Stellaris Vision Enhancement System Operator's Manual

© Bausch & Lomb Incorporated. No part of this publication may be copied, photocopied, reproduced, translated, or reduced to any electronic medium or machine readable form, in whole or in part, without the prior written consent of Bausch & Lomb Incorporated, Rochester, NY 14609 USA. ™/® are trademarks of Bausch & Lomb Incorporated or its affiliates. All other brand/product names are trademarks of their respective owners. Bausch & Lomb Incorporated One Bausch & Lomb Place Rochester, NY 14609 USA

Bausch & Lomb Incorporated 106 London Road, Kingston upon Thames, KT2 6TN, UK

Manufacturing site: Bausch & Lomb Incorporated 3365 Tree Court Industrial Blvd., St. Louis, MO 63122

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Preface

Indications for Use The Bausch + Lomb Stellaris® Vision Enhancement System is designed for use in anterior segment surgeries. It provides capabilities for phacoemulsification, irrigation/aspiration, bipolar coagulation, and vitrectomy operations.

WARNING:

Use only Bausch + Lomb approved disposable packs, tubing sets and Bausch + Lomb handpieces designated for use with this system Safety may be degraded if accessories not meant for the system are connected.

User Profile The Bausch + Lomb Stellaris® Vision Enhancement System is intended for use only by qualified physicians and nurses.

Contraindications Use of accessories not designated by Bausch + Lomb for use with this equipment may result in serious permanent patient injury, adverse surgical outcome, or damage to the equipment, which may not be covered by warranty. See page 1-1 for precautions relevant to patients with implantable defibrillators and cardiac pacemakers. This manual contains precautions (Danger, Cautions, Warnings, Notes, etc.) throughout that should be observed when using this equipment. For safety’s sake, please heed these precautions.

Patents The Bausch + Lomb Stellaris® Vision Enhancement System is covered by the following patents: 5,331,951; 5,370,602; 5,388,569; 5,406,503; 5,624,394; 5,795,328; 5,910,139; 5,964,746; 5,991,142; 6,045,527; 6,055,458; 6,077,272; 6,081,122; 6,083,195; 6,106,512; 6,203,516; 6,251,113; 7,168,930, 7,445,436 and 7,604,607; additional patents pending. Foreign and other patents may also apply.

Trademarks ®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates. All other brand/product names are trademarks of their respective owners.

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Preface

Power Outputs COAG

U/S

BF 7.5 W 100 Ω 1 MHz

BF 35 W 900 Ω 28.5 kHz

Training Following system installation at a surgical facility, Bausch + Lomb personnel will provide on-site training to users who will operate the system. The training includes system startup, accessories and connections, priming and settings adjustment consistent with the instructions provided in this user manual. Subsequent training is provided for new staff, when the system is upgraded, or as requested by the facility.

Manual Concept Bausch + Lomb designs manuals to give you the information you need when you need it, and we don’t want you to have to search to find it. This manual is organized so that in the first chapter you will find enough information to quickly get up and running, and get answers to general questions about the Stellaris® Vision Enhancement System. We have included plenty of pictures so you can grasp concepts quickly. Be sure to read Chapter 2 to become familiar with the Graphical User Interface and the Foot Control. These are your connections to operate the system. Chapter 3 describes information on how to customize the system to suit your particular needs. Chapter 4 has detailed information about each function and feature, how to set up the function and its associated disposables, and how to interact with each function. Chapter 5 provides cleaning and sterilization information. These chapters are meant to serve as a reference to questions of a more technical nature. Chapter 6 through Chapter 8 contain information that you may rarely need, such as unpacking, installing modules, system check-out, meanings of error messages, service information, and system specifications. Make sure that you read and follow all safety precautions set forth in this manual. Information presented in this manual relating to surgical procedures is a suggestion only, and does not constitute any warranty of fitness or claim of responsibility, or undertaking of liability resulting from any surgical techniques practiced. The physician is ultimately responsible for determining the appropriate procedure for each patient.

