013 50001-001 spy-elite_operators_manual_rev_e

The SPY Elite
®
System is exclusively distributed in North America by LifeCell Corporation.

Disclaimer and Limitation of Responsibility
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Federal law restricts this device to sale by or on the order of a physician
IMPORTANT: Personnel operating and maintaining the SPY Elite®
Intraoperative
Perfusion Assessment System should receive training and be familiar with all aspects
of operation. To ensure safety, carefully read all instructions prior to use and observe
all “WARNINGS”, “CONTRAINDICATIONS”, “PRECAUTIONS”, “IMPORTANTS”, and
“NOTES”.
The information contained herein is based on the experience and knowledge relating
to the subject matter gained by LifeCell Corporation and Novadaq Technologies Inc.
prior to publication.
No patent license is granted by this information.
LifeCell Corporation and Novadaq®
reserve the right to change this information
without notice, and make no warranty, express or implied, with respect to this
information. LifeCell Corporation and Novadaq®
shall not be liable for any loss or
damage, including consequential or special damages, resulting from any use of this
information, even if loss or damage is caused by LifeCell Corporation or Novadaq’s
negligence or other fault.
IMPORTANT: Please read the NOVADAQ®
SPY Elite®
SYSTEM SOFTWARE LICENSE
AGREEMENT at page 86 before using the SPY Elite®
software program. Using any part
of the software indicates that you accept the terms of the Software End User License
Agreement.
Changes or modifications to this equipment, not expressly
approved by the manufacturer could void the operator’s authority to operate this
equipment.
The SPY Elite®
System is exclusively distributed in North America by LifeCell
Corporation and is manufactured by Novadaq Technologies Inc.

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Contents
About The SPY Elite®
System............................................................................................. 1
Indications for Use ..................................................................................................... 1
Plastic, Micro, and Reconstructive Surgery .............................................................. 1
Gastrointestinal Surgery ......................................................................................... 2
Cardiovascular Surgery........................................................................................... 2
ICG (Indocyanine Green)............................................................................................. 2
Clinical Pharmacology............................................................................................. 2
SPY Elite®
Sterile Drape............................................................................................... 2
About This Operator’s Manual .................................................................................... 3
Safety Information and Warnings ..................................................................................... 4
General...................................................................................................................... 4
ICG ............................................................................................................................ 4
SPY Elite®
Device ........................................................................................................ 7
SPY Elite®
Sterile Drape............................................................................................... 9
Power Hookup and Computer Dedication.................................................................... 9
Operating the System............................................................................................... 10
Handling, Preparation and Administration of ICG for use with SPY Elite®
System.............. 13
Supplies Required..................................................................................................... 13
Dosage information ............................................................................................. 14
General ICG Preparation Instructions......................................................................... 14
Saline Flush Preparation ........................................................................................... 14
Administration via a Central or Peripheral Venous Line............................................... 14
Timing of ICG Administration ................................................................................ 15
Draping the SPY Elite®
Device.......................................................................................... 16
Cleaning the SPY Elite®
Device......................................................................................... 20
Preparation.............................................................................................................. 20
Cleaning Non-sterile Components ............................................................................. 20
Disinfecting Non-sterile Components ........................................................................ 20
Preparation for Storage and Transport...................................................................... 20
Operating the SPY Elite®
Device ...................................................................................... 21
Logging Onto the Device ................................................................................................ 22
Logging On .............................................................................................................. 22
Study Management ........................................................................................................ 24
Initiating a New Study .................................................................................................... 25
Acquiring a New Sequence ....................................................................................... 29

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Selecting the Field of View.................................................................................... 29
Rotating the Acquired Images .............................................................................. 29
Selecting a Frame Rate and Acquisition Duration................................................... 30
Staying in Range .................................................................................................. 30
Commencing Acquisition Buffering ....................................................................... 31
Terminating the Acquisition.................................................................................. 32
The Intensity Trace............................................................................................... 33
Capturing a Colored Still Image of the Operative Field............................................ 34
Closing a Study Makes it Inactive............................................................................... 34
Reviewing an Image Sequence........................................................................................ 35
Entering Information About a Newly Captured Sequence........................................... 35
Editing an Image Sequence....................................................................................... 38
Reviewing a Sequence with Cine ............................................................................... 39
Enhancing the Display of Image Sequences..................................................................... 40
Colorization ............................................................................................................. 40
Viewing Mode .......................................................................................................... 40
Viewing Gain Presets ................................................................................................ 41
Gain Adjustment....................................................................................................... 42
Zoom and Pan.......................................................................................................... 43
Maximizing the Display............................................................................................. 44
Annotating an Image or a Sequence................................................................................ 45
Activating the SPY-Q Analysis Toolkit.............................................................................. 46
Analyzing Sequences in the Acquisition/Review Screen ................................................... 47
Compensating for Baseline Intensity ......................................................................... 47
Fixed Baseline...................................................................................................... 47
Auto Baseline....................................................................................................... 48
No Compensation ................................................................................................ 48
Quantitative Assessment Tools ................................................................................. 49
Contour Lines ...................................................................................................... 49
Labels.................................................................................................................. 51
Absolute Values ................................................................................................... 52
Variables that may impact tissue perfusion assessment ......................................... 54
Procedure Reports ......................................................................................................... 55
Two Kinds of Procedure Report ................................................................................ 55
Producing a Text Report........................................................................................... 55
Locking and Unlocking a Report................................................................................ 58
Producing an Image Report ...................................................................................... 58

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Study Manager Details and Options ................................................................................ 61
Clinical Options in the Study Manager ....................................................................... 63
Study Information................................................................................................ 63
Delete Study ........................................................................................................ 63
Export Study........................................................................................................ 64
Print Study List..................................................................................................... 64
System Usage ...................................................................................................... 64
System Configuration........................................................................................... 65
Archive Management ........................................................................................... 65
About.................................................................................................................. 66
Options on the Acquisition/Review Screen................................................................. 67
Reactivate Study.................................................................................................. 67
Delete Sequence/Snapshot................................................................................... 68
Export Sequence.................................................................................................. 68
Print Snapshot ..................................................................................................... 69
Export Bitmap...................................................................................................... 69
Synchronization ............................................................................................................. 71
Archive Management ..................................................................................................... 72
Configuration Options.................................................................................................... 74
Site-Specific Configuration........................................................................................ 74
Controlling Acquisition Through Imaging Head ............................................................... 75
Power Management....................................................................................................... 76
Circuit Breakers........................................................................................................ 76
Software Limitations...................................................................................................... 77
Appendix 1 Technical Information .................................................................................. 78
Appendix 2 SPY Elite®
System Symbols........................................................................... 80
Appendix 3 SPY Elite®
Device Labels ............................................................................... 83
Appendix 4 Warranty..................................................................................................... 85
Appendix 5 Software License Agreement....................................................................... 86
Index ............................................................................................................................. 91

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About The SPY Elite® System
About The SPY Elite®
System
The SPY Elite®
System is a fluorescence imaging system that allows surgeons to
capture, review, print and archive high-quality fluorescence images of blood flow in
vessels and micro-vessels, tissue and organ perfusion in real-time during the course
of performing a wide variety of surgical procedures.
The positioning of the Imaging Head is controlled by the surgeon. Image capture is
typically accomplished in less than two minutes, and images can be replayed
immediately for review.
The SPY Elite®
System consists of two components:
 SPY Elite®
Device
 SPY Elite®
Kit
Each SPY Elite®
Pack contains six (6) SPY Elite®
Kits for single patient use.
 Each Single-Vial Pack contains six (6) SPY Elite®
Single-Vial Kits, each with one
(1) 25 mg vial of ICG imaging agent, one (1) 10 ml vial of Water for Injection,
and one (1) SPY Elite®
Sterile Drape.
 Each Double-Vial Pack contains six (6) SPY Elite®
Double -Vial Kits, each with
two (2) 25 mg vial of ICG imaging agent, two (2) 10 ml vial of Water for
Injection, and one (1) SPY Elite®
Sterile Drape.
The SPY Elite®
Device must only be used with the SPY Elite®
Kits.
Each SPY Elite®
Pack contains sufficient amount of ICG, Water for Injection and Sterile
Drapes to carry out six (6) procedures. For a detailed description of the SPY Elite®
Pack contents and dosing of ICG based on indications for use and number of images
to be acquired, please refer to the SPY Elite®
Kit Instructions for Use.
Indications for Use
Plastic, Micro, and Reconstructive Surgery
The SPY Elite®
System is an imaging system used in capturing and viewing
fluorescence images for the visual assessment of blood flow as an adjunctive method
for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue
and free flaps used in plastic, micro-, and reconstructive procedures.

