Leica Envisu C Series Instructions for use

Envisu C-Series SDOIS / 9054-10011 / Revision N 1
HARDWARE
USER MANUAL
EnvisuTM C-Series SDOIS
(Spectral Domain Ophthalmic Imaging System)
C-Series
9054-10011
Revision N 6.2022

Hardware User Manual
Envisu C-Series SDOIS / 9054-10011 / Revision N 2
Thank you for purchasing an EnvisuTM Spectral Domain Ophthalmic Imaging system. In
developing our systems, we have placed great emphasis on simple, self-explanatory operation.
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 EnvisuTM SDOIS system.
For inquiries regarding sales, service, or support contact Leica Microsystemsby 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: 1-800-526-0355 (Option 1, then Option 1)
Portugal: [phone]

Hardware User Manual
Envisu C-Series SDOIS / 9054-10011 / Revision N 3
For issues concerning the Leica manufacturing center please contact:
Leica Microsystems NC, Inc.
4222 Emperor Blvd
Suite 390
Durham, NC 27703 USA
Phone: [phone]
Fax: [phone]
CAUTION
Federal law restricts this device to sale by or on the order of a physician or practitioner.
Leica Microsystems CMS GmbH
Ernst-Leitz-Strasse 17-37
35578 Wetzlar
Germany
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.

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Table of Contents
Contents
Product Information.................................................................................................................... 5
Symbol Key............................................................................................................................ 5
Intended Use & Contraindications.......................................................................................... 6
System Specifications............................................................................................................ 7
Classification.......................................................................................................................... 8
Warnings and Cautions.......................................................................................................... 9
Safety....................................................................................................................................10
Operational Safety.............................................................................................................10
Environmental Conditions..................................................................................................11
Electromagnetic Compatibility (EMC)................................................................................12
General Precautions..........................................................................................................13
Overview of the Hardware.....................................................................................................14
Device Description ............................................................................................................14
Labeling ................................................................................................................................17
SDOIS Scan Engine Front Panel.......................................................................................17
Hand Held Probe Interface Box Front Panel......................................................................17
SDOIS System Rear Panel Label......................................................................................18
System Connections.............................................................................................................18
System Power Up and Power Down......................................................................................19
Troubleshooting........................................................................................................................20
Resolving Hardware Problems..............................................................................................20
Maintenance .........................................................................................................................24
Periodic Safety Checks.............................................................................................................24
Expected Service Life........................................................................................................24
Cleaning and Disinfecting Lenses:........................................................................................25
Disposal....................................................................................................................................26
Appendix 1:...............................................................................................................................27

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Envisu C-Series SDOIS / 9054-10011 / Revision N 5
Product Information
Symbol Key
The following symbols are displayed throughout the User Manual.
Warning
Warnings alert about situations that, if not avoided, could result in death or
serious injury.
Warning
Dangerous Voltage
Note
Notes identify technical requirements to which the user should devote
special attention, such as remarks on common errors, unusual situations,
and tips for optimized use.
Alternating Current Symbol: Found on Electrical Safety Label on the back of
the Engine and Interface Boxes
Operating Instructions: Found on Manufacturer Label Consult User Manual
Protective Ground Earth: Found inside Engine and Interface Boxes

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Intended Use & Contraindications
Leica EnvisuTM Spectral Domain Ophthalmic Imaging system is intended to acquire, process,
display and save depth-resolved images of ocular tissue microstructure using Spectral Domain
Optical Coherence Tomography (SD-OCT).
The EnvisuTM SDOIS is indicatedfor use as an aid in thediagnosis of physiologic and pathologic
conditions of the eye through non-contact optical imaging. Imaging of the various tissues of the
eye is supported through the use of interchangeable lenses. It is indicated for use on patient
populations from premature and neonatal infants to adult, and is suitable for patients ambulatory
or confined. The system is indicated for use in upright or supine imaging, handheld or mounted,
and is suited for imaging patients under anesthesia.
IMPORTANT! Read and understand the entire user’s manual before
operating this system. If you have any questions concerning
the use of this system, contact customer service.
Users of this system should be physicians or technicians with professional training or
experience in the use of retinal imaging equipment.
Contraindications
This device is a Class 1 Laser product in accordance with the IEC 60825-1:Ed 1.2 standard.
As a good practice, subject retina should not be exposed to the direct output of this device for
any longer than necessary for obtaining images.
CAUTION! Use of controls or adjustments or performance of procedures
other than those specified herein and any companion
documents may result in hazardous radiation exposure.

