Quest Engineering SPECTRUM 3 User manual

Instructions for Use
QUEST SPECTRUM®3

QUEST SPECTRUM®3
Instructions for Use
Document Change History
Summary of Change
Document
Version
DCO
number
SCM
Version
Date
dd/mm/yyyy
Performed
by
Description of Change
1.0-1.4
2042
1-4
10/06/2020
NDK/DBO/
RdJ
First issue, based on
QMI0009 Version_16.
QUEST SPECTRUM-IFU
Several Draft versions
made during development
of ECO 2042
2.2
2325
5-7
07/05/2021
NdK
Lay-out and product
information updated as part
of ECO 2042. IFU released
per DCO 2325
2.3
2358
8-11
22/05/2021
NdK
Updated document in
accordance with
Translations and additional
feedback.
Added warnings related to
heat related to CAPA 2243
and CAPA 2244
Released per DCO 2358
3
2547
12-21
23/12/2021
IMO
See SCM History. IFU
released per DCO 2547
4
2646
22-23
22/02/2022
IMO
Update article number on
Capture suite. Update
device class number on
technical specifications
table. Review of residual
risks communicated to user
Include clinical benefits in
intended use, updated
copyright statement

QUEST SPECTRUM®3
Instructions for Use
Intra-operative Fluorescence Imaging
Open and Minimal Invasive Surgery
QUEST SPECTRUM®3

QUEST SPECTRUM®3 p. 1/50
Instructions for Use
Corporate Headquarters
Quest Medical Imaging B.V.
Industrieweg 41
1775 PW Middenmeer
The Netherlands
Website: www.quest-mi.com
Customer Service and Technical Support
Email: [e-mail]
Phone: [phone]
Fax: [phone]
Contact USA
Quest Medical Imaging Inc.
10000 Cedar Avenue
Suite 3-164
Cleveland, OH 44106 U.S.A.
Customer Service and Technical Support
Email: [e-mail]
Phone: [phone]
Fax: [phone]
Document Identification
Document: QMI0023_IFU_EN
Revision: 4
Date of revision: 22/02/2022
Copyright statement: ©2022 Quest Medical Imaging B.V.
All rights reserved. No part of this document may be photocopied, reproduced or
translated in any way, without the prior written consent of Quest Medical Imaging B.V.
Every effort has been made to make the supplied product and its documentation as
accurate as possible.
The information contained in this document is subject to change without notice.
Printed in The Netherlands.

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Instructions for Use
Table of Contents
1Health and Safety Compliance..................................................................................................... 4
1.1 Important Information............................................................................................................................4
1.2 Indication for Use..................................................................................................................................4
1.3 User Qualifications................................................................................................................................4
1.4 Repair and Modification........................................................................................................................5
2System Overview...........................................................................................................................6
2.1 Components .........................................................................................................................................6
2.2 Imaging Agent.......................................................................................................................................6
2.3 Article List .............................................................................................................................................7
3General System Safety..................................................................................................................8
3.1 Electrical Safety –General...................................................................................................................8
3.2Electrical Safety –Power......................................................................................................................8
3.3 Damaged or Malfunctioning Equipment ...............................................................................................8
3.4 Light Safety...........................................................................................................................................9
3.5 Cleaning and Disinfecting.....................................................................................................................9
3.6 Heat ......................................................................................................................................................9
4ICG Safety.....................................................................................................................................11
4.1 Clinical Pharmacology....................................................................................................................... 11
4.2 Contraindications............................................................................................................................... 11
4.2.1 General...................................................................................................................................... 11
4.2.2 Drug Interactions ....................................................................................................................... 11
4.2.3 Drug/Laboratory Test Interactions............................................................................................. 11
4.2.4 Carcinogenesis, Mutagenesis, Impairment of Fertility............................................................... 11
4.2.5 Pediatric Use.............................................................................................................................. 11
4.2.6 Geriatric Use.............................................................................................................................. 11
4.3 Adverse reactions.............................................................................................................................. 12
4.4 Over dosage ...................................................................................................................................... 12
5Symbols and indicator Lights .................................................................................................... 13
6Disposal........................................................................................................................................14
7Unpacking and Setting Up..........................................................................................................15
7.1 Unpacking the System....................................................................................................................... 15
7.2 Setting Up QUEST SPECTRUM®3................................................................................................... 18
7.2.1 Installation of components......................................................................................................... 18
7.2.2 Main power supply..................................................................................................................... 18
7.2.3 Camera and Light Connector..................................................................................................... 19
7.2.4 Connecting Ring Light or Laparoscope to the Camera ............................................................. 19
8Operation......................................................................................................................................21
8.1 Preparing the QUEST SPECTRUM®3.............................................................................................. 21
8.2 Brake instructions .............................................................................................................................. 22
8.3 Powering on and Shutting the QUEST SPECTRUM® 3 down ......................................................... 22

