Johnson and Johnson Surgical Vision SCP135R Compact Console Unit User Manual Users manual

Download:
Mirror Download [FCC.gov]
Document ID	2147559
Application ID	YcCxqTagpwHYcLAWUgjKQA==
Document Description	Users manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	40.53kB (506655 bits)
Date Submitted	2013-12-19 00:00:00
Date Available	2014-02-02 00:00:00
Creation Date	2013-10-22 14:43:49
Producing Software	MFPImgLib V4.0
Document Lastmod	0000-00-00 00:00:00
Document Title	Users manual
Document Creator	TOSHIBA e-STUDIO3530C

COMPACT INTUITIV System
INTRODUCTION
1 - Introduction
About this Manual
About Phamemulsification
COMPACT INTUITIV System
Advanced Fluidics System
Accessories
Safety Precaufions
Warnings
Symbol Definitions
SCP Z370415 Rev. A 0913
1-1
COMPACT INTUITIV Syslem
- Introduction
About this Manual This manual includes information about the design of the COMPACT INTUITIV
System for anterior segment (phacoemulsiftcan'on) surgical procedures.
This manual includes information about optional system enhancements. Your
Abbott Medical Optics Inc. (AMO) representative can confirm the availability of
these features for your system configuration in your area.
About Over forty years ago, Doctor Charles Kelman conceived and developed
Phacoemulsification phaooemulsification, a method of cataract removal by use of ultrasonic
emulsification with aspiration of the cataract lens through a small incision.
Phacoemulsification is advantageous for both patient and surgeon for the following
reasons:
- Greater intraoperative control,
- The smaller incision requires fewer or no sutures, poses less risk of infection and
induced astigmatism, and gives better long-term 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.
AMO supports phxcoemulsification with sophisticated instrumentation that
optimizes the benefits of this surgical procedure.
Indications for Use The COMPACT INTUITIV System is an AC—powered device with a fragmenting
needle for cataract surgery to disrupt a cataract with ultrasound and extract the
cataract,
COMPACT The COMPACT INTUITIV System is a modular ophthalmic micro surgical
INTUITIV System system that fiwilitates anterior segment (cataract) surgery. The modular design
allows the users to configure the system to meet their surgical requirements.
The COMPACT mTUlTlV System contains a number of features based on
extensive research and clinical trials with highly trained and noted
ophthalmologists with experience as phacoernulsification surgeons.
WHITESTAR Technology
The WHITESTAR Technology was the first to deliver finely modulated pulses of
energy, interrupted by extremely brief cooling periods. This allows the system to
achieve full ultrasound cutting efficiency and magnetic followability, while
introducing less energy into the eye. Minimized or eliminated ultrasonic time
reduces the risk of thermal damage.
Pulse Shaping
Pulse Shaping delivers finely modulated, shaped pulses of energy, interrupted by
extremely hrief cooling periods. You can adjust the percentage of Low and High
“kick” and the power of the “kick“. Pulse Shaping allows the COMPACT
INTUITIV System to achieve full ultrasound cutting efficiency and excellent
followability while putting less energy into the eye.
SCPZ370415 Rev. A 0913 1-2
COMPACT INTUITIV System
Advanced Fluidies
System
Accessories
1 - Introduction
Occlusion Mode Phaco
You can use the Occlusion Mode Phaco to regulate the vacuum rise time that
follows the occlusion of the phaco tip, without limiting the choice of aspiration rate
through an unoccluded needle. In order to independently control the aspiration rate
and the vacuum rise time, it is possible to have a different aspiration rate for an
occluded needle and an unoccluded needle.
You can use Occlusion Mode Phaco to regulate ultrasound power modulation. You
can program the power modulation of the phaco handpiece (continuous, pulse,
burst, etc.) to automatically change when the phaco tip changes from an unoccluded
condition to an occluded condition
Chamber Stabilization Environment (CASE)
CASE is an intelligent vacuum monitoring system that regulates the maximum
allowable vacuum used following the occlusion of the phaco tipl When the phaco
tip becomes occluded, the vacuum rises, Clearing of the occlusion while the
vacuum is at a high-level can lead to a post occlusion surge. When CASE is on, the
system monitors the actual vacuum levels. When the vacuum exceeds a specific
threshold for a specified duration, the system automatically adjusts the maximum
allowable vacuum setting to a lower predefined CASE maximum vacuum level.
