InfraScan 2000 Operator'S Manual Download | Manualshive

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CAN Infrascanner Model 2000 Operator Manual

INFRASCAN, INC. VERSION 1 Page 6 of 41

6.0

Cleaning, Inspection, and Preventitive Maintenance

....................................................................................... 35

6.1

Cleaning ..................................................................................................................................................... 35

6.2

Inspection and Preventive Maintenance .................................................................................................... 35

6.2.1

Sterilization ....................................................................................................................................... 35

6.3

Replacement of AA Batteries ..................................................................................................................... 36

6.4

Rechargeable Battery Pack Installation ..................................................................................................... 37

7.0

Support

................................................................................................................................................................. 38

7.1

Electromagnetic Interference ..................................................................................................................... 38

7.2

Transport and Storage ............................................................................................................................... 39

8.0

Warranty

............................................................................................................................................................... 40

8.1

Limited Warranty ........................................................................................................................................ 40

8.2

Limitation of Warranty ................................................................................................................................ 40

8.2.1

This Limited Warranty does not Apply to Defects or Damage .......................................................... 40

8.2.2

This Limited Warranty is Void if ........................................................................................................ 40

8.3

Limitation of Liability ................................................................................................................................... 40

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Summary of Contents for 2000

Page 1: ... to Commander MARCORSYSCOM PM CSS 2200 Lester Street Quantico VA 22134 6050 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 i...

Page 2: ......

Page 3: ...INFRASCAN Infrascanner Model 2000 Operator Manual INFRASCAN INC VERSION 1 Page 2 of 41 2015 InfraScan Inc All Rights Reserved ...

Page 4: ...INFRASCAN Infrascanner Model 2000 Operator Manual INFRASCAN INC VERSION 1 Page 3 of 41 REVISION RECORD Rev Issue Date CRR No CRR Incorporation Approved Date Initials 1 01 09 15 15 001 01 09 15 D Solt ...

Page 5: ...000 Operator Manual INFRASCAN INC VERSION 1 Page 4 of 41 Contact Information MANUFACTURER Address InfraScan Inc 3508 Market Street Philadelphia PA 19104 Phone 215 387 6784 Email support infrascanner com Website www infrascanner com ...

Page 6: ... 1 4 General Notes 15 2 1 5 Tools 15 3 0 System Components 16 3 1 Controls and Indicators 17 3 1 1 Measure Buttons 17 3 1 2 Software Arrows and Enter Button 17 3 1 3 Power and USB Receptacles 17 3 1 4 Charging LEDs and Cradle ON OFF 17 4 0 Theory of Operation 18 4 1 Basic Near Infrared Light Theory 18 4 2 The Infrascanner System 20 5 0 Operating Procedure 22 5 1 Setting Up the System 22 5 2 To Rev...

Page 7: ...ce 35 6 2 1 Sterilization 35 6 3 Replacement of AA Batteries 36 6 4 Rechargeable Battery Pack Installation 37 7 0 Support 38 7 1 Electromagnetic Interference 38 7 2 Transport and Storage 39 8 0 Warranty 40 8 1 Limited Warranty 40 8 2 Limitation of Warranty 40 8 2 1 This Limited Warranty does not Apply to Defects or Damage 40 8 2 2 This Limited Warranty is Void if 40 8 3 Limitation of Liability 40 ...

Page 8: ...Figure 4 6 Model 2000 Cradle 21 Figure 5 1 Power Adaptor 22 Figure 5 2 Cable Connected 23 Figure 5 3 Attaching the Disposable Fiber Optic Shield 24 Figure 5 4 Software Navigation Buttons of the Infrascanner and their Use 24 Figure 5 5 Main Screen when Battery Low 25 Figure 5 6 Select Study ID Whindow 26 Figure 5 7 Measurement Screen 26 Figure 5 8 Scanning Sequence 26 Figure 5 9 Measurement Screen ...

Page 9: ...tions a Dimensions with Disposable 9 0H x 3 4W x 2 4D inch 23H x 8 5W x 6 1D cm b Dimensions without the Disposable Fiber Optic Shield 9 0H x 3 4W x 1 8D inch 23H x 8 5W x 4 6D cm c Weight of Infrascanner 14oz 400g d Number of detectors 1 e Number of light sources 1 f Light Source Detector Separation 4 cm 1 3 2 Functional Specifications a Power 4 8V Rechargeable NiMH Battery pack 1AH or 4 AA dispo...