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System Specifications
This Document covers the following Model Numbers:
Power Supply
System
Internal Light
Source
North
America
Europe /
Australia
Japan
C2300
Very High Resolution
(VHR)
9070-10024
9070-10034
9070-10097
Physical Dimensions
31” wide x 24” deep x 37” tall to cart top
(79 x 61 x 94 cm)
59” tall with monitor arm (150 cm)
Weight
275 lbs (125 Kg)
Product
Operation
Transport &Storage
Use
Temperature:
59 to 86°F (15 to 30°C)
14 to 122°F (-10 to 50°C)
Humidity:
20 to 85% Non-
condensing
15 to 95% Non-condensing
Atmospheric
Pressure:
N/A
N/A
Standards
Compliance
This device conforms to the following standards:
IEC 60601-1:2005
EN 60601-1:2006
UL 60601-1:2003
CAN/CSA-C22.2 No. 601.1-M90
Excluding clause 48 (Biocompatibility)
CAN/CSA C22.2 No.60601-1-08
Excluding clause 11.7 Biocompatibility (ISO 10993-1)
EN 60601-1-2:2007
IEC 60601-1-6:2010
EN ISO 15004-2:2007
IEC60825-1 Ed. 3 (2014)
Optical Source
The system contains an embedded Super- Luminescent Light
Emitting Diode (SLED) light source with a continuous wave
output operating at a center wavelength in the region of
840nm. Maximum optical radiation output from the scanning

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probe is 750uW. The system is compliant to IEC60825-1,
Class 1 Laser.
Mode of Operation
Continuous
Power Requirements
North America:
120V, 60 Hz
Europe and Australia:
185-240 Single Phase VAC, 50/60Hz, 400W max. (Not
evaluated by UL)
Japan:
100V, 50 or 60 Hz
Power Cord
North America: Hospital grade NEMA 5-15 cord, 20’.
Europe: CEE 7/7 plug, 3.5m cord.
Australia: AS/NZS 3112:2000 plug 6.1 m cord
Japan: Hospital grade NEMA 5-15 cord, 4.6m
Type of Protection
Against Electrical
Shock
Class I Equipment
Degree of Protection
Against Ingress Of
Water (Foot pedal
only)
Minimum IPX6 –Ordinary Equipment
Classification
Class 2 Medical Device (Canada)
Class IIa Medical Device (European Union)
Class IIa Medical Device (Australia)
Class II Medical Device (Japan)
Class 1 Laser Product
Continuous Operation
Not for use in flammable environments
Not provided sterile - Cleaning Instructions provided

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Warnings and Cautions
Warning! Explosion Hazard
Risk for explosion exists if the device is operated in the presence of
flammable anesthetics, or other flammable gases or liquids.
Caution!
To reduce risk of electrical shock, do not open enclosure. There are no
serviceable parts inside. Refer service to Leica, Inc. or its authorized agent
only.
Caution!
Do not expose this equipment to rain or moisture.
Note:
Canada, Grounding reliability can only be achieved when this equipment is
connected to matching receptacle marked “Hospital Only” or “Hospital
Grade”.
Europe and Australia: Must be plugged into a grounded receptacle.
Caution!
Individuals that are allergic to system materials such as the HHP sheathing,
chin rest, or other exterior sections of the system with which they come in
contact should limit skin exposure.
Caution! Optical Radiation Hazard
Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous radiation exposure.
Caution! Phototoxicity
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 should be used with
filters that eliminate UV radiation (< 400 nm) and, whenever possible, filters
that eliminate short-wavelength blue light (<420 nm).*
Caution! Phototoxicity
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.*

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Caution! Phototoxicity
While no acute optical radiation hazards have been identified for direct or
indirect ophthalmoscopes, it is recommended that the intensity of light
directed into the subject’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.*
*Note: The Phototoxicity cautions listed above are mandatory text as defined in the CDRH guidance
document #71, “Ophthalmoscope Guidance (Direct and Indirect).”
The EnvisuTM Spectral Domain Ophthalmic Imaging System (SDOIS)
complies with the Group 2 instrument requirements of ISO 15004-
2:2007.
CAUTION - 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
95mW/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) specified in ISO15004-2: 2007.**
**Note: This cautionary statement is mandatory text as defined in ISO 15004-2:2007 for Group 2
ophthalmic instruments.
Safety
Operational Safety
Warning! Danger of High Voltage
Do not remove component covers. Installation, assembly, service, and
maintenance must be performed by the manufacturer or an authorized
service representative only.
Warning! Danger of High Voltage
The signal input parts or signal output parts (SIP/SOP) need to be
connected properly and should never be connected to AC powered devices
when conducting a patient exam.
Warning! Danger of High Voltage
The only direct disconnection from the mains is by unplugging the system
power cable from the wall socket. Keep the power plug accessible at all
times during the system operation.

