Customer Support:

800 624 4422 Toll Free (USA only)

408 754 2039
800 729 2917 Toll Free (USA only) Fax
408 754 2969 Fax
Email: [email protected]

Novadaq Technologies ULC

8329 Eastlake Drive, Unit 101
Burnaby, BC V5A 4W2
Canada

Document: 4-0002428
Edition: English – INTL
Revision: K, 2021-01

Printed in Canada

© 2021 by NOVADAQ Technologies ULC

U.S. Patents: www.stryker.com/patents

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied Permission is hereby granted, free of charge, to any person obtaining a copy of the fonts
for the following trademarks or service marks: NOVADAQ, PINPOINT, SPY-PHI, STRYKER. All accompanying this license ("Fonts") and associated documentation files (the "Font Software"), to
other trademarks are trademarks of their respective owners or holders. The absence of a product, reproduce and distribute the Font Software, including without limitation the rights to use, copy,
feature, or service name, or logo from this list does not constitute a waiver of Stryker’s trademark merge, publish, distribute, and/or sell copies of the Font Software, and to permit persons to whom
or other intellectual property rights concerning that name or logo. the Font Software is furnished to do so, subject to the following conditions:
The above copyright and trademark notices and this permission notice shall be included in all
Copyright © 2006 by Tavmjong Bah. All Rights Reserved. copies of one or more of the Font Software typefaces.
The Font Software may be modified, altered, or added to, and in particular the designs of glyphs
Permission is hereby granted, free of charge, to any person obtaining a copy of the fonts or characters in the Fonts may be modified and additional glyphs or characters may be added to
accompanying this license ("Fonts") and associated documentation files (the "Font Software"), to the Fonts, only if the fonts are renamed to names not containing either the words "Bitstream" or
reproduce and distribute the modifications to the Bitstream Vera Font Software, including without the word "Vera".
limitation the rights to use, copy, merge, publish, distribute, and/or sell copies of the Font This License becomes null and void to the extent applicable to Fonts or Font Software that has
Software, and to permit persons to whom the Font Software is furnished to do so, subject to the been modified and is distributed under the "Bitstream Vera" names.
following conditions: The Font Software may be sold as part of a larger software package but no copy of one or more
The above copyright and trademark notices and this permission notice shall be included in all of the Font Software typefaces may be sold by itself.
copies of one or more of the Font Software typefaces. THE FONT SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND,
The Font Software may be modified, altered, or added to, and in particular the designs of glyphs EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF
or characters in the Fonts may be modified and additional glyphs or characters may be added to MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT
the Fonts, only if the fonts are renamed to names not containing either the words "Tavmjong Bah" OF COPYRIGHT, PATENT, TRADEMARK, OR OTHER RIGHT. IN NO EVENT SHALL
or the word "Arev". BITSTREAM OR THE GNOME FOUNDATION BE LIABLE FOR ANY CLAIM, DAMAGES OR
This License becomes null and void to the extent applicable to Fonts or Font Software that has OTHER LIABILITY, INCLUDING ANY GENERAL, SPECIAL, INDIRECT, INCIDENTAL, OR
been modified and is distributed under the "Tavmjong Bah Arev" names. CONSEQUENTIAL DAMAGES, WHETHER IN AN ACTION OF CONTRACT, TORT OR
The Font Software may be sold as part of a larger software package but no copy of one or more OTHERWISE, ARISING FROM, OUT OF THE USE OR INABILITY TO USE THE FONT
of the Font Software typefaces may be sold by itself. SOFTWARE OR FROM OTHER DEALINGS IN THE FONT SOFTWARE.
THE FONT SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, Except as contained in this notice, the names of Gnome, the Gnome Foundation, and Bitstream
EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF Inc., shall not be used in advertising or otherwise to promote the sale, use or other dealings in
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT this Font Software without prior written authorization from the Gnome Foundation or Bitstream
OF COPYRIGHT, PATENT, TRADEMARK, OR OTHER RIGHT. IN NO EVENT SHALL Inc., respectively. For further information, contact: [email protected]
TAVMJONG BAH BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY,
INCLUDING ANY GENERAL, SPECIAL, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL
DAMAGES, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING
FROM, OUT OF THE USE OR INABILITY TO USE THE FONT SOFTWARE OR FROM OTHER
DEALINGS IN THE FONT SOFTWARE.
Except as contained in this notice, the name of Tavmjong Bah shall not be used in advertising or
otherwise to promote the sale, use or other dealings in this Font Software without prior written
authorization from Tavmjong Bah. For further information, contact: [email protected].

Copyright © 2003 by Bitstream, Inc. All Rights Reserved. Bitstream Vera is a trademark of
Bitstream, Inc.

4-0002428 Rev. K
Chapter 1 Health and Safety Compliance............................................................................ 1
Important Information ................................................................................................................................................. 1
Intended Use ............................................................................................................................................................. 2
Overview of the PINPOINT System ........................................................................................................................... 2
Components .......................................................................................................................................................... 2
User Qualifications ..................................................................................................................................................... 4
General System Safety .............................................................................................................................................. 4
Electrical Safety – General .................................................................................................................................... 4
Electrical Safety – Power....................................................................................................................................... 5
Light Safety- Illumination ....................................................................................................................................... 5
Warning Labels on the PINPOINT System ............................................................................................................ 7
Electromagnetic Compatibility (EMC) and Environmental Safety .......................................................................... 7
Advice When Used with High Frequency Surgical Equipment .............................................................................. 8
Damaged or Malfunctioning Equipment ................................................................................................................ 8
Cleaning and Sterilizing ......................................................................................................................................... 9
Repair and Modification ....................................................................................................................................... 10
Disposal of PINPOINT System Components ........................................................................................................... 10
Symbols Used on the PINPOINT System ................................................................................................................ 11
Chapter 2 Unpacking and Setting Up the PINPOINT System .......................................... 17
System Parts ........................................................................................................................................................... 17
Setting Up the PINPOINT Imaging System.............................................................................................................. 19
Selecting an Appropriate System Installation Location ........................................................................................ 19
Connecting the Video Processor / Illuminator (VPI) ............................................................................................ 20
Connecting to a Medical-grade Video Monitor..................................................................................................... 21
Connecting to a Medical Recorder ...................................................................................................................... 22
Connecting to Ancillary Video Devices (Optional) ............................................................................................... 22
Selecting the Appropriate Video Output Format .................................................................................................. 22
Connecting the PINPOINT Camera to the VPI .................................................................................................... 24
Connecting the Light Guide Cable to the Laparoscope ....................................................................................... 25
Connecting and Disconnecting the Laparoscope to the PINPOINT Camera ....................................................... 27
Storing and Transporting Laparoscopes ............................................................................................................. 28
Chapter 3 Handling, Preparation, and Administration of ICG ......................................... 29
About Indocyanine Green (ICG) Imaging Agent ...................................................................................................... 29
ICG Safety ............................................................................................................................................................... 29
Clinical Pharmacology ......................................................................................................................................... 29
ICG Contraindications ......................................................................................................................................... 29
ICG Warnings ...................................................................................................................................................... 30
ICG Adverse Reactions ....................................................................................................................................... 31
General ICG Preparation Instructions ...................................................................................................................... 31
ICG Administration via Central or Peripheral Venous Line ...................................................................................... 32
Supplies Required for each Imaging Sequence .................................................................................................. 32
Dosage ................................................................................................................................................................ 32
Preparation for ICG Administration ...................................................................................................................... 32

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual i

 ICG Administration .............................................................................................................................................. 32
Timing of ICG Administration............................................................................................................................... 33
Disposal of Consumables and ICG .......................................................................................................................... 33
Chapter 4 Overview of PINPOINT Components ................................................................ 35
PINPOINT Camera Controls, Indicators, and Labels ............................................................................................... 35
VPI Controls, Indicators, and Labels ........................................................................................................................ 37
Chapter 5 Operating the PINPOINT System ...................................................................... 39
Preparing the PINPOINT Camera and Laparoscope ............................................................................................... 39
Powering on the System into Standby Mode ........................................................................................................... 40
Turning On White-light Mode ................................................................................................................................... 42
Performing a White Balance .................................................................................................................................... 43
Focusing the Image ................................................................................................................................................. 46
Turning on Fluorescence Imaging Mode.................................................................................................................. 48
Display Modes in Fluorescence Imaging Mode ....................................................................................................... 50
Selecting Fluorescence Display modes ............................................................................................................... 52
Toggling between Fluorescence Imaging Mode and White-light Mode .................................................................... 53
Turning Off Illumination (Entering Standby Mode) ................................................................................................... 54
Shutting down the System ....................................................................................................................................... 54
In Case of a Malfunction during Use ........................................................................................................................ 55
Loss of Imaging ................................................................................................................................................... 55
Chapter 6 Operating the PINPOINT System: Secondary Functions ............................... 57
Activating and Using the PINPOINT Tools Menu ..................................................................................................... 58
Recording Video ...................................................................................................................................................... 59
Recording Video on Stryker SDC3TM HD Information Management Systems ..................................................... 59
Recording Video on Sony 1000MD and Sony 3300MT Recorders ...................................................................... 61
Recording Video on TEAC UR-4MD Recorders .................................................................................................. 63
Controlling Video Recording from the PINPOINT Camera .................................................................................. 63
Capturing Screenshots ............................................................................................................................................ 64
Capturing Screenshots on Stryker SDC3TM Information Management Systems ................................................. 64
Capturing Screenshots on Sony 1000MD, Sony 3300MT Recorders .................................................................. 65
Capturing Screenshots on TEAC UR-4MD Recorders ........................................................................................ 67
Capturing a Screenshot Directly from the PINPOINT Camera ............................................................................ 67
Using the VPI Options Menu.................................................................................................................................... 68
Accessing the VPI Options Menu from the PINPOINT Camera .......................................................................... 69
Navigating the VPI Options Menu using the PINPOINT Camera ........................................................................ 70
Accessing and Navigating the VPI Options Menu from the VPI .......................................................................... 70
Settings in the VPI Options Menu ............................................................................................................................ 72
Image Quality Settings ........................................................................................................................................ 72
Display Options Settings ..................................................................................................................................... 73
User Profiles ........................................................................................................................................................ 73
Service ................................................................................................................................................................ 74
Language Setting ................................................................................................................................................ 77
Chapter 7 Cleaning and Sterilization ................................................................................. 79
Spaulding Classification of PINPOINT Components and Optional Accessories ...................................................... 81
Materials and Equipment ......................................................................................................................................... 82

ii 4-0002428 Rev. K
 Limitations on Processing.................................................................................................................................... 83
Reprocessing Laparoscopes and Light Guide Cables ............................................................................................. 84
Using Polishing Paste for Laparoscopes ............................................................................................................. 84
Step 1: Preparing Laparoscopes and Light Guide Cables ................................................................................... 85
Step 2: Cleaning Laparoscopes and Light Guide Cables .................................................................................... 87
Step 3: Inspecting Laparoscopes and Light Guide Cables .................................................................................. 89
Step 4: Sterilizing Laparoscopes and Light Guide Cables ................................................................................... 91
Sterilization .......................................................................................................................................................... 95
Expected Service Life of Laparoscopes and Light Guide Cables ............................................................................ 97
References .............................................................................................................................................................. 98
Reprocessing the PINPOINT Camera (PC9002) ..................................................................................................... 99
Step 1: Preparing the PINPOINT Camera ........................................................................................................... 99
Step 2: Cleaning the PINPOINT Camera .......................................................................................................... 101
Step 3: Inspecting the PINPOINT Camera ........................................................................................................ 103
Step 4: Sterilizing the PINPOINT Camera ......................................................................................................... 104
Appendix A: Troubleshooting ............................................................................................... 109
Clearing PINPOINT Camera, Illumination, and Recorder Errors ........................................................................... 109
PINPOINT Camera Communication Error ......................................................................................................... 109
Illumination Error ............................................................................................................................................... 110
Video Recording and Screenshot Errors ........................................................................................................... 111
Setting up the Sony 1000MD Recorder for Control from the VPI ...................................................................... 112
Setting up the Sony 3300MT Recorder for Control from the VPI ....................................................................... 115
General Troubleshooting ....................................................................................................................................... 119
Fuse Replacement Procedure ............................................................................................................................... 122
Appendix B: VPI Menu Options and Settings....................................................................... 123
Image Quality Menu Settings ................................................................................................................................. 123
Sharpening (0-10) ............................................................................................................................................. 123
Brightness (0-255) ............................................................................................................................................. 123
Red Saturation (0-1024) .................................................................................................................................... 123
Blue Saturation (0-1024) ................................................................................................................................... 123
Peak/Mean ........................................................................................................................................................ 123
Default Profile Menu .............................................................................................................................................. 124
Service Menu ......................................................................................................................................................... 125
Display Options Menu ............................................................................................................................................ 125
SPY Image ........................................................................................................................................................ 125
Overlay Image ................................................................................................................................................... 125
SPY Color Segmented Fluorescence (CSF) Image .......................................................................................... 125
Appendix C: Specifications and Standards ......................................................................... 127
Appendix D: Software License Agreement .......................................................................... 133

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual iii

 This page intentionally left blank.

iv 4-0002428 Rev. K
WARNING: Read before use.

This Operator’s Manual contains essential information about using the PINPOINT
Endoscopic Fluorescence Imaging System (PINPOINT System) safely and
effectively. Before use, thoroughly review this manual and use the system as
instructed.

Keep this manual in a safe, accessible location. Questions or comments about any
information in this manual should be sent to Stryker Customer Support.

The words WARNING, CAUTION, and Note carry special meaning and the
associated clauses should be carefully reviewed:

WARNING: Indicates risks to the safety of the patient or user. Failure to

follow warnings may result in injury to the patient or user.

