Stryker Sonopet iQ System - Operation and Setup

6.1.5 To Pair a Wireless Foot Pedal

Follow these steps to pair the wireless foot pedal with the console:

1. From the WIRELESS CONNECTION screen, touch the PAIR WIRELESS button.
2. Slide and hold the WIRELESS/ON/OFF power switch on the foot pedal to the PAIR WIRELESS position until the indicator lamps on the foot pedal blink.
3. Release the WIRELESS/ON/OFF power switch. The foot pedal indicator lamps will stop blinking to indicate a successful pairing.

NOTES:

• A green console port indicator confirms a successful connection.
• An amber console port ring indicator signifies an error condition. Low battery power (10 hours remaining) will also cause an error message. Refer to Section 11 for error message responses.

6.1.6 To Import or Export a Preset

Contact Stryker sales and service personnel to import or export presets. Refer to Section 1.3 Contact Information.

6.1.7 To View System Information

1. From the SYSTEM SETUP screen or HOME screen, touch the SETTINGS button.
2. From the system SETTINGS screen, touch the SYSTEM INFO (information) button.

System information includes component software revisions, component names, part numbers, and serial numbers. Information is displayed when a component is connected to the console.

NOTES:

• The technician (service) mode is access protected and only Stryker-authorized personnel may use this mode. Refer to Section 1.3 Contact Information.

6.1.8 To Manage the Presets

Presets allow users to save and recall specific power, suction, and irrigation settings.

NOTES:

• A DEFAULT preset is provided and cannot be edited, copied, or deleted.
• When the DEFAULT preset is selected, power, suction, and irrigation settings are provided by the installed tip and sleeve set.
• A maximum of 100 presets can be created.
• Preset names can be up to 30 characters long.

6.1.8.1 To Create a Preset

1. From the SYSTEM SETUP screen or HOME screen, touch the PRESET roll-up button.
2. Touch the CREATE NEW button.
3. Using the keyboard, enter the new preset name and touch the FORWARD button.
4. From the SELECT TIP screen, touch to select the desired tip for the preset.
5. From the preset SETTINGS screen, adjust and select the power, suction, irrigation, and Pulse Control settings for the selected tip.
6. Touch the CONFIRM button to save the preset and exit to the SELECT TIP screen.
7. After desired tips are selected and settings assigned, touch the BACK or HOME button to exit the SELECT TIP screen.

6.1.8.2 To Select a Preset

1. From the SYSTEM SETUP screen or HOME screen, touch the PRESET roll-up button.
2. Touch the desired preset to make a selection.
3. Touch the CONFIRM button to save the preset selection.

6.1.8.3 To Select a Favorite Preset

1. From the SYSTEM SETUP screen or HOME screen, touch the PRESET roll-up button.
2. Touch the desired preset to make a selection.
3. Touch the FAVORITE button to create a favorite preset.
4. Touch the CONFIRM button to save the preset as a favorite and exit the screen.

6.1.8.4 To Edit a Preset

1. From the SYSTEM SETUP screen or HOME screen, touch the PRESET roll-up button.
2. To edit a preset, touch and select the desired preset, then touch the EDIT button.

6.1.8.5 To Copy a Preset

1. From the SYSTEM SETUP screen or HOME screen, touch the PRESET roll-up button.
2. Touch the desired preset to be copied, then touch the COPY button.
3. Using the keyboard, edit the preset name and touch CONFIRM.

6.1.8.6 To Delete a Preset

1. From the SYSTEM SETUP screen or HOME screen, touch the PRESET roll-up button.
2. Touch the desired preset to be deleted, then touch the DELETE button.
3. From the confirmation pop-up, touch CONFIRM to delete the preset or CANCEL to cancel.

6.1.9 To Clean and Disinfect the Console

Refer to Section 7 Cleaning and Disinfection.

6.1.10 To Prepare the Foot Pedal

6.1.10.1 To Install or Replace the Batteries (Wireless Advanced Foot Pedal Only)

1. Turn the battery compartment knob to unlock and open the door.
2. Install two AA alkaline batteries into the battery compartment in the correct orientation.
3. Close the door and turn the knob to lock the battery compartment door.