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Warning! Optical Radiation
Do not remove the optical fiber while the system is operational. Turn off
power before removing the optical fiber.
Warning! Optical Radiation
Do not operate the system with the fiber optical cable removed. Do not look
directly into the optical fiber port.
Warning! Patient Contact
Do not simultaneously touch the patient and the computer.
Caution! Ventilation
System requires proper ventilation. Do not block the Front or Sides of the
System.
For product warranty by the manufacturer the following must be observed:
•The device must be used according to this manual, “Leica Spectral
Domain Ophthalmic Imaging System. The system should not be
used in any manner aside from that specified in the user manual.
•Installation, assembly, service, and maintenance must be performed
by the manufacturer or an authorized service representative only.
•No modifications to the device are allowed.
•The electrical installation of the room where the device is used
complies with national standards. Do not remove or disable the
ground pin of any power connection.
•Supply cables are for connecting Leica, Inc. equipment only and
may not be used with any other equipment.
Environmental Conditions
The device is intended for operation in the hospital environment. The device may be
used only in enclosed rooms and must be placed on a solid floor.
Warning! Explosion Hazard
Do not operate the device in an environment where explosive and/or
flammable substances are used or stored. In the event of an emergency,
disconnect the power cords immediately.
Caution!
This device is not designed for use in damp or high humidity environments.
Do not allow condensation to form on any component. Do not place fluid-
filled containers on any surface of the device.

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Electromagnetic Compatibility (EMC)
•The Spectral Domain Ophthalmic Imaging System is in compliance with the
electromagnetic compatibility requirements in accordance with EN 60601-1-2:2007
Medical Electrical Equipment-collateral standard.
•The device 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 system's functionality.
•The Emissions characteristics of this equipment make it suitable for use in hospitals
only (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11
class B is normally required) this equipment might not offer adequate protection to
radio-frequency communication services. The user might need to take mitigation
measures, such as relocating or re-orientating the equipment.
Warning!
Do not attach any accessory, cable, or other device to the system. To do so
may result in increased EMISSIONS or decreased IMMUNITY of the
system.
Warning!
Do not place other equipment adjacent to or on top of the system.
Caution!
The device should not be operated near active
HF SURGICAL EQUIPMENT or near magnetic resonance
imaging, where the intensity of EM DISTURBANCES is
high.
Warning!
Risk of Unspecified Accessories/Cables.
Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
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 that they are operating normally.

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Warning!
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30cm
(12 inches) to any part of the Envisu System including cables specified.
Otherwise, degradation of the performance of this equipment could results
Note: For electromagnetic emissions compliance information please see Appendix 1.
General Precautions
Caution! Patient Contact
The optical working distance of the probe tip is sufficient to avoid patient
contact. Care by the operator should be taken to prevent patient contact
Caution!
Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous radiation exposure.
Caution!
Transporting the system is performed by pushing the system cart in the
forward direction. Do not pull the cart as it may experience instabilities that
could cause it to tip over.

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Overview of the Hardware
Device Description
The Leica Spectral Domain Ophthalmic Imaging System is a noninvasive imaging device
which provides microscopic tomographic images of the retina with < 6 microns axial resolution
or better, depending on the specific model. The Leica Spectral Domain Ophthalmic Imaging
System is capable of >32,000 A-Scans/second. It is composed of a host computer, SDOIS
engine, probe and system cart. The SDOIS engine is driven by instrument cards in the
computer. The device software will allow a user to create, display, load, and save image files
(SDOIS files).
Handheld Scanner
(Probe)
Computer with Preloaded
IVVC Software
Uninterruptible Power
Supply (UPS) and Isolation
Transformer
Scanner (Probe)
Interface Box
Keyboard & Mouse
Scan Engine
Wheels with Locking
Casters
Storage Area
Scanner Holster

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Uninterruptible Power Supply (UPS)
Medical grade PowerVAR UPS systems (UL60601-1/IEC60601-1), available in 100, 120
&230 V, 50/60 Hz, 600 VA (single-phase).
Battery Status
Display
On/Off Button
Test/Silence Button

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UPM LED Display
UPS Status
UPM output on
Battery charge status in 20% increments
UPM load status in 20% increments
UPM in battery operation due to improper incoming AC
UPM overloaded
Battery fault or battery disconnected
High incoming AC: UPS has to reduce the output
compared to the incoming power level
Low incoming AC: UPS has to increase the output
compared to the incoming power level
Fault/error
UPM temperature too high
UPS Status Indicators
Warning! This unit is intended to be used in a system that has a
grounded neutral conductor. Operating this equipment without proper
grounding may present a risk of electrical shock. Do not use AC
adaptors with only two conductors to connect the input line cord to the wall
socket as this will not connect the earth ground to the equipment.
Warning! This equipment services power from more than one source.
The output receptacles may have voltage present even when the unit
is unplugged. Unplugging the UPS does not remove the electrical charge.
To ensure that the UPS is off, turn the power switch “OFF” before
unplugging the UPS from the wall outlet.
.

