RetCam II Service Manual Rev A

Copyright © 2007 Clarity Medical Systems, Inc. All rights reserved. Trademarks All other trademarks used in this document are the property of their respective owners. Clarity Medical Systems, Inc. 5775 W. Las Positas Blvd. Pleasanton, CA 94588 USA Phone: (925) 463-7984 Fax: (925) 251-0078 Toll free: (800) 215-6005 www.retcam.com

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Contents_____________________________________________________ 1.

Notices and Labels ...4 1.1. Electrical Safety Notices ...4 1.2. Emissions Notice ...5 1.3. FDA (USA) Notices ...8 1.4. Important User Safety Notices ...9 1.5. Labels / Symbols ...10

2.

Introduction ...13 1.1. Storage and Transport…………………………………………………………………..13 1.2. System Description……………………………………………………………………..14

3.

Maintenance ...20 3.1. Recommended Maintenance Schedule ...20 3.2. Cleaning Procedures ...20 3.2.1. Lens Piece Cleaning…………………………………………………………….20 3.2.2. System Cleaning………………………………………………………………...21 3.2.3. AAO Bloodbourne Pathogen Information………………………………………23 3.3. Fluorescein Angiography Frequently Asked Questions ...31 3.4. Servicing the interior of the cart ...32

4. Specifications ...33 5. Troubleshooting Guide………………………………………………………………………37 6. Block Diagrams ...43 7. Replacement Parts ...46 8. Technical Support……………………………………………………………………………47 9. License Agreements ...49 10. Appendix……………………………………………………………………………………..51 Appendix number

Procedure number

Revisio n

1 2 3 4 5 6 7 8 9 10 11 12

Vendor 800093 800096 800099 800111 800134 800136 30-000001 N/A N/A 800095 800138

N/A B B B A A A A N/A N/A B A

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Mitsubishi Digital Color Printer CP900DW RetCam II Adding an Optional FA Light Source RetCam II Membrane Control Panel Replacement RetCam II Front Castor Replacement Procedure RetCam II Trackball Replacement Procedure RetCam II Trackball Cleaning RetCam II Replacing the Computer RetCam II Lightbox Replacement Fuse Replacement Changing the illumination bulb Keyboard Replacement RetCam Handpiece Focus

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List of Figures Figure 1. RetCam II ………………………………………………………………….16 Figure 2. Handpiece and Lens Piece …………………………………………………17 Figure 3. Lens Piece Selection ……………………………………………………….18 Figure 4. Membrane Control Panel…………………………………………………………….19 Figure 5. Lens Tip Cleaning

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1.0 Notices and Labels PN 04-03-023 Rev A, Service Manual, RCII

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Electrical Safety Notices The RetCam II 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. Model: RetCam II Manufactured by Clarity Medical Systems, Inc. dba Massie Laboratories, Inc. Pleasanton, CA Made in USA Class I Type BF Electrical Equipment Rated for Continuous Operation IEC 60601-1:1988 + A1:1991 + A2:1995 Accessories equipment connected to the analog and digital interfaces must be certified to the respective IEC standards (i.e. IEC60950 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 that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical services department or your local representative

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.

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Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/

Compliance

Electromagnetic environment – guidance

Group 1

The RetCam II uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class A Class A

flicker emissions IEC 61000-3-3

Complies

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The RetCam II 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 healthcare professionals only. 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 re-orienting or relocating the RetCam II or shielding the location.

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Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The RetCam II is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD) IEC 61000-4-2

IEC 60601-1-2 test level ±6 kV contact ±8 kV air

Compliance level ±6 kV contact ±8 kV air

Electromagnetic environment – guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines

±2 kV for power supply lines

Not all of the required testing met the full limits of IEC61000-4-4. Refer to Important User Safety Notices on page 22 for further information.

Surge IEC 61000-4-5

±1 kV line(s) to line(s) ±2 kV line(s) to earth

±1 kV line(s) to line(s) ±2 kV line(s) to earth

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

>95%, 0.5 cycles 60%, 5 cycles 30%, 25 cycles >95%, 250 cycles

>95%, 0.5 cycles 60%, 5 cycles 30%, 25 cycles >95%, 250 cycles

Mains power quality should be that of a typical commercial or hospital environment. If the user of the RetCam II requires continued operation during power mains interruptions, it is recommended that the RetCam II be powered from an uninterruptible power supply (UPS).

