SOVEREIGN COMPACT
DOCUMENT NO: Z370049
REVISION: 08
LABEL SPECIFICATION
TITLE: SOVEREIGN™ COMPACT OWNER’S MANUAL (US)
SPECIFICATION:
1. BINDER:
1-1/2” white vinyl with clear-view and insert pockets or equivalent. Three rings.
2. TEXT:
Paper stock: 24 lb. White laser paper, 8-1/2” x 11”, 3 ring punched.
Print: one color-black printing on one side. Printing to be clear, and legible with no ink smears. Each
chapter must start on a right-facing page.
3. COVER & SPINE:
See Z330059 for Label Specifications
4. TABS PAGES:
See Z330058 for Label Specifications.
5. ASSEMBLY ORGANIZAITON:
Index tabs in appropriate sections of Manual.
6. PACKAGING:
Shrink-wrap assembled binder with copy
of first page of document (cover page) between shrink and
outside of binder. Manual identify from cover page (version, part number, etc.) must be facing out and
visible for warehouse identification.
7. Point of Use: AMO, Santa Clara
Sanmina-SCI Corp.
SUMMARY OF CHANGES
APPROVAL
DATE
5/13/05 20050506 5.0 Update Manual for the Open-Toe-Footpedal
7/27/05 LCR20050746 6.0 Added disposal procedures for waste electronic equipment and updated trademarks.
10/24/05 LCR20051275 7.0 Added open toe foot pedal SKU # & new accessory for the Sovereign Compact System.
DCN/LCR
NUMBER
VER. DESCRIPTION OF CHANGE
REVISION DESCRIPTION OF CHANGE
08
Add China RoHS symbols/definitions on page 8-9. Add Chines/English tables at the end of section 8. Add Point of Use
on the Label Spec.
Page 1 of 134
SOVEREIGN
™
COMPACT
Manufactured for:
Advanced Medical Optics, Inc.
1700 East St. Andrew Place
Santa Ana, CA 92705
U.S.A.
www.amo-inc.com
WHITESTAR, SOVEREIGN, LAMINAR, AMO, and the AMO logo are trademarks of
Advanced Medical Optics, Inc.,
SOLO is a trademark of Microsurgical Technology.
OWNER’S AND
OPERATOR’S MANUAL
For Order Placement of
Surgical Products
(IOLs and Phaco Supplies)
Call 1-800-366-6554
For Phaco Returns or Technical
Service
Call 1-800-449-3060
All returns must be accompanied
by a RGA#
(Returned Goods Authorization)
Manual Replacement
Order# CMPZ370049
PHACOEMULSIFICATION SYSTEM
WITH RESPECT TO ELECTRIC SHOCK, FIRE
AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH UL2601-1/CAN/CSA C22.2 NO. 601.1
50KK
0050
3032972
Rx Only Z370049 Rev. 08 0407
©2003, 2004, 2005, 2006 AMO, Inc.
AMO Ireland
Dublin 4
Ireland
1
This manual is written to familiarize all surgical team members who will
set-up and operate the SOVEREIGN™ COMPACT System with the
components, set-up, operation and care of your system and its accessories. You should read and understand this manual completely
befor
e using the SOVEREIGN™ COMPACT System in surgery.
SOVEREIGN™ COMPACT System is produced under at least one
of the following U.S. Letters Patent Nos.: D426,882; D462,759;
D463,380; D463,545; 4,983,901; 5,230,614; 5,268,624; 5,342,293;
5,392,653; 5,470,312; 5,591,127; 5,649,905; 5,700,240; 5,852,794;
6,033,376; 6,059,765; 6,083,193; 6,260,434; 6,261,297; 6,360,630;
6,361,520; 6,394,974; 6,398,754; 6,423,074; 6,452,120; 6,452,123;
6,520,929; 6,533,750; 6,579,255; 6,585,683; 6,605,054; 6,629,948;
6,674,030; 6,699,212; 6,780,165; and 6,852,092. Also, European
patent Nos.: 0,643,570; 0,643,808; 0,643,823; 0,664,898; 0,705,084;
0,741,554; 0,954,386; 1,012,686; and 1,056,420. Patents pending.
Other foreign equivalents available upon request.
WHITESTAR™ System is produced under at least one of the
following U.S. Letters Patent Nos.: 6,629,948 and 6,780,165. Patents
pending. Foreign equivalents available upon request.
