Leica Microsystems EnFocus OCT User manual

MEDICAL DIVISION
User Manual
9054-10063_EN - Revision K-00
EnFocus OCT
From Eye to Insight

II EnFocus OCT / 9054-10063_EN / Revision K-00
Thank you for purchasing an EnFocus OCT system.
In developing our systems, we have placed great emphasis on simple, self-
explanatory operation. hte
This user manual contains important information related to the device, safety,
operation, and cleaning. In order to avoid injury to persons or damage to the
system this user manual, including indications, warnings and precautions, must be
read and understood before performing any procedure.
Thank you for choosing our products.We hope that you will enjoy the quality and
performance of your EnFocus OCT system.
For inquiries regarding sales, service, or support contact Leica Microsystems by
either visiting
http://www.leica-microsystems.com/service/
or by calling the One Call support number closest to your facility:
Australia: 1 800 625 286 (Option 2)
Austria: [phone]
Belgium: [phone]
China: [phone]
Denmark: [phone]
France: [phone]
Germany: [phone]
Hong Kong: [phone]
India: 1800 313 2339
Italia: +39 02 57486.1
Japan: [phone]
Korea: [phone]
Netherlands: [phone]
New Zealand: 0800 400 589 (Option 2)
United Kingdom: [phone]
United States: 1-800-248-0223
Portugal: [phone]
For issues concerning the manufacturing center please contact:
Leica Microsystems NC, Inc.
4222 Emperor Blvd
Suite 390
Durham, NC 27703
USA
Phone: [phone]
Fax: [phone]
Rx only
CAUTION
Federal law restricts this device to sale by or on the order of a
physician or practitioner.
(&5(3
Leica Microsystems CMS GmbH
Ernst-Leitz Strasse 17-37
35578Wetzlar
Germany
0123
CE marking
Legal disclaimer
All specifications are subject to change without notice.
The information provided by this manual is directly related to the operation of the
equipment. Medical decision remains the responsibility of the clinician.
Leica Microsystems has made every effort to provide a complete and clear user
manual highlighting the key areas of product use. Should additional information
regarding the use of the product be required, please contact your local Leica
representative.
You should never use a medical product of Leica Microsystems without the full
understanding of the use and the performance of the product.
Liability
For our liability, please see our standard sales terms and conditions. Nothing in this
disclaimer will limit any of our liabilities in any way that is not permitted under
applicable law, or exclude any of our liabilities that may not be excluded under
applicable law.

EnFocus OCT / 9054-10063_EN / Revision K-00 1
Contents
1 Introduction 3
1.1 About this user manual 3
1.2 Symbols in this user manual 3
1.3 Optional product features 3
2 Product Identification 3
3 Safety notes 4
3.1 Intended use 4
3.2 General directions 4
3.3 Directions for the person responsible
for the instrument 4
3.4 Directions for the operator
of the instrument 5
3.5 Expected service life 5
3.6 Dangers of use 5
3.7 Signs and labels 10
4 EnFocus Components 16
4.1 EnFocus Cart Installation 16
4.2 EnFocus Configuration
for Microscope Integration 21
4.3 InVivoVue Software 22
5 Device overview 23
5.1 Anterior segment imaging 23
5.2 Posterior segment imaging 23
6 Installation & removal 24
6.1 Receiving and inspection 24
6.2 Initial set-up 24
6.3 System connections 24
6.4 Installing the scan head 24
6.5 Mounting the EnFocus OCT cable 26
6.6 Glare Mask Install and Remove 27
6.7 Removing the scan head 28
6.8 Removing the EnFocus OCT cable 29
6.9 Accessories Connections 29
7 Operation 31
7.1 Training 31
7.2 Calibration 31
7.3 Draping 31
7.4 Device startup 31
7.5 Standard Workflow 32
7.6 Shutting down the system 32
8 InVivoVue Software 33
8.1 Display Views 33
8.2 Primary Functions 35
8.3 Surgeon Preferences 39
8.4 Patient Management 42
8.5 Data Management 44
8.6 OCT Help Functions 48
8.7 Advanced Functions 49
9 Care and maintenance 53
9.1 Cleaning 53
9.2 EnFocus OCT system maintenance 54
9.3 Periodic safety checks for cart configuration 54
9.4 UPS maintenance for cart configuration 54
9.5 Storage for cart configuration 54
10 Disposal 56
11 Troubleshooting 56
11.1 Hard shutdowns 56
11.2 Hardware malfunctions 57
11.3 Scanning malfunctions 57
11.4 Image malfunctions 58
11.5 Software malfunctions 59
11.6 Software Notifications 60
11.7 Checking the Line Spectrum 65
12 Service and Spares 65
12.1 Issue Escalation 65
12.2 Basic Warranty 65
12.3 Service Contracts and ExtendedWarranty 65
12.4 Replacement Accessories 66
12.5 Service and Repair 66
13 Specifications 67
13.1 Common Technical Specifications 67
13.2 EnFocus Cart Configuration 68
13.3 EnFocus Configuration for Micoscope Integration 68
14 Compliance 69
14.1 EnFocus Cart Configuration 69
14.2 EnFocus Configuration for Micoscope Integration 73
14.3 Common to Configurations 76

