551-6001-001 Vizual Manual Rev 2 - Vision Matrix Surgical...2 Notified Body: LNE/G-Med, No. 0459 10605 Concord St. #205 Kensington, MD 20895 USA 1.301.495.0477 EC Rep: Donawa LifeScience

AMERICAN OPTISURGICAL INC. VIZUAL® PHACOEMULSIFICATION SYSTEM

Operator’s Manual

To Our Customer Thank you for purchasing the Vizual® Phacoemulsification System by American Optisurgical Inc. The Vizual® is intended for use in the disruption and extraction of cataractous lens material from the eye with ultrasonic energy, a process known as phacoemulsification. The Vizual®

is 510k cleared1 and CE Marked2. It offers high-end features and will provide many years of dependable service when properly used and maintained. Features worth noting are:

User-Friendly Controls Articulating, Color LCD Touchscreen Normal, Burst, and Micro Modes of U/S energy delivery Fixed and linear control of power and flow Up to twenty-four user programs 4-crystal piezoelectric U/S Handpiece Non-invasive vacuum measurement Quick & Easy Loading Tubing Cassette Portable, Lightweight, and Attractive Design

Please take the time necessary to read this manual carefully and completely before using the Vizual® Phacoemulsification System. We are honored to have you as a customer. 1 510k No. K080803, dated 09/22/08 2 Notified Body: LNE/G-Med, No. 0459 10605 Concord St. #205 Kensington, MD 20895 USA 1.301.495.0477 EC Rep: Donawa LifeScience Consulting Piazza Albania, 10 00153 Rome, Italy 39.06.578.2665

AMERICAN OPTISURGICAL INC. VIZUAL® PHACOEMULSIFICATION SYSTEM BASIC PURCHASE PACKAGE CONTENTS QTY ITEM PART NUMBER

1 Phacoemulsification Console 551-0034-001 1 Foot Pedal 553-0000-000 1 4 Crystal U/S Handpiece 300-9500-270 1 Reusable Tubing Set 551-0102-001 1 Extra Fuse Set 430-2215-002

1 Power Cord (USA, Europe) 430-4023-001,

430-4024-001 1 Phaco Tip w/wrench (30°, American thread) 100-1000-301 2 Reusable Silicone Sleeves 100-0050-280 1 Reusable Test Chamber 475-1005-001 1 Collection bags (pk/10) 551-0067-001 1 Operator’s Manual 551-6001-001 1 Protective Vinyl Cover 551-7001-001 1 Travel Case 551-7002-001

OPTIONAL PURCHASE ITEMS QTY ITEM PART NUMBER

1 Extra 4 Crystal U/S Handpiece 300-9500-270 1 Cart with I/V Pole 551-0000-001

Additional items for use with the Vizual® System are available for purchase, including phaco tips, sleeves, and wrenches, cautery forceps and pencils, vitrectomy cutters and I/A handpieces and tips.

GENERAL SAFETY This manual must be read carefully by all operators who will use the Vizual®. Do not attempt to use the Vizual® system without having proper knowledge of all of its functions, controls, and limitations. No information on surgical procedures will be given in this manual. American Optisurgical Inc. (AOI) claims no responsibility or liability resulting from any surgical techniques practiced. Prior to each surgical procedure, the clinical staff should inspect the accessories and cables for any damage. American Optisurgical Inc. recommends the use of the provided cables and listed accessories with compatible surgical equipment peak voltage to ensure a safe operating environment. Electrical shock hazard exists. Do not remove the console cover. For service call AOI. Electrode cables should be checked for damage to insulation prior to use. Always use the lowest output power level for the intended purpose, which is compatible with the surgical application. Use only the proper signal output or signal input parts when connecting to the specified equipment. Do not check vibration, aspiration, or irrigation by placing hand or finger against handpiece tip. Prolonged exposure to or direct contact with the vibrating U/S tip may cause damage to healthy tissue. Use of a damaged U/S tip or one that has been used excessively may adversely affect healthy tissue. The U/S handpiece should only be activated in Balanced Salt Solution (BSS), distilled water (at ambient temperature) or during actual surgery. Never activate the U/S handpiece with the phaco tip in air, as immediate irreparable damage will result. HF surgical equipment is for use without a neutral electrode. Sterilization and Cleaning Precautions The U/S handpiece, reusable tube set, phaco tip with wrench, silicone sleeve, and test chamber may be steam sterilized. No other system component is designed to be sterilized (by any sterilization method). American Optisurgical Inc. recommends that only sterilization by steam be used. Other methods of sterilization, including chemical, ETO, radiation, or hot air have not been evaluated, and may result in injury to the patient. Allow steam-sterilized items to adjust to room temperature before use. Use distilled or deionized water only when preparing components for reuse. Do not use abrasive cleaners or solvents on the system console.

Table of Contents

Chapter Topic Page 1 Warnings and Precautions 1

2 Warranty Information 3

3 General Information 4 a) Introduction 4

b) Console 4

c) Foot Pedal 4

d) Cart with I/V Pole 4

e) System Overview 5-9

f) Technical Specifications 10-12

g) Environmental Requirements 12

h) Symbol Description 13

4 Installation 14 a) Introduction 14

b) Contents 14

c) Unpacking 14

d) Connections 14-15

5 System Set-up 16

6 Operation 17 a) Introduction 17

b) Main Menu 17

c) Irrigation (IRR) Mode 17-18

d) Phaco (U/S) Mode (Default Boot screen) 18-21

e) Irrigation/Aspiration (I/A) Mode 22-23

f) Vitrectomy (VIT) Mode 24

g) Bipolar Coagulation (COAG) Mode 25

h) Help Mode 26

i) Options – Programs Mode 27-29

j) Options - Settings Mode – Sound 30

k) Options - Settings Mode – Voice 31

l) Options - Settings Mode – Video 32

m)Options - Settings Mode – Preference 33

n) Options - Settings Mode – Upgrade 34

o) Options – Footpedal 35-36

p) Foot Pedal Calibration Procedure 37

7 Cleaning and Sterilization 38 a) Introduction 38

b) Console 38

c) Foot Pedal 38

d) U/S Handpiece 39

e) Reusable Tubing Set 40

f) Phaco Tip 41

g) Silicone sleeve 42

h) Test Chamber 43

8 Service and Technical Support 44 a) Introduction 44

b) Fuse Replacement 44

c) Maintenance and Unit Repairs 44

d) Contacting Technical Support 44

9 Troubleshooting Guide 45

10 Factory Default Settings 47 a) Introduction 47

b) Factory Default Settings 47

c) Runtime Messages 47-48 TABLES AND FIGURES FIG. 1 & 2 Rear View & Side View 6 FIG. 3 & 4 Front View & Cassette View 7 FIG. 5 & 6 Foot Pedal & Phaco Handpiece 8 FIG. 7 Cart with I/V Pole 9 TABLE 1 Symbols Found on the Vizual® 13 FIG. 8 Peak Output Voltage (no load) Vs. Power Setting 49 FIG. 9 Power Output into 75 Ohm Load Vs. Power Setting 49 FIG. 10 Power Output Vs. Impedance 50 APPENDICES APP. I EMC Requirements 51-54

1

Chapter 1 – WARNINGS AND PRECAUTIONS DANGER – Possible risk of fire or explosion. The Vizual® Phacoemulsification System should never be used in the presence of flammable anesthetics, oxidizing gases (i.e. nitrous oxide and oxygen), endogenous gases, disinfecting agents, cleaning agents or aerosol sprays. WARNING – Failure of the Vizual® Phacoemulsification System could result in an unintended power output increase. WARNING – The patient should not come in contact with earthed metal parts. CAUTION – The height at which the irrigating fluid bottle is suspended will affect intraocular pressure of the eye during surgery. CAUTION – Patient eye level must be between the bottom of the installed tubing cassette and no more than 10 centimeters below the installed tubing cassette to ensure proper fluid dynamics of the vacuum system. WARNING – Hazards may exist for patients with cardiac pacemakers or other active implants due to interference with the action of the pacemaker, or the pacemaker may be damaged. WARNING – Ensure that any other monitoring electrode equipment or electromagnetic equipment near the patient will not interfere with the surgical procedure or place the patient at risk with undue contact when used simultaneously with the Vizual® System. WARNING – Temporarily unused active electrodes should be stored in a location that is isolated from the patient. WARNING – Electrode cables should be positioned away from the patient to avoid possible contact. WARNING – Interference of the Vizual® System may adversely influence the operation of other electronic equipment. WARNING – Surgical waste presents a biological hazard and must be handled and disposed of properly. WARNING – The system console, U/S handpiece, and foot pedal, as well as any cautery accessories are electrical/electronic equipment and must be disposed of properly at the end of their useful lives. CAUTION – Only use the U/S handpiece included with the Vizual® System to ensure that the rated accessory voltage is greater than the maximum output voltage.

2

CAUTION – Bipolar cautery accessories selected should have a rated accessory voltage of equal to or greater than the maximum output voltage. WARNING – Maximum activation (on) time of 10 seconds at maximum power setting followed by minimum deactivation (off) time of 2 seconds while using the Phaco function is necessary for the safe operation of the Vizual® System. CAUTION – Connected accessories should be rated for at least the maximum peak output voltage of the Vizual® System set at the intended output control setting in the intended operating mode. CAUTION – Needle monitoring electrodes are not recommended. CAUTION – Monitoring systems that incorporate high frequency current-limiting devices are recommended for use.

