RetCam 3 Service Manual Rev B

2

Copyright © 2013 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. LasPositas Blvd. Pleasanton, CA 94588 USA Attn: Service Department Technical Services Phone: (925) 463-7984 ext. 222 Technical Services Fax: (925) 474-2093 www.claritymsi.com www.retcam.com [email protected]

MediMark® Europe S.A.R.L. 11 rue Emile Zola 38100 GRENOBLE France Tel: +33 (0)4 76 86 43 22 Fax: +33 (0)4 76 17 19 82 e-mail: [email protected]

Image on the cover of this manual is representative only.

RetCam 3 Service Manual

PN 21-100540 Rev. B

Contents List of Figures ... 5 1

Introduction ... 7 Indications for Use ... 8 Warnings and Cautions ... 8 System Hardware... 10 Main Hardware Components... 12 The Computer Electro-Optical Box (CEO) ... 14 Handpiece Focus Connector ... 15 Fiber Optic Cable ... 15 Camera Handpiece Connector ... 16 Installing Lens Pieces ... 17 Handpiece Connection... 17 Storage... 18 Transport ... 19 Electrical Safety Information ... 19 Important User Safety Notices ... 22 Labels and Symbols ... 23 Product Label ... 26 Turning the System ON... 26 Fluorescein Angiography ... 27 Illumination Lamp ... 27 Turning OFF the RetCam System... 27 Using Hard Shutdown ... 28

2

Maintenance and Support ... 29 Recommended Maintenance Schedule ... 29 Cleaning Procedures ... 30 Cleaning the Lens Piece ... 30 Alternate Cleaning and Disinfection... 31 Cleaning the Rest of the System ... 31 Disposal of Materials... 31 Cable and Connections Inspection ... 32 Auto White Balance (AWB) Procedures... 32 AWB Instructions ... 32 Fuse Replacement ... 36 Replace Illumination Lamp... 39 Field Component Replacement ... 42 Key Validation... 43 Technical Support... 44 Technical Services Contact Information ... 44 Telephone ... 44 E-mail... 44 Mailing Address ... 44 Technical Services Website ... 44

RetCam 3 Service Manual

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4 Replacement Parts... 45 Consumables ... 45 Replaceable Components... 45 Returning Parts for Repair ... 46

3

Technical Specifications ... 47 Hardware... 47 Physical ... 47 Electrical ... 47 Computer (CEO Module) ... 47 Environmental Conditions ... 48

4

Troubleshooting Guide ... 49 Troubleshooting... 49 Technical Support... 53 Returning Parts for Repair... 53

5

License Agreements ... 55 Clarity Software Restricted Rights... 55 RetCam Software End User License Agreement ... 55