6.1.10.2 To Clean and Disinfect the Foot Pedal

Refer to Section 7 Cleaning and Disinfection.

6.1.11 To Prepare the Handpiece

6.1.11.1 To Clean and Sterilize the Handpiece

WARNING: Clean and sterilize the equipment before first and every use. Refer to the Sonopet iQ Handpiece and Accessories Processing Instructions REF 5500-001-700.

6.1.12 To Prepare the Hand Controller (Optional)

Refer to Section 7 Cleaning and Disinfection.

6.2 Before the Procedure

WARNINGS:

• Upon initial receipt and before each use, ALWAYS clean and disinfect the console, foot pedal, and hand controller.
• Reusable handpieces are not shipped sterile. ALWAYS clean and sterilize the handpiece before first and every use. Refer to the Sonopet iQ Handpiece and Accessories Processing Instructions REF 5500-001-700.
• DO NOT use the equipment in areas with flammable anesthetics or flammable agents mixed with air, oxygen, or nitrous oxide.

NOTES:

• When connecting or disconnecting cables, grasp the connector or plug.
• Handpiece, foot pedal, and hand controller cables have keyed, push-pull connectors. DO NOT force a connector into a console port.
• Use connector alignment marks to orient and install cable connectors into console ports.

6.2.1 To Prepare the Console

6.2.1.1 To Connect Console Power

WARNING: ALWAYS connect the console to a hospital-grade, facility power receptacle with protective earth (ground) to avoid electrical shock.

NOTES:

• A Sonopet Cart may be used for a flat, sturdy surface.
• Ensure the console is outside the sterile field.
• Make sure the power cord can be easily removed.
• Ensure vent holes in the back and underside of the console are not covered.
• If equipotential grounding is used, connect the bonding cable to the console's equipotential lug and the facility grounding bus bar.

1. Put the console on a flat, sturdy surface near a hospital-grade power receptacle with protective earth ground.
2. Position the console so the power cord receptacle is easily accessed.
3. Connect the power cord to the console power receptacle and to a hospital-grade power receptacle with protective earth (ground).
4. Push the POWER button to turn ON the system. A SYSTEM SETUP screen will appear.

6.2.1.2 To Install the Fluid Waste Suction Canister

NOTES:

• A disposable fluid waste suction canister is used with the console. Refer to Section 3.3 For Use With.
• Adjust the suction canister holder on the Sonopet Cart for canister size.
• If the Sonopet Cart is not used, ensure the suction canister is placed below the console level.

1. Put the suction canister into the holder on the Sonopet cart.
2. Install the right-angle elbow connectors onto the ports of the suction canister lid.

6.2.1.3 To Hang the Collapsible Irrigation Container

WARNINGS:

• ALWAYS use a collapsible irrigation fluid container.
• DO NOT use a rigid, non-collapsible irrigation fluid container, as this may cause reduced irrigation flow and overheating.
• DO NOT use an irrigation fluid container that holds more than 1000 ml.

Suspend a collapsible irrigation fluid container (bag) from the console Irrigation pole.

6.2.2 To Connect the Foot Pedal

WARNING: Upon initial receipt and before each use, ALWAYS clean and disinfect the foot pedal.

NOTE: A wired or wireless foot pedal may be used. Refer to Section 3.3 For Use With.

1. If using a wired foot pedal, install the foot pedal cable connector into the console foot pedal port.
2. If using a wireless foot pedal, install the wireless receiver into the console foot pedal port.

NOTES:

• The foot pedal port ring indicator will blink green to confirm recognition of a wireless receiver and be solid green when the wireless receiver recognizes the wireless foot pedal.
• The foot pedal status symbol on the SYSTEM SETUP screen will change from white to green to confirm a successful connection.
• An amber foot pedal port ring indicator signifies an error condition. Refer to Section 11 for error message responses.