3

Chapter 2 - Warranty Information

AOI LIMITED WARRANTY American Optisurgical Inc. warrants that the Vizual® Phacoemulsification System will, upon delivery, conform to the manufacturer’s then current version of the published specifications as such. The Vizual® Phacoemulsification System in all material aspects shall be free from defects in material and workmanship from a period of one (1) year from the date of delivery when properly installed, maintained and used for the intended purpose. Optional purchase components that are distributed by American Optisurgical Inc. are not covered by this warranty. The exclusive remedy for any breach of this warranty shall be, at American Optisurgical Inc.’s sole option, the repair or replacement of the non-conforming Vizual® Phacoemulsification System or component thereof, which is returned to American Optisurgical Inc. during the warranty period. Any claim based upon this warranty must be submitted to American Optisurgical Inc. during the applicable warranty period. All replacement components provided during the warranty period shall be deemed to have been delivered on the original delivery date of the Vizual® Phacoemulsification System. This warranty is non-transferable without American Optisurgical Inc.’s prior consent. Any Vizual® Phacoemulsification System or component thereof returned for any reason must be accompanied by return goods authorization (RGA) number obtained by calling American Optisurgical Inc. Technical Support Department at 949.580.1266. Any shipping charges incurred shall be paid by the purchaser/user of the equipment. This warranty does not apply to abnormal use or to defects, malfunctions or failures that result from abuse, neglect, improper installation or maintenance, alteration, modification, accident, or misuse of the Vizual® Phacoemulsification System or its components. Failure to maintain the Vizual® Phacoemulsification System and its components in accordance with manufacturer recommendations shall void the warranty. THIS WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. AMERICAN OPTISURGICAL INC. SHALL NOT BE RESPONSIBLE FOR ANY LOST PROFITS OR OTHER DIRECT, INCIDENTAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES SUFFERED BY ANY PARTY, EVEN IF IT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. In no event shall American Optisurgical Inc.’s liability for any claim, whether in contract or tort, exceed the amount paid to American Optisurgical Inc. for the Vizual® Phacoemulsification System. The warranty set forth herein may not be extended, enlarged, or otherwise modified by any American Optisurgical Inc. agent or employee and American Optisurgical Inc. does not assume any liability or make any warranty except as stated herein. For warranty information outside the USA please contact your local distributor.

4

Chapter 3 - General Information a) INTRODUCTION This Operator’s Manual is your written guide to the Vizual® Phacoemulsification System. Please read the entire manual carefully. DO NOT attempt to use the instrument without having an adequate understanding of all its functions, controls, and limitations. No information on surgical procedures will be given in this manual. American Optisurgical Inc. claims no responsibility or liability resulting from any surgical techniques practiced. If properly maintained and used, the Vizual® Phacoemulsification System should provide years of dependable service. If, after reading this manual, you have any questions, please contact American Optisurgical Inc. or your local distributor. b) CONSOLE The Vizual® Phacoemulsification System utilizes a versatile, advanced microprocessor for control of all primary functions. It operates with timesaving simplicity and is extremely easy to operate. The system requires no external air source and operates on an input voltage range of 100 to 240V AC. It can be used with factory set or user-defined set up parameters (programs). All functions, modes, and options are independently set by pressing clearly marked indicators on the LCD touch screen. Tube set loading is greatly simplified by the use of a tubing cassette and latch type mechanism. Modes are executed in real-time by simply depressing the foot pedal. The Vizual® Phacoemulsification System has five modes of operation: IRRIGATION, PHACO, IRRIGATION/ASPIRATION, VITRECTOMY, and COAGULATION. Each mode is explained in detail in Chapter 6 of this manual. c) FOOT PEDAL The Vizual® Phacoemulsification System is directly controlled by a foot pedal, which is linked by a ten-foot cable to the rear of the console. The foot pedal is composed of two parts that are activated by the operator: the main treadle control and the two side kick bars. The main treadle has three positions of operation. Foot Pedal Position 1 activates the irrigation; Position 2 activates the aspiration pump and Position 3 activates the ultrasonic power. If the vitrectomy mode is selected on the touch screen, foot pedal Position 2 will activate the vitrectomy at the same time as the aspiration pump. Available foot pedal positions are dependent on the mode selected and the amount of travel will vary if the linear option is selected. The right side kick bar will activate reflux by default. The left side kick bar is no function by default. Either side kick bar can be programmed by the user in the foot pedal option screen. Function choices include no function, reflux, irrigation, mode, multi mode, or I/V pole height control. The reflux function overrides all foot pedal functions. The foot pedal is splash proof. However, any fluid that comes in contact with the foot pedal should be wiped off at the end of the surgical procedure. Never attempt to move the foot pedal by pulling on the cable. d) OPTIONAL CART WITH I/V POLE

The Vizual® Phacoemulsification System can include a cart with automated I/V pole. The cart features locking casters, a bracket to hold the system console, another bracket for storing when not in use, and a tray for surgical accessories. The I/V pole has two hangers at the top used to suspend one bottle of BSS each. Height of the I/V pole is controlled from the console touchscreen when the cart is plugged into the connector on the back panel of the system console labeled I/V POLE.

5

e) SYSTEM OVERVIEW

Figures 1, 2, 3, 4, and 5 refer to all controls, indicators and connectors on the Vizual® Phacoemulsification System. Their associated descriptions are below.

NUMBER NAME DESCRIPTION

1 REAR PANEL LABEL Displays system ratings, serial number, all warnings and cautions

2 ON/OFF SWITCH I is ON and O is OFF 3 RJ45 CONNECTOR Connection for Ethernet for Remote debugging

4 EQUIPOTENTIAL GROUND Allows hospital equipment to be tied to a common ground within the O.R.

5 FUSE HOLDER Holds system fuses

6 USB PORT 1 + 2 USB connection used for remote control (Future Option), Or for software updates and saving program settings

7 AC POWER INPUT Provides power connection and overload protection to the system

8 I/V POLE CONNECTOR Automated external IV pole connection 9 FOOT PEDAL CONNECTOR Connection for system foot pedal

10 CASSETTE LOCK Locking mechanism for Cassette 11 VACUUM SENSOR Sensor for cassette non-invasive vacuum sensor 12 CASSETTE RELEASE BUTTON Releases the Cassette when pressed 13 U/S CONNECTOR Provides power to the U/S handpiece 14 COAG CONNECTOR Provides power to the coag cable 15 VIT PORT Supplies air to VIT handpieces 16 IRRIGATION VALVE Controls irrigation of unit 17 REFLUX VALVE Controls reflux of unit 18 PERISTALTIC PUMP HEAD Provides system aspiration 19 FRONT PANEL SCREEN Provides display of system and modes

20 FRONT TOUCH PANEL Transparent panel which allows for control of all mode parameters

21 SPEAKER GRILL Stereo Audio for Audio Indicators 22 CASSETTE- BOTTLE INPUT BSS Bottle Admin Set input 23 TUBING CASSETTE Cassette 24 ASPIRATION TUBE Handpiece tubing output 25 COLLECTION TUBE Peristaltic Pump Output 26 COLLECTION BAG CLIP Provides location to hang Collection Bag 27 IRRIGATION TUBE Handpiece tubing Input 28 FOOT PEDAL User interface to control unit modes 29 MAIN TREADLE Activates basic modes of unit 30 SIDE KICK: LEFT SWITCH Activates Assigned Function (default: Not Used ) 31 SIDE KICK: RIGHT SWITCH Activates Assigned Function (default: Reflux) 32 IRRIGATION PORT Provides connection for irrigating fluid 33 ASPIRATION PORT Provides connection for removing emulsified lens 34 CONNECTOR Plugs into console for power to U/S handpiece 35 BOTTLE HANGER Provides hooks for hanging BSS bottles 36 HANDLE Provides means to grasp cart with hand for moving 37 HIDDEN SHELF Provides secure mounting location for system console

38 ACCESSORY TRAY Provides convenient location for handpiece and surgical accessories

39 CABLE MANAGEMENT Provides place to wrap console power cord around when not in use.

40 FOOTPEDAL HANGER Holds footpedal when not in use

6

12

13

14

15

16

17

18

1110

Figure 2 – Side View

Figure 1 – Rear View

7

Figure 3 – Front View

Figure 4 – Cassette View

22

23

24

25

26 27

8

Figure 5 – Foot Pedal

Figure 6 – Phaco Handpiece

34

32

33

9

Figure 7 – Cart with I/V Pole

37

35

36

38

39

40

10

f) TECHNICAL SPECIFICATIONS Manufacturer AMERICAN OPTISURGICAL INC. Model 551

Classification (IEC60601-1) CLASS I

CONSOLE

PARAMETER SPECIFICATION Electrical

INPUT VOLTAGE 100 TO 240VAC 50/60HZ

POWER CONSUMPTION 80 Watts

LINE FUSES 5A T (Slow blow)

MAX. OUTPUT VOLTAGE (PHACO) 180V

MAX. OUTPUT VOLTAGE (COAG) 30V

MAX. OUTPUT VOLTAGE (FOOT PEDAL) 5V

Irrigation

FLUID DELIVERY Gravity fed

VALVE TYPE Solenoid- actuated pinch valve

DEFAULT BOTTLE HEIGHT 77 inches (with optional I/V pole cart)

CONTROL System foot pedal or Irr soft key

U/S (Ultrasonic) TYPE Ultrasonic generator

MODES Normal, Burst and Micro

FUNCTIONS Prime, Tune, Fixed, Linear, Reset, and Purge

PULSE RANGE (IN NORMAL MODE) 1 to 10 per second

PULSE DURATION (IN BURST MODE) 20 to 100 milliseconds

PULSE RANGE (IN BURST MODE) Single - 1 each time foot pedal is depressed Multi - 10 to 5000 per second

PULSE ON/OFF RANGE (IN MICRO MODE) 5 to 100 milliseconds (On and Off)

FREQUENCY 37KHz to 40.2KHz

DEFAULT PHACO POWER 40% (Normal), 45% (Burst and Micro)

AVAILABLE PHACO POWER 5 to 100%

DEFAULT VACUUM LEVEL 200 mmHg

VACUUM RANGE 20 to 500mmHg

DEFAULT ASPIRATION FLOW 24cc/min

ASPIRATION FLOW RANGE 2 to 50cc/min


CONTROL System foot pedal

I/A (Irrigation/Aspiration)

ASPIRATION Peristaltic pump, low pulsation

FUNCTIONS Fixed flow, Linear flow, Fixed vacuum, Linear vacuum

11

PARAMETER SPECIFICATION

DEFAULT VACUUM LEVEL 460 mmHg

VACUUM RANGE 20 to 500mmHg

DEFAULT ASPIRATION FLOW 26cc/min

ASPIRATION FLOW RANGE 2 to 50cc/min

HANDPIECE Optional accessory



Vit (Vitrectomy)

TYPE Pneumatically-actuated guillotine action

FUNCTIONS Fixed flow, Linear flow, Fixed vac, Linear vac, Single cut, Multi cut

DEFAULT CUT RATE 200 CPM

AVAILABLE CUT RATE From 60 to 700 cuts per minute

MAX. OPERATING PRESSURE 20 psig

DEFAULT VACUUM LEVEL 120mmHg

AVAILABLE VACUUM RANGE 20 to 500mmHg

DEFAULT ASPIRATION FLOW RATE 20cc/min

AVAILABLE ASPIRATION FLOW RATE 2 to 50cc/min



Coag (Coagulation)

