Phacoemulsification Packs

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE FUSION^® DUAL PUMP PACK (OPO73)
Rx Only

INDICATIONS
The DUAL PUMP Pack contains the tubing sets and manifold and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the WHITESTAR SIGNATURE^™ or WHITESTAR SIGNATURE^™ PRO Systems (“WHITESTAR SIGNATURE^™ System(s)”). The DUAL PUMP Pack is sterilized using ethylene oxide and is designed for single use only.

WARNINGS
Single use only. Do not re- sterilize, reprocess, or reuse this device.

PRECAUTIONS
Do not use product after its expiration date marked on product’s packaging labels. Contents are sterile when product tray is sealed with lid and undamaged. Do not resterilize and do not reuse. Only use this DUAL PUMP Pack with the WHITESTAR SIGNATURE Systems. Overall system performance may be impaired when used in combination with non-Johnson & Johnson Surgical Vision products. If product performance becomes compromised during use, discontinue use and perform the appropriate tests as detailed in the Operator’s Manual. If results are not satisfactory, replace the DUAL PUMP Pack according to instructions defined in the Operator’s Manual.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR MULTIPLE-USE PACK (OPO85)
Rx Only

INDICATIONS
The OPO85 is used with the COMPACT INTUITIV System. The OPO85 is sterilized using Ethylene Oxide and is designed for use up to 20 times. Following the first use, the user then follows cleaning and sterilization instructions specified below for up to 19 additional cleaning/sterilization cycles for a total of 20 uses when used according to the Instructions for Use.

CAUTION
Do not sterilize the OPO85 prior to performing the cleaning procedure described in OPO85 Directions for Use.

WARNINGS
Sterility assurance is the responsibility of the user. The use of gas resterilization is not recommended. If the OPO85 is received in an unsatisfactory condition, please contact your local JJSV Sales Office immediately. Each OPO85 is identified by a lot number and this should be included in any correspondence or discussions.

PRECAUTIONS
Contents are sterile when tray is sealed and undamaged. Only use the OPO85 with the COMPACT INTUITIV System. Overall system performance may be impaired when used in combination with non-AMO products. If product performance becomes compromised during use; discontinue use and perform the appropriate steps as detailed in the Operator’s Manual. If results are not satisfactory, replace the OPO85 according to instructions defined in the Operator’s Manual. Improper/inadequate cleaning may result in particulate matter adhering to the internal surfaces of the tubing and MANIFOLD. As a result, the functionality of OPO85 may become compromised. After a maximum of 20 uses (19 reuses), the OPO85 must be discarded. The OPO85 has not been tested past 20 uses. Always ensure proper COMPACT INTUITIV System settings are used with the OPO85. Only use approved OPO85 accessories.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE WHITESTAR SIGNATURE PRO SYSTEM
Rx Only

INDICATIONS
The WHITESTAR SIGNATURE PRO SYSTEM is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery. The modular design allows the users to configure the system to meet their surgical requirements.

WARNINGS
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. Do not modify the WHITESTAR SIGNATURE PRO SYSTEM. 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. DO NOT attempt to use the system if the system 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 and oxidizing agents. Make sure 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. Johnson & Johnson Surgical Vision, Inc. recommends the use of an antistatic mat for this purpose. Use proper handling and disposal methods for biohazards when you dispose of the fluidics pack, Mayo tray drape, and monitor drape. Make sure that the fluidics pack drain bag does not over-fill. The maximum capacity of the bag is 750 cc. Use caution when you extend, retract, or swivel the Mayo tray articulating arm. Stay clear of the hinged hardware. Do not modify the pole height or manually force the pole height because this could cause incorrect indication of bottle height and patient injury. Place monitoring electrodes or other types of equipment as far from those of the WHITESTAR SIGNATURE PRO 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 must 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 the system near conductive materials such as metal bed parts, inner spring mattresses, or similar items. Replace 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 environments. If exposed to a condensing environment, allow the 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.