RetCam 3 Service Manual

PN 21-100540 Rev. B

List of Figures Figure 1

RetCam 3 Ophthalmic Imaging System Front View ... 10

Figure 2

RetCam 3 Ophthalmic Imaging System Rear View ... 11

Figure 3

Control Panel ... 13

Figure 4

Handpiece and Lenspiece ... 13

Figure 5

Lens Piece Selections ... 14

Figure 6

Computer Electro-Optical (CEO) Box ... 14

Figure 7

Fiber Optic Connection ... 15

Figure 8

Inside Connector Notch and CEO Box Notch... 16

Figure 9

Footswitch Controls ... 16

Figure 10

Installing a Lens Piece on the Handpiece ... 17

Figure 11

Handpiece Connections ... 18

Figure 12

RetCam 3 With All Items Stowed ... 18

Figure 13

Shutdown Icon Options ... 27

Figure 14

Footswitch Pocket ... 28

Figure 15

Inverted Lens Piece Showing Permissible Immersion Depth ... 31

Figure 16

AWB Kit: Collapsible Box ... 33

Figure 17

Utilities Menu: User Preferences ... 33

Figure 18

User Preferences: Windows Configuration - Camera AWB... 34

Figure 19

AWB Configuration: Illumination Out of Range ... 35

Figure 20

AWB Configuration: Illumination Within Range for All Colors... 35

Figure 21

Auto White Balance Adjustment: Confirmation... 36

Figure 22

Power Entry Module ... 37

Figure 23

Opening the Fuse Holder Cover ... 37

Figure 24

Removing the Fuse Holder ... 38

Figure 25

Fuses Removed ... 38

Figure 26

Fuse Holder Re-Inserted ... 38

Figure 27

Opening the Front Cover ... 39

Figure 28

Removing the Camera and Focus Cables... 40

Figure 29

Front Panel Showing Lamp Assembly Drawer ... 40

Figure 30

Removing the Illumination Lamp ... 41

Figure 31

Handling the Illumination Lamp ... 41

Figure 32

Key Validation Dialog ... 43

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Introduction The RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye. NOTE Only those modules identified within this service manual are “authorized” for replacement by the customer. Any service or modification of the device outside the scope of this manual shall void the warranty and may compromise the safety or efficacy of the system. This manual is meant to be used in conjunction with the RetCam 3 and RetCam Shuttle User Manual. The supplier will make available, on request, part lists, descriptions, or other information which will assist the user’s appropriately qualified technical personnel to replace those parts of the equipment which are designated by the manufacturer as replaceable.

Use of this manual is intended for qualified technical personnel only. If in doubt, please contact the manufacturer before proceeding. • Indications for Use on page 8 • Warnings and Cautions on page 8 • System Hardware on page 10 • Main Hardware Components on page 12 • Electrical Safety Information on page 19 • Important User Safety Notices on page 22 • Labels and Symbols on page 23 • Turning the System ON on page 26 • Turning OFF the RetCam System on page 27 • Using Hard Shutdown on page 28

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Chapter 1

Introduction

Indications for Use • General ophthalmic imaging including retinal, corneal, and external imaging • Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP) • Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease) or treatment requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease) or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)1, 2 in 35-37 week postmenstrual infants.

Warnings and Cautions

Federal law (US) restricts this device to sale by or on the order of a physician or licensed medical practitioner.

Prior to using the system, read all user safety information.

Before using this equipment to acquire images of patient eyes, users must be trained in proper clinical technique by personnel authorized by Clarity.

The RetCam system is designed and tested as a system. Do not remove or substitute RetCam components because doing so might adversely affect system performance.

Unauthorized modifications or additions to the RetCam system (including hardware and software, etc.) void the warranty and can adversely affect system function.

1. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of prematurity: preliminary results. Archives of Ophthalmology 1988; 106(4):471-479. 2. Early Treatment for Retinopathy of Prematurity Cooperative Group. Revised indications for the treatment of retinopathy of prematurity: results of the Early Treatment for Retinopathy of Prematurity Randomized Trial. Archives of Ophthalmology 2003; 121(12):1684-1694.

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Do not exchange system components such as the handpiece, with components from other RetCam systems. Contact Clarity Technical Services at (925) 463-7984, ext. 222 for information regarding component compatibility.

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. See Cleaning the Lens Piece on page 30 for detailed cleaning instructions.

To mitigate the potential for excess light exposure to the patient while imaging, always start at the lowest light intensity level and increase if necessary. Use only the shortest amount of exposure time necessary; no longer than 5 minutes per eye.

Use care when imaging the eye; i.e., use the least amount of pressure and movement necessary. The lens tip is immersed in coupling gel, and does not contact the eye directly. Ensure the camera is supported (held) in a manner that does not put direct pressure on the cornea. Practice with the simulator eye model is recommended prior to patient imaging.

Assess the risk to benefit ratio before confirming a patient for RetCam imaging if they are: photosensitive, concomitantly exposed to photosensitizing agents, or aphakic.

To mitigate your potential for excess light exposure, do not look directly at the illuminated light source.

To avoid the risk of electric shock, connect the equipment to a supply mains with protective earth.

To avoid the risk of electric shock, inspect cables and electrical cords for damage prior to use.

There are high voltages within the FA module and the cover of the module is not to be removed by customers or distributors.