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Conducted RF IEC 61000-4-6

0.15-80 MHz, 3 Vrms, 80% 1 KHz AM

0.15-80 MHz, 3 Vrms

Radiated RF IEC 61000-4-3

80-2500 MHz, 3/m, 80% 1 KHz AM

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the RetCam II, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 150 kHz to 80 MHz 80 MHz to 800 MHz 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). Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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FDA (USA) Notices This device is listed with the United States of America (USA) Food and Drug Administration (FDA) for commercial distribution.

Device Trade Name Product Code Classification Name Classification Regulation Number Medical Device Classification

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RetCam II 86 HKI Ophthalmic Camera 886.1120 Risk Class II

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Important User Safety Notices

1. Remove the lens and store it in the lens box and secure the handpiece in its storage compartment inside the cart before moving the cart to a new site. 2. Carefully inspect and clean the lens piece before each use. DO NOT use if the front lens of the lens piece is nicked or scratched. 3. Never contact the front of the lens piece with hard or sharp objects. This could damage the precision optics and sealing. 4. Unauthorized modifications or additions to the software or hardware of the system will void the warranty and could adversely affect the system function. 5. DO NOT AUTOCLAVE any part of the device. Refer to the Chapter on Maintenance and Support for cleaning recommendations. 6. Do not use the white light source for longer than 5 cumulative minutes on the same eye during an exam. 7. Appropriately power down and unplug the unit and allow the light source bulb to cool before replacing it. Refer to the instructions to Replace Illumination Lamp as necessary. 8. Never connect the RetCam II to a network or any externally powered devices or peripherals during imaging. 9. Before using this equipment to acquire images from patient eyes, users must be trained in proper clinical technique by personnel authorized by Clarity. 10. The RetCam II is for use by or on the order of a health care professional. 11. It is possible that during Electrical Fast Transients from the AC line, the system’s display may scroll continuously. This is an indication that the source of AC power has electronic disturbance (transients). If this indication is present, imaging should not proceed until the disturbance has ceased: the AC plug is put into a different AC outlet: or RetCam II is run from the UPS. If the disturbance persists, an error message may be displayed, which then may require a system reset. Toe perform a system reset, press the (I/O) power switch on the control panel for approx 6 seconds until the system powers down, then press the (I/O) button again to power the system back on . THIS DOES NOT PRESENT A SAFETY RISK TO THE PATIENT, USER, OR ENVIRONMENT

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Type BF Equipment

Do not use if dropped

Clean lens piece after use

Separate collection of waste at end-of-life as required by European directives.

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2.0 Introduction The RetCam II Wide Field Imaging System (system) is designed using state-of-the-art digital technology to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye. The system is designed for easy use and operation by either a physician or trained staff members. High resolution digital images and videos can be quickly captured, stored, displayed for review, transferred and/or printed by simply using the trackball to point and click. The system as delivered is intended for use indoors, at normal room temperatures (59º F to 95º F or 15º C to 35º C), non-condensing humidity range 25% to 93%, upright, on a level surface, with the front casters locked and the dust cover off for proper ventilation. This manual contains maintenance instructions, specifications and service instructions.

Note: Only those modules identified within this service manual are “authorized” for repair by the customer. Any service outside the scope of this manual shall void the warranty and may compromise the safety/efficacy of the system. This manual is meant to be used in conjunction with the RetCam II User’s Manual. The supplier will make available on request, component part lists, descriptions, or other information which will assist the user's appropriately qualified technical personnel to repair those parts of the equipment which are designated by the manufacturer as repairable.

CAUTION: Use of this manual is intended for qualified technical personnel only. If in doubt, please contact the manufacturer before proceeding.

Storage and Transport Note: Always return the handpiece to the holster on the top surface when not imaging. The handpiece cable can be draped over the side support, but do not wrap it tightly or damage to the fiber optic may result. For storage of the system when not in use, disconnect the power cord and store it in the drawer. Remove all loose objects from the top surface. Fold the display down flat. Wipe down the surfaces with a soft cloth. Place the dust cover over the system. Lock the casters to keep it in place.

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The system is provided with the means to easily move it between operations or between beds in the NICU while it is running. To relocate the system while it is running, disconnect the power cord at both ends, release the front caster locks and gently roll the system to the new location. The internal power supply will keep the computer and monitor running for several minutes. Once in the new position, lock the casters, reconnect the power cord at both ends and continue with imaging. If the floor is uneven or tiled surface, move the system carefully to avoid damage from excessive vibration. The system is not intended to be transported outdoors from building to building. For information on how to safely transport the system out of doors or in anything but an upright position, please contact Customer Service. The RetCam II 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. Inspection and testing of the system by a factorytrained technician after transport outdoors or in a non-upright configuration is necessary to insure continued compliance with all safety standards.