TYPE Bipolar generator

MODES Linear and Fixed

FREQUENCY 315 kHz

NOMINAL POWER 5.5 Watts @ 250 Ohm load

MAXIMUM PEAK VOLTAGE 30 V

DEFAULT COAG POWER 40%

AVAILABLE COAG POWER 10 to 100%


Dimensions

HEIGHT 6.5 inches/16.5 centimeters

WIDTH 14.5 inches/36.8 centimeters

DEPTH 13.5 inches/34.3 centimeters

WEIGHT 21 Lbs

DISPLAY 12.1 inches diagonal 800 x 600 Pixels, Color LCD touchscreen

12

FOOT PEDAL PARAMETER SPECIFICATION

HOUSING Watertight (IEC 60601-2-2)

MAIN TREADLE Control dependent on mode selected 3 positions, 2 detents

DEFAULT RIGHT SIDE KICK Reflux

DEFAULT LEFT SIDE KICK Not used

AVAILABLE SIDE KICK FUNCTIONS Not used, Reflux, Mode, Multimode, Irrigation, I/V pole

FEEDBACK Vibration motor activates at detents

CALIBRATION Available function (when foot pedal has been repaired or replaced)

HANDPIECE


TYPE 4 crystal, piezoelectric

FREQUENCY 37 to 40.2 kHz

TIP THREADS Standard American (4-40 UNC)

CONNECTOR Circular Push-Pull, 5-pin

LENGTH (W/O TIP) 5 5/16”

WEIGHT 4.6 oz. (cable included)

CART WITH I/V POLE


HANGERS 2

CAPACITY 2 - 500cc glass bottles of BSS

TRAVEL 64 to 90 inches (measured from floor to bottom of hanger)

SPEED ~2 inches per second

CONTROL System foot pedal or bottle soft key

g) ENVIRONMENTAL REQUIREMENTS The Vizual® Phacoemulsification System should be used in a clean environment that is suitable for surgery. The requirements for altitude, temperature and relative humidity are shown in the table below.

ENVIRONMENTAL LIMITATIONS

OPERATING STORAGE

Altitude 8000 ft. No limits

Temperature 10°C to 40°C (50°F to 104°F) 5°C to 60°C (-4°F to 140°F)

Relative Humidity 30% to 85% non-condensing 30% to 85% non-condensing

13

h) SYMBOL DESCRIPTION The following table provides the symbols that are found on the Vizual® Phacoemulsification System and their definition. These symbols are used in order to provide quick information or instruction in a limited space. It is important to become familiar with these symbols and their definition before setting up and operating the Vizual® Phacoemulsification System.

TABLE 1 Symbols found on the Vizual® Phacoemulsification System

No. Symbol Definition

1

Date of manufacture

2

Waste electrical and electronic equipment

3

CE Mark

4

Dangerous voltage

5

Caution, consult accompanying documents

6

Equipotentiality

7

ON (power: connection to the mains)

8

OFF (power: disconnection from the mains)

9

Network Connection

10 USB Connection

11

Type B Equipment

12

Type BF Equipment

14

Chapter 4 - Installation a) INTRODUCTION This section contains instructions recommended for the installation of the Vizual® Phacoemulsification System. The operational checkout is a quick check only, used to verify initial setup and instrument operation. Prior to following these instructions, it is recommended that a suitable location be chosen with adequate space, lighting, applicable cleanliness requirements, and utilities. b) CONTENTS The following table lists the contents of the Vizual® Phacoemulsification System Basic Purchase Package. Your system may contain additional items. Use of accessories provided by a source other than American Optisurgical Inc. may affect your warranty. Please contact your local distributor for additional information. QTY ITEM

1 Phacoemulsification Console 1 Foot Pedal 1 4 Crystal U/S Handpiece 1 Reusable Tubing Set 1 Extra Fuse Set 1 Power Cord, 120V, (USA) or 220V (Europe) 1 U/S Phaco Tip w/wrench 2 Reusable Silicone Sleeves 1 Reusable Test Chamber 1 Collection bags (pk/10) 1 Operator’s Manual 1 Protective Vinyl Cover 1 Travel Case

c) UNPACKING Your Vizual® Phacoemulsification System was thoroughly inspected and tested prior to shipment. Carefully unpack and visually inspect all items for any apparent damage that may have occurred during shipment. If any physical damage is found or if the system is not within specification when received, immediately notify the shipping company and American Optisurgical Inc. Customer Service. All claims for damage should be filed promptly. NOTE: All packing material should be saved for returning the system, if necessary. The contents of the case should always be checked against the packing slip to ensure all items have been shipped. If the system is incomplete notify American Optisurgical Inc. Customer Service immediately. d) CONNECTIONS After carefully unpacking the Vizual® Phacoemulsification System and verifying the contents, place the console on a flat surface (or if purchased, the cart with I/V pole). Connect the main components of the system as follows: Foot Pedal – Connect the foot pedal cable to the rear panel receptacle labeled FOOT PEDAL. Align the notch on the connector and the back panel, insert the connector, and screw it in by hand until snug. Electrical Power – Verify that the power switch is in the OFF position. Connect the power cord to the rear panel AC POWER input module (a 120V or 220V, grounded power cord is supplied from the manufacturer. Your distributor should provide the proper power cord for your area).

15

Tube Set – Ensure the tube that mates with the peristaltic pump head (the one in the semi-circular cutout of the cassette) is aligned properly within the groove. Insert the cassette into the console by pressing the cassette straight down until the latching mechanism clicks. Cart with I/V Pole – Connect the cart cable to the rear panel receptacle labeled I/V POLE. Align the notch on the connector and the back panel, insert the connector, and screw it in by hand until snug.

16

Chapter 5 – System Set-up a) INTRODUCTION

This section contains instructions necessary for the setup of the Vizual® Phacoemulsification System prior to use. It assumes that the installation described in the previous chapter has already been completed, and that you have all necessary accessories for surgery, including those not included in the Basic Purchase Package. CAUTION - Patient eye level must be between the bottom of the installed tubing cassette and no more than 10 centimeters below the installed tubing cassette to ensure proper fluid dynamics of the vacuum system. b) SET-UP

1. Power on the console by pressing the power switch to the ON position. 2. Close the roller clamp on the administrative set, and insert the drip chamber spike into the irrigation bottle.

Hang the bottle at an appropriate height. 3. Connect the administration set (male fitting) to the cassette administration tube (female fitting).

4. Connect the cassette irrigation tube (male fitting) to the U/S handpiece irrigation port (female fitting).

5. Connect the cassette aspiration tube (female fitting) to the U/S handpiece aspiration port (male fitting).

6. Mount the collection bag on the collection bag holder located at the bottom center of the tubing cassette.

Connect the cassette drain tube to the collection bag. 7. Install the Phaco tip onto the U/S Handpiece using the supplied wrench; turn clockwise to tighten. Connect the

U/S handpiece connector to the console side panel receptacle labeled U/S. Align the red dot on the connector with the red dot on the panel and push in by hand until snug. Place the silicone sleeve over the tip, and install it fully by turning it clockwise by hand until the desired amount of tip is exposed. The irrigation ports should be perpendicular to the furthermost part of the tip bevel. If a straight tip is used, position the irrigation ports at right angles to the handpiece irrigation tube.

8. Install the test chamber over the Phaco tip and sleeve by hand until snug. 9. Open the roller clamp on the administrative set and depress the PRIME soft key on the front panel. Observe that

irrigation starts and fluid flows into the collection bag. After approximately one minute priming will end and the unit will automatically tune the U/S handpiece.

10. Perform a system fluidics test by first holding the Phaco handpiece at patient eye level. Depress the foot pedal

to Position Two. Pinch off irrigation line. The test chamber should collapse (this checks for proper aspiration) and displayed vacuum level should match the preset value. Release the irrigation line and observe that the test chamber refills within a few seconds (this checks for proper irrigation). Pinch off the aspiration line and depress the foot pedal to Position Two. Verify that the displayed vacuum matches the preset value. Release the pinch on the aspiration line while keeping the foot pedal depressed. Be sure the test chamber does not collapse or dimple. If it does, adjust the bottle height and repeat until no dimpling occurs.

17

Chapter 6 - Operation a) INTRODUCTION This section contains information that identifies the modes, functions, parameter settings, and commands necessary to operate the Vizual® Phacoemulsification System. The following information should be read and thoroughly understood in detail before operating the system. b) MAIN MENU The main portion of the menu screen is designed for easy navigation between all modes. All available modes are located on the lower portion of the front panel screen. By depressing the touch panel the mode may be activated. This is indicated by the mode being surrounded by a shaded box. When the Phacoemulsification System is first turned on, the initialization screen will momentarily display the AOI logo followed by the U/S Phaco Mode. Keys along the right-hand side of the screen in all modes allow for mode operation. When activated, a shaded box will surround the function selected. The up/down arrow soft keys, located to the right side of the preset value, can change the operating presets in all modes. When the up arrow is pressed, the value will increase. Pressing the down arrow will cause the value to decrease. The Vizual® Phacoemulsification System has five basic modes of operation. The basic modes are Irrigation (IRR), Phaco (U/S) (Normal, Burst, and Micro), Irrigation/Aspiration (I/A) (multi mode), Vitrectomy (VIT) and Bipolar Coagulation (COAG). There is also an Options button and a Help button. Programs, Sound Settings, and Footpedal settings are available under the options button. The Help button will show what buttons have available help buy showing a question mark over those locations on the screen. Touching the question mark will display the help text.

