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DOCUMENT NO. 920012 REV 2 EFFECTIVE 03-14-18 INFRASCAN CONFIDENTIAL PAGE 3 OF 35

REVISION RECORD

Rev.

Issue

Date

CRR No.

CRR Incorporation Approved

Date

Initials

0

06-10-15

15-046

06-10-15

D. Solt

1

01-25-18

18-014

01-25-18

T. Groch

2

03-14-19

19-025

03-14-19

I. Shipway

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Summary of Contents for Infrascanner 2000

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

Page 2: ...orldwide 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 CAUTION The Infrascanne...

Page 3: ...IVE 03 14 18 INFRASCAN CONFIDENTIAL PAGE 3 OF 35 REVISION RECORD Rev Issue Date CRR No CRR Incorporation Approved Date Initials 0 06 10 15 15 046 06 10 15 D Solt 1 01 25 18 18 014 01 25 18 T Groch 2 03 14 19 19 025 03 14 19 I Shipway ...

Page 4: ...uipment 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 CE Mark Date of manufacture Attention see Operation Manual for use Attention voir manuel d utilisation Single Patient Use for disposable shield only Usage unique seulement pour protecteur jetable Cradle Power ...

Page 5: ... 0 Operating Procedure 13 3 1 Setting up the System 13 3 2 Measurements with the System 16 3 3 Database Archive and Printing 19 3 4 Settings 23 3 5 Troubleshooting 24 3 6 Error Messages 26 4 0 Cleaning Preventive Inspection and Maintenance 27 5 0 Support 29 6 0 Infrascanner Model 2000 TECHNICAL Specifications 33 7 0 Warranty 34 7 1 Limited Warranty 34 7 2 Limitation of Warranty 34 7 3 Limitation o...

Page 6: ...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 entire Instruction manual before attempting to operate the Infrascanner Only connect the Cradle Power Adapter to the Cradle otherwise hazards may exist The Infrascanner shou...

Page 7: ...scanner may be affected by increased skull thickness o The Infrascanner cannot detect chronic non acute hematomas Do not re use the Disposable Fiber Optic Shield on another patient The Disposable Shield is for single patient use only When the Disposable Shield contacts the patient it is capable of transferring infectious agents The Infrascanner should not be used on patients for whom the use of an...

Page 8: ...e ON OFF switch The blue cradle ON OFF switch is used to turn on the Infrascanner when the Infrascanner is placed in the Cradle instead of using a Disposable Fiber Optic Shield to turn it on When the Infrascanner is being charged in the Cradle an amber LED will illuminate behind the power switch When disposable batteries are used in the Infrascanner the orange Fault LED will illuminate to indicate...

Page 9: ...n scattering characteristics such as x ray Computed Tomography CT and Near InfraRed NIR imaging From the principles of spectroscopy it is also known that different molecules absorb different wavelengths of EM radiation which is synonymously referred to as light at smaller wavelengths Similarly tissue scatters EM radiation to different degrees The Infrascanner is concerned with NIR imaging of the h...

Page 10: ...ntaining a hematoma than on the uninjured side The wavelength of 805nm is sensitive only to blood volume not to oxygen saturation in the blood The Infrascanner is placed successively in the left and right frontal temporal parietal and occipital areas of the head and the absorbance of light at 805 nm is recorded and compared Frontal Left Right forehead above the frontal sinus Temporal In the Left R...

Page 11: ...osable Fiber Optic Shield on the Infrascanner and turned off by removing the Disposable Shield After approximately 10 minutes of inactivity if the shield is not removed the Infrascanner starts beeping until the Disposable Shield is removed When the Infrascanner is in the Measurement screen pressing and releasing one of the Measure Buttons activates a measurement sequence at a given head location W...

Page 12: ...the data is unacceptable the measurement pair is to be repeated before 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 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 Screen Disposabl...

Page 13: ...only When the Disposable Shield contacts the patient it is capable of transferring infectious agents Note The Shield is non sterile and should not be sterilized Note When reusing on same patient the Shield can be cleaned by wiping with a soft tissue damp with alcohol Note Dispose of used Shields in accordance with local ordinances 3 0 OPERATING PROCEDURE 3 1 SETTING UP THE SYSTEM 3 1 1 Battery Ins...

Page 14: ...attery door and use the screwdriver to turn one half turn clockwise You may need to press downwards with the screwdriver while turning to engage the latch 3 1 3 Charging Attach the Cradle Power Adapter to the Cradle and connect it to the AC Power Mains The green Power LED on the Cradle should illuminate Place the Infrascanner in the Cradle taking care to insert the Infrascanner vertically and then...

Page 15: ...s Celsius The Infrascanner detects when disposable batteries are in the Infrascanner and will not charge them There is no hazard under this condition If the orange Fault LED illuminates replace the rechargeable battery pack 3 1 4 Fiber Optic Disposable Shield Press fibers outward so that don t get bent against the windows during installation as shown in Figure 3 3 3 1 5 Attach the Disposable Shiel...

Page 16: ...ed button in the software Use the Up Down arrows to edit the selected field values Figure 3 5 Software Navigation Buttons of the Infrascanner and their use 3 2 MEASUREMENTS WITH THE SYSTEM 1 Attach a Disposable Fiber Optic Shield to turn on the Infrascanner 2 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 Pres...

