AMO PHACOPLUS SENSORY V SYSTEM Users Manual Nov 1992

This manual is written to familiarize all surgical team members who will set-up and operate the Sensory V with the components, set-up, operation and care of your machine and its accessories. You should read and understand this manual completely before using the Sensory V in surgery.

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Table of Contents

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Section

Contents

Page

1

How to Use Your Sensory VTM User’s Manual

1

2

Introduction to the Sensory V System

3

3

Components of the Sensory V System

7

4

Sensory V System Set-Up

11

5

Operation

23

6

Operational Adjustments

39

7

System Check-Out, Safety Precautions and Warnings

41

8

Care and Cleaning

47

9

Error Messages and Troubleshooting Guide

51

10

Warranty and Maintenance

59

11

Specifications

63

12

Accessories and Parts Reordering

67

13

HELP Directory

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List of Illustrations Section

Figure

Description

Page

3.1 3.2

Sensory V System OPO-30WC / OPO-35 Phaco Pack Contents

8 9

Set-Up

4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11

Power Cord and Foot Pedal Connections Assembling the Phaco Handpiece Sensory V Handpiece Receptacles Assembling the Irrigation/Aspiration Handpiece Installing the Irrigation Tubing in the Pinch Valve Attaching the Irrigation Tubing to the Phaco Handpiece Installing the Filter in the Front Console Filter Housing Installing the Aspiration Tubing Attaching the Aspiration Tubing to the Phaco Handpiece Connecting the Cautery Forceps Assembling the Vitrectomy Handpiece

13 14 14 15 16 17 18 19 20 20 21

Operation

5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12 5.13

Front Console Displays and Indications Tactile TouchTM Foot Pedal Foot Pedal Positions Foot Pedal Positions and Functions for Individual Modes Tactile Touch Selection Switches Tactile Touch Switch Settings Reflux Toe Switches Cautery Selection and Adjustment Power IV Pole Foot Switch Operation Phacoemulsification Selections and Adjustments Phaco Aspiration Vacuum Level Low and High Settings Vacuum Preset Adjustment and Indication Audible Vacuum Indicator Volume Adjustment

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Adjustments

6.1

Average Settings for Sensory V Operation

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Sterilization

8.1

Instrument Sterilization Table

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Troubleshooting

9.1 9.2 9.3 9.4 9.5

Error Messages and Corrective Action Troubleshooting Guide Console and IV Pole Fuse Specifications Sensory V Console Fuse Holder Power IV Pole Fuse Holder

51 53 57 58 58

System Components

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Section 1 How to Use Your Sensory V Manual

This manual is organized into sections to allow you to learn the instrument in a logical sequence, and to easily relocate information after your Sensory VTM System is installed and operating. The organization of the manual will allow you and your surgical team to selectively choose that information which is appropriate to each function.

Section 2 Introduction to The Sensory V

This introduction briefly describes the functions and features of the Sensory V system. Reading this section will better prepare you to understand the information presented in this manual.

Section 3 Components of the Sensory V System

This information allows you to identify the different components of your Sensory V system, including all accessories.

Section 4 Sensory V System Set-Up

This section explains how to assemble and/or connect Sensory V System the system components of the Sensory V in preparation Set-Up for surgery.

Section 5 System Operation

The five basic Sensory V modes: • Cautery • Phacoemulsification (Phaco) • Irrigation/Aspiration (I/A) • Vitrectomy • Reflux in Phaco, I/A and Vitrectomy Modes and operation of the Tactile TouchTM Foot Pedal are explained in Section 5. This Section includes instructions on all of the Sensory V front console and back panel settings and adjustments.

Section 6 Operational Adjustments phacoemulsification AMO Phaco PlusTM Sensory VTM 21896 A 010292

Section 6 gives average settings derived from clinical usage for all of the adjustable features. More detailed and specialized information on the different settings and adjustments such as power, vacuum preset limit, and aspiration flow rates are given. 1

Section 7 System Check-Out Safety Precautions and Warnings

Check-out steps are given in Section 7 to insure that you have correctly set-up the Sensory V and that it is operating properly. Safety Precautions and Warnings are provided and should be read thoroughly before the Sensory V is put into actual operation.

Section 8 Care and Cleaning

Recommended instrument cleaning and storage procedures are given in this Section. Following these procedures will maximize the life and usability of your Sensory V and its components. Sterilization procedures for the Sensory V instruments are presented.

Section 9 Error Messages and Troubleshooting

The Sensory V LED display makes troubleshooting easier than ever before. This Section describes the different Error Messages that may be given, with a Troubleshooting Guide that presents recommended corrections for the problem.