18

c) IRRIGATION (IRR) MODE Irrigation is a basic mode and is available in all other modes. It controls the irrigation pinch valve located on the left side of the unit. Irrigation control is used in all anterior surgery procedures. The irrigation source is provided by an inverted container of Balanced Salt Solution (BSS), which is suspended in the operating room. The amount of solution delivered is controlled by bottle height. This is a gravity type system. A drip chamber with connecting tubing is attached to the BSS bottle and routed through the irrigation pinch valve to the handpiece. Bottle height is measured from the floor to the bottom of the bottle hanger. Control of the irrigation pinch valve is accomplished by the foot pedal. By depressing the main treadle of the foot pedal, the irrigation valve will open. Releasing the main treadle will close the valve. Pressing the IRR soft key on the front panel beside the Bottle display will duplicate foot pedal operation. When touched the IRR soft key will highlight to indicate the irrigation valve is activated. Pressing the IRR soft key again will cause the valve to shut off and remove the highlight. If the soft key on the front panel activates the irrigation valve, this will provide constant irrigation and the foot pedal will have no effect on the valve operation.

d) PHACO (U/S) MODE: NORMAL Tab (Default Boot Screen) Phaco is a basic mode that is used to remove the cataract through means of ultrasonic energy. This energy causes a hollow titanium tip attached to the Phaco handpiece to emulsify the cataract with a jackhammer type effect and remove it the through the hollow tip. Functions available in the phaco mode are FIXED, LINEAR, PRIME, TUNE, and PURGE. In addition, there are three phaco locations, selected by depressing the preset selection soft keys 1, 2, and 3, which will allow the user to change settings rapidly. If U/S, Burst Phaco, or Micro Phaco is selected using the soft keys 1, 2, or 3, it will be available in that preset mode. A clock for monitoring phaco power total time and effective phaco power time is shown on the front panel screen.

19

Phaco Mode Functions U/S Soft Key Tabs– the U/S mode can be changed by pressing the Tabs in the main window: the Tabs toggle from Normal, to Burst, to Micro Phaco. Linear – Phaco energy is controlled in a linear fashion by the foot pedal between zero and a maximum limit set by Phaco Preset soft keys on the front panel. The actual phaco power display will show the position of foot pedal travel from zero to maximum preset. The foot pedal has three positions in this mode: Position One is irrigation, Position Two is aspiration, and Position Three is linear phaco. Releasing the main treadle of the foot pedal will cause the phaco energy to stop, the peristaltic pump to cease, the vent valve to open momentarily to release vacuum, followed by the irrigation valve closing.

Fixed – Phaco energy is controlled in a fixed fashion by the foot pedal at the maximum limit set by Phaco Preset soft keys on the front panel. The foot pedal has three positions in this mode: Position One is irrigation, Position Two is aspiration, and Position Three is fixed phaco. Releasing the main treadle of the foot pedal will cause the phaco energy to stop, the peristaltic pump to cease, the vent valve to open momentarily to release vacuum, followed by the irrigation valve closing.

Pulse – May be selected for either linear or fixed phaco function. The Pulse Preset soft keys on the front panel select pulses-per-second (Pulse/s), from zero (no pulse operation), up to ten pulses per second. The foot pedal has three positions: Position One is irrigation, Position Two is aspiration, and Position Three is linear or fixed phaco, depending on which Soft Key is set. Releasing the main treadle of the foot pedal will cause the phaco energy to stop, the peristaltic pump to cease, the vent valve to open momentarily to release vacuum, followed by the irrigation valve closing. Presets 1, 2, and 3 – These settings are used to quickly change phaco settings. By pressing the preset soft keys, the user will be able to switch between U/S 1, 2 and 3. This function is desired when the doctor is using a quadrant type removal where the beginning and ending settings vary greatly. If U/S, Burst Phaco, or Micro Phaco is selected in preset 1, 2, or 3, it will be available in that preset mode. Prime – Used during set up to fill the I/A lines, phaco handpiece and test chamber with BSS. It can also be used at the end of the surgery (only after disconnecting the handpiece) to purge the I/A lines of BSS. To activate the prime function, press the Prime soft key. The priming function will be indicated by a shaded box around the Prime soft key. The aspiration pump will run for approximately 30 seconds, followed by the automatic tuning of the phaco handpiece. The prime cycle may be stopped at any time by again depressing the Prime soft key. Tune – Activated at the end of the prime cycle, Tune is used to match the phaco handpiece to the unit to assure optimum performance. This cycle may also be used by depressing the tune soft key (indicated by the surrounding shaded box). If a problem occurs during the tuning cycle, an error message will be indicated on the front panel. Reset – Resets the Phaco total Time and Effective time to zero. Purge – At the end of the case, disconnect the handpiece, then attach the aspiration and irrigation tubing together to create a closed loop. Close the BSS admin line and disconnect the BSS admin line tube. Remove the fluid from the lines by pressing the purge soft key. The purge cycle may be stopped at any time by again depressing the purge soft key. Reflux – Also available is a sidekick reflux to the bottle, which overrides all normal foot pedal functions. Available in all functions, it is normally used to clear the aspiration line of the handpiece if it becomes clogged with lens material. Activating the right side kick switch (default) on the foot pedal will cause the vent valve to open. Releasing the sidekick switch will shut off the vent valve ending the reflux action. This function can be assigned to either sidekick switch. Factory Arrow – The Vizual® unit when powered up defaults to the Factory settings in all modes. When the arrow on the right of the FACTORY setting is depressed a drop down list will appear of any saved programs. By selecting the desired user saved program all settings will be updated to match that saved program. If there are no saved programs the list will be empty except for the default factory setting.

20

I/V Pole – If the optional cart with I/V pole is connected to the Vizual console, pole height is controlled by sliding the bottle symbol on the touchscreen up or down to raise or lower the I/V pole, or by pressing the arrow soft keys at the bottom of the slider. Each press of the arrow soft key will raise or lower the pole 1 inch. The number displayed on the bottle represents the current pole height, in inches.

Burst – The Vizual® is automatically set to operate in normal U/S Phaco Mode whenever the unit is turned on. To set the unit to Burst mode, you must press the Burst tab. Single or multi-burst functions may be selected in Burst mode. After Burst Mode has been activated, you will now notice that the PULSE area in normal mode now indicates Burst on time in percent per millisecond (%-m/s). The preset soft keys will now control U/S Burst Mode settings. All other functions (Flow, Vacuum, U/S Power) remain the same on the display. Burst Mode may be selected for single or multi-burst functions. Pressing the Burst soft keys on the touch screen will change the pulse width duration from 20 to 100 m/s in increments of 20 (i.e. 0, 20, 40…100). The foot pedal has three positions: Position One is irrigation, Position Two is aspiration, and Position Three is single or multi-burst phaco depending on the selected function key. SINGLE – If the single burst function is selected, when Position Three is activated, a single burst of phaco power will be delivered at the selected pulse width duration and power. MULTI – If the multi-burst function is selected, the further the foot pedal is depressed in Position Three, the time between bursts decreases until a continuous burst is delivered at the selected pulse width and power.

21

Releasing the main treadle of the foot pedal will cause the phaco energy to stop, the peristaltic pump to cease, the vent valve to open momentarily to release vacuum, followed by the irrigation valve closing. NOTE: LINEAR PHACO POWER IS NOT AVAILABLE WHEN IN U/S BURST MODE. THE U/S PHACO POWER PRESET WILL BE DELIVERED IN A FIXED OPERATION DURING THE U/S BURST MODE.

Micro Phaco – The Vizual® is automatically set to operate in normal U/S Phaco Mode whenever the unit is turned on. To set the unit to Micro Phaco mode, you must press the Micro tab. Micro Phaco settings are controlled similar to Pulse mode, with additional control over the time between pulses. After Micro Phaco Mode has been activated, you will notice that the Pulse Phaco area in Normal mode now indicates the On and OFF times for Micro Phaco. The preset soft keys will now control Micro Phaco Mode settings. All other functions (Flow, Vacuum, U/S Power) remain the same on the display. The Micro Phaco soft keys on the touch screen are used to select the desired On time (pulse duration) from 5 to100 m/s in increments of 5 (i.e. 0, 5, 10, 15…100), and the desired Off time (time between pulses) in increments of 5 m/s from 5 to 100 m/s. The foot pedal has three positions: Position One is irrigation, Position Two is aspiration, and Position Three is Micro Phaco.

When the Micro Phaco function is selected, as the foot pedal is depressed in Position Three, the m/s pulse rate will activate to the setting on the screen. Releasing the main treadle of the foot pedal will cause the phaco energy to stop, the peristaltic pump to cease, the vent valve to open momentarily to release vacuum, followed by the irrigation valve closing.

22

e) IRRIGATION/ASPIRATION (I/A) MODE Irrigation/aspiration is a basic mode that controls the irrigation pinch valve, venting pinch valve and peristaltic pump located on the left side of the unit. Available mode functions include: LINEAR VACUUM, LINEAR FLOW, BOTH OR PANEL, AND FIXED-TYPE OPERATION. Irrigation/aspiration is used to remove cortical material, viscoelastic material, and any remaining lens material in the eye. During aspiration, irrigation is required to prevent the collapse of the cornea. The aspirated material is replaced with BSS. The irrigation source is provided by an inverted container of Balanced Salt Solution, which is suspended in the operating room. The amount of solution delivered is controlled by bottle height. A drip chamber with connecting tubing is attached to the BSS bottle and routed through the irrigation pinch valve, venting the pinch valve and peristaltic pump to the handpiece. Bottle height is measured from the middle of the drip chamber to the patient’s eye. Control of the irrigation pinch valve, venting pinch valve and peristaltic pump is accomplished by the foot pedal. When the foot pedal is first depressed, the irrigation valve will open. No aspiration will occur for the first 25% of foot pedal travel. The remaining 75% of foot pedal travel will supply either adjustable aspiration, linear control of the peristaltic pump or both. Linear Flow – The peristaltic pump speed (in cc per minute) is directly controlled in a linear fashion by the foot pedal between zero and a maximum limit set by the Linear Flow Preset soft keys on the front panel. The actual flow rate display will show the position of the foot pedal travel from zero to the preset value (full travel). The foot pedal has two positions in this mode: Position One is irrigation and Position Two is aspiration. Releasing the main treadle of the foot pedal will cause the peristaltic pump to cease, the vent valve to open momentarily to release vacuum, followed by the irrigation valve closing. Fixed Flow – The Flow Rate Preset soft keys on the front panel set the peristaltic pump speed. The foot pedal has two positions in this mode: Position One is irrigation and Position Two is aspiration. Releasing the main treadle

23

of the foot pedal will cause the peristaltic pump to cease, the vent valve to open momentarily to release vacuum, followed by the irrigation valve closing. Linear VAC – The Vacuum Preset soft keys on the front panel set the vacuum limit. The foot pedal has two positions in this mode, Position One is irrigation and Position Two is aspiration. The user has the ability to hold the vacuum by holding the foot pedal main treadle in place. This will cause the peristaltic pump to cease and a message to display on the screen indicating that the pump has stopped. Fully depressing the main treadle of the foot pedal will result in continuous irrigation and aspiration. Releasing the main treadle of the foot pedal will cause the peristaltic pump to cease, the vent valve to open momentarily to release vacuum, followed by the irrigation valve closing. Fixed VAC – The Vacuum Preset soft keys on the front panel set the vacuum limit. The user cannot stop the vacuum in foot pedal position two. The vacuum will build until the preset value is reached at which time the peristaltic pump will stop and the occlusion alarm will sound. The foot pedal has two positions in this mode, Position One is irrigation and Position Two is aspiration. Releasing the main treadle of the foot pedal will cause the peristaltic pump to cease, the vent valve to open momentarily to release vacuum, followed by the irrigation valve closing. Presets 1, 2, – These settings are used to quickly change I/A settings. By pressing the preset soft keys, the user will be able to switch between the presets 1, 2, if more than one preset is desired, other than the primary normal setting and CAP VAC. CAP VAC – Used to quickly change the aspiration settings. By depressing the CAP VAC soft key, the user can change the settings. This function is desired when the doctor is polishing the posterior capsule and requires very low flow and vacuum levels. Reflux - Also available is a side kick reflux to the bottle, which overrides all normal foot pedal functions. Releasing the main treadle of the foot pedal will cause the peristaltic pump to cease, the vent valve to open momentarily to release vacuum, followed by the irrigation valve closing.