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Gastrointestinal Surgery
The SPY Elite®
System is intended to provide fluorescence images for the visual
assessment of blood flow in vessels and related tissue perfusion during
gastrointestinal surgical procedures.
Cardiovascular Surgery
The SPY Elite®
System is intended to provide fluorescent images for the visual
assessment of blood flow in vessels and related tissue perfusion during
cardiovascular surgical procedures.
Examples of cardiovascular applications include confirming blood flow through the
peripheral vasculature and extremities.
ICG (Indocyanine Green)
ICG (Indocyanine Green for Injection, USP) is a sterile, water soluble, tricarbocyanine
dye with a peak spectral absorption at 800 - 810 nm, in blood plasma or blood. ICG
contains not more than 5.0% sodium iodide. The Water for Injection provided with the
ICG is specially prepared to dissolve the ICG.
Before injection of ICG for each patient’s imaging procedure, the ICG must be
reconstituted using the Water for Injection.
Clinical Pharmacology
Following intravenous injection, ICG is rapidly bound to plasma proteins, primarily
lipoproteins with a lesser and variable binding to albumin (2-30% of total).
Simultaneous arterial and venous blood estimations have shown negligible renal,
peripheral, lung, or cerebro-spinal uptake of the dye. ICG is taken up from the plasma
almost exclusively by the hepatic parenchymal cells and is secreted entirely into the
bile. ICG does not undergo significant enterohepatic recirculation. ICG has a normal
biological half-life time of 2.5 – 3.0 minutes.
SPY Elite®
Sterile Drape
The SPY Elite®
Sterile Drape is a custom sterile surgical drape that attaches to the
Imaging Head of the SPY Elite®
Device via a specially designed optical window and
sterile tapes and is designed to maintain sterility of the operating field throughout
the procedure.

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About This Operator’s Manual
This Operator’s Manual contains information on using the SPY Elite®
System. These
icons are used throughout this operator guide:
Note
Notes and recommendations that advise you of important
information.
Important
Alert
Important alert to the operation of the SPY Elite®
Device
Tips Useful tips to assist you in general operation.
Hazard Alert
A warning that advises you that not taking the required
action could result in harm to you or the patient or
damage to the SPY Elite®
Device.
Note: This operator guide assumes you are familiar with the general
operation of a computer.

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Safety Information and Warnings
General
WARNING:
 United States Federal law and European regulations require that this device
be purchased only by a physician or a person acting on behalf of a physician.
 Only operators trained in the use of fluorescence imaging during surgical
procedures should use this device. Novadaq Technologies, Inc. and LifeCell
Corporation cannot be held responsible for any damage or injury that results
from a failure to follow the directions in the operator guide.
 Please ensure that you are entirely familiar with the correct procedures for
operating the instrument before use.
ICG
WARNING:
 Anaphylactic deaths have been reported following ICG injection during
cardiac catheterization.
 ICG is supplied in a single patient use procedure kit along with Water for
Injection. Each kit is intended for use with only one (1) patient. Any prepared
ICG solution remaining after each imaging procedure must be discarded.
Contraindications:
 ICG contains sodium iodide and should be used with caution in patients who
have a history of allergy to iodides or iodinated contrast agents.
 The SPY Elite®
System should not be used during surgical procedures with
patients who are known to be sensitive to iodides or iodinated contrast
agents.

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Adverse Reactions:
 Anaphylactic or urticarial reactions have been reported in patients with or
without history of allergy to iodides. If such reactions occur, immediate
treatment with the appropriate agents (e.g., epinephrine, antihistamines,
and/or corticosteroids) should be administered. Resuscitative measures may
also be required.
Precautions:
 Sterile techniques should be used in handling the ICG imaging agent
solution.
 Once reconstituted, the ICG imaging agent solution must only be used for
one (1) patient and within 6 hours.
 ICG powder may cling to the vial or lump together because it is freeze-dried
in the vials. This is not due to the presence of water; the moisture content is
carefully controlled. The ICG is suitable for use.
 The SPY Elite®
Kit and the outside of the vials are NOT sterile. The contents of
the vials are sterile and must be handled aseptically to maintain the sterile
field during surgery.
 Radioactive iodine uptake studies should not be performed for at least a
week following the use of ICG.
 Pregnancy Category C: Animal Reproduction studies have not been
conducted with ICG. It is not known whether ICG can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity. ICG
should be given to a pregnant woman only if clearly indicated.
 Nursing Mothers: It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when ICG is administered to a nursing woman.
 Only use ICG at indicated doses and concentrations as defined in the SPY
Elite®
Kit Instructions for Use or in this Operator’s Manual.
 Do not use ICG vials that appear to have seals that are compromised in any
way.
 ICG is generally injected through a shared intravenous line with no reported
difficulties or unexpected results to date. However, drug/drug interactions
have not been studied.

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 Only the supplied ICG imaging agent has received regulatory clearance for
use with the SPY Elite®
Imaging System. Users are strongly cautioned
against off-label use of the system with ICG imaging agents from other
sources and any such off-label use is undertaken at the sole responsibility
and risk of the user.

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SPY Elite®
Device
WARNING:
 The SPY Elite®
Device emits visible and invisible laser radiation from the
Imaging Head. Avoid direct eye exposure.

 When the laser emission indicator is illuminated, invisible radiation is emitted
from the laser aperture.
Laser aperture
Laser emission indicator
Laser emission indicator

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 The SPY Elite®
Device must be installed by qualified personnel in accordance
with Novadaq’s instructions.
 There are no user-serviceable components, except for printer consumables.
The keyboard is a detachable part and its installation and repairs are
restricted to qualified service personnel only. Connecting other electrical
equipment to the USB or DVI port designated for the SPY Keyboard may result
in reduced level of safety. For all matters concerning service, repairs and
disposal of the device, please contact LifeCell Customer and Technical
Support.
 Do not use the device if it appears to be defective.
 Do not hang any objects or materials on the articulating arm.
 Do not move the device over a raised threshold.
 Do not attempt to alter the position, bending radius, or attachment of the
fiber optics in the SPY Elite®
device as this may lead to damage to the fiber.
 Use of controls or adjustments, or performance of procedures other than
those specified herein, may result in hazardous radiation exposure. DO NOT
remove or alter cable connections or attempt to remove components (e.g.,
printer, monitor, etc.).
Precautions:
 Move the Imaging Head only by grasping the head.
 Move the mobile cart only by grasping the handles with both hands.
 Stow the Imaging Head in its holder before moving the cart.
 The cart should be moved slowly; otherwise the considerable weight of the
device could make it difficult to stop.
 Keep fingers away from “pinch point” areas at the articulations between the
mobile arm segments.
 Before using the SPY Elite®
Device, verify that the wheels are in the locked
position. Test that this is so by applying force to the handle of the cart to
ensure immobility of the device.
 When in use, do not position the SPY Elite®
Device in any way that blocks
access to the AC wall outlet.

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SPY Elite®
Sterile Drape
WARNING:
 The SPY Elite®
Sterile Drape is supplied sterile and is intended for single use
only. DO NOT RE-STERILIZE OR RE-USE. If a drape becomes compromised
during the protection of the imaging arm, or the imaging procedure, move
the device away from the sterile field, remove the contaminated drape and
replace with a new sterile drape, as per the instructions in this Operator’s
Manual.
Precautions:
 Use only the SPY Elite®
Sterile Drapes.
 The SPY Elite®
Kit and the packaging of the SPY Elite®
Sterile Drape are not
sterile. The drapes are supplied sterile and must be handled aseptically to
maintain the sterile field during surgery.
 Do not use drapes in which the seals on the package appear to be
compromised in any way.
Power Hookup and Computer Dedication
WARNING:
 To power the SPY Elite®
Device, only use the power cord provided with the
device. During a patient surgery, the device must be plugged to an AC wall
outlet marked “hospital only” or “hospital grade”.
 Grounding reliability can only be achieved when this product is connected to
an equivalent receptacle marked “hospital only” or “hospital grade”.
 Do not unplug the SPY Elite®
Device by pulling on the cord.
 Do not use a power cord that shows cracks or abrasion damage.

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 Do not install any additional software on the SPY Elite®
computer. Although
the SPY Elite®
computer uses the Windows™ operating system, it is a
dedicated medical device and must not be used for any other purpose. The
use of this device with any software other than that supplied originally with
the device has not been validated. The manufacturer or distributor cannot be
held responsible for any failures resulting from the use of unauthorized
software.
 Do not have any mains-powered devices connected to the USB port during
clinical procedures. Doing so may affect the leakage current of the SPY Elite®
device. The USB port is only to be used with a portable storage device, e.g.
thumb drive.
 Users must confirm that interconnection of any mains-powered device and
SPY Elite®
via the auxiliary video output (DVI port) must be certified to the
respective IEC standards (i.e. IEC 950 for data processing equipment and IEC
60601-1 for medical equipment) and also complies with the requirements of
the IEC 60601-1-1 system standard. If in doubt, consult the technical services
department or your local representative.
Operating the System
WARNING:
 The SPY Elite®
System is designed to operate with the Imaging Head
positioned 30cm (12 inches) from the patient. Do not make direct contact
between the Imaging Head and the patient.
 In particular, to avoid any risk of fibrillation, ensure that the Imaging Head
does not make direct contact with the patient’s heart.
 Do not simultaneously touch the patient’s heart and any part of the SPY
Elite®
Device.
 Images obtained through the use of the SPY Elite®
System will only provide
qualitative evidence of vascular flow.
 Information obtained through the use of the SPY Elite®
System should be
used in combination with other clinically relevant information when planning
or providing alternative or additional interventions.
 The use of the SPY Elite®
System in carotid surgery adds minimal clinical value
and therefore should only be performed when the benefit exceeds any
patient risk.

