Johnson and Johnson Surgical Vision SIGREMM2 Advanced Control Pedal & Remote Control Master 2.0 User Manual

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Document ID	1241901
Application ID	2H7jwUBpbJPXzY4CC8SUSA==
Document Description	User manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	76.19kB (952374 bits)
Date Submitted	2010-02-15 00:00:00
Date Available	2010-08-14 00:00:00
Creation Date	2007-01-10 15:43:09
Producing Software	Acrobat Distiller 8.2.0 (Windows)
Document Lastmod	2010-02-03 15:13:30
Document Title	untitled
Document Creator	FrameMaker 9.0
Document Author:	AMO Inc.

SYSTEM SETUP
Safety Precautions
Warnings
Symbol Definitions
System Disposal
Setup Sequence – Anterior Segment Surgery
Footpedal
Programmable IV Pole
Wireless Remote Control
Surgical Media Center (SMC) (Optional)
Shutdown Sequence – Anterior Segment Surgery
Rx Only – NGP Z370165 Rev. A 1209
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WHITESTAR SIGNATURE System
Safety Precautions
3 • System Setup
Now that you have set the system up and you have verified that all the functions are
operating properly, you are almost ready to use your WHITESTAR SIGNATURE
System.
Read the following Safety Precautions and Warnings carefully before you use the
WHITESTAR SIGNATURE System in surgery.
1. The WHITESTAR SIGNATURE System comes equipped with 3-prong power
plug which you must plug into an outlet with a ground receptacle.
If the plug does not fit the outlet, contact an electrician. DO NOT modify or
remove the ground pin.
2. Do not use extension cords with your system.
3. Do not overload your electrical receptacle (outlet).
4. If there is damage to the cord or the plug, do not use the instrument. A damaged
cable can cause an electric shock to the user or a fire hazard to the System. Call
AMO customer service to order a new cord.
5. The instrument has ventilation openings at the rear of the console to allow
ambient air intake and the release of heat generated during operation. Do not
block the openings; as heat build-up can cause system failures which can result
in a fire hazard.
6. Do not try to move the WHITESTAR SIGNATURE System cart on deep pile
carpets or over objects on the floor such as cables and power cords.
7. Take care not to trip over power and footpedal cords.
8. Do not try to lift the WHITESTAR SIGNATURE System cart.
9. Do not place the instrument on uneven or sloped surfaces.
10. Only use disposables, accessories, or other surgical instruments designed for
this system. For optimum performance of the System and safety, use only parts
recommended by AMO.
11. Do not operate the WHITESTAR SIGNATURE System in a condensing
environment. Take care to protect the instrument from fluid sprays or fluid
buildup.
12. To protect the patient from contaminated fluids or handpieces, use only:
• sterile tubing packs
• sterile irrigation fluid
• sterile handpieces
13. Use caution when you extend, retract, or swivel the Mayo stand articulating
arm. Stay clear of the hinged hardware.
14. Use caution when you use handpieces with sharp edges or pointed tips.
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WHITESTAR SIGNATURE System
3 • System Setup
15. Always replace the tubing pack between cases.
16. Wrap the excess power cord neatly around the cord wrap on the back of the
console.
Changing Irrigation Flow
Use extreme caution when you lower or raise the balanced salt solution bottle to
decrease fluid flow or increase fluid flow, and fluid pressure. If you lower the bottle
too much it can cause the anterior chamber to collapse. If you raise the bottle too
high it can cause the anterior chamber to deepen. To make sure that the bottle
height does not go too high, you can set the maximum bottle height on the
Diagnostics screen.
Note: Use a new bottle of balanced salt solution at the start of each case.
Phacoemulsification without Adequate Irrigation
Operating phacoemulsification without an adequate irrigation flow can result in an
elevated temperature of the tip and subsequent damage to the eye tissue or could
cause the chamber to collapse. Confirm that there is irrigation flow before you
initiate phacoemulsification. A tight wound or the angle of the needle next to the
wound can also constrict the irrigation flow. Pinching the coaxial irrigation sleeve
assembly on the needle of the phaco handpiece causes the constriction.