Section Contents Page
1 Introduction 1-1
About Phacoemulsification 1-2
About This Manual 1-2
Declaration of Conformity 1-3
Intended Use 1-4
SOVEREIGN™ COMPACT System Features 1-5
SOVEREIGN™ COMPACT Operating Modes 1-7
2 System Components 2-1
Receipt and Inspection Instructions 2-2
SOVEREIGN™ COMPACT Components 2-2
SOVEREIGN™ COMPACT System 2-3
OPO60 Tubing Pack 2-4
OPO65 Tubing Pack 2-5
3 System Setup 3-1
Safety Precautions and Warnings 3-2
System Disposal 3-5
Symbol Definitions 3-6
Setup Sequence 3-7
4 Equipment Operation 4-1
Foot Pedal 4-2
IV Pole 4-5
Controls 4-6
Select Language 4-7
Selecting and Changing Mode Parameters 4-8
Remote Control 4-10
5 Programs 5-1
AMO Default Setups 5-2
Start-Up 5-4
Program 5-4
6 Operating Modes 6-1
Setup 6-2
Continuous Irrigation 6-2
Prime/Tune 6-3
Verify Irrigation/Aspiration Balance 6-6
Diathermy 6-7
Phacoemulsification 6-10
Irrigation/Aspiration 6-16
Vitrectomy 6-18
End Case 6-20
7 Recommended Settings 7-1
Power IV Pole Heights 7-2
Diathermy 7-2
Phacoemulsification 7-2
Irrigation/Aspiration 7-4
Vitrectomy 7-4
Other Settings 7-5
(Contents continued on page 3)
Table of Contents
2
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
Section Contents Page
8 Check-Out, Precautions and Warnings 8-1
System Check-Out 8-2
Safety Precautions 8-4
Warnings 8-7
Symbol Definitions 8-9
9 Care and Cleaning 9-1
Cleaning Procedures 9-2
Sterilization Procedures 9-4
System Cleaning and Care 9-6
10 Error Messages, Troubleshooting and Diagnostics 10-1
Most Commmon User-Correctable Problems 10-2
System Operation Messages 10-3
Troubleshooting 10-7
Diagnostics 10-11
Self Test 10-12
Foot Pedal Test 10-13
Console & Remote Test 10-13
Delete Surgeon Database 10-14
View Logs 10-14
View Software Versions 10-15
Set System Time 10-16
Fuse Replacement Procedure 10-17
11 Warranty and Maintenance 11-1
12 Specifications 12-1
13 Accessories and Parts Reordering 13-1
14 Index 14-1
Table of Contents (Cont.)
3
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
Section Figure Description Page
System Components 2.1 SOVEREIGN™ COMPACT System 2-3
2.2 OPO60 Tubing Pack 2-4
2.3 OPO65 Tubing Pack 2-5
System Setup 3.1 Foot Pedal Connections 3-7
3.2 Assembling the Phaco Handpiece 3-8
3.3 Handpiece Receptacles 3-9
3.4 SOLO
TM
I/A Handpiece 3-10
3.5 OPO60 Tubing Pack 3-11
3.6 Releasing the Manifold Latch and Opening the Pump Latch 3-11
3.7 Positioning the I/A Tubing Manifold in the Pump 3-12
3.8 Pump Segment Installation (part 1) 3-12
3.9 Pump Segment Installation (part 2) 3-12
3.10 Prepared for Priming 3-13
3.11 Attach Drain Bag 3-13
3.12 Installation Troubleshooting Watchouts 3-14
3.13 Attaching I/A Tubing to the Phacoemulsification Ultrasonic Handpiece 3-15
3.14 Connecting the Diathermy Forceps 3-16
3.15 AMO™ Vitrectomy Handpiece 3-16
Equipment Operation 4.1 Foot Pedal 4-2
4.2 Foot Pedal Positions 4-2
4.3 Handpiece Functions in Foot Pedal Positions 4-3
4.4 Foot Pedal Reflux Top Switch 4-3
4.5 Foot Pedal Side Switches 4-4
4.6 Foot Pedal Position Indication 4-5
4.7 Controls 4-6
4.8 Select SYSTEM OPTIIONS 4-7
4.9 Select LANGUAGES 4-7
4.10 Select and SAVE Language 4-7
4.11 Typical Phaco Operating Screen 4-8
4.12 Programming Modes 4-9
4.13 Remote Control Keypad 4-10
Programs 5.1 AMO Default Setups 5-2
5.2 Diathermy 5-2
5.3 I/A 5-2
5.4 Phaco 5-3
5.5 Vitrectomy 5-3
Operating Modes 6.1 Prime Handpiece and Fill Test Chamber 6-4
Recommended 7.1 Diathermy Settings 7-2
Settings 7.2 Phacoemulsification Settings 7-3
7.3 Irrigation/Aspiration Settings 7-4
7.4 Vitrectomy Settings 7-4
7.5 Settings 7-5
4
List of Illustrations
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
Section Figure Description Page
Error Messages and 10.1 System Operation Messages 10-3•10-6
Troubleshooting 10.2 Troubleshooting 10-7•10-10
10.3 Fuse Specifications 10-17
10.4 Back Panel Fuse Holder 10-17
Specifications 12.1 Diathermy Power Graph (10 ohm rated load) 12-2
12.2 Diathermy Power Graph (50 ohm rated load) 12-3
12.3 Diathermy Power Graph (100 ohm rated load) 12-3
12.4 Diathermy Power Graph (200 ohm rated load) 12-4
12.5 Diathermy Power Graph (500 ohm rated load) 12-4
12.6 Diathermy Power Graph (1000 ohm rated load) 12-5
12.7 Diathermy Power VS. Load Impedence (100% power) 12-5
12.8 Diathermy Power VS. Load Impedence (50% power) 12-6
12.9 Phaco Power Graph 12-6
5
List of Illustrations (Cont).