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 This device has not been tested in conjunction with high frequency surgical
equipment (e.g., electrocautery) and should not be used with such
equipment.
 The SPY Elite®
System is not suitable for use in the presence of flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
 Do not operate this equipment outside of its operating environment limits.
Doing this may cause the equipment to malfunction. The operating
environment limits are as follows:
 Temperature: 15° C to 30° C
 Relative humidity: 10 to 85% (non-condensing)
 Atmospheric pressure: 94 kPa to 102 kPa (-100 ft to +2000 ft).
 Changes or modifications to this equipment not expressly approved by the
manufacturer could void the product warranty and the operator’s authority
to operate the instrument.
 The SPY Elite®
Device is a precision medical instrument. Protect the
instrument against dust and moisture, and avoid physical shocks and strong
forces.
 Care should be exercised when handling the Imaging Head. Extreme force
should never be applied when positioning the Imaging Head.
Precautions:
 Assessment of tissue perfusion beyond the supply vessel may require the
operator to capture more than one image sequence.
 The SPY Elite®
Device has been tested and found to comply with
international standards for electromagnetic compatibility (EMC). These
limits are designed to provide reasonable protection against harmful
interferences in clinical environments. The device generates radio frequency
energy and should be installed and used in accordance with the instructions
in order to minimize the possibility of interference with other electro-
medical equipment. However, there is no guarantee that interference will
not occur in any particular installation. If turning the device off and on shows
that it does cause harmful interference to other electro-medical equipment,
the user is encouraged to try to correct the interference by:
 Reorienting or relocating the device or the equipment receiving the
interference.
 Increasing the separation between the device and the equipment
receiving the interference.
 Connecting the device to an outlet on a different circuit from the
one to which the other equipment is connected.

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For further information and guidance refer to “SPY Elite®
Guidance and
manufacturer’s declaration – Electromagnetic Compatibility”.

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Handling, Preparation and Administration of ICG for use with SPY Elite® System
Handling, Preparation and Administration of
ICG for use with SPY Elite®
System
The SPY Elite®
Sterile Drape and the ICG are supplied in SPY Elite®
Kits for single patient use,
provided in the SPY Elite®
Pack.
The SPY Elite®
Kit, the packaging of the SPY Elite®
Sterile Drape and the outside of the vials
are NOT sterile.
The SPY Elite®
Sterile Drape and ICG are supplied in single patient use procedure kits. DO
NOT RE-STERILIZE. DO NOT RE-USE.
Note: For more detailed and specific instructions, please refer to the Instructions
for Use provided within the SPY Elite®
Kit.
Supplies Required
Depending on the number of images performed, one (1) or two (2) vials of ICG and one (1) or
two (2) vials of Water for Injection are required for each imaging procedure.
For each imaging sequence, a set of the following supplies are required:
 One (1) 10ml syringe for reconstituting the ICG with the Water for Injection
 One (1) 3ml or 5ml syringe
 One (1) 10 ml syringe for the saline bolus
 Sterile normal saline for injection
Note: Use of a three-way stopcock is recommended to facilitate prompt
administration of the saline flush following injection of the ICG into the infusion
line.
Note: A dedicated line is not required for ICG injection.
There are no known drug/drug interactions with ICG.
Note: The ICG can be reconstituted and prepared for injection either at the
beginning of, or during, the surgery, depending on the preference of the surgical
team, but must be used within 6 hours of preparation.

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Dosage information
For Plastic, Reconstructive and Micro-surgery applications the recommended injection volume
is 2 ml for most imaging sequences, except for images acquired through the patient’s skin, in
which case a 4 ml injection is recommended.
For Gastrointestinal Surgery applications the recommended injection volume is 2ml.
For Cardiovascular Surgery applications the recommended injection volume is 0.5-1ml.
Prescribed dosages are at the medical discretion of the prescribing physician.
The total dose of ICG injected should be kept to below 2 mg/kg.
General ICG Preparation Instructions
The ICG can be reconstituted and prepared for injection either at the beginning of, or during
the surgery, depending on the preference of the surgical team, but must be used within 6
hours of preparation.
1. Draw up the entire 10 ml of Water for Injection into a 10 ml syringe.
2. Remove the flip-off cap on the first ICG vial (25 mg) and inject the Water for Injection
through the stopper into the ICG vial. This yields a 2.5 mg/ml solution of ICG. Shake
the ICG vial gently to mix.
3. Mix the contents of the ICG vial thoroughly and inspect the reconstituted vial for
precipitation. If precipitation is noted, continue to gently shake until all ICG is
dissolved into solution.
4. If precipitation persists, do NOT use the mixture. Discard the reconstituted vial and
prepare a new vial, as described above.
Note: In order to ensure that the reconstituted solution is used within 6
hours from the time of reconstitution, it is recommended that the second
vial of ICG be reconstituted once the first reconstituted solution has been
used up.
Saline Flush Preparation
With an individual 10 ml syringe, withdraw 10 ml of normal saline.
Administration via a Central or Peripheral Venous Line
ICG administration is to be performed via a central or peripheral venous line. Using a three-
way stopcock attached to an injection port on the infusion line, inject the prepared 2.5
mg/ml ICG solution into the central or peripheral line as a tight bolus. Immediately switch

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access on the stopcock to the syringe containing saline and briskly flush the ICG bolus
through the line with 10 ml of sterile saline.
Optimal image quality is achieved when the injection of ICG enters the field of view as a
sharp wave-front. This requires that dilution of the ICG solution be minimized prior to the
bolus entering fast flowing blood (i.e. the central venous system). Attention to the following
principles will help to optimize image quality:
 If the ICG is administered via a fluid infusion line, ensure that flow from the infusion
bag is clamped off prior to injecting the ICG into the line.
 Ensure that the “dead space” between the site of injection of ICG and the entry point
into the blood vessel is sufficient to accommodate the full volume of the ICG
solution. Failure to do so may result in a partial volume of the bolus entering the
blood vessel during injection of the ICG into the line and a smaller than anticipated
volume being administered with the saline flush. This will effectively result in under-
dosing for the image acquisition.
 Promptly push the bolus of ICG with a brisk flush of 10 ml sterile saline. This is
particularly important when peripheral venous access is employed as this will
minimize dilution in slow flowing blood, e.g. in the antecubital vein, prior to the bolus
reaching fast flowing blood in the central circulation.
Timing of ICG Administration
ICG injection must only occur after the Imaging Head is positioned at the correct distance
from the subject and motionless, and there has been coordinated communication between
the operator of the SPY Elite®
Device and the anesthesiologist regarding route and timing of
ICG injection.
The SPY Elite®
System supports acquisition buffering that captures images for a pre-defined
period of time before the operator begins recording. This is provided to better ensure that
the initial few seconds of fluorescence are captured. Image buffering should be started
before or simultaneously when the ICG is administered. With acquisition buffering enabled,
recording should then be started at the first signs of ingress of ICG. For more details, please
refer to Commencing Acquisition Buffering (page 31).
Discard any unused reconstituted ICG after the surgery is complete.

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Draping the SPY Elite® Device
Draping the SPY Elite®
Device
The SPY Elite®
Sterile Drape is supplied in the SPY Elite®
Kits, provided in the SPY Elite®
Pack.
The SPY Elite®
Kit and the packaging of the SPY Elite®
Sterile Drape are NOT sterile.
The SPY Elite®
Sterile Drape is supplied sterile and must be handled aseptically to maintain
the sterile field during surgery.
The SPY Elite®
Sterile Drape is supplied in single patient use procedure kits. DO NOT RE-
STERILIZE. DO NOT RE-USE.
1. The non‐sterile operator orients the mast (the proximal section of the arm) toward
the sterile field, then extends the arm by pulling the Imaging Head away from the
cart and rotates the Imaging Head so that the buttons are facing the floor.
2. The package containing the SPY Elite®
Sterile Drape is removed from the Kit. Using
proper sterile technique, the package containing the sterile drape is opened and
transferred to the sterile operator.

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3. The sterile operator holds the sterile drape by placing both hands inside the folds of
the sterile drape such that the exterior surface of the optical window is facing the
floor.
4. The sterile operator drapes the Imaging Head and positions the optical window, so
that it is approximately aligned with the flange on the Imaging Head. The non‐sterile
operator may assist by holding the Imaging Head stationary at or below chest‐height.
ONLY THE STERILE OPERATOR MAY TOUCH THE EXTERIOR SURFACE OF THE DRAPE.