24

f) VITRECTOMY (VIT) MODE Vitrectomy is a basic mode that controls the irrigation, venting pinch valves, peristaltic pump and air pump internal to the unit. Available are SINGLE/ MULTI CUT, LINEAR VACUUM, LINEAR FLOW, BOTH OR PANEL, FIXED-TYPE OPERATION AND CUT. Vitrectomy is used to remove vitreous from the anterior chamber of the eye if the posterior chamber is ruptured. Vitreous loss can occur after a trauma or during the primary cataract surgery itself. The procedure is performed with a pneumatically controlled disposable or reusable guillotine type cutter. The vitreous material is aspirated into the port and cut by the guillotine cutting action. During aspiration, irrigation is required to prevent the collapse of the cornea. The aspirated material is replaced with BSS. The irrigation source is provided by an inverted container of Balanced Salt Solution, which is suspended in the operating room. The height of the bottle controls the amount of Balanced Salt Solution delivered. A drip chamber with connecting tubing is attached to the BSS bottle and routed through the irrigation pinch valve, venting the pinch valve and peristaltic pump to the handpiece. Bottle height is measured from the middle of the drip chamber to the patient’s eye. Control of the irrigation pinch valve, venting pinch valve and peristaltic pump is accomplished by the foot pedal. When the foot pedal is first depressed, the irrigation valve will open. No aspiration will occur for the first 25% of foot pedal travel. Depending on the user settings, the remaining 75% of foot pedal travel will supply adjustable aspiration, linear control of the peristaltic pump or both, as well as cuts per minute (cuts/min) if in Multi Mode, or one cut per depression if in Single mode. The aspiration level or pump speed is directly controlled by the foot pedal from zero to the maximum limit set on the front panel. If the fixed aspiration is selected (soft key on front panel), foot pedal Position Two is controlled by the aspiration level set on the front panel. The I/A functions operate the same as the I/A mode (see section (f) of this chapter). Regardless of type of aspiration action, cutting will be activated in foot pedal Position Two. A Preset soft key on the front panel will enables users to select the cut rate. Reflux - Also available is a sidekick reflux to the bottle, which overrides all normal foot pedal functions. Releasing the main treadle of the foot pedal will cause the VIT to stop, the peristaltic pump to cease, the vent valve to open momentarily to release vacuum, followed by the irrigation valve closing.

25

g) BIPOLAR COAGULATION (COAG) MODE Coag is a basic mode that allows either fixed or linear operation. Most surgeons utilize bipolar coagulation for cauterizing small blood vessels. An isolated 315 kHz output frequency cautery circuit allows for non-contact tissue coagulation. An audible safety tone occurs during coag mode. Linear COAG - The coag power is controlled in a linear fashion by the foot pedal between zero and a maximum limit set by the Preset soft keys on the front panel. The foot pedal has one position in this mode. Releasing the main treadle of the foot pedal will stop the coag power.

Fixed COAG – The coag power is controlled in a fixed fashion by the foot pedal at the value set by the Preset soft keys on the front panel. The foot pedal has one position in this mode. Releasing the main treadle of the foot pedal will stop coag power. The power output levels for the coag, when tested, should give results similar to the graphs shown in Figures 6 – 8 on pages 46-47.

26

h) HELP MODE This mode allows users to view the available help for the selected modes screen. When the Help button is depressed the screen will show what buttons have available help buy showing a question mark over those locations. Touching the question mark will display the help text. Touch the help text to close the pop up text box. Touch the Help button again to turn off help, or any other question mark to continue using help.

27

i) OPTIONS - PROGRAMS MODE This mode allows users to save all parameters of all modes in one easy-access location. Up to twenty-four different programs can be stored at any given time. This mode allows the user to Add, Delete, Rename, and Update the User programs. An alphanumeric keyboard appears on the front panel screen to allow the user to customize the program name.

Note: The Unit when powered up defaults to the FACTORY settings. How to save a new program

1. Select desired settings in each mode, except IRRIGATION MODE*, using the preset soft key arrows on the touch panel.

2. After setting desired presets, press the Options soft key.

3. Press the Program soft key Tab on the touch panel. The program screen will be displayed.

4. Press ADD soft key.

5. Type in the desired name of the program using the alphanumeric key pad displayed on the front panel

screen.

6. Next, press the OK or the keyboard ENTER soft key to complete saving the program or CANCEL to exit.

*The IRRIGATION MODE is non-programmable.

28

To Recall a program

1. At the top of any screen, Press the triangular soft key next to the FACTORY text box (default setting) to call up the User Named Programs selection list.

2. Scroll down to the desired program name. Press the desired user program name.

3. The text box should now show the User selected name and the settings will change to the programmed

values. Changing a saved program’s name without changing program settings

1. Press the Program soft key. At the top of the screen, Press the triangular soft key next to the FACTORY text box (default settings) Select the user program name you would like to change by pressing the desired program name.

2. Press the RENAME soft key. Type in the new program name using the alphanumeric soft key.

3. Press the OK or the keyboard ENTER soft key. The new name will be saved, but the program presets will

remain the same. Changing a saved program’s settings without changing the program name

29

1. Press the Program soft key. At the top of the screen, Press the triangular soft key next to the FACTORY text box (default settings) Select the user program name you would like to change by pressing the desired program name.

2. Go through each mode and reset the desired program settings.

3. Once completed, return to the Option / Program Mode Screen.

4. Press the UPDATE soft key followed by the OK soft key to save the program settings without changing the

name. Deleting User Program Names

1. At the top of the screen, Press the triangular soft key next to the FACTORY text box (default settings) Select the user program name you would like to delete by pressing the desired program name.

2. Press the DELETE soft key on the touch display.

3. Press OK or the keyboard ENTER button to delete or the Cancel button to keep the name.

Note: Current Settings will not change when the delete button is used in Program mode; only the name will be removed – Select a new program or the Factory setting to update the settings if needed.

30

j) OPTIONS - SETTINGS MODE - SOUND This mode allows users to set their preferences for audible function indicators. Future options may include a user diagnostics program. Audible Function Indicators - Various tones emitted from the Vizual® Phacoemulsification System indicate specific functions and or warnings. Different tones indicate FOOT PEDAL POSITION, while VACUUM TONE indicates increasing/decreasing vacuum. An occlusion alarm, indicated by a fluctuating tone, sounds when occlusion occurs or when the preset vacuum is reached. A steady tone indicates COAG in use and a constant buzzing indicates REFLUX in use. To Change Audible Function Indicator settings:

1. Press the OPTIONS soft key on the touch display.

2. Press the Settings Tab soft key.

3. Press the SOUND soft key (Default).

4. KEYBOARD, FOOT POSITION, VACUUM TONE, REFLUX TONE and COAG sound levels are set on the touch screen display only. Set the Sound level by touching the arrows or by pressing the slider soft key and dragging it to the desired sound level.

NOTE: If KEYBOARD sound is set to minimum, you will not hear any audible sounds when any soft keys are pressed.

NOTE: Audible function indicators are also saved when saving programmed settings.

31

k) OPTIONS - SETTINGS MODE - VOICE This mode allows users to set their preferences for audible voice mode indicators. Voice Indicators – When any screen mode is changed a voice announcement will be made of the new mode to confirm the change. There are five volume sliders that control what annunciations are audible. They are; Menu, Command, Multimode, Submode, and Irrigation. Menu – Controls the voice volume for the mode buttons on the bottom of the screen: IRR, U/S, I/A, VIT, Coag, Help, and Options. Command – Controls the voice volume for the buttons on the right side of the screen: for each mode. Multimode – Controls the voice volume for the buttons on the top of the screen: In U/S; Multimode 1, 2, and 3. In I/A Multimode 1, 2, and CAP VAC. Submode – Controls the voice volume for the tabs on the lower middle of the screen: In U/S; Normal, Burst, and Micro. In Options: Settings, Programs, and Footpedal. Irrigation – Controls the voice volume for the Irrigation Button on the middle top right of the screen: In all modes except COAG (no irrigation). To Change Voice Mode Indicator settings:

1. Press the OPTIONS soft key on the touch display. 2. Press the Settings Tab soft key. 3. Press the Voice button. 4. Set the voice volume level by touching the arrows or by pressing the slider soft key and dragging

it to the desired level for the selected group. Sliding the volume indicator all the way to the left disables the voice annunciations for the selected group. All sliders default to midrange.

32

l) OPTIONS - SETTINGS MODE - VIDEO This mode allows users to set their preference for the LCD display brightness. To Change Video brightness setting:

a. Press the OPTIONS soft key on the touch display.

b. Press the Settings Tab soft key.

c. Press the VIDEO soft key.

d. Set the Brightness level by touching the arrows or by pressing the slider soft key and dragging it to the desired level.