Section 10 Warranty and Maintenance

In the event that you should have problems with your Sensory V, Section 10 instructs you in who and how to contact for Service.

Section 11 Specifications

Dimensional data, electrical specifications and other technical reference details of the instrument are given in Section 11.

Section 12 Accessories and Parts Reordering

This Section gives detailed lists of all Sensory V accessories, complete with catalog numbers, that you will need to reorder from time to time.

Section 13 HELP Directory

The HELP Directory contains important information that will allow you to quickly and directly access help for different types of questions and problems. Telephone numbers and specific AMO contacts have been listed by your AMO Territory Manager.

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Section 2 Introduction to the Sensory V

ABOUT PHACOEMULSIFICATION

Over twenty years ago, Dr. Charles Kelman conceived and developed phacoemulsification, a method of cataract removal by ultrasonic fragmentation and aspiration of the cataractous lens through a small wound. Phacoemulsification is advantageous for both patient and surgeon: • greater intraoperative control • the smaller wound requires fewer sutures, poses less risk of infection and induced astigmatism, and gives better long and short term predictability of vision • patients are able to resume normal activity much sooner and with fewer restrictions than with traditional cataract extraction surgeries Allergan Medical Optics (AMO) supports phacoemulsification with sophisticated instrumentation that optimizes the benefits of this surgical procedure.

ABOUT THE SENSORY V

The Sensory VTM that you have purchased is the latest in AMO phacoemulsification technology. This machine was developed through extensive research and clinical trials with highly-trained and noted ophthalmologists who are experienced phacoemulsification surgeons. Safety, ease-of-use, reliability and flexibility to different surgeon’s techniques are designed and manufactured into every Sensory V. The Sensory V is designed to meet UL (Underwriter’s Laboratory) and IEC (International Electrotechnical Commission) standards.

FUNCTIONS AND FEATURES

Five basic modes are integrated into the Sensory V: 1 - Cautery 2 - Phacoemulsification 3 - Irrigation/Aspiration 4 - Vitrectomy 5 - Reflux in Phaco, Irrigation/Aspiration, and Vitrectomy Modes

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ULTRASONIC HANDPIECE

The Sensory V ultrasonic handpiece has been designed with a straight-through aspiration channel for more efficient removal of nuclear fragments, to minimize clogging and to facilitate easy cleaning. The handpiece is lightweight, slim, and well-balanced, making it comfortable to use and easy to manipulate.

TACTILE TOUCHTM FOOT PEDAL

All of these functions are controlled by a Tactile-Touch Foot Pedal. This state-of-the-art foot pedal design incorporates space-age technology, giving you greater control through increased linearity and uniform pressure throughout the foot pedal travel, virtually eliminating foot and leg fatigue. You may also select the tactile feedback feature, varying the levels of sensory indication as you move through the foot pedal positions. Reflux is located inside the foot pedal on both sides for immediate response. The foot pedal housing is constructed to be water resistant and splash proof.

SENSORY V CONSOLE

The Sensory V console is easy to read and easy to operate. You and your operating team know at a glance the exact status of the machine. The 32-digit display and color-coded panels give you visual indication of modes, settings, and system status, as well as error messages that can indicate improper connections or selections. All handpiece connections are located on the side of the console for easy set-up and less obstruction of the front panel.

SENSORY V CART

Operating Room teams contributed significantly to the successful design of the Sensory V cart. Its wide wheel base and large diameter wheels give it stability and smooth rolling capability. Open storage shelves, accessible from the back, give ample easy-to-access storage, while the lateral and vertical adjustments on the articulating arm allow you to adjust the configuration for different surgery settings.

QUIET EYETM PUMP

Engineered to eliminate turbulence in the eye, the new Quiet-Eye pump head smoothes linear ramp-up of vacuum and provides a tranquil atmosphere around the phaco tip. The pump improves performance in Phaco, Irrigation/Aspiration and Vitrectomy modes, giving a consistent aspiration level and optimal performance. The calibrated pump latch and easy-loading collared aspiration tubing assure optimal, repeatable performance and eliminate guesswork.

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POWER IV POLE

The power IV pole allows exact adjustment of the IV height through each procedural phase. A remote footswitch is used to accurately raise and lower the bottled saline solution, while maintaining the sterility of the operating field.