When the occlusion clears, the system automatically restores the settings to the
original programmed maximum vacuum setting. This function makes it possible to
have a different maximum vacuum setting when the needle occludes than when the
needle is unoccluded.
CASE One Touch
The CASE One Touch button simplifies the programming of the CASE function
and allows you to easily define the basic CASE settings once. You can adjust the
CASE function with the CASE One Touch settings on the surgical screens When
you use CASE One Touch, the CASE functionality changes to provide enhanced
control or improved efficiency for any combination of cataract density, surgical
technique or personal preferences.
One of the most advanced features of the COMPACT INTUITIV System is the
fluidics system that allows for intraoperative intraocular control. An integral part of
the advanced fluidics is resident in the proprietary technology of the Single-Use
packs. The closed and isolated fluidics system provides the maximum safety and
minimum biohazard risk.
Phacoemulsification Ultrasonic Handpiece
The design of the phaco handpiece has a stmight—tluough aspiration channel for
more efficient removal of nuclear fragments, to minimize clogging and to facilitate
cleaning. The handpiece is lightweight, slim, and wellvbalanced, making it
comfortable to use and easy to control.
SCP 2370415 Rev. A 0913 1.3
COMPACT INTUITlV System
Introduction
COMPACT
INTUITIV System
Console
ELLIPS FX Handpieee
The ELLIPS FX phaco handpieee is available for use with the COMPACT
mTUITIV System. The ELLIPS FX handpiece provides both longitudinal and
transversal movement. You can use the handpiece with a straight tip or a curved tip.
Foot Pedal
The operating modes (Diathermy, I/A, Fhaco, and Vitrectomy) are controlled by
the foot pedal. You can save the degree of travel for each foot pedal position for
each surgeon/procedure.
The foot pedal design offers control through the use of increased linearity with the
foot pedal movement. The design provides uniform pressure throughout the foot
pedal movement, easing foot and leg fatigue. You can select the degrees of
movement for each foot pedal position. You can save the foot pedal pitch settings
for each surgeon. Programmable switches can activate reflux, which gives an
immediate response. The system does not support the Sovereign Compact
closed-toe foot pedal,
Wireless Remote Control
You can access the surgical modes and adjust the surgical settings with the use of
the wireless remote control keypad. The back light supports low light operating
room conditions.
This Cl' " A ‘ ital apparatus meets all retiuirements of the Canadian
Interfcrenee~Cuusing Eguigment Reg rlations.
COMPACT INTUITIV System Cart
The cart‘s solid wheel base and two locking wheels make the cart stable and
smooth rolling, An open design minimizes weight. A Mayo tray with a baling ring
accommodates either an instrument tray that can be put in an autoclave or a solid
troy. The Mayo tray provides easy access for the remote control under the sterile
cover. The open bin and the foot pedal platform are available for storage.
IV Pole
The automated [V pole allows adjustment of the bottle height through each
procedural phase. Use the up and down arrows on the screen or the remote control
to raise and lower the balanced salt solution bottle; this maintains the sterility ofthe
operating field. A separate up/down switch allows access at the rear of the system.
You can remove the pole from the cart for transport.
The COMPACT INTUITIV System screen is easy to read and easy to operate.
You can see at a glance the exact status of the machine. The LCD display gives you
Visual indication of modes, settings, and system status Event messages indicate
improper connections. You can access all handpiece connections fi-om the front for
easy setup.
The design of the graphical user interface (GUI) gives you visual indication of the
status for the control systems at all times. When you select a mode (DIA, PHACO,
IA, or VIT), you see current settings on the screen. As you make adjustments to the
settings, the screen shows the changes.
SCP Z370415 Rev, A 0913 1-4
COMPACT INTUITIV System I 0 Introduction
‘ Each surgical mode and submode has its own distinct screen:
- Diathermy
1 - Phaec
i - Irrigation/Aspiration
i - Vitrectomy
i Fi re 1 l—Phaco Screen
Mann Saleem
9 3i
i mm “ :Bnemmmempmgmm
Additionally, there are screens or sub-screens for:
- Prime/Tune
- End Case
' Program Settings
Surgeon Settings
System Setup
Prime/Tune
Before the 51211 of each surgical case, the system requires that you run prime or
prime/tune The prime mode incorporates the function of clearing the tubing of air.