CAUTION: Indicates risks to the equipment. Failure to follow cautions

may result in product damage.

Note: Provides special information to clarify instructions or present additional

useful information.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 1

 “PINPOINT ENDOSCOPIC FLUORESCENCE IMAGING SYSTEM”, Model
PC9000 (PINPOINT Endoscopic Fluorescence Imaging System) is intended to
provide real-time laparoscopic visible and near infrared fluorescence imaging.
PINPOINT enables surgeons to perform routine visible light laparoscopic
procedures as well as further visually assess circulation including blood flow in
vessels and microvessels, tissue and organ perfusion, and lymphatics and
perfusion associated with tumors and tumor margins with near infrared
fluorescence imaging during minimally invasive surgery.

WARNING: PINPOINT should be used according to its approved Intended Use.

The PINPOINT Endoscopic Fluorescence Imaging System is designed for high

definition (HD) visible (VIS) light and near infrared (NIR) fluorescence imaging.

PINPOINT includes the following components (see Figure 1):

▪ PINPOINT camera optimized for VIS/NIR imaging that mounts to the

laparoscope eyepiece
▪ Video Processor/Illuminator (VPI) to provide VIS/NIR illumination to the
surgical laparoscope via a flexible light guide cable, and the image processing
required to generate simultaneous, real-time HD video color and NIR
fluorescence images
▪ Surgical laparoscope optimized for VIS/NIR illumination and imaging,
available in different diameters, lengths and directions of view. Alternatively, a
surgical laparoscope optimized for visible-light only is available.
▪ Flexible light guide cable

2 4-0002428 Rev. K
 Figure 1: Overview of the PINPOINT Endoscopic Fluorescence Imaging System

1. VPI 4. PINPOINT camera

2. Light guide port 5. Light guide cable
3. Camera port 6. PINPOINT laparoscope

To provide near infrared fluorescence (NIR) imaging, PINPOINT is to be used with

“indocyanine green” (indocyanine green) (ICG) imaging agent. ICG should be
acquired through normal hospital channels.

The PINPOINT System is designed to be connected to a medical-grade color video

monitor, such as those normally used in surgical endoscopy.

Medical-grade accessories, which may be used to support the PINPOINT System

include:

▪ Medical cart
▪ Laparoscopic insufflator
▪ Medical-grade HD video recorder
▪ Printer
▪ Sterilization trays for PINPOINT camera, light guide cable, and laparoscope

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 3

 WARNING: Do not use the PINPOINT VPI and camera with laparoscopes or light guide
cables that have not been clearly identified for use with the system.

WARNING: This manual does not explain or discuss clinical surgical procedures.
Therefore, the healthcare professional using PINPOINT must be a licensed
physician or medical personnel under the supervision of a licensed
physician and must have received sufficient training in clinical procedures
and the use of the PINPOINT System.

WARNING: To avoid the risk of electric shock, this equipment must only be connected to
supply mains with protective earth.

CAUTION: Do not use or store liquids around the VPI. If liquid enters the VPI, immediately turn
the system off and unplug it from the power outlet.

Do not insert objects into the ventilation holes of the VPI enclosure.

Do not connect or disconnect the camera cable while the VPI is powered on.

4 4-0002428 Rev. K
WARNING: Grounding reliability can only be achieved when equipment is connected to
an equivalent receptacle marked 'hospital only' or 'hospital grade’.

Connect the PINPOINT system components only to approved medical

systems or to systems that are powered from approved isolation
transformers.

The patient leakage currents from multiple, simultaneously used, energized

endoscopic accessories may be additive. Use PINPOINT only with Type CF
Applied Part energized endoscopic accessories that minimize leakage
currents to the patient.

Avoid the use of PINPOINT with high-frequency (HF) energized endotherapy

devices in the event of explosive gas concentrations being present in the
area of use.

Do not use the imaging system if the power cord or plug is damaged or
modified in any way.

Do not remove or override the ground connection on the power cords.

CAUTION: Unplug power cords by grasping the plug. Do not unplug power cords by pulling on
the cable.

WARNING: Avoid looking at light emitted directly from the laparoscope or the light guide
cable tip. Table 16 in Appendix C contains specifications for NIR radiation
emitted in fluorescence mode.

Use of controls or performance of procedures other than those specified

herein may result in hazardous radiation exposure.

Always use standby mode by turning illumination off (see Turning Off
System Illumination, in Chapter 5) when connecting or disconnecting the
light guide cable from the laparoscope, or prior to removing the laparoscope
from the patient.

There is high-energy light at the distal end of the laparoscope. This can
cause the temperature of the body tissue to rise to 41°C. Avoid direct contact
of the distal end with body tissue or flammable materials as it can cause
burns.

A laser aperture label is located on the surface of the PINPOINT camera as

prescribed by applicable standards (see Figure 2).

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 5

 Figure 2: Laser aperture on the PINPOINT camera

6 4-0002428 Rev. K
 The PINPOINT camera and VPI* are labeled with the following laser safety warning
labels in accordance with applicable standards:

Table 1: Warning Labels and their Locations

Laser Aperture
indicator, see
Figure 2

Front panel, see

Figure 13

* The Video Processor/Illuminator used with the PINPOINT camera is a component that is shared with
the SPY Portable Handheld Imaging System (SPY-PHI System).

The user is expected to follow all precautions and warnings outlined in this manual,
and adhere to the electromagnetic compatibility (EMC) limits set out in the
electromagnetic compatibility guidance document. Failure to do so may
compromise the system’s ability to maintain basic safety under abnormal EMC
conditions.

The imaging system has been certified for compliance with international standards
for EMC and is suitable for use in professional healthcare environments. The
imaging system generates radio frequency energy and should be installed and
used in accordance with these instructions 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 in turning the imaging system off and on, the PINPOINT System is shown to
cause harmful interference to other electro-medical equipment, the user is
encouraged to try to correct the interference by:

▪ Reorienting or relocating the PINPOINT System or the equipment receiving

the interference
▪ Increasing the separation between the PINPOINT System and the equipment
receiving the interference
▪ Connecting the PINPOINT System to an outlet on a different circuit from the
one to which the other equipment is connected

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 7

 WARNING: Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to
verify normal operation.

WARNING: Use of accessories, transducers and cables other than those specified or
provided by Stryker could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in
improper operation.

Note: The emission characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 Class A). It is not intended for use in a residential
environment (for which CISPR 11 Class B is required).

For further information and guidance refer to “Guidance and Manufacturer’s

Declaration – Electromagnetic Compatibility” included with the PINPOINT System.

If the imaging system becomes unresponsive and does not resume normal function
after turning off and back on, stop using the imaging system, and contact Stryker
Customer Support.

WARNING: PINPOINT rigid laparoscopes are not designed to provide insulation against
high-frequency (HF) electrical currents. To prevent burns and unintended
thermal injury of surrounding tissue, activate electrodes only when visible
through the laparoscope and avoid contact between active electrodes and
the laparoscope.

WARNING: Do not use the PINPOINT camera if any part of the system is damaged or
does not function properly. Failure to follow this warning may lead to injury.

In the event of a drop or impact, inspect the PINPOINT camera and do not
use it:

➢ If there is any visible damage to the camera

➢ If there is evidence of sharp edges or exposed pinch points
➢ If there is concern that the impact might have damaged the camera

If any of the above events occur, please contact Stryker Customer Support.

8 4-0002428 Rev. K
WARNING: Follow the instructions in Chapter 7 to clean and sterilize the PINPOINT
components and accessories.

Keep the light guide cable connectors clean at all times. Contaminants on the
light guide cable connectors may cause overheating.

WARNING: For storage, transport and processing, ensure that the laparoscope is not
subjected to mechanical strain to prevent damage to the sensitive lens
system.

The laparoscopes are delivered non-sterile as reusable products.

In general, users are responsible for validation of their re-processing

processes.

Ensure that the processing, material and personnel are suitable for achieving
the results necessary.

➢ Observe all local regulations for operator safety, protection and training
in performance of manual cleaning and drying processes.
➢ Clean and sterilize the laparoscope prior to initial use as well as each
subsequent use of the laparoscope.
➢ Observe appropriate protective measures to prevent contaminating the
environment.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 9

 WARNING: The PINPOINT system does not contain any user-serviceable parts and does
not require any preventive inspection or maintenance. Do not disassemble,
modify or attempt to repair it. Patient or user injury and/or instrument
damage can result. Refer all servicing to a qualified Stryker service
representative.

If an irregularity appears to be minor, refer to Appendix A: Troubleshooting.

If the irregularity cannot be resolved, contact Stryker Customer Support.

In the case that any component of the PINPOINT System needs to be

returned to Stryker please adhere to the following:

➢ Clean and sterilize the camera, light guide cable, and laparoscope
thoroughly prior to returning for repair.
➢ Ideally, return the part in its original packaging. If this is not possible,
package the part to secure it for transport.
➢ Stryker is not liable for damage resulting from improper shipping.

The PINPOINT Imaging System components should be disposed of in compliance

with local, regional, and national regulations, or returned to Stryker for disposal.

10 4-0002428 Rev. K
 The following section describes symbols and indicators that appear on the
PINPOINT camera and VPI.

Table 2: Symbols on the PINPOINT Camera

Coupler rotation direction to lock Camera

Coupler rotation direction to unlock Camera

Focus buttons Camera

Button 1 Camera

Button 2 Camera

Laser aperture Camera

CE Marking declaring EU Directive compliance Camera

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 11

 Table 3: Symbols on the Video Processor / Illuminator (VPI) and on System Labeling

Front panel
Power

Laser-on indicator Front panel

Type CF patient-applied part* Front panel

Illumination on/off Front panel

White balance Front panel

Menu Front panel

Down (part of menu feature) Front panel

Up (part of menu feature) Front panel

Right (part of menu feature) Front panel

Front panel
Camera socket

Rear panel
Refer to instruction manual/booklet
or

Caution Rear panel

Accompanying
General Warning
Documentation

*applicable to PINPOINT camera and PINPOINT laparoscope

12 4-0002428 Rev. K
 Laser Warning Front panel

Rear panel
Manufacturer

Rear panel
Date of manufacture

Accessory
Reference or Model name/number
Packaging

Accessory
Serial number
Packaging

Accessory
Lot number/Date code
Packaging

Accessory
Made in Germany
Packaging

Accessory
Made in Canada
Packaging

Accessory
Made in USA
Packaging

Accessory
Made in Taiwan
Packaging

Accessory
Do not reuse - single use only
Packaging

Accessory
Expiry (date/time)
Packaging

Fuse Rear panel

Do not dispose in general waste Rear panel

Equipotential symbol Rear panel

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 13

 Rear panel
SGS Q-mark

Rear panel,
CE Marking declaring EU Directive compliance Accessory
Packaging

Accessory
Authorized European (EC) Representative
Packaging

Accessory
Medical Device
Packaging

Table 4: Onscreen Symbols in the Software Interface

Standby mode See Chapter 6

White light mode See Chapter 6

Illumination failed error See Chapter 6

Overlay display mode See Chapter 6

SPY display mode See Chapter 6

CSF display mode See Chapter 6

White balance in progress See Chapter 6

White balance completed See Chapter 6

14 4-0002428 Rev. K
 White balance failed See Chapter 6

Video recording in progress See Chapter 6

Video recording paused See Chapter 6

Video recording in progress (TEAC UR-4MD recorder) See Chapter 6

Video recording paused (TEAC UR-4MD recorder) See Chapter 6

Video recording stopped (TEAC UR-4MD recorder) See Chapter 6

PINPOINT camera connection failure See Chapter 6

Language setting See Chapter 6

Button action- Focus adjustment See Chapter 6

Button action- Focus limit reached See Chapter 6

Button action- Screenshot captured See Chapter 6

Tools menu – Flip image (unavailable with PINPOINT System) See Chapter 6

Tools menu – Flip image unavailable (unavailable with

See Chapter 6
PINPOINT System)

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 15

 Tools menu – Video recording See Chapter 6

Tools menu – Video recording device unavailable See Chapter 6

Tools menu – Screenshot See Chapter 6

Tools menu – Screenshot device unavailable See Chapter 6

Tools menu – White balance See Chapter 6

Tools menu – VPI Options menu See Chapter 6

Table 5: Indicator Lights on the VPI

Laser indicator1 Top left side of front Blue Laser on

panel

Amber Off
Above “Power”
Power indicator
button
Green On

Above “Illumination”
Illumination indicator White Illumination on
button

Below “Illumination”
Green Down
button

(part of menu
Green Up
feature)

Below “White
Green Select
Balance” button

1
A laser-on indicator light is also located on the PINPOINT camera.

16 4-0002428 Rev. K
WARNING: If any items are missing or damaged, do not use the PINPOINT System and
contact a Stryker service representative.

Use Table 6 to identify and inspect all PINPOINT System parts before proceeding
with setting up the system.

Table 6: List of PINPOINT System Parts

Video Processor / Illuminator (VPI)

Model PC9001*

PINPOINT camera

Model PC9002

Fluorescence Imaging
Laparoscopes (if available)
10 mm diameter

Model SC9104 (0° view, 32 cm)

Model SC9134 (30° view, 32 cm)
Model SC9144 (45° view, 32 cm)

Fluorescence Imaging
Laparoscopes (if available)
5 mm diameter

Model SC9504 (0° view, 30 cm)

Model SC9534 (30° view, 30 cm)
Model SC9544 (45° view, 30 cm)

* The Video Processor/Illuminator used with the PINPOINT camera is a component that is shared with
the SPY-PHI System.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 17

 Light Guide Cable

Model PC9004

Power Cord

HD-SDI Cable

DVI Cable

PINPOINT Endoscopic
Fluorescence Imaging System
Operator's Manual

PINPOINT Guidance &

Manufacturer’s Declaration –
Electromagnetic Compatibility

18 4-0002428 Rev. K
WARNING: The PINPOINT System has been certified for compliance with international
standards for electromagnetic compatibility (EMC).

