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Preface

Indications for Use The Bausch + Lomb Stellaris® PC Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laser trabeculoplasty.

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.

Operator Profile The Bausch + Lomb Stellaris® PC Vision Enhancement System is intended for use only by qualified physicians and nurses. The laser functionality is intended for use only by qualified physicians. If you are not a qualified physician, do not attempt to operate the laser system for any reason. Specific indications for Laser Modes are retinal photocoagulation and laser trabeculoplasty. Available delivery devices include the EndoProbe for intraocular Endolaser surgery, and the Laser Indirect Ophthalmoscope (LIO) for transpupillary laser delivery for patients treated in a supine position.

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, and may void warranty coverage. See page 1-1 for precautions relevant to patients with implantable defibrillators and cardiac pacemakers. Photocoagulation is not indicated for patients without pigmentation (albino eyes). In addition, Laser Indirect Ophthalmoscope (LIO) use is not indicated for cases involving laser photocoagulation within the arcades. 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.

Standards Compliance The Stellaris® PC Vision Enhancement System is designed to meet the requirements of EN 60601‑1:2006 3rd edition and all appropriate amendments, collateral standards, particular standards and country differences. All references to 60601 or IEC 60601 and its collateral and particular parts in this manual are in reference to the harmonized versions identified in the table below.

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Preface EN 60601‑1:2006 EN 60601‑1‑2:2007 EN 60601‑2‑2:2009 EN 60601‑2‑22:2013 EN 80601‑2‑58:2009

Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance Part 1‑2: General Requirements for Basic Safety and Essential performance Collateral Standard: Electromagnetic Compatibility - Requirements and tests Part 2‑2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories Part 2‑22: Particular requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Part 2‑58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

This laser system provides a visible green (532 nm CW, 2 W max.) Class 4 laser for photocoagulation, and a Class 2 diode aiming laser (630-650 nm CW < 1 mW max.) per 60825‑1. This device complies with 60601‑2‑22 and 60825‑1, 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007.

Patents The Bausch + Lomb Stellaris® PC Vision Enhancement System is covered by the following patents: 5,910,139; 6,055,458; 6,081,122; 6,083,195; 6,106,512; 6,203,516; and 8,403,917; additional patents pending. Foreign and other patents may also apply.

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 those who will operate the system. The training includes system startup, accessories and connections, priming and settings adjustment consistent with the instructions provided in this operator manual. Subsequent training is provided for new staff, when the system is upgraded, or as requested by the facility.

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Manual Concept Our goal is to provide you with the information you need, with minimal searching. Chapter 1 provides information for a quick set up and answers general questions about the Stellaris® PC Vision Enhancement System. Numerous pictures enhance understanding. Chapter 2 describes the connections to operate the system, including the Graphical User Interface and the Primary (Integrated) Foot Control. Chapter 3 describes information on how to customize the system to suit your particular needs. Chapter 4 details 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. Chapters 3-5 are reference for questions of a technical nature. Chapter 6-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 surgeon is ultimately responsible for determining the appropriate procedure for each patient.

Note:

 he user interface screens displayed in this manual may differ from what is on your system. T While the information on the screens is the same, the depiction of the screens may change. The screen illustrations should not be used in place of the instructions in the manual.

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.

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Note:

 alls attention to an operating procedure, practice, or condition providing essential C 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

Primary (Integrated) Foot Control

Primary (Integrated) Foot Control ready or TruLink® Remote Access Indicator

Battery

Dispose of Properly

Battery Condition Indicator

Serial Number

Manufacturer

Authorised Representative in the European Community

Date of Manufacture

Non Ionizing Electromagnetic Radiation

Caution: Consult Accompanying Documents

Frequency in Hertz

Type BF Applied Part

Fuse

Coagulation

Microscope Camera High Speed Vitrectomy Ethernet Monitor Ultrasound

Stellaris® PC Vision Enhancement System. Ω VA A

USB

Ohms Volt Amps Amperes

Laser Indirect Opthalmoscope Laser Aperture

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Always wear eye protection or face mask when installing or removing the lamp

Warning: Hot surface

Electrostatic-sensitive device

Never touch the silica glass bulb of the lamp with bare hands

Xenon

Xenon-Mercury

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Posterior Functions Fluid/Air Exchange

EtO gas sterilized

Illumination

Gamma Irradiation Sterilized

Do Not Reuse Viscous Fluid Control Do Not Re-Sterilize 21 CFR 801.109 (b) Caution: Federal (USA) law restricts this device to sale by or on the order of a physician

Do Not Use If Package is Damaged

Member Green Dot Scheme

Not made with natural rubber latex

Laser Key On

Transport Symbol. See page 1-32.

Laser Key Off

Laser Emergency Stop

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Table of Contents

Table of Contents

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Table of Contents

Table of Contents 1.