Note:

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The user interface screens displayed in this manual copy may appear different than what is on your system depending on the configuration. While the information is the same, the depiction may change. The illustrations should not be used in place of the instructions in the manual.

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Preface

Symbols and Notes The following are general definitions of the symbols and precautions used on this equipment and in this manual.

DANGER:

Calls attention to an operating procedure, practice, or condition, which if disregarded or incorrectly performed, could result in imminent explosion hazard and risk of death or serious injury.

WARNING:

Calls attention to an operating procedure, practice, or condition, which if disregarded or incorrectly performed, could result in serious and/or permanent injury to personnel and/or patients.

CAUTION:

Calls attention to an operating procedure, practice, or condition, which if disregarded or incorrectly performed, could result in damage to the product and/or equipment.

Note:

Calls attention to an operating procedure, practice, or condition providing essential information. Consult operating instructions.

Caution or warning to consult accompanying documents to avoid patient or operator hazard.

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Preface Direct Current

Alternating Current

Equipotential Ground

Foot Control

Remote Control Reception Indicator (Foot Control On/TruLink® Access)

Battery

Dispose of Properly

Battery Condition Indicator

Serial Number

Manufacturer

Authorized Representative in the European Community

Date of Manufacture

Non Ionizing Electromagnetic Radiation

Caution: Consult Accompanying Documents

Frequency in Hertz

Type BF Applied Part

Coagulation

Fuse or Camera Recorder

Ethernet

Pneumatic Vitrectomy or

Monitor

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Ultrasound

Stellaris® Vision Enhancement System.

or

USB

Ω VA A

Ohms Volt Amps Amperes

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Preface 21 CFR 801.109 (b) Caution: Federal (US) law restricts this device to sale by or on the order of a physician No Latex

Member Green Dot Scheme

Do Not Use if Package is Damaged

System transport information, refer to page 1-12.

Caution: Consult Accompanying Documents

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110017243EN Rev. H

Table of Contents

1. Getting Started 1.1. 1.2. 1.3. 1.4.

System Description ... 1-2 Setting Up Your System ... 1-3 Moving Your System to Another Location ... 1-11 System Components ... 1-12

2. User Interface 2.1. 2.2. 2.3. 2.4.

Basic Interface Controls ... 2-1 Surgical “More Screens” ... 2-6 Surgical Screen Layout ... 2-14 Foot Control ... 2-18

3. Customizing Your System 3.1. 3.2. 3.3. 3.4. 3.5. 3.6.

Manage Settings ... 3-3 System Setup ... 3-18 System Configuration ... 3-21 System Calendar ... 3-22 TruLink® Remote Access ... 3-23 Customization Levels ... 3-25

4. Detailed Reference 4.1. 4.2. 4.3. 4.4. 4.5. 4.6. 4.7. 4.8. 4.9. 4.10. 4.11.

Computer Unit ... 4-1 System Console ... 4-2 IV Pole... 4-5 Remote Control ... 4-6 Advanced Vacuum System Fluidics... 4-7 Advanced Flow System Fluidics ... 4-12 Irrigation/Aspiration Setup ... 4-14 Vitrectomy Function ... 4-15 Ultrasound Function ... 4-20 Coagulation Function ... 4-27 DigiFlow™ Pressurized Infusion Function ... 4-30

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Table of Contents

5. Cleaning and Sterilization Requirements 5.1. 5.2. 5.3. 5.4. 5.5. 5.6. 5.7.

Stellaris® Vision Enhancement System Routine Cleaning ... 5-2 Bipolar Coagulation Accessories ... 5-3 Advanced Flow Fluidics Transducer ... 5-4 Irrigation and Irrigation/Aspiration Handpieces ... 5-5 Phacoemulsification Handpiece and Accessories ... 5-8 Special Instructions for United Kingdom Users ... 5-12 Cleaning the MMC ... 5-14