6.2.3 To Prepare the Handpiece

WARNINGS:

• Reusable handpieces are not shipped sterile. ALWAYS clean and sterilize a reusable handpiece before first and every use. Refer to the Sonopet iQ Handpiece and Accessories Processing Instructions REF 5500-001-700.
• ALWAYS handle the handpiece with care. DO NOT drop it.
• A spare, sterile handpiece is recommended for a surgical procedure. Immediate-use steam sterilization is NOT recommended.

6.2.3.1 To Transfer the Handpiece into the Sterile Field

1. Inspect the sterile barrier before transfer. Ensure it is not compromised.
2. Transfer the handpiece, torque wrench, and reusable cleaning wire into the sterile field.

6.2.3.2 To Connect the Handpiece to the Console (Outside Sterile Field)

1. Pass the connector end of the handpiece cable toward the console.
2. Install the handpiece cable connector into the console handpiece port.

NOTES:

• The handpiece port ring indicator and status symbol will change from white to green upon successful connection.
• The handpiece port ring indicator will blink green until a tip and sleeve set is installed.
• A HANDPIECE TIP SETUP button on the SYSTEM SETUP screen may be used to facilitate tip and sleeve set installation.
• An amber handpiece port ring indicator signifies an error condition. Refer to Section 11 for error message responses.

6.2.3.3 To Transfer a Tip and Sleeve into the Sterile Field

WARNINGS:

• A tip and sleeve set is terminally sterilized using ethylene oxide. Visually inspect the package for damage and sterile barrier integrity before use. DO NOT use if damaged, the sterile barrier is compromised, or the package is opened unintentionally.
• After opening, discard any unused tip and sleeve set. DO NOT reuse, reprocess, resterilize, or repackage.

NOTES:

• Some products use a single or double sterile barrier configuration.
• Aseptic transfer methods include open and drop/dump, or open and offer/pick.

1. Inspect the packaging for damage before transfer. Ensure the sterile barrier is not compromised.
2. Peel the outer package lid to open and transfer the inner package into the sterile field.
3. Peel the inner package lid to open and remove the tip and sleeve from packaging.
4. Inspect the tip and sleeve set for any apparent damage. DO NOT use if damage is apparent. Refer to Section 6.3.7.
5. Properly dispose of the frangible section in an appropriate container. Refer to Section 13 Disposal/Recycle.

6.2.3.4 To Install a Tip and Sleeve on the Handpiece

CAUTION: DO NOT under torque or over torque the tip. Ensure the torque wrench handle pivots correctly and does not exceed 90 degrees to prevent damage to threads and loss of power.

NOTES:

• Use the 7 mm step torque wrench REF 5450-800-039.
• Ensure the tip and sleeve set is assembled correctly.
• Ensure the arrow on the torque wrench head is oriented correctly.
• When installing the torque wrench head onto the tip flats, ensure the mark on the bottom of the torque wrench handle faces the tip end.

1. Manually install the tip into the handpiece finger tight.
2. Install the torque wrench head onto the tip flats.
3. Using the torque wrench, apply rotational force in the direction of the arrow. Stop tightening the tip as illustrated.
4. Remove the torque wrench in the torqued position from the tip.
5. Slide the sleeve over the tip. Push the sleeve into the handpiece until it stops.

NOTES:

• The tip status symbol will change from white to green upon successful connection.
• The tip name will appear on the display screen after the tip sleeve is installed successfully.

6.2.3.4.1 To Remove the Frangible Section of a Tip Sleeve (optional)

WARNINGS:

• If the sleeve frangible section is removed, ALWAYS apply optimal irrigation to the tip during use to prevent excessive heat and thermal damage.
• Ensure the removal of the frangible section results in a clean break with no cracks or sharp edges.

CAUTION: Ensure the removal of the frangible section is performed away from the surgical site.

NOTES:

• Removing the frangible section increases tip exposure and may improve line of sight.
• Removing the frangible section may result in increased irrigation dispersion.
• Removing the frangible section may result in excessive misting at the tip.
• The frangible section is designed to be removed by hand with a levering, prying, twisting force or motion.