Page 17: ...tes if you are interested in a later analysis of the data If the Infrascanner clock was reset due to battery depletion or removal a yellow triangle will ask the user to set the Infrascanner real time clock 4 The Select Study ID screen Figure 3 7 allows the user to select Independent Mode or Guided Mode Guided Mode helps the user through the measurement process by displaying tutorial screens Figure...

Page 18: ... the Infrascanner Re initiate the data collection 6 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 2 4 The blue square on the screen in Figure 3 9 indicates the current measurement location 7 In each location wiggle the light guides so they will be in clear con...

Page 19: ...leting each data pair review the screen If one of the locations is red use the arrow keys to navigate to that location and repeat the measurement of the pair up to two more times to confirm the findings and reduce the chances of a false indication due to a trapped hair under the light guides Continue testing until the entire head scan is complete To assist color blind users the red locations have ...

Page 20: ... the data file that you wish to print Then select the Print button It will take about 10 seconds to transfer the data to the printer and print the label Printing is only possible when the Infrascanner is in the Cradle and is connected to power and the optional label printer Downloading Data Files to a Computer To review the stored data follow the steps below 1 All measurements are automatically sa...

Page 21: ...rds pushing the contacts against the spring loaded cradle pins Press the blue ON button on the Cradle to turn on the Infrascanner 6 The Infrascanner automatically turns OFF after 8 minutes so the blue ON button may have to be pressed again 7 After the Infrascanner boots up Windows Mobile Device Center should appear on the PC as shown in Figure 3 14 Figure 3 14 Windows Mobile Device Center 8 Move t...

Page 22: ...older Drag and drop the HSData folder located on the Storage Card to the PC to copy the data files 11 Use a text editor or Excel to view and analyze the data on your PC Figure 3 16 Storage Card Files 12 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 resets the sequential pat...

Page 23: ...gure 3 6 click on Settings button to reach the Settings Screen Figure 3 17 which allows changing some of the different parameters of the Infrascanner Users will not need to access most of the technical parameters of the Infrascanner and they exist for use by technical support personnel Technical parameters can be accessed by selecting the Technical button To change the most common options Date Tim...

Page 24: ... is drained Recharge the Infrascanner or use fresh 4 AA disposable batteries The disposable batteries are inserted incorrectly Ensure that the batteries are installed with the correct polarity as marked on the case Problem The Infrascanner screen flashes or the Infrascanner continuously restarts when the Disposable Fiber Optic Shield is placed on The battery of the Infrascanner is low Recharge the...

Page 25: ...re that the cradle pins are clean and free of debris on the Infrascanner and the Cradle Ensure that the cradle pins press in and extend freely Problem The date resets to an incorrect date The batteries were removed for more than 5 minutes and the clock backup battery was drained Set the date and time in the Settings section of the software Problem After selecting the Next button to start a measure...

Page 26: ...orrupt serial connection Cradle loses sync with the Infrascanner Disconnect and reconnect power to the Cradle Re start the Infrascanner and the printer Make certain that the serial cable is connected to the printer and the Cradle When starting a printing session always feed a label by pressing the advance paper button on the printer Make sure that the printer status LED is not amber orange or blin...

Page 27: ... or mild cleaning solutions to remove stains or adhesives that may stick to the surface DO NOT immerse the Infrascanner in any solution Subjecting the Infrascanner to excessive moisture may damage the electronic components and nullify the warranty Always ensure that the cradle pins are clean of debris in order to communicate properly with the Cradle Preventive Inspection and Maintenance Ensure tha...

Page 28: ... Figure 4 2 Battery compartment with the rechargeable battery pack installed 1 Remove the battery compartment door with a inch straight screwdriver 2 Orient the Infrascanner as shown 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 pac...

Page 29: ...ife 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 The Parts List and additional Operation Manuals are available upon request The Infrascanner can be powered by 4 disposable AA batteries The Infrascanner can also be powered by a 4 8 volt Nickel Metal Hydride rechargeable battery This battery is not ...

Page 30: ...measurement 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 Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Model 2000 must emit electromagnetic energy...

Page 31: ...inity of equipment containing a transmitter a Field strengths from fixed transmitters such as base stations for radios cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered I...

Page 32: ...l installation However because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in healthcare environments for example electrosurgical units cellular phones mobile two way radios electrical appliances and high definition television it is possible that high levels of such interference due to close proximity or strength of a source may result in di...

Page 33: ...ies 2 2 Standby time 2 weeks 2 3 Operating time on new fully charged batteries 60 minutes 2 4 Operating time on new AA batteries 90 minutes 2 5 Hematoma indication ΔOD 0 2 0 02 3 Laser Diode Specifications 3 1 Wavelength 808nm 3nm 3 2 Maximum peak pulsed power 100 milliwatt 3 3 Safety Class 1 Laser Product 4 Cradle Power Adapter Specification GlobTek Inc 186 Veterans Dr Northvale NJ 07647 201 784 ...

Page 34: ...e Operator Manual is not covered under this LIMITED WARRANTY 7 2 1 This LIMITED WARRANTY does not apply to defects or damage to the Infrascanner resulting from as determined solely at the discretion 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 ...

Page 35: ...vice 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 The product must be returned to InfraScan or a service facility designated by InfraScan Shipping to the InfraScan service facilit...

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