Power Failure during Surgery
If there is a loss of power during a procedure, you need to:
• Withdraw the handpiece from the eye
• Release the footpedal to Position 0
When power is restored:
• Select Prime/Tune to reprime the fluids and tune the phaco handpiece. Use
Bypass to reduce the length of prime time.
• Select the mode that was in use when the system lost power (PHACO, IA,
Vitrectomy, or Diathermy)
Connecting Handpieces
It is very important that the electrical connectors on the handpieces are completely
dry before you connect the handpiece to the WHITESTAR SIGNATURE System
receptacles. You can receive a “Handpiece Ground Fault Error” message if the
connector is wet.
Handling the Phaco Handpiece
The phaco handpiece is a very delicate instrument and you must handle the
handpiece with EXTREME care. If you drop the handpiece or the handpiece
receives any other significant impact, the handpiece will not work properly. The
ultrasonic titanium phaco tip must never touch any solid material while in use.
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WHITESTAR SIGNATURE System
3 • System Setup
Always clear the handpiece of fluid immediately following surgery.
See cleaning instructions in Chapter 9, “Care and Cleaning”.
Handpieces can be extremely hot immediately after sterilization. Use care and
caution when handling.
Phaco and Vitrectomy Operation
Do not activate the phaco handpiece and the vitrectomy cutter with the tips exposed
to air. Do not activate the tips in the air, as this reduces the useful life of the
handpiece and the cutter. When you introduce power to the phaco handpiece or the
vitrectomy cutter, the tips must be in a test chamber filled with a balanced salt
solution, in a container of balanced salt solution, or in the patient's eye.
Vitrectomy
Failure to properly attach the tubing to the appropriate vacuum source or pressure
source can affect the vitrectomy cutter operation. Be sure to read the vitrectomy
cutter package insert for the correct assembly procedures and connection
procedures.
Diathermy
When you select the Diathermy mode, you hear an audible tone. Also, you will hear
an audible tone when you apply diathermy power.
You must check the diathermy cable periodically for damage. If the cable shows
signs of damage, replace the cable immediately with the same type of cable. Use of
other types of cables can affect the diathermy performance.
During surgery, the diathermy output power must be as low as possible for the
intended purpose. AMO recommends the 30% setting to start.
You must position the diathermy cable in such a way that the cable avoids contact
with the patient or other leads. When you use diathermy, grounded or ungrounded
metal parts must not come in contact with the patient.
For proper operation of the diathermy, replace the handpiece with the same type.
Programmable IV Pole
Do not exceed the maximum weight of two 500 ml balanced salt solution bottles on
the IV pole bottle holder.
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WHITESTAR SIGNATURE System
3 • System Setup
Wireless Remote Control
This device complies with Ppart 15.19 of the FCC (Federal Communications
Commission) Rules. Operation is subject to the following two conditions:
1. This device may not cause harmful interference.
2. This device must accept any interference received, including interference that
may cause undesired operation.
Any changes or modifications not expressly approved by AMO can void
the user's authority to operate the equipment. (FCC Part 15.21)
Note: This equipment has been tested and found to comply with the limits for a
Class A digital device, pursuant to pPart 15.105 of the FCC Rules. These
limits are designed to provide reasonable protection against harmful
interference when the equipment is operated in a commercial environment.
This equipment generates, uses, and can radiate radio frequency energy
and, if not installed and used in accordance with the instruction manual,
may cause harmful interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful interference in
which case the user will be required to correct the interference at his own
expense.
Warnings
WARNING: All personnel who might operate this equipment
must read and understand the instructions in this manual before
they use the System. Failure to do so might result in the improper
operation of the system. Only a trained licensed physician can use
this device
WARNING: The surgical nursing staff must monitor the fluid level in
the balanced salt solution bottle. The result of a low bottle or an empty
bottle affects the fluid balance and the intraocular pressure (IOP) while
aspirating. The low or empty bottle can result in:
• The inadvertent chamber shallowing or collapse
• The Aspiration of tissue
• An ultrasonic wound heating commonly called wound burn
(extreme case)
The surgical staff must monitor the fluid level at all times.