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Instructions for Use
8.4 Starting surgery ................................................................................................................................. 22
8.5 Case View.......................................................................................................................................... 29
8.6 Using the Camera.............................................................................................................................. 30
8.7 Using the Camera Arm ...................................................................................................................... 31
8.8 Pin code............................................................................................................................................. 33
8.9 Case manager ................................................................................................................................... 33
8.10 Settings.............................................................................................................................................. 34
8.11 Help.................................................................................................................................................... 37
9Cleaning, Disinfection and Sterilization....................................................................................38
9.1 Cleaning Instructions......................................................................................................................... 38
9.2 Sterilization ........................................................................................................................................ 38
9.3 Maintenance ...................................................................................................................................... 38
10 Appendix A: Trouble Shooting...................................................................................................39
10.1 Trouble shooting................................................................................................................................ 39
10.2 Fuse Replace Procedure................................................................................................................... 40
11 Appendix B: Technical Specifications ......................................................................................41
12 Appendix C: EMC and Environmental Safety ........................................................................... 42
12.1 Electromagnetic interference............................................................................................................. 42
12.2 Electrostatic discharge....................................................................................................................... 42
12.3 General notes and benefits of potential equalization ........................................................................ 42
13 Appendix D: Manufacturer’s declaration .................................................................................. 43

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Instructions for Use
1 Health and Safety Compliance
1.1 Important Information
WARNING: Read Before Use
This instruction manual contains essential information on using the QUEST SPECTRUM®3
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 Quest Medical Imaging B.V.
The following signal words serve to distinguish between warning notes according to the type of danger:
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.
1.2 Indication for Use
The Quest Spectrum® is a fluorescent imaging system used in capturing and viewing fluorescent images
for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer
circulation in tissue and free flaps used during plastic, reconstructive and organ transplant surgeries.
The Quest Spectrum® is intended for intraoperative and minimal invasive visual assessment of blood
vessels and related tissue perfusion, by enabling surgeons to observe fluorescent images of blood
vessels and related tissue.
WARNING: The QUEST SPECTRUM®should be used according to its approved
Indication for Use.
1.3 User Qualifications
This manual is addressed exclusively to qualified and trained personnel (licensed physician, medical
assistants supervised by a licensed physician). The QUEST SPECTRUM®3 is to be used exclusively by
qualified personnel to carry out clinical applications.
WARNING: This manual does not explain or discuss clinical procedures. The
qualified personnel is responsible for correct execution of clinical
procedures.

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Instructions for Use
1.4 Repair and Modification
WARNING: The QUEST SPECTRUM®3 does not contain any user-serviceable parts.
Annual preventive inspection or maintenance is required. Do not
disassemble, modify, or attempt to repair it. Patient or user injury and/or
instrument damage can result.
Minor problems that appear can be solved by Troubleshooting, refer to
10 Appendix A: Trouble Shooting. If a problem cannot be resolved,
contact Quest Medical Imaging. Before sending it back:
❖Clean, disinfect and sterilize the light guide cable and laparoscope
thoroughly prior to returning for repair.
❖Clean and disinfect the QUEST SPECTRUM®3 and its camera and
ring light.
❖Return the part in its original packaging. If this is not possible,
package the part to secure it for transport.
❖Quest Medical Imaging is not liable for damage resulting from
improper shipping.
Note: The QUEST SPECTRUM®3 and its separate components are backed by
a warranty period according to the national regulations on parts and
labor, starting from the moment that the product is dispatched from
Quest Medical Imaging B.V. The warranty covers defects in parts as
described in the Terms and Conditions.