Page 10: ...to 122 F 40 F to 158 F b Relative Humidity non cond 0 to 90 0 to 90 c Barometric Pressure 0 7 1 01 BAR 0 5 1 06 BAR 1 4 Regulatory Compliance Regulatory symbols have been added to indicate regulatory compliance These symbols along with a brief description are shown in the following table Figure 1 1 Regulatory Compliance Symbols SYMBOL DESCRIPTION Qarad b v b a Cipalstraat 3 B 2440 Geel Belgium Con...

Page 11: ...caine IEC60601 1 Type BF equipment having an applied part with or without an intentional electrical path to the patient Équipement de type BF partie appliqué avec ou sans chemin conducteur intentionnel vers le patient Attention see Operation Manual for use Attention voir manuel d utilisation Cradle Power Adapter is 5 volts DC Le bloc d alimentation du support est de 5 VDC WEEE ...

Page 12: ...COMPONENT DAMAGE WARNING INDICATES AREAS WHERE INSUFFICIENT KNOWLEDGE OF A GIVEN PROCEDURE IMPROPER HANDLING OR LACK OF ATTENTION COULD RESULT IN PERSONAL INJURY OR LOSS OF LIFE b Read each labeled message carefully and follow its instructions during operation to reduce the risk of system or component damage and or personal injury c Since it is virtually impossible to foresee all of the possible c...

Page 13: ...OF SERIOUS UNDERLYING INTRACRANIAL HEMATOMA IN THE CLINICAL STUDY OF THE DEVICE PATIENTS WERE TO BE SCANNED WITH THE INFRASCANNER WITHIN 30 MINUTES BEFORE OR AFTER A CT SCAN SINCE A TRAUMATIC HEMATOMA MAY EVOLVE RAPIDLY THE INFRASCANNER RESULT IS NOT PREDICTIVE OF THE ABSENCE OF A HEMATOMA WHEN LONGER THAN 30 MINUTES HAVE ELAPSED SINCE THE TEST WAS COMPLETED COMPLETE THE TRAINING AND READ THE ENTI...

Page 14: ...NER RESULT IS BASED ON THE DIFFERENCE IN INFRARED LIGHT ABSORPTION ON HOMOLOGOUS LEFT AND RIGHT REGIONS OF THE SKULL BECAUSE OF THIS 1 The result may be negative in the presence of bilateral hematomas of similar size and location 2 The Infrascanner may only detect the larger of bilateral hematomas in a similar location 3 The performance of Infrascanner may be affected by the presence of blood with...

Page 15: ...IVE MOISTURE MAY DAMAGE THE ELECTRONIC COMPONENTS AND NULLIFY THE WARRANTY ALWAYS USE THE PROVIDED CRADLE MEDICAL POWER ADAPTER FOR CONNECTING TO THE CRADLE ANY OTHER POWER SUPPLY MAY DAMAGE THE CHARGING CIRCUITRY AND OR THE NIMH RECHARGEABLE PACK NEVER STERILIZE THE INFRASCANNER OR THE DISPOSABLE FIBER OPTIC SHIELD OR IT WILL BE DAMAGED THE BATTERY PACK NEEDS TO BE INSTALLED WITH CARE TO ASCERTAI...

Page 16: ...ght haired light skinned subjects because the dark pigment in skin hair and hair follicles is very absorbent of Near Infrared NIR light resulting in a weaker signal for the Infrascanner Read each labeled message carefully and follow its instructions during removal or replacement to reduce the risk of system or component damage and or personal injury 2 1 5 Tool Symbol SYMBOL GENERAL NOTES Tool requ...

Page 17: ...in the system see Figure 3 1 are The Infrascanner Model 2000 The Infrascanner Model 2000 Cradle An Infrascanner Model 2000 Disposable Shield Transport Case The Infrascanner Model 2000 Operation Manual The USB Cable to connect the Cradle with a PC Computer The Cradle Power Adapter 5VDC OPTIONAL Brother RJ4030 K printer not included in kit An Infrascanner Rechargeable Battery Pack NOTE A computer ru...

Page 18: ...ng to a personal computer See Figure 3 4 3 1 4 Charging Light Emitting Diode LED s and Cradle ON OFF switch The blue Cradle ON OFF switch is used to turn ON the Infrascanner while the Infrascanner is in the cradle see Figure 3 5 When the Cradle is connected to the main power a green Power LED will illuminate When the Infrascanner is set in the cradle and being charged an amber LED will illuminate ...