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WHITESTAR SIGNATURE System
3 • System Setup
WARNING: DO NOT attempt to use the system if the system fails to
perform properly as stated in this manual.
WARNING: DO NOT use the System in the presence of any of the
following as a fire can result:
• flammable anesthetics
• other flammable gases
• flammable fluids
• flammable objects
• oxidizing agents.
WARNING: Make sure that the patient does not have a cardiac
pacemaker as this unit might interfere with any cardiac pacemaker;
therefore obtain qualified advice prior to such use.
WARNING: The patient must not come into contact with grounded
metal parts or metal parts that have appreciable capacitance to ground.
AMO recommends the use of an antistatic mat for this purpose.
WARNING: Use proper handling and disposal methods for
biohazards when you dispose of the tubing pack, mayo stand drape,
and monitor drape.
WARNING: Place monitoring electrodes or other types of equipment
as far from those of the WHITESTAR SIGNATURE System as
possible. AMO recommends high current limiting devices for the
protection of such systems. Do not use needle monitoring electrodes.
WARNING: Keep the diathermy cord away from the patient and other
handpieces or leads (for example, monitoring electrodes).
WARNING: The output power selected must be as low as possible for
the intended purpose.
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WHITESTAR SIGNATURE System
3 • System Setup
WARNING: This unit complies with all Electromagnetic Interference
(EMI) standards and requirements. It is possible that interference
provided by the operation of the HIGH FREQUENCY (HF)
SURGICAL EQUIPMENT can adversely influence the operation of
other electronic equipment.
WARNING: Do not have skin-to-skin contact on the patient. For
example, between the arms and the torso. Insert dry gauze to avoid
contact, as appropriate.
Note: The unit does not contains any neutral electrode.
Note: The diathermy output is bipolar.
Note: AMO recommends that you check the condition of all
interconnecting and handpiece cables on a regular basis.
WARNING: Risk of burns and fire. Do not use the system near
conductive materials such as metal bed parts, inner spring mattresses,
or similar items. Replace electrode cables on evidence of deterioration.
WARNING: Hazardous electrical output. This equipment is for use
only by qualified personnel.
WARNING: Disconnect the power before you service the equipment.
WARNING: Remove the power cord from the power outlet when the
equipment is not in use.
WARNING: Do not obstruct the power outlet so you can readily
remove the power cord.
WARNING: Not recommended for use in condensing environments.
If exposed to a condensing environment, allow the system to
equilibrate to typical operating room conditions prior to use.
Rx Only – NGP Z370165 Rev. A 1209
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WHITESTAR SIGNATURE System
Symbol Definitions
3 • System Setup
WARNING: You do not need to use a NEUTRAL ELETRODE with
this HIGH FREQUENCY (HF) SURGICAL EQUIPMENT.
WARNING: Failure of the HIGH FREQUENCY (HF) SURGICAL
EQUIPMENT could result in an unintended increase of output power.
WARNING: DO NOT try to replace the Wireless Remote Control
batteries. Call your AMO Technical Service representative to replace
the batteries.
WARNING: Sterility assurance is the responsibility of the user. You
must sterilize all nonsterile accessories 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. You must note any
questionable characteristics; use a backup handpiece for surgery. Use
of contaminated or damaged system accessories can cause patient
injury.
WARNING: Do not use non-AMO approved products with the
WHITESTAR SIGNATURE System, as this can affect overall
system performance. AMO cannot be responsible for system surgical performance if you use these products in surgery.
The following symbols appear on the WHITESTAR SIGNATURE System front
and back panels and in the software:
Table 3.1 – Symbol Definitions
Symbol
Definition
Symbol on the power switch indicates Power is On.
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WHITESTAR SIGNATURE System
Symbol
3 • System Setup
Definition
Symbol on the power switch indicates Power is Off.
Indicates there is a possible danger to the user. In the manual,
the symbol indicates information the user must read.
Indicates that there are important operating and
maintenance instructions included in the 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.
Indicates isolation of the patient applied part from earth
ground.