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Chapter 1

Introduction

System Hardware The RetCam 3 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 on page 10 and Figure 2 on page 11 illustrate the system hardware. Figure 1

RetCam 3 Ophthalmic Imaging System1 Front View2

Display (contains 4 USB ports, 2 available

Transport Handle Handpiece with Interchangeable Lens Piece

Input Shelf (extended)

Holster Keyboard & Mouse DVD writer (inside drawer)

USB port

Cord Wrap Post (both sides)

Handpiece Cable with Connectors FA Intensity Control FA Light Connector FA Light Switch Printer on Extended Shelf

Storage Drawers

Lockable Rear Casters Lockable Front Casters

Chassis

Footswitch Storage Pocket Footswitch

1. Shown with optional Fluorescein Angiography (FA) feature. 2. Image shown is representative only.

RetCam 3 Service Manual

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Introduction Figure 2

11

RetCam 3 Ophthalmic Imaging System Rear View1

Ethernet Port

Product Label/Serial Number

Main Power Switch and Power Cord Connection

1. Image shown is representative only.

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Chapter 1

Introduction

Main Hardware Components • Display: A flat panel display is standard with the system. • 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/pause video recording). • Handpiece: Contains the camera. Lightweight and easy to position, it has a long cable for easy reach. Use with changeable lens pieces. • Handpiece Interconnect Harness: Comprises three separate cables: fiber optic cable for subject illumination, the camera controller cable, and the focus motor cable. NOTE Handpiece and Handpiece Interconnect Harness are considered a single replaceable assembly. • Chassis: Contains the control systems, connections, and DVD drive. • Computer Electro-Optical Box (CEO): Contains the illumination lamp, control/power distribution circuitry, processor, and hard drive. • Footswitch: Provides optional means to control illumination intensity, camera focus, video, or image capture. • Storage Drawers: All units have two storage drawers for lens pieces, tools and supplies. • Fluorescein Angiography (FA) Source (optional): An optional blue exciter light source is available for FA digital photography. The FA comes complete with a yellow barrier filter for the handpiece. NOTE FA illumination intensity can ONLY be adjusted by using the intensity control knob on the FA source. • Printer: Color images and reports can be printed. • Power Supply Box: The power supply box contains the input power converter, power to charge the battery backup, power for the computer, camera controller, and the electro-optic circuits. • Battery Backup: The battery backup helps to protect against accidental loss of images due to sudden power loss. The battery backup 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. NOTE Always return the handpiece to the holster when not in use. The handpiece cable can be draped over the cord wrap post, but do not wrap it tightly because damage to the fiber optic cable may result.

RetCam 3 Service Manual

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Introduction Figure 3 System Power indicator (green)

Control Panel

AC/DC indicator (green)

System Power button

Figure 4

13

Relative intensity indicator

Focus

Focus Controls

Snap (capture) button

Illumination ON indicator (amber)

Intensity Controls

Lamp Illumination

Handpiece and Lenspiece

Lens piece

Handpiece

Interconnect harness cable

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Chapter 1 Figure 5

Introduction Lens Piece Selections

Lens Model

Application

Common Field of View

D1300

Premature Infant

130 Degrees

B1200

Standard Baby

120 Degrees

E800

High Contrast Children & Adults

80 Degrees

C300

High Magnification

30 Degrees

PL200

Portrait Lens

N/A

The Computer Electro-Optical Box (CEO) The CEO box is like the central nervous system of the RetCam, receiving your input from the footswitch and camera and directing its output to the camera and display. It contains the illumination lamp, footswitch controller, processor, hard drive, and light intensity and focus controllers and it passes live images from the camera to the display. This section describes the CEO components and the functions you can control with it. Figure 6

Computer Electro-Optical (CEO) Box

Fiber Optic indicator lamp

Handpiece focus Camera Handpiece connector

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NOTE It is not necessary to remove any of the connectors for use, storage, or transportation.

Do not remove any connections while the system is powered ON. The main power switch must be OFF prior to connecting or disconnecting any cables from the CEO box.

Do not look directly into the Lamp (Fiber Optic) opening when the CEO box is ON.

Handpiece Focus Connector The handpiece focus connector is a direct insert receptacle for insertion of the (white) focus motor cable, which is part of the camera interconnect cable. To insert the cable, align the red dot on the connector with the red dot on the Focus port and insert. To detach, pull back on the connector, being careful not to pull on the cable. NOTE The Handpiece focus connector is not threaded. Damage to the connector pins will occur if the connector is rotated.

