RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
Introduction 7
1 Introduction
The RetCam Shuttle Ophthalmic Imaging System (system) is designed to allow
the quick and easy capture of wide field, high resolution, fully digital images and
videos of the eye.
Indications for Use
The RetCam Ophthalmic Imaging Systems are indicated for general ophthalmic
imaging including retinal, corneal, and external imaging.
Warnings and Cautions
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a
physician or licensed medical practitioner.
WARNING: Prior to using the system, read all user safety information.
WARNING: Before using this equipment to acquire images from patient eyes, users
must be trained in proper clinical technique by personnel authorized by Clarity.
WARNING: The RetCam system is designed and tested as a system. Omission or
substitution of RetCam components may adversely affect system performance and
is strongly not recommended.
WARNING: Unauthorized modifications or additions to the RetCam system
(including hardware and software, etc.) could adversely affect system function and
will void the warranty.
WARNING: Carefully inspect and clean the lens piece before each use. DO NOT
USE if the lens piece has nicks, breaks, scratches, or rough surfaces that may
damage the eye.
WARNING: To mitigate the potential for excess light exposure, always start at the
lowest light intensity level and increase if necessary. Use only the shortest amount
of exposure time necessary; no greater than 5 minutes.
WARNING: Use care when contacting the eye; i.e., use the least amount of
pressure and/or movement necessary.
WARNING: To avoid the risk of electric shock, the equipment must be connected to
a supply mains with protective earth.
WARNING: To mitigate the potential for excess light exposure, the user should
avoid looking directly at the illuminated light source.
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
8 Introduction
WARNING: A risk/benefit ratio must be assessed before confirming a patient for
RetCam imaging if they are photosensitive, concomitantly exposed to
photosensitizing agents, or aphakic.
System Hardware
The RetCam Shuttle system consists of modules mounted in a stable, high quality
integrated mobile cart for easy, safe transport from one location to another. The four
casters allow for easy maneuverability and positioning. Figure 1 and Figure 2 below
illustrate the system hardware.
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
Figure 1 RetCam Shuttle Imaging System (Image representative only)
Hardware Components
• Notebook Computer: Pre-loaded with RetCam system software. The notebook
computer includes a DVD/R/RW drive, integrated network adapter and USB
ports.
• Handpiece: Contains the camera. Lightweight and easy to position, it has a
long cable for easy reach. Use with changeable lens pieces.
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
10 Introduction
• Handpiece Interconnect Harness: Comprises three separate cables: the lamp
(fiber optic) cable for subject illumination, the camera controller cable, and the
focus motor cable.
• Handpiece Holster: Holds the handpiece when the handpiece is not in use.
Note: Always return the handpiece to the holster when not in use. The
handpiece cable can be draped over the transport handle, but do not wrap it
tightly or damage to the fiber optic may result.
• Electro-Optical (EO) Box: Contains the camera control unit, illumination lamp,
and the control circuitry.
• Footswitch: Provides optical means to control illumination intensity, camera
focus, and SNAP.
• Cart: Contains the EO box and allows for easy transport from one location to
another. Includes an extendable transport handle.
• Storage Compartment(s): All units have storage compartments for lens
pieces, tools, and supplies.
Handpiece
• Transport Handle: Extends to tilt and roll the cart to another location.
For storage of the system when not in use, disconnect the power cord and store it
inside the cart. Stow the handpiece in its compartment behind the upper door and
the footswitch in its compartment behind the lower door. Remove all loose objects
from the work surfaces. Close the notebook computer and consider removing it to a
secure location. Wipe the surfaces with a soft cloth. Apply the brakes to the front
casters to keep it in place.
Transport
The system is designed to be transportable, both within and between hospitals,
clinics and offices.
Note: The system has no internal power supply (no battery) to support image
acquisition while disconnected from a wall outlet. (The notebook computer
can operate using its own battery.)
To relocate the system within a building:
1. Power down the system through the software by selecting
and then Shutdown.
2. Switch OFF mains power on the back of the unit. Unplug the power cord from
the wall outlet and drape it over the transport handle.
3. Secure the handpiece in its holster or inside the storage compartment.
4. Unlock the caster brakes.
Now you can gently roll the system on all four casters to the new location. Move the
system slowly to minimize vibration. Once in the new location, apply the caster
brakes, plug in the power cord and restart the system.
To transport the system to another location:
1. Power down the system through the software by selecting
and then Shutdown.
2. Switch OFF mains power on the back of the unit. Unplug the power cord from
the wall outlet and drape it over the transport handle or store the power cord
inside the cart.
3. Carefully remove the lens and store it in the lens box. Secure the handpiece and
footswitch in their storage compartments in the cart.
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
12 Introduction
Figure 4 Transporting the Shuttle
4. Remove the notebook computer from the work surface and
carry it separately.
5. Close the cart doors.Unlock the caster brakes.
6. Extend the transport handle upward and use it to tilt the cart
and roll it to a vehicle for transport.
