strict compliance with instructions and safety
precautions contained herein, in all supplements hereto and according to all terms of warranty
and sale relevant to this product.
INFRASCAN, INC.
2000
Operator
Manual
VA 22134-6050
DISCLAIMER
VERSION 1
Infrascanner Model 2000 Operator Manual
Page 1 of 41
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Table of Contents
Summary of Contents for InfraScan 2000
- Page 1 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 is not operated and maintained in strict compliance with instructions and safety precautions contained herein, in all supplements hereto and according to all terms of warranty and sale relevant to this product.
- Page 3 NFRA Infrascanner Model 2000 Operator Manual 2015 InfraScan, Inc. All Rights Reserved INFRASCAN, INC. VERSION 1 Page 2 of 41...
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Page 4: Revision Record
NFRA Infrascanner Model 2000 Operator Manual REVISION RECORD CRR Incorporation Approved Issue Rev. Date CRR No. Date Initials 01-09-15 15-001 01-09-15 D. Solt INFRASCAN, INC. -
Page 5: Contact Information
NFRA Infrascanner Model 2000 Operator Manual Contact Information MANUFACTURER InfraScan, Inc. * A ddress: * 3508 Market Street Philadelphia, PA 19104 215.387.6784 ( P hone: support@infrascanner.com * Email: * www.infrascanner.com : : ... -
Page 6: Table Of Contents
NFRA Infrascanner Model 2000 Operator Manual Table of Contents 1.0 System Information ............................... 8 Classification ..............................8 Intended Use / Indications ..........................8 Specifications ............................... 8 1.3.1 Physical Specifications ........................8 1.3.2 Functional Specifications ........................8 1.3.3 Laser Diode Specifications ......................... 8 1.3.4... - Page 7 NFRA Infrascanner Model 2000 Operator Manual 6.0 Cleaning, Inspection, and Preventitive Maintenance ..................35 Cleaning ..............................35 Inspection and Preventive Maintenance ....................35 6.2.1 Sterilization ............................35 Replacement of AA Batteries ........................36 Rechargeable Battery Pack Installation ..................... 37 7.0 Support .................................
- Page 8 Figure 4-2: Absorption of Light by Hemoglobin ......................18 Figure 4-3: Head Locations of NIR Measurement ......................19 Figure 4-4: Infrascanner Head Scanning Sequence ..................... 19 Figure 4-5: Model 2000 Infrascanner ..........................20 Figure 4-6: Model 2000 Cradle ............................21 Figure 5-1: Power Adaptor ............................. 22 Figure 5-2: Cable Connected ............................
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Page 9: System Information
NFRA Infrascanner Model 2000 Operator Manual 1.0 System Information 1.1 Classification. Detection of superficial supratentorial traumatic • Equipment Function: intracranial hematomas Degree of protect against elec. Type BF applied part. • Shock: Supply connection: Internal rechargeable or disposable battery ... -
Page 10: Cradle Power Adapter Specification
NFRA Infrascanner Model 2000 Operator Manual 1.3.4 Cradle Power Adapter Specification: a. GlobTek, Inc. 186 Veterans Dr. Northvale, NJ 07647, 201.784.1000. Model Number: WR9QA1200LCP-N-MED (R). Input voltage: 100-240 volt AC. Input current: < 0.5 Amps. Input frequency: 50-60 Hz. Output: 5 VDC @ 1.2 amps. - Page 11 NFRA Infrascanner Model 2000 Operator Manual CSA Canada and USA Safety Testing IEC60601-1 CSA Canada et vérification de sécurité Américaine IEC60601-1 Type BF equipment -having an applied part with or without an intentional electrical path to the patient ...