2 EnFocus OCT / 9054-10063_EN / Revision K-00
15 Compatibility with third party devices 77
15.1 Surgical microscope compatibility 77
15.2 Fundus viewing system compatibility 77
16 Glare 79
16.1 Glare Management 79
16.2 Glare Mask Selection 84
17 Annex 84
17.1 Abbreviations 84
17.2 Glossary 85
17.3 Principle of operation 86
17.4 Sampling density and resolution 87
17.5 Expected positions of equipment and people 88
18 Quick Reference Guide 88

EnFocus OCT / 9054-10063_EN / Revision K-00 3
Introduction
1 Introduction
1.1 About this user manual
In addition to notes on the use of the instruments this
user manual gives important safety information (see
chapter "Safety notes").
X Read this user manual carefully before operating the
product.
This revision of the EnFocus User Manual includes the EnFocus Cart Installation and
the EnFocus Microscope Installation.
Read manual addendum prior to reading other sections of manual.
1.2 Symbols in this user manual
The symbols used in this user manual have the following meaning:
Symbol Warning
word
Meaning
Warning
Indicates a potentially hazardous situation
or improper use that could result in serious
personal injuries or death.
Caution
Indicates a potentially hazardous situation
or improper use which, if not avoided, may
result in minor or moderate injury.
Notice
Indicates a potentially hazardous situation
or improper use which, if not avoided, may
result in appreciable material, financial
and environmental damage.
Information about use that helps the user
to employ the product in a technically
correct and efficient way.
X Action required; this symbol indicates that
you need to perform a specific action or
series of actions.
1.3 Optional product features
Different product features and accessories are optionally available.
The availability varies from country to country and is subject to
local regulatory requirements. Please contact your local
representative for availability.
2 Product Identification
The model and serial numbers of your product are located on the
identification label on the illumination unit.
X Enter this data in your user manual and always refer to it when
you contact us or the service workshop regarding any questions
you may have.
Type Serial no.
... ...

