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


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


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


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

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


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

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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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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Appendix 4 Warranty

LifeCell Corporation warrants that its products substantially conform to LifeCell Corporation’s published specifications for such products for a period of (12) twelve months from the date of shipment and will replace products confirmed by LifeCell Corporation as defective products, at LifeCell Corporation’s sole option, during said period. This warranty is contingent upon proper use of products in the application for which they were intended as indicated in the product label claims, and LifeCell Corporation makes no warrant (express, implied, or statutory) for products that are modified or subjected to unusual physical or electrical stress. With regard to LifeCell Corporation products which are labeled FOR SINGLE USE ONLY or DO NOT REUSE, this warranty is null and void following the multiple use of the products. LifeCell Corporation does not provide a warranty for those products subjected to resterilization and/or reuse. EXCEPT FOR THE LIMITED WARRANTY PROVIDED ABOVE, LIFECELL CORPORATION GRANTS NO OTHER WARRANTIES OR CONDITIONS, EXPRESS OR IMPLIED, BY STATUTE IN ANY COMMUNICATIONS WITH BUYER, OR OTHERWISE, REGARDING THE PRODUCTS, THEIR FITNESS FOR ANY PURPOSE, OR THEIR QUALITY OF MERCHANTABILITY. LIFECELL CORPORATION NEITHER ASSUMES NOR AUTHORIZES ANY OTHER CONNECTION WITH THE SALE OR USE OF ANY PRODUCT. IN NO EVENT SHALL LIFECELL CORPORATION BE LIABLE FOR THE PROCUREMENT OF SUBSTITUTED GOODS BY THE CUSTOMER OR FOR ANY CONSEQUENTIAL OR INCIDENTAL DAMAGES FOR BREACH OF WARRANTY. The SPY Elite® System is exclusively distributed in North America by LifeCell Corporation and is manufactured by Novadaq Technologies Inc.

Contact information for service for the SPY Elite® System in North America.

Please contact LifeCell™ Customer Solutions at

1-800-367-5737.

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Appendix 5 Software License Agreement

NOVADAQ® SPY Elite® SYSTEM SOFTWARE LICENSE AGREEMENT

This Software End User License Agreement (“Agreement”) is between you the end user (“You” or “Your” as appropriate) and Novadaq Technologies Inc. (“Novadaq”).

IMPORTANT – READ CAREFULLY

THE SPY ELITE® SYSTEM INCLUDES SPY ELITE

® SYSTEM SOFTWARE WHICH NOVADAQ IS PREPARED

TO LICENSE YOU TO USE AS PART OF YOUR USE OF THE SPY ELITE® SYSTEM BUT ONLY ON THE

TERMS AND CONDITIONS SET OUT IN THIS AGREEMENT. BY CLICKING “I Accept" ON THE SCREEN,

OR BY USING THE SPY ELITE® SYSTEM SOFTWARE IN ANY WAY, YOU CONFIRM YOUR AGREEMENT TO BE BOUND BY THE TERMS AND CONDITIONS OF THIS AGREEMENT. IF YOU DO NOT AGREE, YOU

MUST CEASE ALL USE OF THE SPY ELITE® SYSTEM SOFTWARE AND RETURN IT TO THE DISTRIBUTOR OR VENDOR FOR REFUND OR CREDIT WHERE APPLICABLE.

1. DEFINITIONS

1.1 “Documentation” means the operator guides, manuals and other instructions for use of the Program that Novadaq makes generally available.

1.2 “Program” means Novadaq’s SPY Elite® System Software for operating and using

the SPY Elite® System (in object code form only) and any updates released by Novadaq, together with associated Documentation and media (if any) provided to You.

1.3 “SPY Elite® System” means the fluorescent imaging system designed and manufactured by Novadaq having the following components: automatic focus camera, laser light source, automatic distance sensor, articulating arm mount, computer processor, operating software, hard drive and DVD/CD burner, keyboard, pointing device, image printer and mobile cabinet.