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Page 12: Safety Information
NFRA Infrascanner Model 2000 Operator Manual 2.0 Safety Information 2.1 Symbols and Messages. 2.1.1 Cautions, Warnings and Notes. a. This manual contains important messages with symbols labeled NOTE, CAUTION and WARNING. These messages have the following format and meaning: Figure 2.1: Safety Symbols and Messages Used in Manual... -
Page 13: General Warnings
NFRA Infrascanner Model 2000 Operator Manual 2.1.2 General Warnings SYMBOL GENERAL WARNING THE INFRASCANNER CONTAINS A NEAR INFRARED LASER (CLASS 1). DO NOT ALLOW THE LASER LIGHT TO ENTER THE EYES. THE INFRASCANNER IS NOT SUITABLE FOR USE IN THE PRESENCE OF A FLAMMABLE ANESTHETIC MIXTURE WITH AIR ... - Page 14 NFRA Infrascanner Model 2000 Operator Manual THE ACCURACY OF THE INFRASCANNER IN DETECTING SUBARACHNOID HEMORRHAGE HAS NOT BEEN ESTABLISHED. THE INFRASCANNER SAFETY AND EFFECTIVENESS HAS NOT BEEN ESTABLISHED IN A PRE-HOSPITAL SETTING. THE PERFORMANCE OF THE INFRASCANNER HAS NOT BEEN ESTABLISHED FOR THE DETECTION OF HEMATOMAS LESS THAN ...
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Page 15: General Cautions
NFRA Infrascanner Model 2000 Operator Manual FEEL THE MEASUREMENT AREA WITH YOUR FINGERS TO VERIFY THAT THERE IS NOT A SUBCUTANEOUS SCALP INJURY AT THE MEASUREMENT SITE. THIS CONDITION COULD ADVERSELY AFFECT THE RESULTS. 2.1.3 General Cautions. -
Page 16: General Notes
NFRA Infrascanner Model 2000 Operator Manual 2.1.4 General Notes. SYMBOL GENERAL NOTES The Infrascanner should be operated by trained Health Service Support personnel on order of a physician. Any user of the Infrascanner must be trained on the use of the Infrascanner. The ... -
Page 17: System Components
Infrascanner Model 2000 Operator Manual 3.0 System Components The InfraScan Model 2000 Infrascanner is a handheld 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. Items that are included in the system (see Figure 3-1), are: •... -
Page 18: Controls And Indicators
NFRA Infrascanner Model 2000 Operator Manual 3.1 Control and Indicators. 3.1.1 Measure Buttons. Located on the back of the Infrascanner are two blue buttons (see Figure 3-2), depressing and releasing either one of them initiates a measurement. Figure 3-2: Blue Buttons 3.1.2 Software Arrows and Enter Button. -
Page 19: Theory Of Operation
NFRA Infrascanner Model 2000 Operator Manual 4.0 Theory of Operation 4.1 Basic Near Infrared Light Theory. • All biological tissue is, to differing extent, permeable to electromagnetic (EM) radiation of different frequencies and intensities. This can also be considered permeability to photons of different energy levels. -
Page 20: Figure 4-3: Head Locations Of Nir Measurement
NFRA Infrascanner Model 2000 Operator Manual • The frontal sites are on the left and right sides of the forehead, above the frontal sinus. The temporal sites are on the left and right sides of the temporal fossa in front of the top of the ear. -
Page 21: The Infrascanner System
NFRA Infrascanner Model 2000 Operator Manual 4.2 The Infrascanner System. • The Infrascanner includes a safe Class I NIR 808nm diode laser and a silicon detector. The light to and from the laser and detector are optically coupled to the patient’s head through two short disposable light guides. -
Page 22: Figure 4-6: Model 2000 Cradle
NFRA Infrascanner Model 2000 Operator Manual • Audible signals indicate when the measurement is done. A first short beep indicates when the measurement button is pressed and the measurement begins and a second short beep indicates a completed measurement. Four short beeps indicate a time out message. -
Page 23: Operating Procedure
NFRA Infrascanner Model 2000 Operator Manual 5.0 Operating Procedure 5.1 Setting Up the System. • Attach the Cradle Power Adapter to the Cradle (see Figures 5-1 and 5-2), and connect it to the AC Main Power. -
Page 24: To Review The Data
NFRA Infrascanner Model 2000 Operator Manual • If the rechargeable battery pack is installed, after the variable time of blinking, the amber Charge LED will illuminate continuously. If no batteries are installed, after the 10 seconds of blinking amber LED, neither the amber Charge LED nor the orange Fault LED will illuminate. -
Page 25: The Disposable Fiber Optic Shield
NFRA Infrascanner Model 2000 Operator Manual 5.3 The Disposable Fiber Optic Shield. • Attach the Disposable Shield to the Infrascanner as shown in Figure 5-3. Place the fibers over the optical towers and push firmly at the top/back of the disposable, until you feel the disposable snap onto the Infrascanner. -