Indicates grounding of the patient applied part OR no
involvement of direct electrical energy.
Footpedal connection.
Communications Port
Programmable IV Pole
Diathermy Receptacle
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WHITESTAR SIGNATURE System
Symbol
3 • System Setup
Definition
Phaco Handpiece Receptacle
Vitrectomy Cutter Connection
Potential Equalizer
Indicates compliance with the Medical Device Directive.
Indicates the authorized European Union representative.
Separate Disposal/Collection Required
Indicates manufacturer of the WHITESTAR SIGNATURE
System.
Environment Friendly Use Period in Years (RoHS)
Indicates compliance with IEC 60601-1-2:2001,
“Electromagnetic Compatibility Requirements and Tests
for Medical Electrical Equipment.”
ETL Listed Mark issued to those products that have met the
requirements of product safety standards for the United
States and Canada. (ETL formerly Edison Testing
Laboratory)
Universal Serial Bus (USB) Port
Note: Use only AMO recommended USB stick drives.
Rx Only – NGP Z370165 Rev. A 1209
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WHITESTAR SIGNATURE System
Symbol
3 • System Setup
Definition
Federal Communications Commission (FCC)
The FCC regulates interstate and international
communications by radio, television, wire, satellite, and
cable under the FCC’s jurisdiction.
FUSION Mode button used to open the CASE settings
screen.
Single Linear Foot Pedal Icon. Shows the position of the
footpedal when you press the footpedal. The number
changes when the position of the footpedal changes.
Advanced Control Pedal (Dual Linear) Icon. Shows the
position of the footpedal when you press the footpedal. The
number changes when the position of the footpedal
changes. The letters indicate the location of Aspiration (A),
Irrigation (I), Phaco (P), Reflux (R), Whitestar Increment/
Decrement (WS) and Switch (S).
WHITESTAR Technology is On.
WHITESTAR Technology is On and ICE Pulse Shaping is
On.
ELLIPS Technology is On.
ELLIPS FX Technology is On.
The Reload button cycles through the surgeon’s programs.
Rx Only – NGP Z370165 Rev. A 1209
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WHITESTAR SIGNATURE System
System Disposal
3 • System Setup
WEEE
The electronic components of the WHITESTAR SIGNATURE 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 are 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 nearest you.
Belgium
Denmark
Contact
De Ceunynck Medical
nv/sa
Kontichsesteenweg 36
B-2630 AARTSELAAR
Belgium
Distributor
AMO Denmark ApS
c/o Advanced Medical Optics
Norden AB
Kanalvagen 3A
SE 19461 Upplands Vasby
Sweden
Finland
France
AMO Norden AB
Vantaa/Finland
Rajatorpantie 41 C, 3 krs
FIN-01640 Vantaa
Finland
Phone: +358 9 8520 2192
AMO France SAS
Greenside 15,
750 Avenue de Roumanille
06410 Biot
France
Phone: +33 4 93 00 11 95
Rx Only – NGP Z370165 Rev. A 1209
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WHITESTAR SIGNATURE System
3 • System Setup
Germany
Ireland
AMO Germany GmbH
Rudolf-Plank Strasse 31
D-76275 Ettlingen
Germany
Phone: +49 7243 729 444 (Hotline)
AMO Ireland
Block B
Liffey Valley Office Campus
Quarryvale, Co. Dublin, Ireland
Italy
Netherlands
AMO Italy Srl
Via Pio Emmanuelli, n.1
00143 Rome
Italy
Phone: +39 06 51 29 61
AMO Netherlands B.V.