System Description The RetCam II system consists of several modules mounted in a stable, high quality integrated mobile cart for easy, safe transportation from one location to another. The front pair of lockable casters allow for easy maneuverability and positioning, while the fixed rear wheels guide the unit in a straight line during transport. (Ref. Figures 1 and 2)

1) Display: A high resolution LCD flat panel display is standard with the system. 2) Control Panel: A membrane control panel turns the system on with one button, and has controls for illumination intensity, camera focus and snap (capture an image or start/stop video recording). 3) Handpiece: The handpiece contains the actual 3-chip CCD. It is light weight and easy to use. The front lens pieces are removable, and allow quick and easy exchange. 4) Interconnect Cable: The interconnect harness contains three separate cables, the fiber optic for transmission of illumination light, the camera cable, and the focus motor control cable. 5) Light Box: The light box contains a CCD camera control unit, a halogen illumination light, and the control circuitry for light intensity, focus, image capture and system logic. 6) Computer: The computer is controlled by a keyboard and trackball. It is a Pentium4 based system, running a specialized Embedded Windows XP, with two internal DVD storage drives and media and proprietary software. The system has an integrated network adapter, and USB hub. 7) Uninterruptible Power Supply (UPS): The computer, display and optional image printer are powered by an Uninterruptible Power Supply. The UPS helps to protect against accidental loss of images due to power surges or sudden power loss.

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The UPS can store enough energy to power the computer and display for several minutes allowing the system to be unplugged from the electrical outlet and moved from room to room or bed to bed without having to reboot the system. 8) Footswitch: The footswitch is a rocker style unit with a function switch on each side, and a push button in the middle. The pedal on the left side controls focusing. Rock this pedal to the left to focus closer, and to the right to focus more distant. The pedal on the right controls illumination light intensity. Rock this pedal to the left to decrease intensity and to the right to increase intensity. The push button in the middle is called the snap switch. An image is captured and stored each time the snap switch is depressed. In video mode, this switch can be used to alternately start and stop video recording. 9) Power Conditioner: The power conditioner isolates the RetCam system from power/line disturbance and meets medical electrical device safety requirements. 10) Storage Drawer(s): One storage drawer is supplied on all units for lens pieces, DVDRAM’s and accessories. Without the Fluorescein Angiography light source, an additional drawer is furnished for extra storage. 11) Report Printer (option): A high resolution inkjet printer can print reports on 8.5” x 11” paper. 12) Image Printer (option): The high quality Mitsubishi dye-sublimation printer can print single images of 3.75” x 4.75” or two images one above the other in a smaller size. 13) Fluorescein Angiography Source (option): A blue exciter light source is available complete with green barrier filter for the handpiece for doing F.A. digital photography with the RetCam II.

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Figure 1 RetCam II

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Fig 2 Handpiece and Lens

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Fig 3 Lens Piece Selection

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3.0 Maintenance 3.1

Recommended Maintenance Schedule

Between patients: clean and inspect lens piece. Daily: Back up data to a network Weekly: Wipe down the system. Monthly: Inspect cables and connections for wear. Annually: Vacuum the air inlet screens in the rear of the base Burned out bulb: Replace illumination bulb Blown fuse: Replace system fuses Continuously beeping UPS: Replace UPS

3.2

Cleaning Procedures

For cleaning purposes, the RetCam II is divided into two categories: 1. The Lens Piece that contacts the patient 2. The rest of the system 3.2.1

The Lens Piece

The Lens Piece should be cleaned thoroughly between patients to prevent the spread of infectious disease. As recommended by the American Academy of Ophthalmology, the cleaning liquid of choice is 70% isopropyl alcohol. Moisten a clean towelette with the solution and use a gentle wiping action across the front of the lens piece, being sure to pay special attention to the concave contact lens area. To prevent irritation to the next patient from residue left on the lens, rinse the tip of the lens piece thoroughly with disinfected distilled water.

Warning: To avoid damage, do not autoclave any part of the RetCam II system. The American Academy of Ophthalmology also recommends disinfecting with 1:10 dilution of bleach for 5 minutes.(refer to page inserts following this page). .

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