2. PROGRAM LICENSE

2.1 Limited License. Subject to Your compliance with the terms of this Agreement, Novadaq hereby grants to You, during the term of this Agreement, a limited, non-exclusive, non-transferable license:

(a) to use a single copy of the Program solely for Your own internal business

operations solely on the SPY Elite® System on which the Program was first installed, consistent with the Documentation;

(b) to use the Documentation provided with the Program in support of Your authorized use of the Program; and

(c) to copy the Program for archival or backup purposes.

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2.2 Restrictions. You will not copy or use the Program except as expressly permitted by this Agreement. You will not relicense, sublicense, rent or lease the Program or use the Program for third-party training, commercial time-sharing or service bureau use. You will not, and will not permit any third party to, (a) copy, modify, translate, reverse engineer, disassemble or decompile any Program, or otherwise determine or attempt to determine source code of the Program, or (b)

create any derivative work based upon the Program embedded in the SPY Elite® System, except to

the extent expressly permitted by applicable law. You will not use the Program on multiple processors without the prior written consent of Novadaq. Novadaq may, at its own expense and upon reasonable advance notice to You, conduct an audit of Your use of the Program to verify Your compliance with this Agreement.

2.3 Ownership. Novadaq will retain all right, title and interest in and to patent, copyright, trademark, trade secret and any other intellectual property rights in the Program and any derivative works thereof, subject only to the limited licenses set forth in this Agreement. You do not acquire any other rights, express or implied, in the Program or the Documentation other than those rights expressly granted under this Agreement.

3. WARRANTY AND REMEDIES

3.1 Limited Warranty. Novadaq warrants that the Program will perform the functions described in the Documentation under normal use for a period of twelve (12) months from the date

the Program is shipped to You in the SPY Elite® System by Novadaq.

3.2 Disclaimer. THE WARRANTY IN THIS SECTION 3 IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, SATISFACTORY QUALITY, ACCURACY, AND ANY WARRANTIES THAT MAY ARISE OUT OF COURSE OF PERFORMANCE, COURSE OF DEALING OR USAGE OF TRADE. Novadaq does not warrant that the Program will operate in combination with any hardware, software, systems, data, imaging agent, or

other components or parts other than SPY Elite® System operated with an imaging agent provided or approved by Novadaq or a supplier authorized by Novadaq, except as expressly specified in the Documentation. Novadaq does not warrant that the operation of the Program will be uninterrupted or error-free.

3.3 Exclusive Remedies. You must report to Novadaq or a supplier authorized by Novadaq, pursuant to the notice provision of this Agreement, any breach of the warranty specified in Section 3.1 during the relevant warranty period. Your sole and exclusive remedies, and Novadaq’s entire liability, for such a reported breach will be for Novadaq or a supplier authorized by Novadaq to correct or provide a reasonable workaround for Program errors that caused the breach of warranty. If there is a material, bona fide claim of infringement, misappropriation, or violation of any third party intellectual property right in connection with the Program, Novadaq shall promptly (i) procure for You the right to continue using the Program, or (ii) replace or modify the Program to make it non-infringing.

3.4 Limitations. NOVADAQ WILL HAVE NO OBLIGATION OR LIABILITY WHATSOEVER UNDER THIS AGREEMENT (INCLUDING SECTION 3.3) OR OTHERWISE FOR ANY BREACH OF WARRANTY OR ADVERSE EVENT DUE TO ABUSE, MISUSE, ALTERATION, NEGLECT OR ACCIDENTAL

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DAMAGE OF THE PROGRAM OR THE SPY ELITE® SYSTEM; THE UNAUTHORIZED REPAIR,

MODIFICATION OR INSTALLATION OF THE PROGRAM OR SPY ELITE® SYSTEM; OR THE USE OR

ATTEMPTED USE OF ANY SOFTWARE, HARDWARE, SYSTEMS, DATA, IMAGING AGENT OR OTHER COMPONENTS OR PARTS NOT PROVIDED OR APPROVED BY NOVADAQ OR A SUPPLIER

AUTHORIZED BY NOVADAQ IN CONNECTION WITH THE PROGRAM OR THE SPY ELITE®

SYSTEM. Replacement or repair of a Program does not extend its warranty period beyond the original warranty expiration date.