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5. As the sterile drape is passed over the Imaging Head, the non-sterile operator grasps
the sterile drape by the interior surface and unravels the remainder of the drape over
the yoke and arm. Care should be taken to ensure that the drape is not stretched so
tightly that movement of the Imaging Head or arm is impaired. The sterile operator
attaches the optical window to the Imaging Head by seating the rim of the window
onto the flange of the Imaging Head.

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6. The sterile operator verifies that all degrees of motion of the Imaging Head are
available and not restricted by the sterile drape and that the optical window is
securely seated on the Imaging Head.
7. The sterile operator fastens the ties around the yoke and arm to ensure that the
sterile drape is attached securely. Note the location of the ties in the center of the
yoke and arm sections. (Placing the tie closest to the Imaging Head above the yoke
may restrict movement of the Imaging Head.)

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Cleaning the SPY Elite® Device
Cleaning the SPY Elite®
Device
Preparation
It is recommended that the SPY Elite®
Device be cleaned after each use. Prepare
components for cleaning after surgery using the following procedure:
 Remove and discard the drape.
 Turn off the power to the device.
Failure to power off the device before starting to clean may expose personnel to unsafe
conditions and result in damage to the device.
Cleaning Non-sterile Components
The SPY Elite®
Device, including Imaging Head, arm, monitors and keyboard, is considered
non-sterile and is subject to the following cleaning procedures:
1. Clean all exterior surfaces of these components with a soft cloth moistened with a
mild detergent solution. Remove all residual cleaner from the component surfaces.
2. If the front glass of the imaging head requires cleaning, use a small amount of glass
cleaner and a soft cloth or gauze. Do not use abrasive cleaners or strong solvents.
Do not use caustic or abrasive cleaners that could damage any of the components.
Disinfecting Non-sterile Components
Non-sterile components of the device are classified as “non-critical” under the Spaulding
classification for recommended level of disinfection. Therefore, low-level disinfection will be
sufficient in normal use conditions.
1. Disinfect the exterior surfaces of these components with one of the following:
 70% ethyl or isopropyl alcohol.
 A mild inorganic chlorine solution that is tuberculocidal. For example, 1:50
dilution of bleach containing 5.25% sodium hypochlorite. Refer to the
information provided by the disinfectant manufacturer to ensure proper
selection and preparation of the solution.
2. Dry all component surfaces.
Preparation for Storage and Transport
After cleaning the device, stow the Imaging Head in its receptacle before transporting the
device. Lower the Imaging Head fully into the receptacle, then rotate the arm’s mast as far
away from the head as possible, in order to minimize the height of the arm.

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Operating the SPY Elite® Device
Operating the SPY Elite®
Device
The SPY Elite®
Device has an operator’s touch screen and a keyboard with a glide-pad, a
touch-sensitive pad of about 2″ x 2″ that will track the touch of a finger. This pad acts like a
mouse for pointing, and you can tap quickly on the pad to mimic a click. There are also left
and right buttons that behave as left and right mouse buttons.
This document will refer to “clicking”, “touching” or “selecting” a control but be aware that
this may be done either by touching the control on the touch screen or by moving the cursor
to the control via the glide-pad and tapping rapidly or touching the left button.
Text may be entered via the keyboard. Alternatively, at the time of logging onto the device,
users may enable an on-screen keyboard that allows users to enter text entirely via the
touch screen.
The operator can use the touch screen, keyboard and glide-pad to control the software
through a graphical user interface. In addition, the surgeon has direct control of the
acquisition protocol through buttons located on the imaging head.
Powering On the Device
The power button is beside the keyboard. After pressing the button, the power indicator
will flash while start-up is in progress and then shine solid once the device has booted. This is
all you need to do to power on the device.
Powering Off the Device
The operator can press the power button again to power off the device. The software will
complete any background save operation before proceeding to automatically shut down.
Once shut-down is complete, the power indicator will turn off, and then the operator can
unplug the device.
In the event that the device becomes unresponsive, the operator should hold down the
power button for 4 seconds to force the device to shut down. Please note that this option
should only be used when the device is totally unresponsive as it could lead to loss of
imaging data.
The appliance coupler is the mains disconnect.

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Logging Onto the Device
The SPY Elite®
software has its own system of operator names, passwords and privileges.
User names and passwords are created by the “Administrator” of the device. The
Administrator can add, delete or change user names and passwords in the Configuration
Screen.
Logging On
Upon starting the SPY Elite®
Device, the operator is presented with the Log On Screen.
The software allows an operator to be registered as the Administrator, an Operator, or a
Reviewer. Once logged on, each of these operator categories will have access to different
functionality consistent with the role.
By default, the device comes pre-configured with a “Clinical” operator name with a
password of “SPY”. The operator name and password are both case insensitive.

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When multiple surgical modalities are licensed, the User will be asked to select which
modality they would like to work with. By default, the device is licensed for the plastics
reconstructive surgery modality.
Please note that there is no exit or quit button in the software. To shut down or power off
the device, the operator simply presses the power button next to the keyboard.
Note: The ‘k’ button at the upper right corner of the User name text field
of the Log On Screen activates the on-screen keyboard. Clicking this
button will enable the on-screen keyboard which will pop up
automatically by the software each time the operator selects a text field.
To disable the software keyboard, simply press the “k” again on the
keyboard at any time.

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Study Management
Study Management
Once an operator has successfully logged onto SPY®
Elite, the system presents the Study
Manager screen.
The Study Manager screen can display all of the studies ever captured with the device in the
current surgical modality. The device maintains a permanent record of all studies in a
database. To effectively manage the available system resources, the software may be used
to archive, clean up, and synchronize the image data associated with these studies.
Some of the main features available from the Study Manager screen include:
 Filter the set of studies being displayed by qualifying the search criteria shown in the
left portion of the Study Manager screen above.
 Create a new study.
 Open an existing study.
 Synchronize database to an external drive.
 Explicitly export or archive a study.
 Delete a sequence from a study.
A more detailed description of the Study Manager functions is described in Study Manager
Details and Options (page 61).

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Initiating a New Study
When the operator elects to initiate a new study, the system prompts the operator to enter
information about the study. The system requires that, at a minimum, the medical record
number and patient’s last name must be specified for a study. To expedite urgent studies
the system provides defaults for these that may be overwritten. The following screen
illustrates the information that the operator may enter when creating a new study.
Some fields, like age, study date, and study time are automatically filled in by the software.
To specify a date of birth, the User can either enter the date of birth directly in the field or
hit the “…” button to the right of the field. This will bring up the date entry dialog:

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This dialog has been optimized for touch-screen data entry. The User can quickly pick a
specific date by selecting the decade, year, month, and day and then pressing Ok.
To specify the “Performing Surgeon”, “Assisting Surgeon”, “Anesthesiologist”, or
“Referring Physician”, simply select from the available drop-down selections. If the required
entry is not available, the User may add more entries by selecting the “…” button beside the
respective field. This brings up a dialog allowing them to enter more entries:

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The Procedure tab, which may vary in appearance to reflect the modality selected at logon,
can be used to select or enter a description of the principal procedure.

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Once the operator completes entry of the study information and selects ‘Create Study’, the
device goes into “Live” mode, and displays the Acquisition/Review Screen as illustrated
below. In “Live” mode, the operator is seeing the view of the NIR camera in real time. A set
of headlamp LED’s provide preview illumination. The intensity of these headlamps can be
controlled by an Administrator through the system configuration.
For new studies, the camera zoom will default to its widest setting. This setting can be
changed either using the surgeon controls on the head, or through the operator interface
itself.
At any time, the operator may review or edit the study information by selecting the study
information button marked ‘i’ at the upper left corner of the screen.
As long as the study remains unlocked, the patient name and medical record number can be
edited. Once a study has been archived, exported, or has had its report printed or exported,
it is considered to be locked.
If the goal of the operator is to pre-register a number of patients, return to the study
management screen at this time by selecting the ‘Done’ button. Alternatively, the operator
is now prepared to start acquiring image sequences for the current study.

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Acquiring a New Sequence
In “Live” mode the operator may select the acquisition field of view and the acquisition
frame rate. Optionally, the operator may decide to rotate the image by 180o
to compensate
for rotation of the Imaging Head so that images are acquired in a preferred and/or
consistent anatomic orientation.
Selecting the Field of View
Select the field of view by dragging the camera icon or by clicking anywhere on the camera
zoom selector that appears to the left of the image. Changing the zoom factor will change
the label overlaid in the bottom left hand corner of the viewport.
The number of steps available on the zoom selector may vary from what is shown here
depending on the configuration of the current surgical modality.
Rotating the Acquired Images
Rotate the image presentation by 180 degrees by clicking the rotation button below the
zoom selector.