The prime mode then fills the tubing and completes the fluid aspiration check and
the vacuum check. The tune mode incorporates an ultrasonic power calibration
check and safety check for the attached phaco handpiece. The prime/tune mode
allows the system to prime and then tune the handpieoe,
SCP 2370415 Rev. A 0913 1-5
l COMPACT INTUlTIV System 1
Introduction
Continuous Irrigation
Continuous Irriytion is immediately available by way of the touch screen. Surgeon
control of continuous irrigation with the foot pedal is an available setting for the
foot pedal, You can use continuous irrigation to fill cups prior to prime/tune. You
can use the cup till feature in place of continuous irrigation when you fill a cup. The
cup fill feature is only available from the prime/rune screen. (See “Prime/Tune” on
page 6-2. for detailed information.)
Programmable Operating Parameters
The COMPACT [NTUTTIV System is programmable through the GUI. The
surgeon may preselect their desired settings for each portion of the surgical
procedure. The instrument program memory can store 30 surgeon names, plus the
AMO Default Surgeon settings. Each surgeon can setup 8 unique programs, plus
the AMO Default settings program. This allows different users to preset their
preferences, or an individual user to preselect setups for different procedures.
Multiple Mode Programming (MMP)
Multiple submode memories are available within the COMPACT mTUITIV
System operating modes. The MMP allows users to preset their parameters for
specific techniques such as phaco chop or viscoelastic removal.
COMPACT The design of the system provides all the operating modes and surgical capabilities
INTUITIV that the anterior segment surgeon or the cataract surgeon requires. These
Operating Modes capabilities include:
Diatherrny (DIA)
Most surgeons use diathermy to coagulate blood vessels during the procedure and
some surgeons use diathermy to close 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 charting. The
gentleness of the diathermy mode allows the surgeon to stop bleeding within the
incision with only minimal scleral shrinkage. The surgeon can stop bleeding from a
10—0 suture tract without melting the suture.
Phaooemulsification (Phaco)
The surgeon uses the Phacoemulsifrcation mode to break up (emulsify) the nucleus
of the lens. The surgeon then aspirates the nucleus of the lens from the eye through
a small incision. The continuous auto-tuning circuitry maximizes the emulsification
efficiency for each lens density, even varying densities within the same lens. The
system displays Phaco time in minutes and seconds. Convenient selection of linear
or panel-preset phaco power. in a variety of power delivery options (pulsed, burst,
eta), gives the surgeon increased precision and controlt
SCP 2370415 Rev. A 09l3 1—6
COMPACT INTUITIV System
Safety Precautions
1 ' Introduction
Irrigation/Aspiration (IIA)
The Irrigation and Aspiration mode allows for controlled aspiration of cortical
material from the eye, while maintaining inh'aocular stability by replacing the
aspirated material with the irrigation solution. A peristaltic pump provides a
predictable and stable aspiration rate. You can achieve complete control with
“Aspiration” and “Vacuum".
Note: The vacuum units are available in either mmHg or kPa. To set the vacuum
unis go to System Setup and select Vacuum Units.
Irrigation is gravity»fed. You can regulate the gravity-fed irrigation pressure by
adjusting the height of the irrigation solution bottle This mode gives you flexible
control of each case with the independently adjustable vacuum level settings and
flow rate settings. The adjustable volume tone indicates the vacuum level.
Vitreetomy (VIT)
You use Vitrectomy mode to remove vitreous from the anterior chamber of the eye
during:
- a secondary IOL (intmocular lens) implant procedure
- following vitreous loss associated with trauma
- vitreous loss during primary cataract surgery
If there is vitreous loss during cataract surgery, the vitrectomy capability can be
ready and available in seconds
Once you have set the system up and you have verified that all the functions are
operating properly, you are almost ready to use your system.
Read the following safety precautions and writings carefully before you use the
system in surgery.