3.5 No Support. Novadaq is not obligated to offer any maintenance or support services to You in relation to the Program other than as specified in Section 3.3. Novadaq or its authorized supplier may voluntarily and at its sole discretion offer such support to You.

4. TERMINATION

This Agreement is effective until terminated. Novadaq may terminate this Agreement upon Your breach of any of the provisions hereof by giving sixty (60) days’ written notice identifying a breach of the terms of the Agreement by You and giving You the opportunity to cure within the sixty (60) day period. Either party may immediately terminate the Agreement upon the other’s dissolution, insolvency, receivership, assignment for the benefit of creditors, or bankruptcy. Upon termination of this Agreement, You will (a) cease all use of the Program, (b) return the Program to Novadaq, or destroy the Program and all related materials in Your possession, and (c) so certify to Novadaq. Except for the license granted herein and as expressly provided herein, the terms of this Agreement will survive termination.

5. GENERAL TERMS

5.1 Governing Law. This Agreement and all matters arising out of or relating to this Agreement will be governed by the internal laws of the State of New York without giving effect to any choice of law rule. This Agreement will not be governed by the United Nations Convention on Contracts for the International Sales of Goods, the application of which is expressly excluded.

5.2 Confidentiality. You will treat and hold the Program and the terms of this Agreement in strict confidence and shall restrict access to the Program to Your employees only.

5.3 Limitation of Liability. In no event will either party be liable for any indirect, incidental, special, consequential or punitive damages, or damages, whether direct or indirect, for loss of profits, revenue, business, savings, data, use or cost of substitute procurement, incurred by either party or any third party, whether in an action in contract or tort, even if the other party has been advised of the possibility of such damages or if such damages are foreseeable. In no event will Novadaq’s liability for damages hereunder exceed the amounts actually paid by You to Novadaq or its distributor for the SPY Elite® System. The parties acknowledge that the limitations of liability in this Section 5.3 and in the other provisions of this Agreement and the allocation of risk herein are an essential element of the bargain between the parties without which Novadaq would not have entered into this Agreement. Notwithstanding the foregoing, nothing herein shall limit Novadaq’s liability for death or personal injury caused by Novadaq’s negligent or willful acts or for any other acts or losses for which liability cannot be excluded by mandatory provisions of applicable law.

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5.4 Indemnification. Each party shall indemnify, defend and hold harmless the other party, its successors and assigns and their respective directors, officers, employees and agents from and against any and all liabilities, damages, losses, settlements, penalties, fines, costs and expenses, including, without limitation, reasonable attorneys’ fees of whatever kind or nature (but not

including taxes), to the extent arising from any third-party claim, action, suit or proceeding based upon: (a) the indemnifying party’s negligence or misconduct in the performance of its obligations or exercise of its rights under the Agreement, and (b) the indemnifying party’s breach of the Agreement; provided, however, that in each of (a) and (b), the indemnifying party shall not be obligated to indemnify, defend or hold harmless any other party to the extent that such other party would be obligated to indemnify, defend and hold harmless the indemnifying party pursuant to this Section.

5.5 Severability and Waiver. If any provision of this Agreement is held to be illegal, invalid or otherwise unenforceable, such provision will be enforced to the extent possible consistent with the stated intention of the parties, or, if incapable of such enforcement, will be deemed to be severed and deleted from this Agreement, while the remainder of this Agreement will continue in full force and effect. The waiver by either party of any default or breach of this Agreement will not constitute a waiver of any other or subsequent default or breach.