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
In this section you will find:
• About Phacoemulsification
• About This Manual
• Declaration of Conformity
• Intended Use
• SOVEREIGN™ COMPACT System Features
• SOVEREIGN™ COMPACT Operating Modes
1
INTRODUCTION
1-1
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™ COMPACT System
1•Introduction
About
Phacoemulsification
Over thirty years ago, Dr. Charles Kelman conceived and developed
phacoemulsification, a method of cataract removal by ultrasonic
emulsification and aspiration of the cataractous lens through a small
incision. Phacoemulsification is advantageous for both patient and
surgeon:
• greater intraoperative control.
• the smaller incision requires fewer or no 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.
Advanced Medical Optics, Inc. (AMO) supports phacoemulsification with
sophisticated instrumentation that optimizes the benefits of this surgical
procedure.
This manual includes information regarding optional SOVEREIGN™
COMPACT System enhancements. The availability of these features in
your SOVEREIGN™ COMPACT System configuration and
availability in your area may be confirmed by your AMO representative.
1-2
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
About This
Manual
DECLARATION OF CONFORMITY
Application of Council Directive..........................................Medical Devices
Directive 93/42/EEC
Standards to which Conformity is Declared ........................IEC 601-1
EN 60601-1-2
EN 60601-2-2
Supplier..............................Advanced Medical Optics, Inc.
Address ..............................Santa Ana, CA 92705
U.S.A.
Product ..............................SOVEREIGN™ COMPACT
I, the undersigned, hereby declare that the equipment specified above
conforms to the above Directive.
Place: Santa Ana, California Signature:
Date: Full Name:
Position: Vice President
Quality Assurance
Advanced Medical Optics, Inc.
1•Introduction
1-3
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
0050
1•Introduction
1-4
The SOVEREIGN™ COMPACT Cataract Extraction System is an
AC-powered device with a fragmenting needle intended for use in cataract
surgery to disrupt a cataract with ultrasound and extract the cataract.
This HIGH FREQUENCY (HF) SURGICAL EQUIPMENT is specified for
use without a NEUTRAL ELECTRODE.
Intended Use
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
1•Introduction
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
SOVEREIGN™ COMPACT The SOVEREIGN™ COMPACT System represents over 7 generations of
System Features AMO™ phacoemulsification technology. Safety, ease-of-use, and reliability
are designed and manufactured into every SOVEREIGN™ COMPACT
System. SOVEREIGN™ COMPACT System meets UL (Underwriter’s
Laboratory), I.E.C. (International Electrotechnical Commission) 601-1
and E.M.C.(Electromagnetic Compatibility) requirements for this type of device.
The SOVEREIGN™ COMPACT System contains a number of features
based on extensive research and clinical trials with highly-trained and noted
ophthalmologists who are experienced phacoemulsification surgeons.
WHITESTAR
TM
Technology Optional WHITESTARTMTechnology enhancement for the SOVEREIGN™
COMPACT System delivers finely modulated pulses of energy, interrupted by
extremely brief cooling periods. This allows the SOVEREIGN™ COMPACT
System to achieve full ultrasound cutting efficiency and magnetic
followability, while introducing less energy int the eye.
Advanced Fluidics System One of the most advanced features of the SOVEREIGN™ COMPACT
System is its fluidics system that allows for intraoperative intraocular control.