Page 26: Measurements With The System
NFRA Infrascanner Model 2000 Operator Manual 5.5 Measurements with the System. • Attach a Disposable Fiber Optic Shield to turn on the Infrascanner. • Press the Measure button, see Figure 5-5. The Select Study ID screen appears, (see Figure 5-6). -
Page 27: Figure 5-6: Select Study Id Whindow
NFRA Infrascanner Model 2000 Operator Manual Coupled Mode File Number OK! Waiting Probe Figure 5-6: Select Study ID Window Figure 5-7: Measurement Screen ... -
Page 28: Database And Archive
NFRA Infrascanner Model 2000 Operator Manual • After each successful measurement, the Infrascanner will beep and the blue square indicator will prompt the user to move to the next head location. An error will be indicated by an elongated beep. When an error occurs, look at the screen to read the error message. -
Page 29: To Copy The Files To Your Pc
NFRA Infrascanner Model 2000 Operator Manual 5.6.1 To copy the files to your PC. a. Connect the Cradle’s USB port to the PC’s USB port with the provided cable. b. Place the Infrascanner in the Cradle, taking care to... -
Page 30: Settings
NFRA Infrascanner Model 2000 Operator Manual c. In the list of all the measurements select the required serial number of the measurement and click on “View” button, as shown in Figure 5-13. d. The next screen, the Archived Measurement screen, Figure 5-14, is the same as the Measurement Screen (Figure 5-9) shown at the end of a measurement. -
Page 31: Figure 5-15: Main Screen
NFRA Infrascanner Model 2000 Operator Manual • In the Settings Screen (see Figure 5-16) click on a relevant button. • Use the Left/Right arrows to move between various fields and the Up/down arrows to edit the selected field values. -
Page 32: Troubleshooting
NFRA Infrascanner Model 2000 Operator Manual 5.8 Troubleshooting. Cause Solution Problem: The Infrascanner screen does not turn on when Disposable Fiber Optic Shield is placed on. There are no batteries installed. Install either the rechargeable battery pack or use fresh 4 AA disposable batteries. - Page 33 NFRA Infrascanner Model 2000 Operator Manual Problem: Infrascanner does not communicate with PC. There is dirt on the cradle pins of Ensure that the cradle pins are clean and free of either the Infrascanner or the debris on the Infrascanner and the Cradle.
- Page 34 NFRA Infrascanner Model 2000 Operator Manual Problem: A measurement head location is Red. A possible hematoma. Click on the site of the Red location and repeat the measurement of the pair, up to 3 times, to confirm the findings.
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Page 35: Error Messages
NFRA Infrascanner Model 2000 Operator Manual 5.9 Error Messages. Must be cleared by pressing the GREEN navigation button. Error Message Causes High Signal. Caused by too much ambient light, Infrascanner is especially sensitive to infrared lamps or bright incandescent bulbs. -
Page 36: Cleaning, Inspection, And Preventitive Maintenance
NFRA Infrascanner Model 2000 Operator Manual 6.0 Cleaning, Inspection, and Preventive Maintenance 6.1 Cleaning. Clean the Infrascanner exterior surfaces monthly (or more frequently if necessary) with a damp cloth or sponge. Use alcohol or mild cleaning solutions to remove stains or adhesives that may stick to the surface. -
Page 37: Replacement Of Aa Batteries
NFRA Infrascanner Model 2000 Operator Manual 6.3 Replacement of AA Batteries. Tool Required. ¼” flat blade screwdriver. Procedures. • Use a ¼” flat blade screwdriver to release the battery door latch by turning one half turn counter clockwise. -
Page 38: Rechargeable Battery Pack Installation
NFRA Infrascanner Model 2000 Operator Manual 6.4 Rechargeable Battery Pack Installation. Tool Required. ¼” flat blade screwdriver. Procedures. • Remove the battery door by loosening the screw with a large flat blade screwdriver. o Sometimes the door sticks shut. When this ... -
Page 39: Support
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Model 2000 is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 2000 should assure that it is used in such an environment. Emissions test... -
Page 40: Transport And Storage
NFRA Infrascanner Model 2000 Operator Manual • The Infrascanner has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. -
Page 41: Warranty
8.0 Warranty 8.1 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. ... - Page 42 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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