5.6 Assignment. You may transfer this Agreement and the license granted hereunder to the purchaser of the SPY Elite® System with which the Program is used, however you may not otherwise assign, sell, transfer, delegate or dispose of, whether voluntarily or involuntarily, by operation of law or otherwise, this Agreement or any rights or obligations under this Agreement without the prior written consent of Novadaq. Any purported assignment, transfer or delegation by You in contravention of the foregoing will be null and void. Novadaq is free to assign, sell and transfer its rights and obligations hereunder without restriction or limitation. Subject to the foregoing, this Agreement will be binding upon and will inure to the benefit of the parties and their respective successors and assigns.

5.7 Delegation. You acknowledge that at Novadaq’s sole discretion, the obligations of Novadaq under this Agreement may be delegated to, or performed by, Novadaq’s designated distributor or authorized agent.

5.8 Compliance with Law. Each party shall comply with all applicable laws, governmental statutes, ordinances and regulations relating to license or use of the Program.

5.9 Export Administration. You will not, and You will require Your representatives not to, export, direct or transfer the Program, or any direct product thereof, to any destination, person or entity restricted or prohibited by applicable export control regulations in the jurisdiction in which the product was supplied to You.

5.10 Entire Agreement. This Agreement constitutes the entire agreement between the parties and supersedes all prior or contemporaneous agreements or representations, written or oral, concerning the subject matter of this Agreement. This Agreement may not be modified or amended except in a writing signed by a duly authorized representative of each party. It is expressly agreed that the terms of this Agreement will supersede the terms in any of Your purchase orders or other ordering documents.

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Copyright

Novadaq® and SPY Elite® are trademarks of Novadaq Technologies, Inc.

© Copyright Novadaq Technologies, Inc. 2011. All rights reserved. Printed in Canada.

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Index

A

Acquisition/Review Screen .............................................. 28

Additional software (warning) ........................................ 10

Administrator ................................................. 22, 58, 63, 74

Analysis....................................................................... 46, 47

Annotation ....................................................................... 45

B

Battery Life ....................................................................... 76

C

Cleaning the Device ................................................... 16, 20

Colorization ...................................................................... 40

E

Editing an image sequence.............................................. 38

Exit the program .............................................................. 23

F

Fluorescence imaging ........................................................ 1

Frame Rate ....................................................................... 30

I

ICG ...................................................................... 2, 4, 13, 16

Icons ................................................................................... 3

Imaging Head ............................................................... 1, 75

Indications for Use ............................................................. 1

L

License Agreement .......................................................... 89

Logging onto the device.................................................. 22

O

Operating Conditions ...................................................... 79

Operating the System ................................................ 11, 21

P

Power Button .................................................................. 21

Protect the instrument (caution) ................................... 11

Q

Quantitative Assessment Tools ...................................... 49

R

Record Button ........................................................... 31, 75

Reports ............................................................................ 55

Reviewing an Image Sequence ....................................... 35

S

Safety Information ............................................................ 4

Shipping Conditions ........................................................ 79

SPY Elite® System............................................................. 10

SPY Pack/Kit ....................................................... 1, 9, 13, 16

SPY-Q ............................................................................... 46

Sterile Drape .......................................................... 2, 13, 16

Storage Conditions .......................................................... 79

Study Manager .......................................................... 24, 61

Symbols (equipment)...................................................... 80

T

Technical specifications .................................................. 78

U

USB Port ........................................................ 10, 56, 64, 71

W

Warnings ............................................................................ 4

Warranty .......................................................................... 85

Z

Zoom .............................................................. 28, 29, 43, 75

LifeCell Corporation

One Millennium Way

Branchburg, NJ 08876

Tel: 908.947.1100

Fax: 908.947.1200

LifeCell™

Customer Support

800.367.5737

www.lifecell.com

LifeCell™

Reimbursement

Hotline

888.543.3656

[email protected]

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