1. Remove the sleeve from the handpiece.
2. Grasp the sleeve close to the frangible section perforation.
3. Applying force, remove the frangible section from the distal end of the sleeve.
4. Inspect the end of the sleeve for cracks or sharp edges.
5. Properly dispose of the frangible section.

6.2.3.5 To Confirm a Tip and Sleeve Installation

NOTES:

• The power, suction, and irrigation default setting values assigned to a tip and sleeve set are displayed on the console screen. Pulse Control settings are not assigned.
• The Pulse Control default setting value will also be displayed if activated.
• Ensure the tip and sleeve set information and settings displayed on the console agree with your application requirements.
• If the console detects a tip without a tip aspiration port, the suction control and SYNC mode button on the display screen are disabled.

6.2.4 To Install the Irrigation Suction Cassette

WARNINGS:

• The irrigation suction cassette is terminally sterilized using ethylene oxide. Inspect packaging before use. DO NOT use if packaging is open or damaged.
• Inspect each component for damage before use. DO NOT use any component if damage is apparent.

NOTES:

• A disposable cleaning wire is supplied for clearing clogged handpiece and/or tip.
• Ensure a cleaning wire is readily available.

6.2.4.1 To Transfer the Irrigation Suction Cassette into the Sterile Field

NOTES:

• Outer packaging allows two methods of aseptic transfer: (1) open and drop/dump or (2) open and offer/pick.
• Inner packaging also allows aseptic transfer: open and offer/pick.

1. Inspect packaging for damage before transfer. Ensure the sterile barrier is not compromised.
2. Peel the outer package lid to open and transfer the inner package into the sterile field.
3. Peel the inner package lid to open and remove the cassette tubing bundles.
4. Inspect the packaging for any damage. DO NOT use if damage is apparent.
5. Pass the tubing bundle with the cassette, irrigation spike, and suction canister connectors outside the sterile field toward the console.
6. Remove the paper securing the cassette tubing bundle and separate the bundle.
7. Ensure the handpiece tubing connector bundle remains in the sterile field.

6.2.4.2 To Connect the Suction Canister, Cassette, and Irrigation Tubing (Outside Sterile Field)

NOTES:

• The disposable suction canister may be installed on the Sonopet Cart or in a secure location below the console.
• An irrigation pole may be installed onto the console or nearby. Refer to Section 6.1.2.

1. Connect the suction tube connector marked VACUUM to the suction canister port marked VACUUM.
2. Connect the suction tube connector marked PATIENT to the suction canister port marked PATIENT.
3. Ensure all unused suction canister ports are closed.

NOTE: An optional specimen collector may be used with the suction canister.

1. Using the TOP and ARROW symbols on the cassette, insert the cassette into the console until an audible click is heard.
2. Remove the protective cover from the irrigation tubing spike.
3. Insert the irrigation tubing spike into the port of the collapsible irrigation fluid container or bag.

6.2.4.3 To Connect the Handpiece Tubing Connector (Inside Sterile Field)

CAUTION: Use care when attaching handpiece cable clips to the handpiece cable to prevent damage to surgical gloves.

1. Remove the paper band securing the handpiece tubing connector bundle and the disposable cleaning wire. Keep the disposable cleaning wire for use during the procedure.
2. Separate the tubing bundle and attach the handpiece tubing connector to the end of the handpiece. Ensure the handpiece cable is inserted into the handpiece tubing connector groove.
3. Using the four handpiece cable clips, attach the handpiece cable to the tubing.

WARNINGS:

• ALWAYS initially fill or prime the irrigation tubing connected to the handpiece with irrigation fluid. Failure to comply may result in excessive heat and thermal damage to tissue.
• DO NOT use ultrasonic power without irrigation fluid flowing from the tip of the handpiece.