An integral part of the advanced fluidics is resident in the patented
technology of the disposable and reusable tubing packs. The fluidics system
is fully closed and isolated providing the maximum safety and minimum
biohazard risk.
Phacoemulsification Ultrasonic The Phacoemulsification Ultrasonic Handpiece has been designed with a
Handpiece straight-through aspiration channel for more efficient removal of nuclear
fragments, to minimize clogging and to facilitate easy cleaning. The hand
piece is lightweight, slim, and well-balanced, making it comfortable to use
and easy to manipulate.
Foot Pedal The operating modes (Diathermy, I/A, Phaco and Vitrectomy) are controlled
by the foot pedal. The degree of travel for each foot pedal position may be
selected and saved in memory for each surgeon/procedure.
Reflux is activated by a programmable switch, giving immediate response.
The two lateral foot pedal side switches may also be programmed to change
between surgical sub-modes. Surgeon control of continuous irrigation is also
available through the foot pedal. The foot pedal housing is waterproof to
comply with I.E.C. 601 requirements.
SOVEREIGN™ COMPACT The SOVEREIGN™ COMPACT System screen display is easy to read and
Display easy to operate. You will know at a glance the exact status of the machine.
The LCD display gives you visual indication of modes, settings, and system
status. Messages cue you through the procedure, and error messages indicate
improper connections or selections. All instrument connections are easily
accessed from the front for easy setup and less obstruction of the front panel
displays.
Multi-Lingual The User Interface is available in 14 languages, easily selected from the
User Interface opening display screens. Once selected, all of the programming and operating
screens are in the selected language, and the chosen language remains in
effect until otherwise changed.
1-5
1•Introduction
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
SOVEREIGN™ COMPACT Operating Room teams contributed significantly to the successful design of
System Cart the SOVEREIGN™ COMPACT System Cart. Its solid wheel base and two
locking wheels make it stable and smooth rolling. An open design minimizes
weight. A manually adjustable height Mayo tray with baling ring
accommodates either an autoclavable instrument tray or a solid tray. A tray
for the remote control provides easy access under the sterile drape. An open
bin and footpedal platform are available for storage.
Programmable Power Pole The automated and programmable power pole allows adjustment of the bottle
height through each procedural phase. Two adjustment keys on the front control panel or the remote control are used to accurately raise and lower the bottled saline solution, while maintaining the sterility of the operating field. A
separate circulator up/down switch allows access at the rear of the system.
The pole is easily removed from the cart for transport.
Remote Control The SOVEREIGN™ COMPACT System can be operated/controlled from
the remote control keypad. All modes can be remotely accessed, and all
parameters may be adjusted using the remote control, including full programming and prime capabilities. Backlighting supports low light OR conditions.
Prime/Tune The system incorporates a variety of prime and tune options for various pur-
poses. The comprehensive Prime & Tune mode includes tubing purge and
fill, phaco handpiece tune and vacuum check. Other choices are I/A Prime
and Phaco Tune only, tune only, and irrigation free flow. Irrigation free flow
can be used to set up the case without use of the footpedal. Collecting irrigation may occur prior to priming.
Continuous Irrigation Continuous Irrigation is immediately available via dedicated keys on both the
front panel and remote control. Surgeon control via footpedal programming is
also available.
Programmable Operating The SOVEREIGN™ COMPACT System is programmable through the
Parameters color screen displays and front panel keypad. The surgeon may preselect
his/her desired settings for each portion of the surgical procedure.
Up to 16 different setups, or "surgeon names," plus the AMO default settings program may be stored in the instrument program memory. This allows
different users to preset their preferences, or an individual user to preselect
setups for different procedures.
MMP Multiple sub-mode memories are available within SOVEREIGN™
COMPACT (Multiple Modulation Presets) operating modes. This allows
users to preset their parameters for specific techniques such as phaco
chop or viscoelastic removal.
1-6
1•Introduction
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
SOVEREIGN™ COMPACT The SOVEREIGN™ COMPACT System has been designed to provide all the
Operating Modes surgical capabilities desired by the anterior segment/cataract surgeon. These
capabilities include:
Bipolar Diathermy This mode is used by most surgeons to coagulate blood vessels during the
(DIA) procedure and by some surgeons to "coapt" the conjunctiva at the end of
the procedure. An isolated output frequency allows non-contact tissue
coagulation, eliminating adhesion and traction. Also, the depth of penetration
of the energy field is less than that of higher frequency units, minimizing
tissue shrinkage or charring. The gentleness of the diathermy mode allows
the surgeon to stop "bleeders" within the incision with only minimal scleral
shrinkage, and to stop a "bleeder" from a 10-0 suture tract without melting
the suture.