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Selecting a Frame Rate and Acquisition Duration
The system supports a maximum of 1024 frames in an image sequence. The following frame
rates and acquisition maximum durations are supported:
1. Up to 34 seconds @ 30 frames / second
2. Up to 68 seconds @ 15 frames / second
3. Up to 2 minutes 16 seconds @ 7.5 frames / second
4. Up to 4 minutes 32 seconds @ 3.75 frames / second
Choose the acquisition frame rate with the frame rate selection button that will cycle
through the available frame rates:
The current maximum sequence duration will appear above the button. Please note that by
default the system is configured to 7.5 frames / second for a recording time of 2 minutes and
16 seconds. This default may be changed in the System Configuration option screen.
Note: The acquisition frame rate is handled internally by the system and
does not affect the rate at which the camera image on the screen is
refreshed which is constant at 30 frames / second.
Note: By default most systems are not configured to support 30
frames/second acquisitions.
Staying in Range
SPY Elite®
provides a means of ensuring that the imaging head is the correct distance from
the subject: the range spots on the head.
Operators ensure the distance from the subject is correct by ensuring that the two range
spots overlap on the subject. The range spots are enabled using the button on the
Imaging Head.

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Commencing Acquisition Buffering
Once the operator is satisfied with the camera field of view, the prospective acquisition
frame rate and duration, and the orientation of the images, and once the target is within
acceptable focal range, the acquisition may commence.
Initiate the acquisition by pressing or clicking on the “record” button. Depending on the
configuration of the buffering, the operator may choose to inject the ICG just prior or
immediately following this button press. For details on ICG injection, please refer to
Handling, Preparation and Administration of ICG for use with SPY Elite®
System (page 13).
SPY Elite®
supports acquisition buffering. From the moment the “record” button is selected,
the laser is turned on and the software begins to capture and buffer image frames of a
configured duration, 5 seconds by default. On-screen labels indicate that the laser is on and
that the software is buffering. The “record” button also begins to flash to indicate buffering
is ongoing:
When the operator observes ICG ingress, the button is touched again and looks like this to
indicate recording has commenced:

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The image display shows ‘RECORDING’ to indicate recording has commenced, and the
display also begins to show the number of seconds elapsed since the start of recording.
If operators observe the acquisition duration numerical display at the lower left corner of
the display window, they will observe that timing starts at the 5 second mark. That is
because the 5 seconds immediately preceding the second button press have been captured
by the software, and that is when the captured image sequence will be observed to begin
when the sequence is played back for review or analysis. So, even if the onset of ICG begins
prior to the second button press, the preceding 5 seconds have been captured and hopefully
so has the beginning of ICG ingress.
The length of the buffer is configurable, it is unique to each surgical modality and it may vary
from 0 to 20 seconds. A buffer length of 0 means “no buffering” and the “record” button
will never flash. The software will progress directly from “not recording” to “recording”
without the “record” button going through the buffering, flashing stage.
Terminating the Acquisition
When the software is recording, operators may press the “record” button again to end the
recording. Alternatively, the software will terminate the acquisition automatically when the
maximum duration for the selected frame rate has been reached.
After termination of the acquisition, the system will by default prompt the operator to enter
Sequence Information at the end of the capture. This option can be disabled from the
System Configuration option screen.

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A grey circle will appear at the upper left corner of the screen. The software will commence
automatically saving the newly acquired sequence to the hard drive and the grey circle will
track how much of the sequence remains to be saved. When the sequence is entirely saved,
the grey circle will disappear completely.
After entering the Sequence Information, the software will return itself to “Live” mode and
display a tab on the left of the screen showing the sequence number just captured and the
time the capture was initiated.
Another acquisition may be started immediately, even while the previous sequence is still
being saved.
The Intensity Trace
The intensity trace is the red and yellow graph at the lower right corner of the image display:
It displays, in real time, the average intensity of incoming image frames. It updates at the
current frame rate. The trace comes in on the right at time 0 and proceeds to fill in right to

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left until it reaches the maximum acquisition duration on the left. From there it simply scrolls
off the end of the timeline.
Capturing a Colored Still Image of the Operative Field
At any time in “Live” mode, the operator may take a colored visible light snapshot of the
field of view with the Snapshot button:
The color still will display momentarily and then it will be saved as another sequence in the
study. A sequence tab with a camera image will denote a visible light still image sequence:
Closing a Study Makes it Inactive
A study is closed by selecting the “Done” button at the lower right of the screen:
Once a study has been closed, and it has recorded sequences in it, it is no longer considered
Active. That means no more image sequences may be added to the study by default. When
the study is reopened there will be no “Live” tab available in the Sequence Selector.
An operator may Reactivate the study via the Options menu available via the button on the
lower left of the screen. If the study has been inactive for more than 2 hours, the operator
will be prompted to confirm that they do indeed mean to reactivate the study.
After Reactivation, further sequences may be acquired for the study.

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Reviewing an Image Sequence
The operator may inspect an acquired image sequence at any time (even while it is being
saved) by selecting its tab in the sequence selector on the left side of the screen. The
software exits “Live” mode and the first frame of the target sequence is displayed.
Note: The frame label overlaid on the viewport in the bottom left hand
corner denotes the current frame time, the frame rate at which the
sequence was captured, and the FOV of the camera at the time of the
capture.
Entering Information About a Newly Captured Sequence
Users may want to capture information regarding clinical findings at the current stage of the
surgery and details of the surgical stage itself. Select the Sequence Information button at
the top left of the image display:

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This opens the Sequence Information dialog. The dialog supports the collection of three sets
of information (the contents of which will reflect the modality selected at logon):

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Note: The Camera tab displays the NIR camera’s imaging parameters used for
this acquisition.
Except for the Camera tab, whose purpose is purely informational, all of the information
entered in the Sequence Information dialog will be presented in the Procedure Report for
this study.

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Editing an Image Sequence
Before a study has been closed for the first time and Deactivated, any sequence in that study
may be edited. Editing a sequence means permanently removing frames from the beginning
or end of the sequence.
Select the frame slider, the tubular blue structure immediately to the right of the displayed
image. Drag the yellow frame selector up or down vertically to select any frame in the
sequence. Note how the time display in the lower left corner updates to show the elapsed
acquisition time at the time of capture of each frame. Moving the yellow selector up takes
you toward the end of the sequence, down takes you toward the beginning.
When you select the frame slider, the start and end selectors become active. The start and
end selectors looks like this:
Selecting either of these means you want to delimit the start or the end of the sequence at
the currently displayed frame. When you select a start or end, the frame slider turns grey
from the current frame position to the start or end of the sequence.
The start and end marks are also reflected in the intensity trace where they are denoted by
blue vertical bars while the current frame is denoted by an arrowhead above the trace.
You may restore the start and end definitions to the original beginning and end of the image
sequence by using the restore button:
You can permanently remove all of the sequence frames before your start and/or after your
end by using the cut button:

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Start and end marks may be set at any time when reviewing an image sequence. The start
and end marks will always delimit:
1. The playback segment in cine
2. The segment exported in sequence export
3. The segment copied to SPY-Q for analysis
The only time the sequence may be physically edited, however, is before the current study
has been closed and thus made Inactive for the first time. The study is closed and
Deactivated by selecting ‘Done’.
Before making the final cut, the operator might wish to cine the edited sequence in real time
to review its contents.
Reviewing a Sequence with Cine
An operator may want to review the dynamic qualities of the sequence by playing it back as
a cine. Cine support includes:
 Ability to play frames back at ¼, ½, 1x, 2x, or 4x real-time.
 Loop, yoyo and play to end modes.
 Ability to step through single frames one at a time.
The Play button:
Single-frame step forward and back:
Playback speed slower and faster:
Loop or yoyo or play-to-end playback. The application defaults to loop mode for cine
operations.

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Enhancing the Display of Image Sequences
The SPY Elite®
software provides various means of enhancing the display of fluorescence
angiography images.
Colorization
SPY Elite®
images are gray-scale intensity images. To enhance the perception of detail in
these images it is sometimes helpful to apply an artificial colorization. This can be done at
any time in Live or Review mode and such colorized images will retain their color in
Procedure Reports. The underlying data is always gray-scale and is untouched by the
application of pseudo-color. Use the Colorization button on the right of the screen to enable
and disable colorization.
Viewing Mode
Another level of enhancement is available when the Viewing button on the right of the
screen is enabled. SPY Elite®
currently captures images with 256 shades of gray. Typically,
images are displayed in their original 256 shades of gray or in a colorized version of the
same. However, by modifying how the software maps the image’s pixel values to colors on
the screen, different features of interest can be highlighted. For example, operators can
make it easier to view low contrast regions in the image.