Fiber Optic Cable The Fiber Optic Illumination Port is a receptacle for inserting the black fiber optic cable, which is part of the handpiece interconnect harness. To connect the fiber optic cable, insert its metal connector into the Fiber Optic illumination port. The connector is attached with a pressure fitting, which will click into place when the connector is fully inserted into the port (see Figure 7 on page 15). To detach, pull back on the connector, being careful not to pull on the cable. Figure 7

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Fiber Optic Connection

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Chapter 1

Introduction

Camera Handpiece Connector The camera handpiece connector is a receptacle for insertion of the black camera controller cable, which is part of the handpiece interconnect harness. To insert the camera handpiece connector, align the notch on the inside connector (see Figure 8 on page 16) with the notch on the CEO box (see Figure 8 on page 16), insert, and tighten the threaded sleeve to secure. To detach, unscrew (counterclockwise) the connector sleeve and pull out. Figure 8

Inside Connector Notch and CEO Box Notch

CEO Box Notch Inside Connector Notch

Figure 9

Footswitch Controls Focus Controls Illumination intensity controls Snap toggle switch (Start or pause video or capture a single image)

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Installing Lens Pieces Figure 10

Installing a Lens Piece on the Handpiece

Align lens piece to fit over pins

Alignment pins on handpiece Carefully tighten clockwise until it clicks in place.

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. Attach the desired lens piece to the Handpiece, as shown in Figure 10 on page 17. • Fit the lens piece on the handpiece, aligning the 3 radial pins on the front of the handpiece with the spaces between the tabs of the spring ring on the lens piece. • Twist the lens piece clockwise (as shown in Figure 10 on page 17) until you hear a click, indicating that the lens piece is locked in place.

Handpiece Connection Verify that the handpiece is connected to the system as shown in Figure 11 on page 18.

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Chapter 1 Figure 11

Introduction Handpiece Connections

NOTE Handpiece connection to the optional FA is shown. For normal operation, connect the Fiber Optic Cable to the top port. Always return the handpiece to the holster when it is not in use. You can drape the handpiece cable over the cord wrap post, but do not wrap it tightly or damage to the fiber optics cable might result.

Storage For storage of the system, disconnect the power cord and store it in one of the cart drawers. Stow the handpiece in its holster and the footswitch in its compartment. Remove all loose objects from the work surfaces. Wipe the surface with a soft cloth. Apply brakes to all casters to secure the system in place. NOTE If the RetCam 3 has been stored (without power) for an extended period of time, ensure that it is plugged in (and the main power switch is turned on) for at least two hours before attempting to start the system with the blue System Power button on the Control Panel. Figure 12

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Transport 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, contact Clarity Technical Services. The RetCam 3 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 factory-trained technician after transport outdoors or in a non-upright configuration is necessary to insure continued compliance with all safety standards.

The RetCam 3 system is not meant to be left stationary on a slope nor is it intended to be used on a slope. Do not leave the RetCam 3 unattended on a slope at any time.

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 60601-1:2005 Corrigendum 1 + Corrigendum 2 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 and 60601-1-2. 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 and 60601-1-2. If in doubt, contact Clarity Technical Services.

This equipment should be connected using the power cord supplied by Clarity or agency listed power cord for the country of use.

To avoid the risk of electric shock, inspect cables and electrical cords for damage prior to use.

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Chapter 1

Introduction

To avoid risk of electric shock, this equipment must be connected to a supply mains with protective earth.

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 ake mitigation measures, such as re-orienting or relocating the system or shielding the location.

Table 1

Electromagnetic Emissions Compliance Level: Group 1, Class A Test Type

Compliance Level

Radiated Emissions CISPR 11/ EN 55011

Group 1

Conducted Emissions CISPR 11/ EN 55011

Class A

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

Harmonic emissions EN 61000-3-2

Class A

Voltage fluctuations/flicker emissions EN 61000-3-3

Complies

FCC Part 15B

Complies

RetCam 3 Service Manual

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