For Sale JOHNSON & JOHNSON COMPACT INTUITIV System Phacoemulsifier

JOHNSON & JOHNSON COMPACT INTUITIV System

Outstanding Performance
Proactive Fluidics management with automatic occlusion sensing
Ultrasound efficiency from the ELLIPS FX Handpiece
Responsive fluidics for high surgeon control
Surgical Suite Optimization

Smart, user-centric design for value and efficiency
Convenient, action-ready setup
IOP Through Post-Occlusion Surge and Recovery1

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Results from a nonclinical study.

COMPACT INTUITIV System: Aspiration 30 ccm, Vacuum 400 mmHg, Pump Ramp 100%, Bottle Height 90 cm, CASE Vacuum 200 mmHg, OPO80 and OPO85.
INFINITI System: Intrepid® Plus Fluidics Management System, Aspiration 30 ccm, Vacuum 400 mmHg, Bottle Height 90 cm.

36% less change in IOP than the INFINITI Vision System with the disposable pack*

68% faster IOP recovery than the INFINITI Vision System with the disposable pack**

Ultrasound Efficiency with the ELLIPS FX Handpiece

The ELLIPS FX Handpiece helps protect the eye throughout the process - and in your results.

High-speed cutting and hold ability
Designed to reduce clogging
Reduced heat generated at the incision site 3
Does not present heat buildup2




In both blocked and unblocked conditions, elliptical energy management maintains significantly cooler temperatures than the competitor handpiece.4

Specifications
COMPACT INTUITIV System
Handpiece

ELLIPS® FX Handpiece

Phaco Tips

Supports both curved and straight tips

Phaco Packs

FUSION OPO80 single-use disposable packs and OPO85 reusable packs

Footpedal

Advanced Linear Pedal

FOOTNOTES
*Change in pressure from steady state to post-occlusion surge trough

**Change in time from post-occlusion surge trough back to steady state


INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE COMPACT INTUITIVTM SYSTEM
Rx Only

INDICATIONS
The COMPACT INTUITIVTM System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Single-Use Pack is used with the COMPACT INTUITIVTM System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.



READ THE FOLLOWING SAFETY PRECAUTIONS AND WARNINGS CAREFULLY BEFORE YOU USE THE SYSTEM IN SURGERY
Do not use extension cords with your machine.
Do not overload your AC electrical outlet.
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 Johnson & Johnson Surgical Vision, Inc. customer service to order a new cord.
Do not block the openings as heat build-up can cause system failures that 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.
Do not block the air fans on the bottom of the console as heat build-up can cause system failures which can result in a fire hazard.
Do not try to roll the system cart on carpets or over objects on the floor such as cables and power cords.
Take care not to trip over the power cords and the foot pedal cords.
Do not place the instrument on uneven or sloped surfaces.
Only use disposables, accessories, or other surgical instruments designed for this system. Use only parts recommended by Johnson & Johnson Surgical Vision, Inc.to achieve the optimum performance and safety of the system.
Do not operate the system in a condensing environment. Take care to protect the instrument from fluid sprays or fluid buildup.
Do not exceed the maximum weight of 25 pounds (11.25 Kg) on the Programmable IV Pole bottle holder.
Do not use more than one IV pole extender with the IV pole.
If there is no IV pole attached to the system, hang the irrigation fluid container at least 77 cm from the patient’s eye.
To protect the patient from contaminated fluids or handpieces, use only:
sterile tubing sets
sterile irrigation fluid
sterile handpieces
Use caution when handling handpieces with sharp edges or pointed tips.
Wrap the excess power cord neatly around the cord wrap on the back of the IV pole or cart.
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 phacoemulsification. If you raise the bottle too high it can cause the anterior chamber to deepen. Note: Use a new bottle of irrigation 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 of the coaxial irrigation sleeve assembly on the needle of the phaco handpiece causes constriction.



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 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
The electrical connectors on the handpieces must be 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 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 might not work properly. The ultrasonic titanium phaco tip must never touch any solid material while in use. Always clear the handpiece of fluid immediately following surgery. See cleaning instructions in Chapter 7 "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 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 Vitrectomy handpieces, the tips should be in one of the following:

a test chamber filled with irrigating 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 handpiece operation. Be sure to read the handpiece package insert for correct assembly procedures and connection procedures.



Diathermy
When you select the Diathermy 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. Johnson & Johnson Surgical Vision, Inc. recommends 30% setting to 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 the maximum weight of 25 pounds (11.25 Kg) on the IV pole bottle holder.



Foot Pedal
Never handle the foot pedal by its power cord.

Do not place the foot pedal on a wet surface.



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