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Viewing Gain Presets
When Viewing mode is toggled on, SPY Elite®
provides the user with 4 viewing presets to
choose from. These presets have been calibrated to apply a simple gain to the image, where
each pixel in the image is made N times brighter. For a bright image, a gain of None (1.0x) or
Low (1.3x) is appropriate, while a darker image may call for a Medium (2.0x) or High (4.0x)
gain. The Low, Medium, and High gain settings are compatible with the Bright, Medium and
Dark image type presets available in the SPY-Q Analysis Toolkit software.
By default, when viewing is enabled newly acquired sequences are displayed using a
Medium gain. Pressing the preset button successively will rotate through the presets.
The viewing preset used for a given sequence will be remembered by SPY®
Elite.

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Gain Adjustment
The gain slider provides the user with a simple intuitive mechanism for modifying the
multiplier applied to the image, which is displayed in the top left corner of the screen.
Viewing mode is available in Review mode and Live mode and can be combined with
Colorization mode. Any viewing-adjusted images added to a Procedure Report will be
displayed in the report as seen on the screen.

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Zoom and Pan
Users may zoom an image up to a maximum of 4X magnification with the zoom control at
the left of the image display area.
With Viewing enabled, it is also possible to pan the image and to employ a combination of
zoom and pan to focus on any region of interest. With Viewing enabled, pan the image by
touching anywhere on the image surface not on a control and drag.
This zoomed and panned image may be added to a Procedure Report and will be displayed
in the report as seen on the screen.
At any time the image may be restored to an un-zoomed and un-panned display using the
viewing preset that was last selected for this sequence. This is done by using the viewing
preset button located at the right side of the screen, beneath the viewing mode toggle:

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Maximizing the Display
At any time in either Live or Review mode the operator can maximize the image display so
the image will enlarge to take over almost the entire area of the screen. When used in Live
mode, the surgeon can use the head control to perform the complete acquisition cycle while
continuing to look at the maximized view.
Use the icon at the upper right corner of the screen:
The display maximizes itself:
Note: The operator interface has almost entirely been replaced with the
current image. Only the Study Information selector at the upper left and
the de-maximize control at the upper right remain. Use the latter to
restore the operator interface to its normal state.

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Annotating an Image or a Sequence
Annotating an Image or a Sequence
During Review, the operator may annotate the current image, the entire sequence or a
range of images within the current sequence. The purpose of annotation is to inject
markings or commentary for purposes of a presentation or for the Procedure Report.
The software supports the following annotation types:
 Text
 Elliptical
 Line
Once placed, all annotations can be removed, scaled, translated, and rotated.
A newly created annotation can be associated with a single image, the current image range
(as indicated by the start and end marks), or the entire sequence.
Annotations can be created in a range of colors.
The display of annotations can be toggled on/off by toggling the Annotation button at the
upper right of the screen.
Editing of text annotations is not supported. To change the text, the text annotation must
be deleted and recreated.

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Activating the SPY-Q Analysis Toolkit
Activating the SPY-Q Analysis Toolkit
The SPY Elite®
software works cooperatively with the SPY-Q Analysis Toolkit software
application. From the Acquisition/Review screen, you can make the contents of the current
study available to SPY-Q by selecting:
The SPY-Q application will temporarily disable access to the SPY Elite®
software and open
itself on top of the screen:
There will be one sequence tab in SPY-Q for each NIR image sequence in the current study
(i.e., color still image sequences will not be presented).
Select any sequence tab of interest. There will be a pause of several seconds while every
1024 x 768 pixel image in the sequence is reformatted to the 752 x 480 pixel format required
by SPY-Q. When this operation is complete, the first frame of the target sequence will
appear in the SPY-Q window you’ve chosen to load. At this point you may proceed with any
of the analysis modes supported by SPY-Q.
See the Operator’s Manual for SPY-Q for a detailed explanation of SPY-Q usage. Close SPY-Q
and return to the Acquisition/Review screen at any time via the Done button in the lower
right corner of SPY-Q.

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Analyzing Sequences in the Acquisition/Review Screen
Analyzing Sequences in the
Acquisition/Review Screen
While SPY-Q provides a suite of visual and quantitative analysis functions, the SPY Elite®
software’s Acquisition/Review screen supports its own limited assessment tools that do not
require the transfer of images to the secondary SPY-Q application.
As in SPY-Q, assessment of ICG fluorescence image sequences must be based on a correct
understanding of the baseline compensation modes available to the operator.
Compensating for Baseline Intensity
Prior to the arrival of the latest bolus of ICG laden blood, the baseline intensity captured by
the SPY Elite®
camera may be above 0 for several reasons:
 Camera noise. Even with a capped lens, the SPY Elite®
camera has an average
background signal that is greater than 0.
 NIR from laser reflecting on tissue.
 NIR component of ambient visible light.
 Residual ICG remaining in the circulation from a previous injection.
In order to properly assess sequences, it is necessary to understand the basis of the correct
baseline intensity. The software offers several options for adjusting the baseline:
 Fixed Baseline
 Auto Baseline
 No Compensation
For each of these modes (except “No Compensation”), once a baseline is set, its value is
subtracted from the current frame when it is rendered in the viewport. Also, the Single
Contour analysis mode will compensate for the baseline according to the option selected
when computing the overlay labels and contours.
To select a different compensation option, click on the baseline option label in the top right
corner of the viewport. The label will cycle through the three compensation schemes.
Fixed Baseline
The Fixed Baseline option can be used to compensate for inherent SPY Elite®
camera noise
plus natural skin NIR reflectance and, potentially, ambient NIR light. By default, the Fixed
Baseline is set to 2 units of intensity; however this value can be modified by LifeCell™ service
personnel to account for the specific ambient NIR light conditions that might exist in a
particular operating theatre.

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Whenever a new sequence is displayed in Review mode, Fixed Baseline compensation is
used by default.
Fixed Baseline should be used:
 Whenever only a single ICG injection has been given.
 When there is little additional ambient NIR light in the operating room.
 After multiple injections, provided fluorescence due to earlier ICG injections has
flushed completely from the anatomy of interest.
Auto Baseline
Auto Baseline compensates for residual ICG in the circulatory system that might bias
quantitative assessment and visualization. Unlike the Fixed Baseline which subtracts a single
constant value from every pixel in the current frame, the Auto Baseline mode subtracts a
slightly blurred version of the start frame from each frame in the sequence. (Blurring allows
for the slight frame-to-frame registration differences that result from movement due to
patient breathing.)
IMPORTANT: Auto Baseline should never be used with panning. In such a
case the subtraction start frame would not be in registration with the rest
of the sequence, and the compensation would be incorrect.
Auto Baseline should be used when:
 There is residual ICG remaining in the anatomy of interest, or
 There is a source of ambient NIR lighting in the room that illuminates the anatomy of
interest for the entire duration of the capture, and
 The operator does not pan the camera in the time interval of interest, and
 Recording is started prior to the arrival of the current ICG bolus.
No Compensation
When No Compensation is selected, no baseline compensation is applied. Frames are
visualized exactly as they were captured from the camera, and the raw uncompensated
pixel values are used for labels and the single contour.

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Quantitative Assessment Tools
Quantitative assessment of the current frame is always performed in conjunction with the
baseline compensation mode currently in effect. Changing compensation mode will affect
both the contour and the labels used in quantitative assessment. Enable Quantitative
Assessment Tools by selecting the ‘Contour’ button at the right of the display:
By default, relative contours are enabled, with the ‘100%’ button in the Contour group
selected. With relative contours we are interested in the values of pixels compared to some
anatomic reference point in the picture.
The ‘100%’ reference marker may be dragged to any location in the image display. All labels
and contours take on baseline-compensated percentage values that are expressed in
relation to the reference marker where the pixel value under the marker is taken to be 100%.
Contour Lines
The contour lines on the image represent lines of isofluorescence, where every point on a
contour has equal fluorescence to every other point on the contour. If we consider the
image’s intensity at each point to be represented as a height or elevation above zero,
isofluorescence contours are equivalent to the contour levels used to denote altitude or
elevation on maps. The isobar contours showing lines of constant barometric pressure on a
weather map provide another analogy.

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By default, the system will place a contour line at an intensity level corresponding to 20% of
the fluorescence present beneath the 100% reference marker. The operator can make
coarse adjustments to the contour level by ±10 and fine adjustments by ±1 using these
buttons in the Contour group:
In the example below, the user has adjusted the contour level to 40% of the reference
marker.

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Labels
With contours enabled, click anywhere in the image to add a label at that point:
The label will tell the average intensity of pixels directly under the label. If dissatisfied with
the position of any label, simply touch it and drag to the desired location. Up to 32 labels
may be added to a sequence. To remove the labels, click on the contour Reset button to the
right of the 100% button.
Note: As the operator scrolls or steps through images in a sequence, the
contours and labels will update to reflect the pixel values of the current
image. Also, note that if the study is closed and then re-opened at
another time and if Contours are then enabled, the contour level and the
label positions will automatically all restore themselves where the
operator last left them.