I. Do not use extension cards with your machine.
2. Do not overload your AC electrical outlet.
3. 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 afire hazard to the system Call
AMO customer service to order a new card
4. Do not block the openings; as heat build-up can cause system failures which
can result in a fire hazard. The instrument has ventilation openings at the rear of
the console to allow ambient air intake and the release of heat generated during
operation.
5. Do not block the air fans on the bottom of the console; as heat build-up can
cause system failures which can result in afire hazard.
6. Do not try to roll the system cart on carpets or over objects on the floor such as
cables and power cords.
7. Take care not to trip over the power cords and the foot pedal cords.
Do not place the instrument on uneven or sloped surfaces.
9. Only use disposables, accessories, or other surgical instruments designed for
this system. Use only parts recommended by AMO to achieve the optimum
performance and the safety of the system
9“
SCPZ370415 ReV.A0913 1-7
COMPACT INTUITIV System 1 - Introduction
10. Do not operate the system in a condensing environment. Take care to protect
the instrument from fluid sprays or fluid buildup.
11. Do not exceed maximum weight of 25 pounds (I 1.25 Kg) on the Programmable
IV Pole bottle holder.
12. Do not use more than one IV pole extender with the IV pole.
13. If there is no IV pole attached to the system, hang the irrigation fluid container
at least 77 cm from the patient’s eye.
14. To protect the patient from contaminated fluids or handpieces, use only:
. sterile tubing sets
- sterile irrigation fluid
- sterile handpieces
15. Use caution when handling handpieces with sharp edges or pointed tips.
16. Wrap the excess power cord neatly around the cord wrap on the back of the IV
pole or cart
17. Always replace the Single-Use Pack and irrigation solution bottle between
surgical cases.
Changing Irrigation
Use extreme caution when you lower or raise the irrigation 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 or to become too shallow;
take care to avoid abrasion of tissues during phacoemulsiflcation. If you raise the
bottle too high it can cause the anterior chamber to deepen.
Note: Use a new bottle of inigation solution at the start of each case.
Phacoemulsifieation Without Adequate Irrigation
Operating phacoemulsiflcation 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. Pinehing of the coaxial irrigation
sleeve assembly on the nwdle of the phaco handpiece causes the consn-iction.
Power Failure During Surgery
If there is a loss of power during a procedure, you need to:
- Withdraw the handpiece from the eye; and
- Release the foot pedal to position 0.
When power is restored:
- Select Primefl'une to reprime the fluids and tune the phase handpiece. Use
Bypass to reduce the length of prime time.
- Select the mode that was in use when the system lost power (Phase, IA,
Vitreetomy, or Diathermy).
SCP 23704l5 Rev. A 0913 1-8
COMPACT INTUITIV System
1 - Introduction
Connecting Handpleees
it is very important that the electrical connectors on the haudpieces are completely
dry prior to connecting them to the system receptacles. You may receive a “Phaco
Handpiece Error” message if the connector is Wet.
Handling the Photo 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 might not work properly. The
ultrasonic titanium phaco tip must never touch any solid material while in use.
Always clear the handpiece offluid immediately following surgery.
See cleaning instructions in Chapter 7 "Care and Cleaning”.
Handpieces can be extremely hot immediately other sterilization. Use care and
caution when handling.
Phaco and Vitreetomy Operation
Do not activate the Phaco and Vitrectomy handpieces with the tips in air, as this
reduces the useful life of the handpiece and the cutter. When introducing power to
the Phaco or Vitreetomy handpieces, the tips should be in one of the following:
- a test chamber filled with irrignting solution,
- a container of irrigating solution, or
- the patient’s eye.
Vitrectomy
Failure to properly attach the tubing to the appropriate vacuum source or pressure
source affects the vitrectomy headpiece operation. Be sure to read the handpiece
package insert for correct assembly procedures and connection procedures.
Diatherrny
When you select the Diathenny mode, you hear a tone or a voice. Also, you 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 should be as low as possible for the
intended purpose. AMO recommends 30% settingto start.
The patient should not come into contact with ungrounded metal parts when using
diathermy.
Position the diathermy cable in such a way that the cable avoids contact with the
patient or other leads.