Phacoemulsification This mode is used to break up (emulsify) the nucleus of the lens, allowing
(PHACO) it to be aspirated from the eye through a small incision. The continuous
autotuning circuitry maximizes the emulsification efficiency for each
lens density, even varying densities within the same lens. Phaco time is
displayed in minutes and seconds. Convenient selection of linear or
panel-preset phaco power, in a variety of power delivery options (pulsed,
burst etc.), gives the surgeon increased precision and control.
Irrigation/Aspiration This mode allows for controlled aspiration of cortical material from the eye,
(I/A) while maintaining intraocular stability by replacing the aspirated material
with irrigation solution. A peristaltic pump provides a predictable and stable
aspiration rate. Complete control is achieved with "ASPIRATION RATE"
and "VACUUM". Irrigation is gravity-fed and is mode regulated by adjusting
the height of the irrigating solution bottle. This mode gives you flexible
control of each case with independently adjustable vacuum level and flow
rate settings. The adjustable volume tone indicates the vacuum level.
Anterior Vitrectomy This mode is used to remove vitreous from the anterior chamber of the eye
(VIT) during a secondary IOL (intraocular lens) implant procedure, or following
vitreous loss associated with trauma, or vitreous loss during primary cataract
surgery. If vitreous is lost during cataract surgery, the vitrectomy capability
can be ready and available in seconds.
1-7
1•Introduction
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™ COMPACT System
Programmable Power The SOVEREIGN™ COMPACT System is equipped with a programmable
Pole Capability power pole. If the programmable power pole capability is activated at the
beginning of the customizing program sequence, programmable power pole
height settings can be entered independently for each of the Phaco MMP
modes plus settings for Diathermy, I/A and Vitrectomy. During surgery, the
programmable power pole height will change to the preprogrammed height
when switching modes.
Occlusion Mode Occlusion Mode Phaco is used to regulate the vacuum rise time that is
Phaco experienced following occlusion of the phaco tip, without limiting the choice
of aspiration rate through an unoccluded needle. In order to independently
control aspiration rate and vacuum rise time, it is possible to have a different
aspiration rate when the needle is occluded than when the needle is not
occluded.
Occlusion Mode Phaco is also used to regulate ultrasound power
modulation. The power modulation of the phaco handpiece (continuous,
pulse, burst) can be programmed to automatically change when the phaco tip
changes from an unoccluded condition to an occluded condition.
1-8
2
SYSTEM COMPONENTS
In this section you will find:
• Receipt and Inspection Instructions
• SOVEREIGN™ COMPACT System Components
• SOVEREIGN™ COMPACT System Pack
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
2-1
2•System Components
Receipt and
Inspection
When you receive your SOVEREIGN™ COMPACT System 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 SOVEREIGN™ COMPACT
System and inspect it for damage. If any damage to the package contents
has occurred, you must immediately file a claim with the transporter.
Transporters will accept claims only from the recipient (you), not the
shipper (AMO).
Your AMO Representative will have contacted you to schedule both
Installation and In-Service Training upon receipt of your new
SOVEREIGN™ COMPACT System. We suggest that you leave the
SOVEREIGN™ COMPACT System in its original packaging and
store it in a cool, dry environment until AMOinstallation personnel
arrive to assemble, install and test your equipment. Extreme heat, cold or
moisture can damage any electronic equipment.
Your SOVEREIGN™ COMPACT System may consist of some or all of
the following components:
• SOVEREIGN™ COMPACT System Console
• Programmable IV Pole
• Cart with Mayo Stand
• Instrument Sterilization Tray (s)
• Phacoemulsification Ultrasonic Handpiece
• OPO60 Disposable Tubing Pack or OPO65 Reusable Tubing Pack
• Diathermy Cord with Bipolar Forceps
• Electronic Oscillating Vitrectomy Handpiece
• Foot Pedal with Cord
• Power Cord (detachable)
• Remote Control Module with Cord
• SOVEREIGN™ COMPACT System Owner’s Manual
• SOLO
TM
I/A Handpiece, 20 Gauge, Curved Silicone Sleeve Tip
• SOLO
TM
I/A Handpiece, 20 Gauge, 45˚ Silicone Sleeve Tip
• SOLO
TM
I/A Handpiece, 20 Gauge, Straight Silicone Sleeve Tip
• Spike Mat
The major system components are identified in Figure 2.1.