Getting Started

1.1. Components Shipped with the System... 1-2 1.2. System Description... 1-3 1.3. Connections and Setup... 1-5 1.4. Setting Up Your System... 1-9 1.5. Starting a New Procedure... 1-18 1.6. Using Your System in Surgery... 1-25 1.7. Concluding a Surgical Procedure... 1-27 1.8. Shutting Down the System... 1-31 1.9. Power Interruptions... 1-31 1.10. Moving Your System to Another Location... 1-32 1.11. System Components... 1-33 1.12. Foot Control... 1-42 1.13. Illumination Function... 1-64 1.14. Multimedia Center (MMC) (optional)... 1-69 1.15. Laser Function... 1-72

2.

User Interface

2.1. Basic Interface Controls... 2-1 2.2. Surgical More Screen... 2-7 2.3. Surgical Screen Layout... 2-23

3. 3.1. 3.2. 3.3. 3.4. 3.5. 3.6. 3.7. 3.8.

4.

Customizing Your System Manage Settings... 3-4 Surgeon Level Settings... 3-11 Manage Surgeon Files... 3-17 System Setup... 3-22 System Configuration... 3-26 System Calendar... 3-26 TruLink® Customer Support Network... 3-28 Customization... 3-30

Detailed Reference

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Table of Contents 4.2. 4.3. 4.4. 4.5.

Posterior Functions... 4-5 Anterior Functions... 4-32 Coagulation Function (Posterior & Anterior Modes)... 4-48 Combined Domain... 4-53

5. 5.1. 5.2. 5.3. 5.4. 5.5. 5.6. 5.7.

Cleaning and Sterilization Requirements Routine Cleaning... 5-1 Bipolar Coagulation Accessories... 5-2 Irrigation and Irrigation/Aspiration Handpieces... 5-3 Ultrasound Handpiece and Accessories... 5-6 Special Instructions for United Kingdom Users... 5-11 Cleaning the MMC... 5-14 Laser Protective Eyewear... 5-14

6. 6.1. 6.2. 6.3. 6.4. 6.5. 6.6. 6.7.

Troubleshooting User Troubleshooting... 6-1 Power Issues... 6-1 Laser Calibration Verification... 6-3 Laser Interlocks... 6-4 System Messages... 6-8 Troubleshooting the MMC... 6-42 System Configurations and Accessories... 6-43

7.

Service and Warranty

7.1. Service Information... 7-1 7.2. Environmental Protection... 7-10 7.3. Warranty Information... 7-10

8.

Specifications

8.1. Environmental and Physical Specifications... 8-1 8.2. Primary System Specifications... 8-9 8.3. System Labels... 8-23

9.

Glossary

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Getting Started

Getting Started

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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. It also provides information on setting up your Stellaris® PC Vision Enhancement System and making the necessary connections.

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

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:  All external wiring must be in accordance with local electrical code requirements and NEC Class II signaling system twisted wire with outer shield. The wire length must not exceed 20 meters (60 feet). The wire gage must be 26 AWG to 12 AWG gage, with ends stripped from 9 mm to 10 mm (3/8 inch). At no point should the wire be untwisted more than 5 cm (2 inches).

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.”

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1 Getting Started

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

Note:

 reventative scheduled maintenance is recommended once a year to ensure that the P Stellaris® PC Vision Enhancement System meets its optimum performance, reliability and safety standards. The maintenance shall be done by a Bausch + Lomb certified individual only.

Note:

 luidic stability in the eye during surgery is crucial for safe and effective phacoemulsification F (phaco) surgery. During phaco surgery, fluid is aspirated out of the eye through the phaco needle, and fluid is infused into the eye through the infusion sleeve. Balancing these two flows maintains acceptable intraocular pressure throughout the surgical procedure. Factors that affect the aspiration rate through the phaco needle include the vacuum setting (mmHg), and the internal diameter of the needle and tubing. Factors that affect the infusion rate are the Bottle Height (BH), incision size, and dimensions of the needle-sleeve interface. The Stellaris® PC Vision Enhancement System provides vacuum settings up to 600 mmHg (VFM). The higher the vacuum setting, the higher the aspiration rate. Higher aspiration rates increase the risk of fluidic instability, which could lead to anterior chamber collapse. The maximum safe vacuum setting for each needle-sleeve combination depends on the surgical technique being performed and the surgeon’s level of proficiency. It is surgeon’s sole responsibility to use the system settings to achieve optimal operating conditions.

