Clarity RetCam Shuttle User Manual And Service Instructions

RetCam Shuttle
Ophthalmic Imaging System
User Manual and
Service Instructions
PN 20-000238 Rev. B For use with
software version 5.2
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician or licensed medical practitioner.
2
Copyright
© 2009 Clarity Medical Systems, Inc. All rights reserved.
European Authorized Representative address MediMark® Europe S.A.R.L.
11, rue Emile Zola 38 100 Grenoble France Tel: +33 (0) 4 76 86 43 22 Fax: +33 (0) 4 76 17 19 82 e-mail: info@medimark-europe.com
RetCam Shuttle User Manual and Service Instructions PN 20-000238 Rev. B
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Contents
1 Introduction....................................................................................7
• Indications for Use..................................................................................................... 7
• Warnings and Cautions................................................................................... 7
• System Hardware............................................................................................ 8
• Hardware Components..............................................................................................9
• Storage ..........................................................................................................11
• Transport........................................................................................................11
• Electrical Safety Information ......................................................................... 12
• Electromagnetic Emissions......................................................................................13
• Immunity Test Summary..........................................................................................13
• Important User Safety Notices...................................................................... 15
• Labels and Symbols...................................................................................... 16
• Label........................................................................................................................19
2 System Functions........................................................................21
• System Installation........................................................................................ 21
• Turning ON the RetCam System .................................................................. 21
• Lens Installation............................................................................................ 22
• Turning OFF the RetCam System................................................................. 22
• Hard Shutdown........................................................................................................ 23
• Turning Off for Extended Periods ............................................................................ 23
3 Using the RetCam System..........................................................25
• Managing Patient Records............................................................................ 25
• Add a New Patient Record ......................................................................................25
• Editing a Patient Record.......................................................................................... 26
• Finding Existing Patient Records.............................................................................27
• Performing Exams......................................................................................... 28
• Capturing Still Images .............................................................................................29
• Capturing Video....................................................................................................... 30
• Recommended Procedure.......................................................................................31
• Video Playback........................................................................................................ 32
• Using Helpful Features.................................................................................. 32
• Shortcut Keys ..........................................................................................................32
• Changing Image Capture Options During an Exam ................................................33
• Adding Exam Notes ...................................................................................... 34
4 Image Review and Compare Mode.............................................35
• Image Review Screen................................................................................... 35
• Compare Mode ............................................................................................. 37
• Image Adjustment......................................................................................... 39
• Image Adjustment Parameters ...............................................................................39
• Annotation ...............................................................................................................40
5 Import and Export Images...........................................................41
• Backing Up Images....................................................................................... 41
• Backup Recommendation: Network or Removable USB Mass Storage Device .....41
• Compatible Removable Media.................................................................................41
RetCam Shuttle User Manual and Service Instructions PN 20-000238 Rev. B
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• Exporting Images.......................................................................................... 42
• Select Images for Export .........................................................................................42
• Select Export Options.............................................................................................. 43
• Format Options........................................................................................................ 44
• Export Image Formats............................................................................................. 44
• Export Data Formats ...............................................................................................44
• Select Advanced Options ........................................................................................44
• Complete Export...................................................................................................... 46
• Importing Images .......................................................................................... 46
6 Printing Images............................................................................51
• Printing Images and Reports......................................................................... 51
7 User Preferences.........................................................................53
• Institution .................................................................................................................55
• New Exam ...............................................................................................................55
• Printers ....................................................................................................................56
• Windows Configuration............................................................................................56
8 Maintenance and Support ...........................................................57
• Recommended Maintenance Schedule........................................................ 57
• Cleaning Procedures .................................................................................... 57
• Cleaning the Lens Piece..........................................................................................57
• Alternate Cleaning and Disinfection ........................................................................ 58
• Cleaning the Rest of the System.............................................................................59
• Disposal of Materials ...............................................................................................59
• Fuse Replacement........................................................................................ 60
• Replace Illumination Lamp/Bulb................................................................... 61
• Key Validation............................................................................................... 65
• Technical Support......................................................................................... 66
• Clarity Technical Support Contact Information........................................................66
9 Service.........................................................................................67
• Consumables........................................................................................................... 67
• Components ............................................................................................................ 67
• Servicing the Cart ......................................................................................... 68
• Notebook Computer Information .............................................................................68
• Troubleshooting Guide.................................................................................. 68
10 Technical Specifications..............................................................71
• Hardware ...................................................................................................... 71
• Physical ...................................................................................................................71
• Electrical .................................................................................................................. 71
• Software........................................................................................................ 71