Page 19: ... route to the detector By choosing the wavelengths that are produced by the source it is possible to detect the relative concentration of haemoglobin in the target tissue Figure 4 1 shows the simulated diffusion path through target tissue from source to detector The principle used in identifying intracranial hematomas with the Infrascanner is that extravascular blood absorbs NIR light more than in...

Page 20: ...op of the ear midway between the ear and the occipital protuberance see Figure 4 3 The sites are scanned in a predetermined sequence as shown in Figure 4 4 The difference in optical density OD in the different areas is calculated from the following formula I ΔOD log10 N I H 1 Where IN the intensity of reflected light on the normal side IH the intensity of reflected light on the hematoma side F P P...

Page 21: ...d on the Infrascanner see Figure 4 5 and turned off by removing the Disposable Fiber Optic Shield If the Disposable Fiber Optic Shield is not removed after approximately 8 minutes of inactivity the Infrascanner goes into a sleep mode and starts beeping until the Disposable Fiber Optic Shield is removed Since the Infrascanner is still on this will drain the battery When the Infrascanner is turned o...

Page 22: ...fore proceeding to the next head pair The Infrascanner can be powered either by a rechargeable NiMH battery pack or by 4 disposable AA batteries The Cradle Figure 4 6 is used to charge the rechargeable battery pack if it is used in the Infrascanner to connect to the optional printer and to transfer data from the Infrascanner to a Personal Computer PC LED s and Cradle ON OFF switch Summary of Audio...

Page 23: ... the rechargeable battery pack When the Infrascanner is placed in the Cradle the amber Charge LED will blink for 10 seconds unless the rechargeable battery pack is severely depleted at which point it can blink for longer If the disposable batteries are installed after the 10 seconds of blinking the amber Charge LED and the orange Fault LED will be extinguished If the rechargeable battery pack is i...

Page 24: ...65 MB of available hard disk space actual requirements will vary based on selection of features and user s current system configuration d Available USB port e VGA graphics card or compatible video graphics adapter at 256 color or better f Keyboard g A Mouse or compatible input pointer device h Internet connection is optional If the rechargeable battery pack is installed after the variable time of ...

Page 25: ...til you feel the disposable snap onto the Infrascanner This turns on the Infrascanner Figure 5 3 Attaching the Disposable Fiber Optic Shield 5 4 Software Navigation Use the Left Right arrows to change which button is selected Use the Green central Enter button to execute the selected button in the software Use the Up Down arrows to edit the selected field values See Figure 5 4 Figure 5 4 Software ...

Page 26: ... is de activated but the screen indicates a sequential file number Next Measurement for the patient Record this number in the notes if interested in a later analysis of the patient s data Press the Measure button again to go to the Measurement screen The file number appears in the upper right corner see Figure 5 7 The indicator in the upper right corner of the screen shows the battery capacity sta...

Page 27: ...ra l L e ft P a rie ta l L e ft O c c ip ita l L e ft F ro n ta l R ig h t T e mp o ra l R ig h t P a rie ta l R ig h t O c c ip ita l R ig h t The Infrascanner is ready to begin measuring Take the Infrascanner and start the head scan alternating between left and right positions according to the head scanning sequence in Figure 5 8 The blue square on the screen in Figure 5 9 indicates the current ...

Page 28: ...LP INJURY AT THE MEASUREMENT SITE THIS CONDITION COULD ADVERSELY AFFECT THE RESULTS After completing each data pair review the screen If one of the locations is red touch the right location and repeat the measurement of the pair up to two more times to confirm the findings and reduce the chances of a false alarm due to a trapped hair under the light guides Continue testing until the entire head sc...

Page 29: ...ows Mobile Based Device Drag and drop the HSData folder located on the Storage Card to the PC This folder contains both the data files and the patient database You can also copy individual data files from the HSData folder To make more storage space available for patient data delete the HSData folder the Pindex dat file the Psettings dat file and the HSTrace file s in the root directory This reset...

Page 30: ... forward or backward in the list is to depress the up or down button for 2 seconds Upon release it will page up or page down It will revert to single step after that so if you need to jump another page you need to re press the button for two seconds Figure 5 12 Archive Screen Figure 5 13 List of Measurements Figure 5 14 Archived Measurement 5 7 Settings In the Main Screen Figure 5 15 click on the ...