6. Setup 6.1. 6.2. 6.3.

Setup Instructions ... 6-2 Connections and Setup ... 6-2 Multimedia Center (MMC) (optional accessory) ... 6-3

7. Troubleshooting and Maintenance 7.1. 7.2. 7.3. 7.4. 7.5.

User Troubleshooting ... 7-1 Power Issues ... 7-1 Informational and Warning Messages ... 7-3 Troubleshooting the MMC ... 7-19 System Configurations, Modules, Accessories and Packs ... 7-21

8. Service and Warranty 8.1. 8.2. 8.3.

Service Information ... 8-2 Environmental Protection ... 8-12 Warranty Information ... 8-13

9. Specifications 9.1. 9.2.

Environmental and Physical Specifications ... 9-1 Primary System Specifications ... 9-8

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1 Getting Started

Getting Started This chapter is for people who have used this type of ophthalmic Vision Enhancement System before and want to use the system without reading large portions of the manual.

WARNING:

Implantable defibrillators present a risk of injury if triggered by a fibrillatory event during intraocular surgery, due to involuntary motion by the patient. Patients being considered for intraocular procedures must be questioned to determine if they have such a device and, if so, the defibrillator manufacturer must be consulted to determine the appropriate action.

WARNING:

Electromagnetic interaction between the phacoemulsification (phaco) handpiece and an implanted cardiac pacemaker is unlikely, but cannot be ruled out. Patients should be questioned to determine if they have such an implant and, if so, the manufacturer of the implant should be consulted to determine the proper course of action.

WARNING:

Patient not to come in contact with earthing metal parts.

WARNING:

Avoid skin-to-skin contact.

WARNING:

Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “Hospital Only” or “Hospital Grade.”

WARNING:

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

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1 Getting Started

1.1. System Description The Stellaris® Vision Enhancement System has a modular design which enables it to be upgraded to take advantage of advances in technology. The system consists of a main housing unit which contains a user interface screen and the surgical modules, and a Foot Control, infrared remote control, handpieces, and other accessories.

Note:

Do not use StellarisPC Vision Enhancement System posterior or combined packs on a Stellaris system.

IV Pole

User Interface Screen

System Switch “ON/OFF” Pneumatic Anterior Vit Acuator Expansion Space

Handpiece Connectors

Fluidic Module

Surgical Tray

Drawer

One-Touch Wheel Locking

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1 Getting Started

1.2. Setting Up Your System

DANGER:

Do not use in the presence of flammable anaesthetics, disinfectants, aerosol sprays, or in an oxygen rich atmosphere.

WARNING:

This system should only be operated by personnel who have been trained and are qualified to use this system.

Note:

Do not add unapproved accessories that modify the effective IV pole height.

WARNING:

Do not manually force the IV Pole downward if the system is on.

WARNING:

Do not modify the pole height or manually force the pole height, as this could cause an incorrect indication of the bottle height and patient injury.

WARNING:

When using gravity infusion, the ophthalmic irrigation source shall be at or above the patient’s eye level to avoid patient injury.

Before the first use of the Stellaris® Vision Enhancement System, connect the Foot Control as described on page 6-3. The following pages contain an overview for setup and use of your Stellaris® Vision Enhancement System in a typical cataract surgery. This information is intended for use by someone who is already familiar with this type of system.

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1 Getting Started

Surgical Drape Setup Attach the sterile screen drape by placing the drape over the top of the Stellaris® Vision Enhancement System screen and secure with the adhesive strip to top, not the front, of the display as shown in the illustration below. Apply Screen Drape Here Screen Drape

Remote Control Drape

Tray Drape

Turning System On Plug the power supply cord into the wall. If desired, connect the Ethernet cable to the port at the bottom of the Stellaris® Vision Enhancement System, and the other end to the hospital network port. If you have the optional MMC system, this cable should be connected to the MMC, and the MMC in turn connected to the hospital network port. Turn on the switch at the bottom of the system console.

