User Manual and Service Instructions
78 Pages
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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.
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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: [email protected]
RetCam Shuttle User Manual and Service Instructions
PN 20-000238 Rev. B
3
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
4 • 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
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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
RetCam Shuttle User Manual and Service Instructions
PN 20-000238 Rev. B
6 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
Handpiece with interchangeable lens piece Holster
Work surface Transport Handle Secondary work surface
Container for tools and supplies
Lens storage box
Internal handpiece storage compartment
Upper door (open)
Lower door‚ Electro-Optical (EO) box, footswitch storage
Lockable front casters Footswitch
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. • Transport Handle: Extends to tilt and roll the cart to another location.
Lens piece
Handpiece
Handpiece Interconnected Harness
Figure 2 Handpiece and Lens Piece
Lens Model D1300 B1200
Application Premature Infant Standard Baby
RetCam Shuttle User Manual and Service Instructions
Common Field of View 130 Degrees 120 Degrees
PN 20-000238 Rev. B
Introduction 11
E800 C300 PL200
High Contrast Children’s & Adults High Magnification Portrait Lens
80 Degrees 30 Degrees N/A
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,
Figure 3 Shuttle with all items clinics and offices. stowed 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 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.
Figure 4 Transporting the Shuttle
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
Radiated Emissions
Electromagnetic Environment – Guidance
Class A 30 MHz to 1 GHz The RetCam system uses RF energy for its internal function. Nearby electronic equipment may be affected.
CISPR 11/ EN 55011 Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions IEC 61000-3-3
Complies
The RetCam system is suitable for use in all 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.
Immunity Test Summary Test Type Electrostatic discharge (ESD)
Test and Compliance Level ±6 kV contact ±8 kV air
EN 61000-4-2 Electrical Fast Transients/burst
Electromagnetic Environment Guidance The RetCam Shuttle requires ESD exemption. See Important User Safety Notices.
± 2 kV for power supply lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge
± 0.5, 1 kV Line to Line
EN 61000-4-5
± 0.5, 1, 2 kV Line to earth
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips and interruptions
>95%, 0.5 Cycles
EN 61000-4-11
30%, 25 Cycles
EN 61000-4-4
60%,
5 Cycles
>95%, 250 Cycles Power Frequency (50/60) Hz magnetic field
3A/m
EN 61000-4-8
RetCam Shuttle User Manual and Service Instructions
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). Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
PN 20-000238 Rev. B
14 Introduction
Immunity Test Summary Test Type Conducted RF IEC 61000-4-6 Radiated Immunity EN 61000-4-3
Test and Compliance Level
Electromagnetic Environment Guidance
0.15-80 MHz, 3Vrms, 80% 1 KHZ Portable and mobile RF communications AM equipment should be used no closer to any part of the RetCam system, including cables, than the recommended separation distance 80MHz-2.5GHz calculated from the equation applicable to 3V/m 80%@1kHz 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
3A/m 50/60 Hz
Video display terminals and other electron beam devices (e.g. X-ray image intensifiers) may use a justification for lower IMMUNITY COMPLIANCE LEVELS as allowed by 36.202.1 a).
EN 61000-4-8
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.
RetCam Shuttle User Manual and Service Instructions
PN 20-000238 Rev. B
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
Keep away from the rain
RetCam Shuttle User Manual and Service Instructions
PN 20-000238 Rev. B
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
Introduction 19
Label
RetCam Shuttle User Manual and Service Instructions
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RetCam Shuttle User Manual and Service Instructions
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