Page 31: ... Up Down arrows to set the correct year Similarly navigate to the other fields and set the correct date and time Click on Save to store the new parameters and Back to return to the main screen Similarly the Brightness button allows the selection of Night or Day Figure 5 18 The Battery button allows the battery status to be observed Figure 5 19 By navigating to the mv milli volt window and selectin...

Page 32: ...ly restarts when the Disposable Fiber Optic Shield is placed on The battery of the Infrascanner is low Recharge the Infrascanner or use 4 fresh AA disposable batteries Problem The Cradle amber Charge indicator does not illuminate when charging The battery charging temperature range is exceeded The spring loaded cradle pins are dirty or damaged The Infrascanner ON button has been depressed The batt...

Page 33: ...oftware Problem After selecting the Next button to start a measurement there is a communications error message instead of the waiting probe message in the bottom left of the Measurement screen Software error Take off the Disposable Fiber Optic Shield and put it back on to reset the Infrascanner Problem The error tone was heard and there is an error message on the screen The Infrascanner is low out...

Page 34: ...rement Hair is trapped under the light guides Re position the light guides taking care to wiggle through hair and repeat measurement up to 3 times A bad measurement Placement of the light guides is not done in a symmetrical manner on the patient s head Problem The scanner starts beeping More than 8 minutes elapsed from the previous measurement and the Infrascanner went into the Sleep mode Take off...

Page 35: ...nd the amplifiers need to begin the measurement with a lower gain Re take the data of the pair Saturated Start in Reverse Order The Infrascanner has detected a potential hematoma and needs to re take the data in the reverse order right side first to confirm The message always occurs when a hematoma is present on the left side first side of pair to be measured Timeout Infrascanner gains unable to c...

Page 36: ...ONIC COMPONENTS AND NULLIFY THE WARRANTY 6 2 Inspection and Preventive Maintenance Ensure that the windows over the detector and laser are clear of debris No special cleaning solutions are required If necessary wipe with a soft tissue damp with alcohol View through the Disposable Fiber Optic Shield s light guides and verify that there are no obstructions to the light path through them CAUTION ALWA...

Page 37: ...oor latch by turning one half turn counter clockwise To change the AA disposable batteries remove the used disposable batteries per the image to right Replace the battery door and engage the latch see Figure 6 1 Follow the polarity markings on the floor of the battery compartment NOTE Ensure proper polarity is observed when inserting the new batteries and then this should be added to the safety se...

Page 38: ...s possible Insert the battery compressing the two springs on the left side as in the picture and compress the single spring on the right side if necessary The battery pack should sit flush against the top of the compartment Verify that the leads are positioned as indicated in the picture and not pinched or compressed in any way Replace the battery compartment door NOTE Remove the battery if the In...

Page 39: ...cts by a margin of at least 4 dB The Infrascanner complies with the requirements for radiated power in IEC 60601 1 2 making interference to other devices well within the IEC guidelines NOTE The Infrascanner Model 2000 operated satisfactorily during and after exposure to electromagnetic fields and can be considered compliant to the requirements of EN 61000 4 3 Guidance and Manufacturer s Declaratio...

Page 40: ...le that high levels of such interference due to close proximity or strength of a source may result in disruption of performance of this device This Infrascanner is not designed for use in environments in which its operation can be disrupted by electromagnetic interference CAUTION ELECTROMAGNETIC INTERFERENCE CAN DISRUPT INFRASCANNER OPERATION 7 2 Transport and Storage The Infrascanner should alway...

Page 41: ... of InfraScan a Improper use or misuse b Neglect fire flood loss theft c Normal wear and tear d Improper or inadequate maintenance e Unauthorized modifications or repairs f Use of any Infrascanner with unauthorized accessories or consumables g Use or storage outside the Infrascanner specifications 8 2 2 This Limited Warranty is Void if a Any part of the Infrascanner is repaired or opened by a repa...

Page 42: ...will provide a returned merchandise authorization RMA to return the unit The product must be returned to InfraScan or a service facility designated by InfraScan Shipping to the InfraScan service facility will be paid for by the customer Return of the Infrascanner to the customer will be paid for by InfraScan Products must be shipped back in their original shipping containers Once the returned prod...

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