DO NOT try to replace the batteries for the wireless remote control, the Advanced Control Pedal. Call your JJSV technical service representative to replace the batteries. DO NOT try to replace the wireless remote control batteries. Call your JJSV technical service representative to replace the batteries. 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 have the handpiece tip in the eye of the patient when you prime and tune the handpiece. Do not use non-JJSV approved products with the WHITESTAR SIGNATURE PRO SYSTEM, as this can affect overall system performance. JJSV cannot be responsible for system surgical performance if you use these products in surgery. This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the WHITESTAR SIGNATURE PRO SYSTEM or shielding the location. WHITESTAR SIGNATURE PRO SYSTEM needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. Portable and mobile RF communications equipment can affect WHITESTAR SIGNATURE PRO SYSTEM. The use of accessories, transducers and cables other than those specified by JJSV, may result in increased EMISSIONS or decreased IMMUNITY of the WHITESTAR SIGNATURE^® PRO. The WHITESTAR SIGNATURE PRO SYSTEM should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the WHITESTAR SIGNATURE PRO SYSTEM should be observed to verify normal operation in the configuration in which it will be used. Do not replace the Advanced Linear Pedal (ALP) battery when the pedal is attached to a power source. This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the WHITESTAR SIGNATURE PRO SYSTEM or shielding the location. WHITESTAR SIGNATURE PRO SYSTEM may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements. If you do not properly prime the I/A tubing, errors can occur.

SAFETY PRECAUTIONS
Read the following safety precautions and warnings carefully before you use the system in surgery. Do not use extension cords with your system. Do not overload your electrical receptacle (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 JJSV customer service to order a new cord. 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. Do not try to move the system cart on deep pile carpets or over objects on the floor such as cables and power cords. Take care not to trip over power and foot pedal cords. Do not try to lift the system console. Do not place the instrument on uneven or sloped surfaces. 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 JJSV. Do not operate the system in a condensing environment. Take care to protect the instrument from fluid sprays or fluid buildup. To protect the patient from contaminated fluids or handpieces, use only sterile tubing packs, sterile irrigation fluid, and sterile handpieces. Wrap the excess power cord neatly around the cord wrap on the back of the console. Use caution when you use handpieces with sharp edges or pointed tips. Always replace the tubing pack and the balanced salt solution bottle between cases.

CAUTIONS
Never attempt to straighten a bent needle. This might produce a broken tip when you apply ultrasound. Do not activate the phaco handpiece and vitrectomy cutter with the tip in the air. Exposure of the tip to air drastically reduces the useful life of the handpiece. If you introduce power to the phaco handpiece or vitrectomy cutter, the tip must be in a test chamber filled with balanced salt solution, in a container of balanced salt solution, or in the patient’s eye. If you do not hear a tone when you press the foot pedal and volume adjustment is unsuccessful, the mode is not functioning properly.

WARNINGS FOR CASA
System passwords are set only by JJSV Service personnel. Be sure to keep system passwords in a secure location. The connection to a WHITESTAR SIGNATURE PRO SYSTEM only provides a means to retrieve files from the System, and does not provide the means to send files back to the System. The CASA application will display a notification when the total storage capacity of the iPad device is less than 2 GB. It is important to note there is no patient data on the WHITESTAR SIGNATURE PRO SYSTEM, and no patient data is imported to the CASA application. Care must be taken when removing data from the iPad device. If the data is removed without having exported it in an email, there will be no way to import the data back into the iPad device.

ATTENTION
Reference the Directions for Use for a complete listing of indications, warnings, and precautions.
See Full Indications and Important Safety Information

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

1. Do not use extension cords 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 a fire hazard to the system. Call Johnson & Johnson Surgical Vision, Inc. customer service to order a new cord.
4. 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.
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 a fire 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.
8. 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 Johnson & Johnson Surgical Vision, Inc. to achieve the optimum performance and the safety of the system.
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 (11.25 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 handpiece 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 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; 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
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. Johnson & Johnson Surgical Vision, Inc. 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.
See Full Indications and Important Safety Information

IMPORTANT SAFETY INFORMATION FOR THE WHITESTAR SIGNATURE^™ PHACOEMULSIFICATION SYSTEM
Rx Only

INDICATIONS

The Johnson & Johnson Surgical Vision, Inc. WHITESTAR SIGNATURE Phacoemulsification System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements.
SAFETY PRECAUTIONS
Read the following Safety Precautions and Warnings carefully before you use the WHITESTAR SIGNATURE System in surgery. Risks and complications may include broken ocular capsule or corneal burn. The 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. 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 JJSV customer service to order a new cord. 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. Do not try to move the system cart on deep pile carpets or over objects on the floor such as cables and power cords. Take care not to trip over power and foot pedal cords. Do not try to lift the system console. Do not place the instrument on uneven or sloped surfaces. 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 JJSV. Do not operate the system in a condensing environment. Take care to protect the instrument from fluid sprays or fluid buildup. To protect the patient from contaminated fluids or handpieces, use only sterile tubing packs, sterile irrigation fluid, and sterile handpieces. Wrap the excess power cord neatly around the cord wrap on the back of the console. Use caution when you extend, retract, or swivel the Mayo stand articulating arm. Stay clear of the hinged hardware. Use caution when you use handpieces with sharp edges or pointed tips. Always replace the tubing pack between cases.