1.1. Components Shipped with the System Before unpacking, inspect all packages for damage. Report any damage from shipping to the carrier. Before discarding packaging material, assure all parts are accounted for. Smaller parts may be attached to packing materials. Standard components shipped with the system include:

1-2

•

System Main Console

•

Primary (Integrated) Foot Control with Battery

•

Primary (Integrated) Foot Control Wall Charger

•

Extra Foot Control battery

•

Primary (Integrated) Foot Control Backup cable

•

Operator’s Manual (CD)

•

System Power Cord

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1 Getting Started •

Mayo Tray

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Foot Control battery Charging Cradle

•

Air Hose

•

Zero Level Bottle Hanger

•

Remote Control

Systems equipped with laser functionality also include two laser keys, one pair of safety glasses, and a Connectivity Kit (interlock keys, see page 6-4).

1.2. System Description The Stellaris® PC Vision Enhancement System’s modular design enables easy upgrades as technology advances. The system consists of a main housing unit, a user interface screen, surgical modules, a Primary (Integrated) Foot Control, and an infrared remote control (for anterior application only, optional accessory). Handpieces, packs and other accessories are supplied separately. The Stellaris® PC Vision Enhancement System with laser functionality ships with all essential laser accessories.

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Figure 1.1. Stellaris® PC Vision Enhancement System. Systems without laser functionality will not have the laser panel below the tray, nor the Laser and LIO ports.

Your Stellaris® PC Vision Enhancement System is easily upgraded to take advantage of future technology innovations. The primary interface with the system is a 19 inch, 5:4 aspect ratio color touch screen display. The display screen may be tilted 10 degrees forward and 15 degrees back, and swiveled 90 degrees to the right or left. The brightness of the display is controlled through the A/V More Screen (see page 2-16). An infrared receiver, at the bottom of the display screen, interfaces with the remote control.

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1 Getting Started The computer system includes both audio and visual capabilities, which provide warning messages, alarms, and other audio indications, as well as allowing you to view setup screens, surgical settings, and video from a microscope camera. The volume is adjustable via the touch screen setting globes on the More Screen A/V tab. Two USB ports on the back of the display allow you to save, load, and transfer your customized settings between systems. A single port on the front of the system provides filtered atmospheric air for both Fluid/Air Exchange (F/AX) and Air Forced Infusion (AFI) for posterior and combined surgery. There are two air outputs built into the system to provide filtered atmospheric air for anterior and posterior surgeries. The front port provides air for both Fluid/Air Exchange and Air Forced Infusion in posterior and combined surgery. The port near the IV Pole on the back of the system provides air for Pressurized Infusion (PI) in anterior surgery. The system can be set for either gravity infusion (IV Pole) or infusion using pressurized air (AFI and PI, respectively) through the More Screen Infusion Tab or through the programming interface (see Chapter 3). Both air output ports have lighted rings surrounding them. The ring light will be solidly lit if that function is active and within correct pressure range. If the pressure moves outside of the specified range, the ring will begin blinking. If the pressure remains outside the set range, an error message will appear on the screen. Laser functionality is optional on the Stellaris® PC Vision Enhancement System. The laser functionality can be integrated and shipped with a new Stellaris® PC Vision Enhancement System, or an existing Stellaris® PC Vision Enhancement System can be upgraded in the field.

1.3. Connections and Setup

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

Note:

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

Note:

 or optimum aspiration and reflux performance, the patient’s eye must be at the same level as F the Stellaris® PC Vision Enhancement System aspiration port on the fluid collection cassette. If this is not possible, use the patient eye level offset feature in the programming screen.

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Note:

 he out-of-factory Wireless System Setup is “Disabled”. Performing a software upgrade will T also reset the Wireless System Setup to “Disabled”. To setup wireless operation, see Primary (Integrated) Foot Control System Setup on page 1-49.

This connections and setup section applies to systems without Laser function only. For systems with laser functionality, see “Laser Function” on page 1-72. The Stellaris® PC Vision Enhancement System is pre-configured at the factory to minimize setup and installation requirements. The power cable, Primary (Integrated) Foot Control and Ethernet connections are located at the lower rear of the system.

Figure 1.2. Lower Rear of System. 1. Fuse Holder. 2. Main Power Switch, disconnects system from mains voltage. See 60601-1, paragraph 8.6.7. 3. Ethernet Port. 4. Secondary (LIO) Foot Control Port. 5. Primary (Integrated) Foot Control Backup Cable Port. 6. Microscope Filter Interlock. 7. Room Interlock. 8. Potential Equalization Connector. 9. Power Cord Input. 10. Power Cord Retention Clip. Systems without laser functionality will not have 4, 6 or 7.

Note:

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

Primary (Integrated) Foot Control The Primary (Integrated) Foot Control shipped with all systems contains a laser firing switch, and can use either wired or wireless communication. The first time the Stellaris® PC Vision Enhancement System is used, you must use the wired connection to establish communication between the Primary (Integrated) Foot Control and the Stellaris® PC Vision Enhancement System.

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