PHACO MODE

The Sensory V gives you the choice of linear or preset panel control of the phaco power level, as well as continuous or pulsed delivery of power. Vacuum levels are adjustable between 0 mmHg to 160 mmHg in 10 mm increments. It monitors the phaco time and ultrasonic power of each procedure, and at the end of each case, a summary is available of the relative energy delivered to the eye (represented in Joules “J”).

IRRIGATION/ASPIRATION MODE

The Irrigation/Aspiration mode gives you flexible control of each case with independently adjustable vacuum level and flow rate settings. The variable pitch audible tone can be selected for audible indication of the vacuum level. The unique vent-pulse feature gives exquisite linear aspiration control both up and down the vacuum range.

CAUTERY MODE

Designed for either shrinkage of conjunctiva or bleeding control, the wet-field, low-heat bipolar cautery mode has variable power settings.

VITRECTOMY MODE

The Sensory V vitrectomy cutter is a guillotine-style design with an adjustable aspiration port. Independent settings for flow rate and vacuum level during anterior vitrectomy, in addition to the variable cutting rate, give you maximum flexibility for different situations.

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Section 3 Components of the Sensory V System RECEIPT AND INSPECTION

When you receive your Sensory VTM, inspect the exterior packaging for any signs of damage that may have occurred during shipping and record this damage on the shipping documents. If there are any signs of damage, carefully unpack the Sensory V and inspect it for damage. If any damage to the package contents has occurred, you must file a claim with the transporter. Transporters will accept claims only from the recipient (you), not the shipper (AMO), so be sure to contact the shipper immediately.

INSTALLATION AND IN-SERVICE TRAINING

Your AMO Territory Manager will have contacted you to schedule both Installation and In-Service Training upon receipt of your new Sensory V. We suggest that you leave the Sensory V in its original packaging and store it in a cool, dry environment until AMO installation personnel arrive to assemble, install and test your equipment. Extreme heat, cold or moisture can damage any electronic equipment.

COMPONENTS

Your Sensory V system consists of the following components: • Sensory V Console • Sensory V Cart Power IV Pole with Footswitch Mayo Stand with Articulated Arm • Instrument Sterilization Tray • Phacoemulsification Handpiece • Multi-Tip Irrigation/Aspiration Handpiece Set Round Handle 0.3 mm Curved Tip 0.3 mm Straight Tip Binkhorst Tip ® Luer Tapered Tip Sterilization Tray O-Ring Replacement Kit • Cautery Cord with Bipolar Forceps • Tactile Touch Foot Pedal w/ cord • Detachable Sensory V Power Cord • IV Pole Power Cord • Spike Mat • Dust Cover • Spare Fuses • Sensory VTM User’s Manual • Sensory VTM Quick Reference Guide • Sensory VTM In-Service Video The major system components are identified in Figure 3.1.

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Balanced Salt Solution

Power IV Pole

Spike Pad

Figure 3.1 Sensory V System

Sensory V Console

Mayo Stand with Articulating Arm • Cautery Forceps • Phacoemulsification Handpiece • Multi-Tip I/A Handpiece Set • Vitrectomy Handpiece

Sensory V Cart

Power IV Pole Foot Switch

Tactile TouchTM Foot Pedal with Cord

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Each phacoemulsification procedure requires an OPO-30WC or OPO-35 Phacoemulsification Pack. The OPO-30WC contains the following components, which are identified in Figure 3.2: • Irrigation Tubing • Aspiration Tubing • Tip Wrench - for installing the Ultrasonic Tip • Two Irrigation Sleeve Assemblies - for I/A and Phaco Handpiece Tips • Two Test Chambers - for testing and protecting Phaco and I/A Handpiece Tips • Drainage Bag - to collect aspirated fluids • Mayo Stand Drape - to cover the instrument tray and arm • Micro-Mitts - to perform adjustments in non-sterile fields

Figure 3.2 OPO-30WC Phaco Pack Contents

Located Below Tray: • Drainage Bag • Micro Mitts • Mayo Stand Drape

Collared Aspiration Tubing

AMO Phaco PlusTM Sensory VTM 21896 A 010292

Irrigation Tubing

Components: • Tip Wrench • Test Chambers (2) • Irrigation Sleeves (2)

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PRE-OPERATIVE STERILIZATION

The Instrument Sterilization Table, Figure 8.1 on page 48, identifies those Sensory V Instruments that must be sterilized prior to each surgical case. Recommended sterilization techniques, times and temperatures are given in the table. AMO recommends that you follow these procedures to maximize the life of your Sensory V instruments.

WHAT'S NEXT?

In the next Section, you will learn how to assemble the components of the Sensory V system in preparation for surgery.