Inside the vehicle, we recommend that you lay the RetCam
Shuttle front side up.
Electrical Safety Information
The system has been designed, inspected and tested to comply with the safety
requirements of IEC60601-1 with respect to fire, shock and mechanical hazards
only if used as intended.
Class I Type BF Electrical Equipment
Rated for Continuous Operation
IEC 60601-1:1995
Accessories equipment connected to the analog and digital interfaces must be
certified to the respective IEC standards (i.e. IEC6950 for data processing
equipment and IEC 60601-1-1 for medical equipment.) Furthermore all configurations shall comply with the system standard IEC 60601-1-1. Anyone who connects additional equipment to the signal input part or signal output part
configures a medical system, and is therefore, responsible to ensure the system
complies with the requirements of the system standard IEC 60601-1-1. If in
doubt, contact Clarity service.
WARNING: This equipment should be connected using the power cord supplied by
Clarity.
WARNING: To avoid risk of electric shock, this equipment must be connected to a
supply mains with protective earth.
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
Introduction 13
Electromagnetic Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
Harmonic emissions IEC 61000-3-2Class AThe RetCam system is suitable for use in all
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Class A 30 MHz to 1 GHz The RetCam system uses RF energy for its internal
function. Nearby electronic equipment may be
affected.
Complies
establishments other than domestic, and may be
used in domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes, provided the following warning is
heeded:
Warning: This equipment/system is intended for
use by health care professionals only. This
equipment may cause radio interference or may
disrupt the operation of nearby equipment. It may
be necessary to take mitigation measures, such
as re-orienting or relocating the system or
shielding the location.
Test TypeTest and Compliance LevelElectromagnetic Environment Guidance
Electrostatic discharge
(ESD)
EN 61000-4-2
Electrical Fast
Transients/burst
EN 61000-4-4
Surge
EN 61000-4-5
Voltage dips and
interruptions
EN 61000-4-11
Power Frequency (50/60)
Hz magnetic field
EN 61000-4-8
Immunity Test Summary
±6 kV contact
±8 kV air
± 2 kV for power supply linesMains power quality should be that of a
± 0.5, 1 kV Line to Line
± 0.5, 1, 2 kV Line to earth
>95%, 0.5 Cycles
60%, 5 Cycles
30%, 25 Cycles
>95%, 250 Cycles
3A/mPower frequency magnetic fields should be
The RetCam Shuttle requires ESD
exemption. See Important User Safety
Notices.
typical commercial or hospital environment.
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the RetCam system requires
continued operation during power mains
interruptions, it is recommended that the
RetCam system be powered from an
uninterruptable power supply (UPS).
at levels characteristic of a typical location in
a typical commercial or hospital
environment.
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
14 Introduction
Test TypeTest and Compliance LevelElectromagnetic Environment Guidance
Conducted RF IEC
61000-4-6
Radiated Immunity
EN 61000-4-3
Immunity Test Summary
0.15-80 MHz, 3Vrms, 80% 1 KHZ AMPortable and mobile RF communications
equipment should be used no closer to any
part of the RetCam system, including cables,
80MHz-2.5GHz
3V/m 80%@1kHz
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d= (3.5/ E1)x(square root of P) 80 MHz to
800 MHz
d= (7 /E1)x(square root of P) 800 MHz to
2.5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m). E1 is 3 V/m
Conducted Immunity:
d= (3.5/ V1)x(square root of P) where V1 is
3 Vrms
Field strength from fixed RF transmitters, as
determined by an electromagnetic site
survey, should be less than the compliance
level in each frequency range. Interference
may occur in the vicinity of equipment
marked with the following symbol.
Magnetic Immunity
EN 61000-4-8
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
3A/m 50/60 HzVideo display terminals and other electron
WARNING: Interference may occur in the vicinity of
equipment marked with this symbol. This
equipment/system may cause radio interference or
may disrupt the operation of nearby equipment. It
may be necessary to take mitigation measures such as:
• Reorient or relocate the receiving device.
• Increase the separation between the equipment.
beam devices (e.g. X-ray image intensifiers)
may use a justification for lower IMMUNITY
COMPLIANCE LEVELS as allowed by
36.202.1 a).
Introduction 15
• Connect the equipment into an outlet on a circuit different from that to which the
other device(s) are connected.
• Consult the manufacturer or field service technician for help.
CAUTION: For continued protection against risk of fire, replace only with same type
and rating fuse.
Note: The notebook computer, Hewlett Packard Model 6730B has met all
requirements of EN55024 (IT Equipment Immunity Requirements) and IEC
60601-1-1, General Requirements for Safety Collateral Standard:
Electromagnetic Compatibility Requirements and Tests. However, this
notebook computer does not fully meet Clause 36-202-2 of IEC 60601-1-2.
Refer to the Electromagnetic Environment Guidance section in the “Immunity
Test Summary” on page 17.