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Instructions for Use
2 System Overview
2.1 Components
The QUEST SPECTRUM®3 is a Fluorescent Imaging System designed and developed to assist in open
and minimally invasive fluorescence image-guided surgery and consists of the following components
shown in Figure 1.
Figure 1: Overview of the QUEST SPECTRUM® 3. 1) 4K Monitor, 2) Sensitive camera, 3) Interactive touchpad, 4) Trolley, 5)
Mechanical Arm
WARNING: Do not use the QUEST SPECTRUM®3 with components that have not
been clearly identified for use with the system
WARNING: Do not exchange components of the QUEST SPECTRUM®3 between
devices.
Note: The QUEST SPECTRUM®3 can be used for minimal invasive surgeries
by connecting the QUEST SPECTRUM®Laparoscope to the QUEST
SPECTRUM®Camera.
2.2 Imaging Agent
❖The Indocyanine Green (ICG) imaging agent is a sterile, water-soluble lyophilized green powder.
ICG contains not more than 5.0% sodium iodide.
❖ICG for Injection USP is dissolved using Sterile Water for Injection and is to be administered
intravenously.
❖Instructions for preparation, handling, and administration of ICG imaging agent are provided in
Chapter 4 ICG Safety.

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Instructions for Use
2.3 Article List
Table 1: Overview of all articles sold with the QUEST SPECTRUM® 3. 1Laparoscopes have a separate manual, 2Drapes have a
separate manual, 3USA only.
Article Number
Item Name
System
ART-SYS-0029
QUEST SPECTRUM®3 for VIS/ICG/MB 115V
ART-SYS-0030
QUEST SPECTRUM®3 for VIS/ICG/MB 230V
Included components
ART-HH-0016
QUEST SPECTRUM®Camera
ART-LE-0016
QUEST SPECTRUM®Light Engine
ART-MC-0004
QUEST SPECTRUM®IPC
ART-MC-A01-0012
Barco Branded 4K UHD surgical display
ART-CS-0104
QUEST SPECTRUM®Capture Suite
ART-TR-C01-0006
QUEST SPECTRUM®Mechanical Camera Arm
Optional components
ART-RL-0012
QUEST SPECTRUM®Ring Light & Lens
ART-LAP-0008
QUEST SPECTRUM®Laparoscope 30°1
ART-LAP-0008S
QUEST SPECTRUM®Laparoscope 30° Short1
ART-LAP-0009
QUEST SPECTRUM®Laparoscope 0° 1
ART-LAP-0009S
QUEST SPECTRUM®Laparoscope 0° Short1
ART-OP-0007
QUEST SPECTRUM®Light Cable 1
Drapes
ART-DRP-0-004
QUEST SPECTRUM®one-piece drape for Open Surgery 2,3
ART-DRP-1-000
QUEST SPECTRUM®two-piece drape for Open Surgery 2
ART-DRP-1-001
QUEST SPECTRUM®two-piece drape Laparoscopic Surgery 2
Kits
ART-ICG-0001
QUEST SPECTRUM®Kit for open surgery3
ART-ICG-0002
QUEST SPECTRUM®Kit for laparoscopic surgery3