• Environmental Conditions........................................................................................71
• Notebook Computer ................................................................................................71
11 License Agreements....................................................................73
• CMS Software Restricted Rights................................................................... 73
• RetCam Software End User License Agreement.......................................... 73
Index............................................................................................75
RetCam Shuttle User Manual and Service Instructions PN 20-000238 Rev. B
List of Figures
Figure 1 RetCam Shuttle Imaging System (Image representative only)................................. 9
Figure 2 Handpiece and Lens Piece..................................................................................... 10
Figure 3 Shuttle with all items stowed .................................................................................. 11
Figure 4 Transporting the Shuttle ......................................................................................... 12
Figure 5 Lens installation...................................................................................................... 22
Figure 6 Tighten lens on handpiece ..................................................................................... 22
Figure 7 Start screen ............................................................................................................ 25
Figure 8 Add new patient screen.......................................................................................... 26
Figure 9 Edit patient record screen....................................................................................... 27
Figure 10 Search buttons ....................................................................................................... 27
Figure 11 Patient search options............................................................................................ 27
Figure 12 Patients and Exams Screen (Patient Directory) ..................................................... 28
Figure 13 Patients and Exams screen navigation buttons...................................................... 28
Figure 14 New Exam configuration screen............................................................................. 29
Figure 15 Still image screen ................................................................................................... 30
Figure 16 Deselect the red X to save video............................................................................ 31
Figure 17 Video playback controls.......................................................................................... 31
Figure 18 Video controls and scrollbar ................................................................................... 32
Figure 19 Select options for image capture ............................................................................ 33
Figure 20 Enable mouse-over ................................................................................................ 33
Figure 21 Exam Notes dialog ................................................................................................. 34
Figure 22 Image Review screen ............................................................................................. 35
Figure 23 Compare [Images] screen ...................................................................................... 38
Figure 24 Select patients and exams for export ..................................................................... 42
Figure 25 Export dialog........................................................................................................... 43
Figure 26 Export dialog showing closeup of destination......................................................... 43
Figure 27 File format............................................................................................................... 44
Figure 28 Create subfolders menu ......................................................................................... 45
Figure 29 File name format menu........................................................................................... 45
Figure 30 Export progress dialog............................................................................................ 46
Figure 31 Start screen ............................................................................................................ 47
Figure 32 Import Folder dialog................................................................................................ 47
Figure 33 Select Import Data dialog ....................................................................................... 48
Figure 34 Import options......................................................................................................... 48
Figure 35 Print dialog.............................................................................................................. 51
Figure 36 Access User Preferences....................................................................................... 53
Figure 37 About Clarity software ............................................................................................ 53
Figure 38 User Preferences screen........................................................................................ 54
Figure 39 User Preferences: Institution .................................................................................. 55
Figure 40 User Preferences: New Exam ................................................................................ 55
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RetCam Shuttle User Manual and Service Instructions PN 20-000238 Rev. B
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Figure 41 User Preferences: Printers ..................................................................................... 56
Figure 42 User Preferences: Windows Configuration............................................................. 56
Figure 43 Inverted lens piece showing permissible depth of immersion................................. 59
Figure 44 Power Entry Module ............................................................................................... 60
Figure 45 Opening the fuse holder cover ............................................................................... 60
Figure 46 Removing the fuse holder....................................................................................... 60
Figure 47 Blown fuse removed ............................................................................................... 61
Figure 48 Front panel showing the lamp assembly drawer .................................................... 62
Figure 49 Open lamp assembly drawer.................................................................................. 62
Figure 50 Eject the bulb.......................................................................................................... 63
Figure 51 Catch the bulb ........................................................................................................ 63
Figure 52 Insert new bulb ....................................................................................................... 64
Figure 53 Replace lamp assembly drawer and fiber optic cable ............................................ 64
Figure 54 Key Validation dialog .............................................................................................. 65
RetCam Shuttle User Manual and Service Instructions PN 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 Instructions PN 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 Instructions PN 20-000238 Rev. B
Introduction 9
Notebook Computer
Work surface
Secondary work surface
Container for tools and supplies
Internal handpiece storage compartment
Upper door (open)
Handpiece with
interchangeable
lens piece
Holster
Transport Handle
Lens storage box
Footswitch
Lower door‚ Electro-Optical (EO) box, footswitch storage
Lockable front casters
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 Instructions PN 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.
Lens piece
Handpiece Interconnected Harness
Figure 2 Handpiece and Lens Piece
Lens Model Application Common Field of View
D1300 Premature Infant 130 Degrees B1200 Standard Baby 120 Degrees
RetCam Shuttle User Manual and Service Instructions PN 20-000238 Rev. B
E800 High Contrast Children’s & Adults 80 Degrees C300 High Magnification 30 Degrees PL200 Portrait Lens N/A
Figure 3 Shuttle with all items stowed
Introduction 11
Storage
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 Instructions PN 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 Instructions PN 20-000238 Rev. B
Introduction 13
Electromagnetic Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
Emissions Test Compliance Electromagnetic Environment – Guidance
Radiated Emissions
CISPR 11/
EN 55011
Harmonic emissions IEC 61000-3-2 Class A The 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 Type Test and Compliance Level Electromagnetic 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 lines Mains 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/m Power 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 Instructions PN 20-000238 Rev. B
14 Introduction
Test Type Test and Compliance Level Electromagnetic 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 Instructions PN 20-000238 Rev. B
3A/m 50/60 Hz Video 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 Instructions PN 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 Instructions PN 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 Instructions PN 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 Instructions PN 20-000238 Rev. B
Label
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 Instructions PN 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 Instructions PN 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.
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