Kantoorgebouw La Residence
Weverstede 25
3431 JS Nieuwegein
The Netherlands
Phone: +31 (0)30 600 8787
Norway
Poland
Distributor
Advanced Medical Optics
Norway AS
c/o Advanced Medical Optics Norden
AB
Kanalvagen 3A
SE 194 61 Upplands Vasby
Sweden
Distributor
Oko-Vita Polska sp.z o.o.
ul Marywilska 34,
03-228 Warsaw,
Poland
Portugal
Russia
Advanced Medical Optics Spain S.L.
sucursal em Portugal
Praca Nuno Rodreguez dos Santos
no 7, 1600-171
Lisboa
Portugual
Distributor
Tradomed Ltd.,
Marksistskaya Str. 3,
Bld 1,
Moscow,
109147,
Russia
Spain
Sweden
Advanced Medical Optics
Spain, S.L.
c/Dr. Zamenhof, n. 22, 4B
28027 Madrid
Spain
Phone: +34 9176 88 000
Advanced Medical Optics
Norden AB
Kanalvagen 3A
SE 194 61 Upplands Vasby
Sweden
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WHITESTAR SIGNATURE System
3 • System Setup
Switzerland
United Kingdom
Distributor
AMO Switzerland GmbH,
Churerstrasse 160 B,
CH-8808 Pfäffikon,
Switzerland
AMO United Kingdom Ltd
Jupiter House
Mercury Park
Wooburn Green
High Wycombe
Buckinghamshire
HP10 0HH United Kingdom
Phone: +44 1628 551600
RoHS (Restriction of Hazardous Substances)
For Chinese Regulation: Administrative Measure on the Control of Pollution
Caused by Electronic Information Products.
Names and Content of Toxic and Hazardous Substances or Elements
Parts Name
Toxic and Hazardous Substances or Elements
Pb
Hg
Cd
Cr6+
PBB
PBDE
Housing
Power Supply
Motherboard
Rear Panel
Assembly Board
Pneumatics
LCD
Base Unit
Fluidics
o: Indicates that this toxic or hazardous substance contained in all the
homogeneous materials for this part is below the limit requirement in SJ/
T11363-2006
x: Indicates that this toxic or hazardous substance contained in at least one of
the homogeneous materials used for this part is above the limit requirement in
SJ/T11363-2006. (Enterprises may further provide in this box technical
explanation for marking "X" based on their actual conditions.)
Rx Only – NGP Z370165 Rev. A 1209
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WHITESTAR SIGNATURE System
Setup Sequence –
Anterior Segment
Surgery
3 • System Setup
The following is a general overview of the steps to take to prepare the
WHITESTAR SIGNATURE System for surgery:
1. Connect the WHITESTAR SIGNATURE System power cord to the rear of
system. Plug the power cord into a grounded power outlet.
2. Connect the footpedal to the rear panel receptacle.
3. Connect the compressed air line to the compressed air receptacle (optional).
4. Turn the system On at the back of the console.
5. Press the On/Off button on the Touch Screen monitor.
6. After completion of the Start Up Self Test, select the surgeon and program.
7. Install the tubing pack, attach the required accessories (phaco, vitrectomy, or
diathermy handpieces) and set up the tubing.
8. Prime and tune the handpieces. (Refer to Chapter 4, Equipment Operation,
Prime/Tune.)
9. Perform the final test of the fluidics and the handpiece integrity with the
footpedal. (Refer to Chapter 4, Equipment Operation, Verify Irrigation/
Aspiration Balance.)
Rx Only – NGP Z370165 Rev. A 1209
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WHITESTAR SIGNATURE System
3 • System Setup
Figure 3.1 – Rear Panel Connections
1. USB Port
2. Communications Port
3. Foot Pedal Connector
4. Compressed Air
5. Potential Equalizer
6. Power Switch and Power Cord Connection
Phacoemulsification Ultrasonic Handpiece
WARNING: Sterility assurance is the responsibility of the user.
You must sterilize all nonsterile accessories 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. Use a backup handpiece
for surgery if there are any questionable characteristics of the
handpiece. Use of contaminated or damaged system accessories can
cause patient injury.
1. Use caution to prevent burns when handling the handpiece directly from
sterilization.
2. Remove the tubing pack and accessories from the tubing pack and place them
in the sterile area.
Rx Only – NGP Z370165 Rev. A 1209
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WHITESTAR SIGNATURE System
3 • System Setup
3. Assemble the phaco handpiece as shown below. You need the handpiece,
titanium phaco tip, the appropriate tip wrench, one of the infusion sleeves and
the test chamber.