The PINPOINT system generates radio frequency energy and should be

installed and used in accordance with the instructions 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.

Please see Table 12 in Appendix A if the PINPOINT System is suspected of

causing interference with other electro-medical equipment, despite being
installed according to the instructions.

WARNING: Read and follow the information in “Electrical Safety – Power” in Chapter 1
and only connect the PINPOINT VPI to a “Hospital Only” or “Hospital Grade”
power outlet.

1. Select a location in which to use the PINPOINT System that is within 3 m

access of an appropriate power outlet.

2. Place the VPI on an endoscopy cart, on a shelf supported by a ceiling-mounted

boom, or on a suitable table.

3. Select a location in which to use the PINPOINT System that is within 3 m

access of a medical-grade color video monitor.

CAUTION: Ensure that the selected location provides a minimum 5 cm (2 inches) gap around
the VPI cooling vents to allow for required ventilation.

Do not place heavy objects directly on top of the VPI.

For more information, please refer to Table 14 in Appendix C.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 19

 Connect the VPI cables and components as shown in Figure 3.

Figure 3: PINPOINT System wiring diagram showing connection to video monitors and
recorder

1. SDI co-axial cable 4. VPI power cord

2. SDI co-axial cable 5. Medical video monitor power cord
3. RS232 serial cable 6. OPTIONAL Second video monitor cable
(SDI or DVI)

20 4-0002428 Rev. K
 Figure 4: Video Processor / Illuminator rear panel showing connectors and ports

1. Main power switch 6 RJ45 port (Communication port)

2. Device identification label 7 Ext. sync
3. Equipotential post 8. SDI 1 video out
4. Video format switch 9. SDI 2 video out
5. RS232 port (Communication port) 10. DVI video out

CAUTION: The communication ports on the rear panel are intended for use by Stryker service
representatives only.

Note: Normal use of the system does not require the user to connect to the equipotential
post. The potential equalization conductor is only to be used by qualified personnel.

A medical-grade color video monitor can be connected via the SDI and DVI
connectors on the rear panel of the VPI (see Figure 4).

See Table 11 in Appendix C for specifications of the video output signals and
connectors to ensure compatibility of the selected video monitor. Consult the
operator instructions provided by the manufacturer of the video monitor for details
on operation and adjustment of the video monitor.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 21

 There are several Stryker-certified recorders for use with the PINPOINT System.
Availability varies depending on region.

Note: For the onscreen recorder controls and status to be visible to the operator during
normal operation of the PINPOINT System, the VPI SDI 1 video output must be
connected to the SDI-IN connector on the recorder. The SDI-OUT connector on the
recorder should be connected to the medical-grade video monitor. For more
information, see Figure 3.

For more information about setting up the recorder, please refer to Chapter 6.

WARNING: All electro-medical devices connected to the PINPOINT system must be

certified medical-grade and all interconnected configurations shall comply
with the IEC/EN 60601-1 system standard. Failure to comply with this
standard may result in unsafe operation of the system and/or injury to the
patient or operator.

The VPI may be interconnected to other medical-grade video devices such as:

▪ Video recording, display or printing systems

▪ Digital image-capture stations for hospital PAC systems
▪ Stand-alone image management systems
See Table 11 in Appendix C for specifications of the video output signals and
connectors and to ensure compatibility of the selected video devices.

Use the video-format switch on the rear panel of the VPI to select one of the
following video output formats:

▪ HD-SDI 1080i 59.94

▪ 3G-SDI 1080p 59.94

Note: Ensure that the video-format switch on the VPI is in the correct position for the
recorder that is being used.

22 4-0002428 Rev. K
 The correct output formats are as follows:

▪ Stryker® SDC3 Information Management System: 3G-SDI

▪ Sony 1000MD recorder: HD-SDI
▪ Sony 3300MT recorder: 3G-SDI
▪ TEAC UR-4MD recorder: HD-SDI or 3G-SDI
▪ MediCapture USB300 recorder: HD-SDI or 3G-SDI

WARNING: If the video output is routed through a video recorder, operators must always
be aware of whether they are viewing a live or recorded image. Wave your
hand in front of the camera to determine whether or not you are viewing a
live image.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 23

 To connect the PINPOINT camera to the VPI:

1. Remove the cap from the end of the camera cable and orient the camera cable
connector with the raised arrow facing up (see Figure 5).

Figure 5: Raised arrow on top of the connector facing up

2. Insert the camera cable into the camera port on the VPI (see Figure 6).

Figure 6: Connecting the PINPOINT camera to the VPI

24 4-0002428 Rev. K
WARNING: The following procedures must be performed using proper sterile technique
if they are being performed in preparation for surgery.

CAUTION: The camera and laparoscope are precision medical instruments and must be
handled with great care.

➢ Inspect the laparoscope for damage before and after use. If the laparoscope
is damaged, discontinue use and contact the manufacturer.
➢ Do not subject to impact. Put the laparoscope down carefully.
➢ Hold laparoscope only by the ocular funnel or body and not by the sheath.
Do not bend the sheath.
➢ Store laparoscopes safely in a tray or similar container.

To connect the light guide cable to the laparoscope and VPI:

1. Attach the threaded light guide cable adapters to the laparoscope.

2. Connect the light guide cable to the threaded connector on the laparoscope.

3. Fully insert the other end of the light guide cable into the light guide cable port
of the VPI (see Figure 7).

Figure 7: Connecting the light guide cable to the VPI

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 25

 Figure 8: Overview of the laparoscope and light guide cable

1. Eyepiece 5. Flexible light guide cable

Light guide cable threaded connector (to
2. Proximal tip 6.
laparoscope)
3. Ocular funnel/body 7. Laparoscope shaft
4. Distal tip 8. Light guide cable connector (to VPI)

WARNING: Both ends of the light guide cable and the distal end of the laparoscope can
become hot and may cause patient or operator burns or thermal damage to
surgical equipment (for example, surgical drapes, plastic material, etc.).

Do not touch the glass tip of the light guide cable or the distal end of the
laparoscope. Do not allow the glass tip of the light guide cable or distal end
of the laparoscope to contact the patient, surgical drape, or any other
flammable material.

Avoid looking at light emitted directly from the ends of the light guide cable
and laparoscope.

26 4-0002428 Rev. K
 To connect the laparoscope to the camera:

▪ Firmly insert the laparoscope eyepiece into the camera until the coupler
rotates to the locked position (see Figure 9).

Figure 9: Connecting the laparoscope to the camera

To disconnect the laparoscope from the camera:

1. Hold both the camera and laparoscope and rotate the coupler toward the
unlock symbol on the camera until it clicks (see Figure 10).

2. Pull the laparoscope straight out.

Figure 10: Disconnecting the laparoscope from the camera

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 27

 If possible, reprocess laparoscopes immediately after use.

Always store laparoscopes securely. Transport laparoscopes to reprocessing

facilities in closed containers to prevent damage to the laparoscopes and
contamination of the environment.

Decontaminated and cleaned, unsterile laparoscopes must be stored in a clean,

dry environment. The storage time of unsterile units is not limited; the units are
made of a non-degradable material which maintains its stability when stored under
the recommended conditions:

▪ Avoid direct sunlight.

▪ Store laparoscopes securely either in the original packaging or in a tray or
container.
▪ Observe the applicable valid national provisions when storing in a sterile
condition.
▪ See Table 13 in Appendix C for the storage conditions

28 4-0002428 Rev. K
 ICG imaging agent 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. ICG is to be administered intravenously.

The Sterile Water for Injection, pH of 5.0 to 7.0, provided with the ICG is used to
reconstitute the ICG.

Instructions for preparation, handling and administration of ICG imaging agent are
provided in this chapter.

Note: Stryker does not distribute ICG – ICG imaging agent should be acquired through
normal hospital channels.

Regulation of ICG varies by country. In certain countries, ICG is not registered for
use as a pharmaceutical product. Contact your local distributor for more
information on the availability of ICG at your location.

WARNING: Refer to the ICG Package Insert prior to use.

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 ICG. 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 half-life of 2.5-3.0 minutes.

ICG contains sodium iodide and should be used with caution in patients who have
a history of allergy to iodides or iodinated imaging agents due to a risk of
anaphylaxis.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 29

 The Imaging System should not be used for NIR imaging during surgical
procedures with patients who are known to be sensitive to iodides or iodinated
imaging agents.

WARNING: Anaphylactic deaths have been reported following ICG administration during
cardiac catheterization.

Each vial of ICG and accompanying Sterile Water for Injection are intended for use
with only 1 patient and within 6 hours of reconstitution. Discard any unused
reconstituted ICG after each surgery is completed or 6 hours have lapsed since
reconstitution. If a precipitate is present upon reconstitution, do not use and discard
the solution.

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 outside packaging of needles, syringes, stopcock, ICG vials, and the Sterile
Water for Injection are NOT sterile. The contents of the ICG vial 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 for injection.

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
Portable Handheld Imaging System Operator’s Manual.

Do not use needles, syringes, stopcocks, ICG vials and Sterile Water for Injection
that appear to have packaging or 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 identified in the ICG Package Insert.

30 4-0002428 Rev. K
 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, for example, epinephrine, antihistamines, and corticosteroids
should be administered. Resuscitative measures may also be required.

WARNING: Do not use any ICG that has been reconstituted for more than 6 hours.

Discard any unused reconstituted ICG after each surgery is completed.

The ICG imaging agent can be reconstituted and prepared for injection either at the
beginning of, or during the surgery, depending on the preference of the surgical
team. Prepare ICG for administration as follows:

1. Remove one (1) 25 mg vial of ICG and one (1) 10 ml vial of Sterile Water for
Injection from the kit.

2. Draw up the 10 ml Sterile Water for Injection into a 10 ml syringe.

3. Remove the flip off cap on the ICG vial (25 mg) and inject the 10 ml of Sterile
Water for Injection through the stopper into the ICG vial.

4. Shake the ICG vial gently to mix.

Note: This yields a 2.5 mg/ml solution of reconstituted ICG.

5. 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 in solution.

WARNING: If precipitation persists, do not use the mixture. Discard the reconstituted vial
and prepare a new vial, as described above.

WARNING: The total dose of ICG injected should be kept below 2 mg/kg of patient body
weight.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 31

 ▪ 10 ml reconstituted ICG solution
▪ Sterile normal saline for injection
▪ 3 ml syringe
▪ 10 ml syringe
▪ 3-way stopcock

For recommended dosage per procedure, see Table 7.

Note: Dosing per procedure will vary based on the procedure and is determined at the
discretion of the imaging surgeon.

Table 7: Recommended ICG Dosage for Perfusion Assessment per Procedure

<90 kg 1.25 0.5

2 mg/kg body weight
>90 kg 2.5-3.75 1-1.5

Increase in dose may be required in those patients exhibiting heavy deposits of fat
on the area of interest being imaged.

Dosing is determined at the discretion of the imaging surgeon.

1. Prior to the NIR imaging procedure, withdraw the desired dosage of ICG
solution for each planned imaging sequence into separate single use 3 ml
syringes.

2. With a single use 10 ml syringe, withdraw 10 ml of sterile saline.

1. Switch to Fluorescence mode using the Illumination button on the

PINPOINT camera.

32 4-0002428 Rev. K
 2. ICG administration is to be performed via a central or peripheral venous line.
Use a three-way stopcock attached to an injection port on the infusion line.
Attach one prepared 3 ml syringe of ICG solution and one prepared 10 ml
syringe of saline solution.

3. Inject the prepared 2.5 mg/ml ICG solution into the line as a tight bolus.

4. Immediately switch access on the stopcock to the syringe containing saline

and briskly flush the ICG bolus through the line with 10 ml of sterile saline.

A fluorescence response should be visible in blood vessels visualized with the

PINPOINT System within 5 to 15 seconds after the injection.

Consumables should be disposed of in compliance with local, regional, and

national regulations.

Single-use or consumable components and accessories such as prepared or

partially used ICG should be disposed of in compliance with regulations for the
disposal of such items.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 33

 This page intentionally left blank.

34 4-0002428 Rev. K
 The PINPOINT camera is designed for single-handed operation with ergonomic
controls. The size and weight of the camera have been optimized to ensure user
comfort during imaging when connected to a laparoscope and light guide cable.

The buttons on the camera can be used to control all PINPOINT system imaging
functions, including:

▪ Turning illumination on and off

▪ Focusing the image
▪ Selecting display modes
▪ Starting and pausing video recording*
▪ Capturing screenshots*
▪ Accessing the VPI Options menu
*These functions are available when a recorder is configured with the system.

The controls and indicators on the PINPOINT camera are shown in Figure 11.

Figure 11: Controls and indicators on the PINPOINT camera

1. Laser-on indicator 3. Display Mode / Menu button

2. Focus buttons (Image capture 4. Illumination button
and recorder control buttons)

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 35

 An overview of primary button functions on the PINPOINT camera is shown in
Figure 12.

Figure 12: Primary button functions on the PINPOINT camera (top view)

Focus buttons Press and hold to focus in

Short press to take a screenshot (if enabled).
Press and hold to focus out
Short press to start or pause video recording (if enabled).

Illumination button From Standby mode:

Press button to turn on white light illumination
With illumination turned on:
Press button to toggle between fluorescence imaging mode and
white light mode
In all modes:
Press and hold at any time to turn off all illumination and return
to Standby mode.
Display Mode / When white-light mode is active:
Menu button
Pressing button has no effect
When fluorescence imaging mode is active:
Press button to cycle through fluorescence display modes.
In all modes:
Press and hold at any time to open the PINPOINT Tools menu.