CAUTION:

Do not turn this switch off until the system has been properly powered down.

CAUTION:

Do not disconnect system from power while in use.

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1 Getting Started

Figure 1.1. Lower Rear of System. 1. Fuse Holder. 2. Main Power Switch, disconnects system from mains voltage. See IEC 60601-1, paragraph 8.6.7 3. Ethernet Port. 4. Foot Control Backup Cable Port. 5. Power Cord Input. 6. Power Cord Retention Clip. 7. Potential Equalization Connector.

Note:

Turning off the Main Power Switch will disconnect the system from mains.

Press the power button on the front of the system, and wait for the screen to come on and the animation to finish. The front power switch is brighter when the system is off, and dims when you turn the system on. The Stellaris® Vision Enhancement System performs a self-check each time the power is turned on. The system automatically checks its configurations for any changes since the last time it was turned on. 110017243EN Rev. H

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CAUTION:

Observe system diagnostic messages when powering up system for first use each day and take appropriate action if required. Also observe first cassette priming or calibration, phaco/frag handpiece tuning and/or vitrectomy handpiece testing for correct completion.

Only after the Foot Control has been synchronized to the specific Stellaris® Vision Enhancement System (see page 6-3), may you use wireless communication.

Note:

The out-of-factory Wireless System Setup is “Disabled.” Software upgrade will also reset the Wireless System Setup to “Disabled.” See System Setup Instructions (Chapter 3) to configure Foot Control to wireless operation.

If you are going to use the Foot Control in wireless mode, ensure the Foot Control battery is charged, then hold down any button on the Foot Control until the green ready light comes on, indicating that communication has been initiated. This light will turn solid green when full communications have been established. When the system check is completed following system power-up, the Select Surgeon screen will appear.

Note:

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Following system shut down, wait a minimum of 15 seconds before restarting the system. The system is fully shut down after the front panel power button light changes from dim to bright.

Operator's Manual

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1 Getting Started

Select Options Touch the surgeon’s name on the list that appears, and it will be highlighted. Then select Confirm to load the parameters for that surgeon and advance to the Setup Screen. To setup a new surgeon instead of using an existing one, select Create New to setup a surgeon preference file for a new surgeon, using parameters from an existing surgeon.

Setup Screen The Setup Screen allows you to set certain procedure parameters, and prepare the system for surgical procedures. If desired, select Select Room and choose the case number, number of operating rooms being used by the surgeon, and the particular operating room to be used. If desired, select Select Case and choose the specific technique, needle, grade and pathology for the current procedure. Advance to open pack step by selecting Open Pack Insert Cassette from the clock menu.

Uninterruptible Operation of Your System Some Stellaris models may have a 60-second memory back-up battery. This battery is not considered a UPS (uninterruptible Power Supply) as it only sustains the software but is not sufficient to power surgical functions. If the user of the Stellaris® Vision Enhancement System requires continued operation during power main interruptions, it is recommended that the Stellaris® Vision Enhancement System be powered from an uninterruptible power supply. All new Stellaris systems and Power modules manufactured after November 2009 will cease to have memory back-up battery function.

Note:

In the event the power source is interrupted causing the system to shut down, remove handpiece from the eye safely and pinch off irrigation clamp to stop fluid flowing into the cassette.

To Start a New Procedure Note:

Ensure tube set connection is secure when connecting to the handpiece and system.

The Stellaris® Vision Enhancement System is user-friendly, and will highlight whichever step is next in a typical procedure. The steps shown on the display screen will vary slightly depending on which optional features are installed on your machine. On-screen instructions take precedence over information in this manual.

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1 Getting Started

Note: 1.