NOTES:

• After successful connection of the handpiece, tip, and irrigation suction cassette, the INITIAL PRIME button will appear on the SYSTEM SETUP screen.
• During priming, the irrigation tubing is filled with irrigation fluid.
• If power is lost or interrupted and then applied after successful installation of all system components, a quick start confirmation pop-up will appear. Touch the INITIAL PRIME button. Ensure irrigation fluid is present at the tip.

6.2.5 To Fill (Prime) the Irrigation Tubing

1. From the SYSTEM SETUP screen, touch the INITIAL PRIME button.
2. Make sure irrigation fluid is present at the tip.

6.2.6 To Connect the Hand Controller (Optional)

WARNINGS:

• Upon initial receipt and before each use, ALWAYS clean and disinfect the hand controller.
• DO NOT put a connected hand controller on a patient.
• ALWAYS use a sterile drape when using a hand controller in a sterile field. Ensure the sterile drape covers the hand controller cord used within the sterile field. Failure to comply may lead to infection and patient injury.

NOTE: The hand controller is used to adjust console settings inside the sterile field, including ultrasonic power, irrigation, and suction. A handpiece irrigation flush may also be initiated.

1. Install the hand controller cable connector into the console port.
2. Transfer the sterile drape into the sterile field.
3. Open the sterile drape within the sterile field.
4. Pass the hand controller housing body into the sterile field and into the sterile drape.
5. Cover the length of the hand controller cord in the sterile field with the sterile drape. Secure the end of the sterile drape to the hand controller cord.

NOTES:

• The hand controller port ring indicator will change from white to green to confirm a successful connection.
• An amber hand controller port ring indicator signifies an error condition. Refer to Section 11 for error message responses.

6.2.7 To Test the Handpiece Before Use

NOTES:

• Touch the PRIMING button, if necessary, to stop the filling of the irrigation tubing.
• If there is insufficient or excessive irrigation fluid during initial priming, refer to Section 10 Troubleshooting.
• Once all required system components are installed and initial priming is complete, the HOME screen appears, and the system is ready for use.

Test the operation of the handpiece for 10 to 15 seconds. If there are any unusual sounds or vibration, refer to Section 10 Troubleshooting. To respond to error messages, refer to Section 11 Pop-up Codes, Messages, and Corrective Actions.

6.3 During the Procedure

WARNING: DO NOT service or repair this equipment during a procedure with a patient.

NOTES:

• DO NOT touch the console display screen with any sharp or hard object.
• To create presets, refer to Section 6.1.8.1.
• To respond to error messages, refer to Section 11 Pop-up Codes, Messages, and Corrective Actions and Section 10 Troubleshooting.

6.3.1 To Operate the Handpiece

WARNINGS:

• Continuous cutting at higher power settings may result in excessive heat and thermal damage to tissue. Refer to Table 20 Tip and Sleeve Duty Cycle and Section 16 Glossary.
• DO NOT touch the exposed tip when applying ultrasonic power.
• DO NOT put a connected handpiece on a patient.
• DO NOT strike the tip against a surgical instrument when applying ultrasonic power.
• DO NOT apply excessive force or side loading on the tip or tip sleeve during handpiece use. Failure to comply may cause the handpiece and/or tip and tip sleeve to overheat.

CAUTION: ALWAYS operate the handpiece within the specified environmental condition values. Refer to Section 14 Specifications.

NOTES:

• The characteristics of handpiece operation depend on the mode of operation. Refer to Table 21 and Table 22.
• To activate the handpiece, ensure the suction level is greater than zero percent. Handpiece output is disabled if suction level is zero.
• Suction is not available (or necessary) when using a tip without an aspiration port.
• To activate the handpiece, push down on the foot pedal treadle to apply ultrasonic power, suction, and irrigation to the surgical site.

6.3.2 To Flush the Irrigation Tubing

1. To provide additional irrigation fluid to the tip, touch and hold the FLUSH button.
2. Release the FLUSH button to stop irrigation fluid flow to the tip.

NOTE: A FLUSH button is located on the console touchscreen, foot pedal, and hand controller. Refer to Section 3.4.4 and Section 3.4.5.