CAUTION: NEVER ATTEMPT TO STRAIGHTEN A BENT
NEEDLE. THIS MIGHT PRODUCE A BROKEN TIP WHEN
YOU APPLY ULTRASOUND.
Figure 3.2 – Phaco Handpiece Assembly
1. Test Chamber
2. Infusion Sleeve
3. Handpiece with Tip
4. Attach the connector end of the handpiece to the phaco receptacle on the front
of the WHITESTAR SIGNATURE System. Make sure there is no moisture on
the connectors prior to connecting. Moisture prevents the handpiece from
operating properly.
Figure 3.3 – ELLIPS Handpiece and ELLIPS FX Handpiece
Note: You can use the ELLIPS handpiece or the ELLIPS FX handpiece with
WHITESTAR Technology and ELLIPS Technology phaco settings.
Irrigation/Aspiration Handpiece
1. Assemble the SOLO Irrigation/Aspiration (IA) Handpiece by attaching the
infusion sleeve.
Note: Both the infusion sleeve and the test chamber are provided in the
FUSION Tubing Pack. The LAMINAR Flow 20 ga. infusion sleeves
can also be used and are available with the OPOS20L or any 20 ga.
LAMINAR Phaco Tip.
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WHITESTAR SIGNATURE System
3 • System Setup
Figure 3.4 – IA Handpiece Assembly
1. Infusion Sleeve
2. SOLO Straight Tip
3. Handpiece
4. SOLO Curved Tip
5. SOLO 45o Silicone Sleeve Tip
2. Load the FUSION Tubing Pack
3. Open the tubing pack packaging.
4. Install the FUSION pack into the side receptacle, as shown below.
5. Make sure that the pack has a properly attached drainage bag.
Figure 3.5 – Loading the FUSION Tubing Pack
Note:
Press the button above the pack to remove the pack.
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WHITESTAR SIGNATURE System
3 • System Setup
Setup Completion
IMPORTANT: Before you insert the spike into the bottle, shake the irrigation drip
chamber at the end of the irrigation tubing to confirm that the irrigation valve
moves. If the valve does not rattle, the valve cannot operate properly and irrigation
cannot flow.
1. Place a new bottle of balanced salt solution on the top of the system console.
2. Insert the drip chamber spike into the balanced salt solution bottle.
3. Hang the balanced salt solution bottle from the Programmable IV Pole and
squeeze the drip chamber.
4. Fill the drip chamber with fluid to the half-full level. The Programmable IV
Pole moves to the appropriate height automatically.
5. Raise or lower the pole if needed. Use the IV pole Up and Down arrows on
upper right of the touch screen. You can also use the Up/Down switch on the
console.
Figure 3.6 – System Setup
6. Connect the IA tubing to the desired handpiece.
7. Insert the male luer end of the irrigation tubing into the phaco handpiece.
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WHITESTAR SIGNATURE System
3 • System Setup
8. Attach the female luer fitting end of the aspiration tubing to the phaco
handpiece.
Note: To protect the patient from contamination, use only:
• sterile tubing sets
• sterile irrigation fluid
• sterile handpieces
Figure 3.7 – Phaco Handpiece Connections
Diathermy
1. Connect the diathermy cord to the Diathermy Forceps or Pencil Probe.
2. Connect the diathermy cord to the diathermy receptacle on the front panel.
Figure 3.8 – Diathermy Forceps
Figure 3.9 – Diathermy Pencil
Note: Other diathermy accessories are regionally available. Contact your AMO
representative.
Vitrectomy
If you need to use vitrectomy during surgery:
1. Connect the AMO Vitrectomy Cutter as shown below. Vitrectomy requires the
following components:
• IA Tubing (from FUSION Tubing Pack)
• Vitrectomy Cutter
• Vitrectomy Infusion Sleeve, or a 23 Gauge Limbal Infusion Needle, if
desired.
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WHITESTAR SIGNATURE System
3 • System Setup
2. Use the instructions provided with the vitrectomy cutter to assemble the
handpiece.
Figure 3.10 – Vitrectomy Cutter
3. Attach the connector end of the vitrectomy cord to the vitrectomy receptacle on
the front panel.