36 4-0002428 Rev. K
 The VPI provides NIR and white light illumination, video processing, user interface,
and other control capabilities for the PINPOINT system.

The front panel includes buttons for controlling the primary functions of the system,
indicators for power and laser-on, and ports for the PINPOINT light guide and
camera cables (see Figure 13). The rear panel includes the device identification
label and power connection ports (see Figure 4).

Figure 13: Overview of VPI front panel controls and indicators

1. Light guide port 7. Laser warning label

2. Laser-on indicator 8. Power button

3. Power indicator 9. Illumination button

4. Illumination indicator 10. White balance button

5. Menu control indicators 11. Menu button

6. Camera port

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 37

 This page intentionally left blank.

38 4-0002428 Rev. K
WARNING: Proper sterile technique must be used when preparing the camera and
laparoscope for surgical endoscopy. The following components are not
sterile and should not be handled by a sterile operator:

➢ Video Processor / Illuminator (VPI)

➢ Camera Connector

Do not remove the cap of connector while it is in a sterile field.

To prepare the PINPOINT camera and laparoscope:

1. Inspect the laparoscope prior to connecting it to the camera:

▪ Ensure that no parts are missing or loose.

▪ Ensure that the proximal end is dry to prevent the laparoscope from
fogging during examination / procedure.
▪ Ensure that there are no residual cleaning agents or disinfectants on the
laparoscope.
▪ Inspect the entire laparoscope, particularly the shaft, for contaminants and
damage of any type, such as dents, scratches, cracks, bending or sharp
edges.
▪ Inspect distal end, proximal end and irradiation surface of the illumination
fibers for contamination and scratches. Make contaminants and scratches
visible using light reflections. Hold the connection of the optical fibers
against the light and inspect whether the optical fibers illuminate evenly at
the distal end. Contaminants on the irradiation surface of the illumination
fibers can damage fibers, which impacts image quality.
2. Connect the desired laparoscope to the camera following the instructions in
Chapter 2.

Note: High-Definition Imaging Laparoscopes are optimized for imaging with visible light
and will not perform ICG fluorescence imaging. To perform ICG fluorescence
imaging, use an ICG Fluorescence Imaging Laparoscope.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 39

 1. Move the PINPOINT system into an appropriate position for the clinical
imaging procedure.

2. Plug the VPI power cord into an AC wall outlet or isolation transformer.

The power indicator on the front of the VPI above the VPI power button should
illuminate amber.

▪ If the power indicator does not illuminate, check to confirm that the main
power switch (on the rear panel of the VPI) is turned to the ‘on’ position.

▪ If, after confirming that the main power switch is in the ‘on’ position, the
indicator still does not illuminate, please consult Appendix A:
Troubleshooting.

3. Connect the PINPOINT camera to VPI by plugging the camera and light guide
cables into the appropriate ports on the VPI front panel (see Chapter 2 and
Figure 13).

CAUTION: For the PINPOINT camera to initialize correctly, it must be connected to the VPI,
prior to powering on the system.

4. Press the power button on the front panel of the VPI.

The power indicator turns green and the system enters Standby mode. The

Standby mode icon displays in the top-right corner of the video image
(see Figure 14).

Note: In Standby mode, video display is enabled and ventilation fans are on. Illumination
is not active and the video image on the display may be dark.

As the VPI powers on, the PINPOINT System emits dim flashes of colored light.

40 4-0002428 Rev. K
 Figure 14: Onscreen Standby mode icon

Standby mode

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 41

 WARNING: Avoid looking at light emitted directly from the tip of the laparoscope.

In White-light mode, the VPI provides visible-spectrum illumination through the light
guide cable and laparoscope for viewing a white-light image on the system display.

To turn on White-light mode:

▪ Press the Illumination button on the PINPOINT camera (see Figure 15).

OR

▪ Press the Illumination button on the front panel of the VPI.

Figure 15: Illumination button on the PINPOINT Camera

▪ The system displays the white-light image.

▪ On the VPI, the indicator above the Illumination button glows white.

▪ The White-light mode icon displays in the top-right corner of the display
image (see Figure 16).

Note: From Standby mode, pressing the illumination button activates White-light mode.
Fluorescence imaging cannot be activated directly from Standby mode.

42 4-0002428 Rev. K
 Figure 16: White-light mode icon

White-light mode

The color fidelity of the color image may be affected by external sources of white
light, such as surgical lights, overhead lighting, or daylight. Performing a white
balance optimizes the image so that white objects appear white.

Note: It is recommended that a white balance be performed prior to each clinical

procedure.

Illumination must be turned on to perform a white balance.

Always perform a white balance if the image color fidelity appears inaccurate.

A white balance can be performed using the controls on the front panel of the VPI,
or using the buttons on the PINPOINT camera.

To perform a white balance:

1. Hold the laparoscope tip approximately 5 cm (2 inches) from a matte, white

surface such as gauze or white cloth.

2. Press the White Balance button on the front panel of the VPI.

OR

a. Press and hold the Display Mode button to open the Tools menu.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 43

 b. Press the bottom focus button to navigate to the White Balance

icon in the list (see Figure 17).

c. Press the Display Mode button to execute a white balance.

Figure 17: White balance in the Tools menu

An icon will appear in the center of the video image for several seconds to indicate
that the white balance is in progress and the result of the adjustment (see Figure
18).

indicates that white balance has successfully completed. Proceed to use

the PINPOINT system.

indicates that the system has been unable to complete the white balance.
Repeat the white balance procedure.

If the white balance procedure fails a second time, turn off the system power and
contact a qualified Stryker service representative.

44 4-0002428 Rev. K
 Figure 18: Onscreen white balance icons

White balance is active

White balance completed

White balance failed

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 45

 To focus the video image:

1. If the system is in Standby mode, turn illumination on by pressing the

Illumination button on the PINPOINT camera.

2. Hold the laparoscope tip approximately 5 cm (2 inches) from a suitable surface

to be imaged.

3. While viewing the image on the video monitor, press the focus buttons

on the camera (see Figure 19) to achieve a sharp and focused image.

Figure 19: Focus adjustment buttons

An animated focus adjustment icon displays onscreen when either focus

button is pressed (see Figure 20).

If the focus-stop icon displays, the focus has reached the end of its
adjustment range, press the opposite focus button.

46 4-0002428 Rev. K
 Figure 20: Onscreen focus adjustment icon

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 47

 WARNING: Avoid looking at light emitted directly from the tip of the laparoscope.

In Fluorescence Imaging mode, the VPI provides near-infrared spectrum

illumination through the light guide cable and laparoscope for viewing a
fluorescence image on the system display.

Note: It is recommended that a white balance be performed prior to each clinical

procedure (see Performing a White Balance on Page 44).

To turn on Fluorescence Imaging mode:

▪ From White-light mode, press the Illumination button on the PINPOINT

camera (see Figure 21).
Figure 21: Illumination button on the PINPOINT camera

▪ The laser-on indicator LED on the camera and the laser-on indicator on the
front panel of VPI illuminate to indicate that the NIR laser is on (see Figure
22).

▪ The Overlay mode icon displays in the top-right corner of the video
image (see Figure 23).

48 4-0002428 Rev. K
 Figure 22: Laser-on indicator in Fluorescence Imaging mode

1. Laser-on indicator LED

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 49

 In Fluorescence Imaging mode, the PINPOINT System generates a parallel display
showing four simultaneous video feeds on the monitor (see Figure 23).

Figure 23: Parallel display in Fluorescence Imaging mode

1. White-light mode 4. Main display in Overlay mode (current display

mode icon shown in the top corner of the screen)
2. SPY mode 5. Parallel display (3 smaller simultaneous video
images)
3. Overlay mode

Note: For fluorescence imaging using the Overlay display mode, ensure that a
fluorescence imaging laparoscope is used. Attempting to use Overlay mode with
any other laparoscope, including PINPOINT white-light imaging laparoscopes, will
produce an image in which the video screen is flooded with fluorescence signal,
obscuring the white light image.

While Fluorescence Imaging mode is active, up to three different display modes

are available:

▪ Overlay mode – see Figure 24

▪ SPY Color-Segmented Fluorescence (CSF) mode – see Figure 25
▪ SPY mode – see Figure 26

50 4-0002428 Rev. K
Note: The fluorescence display modes which are available in the Display mode cycle can
be configured in the VPI Options Menu (see Appendix B, Display options).

An NIR fluorescence image is superimposed in pseudo-color (green) on a

white light image.

Figure 24: Overlay mode

In SPY Color-Segmented Fluorescence (CSF) mode, a white light image is

displayed in grayscale with NIR fluorescence overlaid in a color scale.
Increasing fluorescence levels transition from blue to yellow to red. A color
legend is provided on the right side of the screen.

Figure 25: SPY CSF mode

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 51

 An NIR fluorescence image is displayed in grayscale.

Figure 26: SPY mode

To cycle through available fluorescence display modes:

1. Turn on Fluorescence Imaging mode.

2. Press the Display mode button on the PINPOINT camera (see Figure 27).

The current Display mode is shown in the main display area of the screen and
the Display mode icon is shown in the top right corner (see Figure 23).

Figure 27: Display mode button on the PINPOINT camera

52 4-0002428 Rev. K
 The PINPOINT System enables the operator to toggle between Fluorescence
Imaging mode and White-light mode at any time during an imaging procedure. The
parallel display option is not available in White-light mode.

To toggle between Fluorescence Imaging mode and White-light mode:

1. On the PINPOINT camera, press the Illumination button .

The White-light mode icon displays in the top right corner of the screen (see
Figure 28).

Figure 28: White-light mode icon

2. In White-light mode, press the Illumination button again to return to

Fluorescence Imaging mode.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 53

 WARNING: Turn illumination off before disconnecting the light guide cable.

To turn off illumination at any time (from White-light mode or Fluorescence Imaging
mode) and return to Standby mode:

▪ Press and hold the Illumination button on the PINPOINT camera.

OR

▪ Press the Illumination button on the front panel of the VPI.

The light guide cable can now be safely disconnected from the laparoscope, or
the laparoscope can be safely removed from the patient (without powering off
the VPI).

To shut down the PINPOINT System at the end of a procedure:

1. Ensure that the system is in Standby mode (see Turning Off Illumination
(Entering Standby Mode)).

2. If using the Sony video recorder (PC9026), press the Stop button on the
recorder to close the video case.

3. Press the power button on the front panel of the VPI. The system shuts
down and the power indicator glows amber, indicating that the main power
switch on the rear panel is in the on position.

4. Power off the Sony recorder.

Note: After the PINPOINT System has been used for the first time, the VPI can be
powered off using the power button on the front panel. It is unnecessary to power
off the system using the main power switch on the back of the VPI.

54 4-0002428 Rev. K
 If the PINPOINT system fails to produce continuous imaging, switch the main
power off (on the VPI rear panel) for five seconds and then switch the power on
again.

The PINPOINT camera, light guide cable, and camera cable should remain
connected to the VPI during this time.

If fluorescence imaging fails to resume:

1. Disconnect the laparoscope from the PINPOINT camera.

2. Use direct visualization through the laparoscope eyepiece in conjunction with

white light illumination to safely conclude the procedure.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 55

 This page intentionally left blank.

56 4-0002428 Rev. K
 The PINPOINT System offers several functions that are independent of the
imaging mode. These functions can be controlled from the PINPOINT Camera at
any time during a clinical imaging procedure:

▪ Using the PINPOINT Tools menu

▪ Starting and pausing video recording
▪ Capturing screenshots
▪ Accessing the VPI Options menu

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 57

 The Tools menu provides access to additional functions at any time during
imaging. When accessed, the tools menu displays overlaid on the left side of the
video image.

Figure 29: Overview of the Tools menu

Flip image (unavailable for PINPOINT camera)

Start and pause video recording

Capture screenshot

Perform white balance

Access VPI Options menu.

To access the Tools menu:

1. Press and hold the Display Mode button at any time during imaging (see
Figure 30).

Figure 30: Display Mode button on the PINPOINT Camera activates the Tools menu

The Tools menu displays on the left side of the screen (see Figure 31).

58 4-0002428 Rev. K
 Figure 31: Tools menu

2. Navigate the menu by pressing the focus buttons, (up) and (down).

3. Press the Display Mode button to activate the selected icon in the menu.

4. To exit the Tools menu and return to a live image at any time, press the

Illumination button .

Video recording can be started and paused from the Tools menu or, if enabled,
using a button on the PINPOINT camera.

Note: MediCapture recorders cannot be controlled from the Tools menu or PINPOINT
camera.

To start and pause video recording:

1. Press and hold the Display Mode button to activate the Tools menu.

2. In the Tools menu, select the Record icon (see Figure 32).

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 59

 Figure 32: Recording icon in the Tools menu

3. Press the the Display Mode button on the camera to start and pause
recording.

A recording-active message displays in the top left corner of the screen during
recording (see Figure 33).

Figure 33: Recording-active message

A recording-paused message displays in the top left corner of the screen when
recording is paused (see Figure 34).

60 4-0002428 Rev. K
 Figure 34: Recording-paused message

If the recorder-unavailable icon displays, see Video Recording and

Screenshot Errors on page 111.

Note: For more information about using the Stryker SDC3TM HD Information Management
System, see the device operating instructions.

To start and pause video recording:

1. Press and hold the Display Mode button to activate the Tools menu.

2. In the Tools menu, select the Record icon (see Figure 35).

Figure 35: Recording icon in the Tools menu

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 61

 3. Press the the Display Mode button to start and pause recording.

A recording icon displays in the top right corner of the screen during
recording (see Figure 36).

Figure 36: Onscreen recording icon

A recording-paused icon displays in the top right corner of the screen

when recording is paused (see Figure 37).