For proper operation of the diathermy, replace the handpiece with the same type.
Power IV Pole
Do not exceed maximum weight of 25 pounds (11.25 Kg) on me IV pole bottle
holder.
SCP Z370415 Rev. A 0913 1.9
COMPACTINTUITIV System
1 - Introduction
Warnings
Foot Pedal
Never handle the foot pedal by its power cord.
Do not place the foot pedal on a wet surface.
Wireless Remote Control Buttery Management System
This device complies with Part 15,19 of the Federal Communications Commission
(FCC) Rules. Operation is subject to the following two conditions:
- This device may not cause harmful interference.
- 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 complies with the limits for a Class A digital device,
pursuant to Part 15.105 of the FCC Rules. These limits provide reasonable
protection against harmful interference when the equipment is operating 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 hEImfiJi interference to radio
communications. Operation of this equipment in a residential area is likely
to cause harmful interference in which case the user has to correct the
interference at his own expense.
WARNING: All personnel should read and understand the
instructions in this manual before they use the system. Failure
to do so may result in the improper operation of the system.
Only a trained and licensed physician is to use this device.
WARNING: The system comes equipped with a 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.
WARNING: The surgical staff must monitor the irrigation
solution bottle height and the fluid level at all times. A low
bottle or empty bottle affects the fluid balance and the
intraocular pressure (10?) while aspirating. Low bottle height
or low or empty bottle fluid level can result in:
- Inadvertent chamber shallowing or collapse
- Aspiration or abrasion of the iris or other eye tissue
- An ultrasonic wound heating commonly called wound burn
(extreme case)
SCP 2370415 Rev. A 0913 1710
COMPACT INTUITIV System
Introduction
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 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 Single-Use Pack, Mayo
stand cover, and monitor covert
WARNING: Follow good operating room procedures to
prevent injury or contamination.
WARNING: Use caution when you extend, retract, or swivel
the Mayo stand articulating arm. Stay clear of the hinged
hardware
WARNING: Make sure that you unlock the wheels before
you move the cart. Make sure that the wheels move freely
when moving the cart.
SCP Z370415RevtA0913 1-11
COMPACT INTUITIV System
‘
Introduction
WARNING: Place monitoring electrodes or other types of
equipment as far from those of the CONEACT INTUITIV
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). Keep unused ACTIVE ELECTRODES away
from the patient.
WARNING: The output power selected should he as low as
possible for the intended purpose.
WARNING: This unit complies with all Electromagnetic
Interference (EMJ) standards and requirements. It is possible
that interference provided by the operation of the HIGH
FREQUENCY (HT) 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 contain 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 near
conductive materials such as metal bed pans, 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.
SCP 2370415 Rev. A 0913 1-12
COMPACT lNTUITlV System
Introduction
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
environment If exposed to condensing environment, allow
system to equilibrate to typical operating room conditions
prior to use.
WARNING: You do not need to use a NEUTRAL
ELECTRODE with this HIGH FREQUENCY (HP)
SURGICAL EQUIPMENT.
WARNING: Failure of the HIGH FREQUENCY (HF)
SURGICAL EQUIPMENT could result in an unintended
increase of output power.
WARNING: Sterility assurance is the responsibility of the
user. You must sterilize all non-sterile 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 foneign
material. You must note any questionable characteristics; use
a backup handpiece for surgery. Use of contaminated or
damaged system accessories can cause patient injury,
SCP 2370415 Rev.A()9l3 1-13
COMPACT INTUlTIV System
1 ' Introduction
WARNING: Do not use non-AMO approved products with
the COMPACT INTU'ITIV System, as this can affect overall
system performance. AMO cannot be responsible for system
surgical performance if you use these products in surgery.
Symbol Definitions The following symbols appear on the COMPACT lNTUITIV System:
Symbol
Definition
This symbol on the power switch indicates Power is ON
This symbol on the power switch indicates Power is OFF.
Indicates WARNING; apmentially hazardous situation
which, if not avoided, could result in serious injury.
Indicates that there are important operating and maintenance
instructions included in the Operator’s Manual.
Indicates manufacturer of the COMPACT INTUITIV
System.
Indicates the presence of uninsulaterl high voltage inside the
instrument. Risk of electric shock. Do not remove the
instrument cover.