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
2-2
SOVEREIGN™
COMPACT System
Components
2•System Components
Figure 2.1
SOVEREIGN™ COMPACT
System with
Optional
Cart and I/V Pole
DIA
Handpiece
Connections
Remote
Control
Foot Pedal
Programmable IV Pole
Display Screen
Mayo Stand with
Articulating Arm
Cart
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
2-3
Open-Toe Foot Pedal
Rx Only - Z370049 Rev. 08 0407
2•System Components
SOVEREIGN™COMPACT System
2-4
SOVEREIGN™ COMPACT
System Pack
Each phacoemulsification procedure requires a disposable OPO60 Tubing
Pack or a sterilized OPO65 reusable Tubing Pack. The OPO60 Tubing Pack
contains the following components, some of which are identified in Figure 2.2:
• Tubing manifold with irrigation and aspiration tubing
• Drain Bag - attached and sealed
• One Tip Cap Sleeve
• Test Chamber - for testing and protecting
Phaco Tips and I/A Handpiece Tip
• Mayo Stand Drape - to cover the instrument tray and arm
Pump Segment
Irrigation
Bottle Spike
Drip
Chamber
I/A Tubing Manifold
Vent
Tube
Drain Bag
Aspiration from
Handpiece
Irrigation to
Handpiece
Aspirated Fluid
to Drain Bag
Figure 2.2
OPO60 Tubing Pack
Rx Only - Z370049 Rev. 08 0407
2•System Components
SOVEREIGN™COMPACT System
2-5
Pump Segment
I/A Tubing Manifold
Vent
Tube
Drain Bag
Aspiration from
Handpiece
Irrigation to
Handpiece
Aspirated Fluid
to Drain Bag
Pre-Operative
Sterilization
The OPO65 Tubing Pack consists of a tubing manifold with irrigation and
aspiration tubing. The pack is joined with a drain bag and administration set.
Figure 2.3
OPO65 Tubing Pack
and Tubing Assembly
The Instrument Sterilization Procedures in Section 9 identify those
SOVEREIGN™ COMPACT System instruments that must be sterilized prior
to each surgical case. Recommended sterilization techniques, times and
temperatures are given in Section 9. AMOrecommends that you follow the
sterilization guidelines to maximize the life of your SOVEREIGN™
COMPACT System instruments.
Administration Set
3
SYSTEM SETUP
In this section you will find:
• Safety Precautions and Warnings
• System Disposal
• Symbol Definitions
• Setup Sequence
Power Connections
Phaco Handpiece
Irrigation/Aspiration Handpiece
SOVEREIGN™ COMPACT System Pack
Diathermy
Vitrectomy
3-1
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
3•System Setup
Before proceeding with system setup, thoroughly read the following safety
precautions and familiarize yourself with the symbols found on the back of
the SOVEREIGN™ COMPACT System.
1. The SOVEREIGN™ COMPACT System is 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.
2. Do not use extension cords with your machine.
3. Do not overload your AC electrical outlet.
4. 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.
5. The instrument has ventilation openings to allow the release of heat
generated during operation. If these openings are blocked, heat
buildup can cause system failures which may result in a fire hazard.
6. Do not try to roll the SOVEREIGN™ COMPACT System cart on deep
pile carpets or over objects on the floor such as cables and power cords.
7. Do not place the instrument on uneven or sloped surfaces.
8. Do not use disposables, accessories or other surgical instruments that
are not designed for this system. Use only parts recommended by
AMO to achieve optimum performance and safety.
9. Do not exceed maximum weight of 25 pounds (11.25 Kg) on the
Programmable IV Pole bottle holder.
10. To protect patient from contaminated fluids or handpieces, use only:
• sterile tubing sets
• sterile irrigation fluid
• sterile handpieces
11. Use caution when extending, retracting or swiveling the mayo stand
articulating arm. Stay clear of hinged hardware.
12. Use caution when handling handpieces with sharp edges or pointed tips.
13. When using OPO65, always replace the drain bag with a clean bag
between cases.
14. Wrap the excess power cord neatly around the cord wrap on the back of
the I/V pole or cart.
15. Electrode cables and accessories should be regularly inspected for
possible damage to the insulation. This includes the Diathermy, EVIT
and Phaco cables.
3-2
SAFETY PRECAUTIONS
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
3•System Setup
3-3
• The SOVEREIGN™ COMPACT System meets ETL
(Laboratory 2601.1), I.E.C. (International Electromechanical
Commission) 601-1 and E.M.C. (Electromagnetic Compatibility)
requirements for this type of device.
