InfraScan 2000 Manual de usuario

INFRASCAN Infrascanner Model 2000 Operator Manual

INFRASCAN, INC. VERSION 1 Page 1 of 41



Infrascanner Model

2000



Operator

Manual



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,

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, in all supplements hereto and according to all terms of warranty

and sale relevant to this product.



INFRASCAN Infrascanner Model 2000 Operator Manual

INFRASCAN, INC. VERSION 1 Page 2 of 41

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

INFRASCAN Infrascanner Model 2000 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: [email protected]





Website: www.infrascanner.com

INFRASCAN Infrascanner Model 2000 Operator Manual

INFRASCAN, INC. VERSION 1 Page 5 of 41

Table of Contents

1.0 System Information ...............................................................................................................................................8

1.1 Classification ................................................................................................................................................ 8

1.2 Intended Use / Indications............................................................................................................................ 8

1.3 Specifications ............................................................................................................................................... 8

1.3.1 Physical Specifications.......................................................................................................................8

1.3.2 Functional Specifications.................................................................................................................... 8

1.3.3 Laser Diode Specifications................................................................................................................. 8

1.3.4 Cradle Power Adapter Specification................................................................................................... 9

1.3.5 Operational Limits............................................................................................................................... 9

1.4 Regulatory Compliance................................................................................................................................ 9

2.0 Safety Information ............................................................................................................................................... 11

2.1 Symbols and Messages ............................................................................................................................. 11

2.1.1 Cautions, Warnings and Notes.........................................................................................................11

2.1.2 General Warnings............................................................................................................................. 12

2.1.3 General Cautions..............................................................................................................................14

2.1.4 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 Review the Data.................................................................................................................................... 23

5.2.1 Minimum PC Computer Requirements............................................................................................. 23

5.3 The Disposable Fiber Optic Shield............................................................................................................. 24

5.4 Software Navigation ...................................................................................................................................24

5.5 Measurements With the System ................................................................................................................25

5.6 Database and Archive................................................................................................................................ 27

5.6.1To copy the Files to Your PC............................................................................................................28

5.6.2 To View Archived Measurements on the Infrascanner.....................................................................28

5.7 Settings ...................................................................................................................................................... 29

5.8 Troubleshooting .........................................................................................................................................31

5.9 Error Messages..........................................................................................................................................34

INFRASCAN 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

INFRASCAN Infrascanner Model 2000 Operator Manual

INFRASCAN, INC. VERSION 1 Page 7 of 41

Table of Figures

Figure 1-1: Regulatory Compliance Symbols .................................................................................................................. 9

Figure 2-1: Safety Symbols and Messages used in Manual ......................................................................................... 11

Figure 3-1: Transport Case with System Components.................................................................................................. 16

Figure 3-2: Measurement Button................................................................................................................................... 17

Figure 3-3: Control Buttons............................................................................................................................................ 17

Figure 3-4: Cradle Connectors ..................................................................................................................................... 17

Figure 3-5: Cradle LED On and Off ............................................................................................................................... 17

Figure 4-1 :Simulated Photon Diffusion Path................................................................................................................. 18

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......................................................................................................................................... 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 with Results.............................................................................................................. 27

Figure 5-10: Mobile Device Center................................................................................................................................ 28

Figure 5-11: Active Sync View....................................................................................................................................... 28

Figure 5-12: Archive Screen.......................................................................................................................................... 29

Figure 5-13: List of Measurements................................................................................................................................ 29

Figure 5-14: Archived Measurement ............................................................................................................................. 29

Figure 5-15: Main Screen .............................................................................................................................................. 30

Figure 5-16: Settings Screen......................................................................................................................................... 30

Figure 5-17: Date/Time Setup Screen........................................................................................................................... 30

Figure 5-18: Screen Brightness..................................................................................................................................... 30

Figure 5-19: Battery Status............................................................................................................................................ 30

Figure 6-1: Battery Compartment .................................................................................................................................. 36

Figure 6-2: Battary Pack Installation.............................................................................................................................. 36

INFRASCAN Infrascanner Model 2000 Operator Manual

INFRASCAN, INC. VERSION 1 Page 8 of 41

1.0 System Information

1.1 Classification.

1.2 Intended Use / Indications.



The Infrascanner is indicated for the detection of traumatic supratentorial hematomas of

greater than 3.5 mL in volume that are less than 2.5 cm from the brain surface, as an

adjunctive device to the clinical evaluation in the acute hospital setting of patients 18 years

old or greater with suspected traumatic supratentorial intracranial hematoma. The device is

indicated to assess patients for Computed Tomography (CT) Scans but should not serve

as a substitute for these scans. 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.



1.3 Specifications.



1.3.1 Physical Specifications:

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 disposable

batteries.

b. Standby time 2 weeks.

c. Operating time on new fully charged batteries: >60 minutes.

1.3.3 Laser Diode Specifications:

a. Wavelength: 808nm (±3nm).

b. Maximum peak pulsed power: 100 milliwatt.

c. Safety: Class 1 Laser Product.

•

Equipment Function:

Detection of superficial supratentorial traumatic

intracranial hematomas

•

Degree of protect against elec.

Shock:

Type BF applied part.



•Supply connection:

Internal rechargeable or disposable battery

•Cradle Power Adapter:

Medical Grade 5 VDC at >1 Amp 

•Mode of Operation:

Continuous with intermittent loading

•

Degree of mobility:



Handheld

•Laser Classification:

Class 1 Laser Product

INFRASCAN Infrascanner Model 2000 Operator Manual

INFRASCAN, INC. VERSION 1 Page 9 of 41

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.

1.3.5 Operational Limits:



Environmental:

Operational

Storage

Temperature

14°F to 122°F

-40°F to 158°F

Relative Humidity (non-cond)

0% to 90%

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



“Conformite Europeen” Mark 2008



SinglePatientUse

(fordisposableshieldonly)

Usage unique

(seulement pour protecteur

jetable)



 



NOTE: Complies with IEC 60601-1 3rd Edition, C22.2 No 601.1-M90 and

UL Std. No 60601-1.



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