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Labeling
SDOIS Scan Engine Front Panel
Note: The Scan Engine and Interface Box rear panels are not visible with system back panel in place.
Hand Held Probe Interface Box Front Panel
Power Indicator
Probe Cable
Power Indicator
Scanning Indicator
Reference Arm
Position Adjust
Reference Arm
Power Adjust

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SDOIS System Rear Panel Label
Rear Panel Label
System Connections
The Leica Spectral Domain Ophthalmic Imaging System is installed on site by authorized Leica
service personnel. All electrical and optical signal connections will be secured at the time of
installation. The operator will only be required to connect the system input power cord to an
appropriate electrical outlet. No other connections are required by the operator.
Standard System Cables
The system uses the following cables for operation:
Cable
Length
Description
Mains
Power Cord
North America: Hospital grade NEMA 5-15 cord, 20’.
Europe: CEE 7/7 plug, 3.5m cord.
Australia: AS/NZS 3112:2000 plug 6.1 m cord
Japan: Hospital grade NEMA 5-15 cord, 4.6m
Permanently attached
mains input power cable
2-button
Foot pedal
7' [2.1 m]
Foot pedal USB cable to
the system
Scan head
6.5’2m
Fiber optic cable,
connection between the
scan-head module and
cart
Power Input
Requirements
Product Optical
Output
Classification
Cautions
Warnings

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System Power Up and Power Down
Powering Up the System
To power up the Leica Spectral Domain Ophthalmic Imaging System, use the following steps:
1. Power on the system switch located on the front of the UPS.
2. Check to insure the SDOIS Scan engine and Hand Held Probe interface box are
powered on.
3. Power on the computer.
4. Once the computer has finished the boot cycle, launch the IVVC image acquisition
software application using the applicable desktop shortcut.
Powering Down the System
About Powering Down the System
The light source in the SDOIS engine has a limited lifetime and therefore, the system should
be powered down at the end of each day.
Points to consider before powering down the system:
•Exporting patient exams
•Archiving patient exams
•Backing up system data
Power Down
To power down the Leica Spectral Domain Ophthalmic Imaging System, use the following
steps:
1. Close the IVVC Image Acquisition Software Application.
2. Shut down the system computer using the standard operating system shut down
procedure.
3. Once the system computer shut down sequence is complete, power off the system
switch located on the front of the UPS. To turn the UPS system off press and hold the
power switch for at least 2 seconds.
Note:
The SDOIS engine and probe interface box must be powered on
prior to starting the IVVC image acquisition software application.
Note:
Consult the IVVC Software Users Manual for proper instructions
on exporting and archiving patient data along with backing up
system data.

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Troubleshooting
Resolving Hardware Problems
Symptom
Possible cause
Actions to correct
Power Issues: When the system is operating properly, the green power light will be lit on
the engine and the interface box.
When master power on
UPS is turned on, nothing
happens.
Unit not plugged into the
wall.
Plug on back of UPS loose.
Reconnect plug.
Remove back panel;
reconnect the plug
When master power on
UPS is turned on, system
alarms.
Same as above, but
because of battery backup,
UPS is alerting you of the
problem.
Reconnect plug.
Remove back panel;
reconnect the plug
UPS alarms while system
is in operation.
Loss of power at the outlet.
Plug at wall has come
loose.
Restore wall power.
Reconnect plug.
UPS turns on, but other
components do not.
Plug on back of UPS is
loose.
Remove back panel, and
verify all connections from
UPS.
Green light on either
Engine or UPS does not
turn on.
Switch on back of
component is not turned
on.
Plug is loose.
Remove back panel; verify
switch on engine &
interface box is switched to
on position. Verify plugs
are installed.
Fuse is blown.
Contact Leica
Microsystems for support
Computer does not turn on.
Note: Computer will not
turn on automatically when
UPS is turned on.
Plug on computer is loose.
Remove back panel;
reconnect the plug.