Pre-Operative Sterilization
Prior to each surgical case, sterilize the WHITESTAR SIGNATURE System
instruments identified in Chapter 9, “Care and Cleaning” Instrument Sterilization
Procedures. The recommended sterilization techniques, times and temperatures are
given in Chapter 9, “Care and Cleaning”. AMO recommends that you follow the
sterilization guidelines to maximize the life of your WHITESTAR SIGNATURE
System instruments.
Footpedal
The footpedal controls all of the WHITESTAR SIGNATURE System functions,
therefore, it is essential that you understand the footpedal operation.
The System software automatically detects if a footpedal and what type of
footpedal is connected during power up.
The footpedal settings and adjustments can be selected and preset for the footpedal
in the Configuration screen. Instructions for the footpedal settings are given in
Chapter 5, “Anterior Segment Surgery Operating Modes”. The footpedal housing
incorporates a handle, making the footpedal easy to grip for repositioning and
storage.
The Footpedal cable attaches to the footpedal connector on the rear of the console.
Note: You must NEVER handle the footpedal by the cable.
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WHITESTAR SIGNATURE System
3 • System Setup
Figure 3.11 – Footpedal - Single Linear
Figure 3.12 – Footpedal - Advanced Control Pedal (Dual Linear)
Footpedal Operation
The footpedal has three active “PITCH” ranges, which are referred to as Positions
1, 2 and 3. Position 0 is the Off position, and Position 3 is the fully pressed position.
The ranges are shown below. The Advanced Control Pedal has two Yaw switches.
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WHITESTAR SIGNATURE System
3 • System Setup
Figure 3.13 – Footpedal “Pitch” and “Yaw” Positions
1. Pitch
Toe Down/Up
Configurable Ranges
2. Yaw
Toe Right/Left
Configurable Ranges
The footpedal position determines the function that is delivered by the handpiece,
which depends on the mode selected on the touch screen. When the footpedal has
been connected, place your foot on the pedal and press to the desired position. The
footpedal settings and programming are addressed in Chapter 5, “Anterior Segment
Surgery Operating Modes”.
Reflux
Reflux is the controlled backflow of fluid through the aspiration port of the
handpiece. Reflux is used to gently release or dislodge unwanted material from the
handpiece tip. Reflux can also be used to “tent” the incision site to allow easier tip
insertion. Reflux pressure depends on bottle head pressure (IV pole height and
gravity) for the FUSION Fluidics pack (OPO70), and as such, is not intended to
clear a clogged handpiece. However, reflux can be used to identify a blockage.
The reflux action can be programmed on any available footpedal switch. This
causes fluid to be expelled from the aspiration line into or towards the eye.
The reflux is active until the footpedal switch is released.
The FUSION Fluidics pack (OPO70):
• allows an inter-connection of the irrigation line to the aspiration line, so that
sterile balanced salt solution can enter the aspiration line.
• has no time restriction for Reflux as there is no pump reversal
The DP pack (OPO71):
• includes support for the vacuum tank used in the Venturi vacuum system
• does not support inter-connecting the irrigation line to the aspiration line.
Therefore, only previously aspirated fluid is being refluxed.
Rx Only – NGP Z370165 Rev. A 1209
3-23
WHITESTAR SIGNATURE System
Programmable IV
Pole
3 • System Setup
The Programmable IV Pole is controlled by the Up and Down arrows on the upper
right of the touch screen, next to the bottle height indicator. The buttons on the
remote control and the switch on the side of the console can also be used to control
the IV Pole. These controls are used to raise and lower the pole, and the height is
indicated in the Programmable IV Pole screen. The Programmable IV Pole moves
at a rate of approximately 6 cm (2 inches) per second.
The Programmable IV Pole is adjustable from 0 to 104 centimeters, and can be set
for either inches or centimeters. The height measurement is relative to the distance
from the irrigation valve to the center of the drip chamber. The Programmable IV
Pole height for each fluidic mode or submode (PHACO, IA, VIT) is saved in the
WHITESTAR SIGNATURE System memory. A Maximum IV Pole height can be
set on the Diagnostics screen.