Important User Safety Notices
1. Before moving the system to a new site, carefully remove the lens from the
handpiece and store it in the case. Store the handpiece in the cart.
2. Never contact the front of the lens piece with hard or sharp objects. This could
damage the precision optics and sealing.
3. DO NOT AUTOCLAVE any part of the device.
4. Appropriately power down and unplug the unit and allow the illumination bulb to
cool before replacing it.
5. Newly acquired data may be lost if power is interrupted during live imaging.
6. The system comes protected from viruses, worms, and spyware with Microsoft's
anti-malware. Please refer to your warranty prior to adding any additional
software or contact Clarity Service.
7. It is possible during the connection of any cable or device into any of the
Notebook computer ports the computer may lock up. This is an indication that a
source of High Electrostatic Discharge (+/-6 Kv) was discharged into one of the
ports of the computer. If this should occur, please reset the Notebook
computer’s power. To perform a system reset, press the power ON button on
the Notebook computer for a few seconds until the system powers down, then
press the power button ON again to power the Notebook back ON. This does
not present a safety risk to the patient, user, or environment.
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
16 Introduction
Labels and Symbols
Focus Controls
Intensity Controls
SNAP (capture) switch
Read instructions
Caution:
Do not look directly into light source
Protective earth (ground)
Alternating current (AC)
System contains fuse of indicated type.
Do not use any other type.
Non-ionizing radiation
Read accompanying user documentation
Fragile contents
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
Introduction 17
This side of carton up
Temperature limits
Authorized representative in the EU
Type BF equipment (applied part is handpiece)
To prevent damage to lens piece, carefully store
handpiece in holster when not in use.
Clean lens piece after use
Separate collection of waste at end-of-life as required by
European directives. Contact Clarity for equipment
disposal instructions.
European conformity
North American compliance certification
Serial number
Manufacturer
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
Keep away from the rain
18 Introduction
Go to next screen
Hide image
Delete image
Flag or select item
Reset
View patient directory
Utilities
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
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Introduction 19
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System Functions 21
2 System Functions
This section describes some important system functions.
System Installation
Note: Place components and cabling in a manner to prevent inadvertent
hazards to users or equipment.
1. Place the notebook computer on the top of the cart. Open the computer.
2. Install the notebook computer power supply cable from the notebook to the EO
box.
3. Install the USB video cable from the notebook to the EO box.
4. Carefully remove the footswitch from the cart.
5. Install the power cord from the back of the cart to the wall power (supply mains
with protective earth).
WARNING: This equipment should be connected using the power cord supplied by
Clarity.
WARNING: To avoid the risk of electric shock, this equipment must be connected to
a supply mains with protective earth.
Turning ON the RetCam System
1. Turn ON the front power switch on the EO box.
2. Turn ON the main power switch on the back of the EO box. The lamp indicator
light should be illuminated.
3. Power on the notebook computer. The software should initiate.
4. Carefully remove the handpiece from the case or storage drawer.
Note: Store the handpiece in the case or on the holster when not in use.
5. Attach the desired lens piece to the handpiece as shown in Figure 5 and
Figure 6. The display will prompt you when the software is ready.
Note: The system has no internal power supply (no battery) to support image
acquisition after disconnected from a wall outlet. (The notebook computer
can operate using its own battery.)
WARNING: Carefully inspect the lens and clean the lens piece before each use.
DO NOT use if the lens piece has nicks, breaks, scratches, or rough surfaces that
may damage the eye.
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
22 System Functions
WARNING: To mitigate the potential for excess light exposure, always start at the
lowest light intensity level and increase if necessary. Use only the shortest amount
of exposure time necessary; no greater than 5 minutes.
Note: To conserve lamp life, turn OFF the power switch on the front of the EO
box.
Lens Installation
Figure 5 Lens installation
1. Align lens to fit over the pins on the handpiece.
Figure 6 Tighten lens on handpiece
2. Carefully tighten clockwise until the lens clicks into place. Do not overtorque.
Turning OFF the RetCam System
Note: We strongly suggest that you backup and store your data prior to
turning OFF the system.
1. Select the red shutdown icon at the bottom right corner of the screen.
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
System Functions 23
2. Select “Shutdown” and confirm.
3. Turn OFF the main power switch on the back of the EO box.
Hard Shutdown
WARNING: Do not use the hard shutdown method unless necessary because data
corruption can occur.
1. In the event that hard Shutdown is required, continuously press the System
Power button on the notebook computer for at least 6 seconds to force the
system, including backup battery, to shutdown.
2. Turn OFF the main power switch on the back of the EO box.
Turning Off for Extended Periods
If you are not going to use the system for an extended period (such as one day or
more), it is advisable to switch OFF the EO box only. This will help preserve the
illumination lamp.
Note: These actions will remove power from the entire system except the
notebook computer.
RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
24 System Functions
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RetCam Shuttle User Manual and Service InstructionsPN 20-000238 Rev. B
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