COMPACT INTUITIV System

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

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

Alcon, Inc. is a trademark of Novartis AG.

REFERENCES

1. Data on File. Johnson & Johnson Surgical Vision, Inc., 2016 DOF2016CT0035.
2. Schmutz JS, Olson RJ. Thermal comparison of Infiniti OZil and Signature Ellips phacoemulsification systems. Am J Ophthalmol. 2010 May; 149:5(762-7).
3. Floyd M, Valentine J, et al. (2006) Effect of incisional friction and ophthalmic viscosurgical devices on the heat generation of ultrasound during cataract surgery. J Cataract Refract Surg, 32, 1222-1226.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE COMPACT INTUITIV SYSTEM

Rx Only

INDICATIONS

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. The Single-Use Pack is used with the COMPACT INTUITIV 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 the 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 maximum weight of 25 pounds (11.25 Kg) on the Programmable IV Pole bottle holder.
• o 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 handpiece 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 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 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

It is very important that the electrical connectors on the handpieces 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 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 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.

WARNINGS

All personnel should read and understand the instructions in the COMPACT INTUITIV System operator’s 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. 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. 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 (IOP) 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). DO NOT attempt to use the system if it fails to perform properly as stated in this manual. 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. 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. The patient must not come into contact with grounded metal parts or metal parts that have appreciable capacitance to ground. JJSV recommends the use of an antistatic mat for this purpose. Use proper handling and disposal methods for biohazards when you dispose of the Single-Use Pack, Mayo stand cover, and monitor cover. Follow good operating room procedures to prevent injury or contamination. Use caution when you extend, retract, or swivel the Mayo stand articulating arm. Stay clear of the hinged hardware. Make sure that you unlock the wheels before you move the cart. Make sure that the wheels move freely when moving the cart. Place monitoring electrodes or other types of equipment as far from those of the COMPACT INTUITIV System as possible. JJSV recommends high current limiting devices for the protection of such systems. Do not use needle monitoring electrodes. 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. The output power selected should be as low as possible for the intended purpose. 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. 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: JJSV recommends that you check the condition of all interconnecting and handpiece cables on a regular basis. 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. Hazardous electrical output. This equipment is for use only by qualified personnel. Disconnect the power before you service the equipment. Remove the power cord from the power outlet when the equipment is not in use. Do not obstruct the power outlet so you can readily remove the power cord. Not recommended for use in condensing environment. If exposed to condensing environment, allow system to equilibrate to typical operating room conditions prior to use. You do not need to use a NEUTRAL ELECTRODE with this HIGH FREQUENCY (HF) SURGICAL EQUIPMENT. Failure of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT could result in an unintended increase of output power. Sterility assurance is the responsibility of the user. You must sterilize all non-sterile accessories prior to use. 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. Do not use non-JJSV approved products with the COMPACT INTUITIV System, as this can affect overall system performance. JJSV cannot be responsible for system surgical performance if you use these products in surgery.

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PP2023CT5087