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Section 4 Sensory V System Set-Up

Before proceeding with system set-up, thoroughly read the following safety precautions and familiarize yourself with the symbols found on the back of the Sensory VTM machine. SAFETY PRECAUTIONS 1. The Sensory V uses high frequency energy which may cause interference with other medical electrical equipment. 2. The use of cautery may interfere with cardiac implants. If in doubt, contact the patient's cardiologist for advice. 3. Do not use the instrument with flammable anesthetics. Avoid usage of nitrous oxide and oxygen. 4. The Sensory V and Power IV pole are equipped with 3-prong plugs which should be plugged into an outlet with a ground receptacle. If the plug does not fit the outlet, contact an electrician. DO NOT defeat or remove the ground pin. 5. DO NOT use extension cords with your machine. 6. DO NOT overload your AC electrical outlet. 7. If the cord or plug is damaged, do not continue using the instrument. Electric shock or fire hazard may result. Call AMO to order a new cord. 8. The instrument has ventilation openings to allow the release of heat generated during operation. If these openings are blocked, heat build up can cause failures which may result in a fire hazard. 9. Use only the Sensory V cart supplied with your Sensory V System. 10. Do not try to roll the Sensory V cart on deep pile carpets or over objects on the floor such as cables and power cords. 11. Do not place the instrument on uneven or sloped surfaces. 12. Do not use accessories that are not designed for this instrument. Use only parts recommended by AMO to achieve optimum performance and safety. 13. Do not hang more than 10 pounds of fluid on the IV pole hook. AMO Phaco PlusTM Sensory VTM 21896 A 010292

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SYMBOLS

The following symbols appear on the back of the Sensory V console:

Symbol on power switch indicates Power is OFF.

Symbol on power switch indicaties Power is ON.

!

Indicates that there are important operating and maintenance instructions included in the User's Manual. Indicates the presence of uninsulated high voltage inside the instrument. Risk of electric shock. Do not remove the instrument cover. Indicates fuse. Single phase alternating current.

Patient applied part is isolated from earth ground.

Patient applied part is grounded OR no direct electrical energy is involved.

Foot pedal connection. Ear phone jack. Danger: Do not use in the presence of flammable

AP anaesthetics, as there is a risk of explosion. SET-UP SEQUENCE

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The following set-up sequence is recommended when learning the Sensory V system. After you have gained more experience with the Sensory V, the sequence may be modified to conform to specific hospital or surgical center requirements.

AMO Phaco PlusTM Sensory VTM 21896 A 010292

This set-up sequence will be demonstrated to you during In-Service Training. 1. Connect the Sensory V power cord to the back of the console as shown in Figure 4.1. Plug the power cord into a grounded power receptacle.

Figure 4.1 Power Cord and Foot Pedal Connections

ALIEURYHASLKHLAWIEURLKLIVCHLSICNVWI ULBLISUWIFKBHW.SIKCHWUEFSKWRIKISWUL FHLAWFLIDWUEWIKFJL.IKSDAIRUALWISLIERI DUHAAELINBFVAWLSIKKL,RUSVDUVHYALEKS IVHSRAIUYSLDVIAWRKJIWADFWELRKJHSLAI DUVHYSLD.IWA ALIEURYHASLKHLAWIEURLKLIVCHLSICNVWI ULBLISUWIFKBHW.SIKCHWUEFSKWRIKISWUL FHLAWFLIDWUEWIKFJL.IKSDAIRUALWISLIERI DUHAAE

Power Cord Receptacle

Foot Pedal Receptacle

NOTE: The Sensory V is designed for multiple voltages. The voltage is preselected at the factory and can be changed only by a service technician. The voltage label on the back of the console (near the power cord connection) indicates the factory voltage setting. If you are unsure of the power supply voltage in your area, consult your local power company. The IV pole has an automatic voltage selector and will operate from 100 to 240 VAC without any adjustments. 2. Connect the Tactile TouchTM Foot Pedal to the back of the Sensory V (see Figure 4.1). Once connected, the foot pedal can be stored in the back storage area of the cart without disconnecting. 3. Connect the IV pole power cord to the power inlet on the back of the IV pole. Plug the power cord into a grounded power receptacle. 4. Connect the IV pole footswitch to the footswitch receptacle on the back of the IV pole. Hold the connector body (not the sleeve ring) and push the connector until it snaps in. 5. Assure that all instruments are sterile in accordance with hospital procedures. 6. Take caution to prevent burns when handling the handpieces directly from sterilization.

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