• Page 1-3 contains the Declaration of Conformity for the
SOVEREIGN™ COMPACT System.
WARNING: All personnel should read and understand the
instructions in this manual before the system is used. Failure to do
so may result in the improper operation of the system. This device
is only to be used by a trained licensed physician.
WARNING: DO NOT attempt to use the system if it fails to
perform properly as stated in this manual.
WARNING: DO NOT use the system in the presence of flammable
anesthetics, or other flammable gases, near flammable fluids or
objects, or in the presence of oxidizing agents, as fire could result.
WARNING: This unit may interfere with any cardiac pacemaker
fitted to the patient, therefore qualified advice should be obtained
prior to such use.
WARNING: The patient should not come into contact with metal
parts which are earthed or have appreciable capacitance to earth.
The use of an antistatic mat for this purpose is recommended.
WARNING: Monitoring electrodes or other types of equipment
should be placed as far from those of the SOVEREIGN™
COMPACT System as possible. High current limiting devices are
recommended for the protection of such systems.
WARNING: The output power selected should be as low as
possible for the intended purpose.
WARNING: Although this unit complies with all EMI standards
and requirements, it is possible that this unit could interfere with
other types of electronic equipment.
!
!
!
!!!
!
!
WARNINGS
Continued on next page
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACTTMSystem
WARNING: Skin to skin contact on the patient, e.g., between the
arms and the torso is not recommended.
Note: The unit contains no neutral electrode.
Note: The diathermy output is bipolar.
Note: It is recommended that the condition of all inter-connecting
and handpiece cables be checked on a regular basis.
WARNING: Risk of burns and fire. Do not use near conductive
materials such as metal bed parts, inner spring mattresses, and the
like. Renew electrode cables on evidence of deterioration.
WARNING: Hazardous electrical output. This equipment is for use
only by qualified personnel.
WARNING: Disconnect power before servicing.
WARNING: Not recommended for use in condensing environment.
If exposed to condensing environment, allow system to equilibrate
to typical operating room conditions prior to use.
WARNING: This HIGH FREQUENCY (HF) SURGICAL
EQUIPMENT is specified for use without a NEUTRAL
ELECTRODE.
WARNING: Failure of the HIGH FREQUENCY (HF) SURGICAL
EQUIPMENT could result in an unintended increase of output
power.
WARNING: Interference provided by the operation of the
HIGH FREQUENCY (HF) SURGICAL EQUIPMENT may
adversely influence the operation of other electronic equipment.
!
!!!!!
!
WARNINGS
3-4
!
3•System Setup
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
Rx Only - Z370049 Rev. 08 0407
3•System Setup
SOVEREIGN™ COMPACT System
3-5
SYSTEM DISPOSAL
The electronic components of the SOVEREIGN™ COMPACT System are subject to the European Union
Directive 2002/96/EC on Waste Electrical and Electronic Equipment. This directive applies to all electronic
equipment in the European Union only.
The disposal to municipal waste is prohibited for electronic equipment subject to this directive; this equipment
must be treated or recycled. Each component that is subject to this regulation is marked on the component itself
with the following symbol:
In some cases where the component’s size prohibits marking (such as handpieces) the marking can be found on
the directions for use and the warranty.
Treatment and/or recycling of the electronic equipment is provided at no cost to you. Please see the contact
information below for disposition of unwanted AMO electronic equipment.
For disposal of your unit, contact your local AMO subsidiary or the AMO service center.
AMO Germany GmbH
Surgical Systems Service
+49 7243 729 444 (Hotline)
SE_Service@amo-inc.com
AMO France SAS
Mougins/France
Phone: +33 49 22 87 228
AMO Italy Srl
Rome/Italy
Phone: +39 06 51 29 61
AMO Netherlands B.V.
Nieuwegein/Netherlands
Phone: +31 30 75 03 740
AMO Norden AB
Vantaa/Finland
Phone: +358 9 8520 2192
AMO Norden AB
Upplands Vasby/Sweden
Phone: +46 8594 21 000
AMO Spain S.L.
Madrid/Spain
Phone: +34 9176 88 000
AMO Switzerland GmbH
Lachen/Switzerland
Phone: +41 554 51 07 80
AMO UK Ltd
Woodburn Green/
United Kingdom
Phone: +44 162 85 51 600
3-6
3•System Setup
The following symbols appear on the SOVEREIGN™ COMPACT System
front and back panels:
Symbol on power switch indicates Power is ON.