6.3.3 To Adjust Power, Suction, Irrigation, and Pulse Control (optional) Setting Values

WARNINGS:

• Low irrigation settings (below 15 mL/min) may increase the risk of thermal damage to tissue.
• DO NOT use insufficient irrigation flow. Failure to comply may result in excessive heat and thermal damage to tissue.
• DO NOT use ultrasonic power without irrigation fluid flowing from the tip of the handpiece.
• DO NOT put a connected hand controller on a patient.

CAUTION: DO NOT use excessive irrigation flow. Failure to comply may reduce the visibility of the surgical site.

NOTES:

• The hand controller is used to adjust console settings inside the sterile field, including ultrasonic power, irrigation, and suction. A handpiece irrigation flush may also be initiated.
• Optional Pulse Control settings must be adjusted from the console touchscreen. Changing Pulse Control settings may result in a change in vibrational feel of the handpiece.

6.3.4 To Restore the Settings

If any preset values are modified on the HOME screen, a RESTORE button appears. Touch the RESTORE button to return to the original preset values.

6.3.5 To Change a Preset Selection

Refer to Section 6.1.8 To Manage the Presets.

6.3.6 To Clear a Clogged Tip

NOTES:

• A disposable cleaning wire is supplied with the irrigation suction cassette. A reusable cleaning wire is an optional accessory.
• To help prevent tip clogging during intermittent or delayed use, periodically place the tip into sterile irrigation fluid with suction on.
• If there is insufficient suction or excessive misting at the end of the tip, refer to Section 10 Troubleshooting.

1. Insert a cleaning wire into the tip aspiration port and handpiece suction lumen to dislodge and remove debris.
2. Inspect the tip aspiration port and suction tubing to confirm the removal of debris.

6.3.7 To Inspect a Tip and Tip Sleeve

NOTES:

• Inspect the tip and sleeve set for damage or signs of wear. DO NOT use a damaged or worn tip or tip sleeve during a procedure.
• Ensure the tip and tip sleeve are not bent, scratched, or cracked.
• Ensure no part of the tip and tip sleeve is broken or missing.
• If the tip has a pre-aspiration hole, ensure the hole is not exposed when the tip sleeve is installed.

6.3.8 To Replace a Tip and Sleeve Set

Replace a tip and sleeve set using the step torque wrench REF 5450-800-039. Refer to Section 6.2.3.3.

6.3.9 To Enable or Disable the Handpiece Power Indicator

Touch the HANDPIECE POWER INDICATOR button to enable or disable the audible handpiece power indicator. The default setting is OFF (muted).

6.3.10 To Change a System Setting

Refer to Section 6.1.3 To Manage Settings.

6.4 After the Procedure

NOTE: Before removing power and system components, use suction to empty the irrigation suction cassette tubing of any visible solid or liquid waste.

6.4.1 To Remove Power

CAUTION: Some power cords have a locking mechanism. To remove, slide back the red locking tab.

1. Push the power button to turn OFF system power.
2. Disconnect the power cord from the console power receptacle and the hospital-grade power receptacle.
3. If used, disconnect the equipotential bonding cable from the console and the facility grounding bus bar.

6.4.2 To Remove System Components

WARNINGS:

• ALWAYS follow local regulations for proper handling and disposal of biohazard waste. Failure to comply may cause environmental contamination and injury.
• ALWAYS follow local regulations for proper handling and disposal of sharps.
• DO NOT reuse, reprocess, or repackage single-use items such as tip and sleeve sets, irrigation suction cassettes, sterile drapes, or suction canisters.
• Single-use devices may not withstand chemical, chemical vapor, or high-temperature sterilization reprocessing.
• Design features may make cleaning difficult. Reuse may create contamination risks and compromise structural integrity.
• Critical product information may be lost during repackaging.

Failure to comply may lead to infection or cross-infection and result in patient and/or healthcare staff injury.

Table 23 - Reusable Components to Keep and Components to Discard