Safety notes
4 EnFocus OCT / 9054-10063_EN / Revision K-00
3 Safety notes
Always follow the instructions in this user manual, and in particular
the safety notes.
3.1 Intended use
The EnFocus OCT device is intended to acquire, process, display and
save depth-resolved images of ocular tissue microstructure using
Spectral Domain Optical Coherence Tomography (SDOCT).
• The EnFocus OCT system is indicated for use as an aid in the
visualization of physiologic and pathologic conditions of the eye
through non-contact optical imaging.
• The EnFocus OCT system is indicated for use on patient
populations from premature and neonatal infants to adult.
• The EnFocus OCT system is indicated for use in supine imaging,
mounted to a surgical microscope, with cooperative patients or
patients under anesthesia.
Contraindications
The EnFocus device is not for use with the following surgical
microscopes:
• Microscopes contra-indicated for pediatric use or restricted to
adult use only.
• Microscopes with illumination systems that do not
independently conform to ISO 15004-2:2007 Group 2.
WARNING
Risk of injury to the patient.
Images from the EnFocus OCT device are to serve only as
supplementary information.
X Ensure that the images from the EnFocus OCT are not
used as the sole basis for any diagnosis.
CAUTION
Danger of eye injury due to laser radiation.
This device is a Class 1 Laser Product product in accordance
with the IEC60825-1 standard.
X Make sure that exposure to the direct output of this
device is limited to the minimum duration necessary for
images.
3.2 General directions
• The EnFocus OCT system may be used only in enclosed rooms
and must be placed on a solid floor.
• The EnFocus OCT system is subject to special precautionary
measures for electromagnetic compatibility: It must be
installed and commissioned in accordance with the guidelines
and manufacturer's declarations and recommended safety
distances (according to EMC tables based on IEC60601-1-2).
• Portable and mobile as well as stationary radio communications
equipment can have a negative effect on the reliability of the
EnFocus OCT system's functionality.
CAUTION
Risk of EM Compatibility Issues.
X The EnFocus System should not be operated near active
HF SURGICAL EQUIPMENT or near magnetic resonance
imaging, where the intensity of EM DISTURBANCES is
high.
• The EnFocus is intended for operation in the hospital
environment.
3.3 Directions for the person
responsible for the instrument
The intended users of the EnFocus OCT system are physicians or
technicians with professional training or experience in the use of
ophthalmic imaging equipment. Nurses and other clinical staff will
interact with the system by performing setup and shut down
functions, and may also run the software during the procedure.
X Read and understand the entire user manual before operating
this system. If there are any questions concerning the use of this
system, contact your Leica customer service representative.
X Ensure that the EnFocus OCT system is used only by persons
qualified to do so.
X Ensure that this user manual is always available at the place
where the EnFocus OCT system is in use.
X Inform your Leica Microsystems representative or customer
service immediately about any product defect that could
potentially cause injury or harm.
X Service on the EnFocus OCT system may be carried out only by
technicians who are explicitly authorized by Leica Microsystems
to do so.
X Only original Leica Microsystems replacement parts may be
used in servicing the product.
X After service work the device must be readjusted in accordance
with our technical specifications.
X If the instrument is serviced by unauthorized persons, is
improperly maintained (as long as maintenance was not carried
out by us), or is handled improperly, Leica Microsystems will not
accept any liability and any warranty will be void.
X The effect of the system on other instruments has been tested
as specified in IEC60601-1-2. The system passed the emission
and immunity test and complies with the usual precautionary
and safety measures relating to electromagnetic and other
forms of radiation.
X The electric installation in the building must conform to the
applicable national standards, e.g., current-operated ground
leakage protection (fault-current protection).

EnFocus OCT / 9054-10063_EN / Revision K-00 5
Safety notes
3.4 Directions for the operator of the
instrument
X Read and understand the entire user manual before operating
the EnFocus OCT system. If there are any questions concerning
the use of the EnFocus OCT system, contact customer service.
X Follow the instructions described in this user manual.
X Follow the instructions given by your employer regarding the
organization of work and safety at work.
3.5 Expected service life
The expected service life of the EnFocus OCT system is 7 years. After
7 years, please contact Leica customer service to arrange for further
servicing.
3.6 Dangers of use
3.6.1 Overall system
WARNING
Danger of injury for pediatric patients.
X Do not image pediatric patients with devices that are
contraindicated for pediatric use or that are indicated
for use only in adult populations.
WARNING
Danger of fatal electrical shock.
X To reduce risk of electrical shock, do not open
enclosures. There are no serviceable parts inside.
X Ensure that only authorized service personnel performs
installation, assembly, service, and maintenance.
WARNING
Danger of fatal injury and burns.
X Do not operate the EnFocus OCT in potentially explosive
areas.
X Do not operate the EnFocus OCT within 25cm of
flammable anesthetics or volatile solvents, benzene or
similar flammable materials.
WARNING
Risk of Performance Degradation.
X 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 that they are operating normally.
CAUTION
Risk of injury to the patient.
X Ensure the EnFocus OCT scan head is securely attached
to the microscope prior to moving it into position above
the patient.
X Do not attempt to remove the scan head while a patient
is underneath the microscope. The scan head could fall
on the patient resulting in injury.
CAUTION
Risk of injury to the patient.
X Do not perform the balancing procedure while a patient
is underneath the microscope.
X To avoid unintentional movement of the microscope
make sure that the arm system is properly balanced
before starting an operation.
CAUTION
Risk of infection.
X Leica recommends that the EnFocus OCT system be
draped during surgical procedures consistent with
draping of the surgical microscope.
CAUTION
Risk of injury to the operator.
X Do not remove glare masks from microscope without
waiting 30 seconds after turning o main illumination
as there is a potential to be burned.
CAUTION
Risk of allergic reactions.
X Individuals that are allergic to system materials with
which they come in contact should limit skin exposure.
CAUTION
Risk of injury due to contact with the device.
X Ensure that the optical working distance of the scanner
is sucient to avoid contact with the patient.
X The operator should take care that the patient does not
come into contact with the device.
CAUTION
Tripping Hazard.
Transporting the system is performed by pushing the
system cart in the forward direction.
X Do not pull the cart as this may cause it to tip over.