Symbol on power switch indicates Power is OFF.
Indicates that there are important operating and maintenance instructions
included in the Owner’s and Operator’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.
Communications Port
Remote
Programmable Power Pole
Diathermy Forceps
Phaco Handpiece Receptacle
TAC Cutter (Oscillating)
Potential Equalizer
Indicates compliance with the Medical Device Directive
Separate Collection Required
Indicates product listed with Intertek Testing Services
Indicates compliance with IEC 60601-1-2:2001, “Electromagnetic
Compatibility Requirements and Tests for Medical Electrical Equipment”
Environment Friendly Use Period, in Years
Below the hazardous materials limits in SJ/T11363-2006 (China)
Symbol Definitions
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
0050
!
3•System Setup
Setup Sequence
The following is a general overview of the steps to be taken to prepare the
SOVEREIGN™ COMPACT System for surgery:
1. Connect the power.
2. Turn the system on.
3. After completion of the Start Up test, select the surgeon program.
4. Attach the intended accessories and set up the tubing.
5. Prime and tune the handpiece.
6. Perform the final test of fluidics and handpiece integrity with the
footpedal.
1. Connect the Foot Pedal to the back of the SOVEREIGN™ COMPACT
System console (see Figure 3.1) Once connected, the foot pedal can be
stored in the bottom storage bin of the cart without disconnecting.
2. Connect the Remote Control to the receptacle on the back of the
console (see Figure 3.1).
3. Connect the SOVEREIGN™ COMPACT System power cord to the
rear of system. Plug the power cord into a grounded power outlet.
4. Turn the system ON.
Power Connections
Figure 3.1
Foot Pedal Connection
3-7
Foot Pedal
Receptacle
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
IV Pole
Receptacle
Remote Control
Receptacle
On/Off
Switch
Power Cord
Receptacle
3•System Setup
Phacoemulsification
Ultrasonic Handpiece
Figure 3.2
Assembling
the Phaco
Handpiece
CAUTION
NEVER ATTEMPT TO STRAIGHTEN A BENT NEEDLE. THIS
WILL PRODUCE A BROKEN TIP WHEN PHACO IS APPLIED.
Warning: Sterility assurance is the responsibility of the user. All
non-sterile accessories should be sterilized prior to use.
Warning: Prior to using any invasive portions of the handpiece
assembly, examine under the microscope for any obvious damage,
oxidation, or the presence of foreign material. If any questionable
characteristics are noted, use a backup handpiece for surgery. Use
of contaminated or damaged system accessories may cause patient
injury.
1. Take caution to prevent burns when handling the handpiece(s) directly
from sterilization.
2. Remove the tubing manifold and accessories from the tubing pack
and place them in the sterile area.
3. Assemble the ultrasonic handpiece as shown in Figure 3.2. You
will need the handpiece, titanium phaco tip, the appropriate tip wrench,
the tip cap sleeve and the test chamber.
!
!
Test
Chamber
Tip Cap
Sleeve
LAMINAR
TM
Flow
Metal Tip
Wrench
LAMINAR
TM
Flow
Phaco Tip
Handpiece
3-8
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
3•System Setup
3-9
Phaco
Diathermy
Vitrectomy
Figure 3.3
Handpiece Receptacles
Rx Only - Z370049 Rev. 08 0407
SOVEREIGN™COMPACT System
4. Attach the connector end of the handpiece to the phaco receptacle
on the front of the SOVEREIGN™ COMPACT System, shown in
Figure 3.3.
Make sure that there is no moisture on the connectors prior to
connecting. Moisture will prevent the handpiece from operating
properly.
D
I
A
Open-Toe Foot Pedal
Rx Only - Z370049 Rev. 08 0407
3•System Setup
SOVEREIGN™COMPACT System
Figure 3.4
SOLO
TM
I/A Handpiece
SOLO
TM
Straight Tip
Handpiece
1. Assemble the SOLOTMIrrigation/Aspiration (I/A) Handpiece
by attaching the tip cap sleeve*.
• Irrigation sleeve and test chamber are found in the
SOVEREIGN™ COMPACT System Pack, OPO60.
• The LAMINAR
TM
Flow 20 ga. irrigation sleeves may also be used
and are available with the OPOS20L or any 20 ga. LAMINAR
TM
Phaco Tip.
Irrigation/Aspiration
Handpiece
SOLO
TM
Curved Tip
SOLO
TM
45˚ Silicone
Sleeve Tip
3-10
Tip Cap
Sleeve
Loading...