WARNINGS
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. The surgical staff must monitor the balanced salt solution bottle height and 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 tissue, An ultrasonic wound heating commonly called wound burn (extreme case). DO NOT attempt to use the system if the system 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, and 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 tubing pack, mayo stand drape, and monitor drape. Place monitoring electrodes or other types of equipment as far from those of the WHITESTAR SIGNATURE 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). The output power selected must 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 the system near conductive materials such as metal bed parts, inner spring mattresses, or similar items. Replace 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 environments. If exposed to a condensing environment, allow the 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. DO NOT try to replace the wireless remote control batteries. Call your JJSV technical service representative to replace the batteries. 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 WHITESTAR SIGNATURE System, as this can affect overall system performance.

JJSV cannot be responsible for system surgical performance if you use these products in surgery. VITRECTOMY: CAUTION: Do not activate the phaco handpiece and vitrectomy cutter with the tip in the air. Exposure of the tip to air drastically reduces the useful life of the handpiece. If you introduce power to the phaco handpiece or vitrectomy cutter, the tip must be in a test chamber filled with balanced salt solution, in a container of balanced salt solution, or in the patient’s eye. PHACO HANDPIECE SETUP CAUTION: Never attempt to straighten a bent needle. This might produce a broken tip when you apply ultrasound. CAUTION: Do not sterilize the handpieces prior to performing the cleaning procedures described in the Owner’s Manual. CAUTION: Do not clean the phaco handpiece with any type of ultrasonic cleaning device; the cleaning device can damage the piezoelectric crystals. WARNING: Improper/inadequate cleaning may result in particulate matter adhering to the instrument and exfoliation of particles into the surgical field. In addition, the function and life expectancy of the phaco handpiece can become compromised. WARNING: Handle the phaco handpiece with extreme care. The piezoelectric crystal in the handpiece is very sensitive to shock. If the handpiece is dropped, it is possible that the handpiece might not function correctly. If this happens, contact JJSV for repair information or replacement handpiece. 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. WARNING: The handpiece can deteriorate with the use of balanced salt solutions. Balanced salt solution tarnishes and pits metal. Proper cleaning of the instruments prolongs their useful life. JJSV recommends using sterile non pyrogenic water to clean the handpieces and accessories. STERILIZATION: CAUTION: JJSV does not recommend gas sterilization. CAUTION: Do not sterilize the handpieces prior to performing the cleaning procedures described in the Owner’s Manual. Do not place the storage cases provided in an autoclave. WARNING: Sterility assurance is the responsibility of the user. You must sterilize all non-sterile accessories prior to use. In addition, JJSV recommends a terminal sterilization cycle in the autoclave after the final case of the day. This cycle must include a drying cycle to remove moisture from the tubing and handpieces for storage. WARNING: Handle the phaco handpiece with extreme care. The piezoelectric crystal in the handpiece is very sensitive to shock. If you drop the handpiece, it is possible that the handpiece might not function correctly. If this happens, contact JJSV for repair information for the handpiece or a replacement handpiece. DIATHERMY: CAUTION: If you do not hear a tone when you press the foot pedal and volume adjustment is unsuccessful, the mode is not functioning properly. PRIME/TUNE: WARNING: If you do not properly prime the IA tubing, errors can occur. CAUTION: Do not activate the phaco handpiece and vitrectomy cutter with the tip in the air. Exposure of the tip to air drastically reduces the useful life of the handpiece. If you introduce power to the phaco handpiece or vitrectomy cutter, the tip must be in a test chamber filled with balanced salt solution, in a container of balanced salt solution, or in the patient’s eye. REMOTE CONTROL WARNING: DO NOT try to replace the Wireless Remote Control batteries. Call your JJSV Technical Service representative to replace the batteries.
See Full Indications and Important Safety Information

PP2023OTH5531