Figure 37: Onscreen recording-paused icon

If the recorder-unavailable icon displays, see Video Recording and

Screenshot Errors on page 111.

Note: For more information about using Sony recorders, see the device operating
instructions.

62 4-0002428 Rev. K
 To start and stop video recording:

1. Press and hold the Display Mode button to activate the Tools menu.

2. In the Tools menu, select the Record icon (see Figure 35).

3. Press the the Display Mode button to start and pause recording.

A recording icon displays in the top right corner of the screen during
recording (see Figure 36).

4. A recording-stopped icon displays in the top right corner of the screen

when recording is stopped.

5. To pause video recording, press the VIDEO/PAUSE button on the front panel

of the recorder. A recording-paused icon displays on the screen. To

resume recording, press the VIDEO/PAUSE button again.

6. To enable playback, press the CLOSE button on the front panel of the
recorder.

If the record icon displays briefly and then disappears, the TEAC recorder
may not be selected in the VPI Service menu. See Video Recording and
Screenshot Errors on page 111.

Note: For more information about using the TEAC UR-4MD recorder, see the device
operating instructions.

Note: This button function is disabled by default and must be enabled in the VPI Options
menu after the PINPOINT System is installed.

1. Press the rear focus button to start recording video (see Figure 38). A
recording icon displays on the monitor.

2. When using a Stryker SDC3 system or Sony recorder, press the rear focus
button again to pause recording. When using a TEAC recorder, press the rear
focus button again to stop recording.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 63

 Figure 38: Start/pause/stop recording button

Screenshots can be captured from the Tools menu or, if enabled, using a button on
the PINPOINT camera.

Note: When using a MediCapture recorder, control from the Tools menu or PINPOINT
camera is not available.

To capture a screenshot:

1. Press and hold the Display Mode button to activate the Tools menu.

2. In the Tools menu, select the Screenshot icon (see Figure 39).

Figure 39: Screenshot icon in the Tools menu

3. Press the Display Mode button to capture the screenshot.

64 4-0002428 Rev. K
 The screenshot thumbnails momentarily display on the screen with the image
number in a picture-in-picture window bar (see Figure 40).

The screenshot will be automatically saved to the system.

Figure 40: Capturing screenshots on the Stryker SDC3

Note: For more information about using the Stryker SDC3TM HD Information Management
System, see the device operating instructions.

To capture a screenshot:

1. Press and hold the Display Mode button to activate the Tools menu.

2. In the Tools menu, select the Screenshot icon (see Figure 41).

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 65

 Figure 41: Screenshot icon in the Tools menu

3. Press the Display Mode button to capture the screenshot.

The screenshot icon momentarily displays in the top right corner of the screen
and the captured screenshot appears briefly in a picture-in-picture window in
the lower-right corner of the screen, followed by the image number (see Figure
42).

The screenshot will be automatically saved to the system video recorder.

Figure 42: Onscreen screenshot display

If the recorder-unavailable icon displays, see Video Recording and

Screenshot Errors on page 111.

Note: For more information about using Sony recorders, see the device operating
instructions.

66 4-0002428 Rev. K
 To capture a screenshot:

1. Press and hold the Display Mode button to activate the Tools menu.

2. In the Tools menu, select the Screenshot icon (see Figure 41).

3. Press the Display Mode button to capture the screenshot.

The screenshot icon momentarily displays in the top right corner of the
screen and the screenshot will be automatically saved to the system video
recorder.

Note: This button function is disabled by default and must be enabled in the VPI Options
menu after the PINPOINT System is installed.

To capture a screenshot directly from the PINPOINT camera:

▪ Press the front focus button (see Figure 43).

Figure 43: Screenshot button

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 67

 The following settings and options can be configured from the menu (see Figure
44):

▪ Image Quality
▪ Display Options (PINPOINT camera)
▪ Default Profile
▪ Load Profile (1-4)
▪ Save Profile
▪ Service
▪ Exit
▪ Language
For more information about the VPI Options menu, see Appendix B.

Figure 44: Options and settings that are available from the VPI Options menu

68 4-0002428 Rev. K
 To access the VPI Options menu from the PINPOINT camera:

1. Press and hold the Display Mode button to open the Tools menu. Press

the bottom focus button to navigate to the wrench icon in the list
(see Figure 45).

Figure 45: Accessing the VPI Options menu in the Tools menu

2. Press Display Mode button again to open the VPI Options menu (see
Figure 46).

3. To exit the VPI Options Menu and return to a live image at any time, press the

Illumination button .

Figure 46: Display screen showing the VPI Options menu overlying the video image

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 69

 When the VPI Options menu is displayed on the monitor, it can be navigated using
the buttons on the PINPOINT camera.

To navigate the VPI Options menu using the PINPOINT camera:

1. With the VPI Options menu open, navigate by pressing the focus buttons,

(up) and (down).

2. Press Display Mode button to select the highlighted options in the menu.

The control indicators on the front panel of VPI also illuminate to reveal a down
arrow (Illumination button), up arrow (White Balance button) and right arrow
(Menu button). The buttons in the VPI front panel can also be used to navigate
the Options menu directly from the VPI.

3. Press the Illumination button on the camera to exit the VPI Options menu.

Note: If no menu selection is made within approximately 15 seconds, the VPI Options
menu will timeout and automatically exit.

To access and navigate the VPI Options menu from the VPI front panel:

▪ Press the Menu button on the VPI front panel.

▪ Press the illuminated Down arrow (Illumination button), Up arrow (White
Balance button) and Right arrow (Menu button) to navigate the menu (see
Figure 47).
▪ To return to a higher level of the menu, select the back item on the monitor,
indicated by “ ”, and press the Right arrow button to select.

70 4-0002428 Rev. K
 Figure 47: Menu controls on the VPI front panel

For more information about the User Menu, see Appendix B.

Note: When it appears on the display, the VPI Options Menu will obstruct the video
image. It is therefore not intended to be used during a clinical procedure (see
Figure 46).

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 71

 The following are image quality settings that a user can configure. For a more
complete description of these settings refer to Appendix B.

Sharpening From 0 to 10 Larger values increase image

sharpening

Brightness From 0 to 255 Larger values increase image

brightness

Red Saturation From 0 to 1024 Larger values increase red saturation—

red objects look more deeply red

Blue Saturation From 0 to 1024 Larger values increase blue

saturation—blue objects look more
deeply blue

Peak / Mean Peak Select Peak to set the brightness for

Mean viewing small, foreground objects that
Balanced are closer to the front of the
laparoscope.
Select Mean to set the brightness by
weighting the adjustment more by the
mean brightness of the scene and less
by the brightest points.
Select Balanced to set the brightness
by balancing the Peak and Mean
settings.

To adjust an image quality setting:

1. Press the Menu button on the front panel of the VPI or select the VPI Options

menu in the Tools menu .

2. On the menu, select Image Quality.

3. Press the Up or Down arrow button to highlight the desired image setting.

4. Press the Right arrow button or the button to select.

5. Press the Up or Down arrow button to adjust the setting. The setting takes
effect immediately and is visible in the image.

72 4-0002428 Rev. K
 6. Press the Right arrow button or the button to deselect when done.

To select available fluorescence display modes:

1. Press the Menu button on the front panel of the VPI or select the VPI Options

menu in the Tools menu .

2. Highlight Display Options and press the Right arrow button or the button
to select.

3. Press the Up or Down arrow button to choose the desired display options.

4. Press the Right arrow button or the button to select or deselect.

To restore the Image Quality settings and Display Modes selections to the default
settings:

1. Press the Menu button on the front panel of the VPI or select the VPI Options

menu in the Tools menu .

2. Highlight Default Profile and press the Right arrow button or the button
to select.

Load User Profiles allows the user to retrieve a previously saved set of
configurable settings:

▪ Display Modes
▪ Image Quality
▪ On-screen Info
Up to 4 profiles are available.

To load a profile:

1. Press the Menu button on the front panel of the VPI or select the VPI Options

menu in the Tools menu .

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 73

 2. Highlight Load Profile “#” and press the Right arrow button or the button
to select.

Save Profile allows the user to save a set of configurable settings for future use.
These settings include:

▪ Display Modes
▪ Image Quality
▪ On-screen Info
Up to 4 profiles are available.

To save a profile:

1. Press the Menu button on the front panel of the VPI or select the VPI Options

menu in the Tools menu .

2. Highlight Save Profile and press the Right arrow button or the button to
select.

3. Press the Up or Down arrow button to choose the profile number to save to.

4. Press the Right arrow button or the button to select the profile.

Selecting Service in the menu will display device specific information about the
device.

To view the VPI properties:

1. Press the Menu button on the front panel of the VPI or select the VPI Options

menu in the Tools menu .

2. Highlight Service and press the Right arrow button or the button to
select.

74 4-0002428 Rev. K
 To select the recorder used with the system and enable recorder control from the
Tools menu:

1. Press the Menu button on the front panel of the VPI or select the VPI Options

menu in the Tools menu .

2. Highlight Service and press the Right arrow button or the button to
select.

3. Highlight Recorder Setup and press the Right arrow button or the button
to select.

4. Press the Up or Down arrow button to choose a recorder from the list.

5. Press the Right arrow button or the button to select.

The focus buttons on the PINPOINT Camera have two optional function presets:

▪ Focus only
▪ Focus, start/pause record, capture screenshot
To set the focus button functions:

1. Press the Menu button on the front panel of the VPI or select the VPI Options

menu in the Tools menu .

2. Highlight Service and press the Right arrow button or the button to
select.

3. Highlight Recorder Setup and press the Right arrow button or the button
to select.

4. Press the Up or Down arrow button to choose a recorder from the list.

5. Press the Right arrow button or the button to select.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 75

 To turn on or turn off the image information that appears on the bottom-left corner
of the screen:

1. Press the Menu button on the front panel of the VPI or select the VPI Options

menu in the Tools menu .

2. Highlight Service and press the Right arrow button or the button to
select.

3. Highlight Focus Button (PINPOINT Camera) and press the Right arrow button

or the button to select.

4. Press the Up or Down arrow button to choose between Focus and Focus -
Record.

5. Press the Right arrow button or the button to select.

To display a test pattern on the screen, complete the following steps:

1. Press the Menu button on the front panel of the VPI or select the VPI Options

menu in the Tools menu .

2. Highlight Service and press the Right arrow button or the button to
select.

3. Highlight Test Patterns and press the Right arrow button or the button to
select.

4. Press the Up or Down arrow button to choose the desired test pattern.

5. Press the Right arrow button or the button to display the test pattern.

6. Press the Right arrow button or the button to exit the test pattern when
done.

76 4-0002428 Rev. K
 To change the language setting, complete the following steps:

1. Press the Menu button on the front panel of the VPI or select the VPI Options

menu in the Tools menu .

2. Highlight and press the Right arrow button or the button to

select.

3. Highlight the desired language and then press the Right arrow button or the

button to select.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 77

 This page intentionally left blank.

78 4-0002428 Rev. K
 The following chapter describes required processing (cleaning and sterilization) for
PINPOINT System components.

WARNING: The PINPOINT components must be cleaned and sterilized prior to the first
use and after every subsequent use. Follow the instructions provided in this
manual.

Prior to cleaning, disinfection, or sterilization, separate the camera head, and

laparoscope. Also, remove any adapters from the light guide cable and
laparoscope. Failure to follow this instruction will render the devices non-
sterile.

Use only the sterilization cycles outlined in this guide. Using unspecified
sterilization cycles can damage the device or result in incomplete
sterilization.

Failure to power off the VPI before starting to clean may expose personnel to
unsafe conditions and result in damage to the system.

Because some components will likely be contaminated with human blood or

body fluids capable of transmitting pathogens, all cleaning facilities must be
in compliance with (U.S.) OSHA Standard 29 CFR 1910.1030 “Bloodborne
Pathogens” or an equivalent standard. For more information, visit
www.osha.gov.

WARNING: Availability of cleaning and sterilization products varies by country, and

Stryker is unable to test products in every market. For more information,
please contact Customer Support or your local representative.

Ensure that you follow the manufacturer’s instructions for handling or

disposing of the cleaning or sterilization solutions provided in this manual.

Do not reuse, reprocess or re-sterilize single-use components. Reuse,

reprocessing or re-sterilization may create a risk of contamination of the
device or cause patient infection or cross-infection.

Since no reprocessing methods have been validated for removal of

transmissible spongiform encephalopathy (TSE) agents from these devices,
the light guide cable and the PINPOINT camera should not be used for
patients with known or suspected TSE agent disease, including Creutzfeldt-
Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD).

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 79

 CAUTION: To minimize galvanic corrosion, avoid soaking dissimilar metals in close
proximity.

Inspect camera head cables and light guide cables for cuts and breaks
before soaking in any fluid. See the Inspection section for more information.

Do not pull, stretch, kink, puncture, or otherwise alter the light guide cables.
Doing so will cause irreversible damage to the glass optical fibers, which will
impair light transmission through the cable.

Brush carefully around light guide cable tips to avoid damaging the optical
fibers, or light transmission loss can occur.

Do not process the VPI. The device is not designed to withstand the
procedures described in this guide. To properly clean the VPI:

▪ 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.

80 4-0002428 Rev. K
 The following table uses the Spaulding classification to define the minimum level of
sterilization required for each PINPOINT component.

