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INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE COMPACT INTUITIV SYSTEM
CAUTION: US Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner.
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 AMO 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 AMO 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.
- 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 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.
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.
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.
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. AMO 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.
Never handle the foot pedal by its power cord.
Do not place the foot pedal on a wet surface.
- 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. AMO 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. AMO 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: AMO 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-AMO approved products with the COMPACT INTUITIV System, as this can affect overall system performance. AMO cannot be responsible for system surgical performance if you use these products in surgery.
CONTRAINDICATIONS AND ADVERSE EVENTS: Risks and complications may include broken ocular capsule or corneal burn. Prior to use, please refer to the COMPACT INTUITIV System Owner’s Manual for more information on intended use, warnings, and precautions.