Safety notes
6 EnFocus OCT / 9054-10063_EN / Revision K-00
CAUTION
Tripping Hazard.
X Do not create a tripping hazard with the cord of the
EnFocus OCT device.
NOTICE
Risk of System Overheating.
System requires proper ventilation.
X Do not block the front, back or sides of the system during
operation.
NOTICE
Risk of damage to the lens.
X Never use the same lens cleaning tissue twice to avoid
scratching the lens.
NOTICE
Risk of damage to the EnFocus OCT scan head during transportation.
X When carrying the scan head, hold the scan head by the
extension tube and keep the cover on the objective lens.
NOTICE
Risk of damage to the EnFocus OCT system.
X Only connect items that have been specied as part of or
compatible with the EnFocus OCT System.
NOTICE
Risk of damage to the EnFocus OCT system due to a computer virus.
X Use caution when connecting the system to a network, thumb
drive, or other device as the connection could result in the
introduction of a computer virus to the system.
NOTICE
Risk of damage to the EnFocus OCT system.
X Do not expose this equipment to rain or moisture.
NOTICE
Risk of damage to the EnFocus OCT scan head due to immersion in a
liquid.
X Do not immerse the scan head in any liquid. Immersion will
result in damage to the electronics in the scan head.
NOTICE
Risk of damage to the EnFocus OCT system due to use in humid
environments.
This device is not designed for use in damp or high humidity
environments.
X Do not allow condensation to form on any component.
X Do no place uid-lled containers on any surface of the device.
NOTICE
Risk of damage to the EnFocus OCT system due to incorrect
assembling.
X System must be assembled and calibrated by a Leica service
representative prior to initial use.
NOTICE
Obstruction of the view.
X If the objective lens becomes scratched or damaged and
obstructs the view through the scope, remove the OCT scan
head from the scope.
NOTICE
Risk of damage to the system.
X Do not use the system adjacent to or stacked with other
equipment.
X If adjacent or stacked use is necessary, observe the system to
verify normal operation in this conguration.
NOTICE
Risk of damage to the device.
X Do not use the foot pedal if any damage is found.
X Contact Leica customer service to order a replacement foot
pedal.