Table 8: Spaulding Classification and Minimum Reprocessing Requirements for PINPOINT

Components

Laparoscopes Nonsterile Reusable Critical

Light Guide 1
Nonsterile Reusable Non-Critical
Cable

Camera Nonsterile Reusable Non-Critical 1

VPI Nonsterile Reusable Non-Critical2

Cart Nonsterile Reusable Non-Critical2

Insufflator Nonsterile Reusable Refer to Insufflator

Instructions

Monitor Nonsterile Reusable Refer to Manufacturer’s

Instructions

Refer to Manufacturer’s
Recorder Nonsterile Reusable
Instructions

Refer to Manufacturer’s
Printer Nonsterile Reusable
Instructions

Sterilization 4
Nonsterile Reusable Non-Critical
Trays

Introducer Nonsterile Single Use DO NOT REPROCESS. Dispose after use.

indicates the minimum required reprocessing level

1 The PINPOINT camera and light guide cable are classified as non-critical, but both must be sterilized because they enter the
sterile field and are subject to aseptic technique.
2 Clean the VPI or cart when visibly soiled and at regular intervals, as per a schedule established by the medical care facility or
provider.
3 Optional accessories vary based on regional and customer configuration.
4 Sterilization trays are classified as non-critical, but are sterilized during sterilization of PINPOINT components.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 81

 The user shall supply all materials and equipment required to process the device
unless otherwise noted. This section is an overview of materials for all
components. Consult the component specific cleaning sections to verify compatible
methods for that component.

Item Description or Purpose

All Phases

Wear personal protective equipment (PPE) as required by the

Gloves, eye protection, etc.
medical facility and procedure

Cleaning/Thermal Disinfection

Large enough to accommodate the device without causing

Water basin or sink excessive bending or other physical stress that could damage the
device

Detergent1 To remove surgical debris during automated and manual cleaning

Utility Water Water as it comes from the tap. Used to rinse during pre-treatment
and to prepare cleaning solutions

Soft-bristle brush2 To clean exterior of device and hard-to-reach areas of the device

Bottle brush To clean dead-end holes or hard-to-reach areas of the device

Water that has been extensively treated, such as RO/DI or

Critical Water3
distilled. Used for final rinsing following soaking and brushing.

Clean cloth or filtered pressurized

For drying
air (≤40 psi)

Automated Washer For executing automated cleaning/thermal disinfection procedure

Sterilization

• Sterrad® 100S, NX®, NX ALLClear®, 100NX®, or 100NX

ALLClear
Sterilization System • Steris/Amsco® V-PRO® 1, V-PRO 1 Plus, V-PRO maX, V-
PRO maX 2, or V-PRO 60
• Steam (autoclave)

Sterilization Tray Sterilization tray (PC9017 or PC9018) supplied by Stryker

82 4-0002428 Rev. K
1Thefollowing detergents were validated for cleaning efficacy according to the detergent manufacturer’s instructions.
Choose one (1) detergent listed below or a substantially equivalent detergent. Do not exceed the concentration and
temperature recommended by the detergent manufacturer.

Minimum
Detergent Type Minimum Soak Time
Concentration

Prolystica® HP
1/4 oz/gallon
Enzymatic Enzymatic 1 minute
(2 ml/L)
(1C22/1C24) – pH: 8.0

Prolystica HP
1/4 oz/gallon
Neutral Detergent Neutral 1 minute
(2 ml/L)
(1C21/1C27) – pH: 8.0

Prolystica HP
1/4 oz/gallon
Alkaline Alkaline 1 minute
(2 ml/L)
(1C20/1C26) – pH: 11.0

2Cleaning was validated with an M16 soft-bristle brush.

3Reverse Osmosis/Deionized (RO/DI) water was validated for efficacy.

▪ Do not cross-sterilize the device. Using multiple sterilization methods can

significantly reduce the performance of the device.
▪ Damage caused by improper processing is not covered by the warranty.
▪ Improper processing will negate the responsibility of Stryker for the
performance of the device.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 83

 Reprocessing laparoscopes and light guide cables requires a four-step process:

Step 1 Prepare
Step 2 Clean
Step 3 Inspect
Step 4 Sterilize

WARNING: Following all four steps is critical to ensuring the component is ready for use.
Failure to properly prepare and clean the devices could result in
contaminated components after reprocessing.

CAUTION: Laparoscope optics may be damaged if the instruments are dropped. Always
handle with care.

Handle the light guide cable with care as damage to the protective outer cover
causes damage to fiber optic light guide cable. Protect the light guide cable from
bending tightly which may damage the inner fiber bundle. It is very important to
prevent impacts, especially to the fused light entry, as this can lead to the
destruction of the fusing.

Polishing paste is included with the laparoscope. If any of the three optical surfaces
(distal end, light guide cable connector, or proximal end) have deposits that cannot
be removed in normal cleaning practices, they can be removed with polishing paste
prior to cleaning, disinfection, and sterilization.

1. Apply a small amount of polishing paste to a clean cotton swab.

2. Gently rub the cotton swab on the optical surface, cleaning in a circular motion.

3. Use acetone or alcohol on a clean cotton swab to remove the paste residue.

4. Clean and sterilize the laparoscope before its next use.

CAUTION: Polishing optical surfaces should not be part of routine cleaning procedures.
Repeated application of polishing paste to the laparoscope lens can cause
damage. It should only be performed when the laparoscope image is cloudy due to
deposits that cannot be removed in normal cleaning practices.

84 4-0002428 Rev. K
 1. Wipe excess soil from the device.

2. Prevent soil from drying by keeping the device moist until it is ready for further
processing.

1. Transport the device in a tray to avoid damage. Follow the facility’s internal
procedures for the transportation of contaminated surgical instruments and
devices.

2. Process the device as soon as possible following use.

1. Disconnect the device from all other devices.

2. Disassemble the device as instructed in Figures 48 and 49.

Figure 48: Removing the adapters from the laparoscope

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 85

 Figure 49: Removing the adapters from the light guide cable

WARNING: Compatibility with an ultrasonic treatment has not been evaluated and it can impact
functional performance.

CAUTION:

▪ Do not use brushes or pads with metal or abrasive materials to clean or

disinfect the device, as permanent scoring or damage could result.
▪ Do not allow the device to remain in any solution longer than the
manufacturer’s indicated times, as corrosion or damage could result.
▪ Exposure to excessive pH will strip protective coatings from metals, especially
aluminum.

1. Rinse the device under cool, running utility water to remove gross soil from
device. Ensure all external surfaces and any accessible internal surfaces are
rinsed.

2. Drain excess water from the device.

3. Follow the instructions for manual or automated cleaning.

86 4-0002428 Rev. K
 1. Soak

a. Prepare a fresh solution of detergent with utility water according to the

detergent manufacturer’s instructions.
b. Immerse the device in the detergent solution, ensuring the solution
contacts all inner and outer surfaces.
c. Soak the device in the solution according to the detergent manufacturer’s
recommendations.
2. Brush

a. With the device immersed in the solution, thoroughly brush the exterior
with a soft-bristle brush. Focus brushing on dead-end holes and mated or
rough surfaces.
b. Actuate and brush any movable parts in all extreme positions.
c. With the device immersed in the solution, use a bottle brush to thoroughly
clean any dead-end holes or hard-to-reach areas of the device.
3. Rinse

a. Rinse the device with critical water until all detergent residue is removed.
b. Once all detergent residue is removed, continue to rinse for 10 seconds.
c. Drain excess water from the device and dry it using a clean, lint-free cloth
or pressurized air.
d. Visually inspect the device for cleanliness, paying close attention to hard-
to-reach areas. If visible soil remains, repeat steps 1-3.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 87

 WARNING: Disinfecting the product is NOT a substitute for sterilization as part of the
reprocessing process. The product must be sterilized prior to use on a patient.

1. Place the device in the automated washer (on an incline, if feasible, to facilitate
drainage).

2. Select the washer-disinfector cycle. A low-impingement cycle is recommended.

The following minimum and maximum washer parameters have been validated for cleaning
efficacy and device functionality:

Pre-Wash 1-2 minutes Cold water N/A

Enzyme Wash (optional) 1 minute 43–50 °C (110–122 °F) Enzymatic

Main Wash 2-4 minutes 43–66 °C (110–151 °F) Neutral or Alkaline

Rinse 1 1-2 minutes 43–66 °C (110–151 °F) N/A

Thermal Rinse 1-5 minutes 90–93 °C (194–199 °F) N/A

Dry Phase 3-15 minutes High (≤115 °C or 239 °F) N/A

3. Drain excess water from the device and dry it using a clean, lint-free cloth or
pressurized air.

4. Visually inspect the device for cleanliness, paying close attention to hard-to-
reach areas. If visible soil remains, repeat steps 1-4.

Note: Thermal disinfection value A0 ≥3000 may be utilized for compatible devices.
Do not exceed the time and temperature specified in the table above.

88 4-0002428 Rev. K
 Inspect the laparoscope before each use. If a problem relating to functionality or
appearance is observed or suspected, the device should be returned to Stryker for
repair.

1. Inspect all surfaces of the laparoscope before each use. If a problem is

observed or suspected – such as (but not limited to) cracks, rough surfaces,
sharp edges, protrusions, dents, bends, excessive wear, moisture ingress,
discoloration, or signs of mechanical or thermal damage – the device should
be returned to Stryker for repair.

2. Test the image quality of the laparoscope before each use. The image shall not
be dark, blurry, or cloudy, or have any obstruction, debris, or abnormalities in
the field of view. Also ensure that light is transmitting efficiently from the light
guide connector to the distal end. Fiber transmission can be evaluated by
orienting the light post toward an overhead light and looking at the fiber
illumination pattern at the distal end of the laparoscope. If a problem is
observed that cannot be resolved from cleaning or polishing the optical
surfaces, the device should be returned to Stryker for repair.

3. Inspect all components for cleanliness. If fluid or tissue buildup is present,

repeat the cleaning and sterilization procedures in this user guide.

4. Inspect the optical surfaces of the laparoscope for clarity. If there are deposits
that need to be removed, follow the instructions in the “Using Polishing Paste”
section.

Inspect light guide cables and adapters before each use.

If a problem relating to functionality or significant appearance degradation, such as

but not limited to the following, is observed or suspected, discontinue use
immediately and contact your Stryker representative.

Inspect light guide cables for:

1. Significantly diminished light output

a. Point one end of the light guide cable toward a light source such as a
window or lamp.
b. Visually check the other end of the cable for dark spots. Dark spots
indicate broken optical fibers.
c. If the dark spots cover more than 20 to 25% of the light-output surface,
discard the light guide cable.
d. Inspect the light entry and exit surfaces of the light guide cable to ensure
they are smooth and clean. Debris deposits on these surfaces may result
in insufficient light output. Continued use of light guide cables with debris
may result in progressive damage to the laparoscope.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 89

 e. Verify that the proximal and distal glass surfaces are clean and free of
debris. Remove any soil or debris deposits using:
i. Appropriate cleaning pastes (supplied with the laparoscopes)

OR

ii. Cotton swabs soaked in alcohol

2. Significant physical damage at the proximal or distal ends of the cable such as:

▪ Connectors bulging through the overmold

▪ Inability to connect or disconnect to supported devices

▪ Corrosion

▪ Sharp edges

3. Tearing, peeling, or other gaps in the cable sheath

Inspect light guide cable adapters for:

1. Corrosion or discoloration

2. Pitting, sharp edges or protrusions

3. Binding, excessive wear, or abnormal noises

90 4-0002428 Rev. K
WARNING: Laparoscopes must be sterilized in the sterilization tray (PC9017) supplied by
Stryker.

WARNING: Maintain sterilization trays regularly and per the manufacturer’s instructions
provided on Case Medical’s website.

WARNING: DO NOT Use “Immediate Use” autoclave sterilization (formerly known as

flash sterilization).

CAUTION: Ensure that optical surfaces do not contact hot metal surfaces, as this may damage
the entire system.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 91

 1. Clean, inspect, and prepare the device as recommended in this operator’s
manual.

2. Ensure that all devices are disassembled for sterilization; refer to Figure 48
and 49.

3. Insert four new filters, provided in the sterilization accessories kit (PP9076 or
PP9066), two each in both the sterilization tray (PC9017) bottom and lid as
shown in the following figures. The tray must be clean and dry prior to use.

WARNING: Using the incorrect filters will result in the product not being properly
sterilized and may lead to the failure of the sterile barrier.

All four filters must be replaced with new filters prior to sterilization.

Figure 50: Installing filters in the sterilization tray (PC9017) bottom

92 4-0002428 Rev. K
 Figure 51: Installing filters in the sterilization tray (PC9017) lid

4. Pack the cleaned, dried, and inspected laparoscopes in the sterilization tray
(PC9017) supplied by Stryker (see Figure 52).

Figure 52: Packing the laparoscopes

5. Mount the cable basket onto the four posts and then pack the clean, dried, and
inspected light guide cable in the cable basket (see Figure 53).

Figure 53: Packing the light guide cable

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 93

 6. Pack the clean, dried, and inspected laparoscope and light guide cable
connectors in the connector basket (see Figure 54).

Figure 54: Packing the connectors

7. Secure the lid to the sterilization tray (PC9017) and apply the tamper-evident
seals (see Figure 55).

Figure 55: Tamper-evident seals

Note: The color of the seal will vary depending on the sterilization process used.

8. Sterilize the sealed sterilization tray (PC9017) supplied by Stryker using one of
the methods below.

94 4-0002428 Rev. K
 Perform one of the following sterilization cycles.

Sterrad 100S Standard

Sterrad NX Standard

Sterrad NX ALLClear Standard

Sterrad 100NX Standard

Sterrad 100NX ALLClear Standard

V-PRO 1 Sterilizer Standard

V-PRO 1 Plus Sterilizer Non-Lumen or Lumen

V-PRO maX Sterilizer Non-Lumen or Lumen

V-PRO 60 Sterilizer Non-Lumen or Lumen

V-PRO maX 2 Sterilizer Non-Lumen or Lumen

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 95

 Note: The water used in the autoclave process must meet standards for clean steam per
AAMI ST79 Annex – Steam Quality.