33

m) OPTIONS - SETTINGS MODE - PREFERENCE This mode allows users to set their preference for the control of Flow while in the U/S mode of operation. Linear Flow – When selected, flow, or the peristaltic pump speed (in cc per minute) is controlled from zero to a maximum limit set by the Flow Preset soft keys on the front panel, when the foot pedal is depressed through Position Two (aspiration). When the foot pedal reaches Position Three (Phaco), flow remains at the maximum preset limit. Fixed Flow (default) – When selected, flow, or the peristaltic pump speed (in cc per minute) is controlled at the value set by the Flow Preset soft keys on the front panel, when the foot pedal is depressed through Position Two (aspiration) and Position Three (Phaco). To Change the Preference setting:

a. Press the OPTIONS soft key on the touch display.

b. Press the Settings Tab soft key.

c. Press the PREFERENCE button.

d. Press the desired option Fixed (default) or Linear.

34

n) OPTIONS - SETTINGS MODE – UPGRADE This mode allows users to upgrade the Vizual® system software. If any upgrades are necessary the new software will be sent to the end user stored in a USB flash drive along with a 12-digit key. To Upgrade the Vizual® Software:

a. Install the USB flash drive into either of the USB ports on the back of the Vizual® unit.

b. Power on the unit.

c. After the main screen comes on, press the OPTIONS soft key on the touch display.

d. Note the current revision of the software that is displayed in the upper left corner.

e. Press the UPGRADE soft key located to the right of the settings menu.

f. If the unit sees a valid software file it will prompt you to enter the 8-digit key.

g. Enter the key; if the key is correct the unit will highlight the OK button.

h. Press the OK button to proceed with the upgrade or cancel to quit.

Do not power off the system until the upgrade is complete.

i. After the upgrade is complete the unit will display “Restart the Machine”. Remove the USB flash drive.

j. Power off the unit. Turn the power back on, press the OPTIONS soft key and verify the unit is displaying the new revision of the software.

35

o) OPTIONS - FOOTPEDAL

RIGHT SIDE KICK MODE (default: Reflux only) LEFT SIDE KICK MODE (default: Not used)

The foot pedal side kick functions can be changed from the default right side kick Reflux only mode to alternate functions.

Not Used– When set to this option the selected side kick has no function. Reflux– When set to this option the selected side kick functions as reflux in any footpedal position. Mode– When set to this option and the footpedal is in the full up-position the selected side kick will switch between the main modes of operation: IRR, U/S, I/A, VIT, and COAG. Multimode –When set to this option and the footpedal is in the full up-position the selected side kick will switch between Presets 1, 2, and 3 in U/S mode and in I/A mode it will switch between normal I/A presets 1 and 2, and Cap Vac. Irrigation –When set to this option and the footpedal is in the full up-position the side kick will switch on Irrigation until the sidekick is activated again.

36

I/V Pole –When set to this option and the footpedal is in the full up-position, activating the selected side switch once will raise the I/V pole 1 inch. Pressing and holding the switch in will raise the I/V pole until the switch is released. Double clicking the selected side switch will lower the I/V pole 1 inch. Double clicking and holding the second click in will lower the I/V pole until the switch is released. Calibrate – Pressing this softkey enters into footpedal calibration. (See the next section) Vibrate On– Pressing this softkey enables tactile feedback on the foot pedal. When moving between foot pedal positions 1, 2, and 3 the vibration motor in the footpedal will be activated at that position. The positions At which the motor is enabled can be customized in the footpedal calibration procedure. Vibrate Off– Pressing this softkey disables tactile feedback on the foot pedal.

37

p) FOOT PEDAL CALIBRATION PROCEDURE The foot pedal should not be calibrated unless there is a problem or the foot pedal was replaced. The Vizual® comes pre-calibrated with the foot pedal included in the original system package. Under normal situations, calibration of the foot pedal will not need to be performed. If the foot pedal is repaired or replaced, recalibration procedures as described below must be performed.

1. Press the OPTIONS soft key on the touch screen to access the OPTIONS screen.

2. Press the FOOTPEDAL tab.

3. Press the Calibrate button on the touch screen.

4. Follow the directions given on the screen to calibrate the foot pedal. The calibration procedure must be completed in its entirety once started. If you do not want to carry out the procedure, simply press the CANCEL soft key to exit. Set the desired position of the foot pedal positions 1, 2, and 3 and press ok after each prompt.

NOTE: The user has the option of setting the programmed detent location.

38

Chapter 7 – Cleaning and Sterilization a) INTRODUCTION This section contains instructions for cleaning the console and foot pedal. This section also contains instructions for cleaning and sterilizing the U/S handpiece, reusable tubing set, Phaco tip (and tip wrench), silicone sleeve, and test chamber. Instructions for cleaning and sterilizing additional accessories included with your system (optional purchase items not manufactured by American Optisurgical Inc.), such as cautery, vitrectomy, and I/A accessories, are provided by the accessory manufacturer, where applicable. NOTE: Sterility assurance is the responsibility of the user. b) CONSOLE When cleaning any external surface on the console, use only isopropyl alcohol (70%) or a mild soap and water solution. Use of any other type of cleaning solutions or solvents can damage the surface of the console and void your warranty. Before cleaning the console, be sure the AC input power has been disconnected. Use a soft cloth moistened with cleaning solution and gently wipe the surface of the console. Use only a very small amount of cleaning solution around the electrical and pneumatic connectors and front panel display. Thoroughly wipe the unit with a lint-free cloth and do not leave any cleaning solution residue or water spots on the surface. Never spray cleaning solution directly onto the front panel screen. c) FOOT PEDAL Follow the procedure above when cleaning the foot pedal. Even though the foot pedal is waterproof, always wipe away any fluids that come into contact with the foot pedal during the course of surgery. The foot pedal surface finish could corrode or rust if not thoroughly cleaned. Also, gently clean the connecting cable at the end of each day using only isopropyl alcohol (70%) or a mild soap and water solution. Be sure to examine the foot pedal cord for nicks or tears. Instructions for cleaning and sterilizing the U/S handpiece, reusable tubing set, Phaco tip (and tip wrench), silicone sleeve, and test chamber items are found on the following pages.

39

d) U/S Handpiece

Follow this procedure before the initial and each subsequent use of the U/S handpiece.

WARNINGS AND PRECAUTIONS

Clean the U/S handpiece immediately after each surgical procedure.

Never use wire cleaning instruments or steel brushes to clean any part of the U/S handpiece.

Never use enzymatic or ultrasonic cleaners to clean any part of the U/S handpiece.

The use of chemical cleansers or sterilizing agents is not recommended.

You must thoroughly clean the U/S handpiece before sterilizing it with moist heat (steam).

Do not rapidly cool the U/S handpiece after autoclaving by immersing in a cold bath.

Do not bypass the drying step of your autoclave and be sure to allow the U/S handpiece to cool to room temperature before use.

Allow U/S handpiece to cool to room temperature before use.

Sterility assurance is the responsibility of the institution performing the sterilization.

INSTRUCTIONS CLEANING

1. Disconnect tubing from U/S handpiece. Remove the silicone sleeve and Phaco tip (if applicable) for separate

cleaning and sterilization. 2. Rinse the exterior of the U/S handpiece under warm tap water (72°-110°F/22°C-43°C) for 15 seconds. If

necessary, remove all visible soil from the outside of the U/S handpiece and cable using a soft cloth moistened with water and mild soap. Remove all traces of the solution with another soft cloth moistened with distilled water.

3. AUTOMATED Prepare the QuickRinse™ manufactured by American Optisurgical Inc. for use as described in the Operator’s Manual. Connect the Nose Cone Flush Attachment accessory to the U/S handpiece nose cone and press the Cycle button to begin the automated flush/dry cycle. After 30 seconds both amber lights will turn off, indicating that the cycle is complete. Press the Cycle button again to run a second cycle.

Note: Each QuickRinse™ automated cycle delivers >150cc of fluid through the connected instrument.

4. MANUAL Flush each lumen of the U/S handpiece with at least 150cc of ambient distilled, or de-ionized water followed by air using a syringe and appropriate attachment. AOI recommends flushing from the nose cone out the back of the handpiece using an appropriate adapter.

5. Check the cable and strain relief for cuts and tears. Check the connector for bent pins. Do not use if damage is found.

STERILIZATION

1. Double wrap the U/S handpiece in muslin, i.e. CSR blue hospital wrap, and sterilize using steam following your institution’s validated procedures and cycle parameters. AOI recommends the following temperatures and times:

Recommended Steam Sterilization Parameters Type of Sterilizer Temperature Exposure Time Dry Time

Gravity 270°F (132°C) 15 minutes 30 minutes Pre-vacuum 270°F (132°C) 4 minutes 20 minutes

40

e) Reusable Tube Set Follow this procedure before the initial and each subsequent use of the reusable tube set.


For limited reuse. This product may be used up to forty (40) times maximum.

Clean the reusable tube set immediately after each surgical procedure.

If using compressed air to blow out tubing, only use low pressure (30psi max) or immediate, irreparable damage will result.


Sterilize prior to surgical use with moist heat (steam).



1. Disconnect collection bag, administrative set, and U/S handpiece from the reusable tube set.

2. Remove all visible soil from the outside of the reusable tube set using a soft cloth moistened with water and

mild soap. Remove all traces of the solution with another soft cloth moistened with distilled water. 3. AUTOMATED Prepare the QuickRinse™ manufactured by American Optisurgical Inc. for use as described in

the Operator’s Manual. On the reusable tube set, connect the irrigation tube to the aspiration tube. Connect the QuickRinse™ instrument interface tube to the cassette bottle input tube. Place the collection tube in an appropriate waste container. Press the Cycle button to begin the automated flush/dry cycle. After 30 seconds both amber lights will turn off, indicating that the cycle is complete. Press the Cycle button again to run a second cycle. Note: Each QuickRinse™ automated cycle delivers >150cc of fluid through the connected instrument.

4. MANUAL On the reusable tube set, connect the irrigation tube to the aspiration tube. Using an appropriate attachment, connect a syringe to the cassette bottle input. Place the collection tube in an appropriate waste container. Flush the reusable tube set with at least 300cc of ambient, distilled or de-ionized water followed by air using a syringe and appropriate attachment.