Ensure sufficient volume of irrigation solution is available for the procedure. The level should be monitored during the procedure. Setup Fluid Collection System Open disposables pack and connect fluid collection system. •

If using a vacuum system, insert the fluidics cassette all the way in and hold until it is automatically captured by the system. The cassette housing backlight will stop blinking and turn solid when the system captures the cassette. For surgical techniques that uses high vacuum settings please use vacuum-based packs containing the StableChamber® tubing to increase holdability (higher vacuum levels) while maintaining followability (controlled flow).

•

If using a flow system, insert the Fluidics Cartridge and select Close Drawer.

The system will automatically conduct a vacuum sensor and calibration check. Wait until the progress bar shows successful completion to proceed. If the system does not pass, corrective actions will be suggested.

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1 Getting Started 2.

Connect the accessories to the system for either an ultrasound or vitrectomy procedure. The steps needed to setup for a surgical procedure are Spike Bottle, Connect Tubing, Plug-in Handpiece, Attach Needle, Attach Sleeve, and Fill Test Chamber, as detailed below.

Note:

If a linear coagulation in setup is enabled or a Foot Control button is programmed for coagulation, begin by plugging in the coagulation cord. a.

Spike the Balanced Salt Solution bottle and hang it at the desired bottle height. Additional step if pressurized infusion is used: Connect the Air Tubing Line (D4600A) to the vent port at the bottle spike and the other end with air filter to the Stellaris® air output connector. Switch on the air pump from the system setup screen, the control is at the upper right hand of the screen. The output connector will remain lit when it is at commanded pressure, and blink on and off when it is not at the commanded pressure.

b.

Connect the irrigation and aspiration tubing to the appropriate (phaco or vitrectomy) handpiece, and plug the handpiece into the Stellaris® Vision Enhancement System. The connector will flash until the handpiece is connected, and then will remain solidly lit.

c.

Attach the ultrasound handpiece needle.

d.

Attach the irrigation sleeve.

e.

Fill beaker and test chamber and attach the test chamber to the handpiece. The irrigation pinch valve shall be opened when this step is displayed.

For detailed instructions, select Show Me Steps Ultrasound or Show Me Steps Vitrectomy and a tabbed screen will appear, detailing the required steps and showing animations of how to perform each step.

WARNING:

The animations illustrate the steps but do not represent sterile technique.

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1 Getting Started

Advance to Surgery Phase WARNING:

Inadvertent activation of functions that are intended for priming or tuning handpieces while the handpiece is in the eye can create a hazardous situation that could result in patient injury.

When the fluidics collection device has been attached and all accessories, tubing and handpieces have been connected, the system will automatically advance to the Prime and Tune phase. This step will be highlighted on the clock menu. •

If you are performing an ultrasound procedure, select Prime and Tune from the menu on the left side of the screen.

•

If you are performing a vitrectomy procedure, select Prime from the menu on the left side of the screen.

The selected action will begin, and the progress bar at the bottom of the screen will show when it is completed. If the system does not pass, the system status screen will suggest corrective action. Once the system setup has completed successfully, the system will automatically move to the main surgical screen. Manually selecting Advance to Surgery produces the same result.

Note:

If the system is not primed and tuned, the aspiration and phaco functions will be unavailable.

Using Your System in Surgery Default parameters and settings are saved in the surgeon preference file, but can be modified during a procedure using the on screen controls and surgical More Screens (see page 2-6). Your system is now ready for the surgical procedure. For irrigation/aspiration procedures, select I/A and connect the I/A handpiece to the tube set, replacing the phaco handpiece.

Surgical Procedure Conclusion Select End from the clock menu. You must confirm that you are ready to end the case and eject the fluid collection device, and you will be reminded to close the pinch valves.

Note:

Make sure to close the Irrigation Clamp on the Administration Tube Set before ending a procedure or overflow may occur.

The system will then advance to the End of Case screen, lower the IV Pole, and eject the vacuum fluidics cassette or open the flow module drawer.

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