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Absolute Values
Sometimes we are more interested in the absolute values of pixels. To enable Absolute
Values, toggle the ‘100%’ button in the Contour group:
Pixels in SPY Elite®
images take on values from 0 to 255. In the example above we are using
Absolute Values mode to directly evaluate the baseline-compensated intensity of the
underlying pixel values.
In this example, the contour line represents all pixels with a fluorescence value of 90 after
baseline compensation. Because we have a fixed baseline of 2 units, this means that all
pixels on the contour line had a reading of 101 + 2 = 103 from the camera.
Again, the software will remember and reproduce the position of the reference marker
when this sequence is reopened in the future.

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All of the analyses shown may also be done with colorization enabled:
Or even with Viewing gain and zoom/pan adjustments:

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Variables that may impact tissue perfusion assessment
Characteristics associated with ischemia Previous radiation treatment
Previous surgery*
Current smoking
Obesity
Diabetes
Vasculopathy
Chronic corticosteroid use
Thin mastectomy flaps
Agents that interfere with imaging techniques Methylene blue
Lymphazurin blue
Agents that affect blood flow Vasoconstrictors (eg, epinephrine)**
* Previous incisions may affect blood flow; ICG angiography may be of particular utility for
detection of perfusion across scars.
** Vasopressors affect all methods of estimation of perfusion in tissue. Diminished blood
flow following administration of epinephrine may indicate the need to wait ≥2 hours for
accurate ICG imaging. A negative result on ICG angiography may indicate the need to wait
longer for recovery of perfusion.
IMPORTANT: You cannot pan in this mode, because the software would be
unable to differentiate panning from label placement. Zoom and pan first,
then enable Contour and add labels.
IMPORTANT: None of the Viewing enhancements affect the values
produced by the Quantitative Assessment Tools. They alter the visual
display only.
IMPORTANT: All assessments are adjunctive to the surgeon’s clinical
judgment.
Finally, any of the images displayed above may be added to a Procedure Report.

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Procedure Reports
Procedure Reports
Most of the information entered and the selections made from the Study Information dialog
will show up in a Procedure Report for that study.
Two Kinds of Procedure Report
Operators can produce two variations on the Procedure Report:
1. Text-only report with information from every sequence in the study.
2. Image report with information only from sequences that pertain to specific images
that have been added to the report.
The information entered and selections made from the Sequence Information dialog for
every sequence in a study will make its way into the Procedure Report for that study if the
operator elects to produce a Text Procedure Report.
The operator may select and add any number of NIR or color images to the Procedure
Report in which case only Sequence Information pertaining to the sequences of the added
images will show up in an Image Procedure Report.
The procedure and sequence-specific information displayed in a report may vary to reflect
the modality selected during logon.
Producing a Text Report
To produce a text-only report, simply select the Report button on the right of the screen:
The report viewer will come up, and you may preview the report:

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Procedure Reports
From the report viewer you may go from page to page with these buttons:
When the operator is satisfied with the report’s contents, the report may be printed directly
on the printer or exported as a PDF format file to a USB drive attached to the USB port.
Here is a text report:

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Procedure Reports

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Procedure Reports
Locking and Unlocking a Report
Once a Procedure Report has been printed or exported as PDF, the report itself and the
Study and Sequence information dialogs become locked. Neither the dialogs nor the report
can now be changed, though more copies may be printed or exported. Note the locked
symbol on the report viewer:
This control will always be visible to reflect the locked or unlocked state of the Procedure
Report but only an operator in the Administrator role will be able to select the Locked
button and unlock the report to enable changes. This action will unlock the report and the
Study and Sequence Information dialogs.
The action will also be recorded in the software’s Audit database, noting who unlocked the
report, for which study and when the action was performed.
IMPORTANT: The Audit database may only be accessed by the
Administrator role.
Producing an Image Report
The operator may produce an Image Report by choosing specific frames with regular or
enhanced images and simply adding them to a report with this control in the report group:
Any number of images from any number of sequences may be added to a report. When an
image is added to a report, the Sequence Information pertaining to the images’ sequence is
added to the report. Only Sequence Information pertaining to sequences from which images
have been included will show up.
Images may be removed from the report with this button:
Selecting this button will cause a dialog to appear with all of the images which have been
added to the report, appearing in the order in which they were added. The user can select

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Procedure Reports
an image and remove it from the report, or elect to remove all images from the report. At
any time the operator may inspect the report with the Report Viewer.
IMPORTANT: If all images are removed from a report, it will revert to being
a Text Report.

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Procedure Reports
Here is an image report:

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Study Manager Details and Options
Now that the major features have been presented, it may be helpful to review the Study
Manager screen in detail with the functionality available under its Options menu:
The icons in the status column provide useful information about each study.
The first study in the list shows that no image sequences have been acquired for this study.
It is empty:
The empty folder indicates the study has been created, possibly for pre-registration of the
patient information, but no image data has yet been acquired. When this study is opened, it
will go directly into Live mode.
The second study from the top shows that it contains image data:
If it is selected, thumbnails of its image sequences will display in the thumbnail selector on
the right.

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Any study may be opened directly by doing a double-click or double-tap action on its entry in
the Study Manager.
Alternatively, the operator may navigate directly to a specific sequence by doing the same
action on the pertinent sequence thumbnail image.
The fourth study from the top shows that a Procedure Report has been either printed or
exported to USB and, therefore, this study is locked.
No more image data may be added to it, and its various Study and Sequence Information
dialogs may not be edited. Only an Administrator can unlock this study.
The last study in the list has an icon to denote that it has been archived.

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Clinical Options in the Study Manager
This is the menu of options available by selecting the Options button on the Study Manager.
Only an Administrator will be able to access all of these items. Here only the options
available to a Clinical User are shown as enabled.
Study Information
Another way of opening the Study Information dialog.
Delete Study
Deletes the current study from the database. This action is audited.

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Export Study
Exports a SPY Elite®
study to the data drive or a USB drive. The following dialog is presented
to allow the User to select the format that they would like to export the study in. Not all
options are available for all selections. For example, when exporting to DICOM, the User
may only export the raw grayscale data.
Print Study List
Prints the part of the study list currently visible in the Study Manager.
System Usage
Opens the System Usage dialog for an Administrator to inspect the history of laser firings
and new studies created in the current clinical modality. The User can filter the information
by specifying a start and end date range.

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System Configuration
Opens all of the configurable features available for inspection or editing. Depending on
whether the User is logged on as an Administrator or operator, they will have access to
different configuration settings. See Configuration Options (page 74) below for details.
Archive Management
Opens the Archive Management dialog so the operator can commence archiving studies to
DVD or review an archive operation that is currently in progress.

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About
The About Dialog gives information about the version of the software being run, as well as
the firmware that is loaded on the device. From this dialog, the user may also review the
terms of the EULA (End User License Agreement) that was agreed to or a soft copy of the
Operator’s Manual.

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Options on the Acquisition/Review Screen
The Acquisition and Review screen also has an option menu:
Reactivate Study
Image and color still sequences may only be added to an Active study. Studies become
Inactive once they are closed. To add new image data they must be explicitly reactivated by
an Administrator, an action that is audited. Locked studies cannot be reactivated unless they
are first unlocked by an Administrator.
When re-activating a study, the system will prompt the User as follows to ensure that they
would really like to reactivate the study:
If more than two hours has elapsed since the last sequence was added, the User will also be
prompted to ensure that they are indeed adding new sequences to the correct study:

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Delete Sequence/Snapshot
An Administrator can delete the current image sequence or snapshot from the study. The
User will be prompted to confirm the action, and the action itself will be audited.
Export Sequence
The current sequence may be exported to either the data drive or a USB drive in a variety of
compressed and uncompressed sequence formats:
The operator may choose the format, compression options and target device.
Here are some important points to note about sequence export:
 If a start and end range has been set, then only those images will be exported as part
of the sequence.
 When “Export as shown” is selected, the sequence will be exported as a color image
with all the artifacts currently shown in the viewer including all frame information,

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colorization, viewing, annotations, and contour settings. When the sequence is not
exported as shown, it is exported as a grayscale image and only includes the
underlying image data.
 When exporting for SPY-Q use, the image data is scaled to the native resolution
supported by SPY-Q, namely 752x480. Although SPY-Q will support viewing of
1024x768 images, these files would be unnecessarily large as SPY-Q will scale them to
its 752x480 resolution.
 Not all options are available for all types of export. For example, when exporting to
DICOM, images cannot be exported as shown.
Print Snapshot
The SPY Elite®
software supports the notion of a Snapshot Report, an ad hoc report with a
single image and allowing multiple lines of commentary that may be generated and printed
or exported to PDF at any time.
Export Bitmap
This currently displayed image may be exported to either the data drive or a USB drive as a
BMP format file. The system provides an interface to navigate the contents of the selected
drive.

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The operator may double-click on any of the displayed folders to navigate to that folder. The
image file will be saved under the name provided.