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Instructions for Use
3 General System Safety
3.1 Electrical Safety –General
WARNING: To avoid risk of electric shock, this equipment must only be connected
to a supply main with protective earth.
WARNING: Do not use the system adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, observe to verify normal operation
in the configuration in which it will be used.
WARNING: Do not connect multi-socket extension cords to QUEST SPECTRUM®3.
Connecting additional devices may overload the power supply of the
QUEST SPECTRUM®3.
WARNING: Do not connect devices to QUEST SPECTRUM®3 that are not compliant
with IEC 60601-1. Non-compliant devices may cause the QUEST
SPECTRUM®3 to stop functioning or show abnormal behavior.
CAUTION: Do not use or store liquids around the QUEST SPECTRUM®3. If liquid
enters components of the QUEST SPECTRUM®3, immediately turn
system off and unplug it from the power outlet.
CAUTION: Do not insert objects into the ventilation holes of QUEST SPECTRUM®3
enclosure.
CAUTION: Do not connect or disconnect the camera cable while QUEST
SPECTRUM®3 is powered on.
3.2 Electrical Safety –Power
WARNING: Do not connect any devices to the power connectors inside the QUEST
SPECTRUM®3. Connecting additional devices may overload the power
supply of the QUEST SPECTRUM®3.
WARNING: Do not use the QUEST SPECTRUM®3 if the power cord or plug is
damaged or modified in any way.
WARNING: 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.
3.3 Damaged or Malfunctioning Equipment
WARNING: Do not use QUEST SPECTRUM®if any part of the system is damaged or
does not function properly. Failure to follow this warning may lead to
injury.

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Instructions for Use
3.4 Light Safety
WARNING: Do not detach the optical fiber from the ring light or laparoscope when
the excitation light source is enabled. Without qualified optical
components ring light or laparoscope, the excitation light source must
be considered class 3R and corresponding precautions must be taken.
WARNING:
WARNING: Do not directly view in the beam
WARNING: Do not look in the QUEST SPECTRUM Light Engine’s exit port (see 7.2.2
for the exact location of the exit port).
WARNING: Do not stare into the output of the light engine. The brightness of this
light source is higher than most commercial lighting fixtures and is
intended to couple directly into a lighting cable.
CAUTION: Do not open the unit. There are no serviceable parts inside and opening
the Light Engine enclosure will void the manufacturer’s warranty.
CAUTION: Do not shine Light Engine beam in the direction of other people or at
reflective surfaces.
3.5 Cleaning and Disinfecting
WARNING: Follow the instructions in Chapter 9 to clean, disinfect and/or sterilize
the QUEST SPECTRUM®3 components and accessories.
WARNING: Do not sterilize the Ring Light with Lens.
3.6 Heat
WARNING: The light source can generate significant amount of heat (exceeding
41°C/106°F) at the scope tip, the scope light post, the light cable tip,
and/or near the light cable adapter. Higher levels of brightness from the
light source result in higher levels of heat. Always adjust the brightness
level of the camera and the monitor before adjusting the brightness level
of the light source. If the brightness level of the light source can be
adjusted, set it to the minimum brightness necessary to adequately
illuminate the surgical site.
In addition, adjust the internal shutter of the camera higher in order to
run the light source at a lower intensity. Avoid touching the scope tip or
the light cable tip to the patient, and never place them on top of the
patient, as doing so may result in burns to the patient or user. In addition,
LASER RADIATION
AVOID DIRECT EYE EXPOSURE
CLASS 3R LASER PRODUCT
Max output: 41 mW
Emitted wavelengths: 680nm / 780 nm
IEC 60825-1:2014

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Instructions for Use
never place the scope tip, the scope light post, the light cable adapter,
or the light cable tip on the surgical drapes or other flammable material,
as doing so may result in fire.
Always place the light source in standby mode whenever the scope is
removed from the light cable, or the device is unattended. The scope tip,
scope light post, light cable adapter, and light cable tip will take several
minutes to cool off after being placed in standby mode, and therefore
may still result in fire mode, and therefore may still result in fire or burns
to the patient, user, or inanimate objects.
WARNING: Never use the QUEST SPECTRUM®3 in the presence of flammable or
explosive gases