When a surgery mode is selected, the Programmable Power IV Pole automatically
moves to the preset height. To manually adjust the IV pole height, use the Up and
Down arrows on the touch screen. Manual adjustments to the IV pole can also be
made by pressing the rocker switch located on the side of the console. If a
maximum height has been set, the IV pole will not move above that height.
Rx Only – NGP Z370165 Rev. A 1209
3-24
WHITESTAR SIGNATURE System
Wireless Remote
Control
3 • System Setup
The wireless remote control keypad can be used to operate the WHITESTAR
SIGNATURE System. All Modes, Programs, Diagnostics and End Case can be
accessed and adjustments to the settings can be made with the remote control. The
buttons on the remote keypad work the same as the controls on the WHITESTAR
SIGNATURE System touch screen.
Figure 3.14 – Wireless Remote Control Module
1. Remote Backlight On
6. Mode Select
2. Reload
7. Mode Down
3. IV Pole Up
8. Navigation Up/Down
4. IV Pole Down
9. Navigation Left/Right
5. Mode Up
10. Select
When not in use, store the Wireless Remote Control on the top of the system to
charge the batteries.
After you turn the system On, press the Remote Control Backlight button to
activate the Remote Control. When the system is Off the Remote Control is in a
power save mode.
Note: After four to six minutes of idle time, the Remote Control goes into a
power-save mode. To turn the Remote Control on, press the Backlight
button.
WARNING: DO NOT try to replace the Wireless Remote Control
batteries. Call your AMO Technical Service representative to replace
the batteries.
Rx Only – NGP Z370165 Rev. A 1209
3-25
WHITESTAR SIGNATURE System
3 • System Setup
Figure 3.15 – Wireless Remote Control Module Storage
Surgical Media
Center (SMC)
(Optional)
The Surgical Media Center (SMC) is used to record the surgery and the instrument
settings to be viewed at a later date and time. The surgery is displayed on a monitor
with the instrument settings. The SMC hardware is connected to your
WHITESTAR SIGNATURE System Communications port on the rear panel. (See
Figure 3.1 Rear Panel Connections.)
Note: If you select Configuration during surgery, the Program Settings screen
opens directly. The Configuration dialog box only shows when you are not
in a case. If you need to access the System Configuration screens, you must
select End Case, Next Case and then select the Configuration button.
1. To configure the Surgical Media Center, select:
• Configuration
• System Configuration
• SMC
Rx Only – NGP Z370165 Rev. A 1209
3-26
WHITESTAR SIGNATURE System
3 • System Setup
Figure 3.16 – Surgical Media Center Pop-up Window
2. Use the Up and Down arrows to adjust the settings. Translucency is used to
make the overlay (instrument settings) more or less opaque.
Note: Press on the number in the control panel to open a numeric keypad and
enter the required value. Press Enter on the Keypad pop-up window
when you are finished.
Figure 3.17 – Numeric Keypad Pop-up Window
3. Select the Recording Mode. Off, On, or Automatic. If the Recording Mode is
On, the recording continues between cases. Automatic stops recording between
cases.
Note: The Footpedal Switch can be set up to activate the SMC Record
function.
4. Press Finished to close the pop-up window.
Rx Only – NGP Z370165 Rev. A 1209
3-27
WHITESTAR SIGNATURE System
Shutdown Sequence
– Anterior Segment
Surgery
3 • System Setup
The following is a general overview of the steps to be taken to shut the System
down after surgery:
1. Select End Case.
2. Select Shutdown. At the prompt, select Yes.
3. Wait for shutdown sequence to complete.
4. Turn the system Off at the back of the console.
5. Remove the power cord from the power outlet.
6. Wrap the excess power cord neatly around the cord wrap on the back of the
console.
7. Place the footpedal in the storage area on the console.
8. Place the Wireless Remote Control on top of the console to charge.
9. Refer to Chapter 9, “Care and Cleaning”, Cleaning Procedures for additional
information.
Rx Only – NGP Z370165 Rev. A 1209
3-28

---

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