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Synchronization
Synchronization
The SPY Elite®
software supports automatic synchronization to an external hard drive. This
external drive is provided by the institution and should be at least a terabyte drive to match
the one used internally on the device.
If the external drive is mains-powered, it must not be connected to the device during a
clinical procedure.
After each study, the operator should plug the external drive into the USB port and select
the “Synchronize” option from the study management screen. Selecting this operation will
cause the software to automatically compare the contents of the local database with that of
the attached external drive. The system will then automatically synchronize the contents of
the external drive to match that of the local database. Only those files which have changed
since the last synchronize operation will be saved. Depending on the number of studies on
the system, and the speed of the external drive, this operation could require a few minutes.
Once the scan is complete, the synchronization process begins. The User may interrupt the
synchronization process at any time and resume the synchronization at some later time.
Should the local disk fail, service personnel can restore the study database from the
contents of the synchronized external drive, so it is important for the clinical Users to
synchronize after each procedure.
If more than one terabyte drive is connected, the user will be prompted to select the drive
they would like to synchronize to.

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Archive Management
Archive Management
The Archive Management screen displays a list of the currently unarchived studies, showing
the oldest unarchived first.
The operator has the option of archiving a single study per disk, or filling the disk with
multiple studies. When the archive operation is started, the operator will be prompted to
insert a blank DVD into the drive. The archiver will then start by archiving the oldest
unarchived study to the DVD. Each sequence in the study is converted into a DICOM file and
burnt to the DVD until the entire study is archived.
By pausing the archive, the archiver will stop placing sequences on the disk until the
operator resumes the archive operation.
By selecting “Finish Archiving”, the archiver will close the current DVD session once the
sequences for the current study have been placed on the disk.
By selecting “Cancel Archiving”, the archiver will stop as soon as possible, and the disk
should be thrown away. Any studies that were previously placed on the disk will have their
status reverted to unarchived.

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Archive Management
An archive operation may complete successfully:
 After a single study has been placed on the DVD and the archiver is configured for
completion after a single study.
 The operator requesting the archive operation to complete.
 The disk is full and does not have room for additional studies.
When the operation completes for any of the reasons described above, the operator will be
prompted to label the disk with a label that uniquely identifies the contents of the disk. The
label consists of the date and a unique serial number.

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Configuration Options
Configuration Options
The System Configuration dialog is available to all operators, although different options are
available depending on the role of the current operator. All configurable options for the
Clinical User are presented here.
As previously mentioned, all configuration is on a per modality basis. The settings for one
modality may be completely different from those of another modality.
Site-Specific Configuration
From the site configuration screen, the Administrator may configure:
 Default Site Name: This field should be initialized with the institution’s name. It
appears in all reports.
 Default contour percentage: When contouring is selected, this value will be used to
place the default contour line.
 Default FPS: Default frame rate to use sequence capture.
 Number of seconds to pre-record: Allows the User to configure how long the system
will pre-buffer. If set to 0, only a single press of the record button will be used to
start recording.
 Show sequence info after recording: This can be enabled or disabled.

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Controlling Acquisition Through Imaging Head
Controlling Acquisition Through Imaging
Head
The SPY Elite®
software allows the surgeon to have direct control over acquisition through a
set of buttons on the Imaging Head. The following buttons are available:
 Range spots
 Record
 Snapshot
 Image flip
 Zoom in
 Zoom out
All of the buttons behave exactly as their GUI counterparts, with the exception of the range
spots, which are only controllable through the Imaging Head button.
Pressing the range spots button will toggle the pair of range spots on/off. When these spots
are aligned, the surgeon can be confident that the head is at the optimum distance of 30 cm
(12 inches) from the patient.
While in review mode for an active study, pressing any of the buttons on the head will first
cause the SPY Elite®
software to immediately return to live mode.

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Power Management
Power Management
The SPY Elite®
software actively monitors the status of the power supply. When the device
suffers an interruption to its power, a backup battery continues to supply power to the main
computer for 10 minutes, although the peripheral hardware does shut off, including the
displays and printer.
When the device first detects the power loss, it reduces its power consumption by stopping
any activity currently in progress, including recording, archiving, synchronization, and
exporting. The device will continue saving any unsaved sequences to prevent any data loss.
The device will also block any further operator interaction with the software until either
power is restored or the computer shuts down. If power is restored to the device within 10
minutes, normal operation is resumed; otherwise the device shuts down.
Circuit Breakers
If the device powers off spontaneously, check if one or more of the circuit breakers is
protruding, indicating that it has tripped. The circuit breakers are located on the power inlet
panel, beside the power cord. To reset the circuit breakers:
1. Disconnect the power cord.
2. Press and release the circuit breaker to reset it.
3. Re-connect the power cord. The device may resume operation on its own, or you
may need to press the power button to re-start.
4. If the circuit breaker trips again, stop using the device and contact a LifeCell™ service
representative.

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Software Limitations
Software Limitations
The preceding description provides details as to the various functions performed by
Novadaq’s SPY Elite®
software. However, the software also possesses a few limitations or
restrictions.
As far as software functions are concerned, these are all predetermined and set during
software development and, thus, are unchangeable by the User. For example, the type of
information presented in a procedure report for a given modality is set and cannot be
customized.
Overall, all Users interact with the software through a touch-screen optimized interface.
Use of a keyboard is limited primarily to data entry of field entries during study and
sequence capture.

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Appendix 1: Technical Information
Appendix 1
Technical Information
SPY Elite®
Device Laser Characteristics
Feature Specification
Medical device
classification
Class II as per US FDA classification
Type of protection against
electric shock
Class I as per IEC 60601-1
The system is isolated from the supply mains by an
isolation transformer, such that the leakage current is
less than the requirements of UL/IEC 60601-1.
Laser class
Class 3R as per IEC 60825-1
Wavelength Maximum Output Divergence
805nm 119mW 40°
650nm 5mW <0.2°
Complies with 21CFR 1040.10 and 1040.11 except for
deviations pursuant to Laser Notice No. 50, dated June
24, 2007.
Radio Frequency emissions Group 1, Class A as per CISPR 11
Harmonic emissions Class A as per IEC 61000-3-2
SPY Elite®
Device Embedded Laser Source
Parameter Specification
Wavelength 805 nm
Maximum Power Output 15000 mW
Beam Divergence 25°
Laser Class of Embedded Source 4
Technical specifications for the SPY Elite®
System including storage and operating
conditions are as follows:

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Appendix 1: Technical Information
Technical Specifications
 Video Output:
 Signal: Digital video
 Standard: DVI-D (Single-link)
 Mode: 1680 x 1050 @ 60 Hz non-interlaced
 Connector: DVI-D (digital only)
 External data interface:
 Standard: USB-2.0
 Interfacing devices: Data storage devices
 Optical drive:
 Mode: Read/Write
 Media: DVD-R
 External power supply:
o Voltgage: 120VAC
o Frequency: 60Hz
o Power: 1000VA
 Weight: 165Kg
Operating Conditions
 Temperature +15C to +30C
 Humidity 10% to 85% relative humidity, non-condensing
 Atmospheric Pressure: 94 kPa to 102 kPa (-100 ft to +2000 ft).
Storage Conditions
 Temperature +10C to +30C
 Humidity 10% to 90% relative humidity, non-condensing
Shipping Conditions
 Temperature -20C to +40C
 Humidity 10% to 100% relative humidity, condensing
 Allow time after transport for temperature and humidity to equalize before
operating the device.

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Appendix 2: SPY® Elite System Symbols
Appendix 2
SPY Elite®
System Symbols
The following symbols are used on the SPY Elite®
system labels to convey information
essential for proper use.
Symbol Referent
Product was tested and shown to
comply with safety standards applicable
in Canada and the United States.
Do not reuse - single use only.
Use by date.
Serial number.
Lot number.
Attention, consult the
accompanying instructions for use.
Date of manufacture.
Manufacturing location
Read Operator’s Manual

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Keyboard symbol
Not for general waste
Laser
Fragile
Keep dry
Temperature limitation
Atmospheric pressure limitation
Humidity limitation
Circuit breaker
Equipotential ground post
DVI Auxiliary video out

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Network
USB
This way up

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Appendix 3: Warranty
Appendix 3
SPY Elite®
Device Labels
The following labels have been placed on the LC3000 Devices for operator and patient
safety.
Device identification
label – located on the
rear panel of the cart.
Grounding reliability
instructions label
Laser label – located
on the cart, below the
keyboard
For use with SPY
printer only – located
near power outlet in
printer bay.
USB only warning label
– located next to the
USB port on the side
of the keyboard.
For use with SPY
keyboard only –
located under the
keyboard, next to the

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Appendix 3: Warranty
USB port.
USB port for SPY
printer only – located
beside the USB port in
the printer bay.
Customer service label
– located on the rear
panel of the cart.
Laser aperture
location label – located
on the imaging head

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