Temperature 132°C (270°F) 134–137 °C (273–279 °F) 134°C (273°F)

Exposure Time 4 minutes 3-5 minutes 18 minutes2

Dry Time3 30 minutes (minimum, in chamber)

1
Caution: The Prion Cycle is only validated for use with the laparoscope. Do not use this cycle for
the light guide cable or the camera.

2
Caution: This cycle, recommended for control or elimination of Transmissible Spongiform
Encephalopathies, may be used. However, a device exposed to a long cycle should be expected to
have reduced functional life.

3
Drying time depends on several variables; including altitude, humidity, preconditioning, size of
chamber, mass of load, and placement in the chamber. Users must verify that drying time set in their
autoclave yields dry surgical equipment.

WARNING: After sterilization, allow all devices to cool to room temperature and dry
completely before reassembly and reconnection to consoles. Any moisture
on the device can cause fog during use, resulting in potential image
occlusion.

96 4-0002428 Rev. K
 The device’s service life is largely determined by wear, processing methods, and
any damage resulting from use. To extend the time between device servicing,
always follow the care and handling instructions in this user manual.

Before each use, test the device functionality and inspect it for any sign of damage
per the Inspection section. If the device does not function properly or appears to be
damaged, return it to Stryker for evaluation and possible repair or replacement.
Repairs through Stryker as the equipment manufacturer bring the device back to
manufacturer specifications. Clean and (when applicable) sterilize all potentially
contaminated devices before returning them to Stryker.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 97

 These processing instructions are provided in accordance with the below
referenced standards. While they have been validated by Stryker as being capable
of preparing the device for re-use, the end user is responsible for ensuring that the
processing, as actually performed (using equipment, materials, and personnel in
the processing facility), achieves the desired result. This normally requires routine
monitoring and validation of the facility’s processing procedures. Stryker
recommends users observe these standards when processing medical devices.

1. AAMI TIR12: Design, testing and labeling reusable medical devices for
reprocessing in healthcare facilities: a guide for medical device manufacturers

2. AAMI TIR30: A compendium of processes, materials, test methods, and

acceptance criteria for cleaning reusable medical devices

3. AAMI TIR34: Water for reprocessing of medical devices

4. ANSI/AAMI ST58: Chemical sterilization and high-level disinfection in health

care facilities

5. ANSI/AAMI ST77: Containment devices for reusable medical device

sterilization

6. ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility

assurance in healthcare facilities

7. ISO 15883-1: Washer-disinfectors — Part 1: General requirements, terms and

definitions and tests

8. ISO 17664: Sterilization of re-usable instruments — Information to be provided

by the manufacturer for the processing of resterilizable re-usable instruments.

98 4-0002428 Rev. K
 Reprocessing the PINPOINT camera requires a four-step process:

Step 1 Preparation
Step 2 Manual Cleaning
Step 3 Inspection
Step 4 Sterilization

WARNING: Following all four steps is critical to ensuring the component is ready for
use. Failure to properly prepare and clean the device could result in a
contaminated component after reprocessing.

When preparing and cleaning, ensure all foreign matter is removed from the
surface of the device. This allows the active ingredients of the sterilization method
to reach all the surfaces of the device.

CAUTION: Do not clean the PINPOINT camera using an ultrasonic bath.

CAUTION: Do not use metal or abrasive brushes, scrub pads, or rigid tools when cleaning the
PINPOINT camera. The optical elements can be scratched, permanently damaging
the equipment.

Note: The PINPOINT camera may be contaminated by contact with human tissue and
fluids during clinical use. To avoid drying of blood, protein, and other substances
on the camera, prepare it for cleaning within one hour after use.

Detailed pre-treatment instructions:

1. Fill a wash basin with lukewarm water.1

2. Measure and dispense enzymatic detergent into the water based on the
detergent manufacturer instructions.2

3. Gently mix the detergent into the water by hand.

4. Submerge the device into the prepared wash basin.

5. With the device immersed in the solution, thoroughly brush the exterior with a
soft-bristled brush, focusing on any mated or rough surfaces.

6. Actuate and brush any movable parts in all extreme positions.

7. Rinse each device with water1 until all detergent residue is removed.

8. Once all detergent residue is removed, continue to rinse for 30 seconds.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 99

 9. Drain excess water from the device and dry it using a clean cloth or
pressurized air.

10. Visually inspect each device for cleanliness, paying close attention to hard-to-
reach areas (see Figure 56).
1 Reverse Osmosis/Deionized water (RO/DI) at 30°C was used for validating cleaning efficacy.

2 Neodisher MediClean Forte will work at a ratio of 5-30 ml/L.

Figure 56: Hard to reach areas on the PINPOINT camera

100 4-0002428 Rev. K

WARNING: The pre-cleaning steps described in preparing the PINPOINT camera should
always be performed prior to cleaning the PINPOINT camera.

WARNING: Strictly adhere to the instructions provided by the cleaning agent

manufacturer to determine concentration and exposure time.

CAUTION: Excessive concentrations of cleaning solution or excessive soaking time can

permanently damage the PINPOINT camera.

CAUTION: Do not use the following substances as cleaning agents or disinfectants:

➢ Organic, mineral or oxidizing acids (minimum acceptable pH 5.5)

➢ Strong alkalis (maximum acceptable pH 11; neutral/enzymatic or slightly
alkaline detergent recommended)
➢ Organic solvents (for example., alcohols, ethers, ketones, benzenes)
➢ Oxidizing agents (for example, hydrogen peroxide)
➢ Halogens (for example, chlorine, iodine, bromine)
➢ Aromatic/halogenated hydrocarbons
➢ Oils

CAUTION: Do not scratch contaminants off the camera using hard instruments as this can
damage the lens, cable, or buttons.

▪ Use freshly prepared solutions only.

▪ Use sterile or low-bacteria (up to 10 bacteria/ml) and low-endotoxin (maximum
0.25 EU/ml) water (e.g., purified or highly purified water).
▪ Use filtered air for drying.
▪ Corrosion on the product can occur from using chloride-containing water,
therefore, fully demineralized water should be used for the final rinse
procedure
▪ The cleaning agents used must be dispensed according to the prescription of
the manufacturer.

After preparation and following the General Practice guidelines, manually clean the
PINPOINT camera according to the following detailed manual cleaning instructions.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 101

 Note: Ensure that the camera connector cap is secured over the connector during the
cleaning process.

Detailed manual cleaning instructions:

1. Prepare a fresh solution of enzymatic detergent2 with lukewarm water1.

2. Wipe the entire surface of the device using a soft clean cloth dipped in the
detergent solution.

3. Immerse the device in the detergent solution, ensuring the solution contacts all
inner and outer surfaces.

4. Soak the device in the solution according to the manufacturer’s

recommendations.3

5. With the device immersed in the solution, thoroughly brush the exterior with a
soft-bristled brush, focusing on any mated or rough surfaces.

6. Actuate and brush any movable parts in all extreme positions.

7. Rinse each device with water1 until all detergent residue is removed.

8. Once all detergent residue is removed, continue to rinse for 30 seconds.

9. Drain excess water from the device and dry it using a clean cloth or
pressurized air.

10. Visually inspect each device for cleanliness, paying close attention to hard-to-
reach areas.
1 Reverse Osmosis/Deionized water (RO/DI) at 30°C was used for validating cleaning efficacy.

2 Neodisher MediClean Forte will work at a ratio of 5-30 ml/L.

3 Neodisher MediClean Forte recommends a soaking time of 5 minutes.

102 4-0002428 Rev. K

CAUTION: A PINPOINT camera with a damaged glass surface, impaired image quality, or any
deformation (for example, unintended rough surfaces, sharp edges, or protrusions)
may no longer be used and should be discarded or returned for repair.

After cleaning, inspect the camera for corrosion, damaged surfaces, chips, or
contamination. Soil may accumulate on the surfaces of mechanics and optics. If
the PINPOINT camera is found to be contaminated, it must be cleaned again
following the procedures described in Steps 1 and 2.

To inspect the PINPOINT camera:

1. Inspect all surfaces of the camera to ensure it has no

▪ damage
▪ sharp edges
▪ dents
▪ cracks
▪ signs of mechanical or thermal damage
2. Verify that the proximal and distal glass surfaces are clean and free of debris.
Remove any soil or debris deposits using cotton swabs soaked in alcohol.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 103

 After proper cleaning and inspection, the PINPOINT camera may be sterilized
using the sterilization tray (PC9018) supplied by Stryker.

WARNING: Maintain sterilization trays regularly and per manufacturer’s instructions.

WARNING: Follow sterilizer manufacturer’s instructions.

WARNING: Relevant, national/regional legal regulations must be observed.

CAUTION: DO NOT use autoclave cycles to sterilize the PINPOINT camera.

To sterilize the PINPOINT camera using the Stryker Sterilization Tray (PC9018):

1. Insert three new filters provided in the sterilization accessories kit (PP9066):
two in the sterilization tray (PC9018) bottom and one in the lid (see Figure 57
and Figure 58).

The sterilization tray (PC9018) must be clean and dry prior to use.

WARNING: Using the incorrect filters will result in the product not being properly
sterilized and may lead to the failure of the sterile barrier.

All three filters must be replaced with new filters prior to sterilization.

104 4-0002428 Rev. K

 Figure 57: Installing filters in the sterilization tray (PC9018) bottom

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 105

 Figure 58: Installing the filter in the sterilization tray (PC9018) lid

2. Pack the cleaned, dried, and inspected PINPOINT camera in the sterilization
tray (PC9018) supplied by Stryker (see Figure 59 and Figure 60).

Ensure that the connector cap is secured over the connector.

Figure 59: Packing the PINPOINT camera for sterilization

106 4-0002428 Rev. K

 Figure 60: Securing the PINPOINT camera and connector

3. Secure the lid to the sterilization tray (PC9018) and apply the tamper-evident
seals (see Figure 61).

Figure 61: Tamper-evident seals

Note: The color of the seal will vary depending on the sterilization process used.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 107

 4. Sterilize the sealed sterilization tray (PC9018) supplied by Stryker using one of
the methods in Table 10.

Table 10: Validated Sterilization Methods for the PINPOINT Camera

PINPOINT STERRAD 100NX Standard Cycle

CAMERA
PC9002 STERRAD NX Standard Cycle

STERRAD 100S Short Cycle

STERIS V-PRO 1 Standard

STERIS V-PRO 1 Plus Lumen or Non-lumen Cycles

STERIS V-PRO maX Lumen or Non-lumen Cycles

108 4-0002428 Rev. K

WARNING: Do not use PINPOINT if any part of the system is damaged or does not
function properly. Failure to follow this warning may lead to injury.

PINPOINT contains no user serviceable parts. Do not attempt to open PINPOINT

components. Refer all servicing to a qualified Stryker service representative.

As the system enters Standby mode, it will initialize the connected camera. If a

communication error is detected, the camera-failed error icon will display

and there will be no illumination (see Figure 62). If this error occurs:

1. Power off the VPI.

2. Disconnect and reconnect the PINPOINT camera, and then power on the VPI
again to clear the error.

3. If the camera fails a second time, turn the VPI power off and contact a qualified
Stryker service representative.

Figure 62: Camera-failed icon

Camera failed

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 109

 If the system detects an illumination failure, the illumination-failed icon
displays (see Figure 63).

If an Illumination-failure error occurs:

1. Press the illumination button on the VPI twice to clear the error.

2. If the illumination fails a second time, turn off the system power off and contact
a qualified Stryker service representative.

Figure 63: Onscreen Illumination-failed icon

Illumination-failed

110 4-0002428 Rev. K

 If the VPI is not configured for recording and Video Recording or Screen Capture is
selected, or when a PINPOINT camera is connected and Image Flip is selected,
the icons in Figure 64 display in the Tools menu.

If the VPI is configured for recording but not properly connected to the recorder, or
the recorder is unresponsive and Video Recording or Screen Capture is selected,
the screen may momentarily pause (<0.5s) before returning to normal without
providing confirmation of the recording occurring.

Figure 64: Recorder or image flip unavailable icons in the Tools menu

Image Flip unavailable – Image Flip cannot be

enabled when using the PINPOINT camera

Recorder unavailable when video record selected

Recorder unavailable when screenshot selected

To select the recorder in the VPI Options menu, see Recorder Setup on page 72.

For more information about configuring Sony recorders, see Setting Up the Sony
1000MD Recorder for Control from the VPI on page 102 or Setting up the Sony
3300MT Recorder for Control from the VPI on page 105.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 111

 If the recorder is being installed for the first time, or if the recorder has reverted to
its factory default settings, it will be necessary to reconfigure the recorder settings
to enable direct control from the PINPOINT camera.

To configure the Sony 1000MD recorder:

1. Press the MENU button on the front panel of the recorder. The main recorder
menu opens on the display.

2. Using the arrow buttons on the front panel, navigate to Settings and press the
ENTER button.

3. In the Settings menu, select System Admin Settings and press the ENTER
button.

112 4-0002428 Rev. K

 4. In the warning dialog box, select Confirm and press the ENTER button.

5. In the System Admin Settings menu, select Device Settings and press the
ENTER button.

6. In the Device Settings menu, select the RS-232C 1 field and press the
ENTER button.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 113

 7. Select System Control from the list and press the ENTER button.

8. Next to the RS-232C field, select Advanced and press the ENTER button.

9. In the System Control Setting dialog box, in the Speed field, select 115200
bps from the list.

114 4-0002428 Rev. K

 10. Select Apply and press the ENTER button.

11. In the Device Settings menu, select Apply and press the ENTER button.

12. Press the MENU button to exit.

To configure the Sony 1000MD recorder:

1. Press the MENU button on the front panel of the recorder. The main recorder
menu opens on the display.

2. Using the arrow buttons on the front panel, navigate to Settings and press the
ENTER button.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 115

 3. In the Settings menu, select System Admin Settings and press the ENTER
button.

4. In the warning dialog box, select OK and press the ENTER button.

5. In the System Admin Settings menu, select Device Settings and press the
ENTER button.

116 4-0002428 Rev. K

 6. Select the Control tab.

7. In the RS-232C field, select System Control from the list.

8. Next to the RS-232C field, select Advanced and press the ENTER button.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 117

 9. In the Speed field, select 115200 bps.

10. In the Protocol Mode field, select HVO-1000MD.

11. In System Control Setting dialog, click Apply.

12. In the Device Settings dialog, click Apply and then press the MENU button to
exit.

118 4-0002428 Rev. K

 For a general troubleshooting guide see Table 9.