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Instructions for Use
4 ICG Safety
4.1 Clinical Pharmacology
Following intravenous injection, Indocyanine Green (ICG) is rapidly bound to plasma protein, of which
albumin is the principle carrier (95%). ICG undergoes no significant extrahepatic or enterohepatic
circulation; simultaneous arterial and venous blood estimations have shown negligible renal, peripheral,
lung or cerebral-spinal uptake of the dye. ICG is taken up from the plasma almost exclusively by the
hepatic parenchymal cells and is secreted entirely into the bile. After biliary obstruction, the dye appears
in the hepatic lymph, independently of the bile, suggesting that the biliary mucosa is sufficiently intact to
prevent diffusion of the dye, though allowing diffusion of bilirubin. These characteristics make ICG a
helpful index of hepatic function.
The plasma fractional disappearance rate at the recommended 0.5 mg/kg dose has been reported to be
significantly greater in women than in men, although there was no significant difference in the calculated
value for clearance.
4.2 Contraindications
ICG for Injection USP contains sodium iodide and should be used with caution in patients who have a
history of allergy to iodides.
4.2.1 General
ICG Powder and Solution: ICG is unstable in aqueous solution and must be used within 6 hours.
However, the dye is stable in plasma and whole blood so that samples obtained in discontinuous sampling
techniques may be read hours later. Sterile techniques should be used in handling the dye solution as
well as in the performance of the dilution curves.
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.
4.2.2 Drug Interactions
Heparin preparations containing sodium bisulfite reduce the absorption peak of ICG in blood and,
therefore, should not be used as an anticoagulant for the collection of samples for analysis.
4.2.3 Drug/Laboratory Test Interactions
Radioactive iodine uptake studies should not be performed for at least a week following the use of ICG.
4.2.4 Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of fertility.
Pregnancy Category C: Animal Reproduction studies have not been conducted with ICG. It is not known
whether ICG can cause fatal 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.
4.2.5 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
4.2.6 Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger
patients.

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Instructions for Use
4.3 Adverse reactions
Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to
iodides. If such reactions occur, treatment with the appropriate agents (e.g., epinephrine, antihistamines,
and corticosteroids) should be administered.
4.4 Over dosage
There are no data available describing the signs, symptoms, or laboratory findings accompanying over
dosage. The LD 50 after I.V. administration ranges between 60 and 80 mg/kg in mice, 50 and 70 mg/kg
in rats and 50 and 80 mg/kg in rabbits.
Under sterile conditions, the ICG for Injection USP powder should be dissolved with Sterile Water for
Injection, USP. Exactly 5 mL of Sterile Water for Injection, USP, should be added to the 25-mg vial, giving
5 mg of dye per mL of solution.

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Instructions for Use
5 Symbols and indicator Lights
Table 2: General Symbols and Signs
Article number
Serial number
Applied part Class 1 BF type
Manufacturer
Follow instructions for use
Table 3: Symbols and Signs IPC
On/ off button with blue light indicator
Table 4: Symbols and Signs Trolley
Aperture
Warning: Do not view the beam with magnifying optical
instruments (e.g., a loupe).
Laser warning indications
Do not step
Mind your fingers
Do not use the mechanical camera arm with the laparoscope
LASER RADIATION
AVOID DIRECT EYE EXPOSURE
CLASS 3R LASER PRODUCT
Max output: 41 mW
Emitted wavelengths: 680nm / 780 nm
IEC 60825-1:2014

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Instructions for Use
6 Disposal
The QUEST SPECTRUM®components and consumables should be disposed of in compliance with local,
regional, and national regulations.
❖Single use or consumable components and accessories such as the QUEST SPECTRUM®
Drapes should be disposed in compliance with the regulatory regulations.
❖Other QUEST SPECTRUM®3 components should be returned to Quest Medical Imaging B.V.
for disposal.

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Instructions for Use
7 Unpacking and Setting Up
7.1 Unpacking the System
WARNING: Check according to Table 5 below if all components are complete and
undamaged before proceeding installing the QUEST SPECTRUM®3.
Contact Quest Medical Imaging B.V. or representative if components are
missing or damaged.
Note: The QUEST SPECTRUM®Drapes are purchased separately.
Table 5: Component summary
Description
Component
QUEST SPECTRUM®Camera
+
QUEST SPECTRUM®Ring Light
(Optional)
QUEST SPECTRUM®Camera
+
QUEST SPECTRUM®Laparoscope
(Optional)
QUEST SPECTRUM®Mechanical
Camera Arm

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Instructions for Use
QUEST SPECTRUM®IPC
Trolley
Barco Branded 4K UHD surgical display

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Instructions for Use
Instructions for Use
Draping Instructions
Quick Start