5. Check the tubing for cuts and tears. Check the cassette for loose fittings. Do not use if damage is found. STERILIZATION

1. Loosely coil the tubing and lay flat on top of the cassette. Double wrap the reusable tube set in muslin, i.e. CSR blue hospital wrap, and sterilize using steam following your institution’s validated procedures and cycle parameters. AOI recommends the following temperatures and times:

Recommended Steam Sterilization Parameters Type of Sterilizer Temperature Exposure Time

Gravity 270°F (132°C) 30 minutes Pre-vacuum 270°F (132°C) 20 minutes

41

f)Phaco Tip Follow this procedure before the initial and each subsequent use of the Phaco tip.


For limited reuse. This product has a limited life of twenty (20) uses or less depending on cataract hardness, handling and reprocessing.

Clean the Phaco tip immediately after each surgical procedure.

You must clean the Phaco tip before sterilizing it with moist heat (steam).

Never use enzymatic or ultrasonic cleaners to clean the Phaco tip.




1. Rinse the Phaco tip under warm tap water (72°-110°F/22°C-43°C) for 15 seconds. If necessary, remove all

visible soil from the outside of the Phaco tip using a soft cloth moistened with water and mild soap. Remove all traces of the solution with another soft cloth moistened with distilled water. CAUTION: THE PHACO TIP IS SHARP!

2. Flush the Phaco tip with at least 60cc of ambient, distilled or de-ionized water followed by air using a syringe and appropriate attachment.

3. Inspect the Phaco tip for flaking (titanium particle breakdown) under a standard microscope after each cleaning. Discard immediately if flaking is observed.

STERILIZATION

1. Double wrap the Phaco tip in muslin, i.e. CSR blue hospital wrap, and sterilize using steam following your institution’s validated procedures and cycle parameters. Note: Phaco tips may be sterilized inside the manufacturer-provided plastic tip wrench. The plastic tip wrench should first be cleaned following step 1 of the cleaning instructions above.



42

g)Silicone Sleeve Follow this procedure before the initial and each subsequent use of the silicone sleeve.


You must clean the silicone sleeve before sterilizing it with moist heat (steam).




1. Rinse the Silicone sleeve under warm tap water (72°-110°F/22°C-43°C) for 15 seconds. If necessary, remove

all visible soil from the outside of the Phaco tip using a soft cloth moistened with water and mild soap. Remove all traces of the solution with another soft cloth moistened with distilled water. CAUTION: THE SILICONE SLEEVE IS FRAGILE!

2. Flush the Silicone sleeve with at least 60cc of ambient, distilled or de-ionized water followed by air using a syringe and appropriate attachment.

3. Inspect the silicone sleeve for holes and tears. Do not use if damage is found. STERILIZATION

1. Double wrap the silicone sleeve in muslin, i.e. CSR blue hospital wrap, and sterilize using steam following your institution’s validated procedures and cycle parameters. AOI recommends the following temperatures and times:



43

h)Test Chamber Follow this procedure before the initial and each subsequent use of the test chamber.


You must clean the test chamber before sterilizing it with moist heat (steam).




1. Rinse the test chamber under warm tap water (72°-110°F/22°C-43°C) for 15 seconds. If necessary, remove all

visible soil from the outside of the Test chamber using a soft cloth moistened with water and mild soap. Remove all traces of the solution with another soft cloth moistened with distilled water. CAUTION: THE TEST CHAMBER IS FRAGILE!

2. Inspect the test chamber for holes and tears. Do not use if damage is found. STERILIZATION

1. Double wrap the test chamber in muslin, i.e. CSR blue hospital wrap, and sterilize using steam following your institution’s validated procedures and cycle parameters. AOI recommends the following temperatures and times:



44

Chapter 8 – Service and Technical Support a) INTRODUCTION The following section contains information on fuse replacement procedure and technical support issues for the Vizual® Phacoemulsification System.

b) FUSE REPLACEMENT The AC power input module contains two fuses that protect the unit from excessive loads and line fluctuations. The module is located at the rear of unit, with the power cord plug and power switch. Should an over voltage condition occur, these fuses must be replaced with the same value fuses. Only replace with 5 x 20 250V T 5.0A fuses. These fuses are available from AOI in a Fuse Set, AOI Part No. 430-2215-002. To replace the fuses, perform the following steps:

1. Remove the AC power cord from the unit. 2. Use a small screwdriver to pull out on the notch on the fuse cover tab above the switch and pull the cover

down. The fuse holders can then be removed. 3. Push the fuse holders the opposite way of the arrow on the top of the holders and pull them up. 4. Remove the old fuses and replace with AOI Part No. 430-2215-002 (fuse type 5 x 20 250V T 5.0A). 5. Push the fuse holders back into place toward the arrow on the holders, Push the fuse holder cover closed

until it snaps closed. 6. Connect the AC power cord.

c) MAINTENANCE AND UNIT REPAIRS Periodically, the Vizual® Phacoemulsification System may need to be returned for service or maintenance. Prior to the returning the unit, a Return Goods Authorization (RGA) number must be obtained. This will help the Technical Support Department to expedite the repairs. Ship the unit, transportation and shipping prepaid, to the following address: American Optisurgical Inc. 26902 Vista Terrace Lake Forest, CA 92630 USA d) CONTACTING TECHNICAL SUPPORT For technical support contact: Tel. 949.580.1266 Outside USA or contact your local AOI Distributor Toll Free 800.576.1266 In USA only Fax 949.580.1270 E-mail [email protected] Internet www.optisurgical.com

45

Chapter 9 – Troubleshooting Guide

Problem Suggested Action AC POWER Unit will not turn on *AC power cord not connected.

*AC line fuse blown – replace fuses. PRIMING CYCLE “Check Cassette” error message *The action of a priming cycle may cause a tubing cassette to

slightly dislodge and result in this error message. Remove and reinstall the cassette to activate the interlock switch, and then run the priming cycle again.

“Fluid path blocked, prime again” error message

*During a priming cycle, the unit is checking for the presence of irrigation and that the irrigation path to the cassette is not blocked. If this error message is displayed, check the I/V administrative set (inflow) to be sure that the irrigation line is not clamped, kinked or clogged. If the error message is displayed again, replace the I/V administrative set.

“Vac test failed, prime again” error message

*During a priming cycle, the unit is checking for the ability to build vacuum. If the error message is displayed, remove the cassette and check that the peristaltic tube sits inside the groove, reinstall the cassette, and then run the priming cycle again. If the error message is displayed again, disconnect the irrigation and aspiration lines from the Phaco handpiece, connect the lines together, and then run the priming cycle again. If the unit primes successfully, the source of the leak is the Phaco handpiece. If the error message is displayed again even without the handpiece, replace the tubing cassette and run the priming cycle again. If the error message displays again even with a different tubing cassette, the problem may be the Phaco unit. Contact your local distributor or our technical support department for assistance.

IRRIGATION SYSTEM No Irrigation *Irrigation pinch valve is closed. Verify operation by

depressing foot pedal and observing pinch valve operation. *Irrigation line is not connected to the handpiece; connect irrigation line. *Irrigation tubing improperly installed. Install correctly. *Kinked or damaged irrigation line. Straighten kink if possible; replace line if needed. *Closed clamp on administration set. Release the clamp to allow irrigation flow. *Low bottle height. Adjust to proper level. *Improper wound size. Verify proper size.

ASPIRATION SYSTEM No or poor aspiration (vacuum) *Verify unit is in I/A mode.

*Vacuum setting is too low. Verify unit is in I/A 1, increase vacuum preset. *Tube set installed incorrectly. Verify proper routing and correct if necessary. *Faulty tube set. Replace tube set. *I/A handpiece leaking. Replace I/A handpiece. *Reflux is being activated. Ensure that foot pedal is not activating reflux.

46

Chapter 9 – Troubleshooting Guide (cont.)

Problem Suggested ActionUnit will not vent *Venting pinch valve not operating. Verify operation by

activating reflux and venting pinch valve operation. *Bad tubing holder or bad tubing. Replace tubing set. *Closed clamp on administration set. Release clamp to allow proper venting action. *Tubing clogged. Remove clog or replace tubing set.

U/S (PHACO) U/S handpiece will not tune; “Check Handpiece” message appears

*Loose Phaco tip. Tighten Phaco tip with tip wrench. *Damaged Phaco tip. Replace with new tip. *Bad U/S handpiece. Replace U/S handpiece.

VACUUM ERROR Display message appears.

*Check roller clamp and administration set to see that it is not engaged. *Verify that there are no vacuum levels in I/A lines.

Poor U/S power *Low U/S power setting. Increase U/S power preset. *Foot pedal not fully depressed in linear function. Depress foot pedal to maximum travel. *Bad or loose Phaco tip. Replace as needed. *Bad U/S handpiece. Replace the U/S handpiece. *Reflux is being activated. Ensure that foot pedal is not activating reflux.

VIT (VITRECTOMY) Vit handpiece will not function *Verify unit is in VIT mode.

*Handpiece connector not properly installed onto unit luer fitting. Verify proper connection. *Bad handpiece. Replace handpiece. *Reflux is being activated. Ensure that foot pedal is not activating reflux.

COAG (BIPOLAR COAGULATION) No coag power *Verify connector is properly connected to the unit. Insert

plug properly. *Verify that unit is in coag mode. Activate coag mode. *Low coag power setting. Increase coag preset power. *Bad coag cord or accessory. Verify accessory connection, change coag cord.

CHAMBER FLUCTUATIONS Bottle/Patient height *Bottle height too low. Raise bottle to adequate height.

*Patient eye level must be between the bottom of the installed tubing cassette and no more than 10 centimeters below the installed tubing cassette.

Administrative set *Use a high-flow, non-filtered I/V administrative set. *Filtered I/V administrative sets must be discarded after one use. *Do not allow I/V administrative set to sit for an extended period of time (i.e. overnight).

Other *Vacuum setting too high, lower setting. *Improper wound size. Verify proper size. *Verify proper irrigation flow. Check U/S handpiece, Phaco tip, and silicone sleeve. Replace if needed.