Table 9 Troubleshooting

Operating mode does not PINPOINT is in If PINPOINT is in standby (illumination off) mode:
change when illumination Standby
1. Press the illumination button on the front
button is pressed and (illumination off) panel of the VPI.
released. mode.
2. Press illumination button on the camera
to change operating mode.

Display option does not PINPOINT is not in If PINPOINT is in white light operating mode:
change when display Fluorescence 1. Press the illumination button on the front
button is pressed and Imaging Mode panel of the VPI.
released.
2. Press illumination button on the camera
to change operating mode.
If PINPOINT is in standby (illumination off) mode, see
previous troubleshooting item.

“White balance failed” icon PINPOINT was 1. Check that:

is displayed after unable to adjust the
a. Camera and laparoscope are
attempting to white color response of
connected to the VPI.
balance PINPOINT the camera.
camera. b. PINPOINT is in white light operating
mode.
c. The tip of the laparoscope is clean.
d. The tip of the laparoscope is being
held approximately 5 cm (2 inch) from
a matte white surface such as gauze
or white cloth when the white balance
switch is pressed.
2. Retry the white balance.
▪ If the white balance fails a second
time, contact a qualified Stryker
service representative.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 119

 An operating mode icon is The VPI is not able 1. Power off the VPI.
displayed on the video to communicate
monitor, but no video is with the camera.
CAUTION: The camera may be damaged if it is
displayed.
connected to or disconnected from the VPI while it is
powered on.
2. Check that the camera cable is properly
connected to the camera and the VPI.
3. Power on the VPI.
4. If no video image is being displayed on
the video monitor, contact a qualified
Stryker service representative.

The video image is out of The focus Press the focusing buttons on the camera until a clear
focus. adjustment on the image is achieved.
camera has not
been set to the
correct position.

The tip of the Clean the tip of the laparoscope.

laparoscope is
obstructed by
foreign material

Upon selecting the A High-Definition 1. Check the laparoscope in the camera.

Fluorescence Imaging laparoscope, not a 2. If the laparoscope is not intended to
mode, the entire image Fluorescence provide ICG fluorescence imaging,
appears to show a strong Imaging exchange the laparoscope for a one
fluorescence signal. laparoscope, is in capable of ICG fluorescence imaging.
use.

The video image appears The Sharpening 1. Check the Image Quality value for
grainy or noisy. value is too large. Sharpening using the option menu.
2. If the value is 5 or greater, reduce the
value.

The video image appears The Brightness 1. Check the Image Quality value for
too bright. value is too large Brightness using the option menu.
2. If the value is greater than 192, reduce
the value.

The video image appears The Brightness 1. Check the Image Quality value for
too dark. value is too small Brightness using the option menu.
2. If the value is less than 175, increase
the value.

120 4-0002428 Rev. K

The video image appears The Red or Blue 1. Check the Image Quality value for the
too red or blue. Saturation value is Red or Blue Saturation using the option
too large menu.
2. If the Red value is greater than 768 or
the Blue value is greater than 1024,
decrease the value.

Image quality is poor due Image quality Reset the Image Quality settings by selecting the
to poor color or brightness. settings have been Default Profile from the user options menu.
altered significantly

Other equipment in the Radio frequency 1. Check to see if any of the following
vicinity of PINPOINT interference may be resolve the problem:
seems to malfunction occurring between ▪ Reorient or relocate PINPOINT or
when PINPOINT is PINPOINT and the the equipment receiving the
powered on, but works malfunctioning interference.
normally when PINPOINT equipment.
is powered off. ▪ Increase the separation between
PINPOINT and the equipment
receiving the interference.
▪ Connect PINPOINT to a power
outlet on a different circuit from that
to which the other equipment is
connected.
2. If PINPOINT becomes unresponsive,
and does not resume normal function
after turning off and back on, stop using
PINPOINT and contact a qualified
Stryker service representative.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 121

 1. Unplug the power cord to the VPI.

2. Carefully remove the fuse cover with the fuse located next to the three-prong
power connector on the rear panel of the VPI.

3. Replace the fuse (Littelfuse, 021806.3HXP, 5x20mm, T6.3A L 250VAC) with

the same model or a listed fuse with the same ratings.

4. Re-install the fuse cover.

5. If the VPI fails to operate properly again, contact a qualified Stryker service
representative for repair.

122 4-0002428 Rev. K

 Users can adjust displayed video image settings in the Image Quality menu.

Increasing the sharpening value increases the degree to which the displayed video
is sharpened. Video sharpening is an image processing feature and does not affect
the focus of the PINPOINT camera.

The Sharpening setting can be set to any value between 0 and 10.

The Brightness setting controls the overall image brightness displayed on the video
monitor. The system maintains the displayed video brightness at a constant value
regardless of the distance between the distal tip of the laparoscope and the tissue.

The Brightness setting can be set to any value between 0 and 255. Increasing this
value, increases the brightness of the video displayed on the monitor.

Increase the Red Saturation value to increase the overall redness of the video
displayed on the monitor.

The Red Saturation can be set to any value between 0 and 1024.

Increase the Blue Saturation value to increase the overall blueness of the video
displayed on the monitor.

The Blue Saturation can be set to any value between 0 and 1024.

The Peak/Mean menu enables control of the method that the imaging system uses
to set the scene brightness for viewing objects at different distances from the tip of
the laparoscope. There are three modes in the Peak/Mean menu: Peak, Mean, and
Balanced.

Select Peak to set the brightness for viewing small, foreground objects that are
closer to the tip of the laparoscope. Background objects farther from the
laparoscope may fall into darkness.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 123

 Select Mean to set the brightness by weighting the adjustment more by the mean
brightness of the scene and less by the brightest points.

For example, use the Mean setting to set the brightness for viewing objects that are
farther from the front of the laparoscope. Foreground objects may appear too bright
to see detail.

Select Balanced to set the brightness by balancing the Peak and Mean settings.

For example, use the Balanced setting when viewing objects both near to and
farther away from the tip of the laparoscope. Balanced is the default setting and is
suitable for most scenarios.

Default Profile allows the user to return to the settings as originally installed on the
imaging system. The following are the default settings:

Table 10 Default Profile

SPY

Display Options Overlay

SPY CSF (if available)

Sharpening: 4

Brightness: 192

Image Quality Red Color Saturation: 768

Blue Color Saturation: 1024

Peak/Mean: Balanced

On-screen Info Off

124 4-0002428 Rev. K

 Entering the Properties / Service menu displays device-specific information. The
information shown includes:

▪ DSP version
▪ Boot version
▪ FPGA version
▪ LCB version
▪ VPI serial number
▪ PINPOINT camera version
▪ PINPOINT camera serial number

During fluorescence imaging, the imaging system offers up to three different video
display options.

The SPY image display shows only the NIR fluorescence on the monitor in gray
scale. No white-light image is displayed.

The Overlay image display combines the white light image and the NIR fluorescent
image. In this mode, the NIR fluorescence appears green on top of a high-definition
white-light image.

In this imaging display, the white-light image is shown as a gray scale image. The
NIR fluorescent image is color-scaled, with red representing most fluorescence and
blue representing least fluorescence and displayed on top of the white-light image.
In addition, the color scale of fluorescence is shown such that as the distance
between the tip of the laparoscope and the tissue changes, the colors remain
approximately the same. This allows assessment of the fluorescent image at
different imaging distances.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 125

 This page intentionally left blank.

126 4-0002428 Rev. K

 Table 11: VPI Specifications

Spectrum Visible (VIS) Near infrared (NIR)

Light Sources
Type Light-emitting diode array NIR laser diode

Video output signals HD-SDI, 3G-SDI, DVI

HD Format HD-SDI 1080i 59.94 / 3G-SDI 1080p 59.94

Inputs/Outputs
Picture elements 1920x1080

Service port I/O RS-232 (via D-subminiature 9-pin connector)

Power On/Off Back panel switch

Standby Front panel button

Operator Controls White balance Front panel button

White light/PINPOINT
Camera
mode

Video display option Camera

Operating temperature +10 to +30°C

Operating
Environment
Relative Humidity 10 to 85%RH

Humidity range (storage) 10 to 85%RH

Storage and Temperature range

Transport -10 to +55°C
(storage)
Environment
Humidity range
5 to 95%RH
(transport)

Dimensions Width: 382 mm, Height: 145 mm, Depth 409 mm

Physical
Weight 14.5 kg

Voltage 100 – 240 V~

Electrical Power Power frequency 50/60 Hz

Power consumption 300 VA

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 127

 Table 12: PINPOINT Camera Specifications

Image sensors CMOS HD sensor assembly

Optical HD format 1080p

Aspect ratio 16:9

Dimensions Diameter: 48 mm, Length: 115 mm

Physical Weight 240 g (without cable)

Cable length 3m

Operating temperature +10 to +30°C

Environment Relative Humidity 10 to 85%RH

Storage temperature -10 to +55°C

Refer to the Cleaning and Sterilization sectionTable 10: Validated Sterilization

Sterilization
Methods for the PINPOINT Camera

128 4-0002428 Rev. K

 Table 13: Laparoscope Specifications

0° (SC9100, SC9101, SC9104, SC9504)

Viewing angle 30° (SC9130, SC9131, SC9134, SC9534)
45° (SC9144, SC9544)

70° (SC9100, SC9130)

Field of view 75° (SC9101, SC9131, SC9104, SC9134, SC9144,
Optical
SC9504, SC9534, SC9544)

Resolution HD compatible

VIS (SC9101, SC9131)

Transmission spectrum VIS + NIR (SC9100, SC9130, SC9104, SC9134,
SC9144, SC9504, SC9534, SC9544)

10 mm (SC9101, SC9131, SC9100, SC9130, SC9104,

Outer diameter SC9134, SC9144)
5.5 mm (SC9504, SC9534, SC9544)

300 mm (SC9504, SC9534)

302 mm (SC9544)
320 mm (SC9104, SC9134)
Working length
323 mm (SC9144)

Physical 330 mm (SC9101, SC9131)

420 mm (SC9100, SC9130)

372 mm (SC9504, SC9534)

373 mm (SC9544)
406 mm (SC9101, SC9131)
Total length
410 mm (SC9104, SC9134)
414 mm (SC9144)
497 mm (SC9100, SC9130)

Operating temperature +10 to +40°C

Environment
Storage temperature -10 to +40°C

Sterilization Refer to the Cleaning and Sterilization section

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 129

 Table 14: Light Guide Cable Specifications

Optical Transmission spectrum Visible + NIR

Fiber diameter 4.9 mm

Physical Length 3m

Weight/length 125 g/m

Operating temperature +10 to +40°C

Environment
Storage temperature -40 to +70°C

Sterilization Refer to the Cleaning and Sterilization section

Table 15: Equipment Classification

Type of protection against electric shock Class I

Degree of protection against electric shocks CF-type as per IEC 60601-1

Degree of protection against moisture Ordinary

Class 3R as per IEC 60825-1

Laser class 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

130 4-0002428 Rev. K

 Table 16: PINPOINT SYSTEM NIR Radiation and Source Characteristics

Apertures for NIR radiation emission Laparoscope tip, light guide cable tip

Wavelength 805 nm

Repetition rate 20 pulses/s

Accessible NIR radiation (at
Energy output (maximum) 2 mJ/pulse
the tip of the laparoscope)
Pulse duration 16.6 ms

Beam divergence 75°± 5°

Embedded laser source Classification Class 4, invisible

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 131

 This page intentionally left blank.

132 4-0002428 Rev. K

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

THE PINPOINT SYSTEM INCLUDES PINPOINT SYSTEM SOFTWARE WHICH NOVADAQ IS PREPARED TO
LICENSE YOU TO USE AS PART OF YOUR USE OF THE PINPOINT SYSTEM BUT ONLY ON THE TERMS AND
CONDITIONS SET OUT IN THIS AGREEMENT. BY CLICKING “I Accept" ON THE SCREEN, OR BY USING THE
PINPOINT 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 PINPOINT 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 PINPOINT System Software for operating and using the PINPOINT 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 “PINPOINT System” means the fluorescent imaging system designed and manufactured by Novadaq having
the following components: a surgical laparoscope, a camera head (“PINPOINT Camera”), a SPY-PHI
handheld camera head, a flexible light guide cable, an endoscopic video processor, PINPOINT cart, monitor,
recorder, printer and sterilization trays.
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 PINPOINT
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.
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
PINPOINT 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
PINPOINT System by Novadaq.

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 133

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 PINPOINT 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 DAMAGE OF
THE PROGRAM OR THE PINPOINT SYSTEM; THE UNAUTHORIZED REPAIR, MODIFICATION OR
INSTALLATION OF THE PROGRAM OR PINPOINT 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 PINPOINT 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 PINPOINT 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.

134 4-0002428 Rev. K

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
PINPOINT 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.

Copyright
Novadaq® is trademark of Novadaq Technologies ULC

PINPOINT Endoscopic Fluorescence Imaging System Operator’s Manual 135

 This page intentionally left blank.

136 4-0002428 Rev. K