,__
Indicates fuset
Single phase altemeting current.
SCP Z370415 Rev. A 0913 1-14
COMPACT iNTUITIV System
1 - Introduction
Symbol
Definition
Patient applied part is isolated from earth ground.
Patient applied part is grounded OR no direct electrical
energy is involve/:11
Foot Pedal connection.
Communications Port
-_[:: Ethernet Port
U1 1‘! Pole Connection
. Pack Eject
—
Diathermy Forceps Receptacle
Phn H d ' Rece 1e
00 an piece ptac
_‘ Vitrectomy Cutter Receptacle
Potential equalizer used to identify the terminals which,
when you connect them together. bring the Various parts of
the equipment or of a system to the same potential, not
necessarily being the earth (ground) potential, eg. for local
bonding
IPX8
IPXS is the International Protection code that indicates that
the device is protected against the effects of continuous
immersion in water.
SCP 2370415 Rev. A 0913
1-15
COMPACT INTUITIV System
Symbol
Definition
IPX4
IPX4 is the International Protection code that indicates that
the device is protected against splashing water sprayed at all
angles.
|PX6
IPXG is the International Protection code that indicates that
the device is protected against powerful waterjets.
Indicates compliance with the Medical Device Directive
Indicates the authorized European Union representative.
Indicates compliance with EN IEC 60601-1-2:2007,
“Electromagnetic Compatibility Requirements and Tests for
Medical Electrical Equipment."
Indicates product listed with Intertek Testing Services
Introduction
0%
Universal Serial Bus (USB) port
Note: Use only AMO recommended USB devices (flash
drives). External hard drives are not supported on
the COMPACT INTUITIV System.
Federal Communications Commission (FCC)
The FCC regulates interstate and international
communications by radio, television, wile, satellite, and
cable under the FCC’s jurisdiction.
Mark on shipping container indicating not to open the
container except by authorized personnel.
®
®
Do not reuse
SCP Z}70415Rev.A0913 1-16
COMPACT lNTUlTIV System 1 - Introduction
Symbol Definition
® Do not re-sterilizer
Symbol for sterile medical devices processed using Ethylene
—-8TERILE IE“
Oxide (EtO).
Do not use if package is damaged. Do not use if the product
@ sterilization barrier or its packaging is compromised,
Standard Foot Pedal. Shows the current position of the foot
pedal as you press the foot pedal and the activated foot
switch. The number changes when the position of the foot
pedal changes. When you press the icon, the Foot Pedal
Configuration screen opens.
Fotu Button Foot Pedal. Shows the current position of the
foot pedal as you press the foot pedal and the activated foot
switch. The number changes when the position of the foot
pedal changes. When you press icon, the Foot Pedal
Configuration screen opens.
Timers. When pressed shows an enlarged version of the
timer and allows the resetting of the timers to zero.
WIHTESTAR technology is on.
WHITESTAR technology is on and pulse shaping is on.
FXfi ELLIPS FX handpiece is connected.
Continuous Irrigation. Used to tum continuous irrigation on
or off.
Used to save changes made to settings.
SCP 2370415 Rev. A 0913 1.17
COMPACT INTUITIV System
1 - Introduction
Definition
Save As. Creates a new program with the current settings.
Restore Program afler to any modifications. Must be done
before you save any changes.
Restore Submode ether to any modifications. Must be done
before you save any changes
Keyboard, when pressed the Virtual keyboard shows on the
screen.
Exit Settings without saving any changes,
Indicates the selected surgeon. When selected goes to the
Surgeons and Programs screen.
The program is locked. You cannot save any changes or
delete the program.
Brightness indicators. The top icon increases the brightness
of the screen. The bottom icon decreases the brightness of
the screen.
Volume indicators. The greater the number on the setup
screen, the louder the volume.
IV Pole
SCP Z370415 Rev. A 0913
1-18

---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.7
Linearized                      : No
Producer                        : MFPImgLib V4.0
Create Date                     : 2013:10:22 14:43:49-08:00
Creator                         : TOSHIBA e-STUDIO3530C
Page Count                      : 18

EXIF Metadata provided by EXIF.tools