EnFocus OCT / 9054-10063_EN / Revision K-00 7
Safety notes
3.6.2 Laser Safety
WARNING
Danger of eye injury due to laser radiation.
This device is a Class 1 Laser product.
Use of controls or adjustments or performance of
procedures other than those specied herein and any
companion documents may result in hazardous radiation
exposure.
X Do not operate the system when the ber optic cable is
removed from the optical ber port.
X Do not look directly in to the optical ber port.
X Do not remove the optical ber while the system is
powered on.
X Turn o power before removing the optical ber.
The following Photo toxicity cautions are mandatory text as defined
in the CDRH guidance document #1241, “Ophthalmoscope Guidance
(Direct and Indirect).
CAUTION
Photo toxicity.
Because prolonged intense light exposure can damage the
retina, the use of the device for ocular examination should
not be unnecessarily prolonged, and the brightness setting
should not exceed what is needed to provide clear
visualization of the target structures. This device does not
emit optical radiation outside of the near infrared
wavelength region 770nm – 1100nm.
CAUTION
Photo toxicity.
The retinal exposure dose for a photochemical hazard is a
product of the radiance and the exposure time. If the value
of radiance were reduced in half, twice the time would be
needed to reach the maximum exposure limit.
CAUTION
Photo toxicity.
While no acute optical radiation hazards have been
identied for direct or indirect ophthalmoscopes, it is
recommended that the intensity of light directed into the
patient's eye be limited to the minimum level which is
necessary for diagnosis. Infants, persons with aphakia and
other diseases of the eyes will be at greater risk. The risk
may also be increased if the person being examined has had
any exposure with the same instrument or any other
ophthalmic instrument using a visible light source during
the previous 24 hours. This will apply particularly if the eye
has been exposed to retinal photography.
The following cautionary statement is mandatory text as defined in
ISO15004-2:2007 for Group 2 ophthalmic instruments.
CAUTION
Photo toxicity.
The light emitted from this instrument presents a potential
thermal hazard to the cornea and lens. The longer the
duration of exposure, the greater the risk of ocular damage.
The maximum corneal and lenticular infrared radiation
irradiance emitted from this instrument is 95mW/cm² when
operated at worst case conditions (i.e., no eye movement
and with non-scanning beam). This value is 5% below the
safety guideline (100 mW/cm2) specied in ISO15004-2:
2007.
The EnFocus™ Spectral Domain Ophthalmic Imaging System (SDOIS)
complies with the Group 2 instrument requirements of ISO 15004-
2:2007.
CAUTION
Risk of injury to the retina due to prolonged light exposure.
X Do not unnecessarily prolong the use of the device for
ocular examination.
CAUTION
Thermal hazard to the cornea and lens.
X To limit the risk of ocular damage do not unnecessarily
prolong the duration of exposure.

Safety notes
8 EnFocus OCT / 9054-10063_EN / Revision K-00
3.6.3 Electrical Safety Precautions
WARNING
Danger of fatal electrical shock due to high voltage.
X Do not remove component covers. There are no
serviceable parts inside.
X Only authorized service personnel may perform
installation, assembly, service, and maintenance.
WARNING
Risk of electrical shock.
Not correctly connecting the system may result in injuries to
the patient or operator, or in damage to the equipment.
X Ensure that the system always is connected to a
protective earth when in operation.
WARNING
Danger of fatal electrical shock.
This equipment receives power from more than one source.
The output receptacles may be energized even when the
unit is unplugged. Unplugging the UPS puts it into backup
mode and does not remove the electrical charge.
X To ensure that the UPS is o, turn the power switch
“OFF” before unplugging the UPS from the wall outlet.
WARNING
Risk of electrical shock.
X Do not simultaneously touch the patient and the
computer.
WARNING
Risk of electrical shock due to improper grounding.
X To achieve grounding reliability connect this equipment
to matching receptacle marked "Hospital Only" or
"Hospital Grade".
WARNING
Risk of electrical shock due to interrupted grounding.
X Periodically check grounding continuity.
WARNING
Risk of reduced electrical safety.
Connecting electrical equipment to an extension cable can
result in a reduced level of safety.
X Plug the system directly into the wall outlet.
X Do not connect additional equipment to the UPS of the
system.
X Do not add an additional multiple socket-outlet or
extension cord to the system.
WARNING
Risk of electrical shock.
The rear video input ports are not electrically isolated.
X Only use the rear video input ports with medical grade
microscope cameras.
WARNING
Risk of electrical shock.
The USB ports are not electrically isolated.
X Only use the USB ports with bus-powered devices such
as ash drives.
X Do not use the USB ports with any device that connects
to an external power source.
WARNING
Fire danger.
X Do not use the UPS in the presence of a ammable
anesthetic mixture with air, oxygen, or nitrous oxide.
WARNING
Danger for the patient health due to changes to the
equipment.
X Do not modify or adulterate this equipment.
CAUTION
Electrical or optical hazards.
X Never attempt to repair or disassemble the system
yourself. Only a qualied service representative can
service the system or perform maintenance.
CAUTION
Risk of electrical shock for the patient or the operator, or
damage to the equipment.
X Never use a converter adapter to connect the three-
pronged AC plug into a two-pronged, ungrounded wall
outlet.