47

Chapter 10 – Factory Default Settings a) INTRODUCTION The Vizual® Phacoemulsification System comes with standard factory settings for all modes. These factory default settings are automatically set each time the system is turned on. During use, any of these settings may be changed. They can be stored in memory for future use or for just a particular case. If the settings are changed and not stored in memory (programmed) they will be lost when the unit is turned off. b) FACTORY DEFAULT SETTINGS

MODE FLOW

(CC/MIN) VACUUM (mmHg)

POWER U/S

PULSE (per sec)

FUNCTION CUT RATE

(CUTS/MIN) BURST (%-ms)

ON/OFF (ms)

Optional Automated

I/V Pole height

(inches)

IRR N/A N/A N/A N/A N/A N/A N/A N/A 77 U/S

Normal 24 200 40 0 LINEAR N/A

N/A N/A 77

U/S Burst

24 200 45 N/A MULTI N/A 20 N/A 77

U/S Micro

24 200 45 N/A LINEAR N/A N/A 20/80 77

I/A 26 460 N/A N/A LFLOW/FVAC N/A N/A N/A 84 I/A

CAP VAC

6 20 N/A N/A LFLOW/FVAC N/A N/A N/A 84

VIT 20 120 N/A N/A LFLOW/LVAC/

MULTI 200 N/A N/A 74

COAG N/A N/A 40 N/A LINEAR N/A N/A N/A N/A

Legend CAP VAC Capsule Vacuum IRR Irrigation U/S Ultrasonic COAG Bipolar Coagulation LFLOW Linear Flow VIT Vitrectomy FVAC Fixed Vacuum LVAC Linear Vacuum I/A Irrigation/Aspiration MULTI Multi Mode c) MESSAGES Runtime Messages:

U/S – PRIMING MESSAGES DESCRIPTION

Priming ... Please Wait! Prime Button Pressed -will clear when finished priming -goes to Tuning handpiece automatically.

Vac Test Failed! Prime again! Can't build vacuum when testing during Prime- check the tube set for open connections, leaks.

Fluid Path Blocked! Prime Again!

Vacuum too high during Prime - check that the admin set clamp is released and BSS is flowing and the tube set is not pinched or blocked.

OCCLUSION! Phaco Tip occluded, Vacuum reached preset. Reflux Reflux activated on the Footpedal. Handpiece Tuned Message appears at the end of a Prime cycle or Tune button press. Check Cassette! Cassette not seated all the way down - should click into place when

seated correctly

48

Check Handpiece! Handpiece not plugged in, Loose tip, Handpiece failed tuning. Check Footpedal! Footpedal not plugged in. Purging... Please Wait! Purge button pressed- will clear after tubing purged.

I/A and VIT MESSAGES

OCCLUSION! Tip occluded, Vacuum reached preset. Reflux Reflux activated on the Footpedal. Check Cassette! Cassette not seated all the way down - should click into place when

seated correctly Check Footpedal! Footpedal not plugged in. Pump Stopped In Linear Vacuum: when the vacuum limit is reached the peristaltic pump

will stop and this message will display.

IRR MESSAGES

Check Cassette! Cassette not seated all the way down - should click into place when seated correctly

Check Footpedal! Footpedal not plugged in.

UPGRADE MESSAGES

Checking for updates... Unit checks for a valid image file on a USB flash drive inserted into USB port 1 or 2 on the back of the unit.

No updates found! No USB flash drive installed or no image on the drive. Enter Key for vx.x.x: Found valid image of version x.x.x Key not valid! 12 digit key code entered on touch screen QWERTY keyboard entered

incorrectly or not valid for the upgrade image. Reading info failed! No info file found on USB flash drive or bad info file. Current version is newer! The version of the image on the flash drive is older than the current

version on the machine, Upgrade will not be allowed. Writing Files... Image is being written to the unit. Do not power off the system until the

upgrade is complete. Restart the machine! Upgrade is complete. Power off the unit and remove the USB flash drive,

power on the unit and look on the options page for the current version, it should match the USB flash image.

PROGRAM MESSAGES Add Program Message will be displayed when the ADD button is pressed, enter the

program name, it will appear on the program list box at the top of the screen

Delete Program Message will be displayed when the Delete button is pressed, select the program from the List box to delete and press OK or enter.

Rename Program Message will be displayed when the Rename button is pressed, select the program from the List box to rename, type in the new name and press OK or enter.

Save Program Message will be displayed when the Update button is pressed, select the program from the List box to Update, and press OK or enter.

FOOTPEDAL CALIBRATION

Move to First Detent! Depress the Footpedal until the OK button is enabled. Set First Detent! Set the first detent position; press the OK button. Move to Second Detent! Depress the Footpedal until the OK button is enabled. Set second Detent! Set the second detent position; press the OK button. Depress the Footpedal! Depress the pedal completely. Set Down Position! With the Footpedal in the down position press the OK button to set. Release the Footpedal! Let the Footpedal return all the way up. Set Released Position! With the Footpedal in the up position press the OK button to set.

49

Figure 8 shows the power output levels for each control setting.

Figure 9 shows the power output levels for each control setting.

0

20

40

60

80

100

120

140

160

10 20 30 40 50 60 70 80 90 100

Pea

k O

utp

ut(

Vo

lts)

Power Setting(Percent)

Figure 8- AOI PHACO VIZUAL CAUTERYPeak Output Voltage (no load ) Vs Power Setting

O

0

2

4

6

8

10

12

14

16

18

10 20 30 40 50 60 70 80 90 100

Po

wer

Ou

tpu

t (W

atts

)

Power Output(Percent)

Figure 9 - AOI PHACO VIZUAL CAUTERYPower Output Into 75 Ohm Load Vs Power Setting

50

Figure 10 shows the power output levels versus impedance at full power and 50% power.

Figure 10

0

5

10

15

20

25

30

35

40

45

50

10 75 100 200 300 400 500 600 700 800 900 1000

Po

wer

Ou

tpu

t (W

atts

)

Impedance (Ohms)

AOI PHACO VIZUAL CAUTERYPower Output Vs Impedance

50% Power

Full Power

51

Appendix I EMC Requirements for Vizual® Phacoemulsification System

The Vizual® Phacoemulsification System needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Appendix. Portable and mobile RF communications equipment can affect the operation of the Vizual® Phacoemulsification System. The following is a list of the Vizual® Phacoemulsification System cables and other accessories that are used as part of the Vizual® Phacoemulsification System that comply with sections 36.201 and 36.202 of the EMC Standard IEC60601-1-2 (E):

Handpiece, P/N 300-9500-270 Power Cord, P/N 430-4023-001, 430-4024-001 Foot Pedal, P/N 553-0000-000, 553-0000-001

Use of cables or accessories other than those specified, with the exception of cables and accessories sold by the manufacturer of the Vizual® Phacoemulsification System as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the Vizual® Phacoemulsification System. Table 1 – Guidance and manufacturer’s declaration – electromagnetic emissions – for the Vizual® Phacoemulsification System

Guidance and manufacturer’s declaration – electromagnetic emissions The Vizual® Phacoemulsification System is intended for use in the electromagnetic environment specified below. The customer or the user of the Vizual® Phacoemulsification System should assure that it is used in such as environment.

Emissions Test Compliance Electromagnetic environment – guidance RF emissions CISPR 11

Group 1 The Vizual® Phacoemulsification System 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 environment.

RF emissions CISPR 11

Class A Vizual® Phacoemulsification System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

52

Table 2 – Guidance and manufacturer’s declaration – electromagnetic immunity – for the Vizual® Phacoemulsification System

Guidance and manufacturer’s declaration – electromagnetic immunity The Vizual® Phacoemulsification System is intended for use in the electromagnetic environment specified below. The customer or the user of the Vizual® Phacoemulsification System should assure that it is used in such as environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic materials, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines

±2 kV for power supply lines ±1 kV for input/output lines

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

Surge IEC 61000-4-5

2kV Line to Ground 1kV Line to Line

2kV Line to Ground 1kV Line to Line

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

<5% UT (<95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (<95% dip in UT) for 5 sec

<5% UT (<95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (<95% dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Vizual® Phacoemulsification System requires continued operation during power mains interruptions, it is recommended that the Vizual® Phacoemulsification System be powered from an uninterruptible power supply or a battery.

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

3 A(rms)/m

3 A(rms)/m

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

NOTE: UT is the A.C. mains voltage prior to application of the test level.

53

Table 3 – Guidance and manufacturer’s declaration – electromagnetic immunity – for the Vizual® Phacoemulsification System

Guidance and manufacturer’s declaration – electromagnetic immunity The Vizual® Phacoemulsification System is intended for use in the electromagnetic environment specified below. The customer or the user of the Vizual® Phacoemulsification System should assure that it is used in such as environment.

Immunity test IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz 3 V(rms)/m 80 MHz to 2.5 GHz

3 Vrms 3 V(rms)/m

Portable and mobile RF Communications equipment should be used no closer to any part of the Vizual® Phacoemulsification System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance d = 1.2 √ P d = 1.2 √ P 80 MHz to 800 MHz d = 1.2 √ 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). Field strengths from the fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land

mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Vizual® Phacoemulsification System is used exceeds the applicable RF Compliance level above, the Vizual® Phacoemulsification System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the Vizual® Phacoemulsification System.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V(rms)/m.

54

Table 4 – Recommended separation distances between portable and mobile RF communications and the Vizual® Phacoemulsification System Recommended separation distances between Portable and mobile RF communications

equipment and the Vizual® Phacoemulsification System The Vizual® Phacoemulsification System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Vizual® Phacoemulsification System can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Vizual® Phacoemulsification System as recommended below, according to the maximum outpower of the communications equipment.

Rated maximum output

power of transmitter

W

Separation distance according to frequency of transmitter

m

150 kHz to 80 MHz

d = 1.2 √ P

80 MHz to 800 MHz

d = 1.2 √ P

800 MHz to 2.5 GHz

d = 1.2 √ P 0.01 0.12 0.12 0.12 0.1 0.38 0.38 0.38 1 1.2 1.2 1.2

10 3.8 3.8 3.8 100 12 12 12

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz to 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

V I Z U A L ® P H A C O E M U L S I F I C A T I O N S Y S T E M

Operator’s Manual

American Optisurgical In

26902 Vista Terrace, Lake Forest, CA 92630 USA Phone 949.580.1266 • Fax 949.580.1270

Toll Free Customer Service

800.576.1266

Email: [email protected]

Internet:

www.optisurgical.com

PN 551-6001-001 Rev. 2 (7-18-11)

Documents

551-6001-001 Vizual Manual Rev 2 - Vision Matrix Surgical...2 Notified Body: LNE/G-Med, No. 0459 10605 Concord St. #205 Kensington, MD 20895 USA 1.301.495.0477 EC Rep: Donawa LifeScience